The feasibility and benefit of a brief psychosocial intervention in addition to early palliative care in patients with advanced cancer to reduce depressive symptoms: a pilot randomized controlled clinical trial.

PubMed

do Carmo, Thamires Monteiro; Paiva, Bianca Sakamoto Ribeiro; de Oliveira, Cleyton Zanardo; Nascimento, Maria Salete de Angelis; Paiva, Carlos Eduardo

2017-08-23

The aim of this study was to assess the feasibility and potential benefit of a brief psychosocial intervention based on cognitive-behavioral therapy performed in addition to early palliative care (PC) in the reduction of depressive symptoms among patients with advanced cancer. An open-label randomized phase II clinical trial with two intervention arms and one control group. Patients with advanced cancer starting palliative chemotherapy and who met the selection criteria were included. The participants were randomly allocated to three arms: arm A, five weekly sessions of psychosocial intervention combined with early PC; arm B, early PC only; and arm C, standard cancer treatment. Feasibility was investigated by calculating rates (%) of inclusion, attrition, and contamination (% of patients from Arm C that received PC). Scores of depression (primary aim), anxiety, and quality of life were measured at baseline and 45, 90, 120, and 180 days after randomization. From the total of 613 screened patients (10.3% inclusion rate), 19, 22, and 22 patients were allocated to arms A, B, and C, respectively. Contamination and attrition rates (180 days) were 31.8% and 38.0%, respectively. No interaction between the arms and treatments were found. Regarding effect sizes, there was a moderate benefit in arm A over arms B and C in emotional functioning (-0.66 and -0.61, respectively) but a negative effect of arm A over arm C in depression (-0.74). Future studies to be conducted with this population group need to revise the eligibility criteria and make them less restrictive. In addition, the need for arm C is questioned due to high contamination rate. The designed psychosocial intervention was not able to reduce depressive symptoms when combined with early PC. Further studies are warrant to evaluate the intervention on-demand and in subgroups of high risk of anxiety/depression. Clinical Trials identifier NCT02133274 . Registered May 6, 2014.

The Effect of Single or Repeated Home Visits on the Hanging and Use of Insecticide-Treated Mosquito Nets following a Mass Distribution Campaign - A Cluster Randomized, Controlled Trial

PubMed Central

Kilian, Albert; Balayo, Connie; Feldman, Mitra; Koenker, Hannah; Lokko, Kojo; Ashton, Ruth A.; Bruce, Jane; Lynch, Matthew; Boulay, Marc

2015-01-01

Background Study objective was to evaluate the effectiveness of commonly used post-campaign hang-up visits on the hanging and use of campaign nets. Methods A cluster-randomized trial was carried out in Uganda following an ITN distribution campaign. Five clusters (parishes, consisting of ∼11 villages each) were randomly selected for each of the three study arms with between 7,534 and 9,401 households per arm. Arm 1 received one hang-up visit, while Arm 2 received two visits by volunteers four and seven months after the campaign. Visits consisted of assistance hanging the net and education on net use. The control arm was only exposed to messages during the campaign itself. Three cross-sectional surveys with a two-stage cluster sampling design, representative of the study populations, were carried out to capture the two key outcome variables of net hanging and ITN use. Sample size was calculated to detect at least a 15 percentage-points change in net use, and was 1811 at endline. The analysis used an intention-to-treat approach. Findings Both hanging and use of ITN increased during follow-up in a similar way in all three study arms. The proportion of the population using an ITN the previous night was 64.0% (95% CI 60.8, 67.2), for one additional visit, 68.2% (63.8, 72.2) for two visits and 64.0% (59.4, 68.5) for the control. The proportion of households with all campaign nets hanging increased from 55.7% to 72.5% at endline (p<0.0005 for trend), with no difference between study arms. Financial cost per household visited was estimated as USD 2.33 for the first visit and USD 2.24 for the second. Conclusions Behavior change communication provided during the campaign or through other channels was sufficient to induce high levels of net hanging and use and additional “hang-up” activities were not cost-effective. PMID:25774676

Evidence-based narratives to improve recall of opioid prescribing guidelines: a randomized experiment.

PubMed

Kilaru, Austin S; Perrone, Jeanmarie; Auriemma, Catherine L; Shofer, Frances S; Barg, Frances K; Meisel, Zachary F

2014-03-01

Physicians adopt evidence-based guidelines with variable consistency. Narratives, or stories, offer a novel dissemination strategy for clinical recommendations. The study objective was to compare whether evidence-based narrative versus traditional summary improved recall of opioid prescribing guidelines from the American College of Emergency Physicians (ACEP). This was a prospective, randomized controlled experiment to compare whether narrative versus summary promoted short-term recall of six themes contained in the ACEP opioid guideline. The experiment was modeled after the free-recall test, an established technique in studies of memory. At a regional conference, emergency physicians (EPs) were randomized to read either a summary of the guideline (control) or a narrative (intervention). The fictional narrative was constructed to match the summary in content and length. One hour after reading the text, participants listed all content that they could recall. Two reviewers independently scored the responses to assess recall of the six themes. The primary outcome was the total number of themes recalled per participant. Secondary outcomes included the proportion of responses in each study arm that recalled individual themes and the proportion of responses in each arm that contained falsely recalled or extraneous information. Ninety-five physicians were randomized. Eighty-two physicians completed the experiment, for a response rate of 86%. The mean of the total number of themes recalled per participant was 3.1 in the narrative arm versus 2.0 in the summary arm (difference = 1.1, 95% confidence interval [CI] = 0.6 to 1.7). For three themes, the proportion of responses that recalled the theme was significantly greater in the narrative arm compared to the summary arm, with the differences ranging from 20% to 51%. For one theme, recall was significantly greater in the summary arm. For two themes, there was no statistically significant difference in recall between the arms. In the summary arm, 54% of responses were found to contain falsely recalled or extraneous information versus 21% of responses in the narrative arm (difference = 33%, 95% CI = 14% to 53%). Physicians exposed to a narrative about opioid guidelines were more likely to recall guideline content at 1 hour than those exposed to a summary of the guidelines. Future studies should examine whether the incorporation of narratives in dissemination campaigns improves guideline adoption and changes clinical practice

Evidence-based Narratives to Improve Recall of Opioid Prescribing Guidelines: A Randomized Experiment

PubMed Central

Kilaru, Austin S.; Perrone, Jeanmarie; Auriemma, Catherine L.; Shofer, Frances S.; Barg, Frances K.; Meisel, Zachary F.

2014-01-01

Objectives Physicians adopt evidence-based guidelines with variable consistency. Narratives, or stories, offer a novel dissemination strategy for clinical recommendations. The study objective was to compare whether evidence-based narrative versus traditional summary improved recall of opioid prescribing guidelines from the American College of Emergency Physicians (ACEP). Methods This was a prospective, randomized controlled experiment to compare whether narrative versus summary promoted short-term recall of six themes contained in the ACEP opioid guideline. The experiment was modeled after the free-recall test, an established technique in studies of memory. At a regional conference, emergency physicians were randomized to read either a summary of the guideline (control) or a narrative (intervention). The fictional narrative was constructed to match the summary in content and length. One hour after reading the text, participants listed all content that they could recall. Two reviewers independently scored the responses to assess recall of the six themes. The primary outcome was the total number of themes recalled per participant. Secondary outcomes included the proportion of responses in each study arm that recalled individual themes and the proportion of responses in each arm that contained falsely recalled or extraneous information. Results Ninety-five physicians were randomized. Eighty-two physicians completed the experiment, for a response rate of 86%. The mean of the total number of themes recalled per participant was 3.1 in the narrative arm versus 2.0 in the summary arm (difference = 1.1, 95% confidence interval [CI] = 0.6 to 1.7). For three themes, the proportion of responses that recalled the theme was significantly greater in the narrative arm compared to the summary arm, with the differences ranging from 20% to 51%. For one theme, recall was significantly greater in the summary arm. For two themes, there was no statistically significant difference in recall between the arms. In the summary arm, 54% of responses were found to contain falsely recalled or extraneous information versus 21% of responses in the narrative arm (difference = 33%, 95% CI = 14% to 53%). Conclusions Physicians exposed to a narrative about opioid guidelines were more likely to recall guideline content at 1 hour than those exposed to a summary of the guidelines. Future studies should examine whether the incorporation of narratives in dissemination campaigns improves guideline adoption and changes clinical practice. PMID:24761456

Social Norms and Financial Incentives to Promote Employees’ Healthy Food Choices: A Randomized Controlled Trial

PubMed Central

Thorndike, Anne N.; Riis, Jason; Levy, Douglas E.

2016-01-01

Population-level strategies to improve healthy food choices are needed for obesity prevention. We conducted a randomized controlled trial of 2,672 employees at Massachusetts General Hospital who were regular customers of the hospital cafeteria with all items labeled green (healthy), yellow (less healthy), or red (unhealthy) to determine if social norm (peer-comparison) feedback with or without financial incentives increased employees’ healthy food choices. Participants were randomized in 2012 to three arms: 1) monthly letter with social norm feedback about healthy food purchases, comparing employee to “all” and to “healthiest” customers (feedback-only); 2) monthly letter with social norm feedback plus small financial incentive for increasing green purchases (feedback-incentive); or 3) no contact (control). The main outcome was change in proportion of green-labeled purchases at end of 3-month intervention. Post-hoc analyses examined linear trends. At baseline, the proportion of green-labeled purchases (50%) did not differ between arms. At end of the 3-month intervention, the percentage increase in green-labeled purchases was larger in the feedback-incentive arm compared to control (2.2% vs. 0.1%, P=0.03), but the two intervention arms were not different. The rate of increase in green-labeled purchases was higher in both feedback-only (P=0.04) and feedback-incentive arms (P=0.004) compared to control. At end of a 3-month wash-out, there were no differences between control and intervention arms. Social norms plus small financial incentives increased employees’ healthy food choices over the short-term. Future research will be needed to assess the impact of this relatively low-cost intervention on employees’ food choices and weight over the long-term. Trial Registration: Clinical Trials.gov NCT01604499 PMID:26827617

Social norms and financial incentives to promote employees' healthy food choices: A randomized controlled trial.

PubMed

Thorndike, Anne N; Riis, Jason; Levy, Douglas E

2016-05-01

Population-level strategies to improve healthy food choices are needed for obesity prevention. We conducted a randomized controlled trial of 2672 employees at the Massachusetts General Hospital who were regular customers of the hospital cafeteria with all items labeled green (healthy), yellow (less healthy), or red (unhealthy) to determine if social norm (peer-comparison) feedback with or without financial incentives increased employees' healthy food choices. Participants were randomized in 2012 to three arms: 1) monthly letter with social norm feedback about healthy food purchases, comparing employee to "all" and to "healthiest" customers (feedback-only); 2) monthly letter with social norm feedback plus small financial incentive for increasing green purchases (feedback-incentive); or 3) no contact (control). The main outcome was change in proportion of green-labeled purchases at the end of 3-month intervention. Post-hoc analyses examined linear trends. At baseline, the proportion of green-labeled purchases (50%) did not differ between arms. At the end of the 3-month intervention, the percentage increase in green-labeled purchases was larger in the feedback-incentive arm compared to control (2.2% vs. 0.1%, P=0.03), but the two intervention arms were not different. The rate of increase in green-labeled purchases was higher in both feedback-only (P=0.04) and feedback-incentive arms (P=0.004) compared to control. At the end of a 3-month wash-out, there were no differences between control and intervention arms. Social norms plus small financial incentives increased employees' healthy food choices over the short-term. Future research will be needed to assess the impact of this relatively low-cost intervention on employees' food choices and weight over the long-term. Clinical Trials.gov: NCT01604499. Copyright © 2016 Elsevier Inc. All rights reserved.

A prospective randomized controlled trial comparing early postoperative complications in patients undergoing loop colostomy with and without a stoma rod.

PubMed

Franklyn, J; Varghese, G; Mittal, R; Rebekah, G; Jesudason, M R; Perakath, B

2017-07-01

A stoma rod or bridge has been traditionally placed under the bowel loop while constructing a loop colostomy. This is believed to prevent stomal retraction and provide better faecal diversion. However, the rod can cause complications such as mucosal congestion, oedema and necrosis. This single-centre prospective randomized controlled trial compared outcomes after creation of loop colostomy with and without a supporting stoma rod. The primary outcome studied was stoma retraction rate; other stoma-related complications were studied as secondary outcomes. One hundred and fifty-one patients were randomly allotted to one of two arms, colostomy with or without a supporting rod. Postoperative complications such as retraction, mucocutaneous separation, congestion and re-exploration for stoma-related complications were recorded. There was no difference in the stoma retraction rate between the two arms (8.1% in the rod arm and 6.6% in the no-rod arm; P = 0.719). Stomal necrosis (10.7% vs 1.3%; P = 0.018), oedema (23% vs 3.9%; P = 0.001), congestion (20.3% vs 2.6%; P = 0.001) and re-admission rates (8.5% vs 0%; P = 0.027) were significantly increased in the arm randomized to the rod. The stoma rod does not prevent stomal retraction. However, complication rates are significantly higher when a stoma rod is used. Routine use of a stoma rod for construction of loop colostomy can be avoided. Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

Efficacy of Topical Alpha Ointment (Containing Natural Henna) Compared to Topical Hydrocortisone (1%) in the Healing of Radiation-Induced Dermatitis in Patients with Breast Cancer: A Randomized Controlled Clinical Trial

PubMed Central

Ansari, Mansour; Dehsara, Farzin; Mosalaei, Ahmad; Omidvari, Shapour; Ahmadloo, Niloofar; Mohammadianpanah, Mohammad

2013-01-01

Background: This two-arm, randomized clinical study aimed to compare efficacy between topical Alpha ointment and topical hydrocortisone cream (1%) in the healing of radiation-induced dermatitis in breast cancer patients. Methods: The inclusion criteria comprised newly pathologically proven, locally advanced breast cancer (treated with modified radical mastectomy followed by sequential adjuvant treatments, including chest wall radiotherapy [45-50.4 Gy]) and grade 2 and/or 3 chest wall dermatitis. The exclusion criteria were comprised of any underlying disease or medications interfering with the wound healing process, previous history of chest wall radiotherapy, and concurrent use of chemotherapy. Sixty eligible patients were randomly assigned to use either topical Alpha ointment (study arm, n=30) or topical hydrocortisone cream (1%) (control arm, n=30) immediately after receiving a total dose of 45-50 Gy chest wall radiotherapy. Results: The mean radiation dose was 49.1 Gy in the control arm and 48.8 Gy in the study arm. The mean dermatitis area was 13.54 cm2 in the control arm and 17.02 cm2 in the study arm. Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) (P=0.001). This effect was significant in the second week (P=0.007). In addition, Alpha ointment decreased the patients’ complaints such as pain (P<0.001), pruritus (P=0.009), and discharge (P=0.010) effectively and meaningfully. Conclusion: Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) in our patients with breast cancer. Trial Registration Numbers: IRCT201206099979N1, ACTRN12612000837820 PMID:24293782

Efficacy of topical alpha ointment (containing natural henna) compared to topical hydrocortisone (1%) in the healing of radiation-induced dermatitis in patients with breast cancer: a randomized controlled clinical trial.

PubMed

Ansari, Mansour; Farzin, Dehsara; Mosalaei, Ahmad; Omidvari, Shapour; Ahmadloo, Niloofar; Mohammadianpanah, Mohammad

2013-12-01

This two-arm, randomized clinical study aimed to compare efficacy between topical Alpha ointment and topical hydrocortisone cream (1%) in the healing of radiation-induced dermatitis in breast cancer patients. The inclusion criteria comprised newly pathologically proven, locally advanced breast cancer (treated with modified radical mastectomy followed by sequential adjuvant treatments, including chest wall radiotherapy [45-50.4 Gy]) and grade 2 and/or 3 chest wall dermatitis. The exclusion criteria were comprised of any underlying disease or medications interfering with the wound healing process, previous history of chest wall radiotherapy, and concurrent use of chemotherapy. Sixty eligible patients were randomly assigned to use either topical Alpha ointment (study arm, n=30) or topical hydrocortisone cream (1%) (control arm, n=30) immediately after receiving a total dose of 45-50 Gy chest wall radiotherapy. The mean radiation dose was 49.1 Gy in the control arm and 48.8 Gy in the study arm. The mean dermatitis area was 13.54 cm(2) in the control arm and 17.02 cm(2) in the study arm. Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) (P=0.001). This effect was significant in the second week (P=0.007). In addition, Alpha ointment decreased the patients' complaints such as pain (P<0.001), pruritus (P=0.009), and discharge (P=0.010) effectively and meaningfully. Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) in our patients with breast cancer. IRCT201206099979N1, ACTRN12612000837820.

Chemoprevention of Nonmelanoma Skin Cancer With Celecoxib: A Randomized, Double-Blind, Placebo-Controlled Trial

PubMed Central

Viner, Jaye L.; Pentland, Alice P.; Cantrell, Wendy; Bailey, Howard; Kang, Sewon; Linden, Kenneth G.; Heffernan, Michael; Duvic, Madeleine; Richmond, Ellen; Elewski, Boni E.; Umar, Asad; Bell, Walter; Gordon, Gary B.

2010-01-01

Background Preclinical studies indicate that the enzyme cyclooxygenase 2 plays an important role in ultraviolet-induced skin cancers. We evaluated the efficacy and safety of celecoxib, a cyclooxygenase 2 inhibitor, as a chemopreventive agent for actinic keratoses, the premalignant precursor of nonmelanoma skin cancers, and for nonmelanoma skin cancers, including cutaneous squamous cell carcinomas (SCCs) and basal cell carcinomas (BCCs). Methods A double-blind placebo-controlled randomized trial involving 240 subjects aged 37–87 years with 10–40 actinic keratoses was conducted at eight US academic medical centers. Patients were randomly assigned to receive 200 mg of celecoxib or placebo administered orally twice daily for 9 months. Subjects were evaluated at 3, 6, 9 (ie, completion of treatment), and 11 months after randomization. The primary endpoint was the number of new actinic keratoses at the 9-month visit as a percentage of the number at the time of randomization. In an intent-to-treat analysis, the incidence of actinic keratoses was compared between the two groups using t tests. In exploratory analyses, we evaluated the number of nonmelanoma skin cancers combined and SCCs and BCCs separately per patient at 11 months after randomization using Poisson regression, after adjustment for patient characteristics and time on study. The numbers of adverse events in the two treatment arms were compared using χ2 or Fisher exact tests. All statistical tests were two-sided. Results There was no difference in the incidence of actinic keratoses between the two groups at 9 months after randomization. However, at 11 months after randomization, there were fewer nonmelanoma skin cancers in the celecoxib arm than in the placebo arm (mean cumulative tumor number per patient 0.14 vs 0.35; rate ratio [RR] = .43, 95% confidence interval [CI] = 0.24 to 0.75; P = .003). After adjusting for age, sex, Fitzpatrick skin type, history of actinic keratosis at randomization, nonmelanoma skin cancer history, and patient time on study, the number of nonmelanoma skin cancers was lower in the celecoxib arm than in the placebo arm (RR = 0.41, 95% CI = 0.23 to 0.72, P = .002) as were the numbers of BCCs (RR = 0.40, 95% CI = 0.18 to 0.93, P = .032) and SCCs (RR = 0.42, 95% CI = 0.19 to 0.93, P = .032). Serious and cardiovascular adverse events were similar in the two groups. Conclusions Celecoxib may be effective for prevention of SCCs and BCCs in individuals who have extensive actinic damage and are at high risk for development of nonmelanoma skin cancers. PMID:21115882

Cluster Randomized Trial of a Toolkit and Early Vaccine Delivery to Improve Childhood Influenza Vaccination Rates in Primary Care

PubMed Central

Zimmerman, Richard K.; Nowalk, Mary Patricia; Lin, Chyongchiou Jeng; Hannibal, Kristin; Moehling, Krissy K.; Huang, Hsin-Hui; Matambanadzo, Annamore; Troy, Judith; Allred, Norma J.; Gallik, Greg; Reis, Evelyn C.

2014-01-01

Purpose To increase childhood influenza vaccination rates using a toolkit and early vaccine delivery in a randomized cluster trial. Methods Twenty primary care practices treating children (range for n=536-8,183) were randomly assigned to Intervention and Control arms to test the effectiveness of an evidence-based practice improvement toolkit (4 Pillars Toolkit) and early vaccine supplies for use among disadvantaged children on influenza vaccination rates among children 6 months-18 years. Follow-up staff meetings and surveys were used to assess use and acceptability of the intervention strategies in the Intervention arm. Rates for the 2010-2011 and 2011-2012 influenza seasons were compared. Two-level generalized linear mixed modeling was used to evaluate outcomes. Results Overall increases in influenza vaccination rates were significantly greater in the Intervention arm (7.9 percentage points) compared with the Control arm (4.4 percentage points; P<0.034). These rate changes represent 4522 additional doses in the Intervention arm vs. 1,390 additional doses in the Control arm. This effect of the intervention was observed despite the fact that rates increased significantly in both arms - 8/10 Intervention (P<0.001) and 7/10 Control sites (P-values 0.04 to <0.001). Rates in two Intervention sites with pre-intervention vaccination rates >58% did not significantly increase. In regression analyses, a child's likelihood of being vaccinated was significantly higher with: younger age, white race (Odds ratio [OR]=1.29; 95% confidence interval [CI]=1.23-1.34), having commercial insurance (OR=1.30; 95%CI=1.25-1.35), higher pre-intervention practice vaccination rate (OR=1.25; 95%CI=1.16-1.34), and being in the Intervention arm (OR=1.23; 95%CI=1.01-1.50). Early delivery of influenza vaccine was rated by Intervention practices as an effective strategy for raising rates. Conclusions Implementation of a multi-strategy toolkit and early vaccine supplies can significantly improve influenza vaccination rates among children in primary care practices but the effect may be less pronounced in practices with moderate to high existing vaccination rates. PMID:24793941

The Mental Vitality @ Work study: design of a randomized controlled trial on the effect of a workers' health surveillance mental module for nurses and allied health professionals

PubMed Central

2011-01-01

Background Employees in health care service are at high risk for developing mental health complaints. The effects of mental health complaints on work can have serious consequences for the quality of care provided by these workers. To help health service workers remain healthy and productive, preventive actions are necessary. A Workers' Health Surveillance (WHS) mental module may be an effective strategy to monitor and promote good (mental) health and work performance. The objective of this paper is to describe the design of a three arm cluster randomized controlled trial on the effectiveness of a WHS mental module for nurses and allied health professionals. Two strategies for this WHS mental module will be compared along with data from a control group. Additionally, the cost effectiveness of the approaches will be evaluated from a societal perspective. Methods The study is designed as a cluster randomized controlled trial consisting of three arms (two intervention groups, 1 control group) with randomization at ward level. The study population consists of 86 departments in one Dutch academic medical center with a total of 1731 nurses and allied health professionals. At baseline, after three months and after six months of follow-up, outcomes will be assessed by online questionnaires. In both intervention arms, participants will complete a screening to detect problems in mental health and work functioning and receive feedback on their screening results. In cases of impairments in mental health or work functioning in the first intervention arm, a consultation with an occupational physician will be offered. The second intervention arm offers a choice of self-help e-mental health interventions, which will be tailored based on each individual's mental health state and work functioning. The primary outcomes will be help-seeking behavior and work functioning. Secondary outcomes will be mental health and wellbeing. Furthermore, cost-effectiveness in both intervention arms will be assessed, and a process evaluation will be performed. Discussion When it is proven effective compared to a control group, a WHS mental module for nurses and allied health professionals could be implemented and used on a regular basis by occupational health services in hospitals to improve employees' mental health and work functioning. Trial Registration NTR2786 PMID:21569282

The Mental Vitality @ Work study: design of a randomized controlled trial on the effect of a workers' health surveillance mental module for nurses and allied health professionals.

PubMed

Gärtner, Fania R; Ketelaar, Sarah M; Smeets, Odile; Bolier, Linda; Fischer, Eva; van Dijk, Frank J H; Nieuwenhuijsen, Karen; Sluiter, Judith K

2011-05-10

Employees in health care service are at high risk for developing mental health complaints. The effects of mental health complaints on work can have serious consequences for the quality of care provided by these workers. To help health service workers remain healthy and productive, preventive actions are necessary. A Workers' Health Surveillance (WHS) mental module may be an effective strategy to monitor and promote good (mental) health and work performance. The objective of this paper is to describe the design of a three arm cluster randomized controlled trial on the effectiveness of a WHS mental module for nurses and allied health professionals. Two strategies for this WHS mental module will be compared along with data from a control group. Additionally, the cost effectiveness of the approaches will be evaluated from a societal perspective. The study is designed as a cluster randomized controlled trial consisting of three arms (two intervention groups, 1 control group) with randomization at ward level. The study population consists of 86 departments in one Dutch academic medical center with a total of 1731 nurses and allied health professionals. At baseline, after three months and after six months of follow-up, outcomes will be assessed by online questionnaires. In both intervention arms, participants will complete a screening to detect problems in mental health and work functioning and receive feedback on their screening results. In cases of impairments in mental health or work functioning in the first intervention arm, a consultation with an occupational physician will be offered. The second intervention arm offers a choice of self-help e-mental health interventions, which will be tailored based on each individual's mental health state and work functioning. The primary outcomes will be help-seeking behavior and work functioning. Secondary outcomes will be mental health and wellbeing. Furthermore, cost-effectiveness in both intervention arms will be assessed, and a process evaluation will be performed. When it is proven effective compared to a control group, a WHS mental module for nurses and allied health professionals could be implemented and used on a regular basis by occupational health services in hospitals to improve employees' mental health and work functioning. NTR2786.

Combined Cognitive-Strategy and Task-Specific Training Affects Cognition and Upper-Extremity Function in Subacute Stroke: An Exploratory Randomized Controlled Trial

PubMed Central

Polatajko, Helene; Baum, Carolyn; Rios, Jorge; Cirone, Dianne; Doherty, Meghan; McEwen, Sara

2016-01-01

The purpose of this study was to estimate the effect of Cognitive Orientation to Daily Occupational Performance (CO–OP) compared with usual occupational therapy on upper-extremity movement, cognitive flexibility, and stroke impact in people less than 3 mo after stroke. An exploratory, single-blind randomized controlled trial was conducted with people referred to outpatient occupational therapy services at two rehabilitation centers. Arm movement was measured with the Action Research Arm Test, cognitive flexibility with the Delis–Kaplan Executive Function System Trail Making subtest, and stroke impact with subscales of the Stroke Impact Scale. A total of 35 participants were randomized, and 26 completed the intervention. CO–OP demonstrated measurable effects over usual care on all measures. These data provide early support for the use of CO–OP to improve performance and remediate cognitive and arm movement impairments after stroke over usual care; however, future study is warranted to confirm the effects observed in this trial. PMID:26943113

Estimating the Standard Error of the Impact Estimator in Individually Randomized Trials with Clustering

ERIC Educational Resources Information Center

Weiss, Michael J.; Lockwood, J. R.; McCaffrey, Daniel F.

2016-01-01

In the "individually randomized group treatment" (IRGT) experimental design, individuals are first randomly assigned to a treatment arm or a control arm, but then within each arm, are grouped together (e.g., within classrooms/schools, through shared case managers, in group therapy sessions, through shared doctors, etc.) to receive…

A randomized controlled study of socioeconomic support to enhance tuberculosis prevention and treatment, Peru

PubMed Central

Tovar, Marco A; Huff, Doug; Boccia, Delia; Montoya, Rosario; Ramos, Eric; Datta, Sumona; Saunders, Matthew J; Lewis, James J; Gilman, Robert H; Evans, Carlton A

2017-01-01

Abstract Objective To evaluate the impact of socioeconomic support on tuberculosis preventive therapy initiation in household contacts of tuberculosis patients and on treatment success in patients. Methods A non-blinded, household-randomized, controlled study was performed between February 2014 and June 2015 in 32 shanty towns in Peru. It included patients being treated for tuberculosis and their household contacts. Households were randomly assigned to either the standard of care provided by Peru’s national tuberculosis programme (control arm) or the same standard of care plus socioeconomic support (intervention arm). Socioeconomic support comprised conditional cash transfers up to 230 United States dollars per household, community meetings and household visits. Rates of tuberculosis preventive therapy initiation and treatment success (i.e. cure or treatment completion) were compared in intervention and control arms. Findings Overall, 282 of 312 (90%) households agreed to participate: 135 in the intervention arm and 147 in the control arm. There were 410 contacts younger than 20 years: 43% in the intervention arm initiated tuberculosis preventive therapy versus 25% in the control arm (adjusted odds ratio, aOR: 2.2; 95% confidence interval, CI: 1.1–4.1). An intention-to-treat analysis showed that treatment was successful in 64% (87/135) of patients in the intervention arm versus 53% (78/147) in the control arm (unadjusted OR: 1.6; 95% CI: 1.0–2.6). These improvements were equitable, being independent of household poverty. Conclusion A tuberculosis-specific, socioeconomic support intervention increased uptake of tuberculosis preventive therapy and tuberculosis treatment success and is being evaluated in the Community Randomized Evaluation of a Socioeconomic Intervention to Prevent TB (CRESIPT) project. PMID:28479622

A randomized controlled study of socioeconomic support to enhance tuberculosis prevention and treatment, Peru.

PubMed

Wingfield, Tom; Tovar, Marco A; Huff, Doug; Boccia, Delia; Montoya, Rosario; Ramos, Eric; Datta, Sumona; Saunders, Matthew J; Lewis, James J; Gilman, Robert H; Evans, Carlton A

2017-04-01

To evaluate the impact of socioeconomic support on tuberculosis preventive therapy initiation in household contacts of tuberculosis patients and on treatment success in patients. A non-blinded, household-randomized, controlled study was performed between February 2014 and June 2015 in 32 shanty towns in Peru. It included patients being treated for tuberculosis and their household contacts. Households were randomly assigned to either the standard of care provided by Peru's national tuberculosis programme (control arm) or the same standard of care plus socioeconomic support (intervention arm). Socioeconomic support comprised conditional cash transfers up to 230 United States dollars per household, community meetings and household visits. Rates of tuberculosis preventive therapy initiation and treatment success (i.e. cure or treatment completion) were compared in intervention and control arms. Overall, 282 of 312 (90%) households agreed to participate: 135 in the intervention arm and 147 in the control arm. There were 410 contacts younger than 20 years: 43% in the intervention arm initiated tuberculosis preventive therapy versus 25% in the control arm (adjusted odds ratio, aOR: 2.2; 95% confidence interval, CI: 1.1-4.1). An intention-to-treat analysis showed that treatment was successful in 64% (87/135) of patients in the intervention arm versus 53% (78/147) in the control arm (unadjusted OR: 1.6; 95% CI: 1.0-2.6). These improvements were equitable, being independent of household poverty. A tuberculosis-specific, socioeconomic support intervention increased uptake of tuberculosis preventive therapy and tuberculosis treatment success and is being evaluated in the Community Randomized Evaluation of a Socioeconomic Intervention to Prevent TB (CRESIPT) project.

Study designs for determining and comparing sensitivities of disease screening tests.

PubMed

Prorok, Philip C; Kramer, Barnett S; Miller, Anthony B

2015-12-01

To investigate the capability of various study designs to determine the sensitivity of a disease screening test. Quantities that can be calculated from these designs were derived and examined for their relationship to true sensitivity (the ability to detect unrecognized disease that would surface clinically in the absence of screening) and overdiagnosis. To examine the sensitivity of one test, the single cohort design, in which all participants receive the test, is particularly weak, providing only an upper bound on the true sensitivity, and yields no information about overdiagnosis. A randomized design, with one control arm and participants tested in the other, that includes sufficient post-screening follow-up, allows calculation of bounds on, and an approximation to, true sensitivity and also determination of overdiagnosis. Without follow-up, bounds on the true sensitivity can be calculated. To compare two tests, the single cohort paired design in which all participants receive both tests is precarious. The three arm randomized design with post screening follow-up is preferred, yielding an approximation to the true sensitivity, bounds on the true sensitivity, and the extent of overdiagnosis of each test. Without post screening follow-up, bounds on the true sensitivities can be calculated. When an unscreened control arm is not possible, the two-arm randomized design is recommended. Individual test sensitivities cannot be determined, but with sufficient post-screening follow-up, an order relationship can be established, as can the difference in overdiagnosis between the two tests. © The Author(s) 2015.

Accelerometry Measuring the Outcome of Robot-Supported Upper Limb Training in Chronic Stroke: A Randomized Controlled Trial

PubMed Central

Lemmens, Ryanne J. M.; Timmermans, Annick A. A.; Janssen-Potten, Yvonne J. M.; Pulles, Sanne A. N. T. D.; Geers, Richard P. J.; Bakx, Wilbert G. M.; Smeets, Rob J. E. M.; Seelen, Henk A. M.

2014-01-01

Purpose This study aims to assess the extent to which accelerometers can be used to determine the effect of robot-supported task-oriented arm-hand training, relative to task-oriented arm-hand training alone, on the actual amount of arm-hand use of chronic stroke patients in their home situation. Methods This single-blind randomized controlled trial included 16 chronic stroke patients, randomly allocated using blocked randomization (n = 2) to receive task-oriented robot-supported arm-hand training or task-oriented (unsupported) arm-hand training. Training lasted 8 weeks, 4 times/week, 2×30 min/day using the (T-)TOAT ((Technology-supported)-Task-Oriented-Arm-Training) method. The actual amount of arm-hand use, was assessed at baseline, after 8 weeks training and 6 months after training cessation. Duration of use and intensity of use of the affected arm-hand during unimanual and bimanual activities were calculated. Results Duration and intensity of use of the affected arm-hand did not change significantly during and after training, with or without robot-support (i.e. duration of use of unimanual use of the affected arm-hand: median difference of −0.17% in the robot-group and −0.08% in the control group between baseline and after training cessation; intensity of the affected arm-hand: median difference of 3.95% in the robot-group and 3.32% in the control group between baseline and after training cessation). No significant between-group differences were found. Conclusions Accelerometer data did not show significant changes in actual amount of arm-hand use after task-oriented training, with or without robot-support. Next to the amount of use, discrimination between activities performed and information about quality of use of the affected arm-hand are essential to determine actual arm-hand performance. Trial Registration Controlled-trials.com ISRCTN82787126 PMID:24823925

Do early changes in the HAM-D-17 anxiety/somatization factor items affect treatment outcome among depressed outpatients? Comparison of two controlled trials of St John’s Wort (Hypericum Perforatum) versus an SSRI

PubMed Central

Bitran, Stella; Farabaugh, Amy H; Ameral, Victoria E; LaRocca, Rachel A; Clain, Alisabet J; Fava, Maurizio; Mischoulon, David

2011-01-01

Objective To assess whether early changes in HAM-D-17 anxiety/somatization items predict remission in two controlled studies of hypericum perforatum (St. John’s wort) versus an SSRI for major depressive disorder (MDD). Methods The Hypericum Depression Trial Study Group (NIMH) study randomized 340 subjects to hypericum, sertraline, or placebo for 8 weeks. The MGH study randomized 135 subjects to hypericum, fluoxetine, or placebo for 12 weeks. We examined whether remission was associated with early changes in anxiety/somatization symptoms. Results In the NIMH study, significant associations were observed between remission and early improvement in the anxiety-psychic item (sertraline arm), somatic-gastrointestinal item (hypericum arm), and somatic symptoms-general (placebo arm). None of the three treatment arms of the MGH study showed significant associations between anxiety/somatization symptoms and remission. When both study samples were pooled, we found associations for anxiety-psychic (SSRI arm), somatic-gastrointestinal and hypochondriasis (hypericum arm), and anxiety-psychic and somatic symptoms-general (placebo arm). In the entire sample, remission was associated with improvement in the anxiety-psychic, somatic-gastrointestinal, and somatic symptoms-general items. Conclusions The number and type of anxiety/somatization items associated with remission varied depending on the intervention. Early scrutiny of the HAM-D-17 anxiety/somatization items may help predict remission of MDD. PMID:21278577

Impact and Costs of Incentives to Reduce Attrition in Online Trials: Two Randomized Controlled Trials

PubMed Central

Murray, Elizabeth; Kalaitzaki, Eleftheria; White, Ian R; McCambridge, Jim; Thompson, Simon G; Wallace, Paul; Godfrey, Christine

2011-01-01

Background Attrition from follow-up is a major methodological challenge in randomized trials. Incentives are known to improve response rates in cross-sectional postal and online surveys, yet few studies have investigated whether they can reduce attrition from follow-up in online trials, which are particularly vulnerable to low follow-up rates. Objectives Our objective was to determine the impact of incentives on follow-up rates in an online trial. Methods Two randomized controlled trials were embedded in a large online trial of a Web-based intervention to reduce alcohol consumption (the Down Your Drink randomized controlled trial, DYD-RCT). Participants were those in the DYD pilot trial eligible for 3-month follow-up (study 1) and those eligible for 12-month follow-up in the DYD main trial (study 2). Participants in both studies were randomly allocated to receive an offer of an incentive or to receive no offer of an incentive. In study 1, participants in the incentive arm were randomly offered a £5 Amazon.co.uk gift voucher, a £5 charity donation to Cancer Research UK, or entry in a prize draw for £250. In study 2, participants in the incentive arm were offered a £10 Amazon.co.uk gift voucher. The primary outcome was the proportion of participants who completed follow-up questionnaires in the incentive arm(s) compared with the no incentive arm. Results In study 1 (n = 1226), there was no significant difference in response rates between those participants offered an incentive (175/615, 29%) and those with no offer (162/611, 27%) (difference = 2%, 95% confidence interval [CI] –3% to 7%). There was no significant difference in response rates among the three different incentives offered. In study 2 (n = 2591), response rates were 9% higher in the group offered an incentive (476/1296, 37%) than in the group not offered an incentive (364/1295, 28%) (difference = 9%, 95% CI 5% to 12%, P < .001). The incremental cost per extra successful follow-up in the incentive arm was £110 in study 1 and £52 in study 2. Conclusion Whereas an offer of a £10 Amazon.co.uk gift voucher can increase follow-up rates in online trials, an offer of a lower incentive may not. The marginal costs involved require careful consideration. Trial registration ISRCTN31070347; http://www.controlled-trials.com/ISRCTN31070347 (Archived by WebCite at http://www.webcitation.org/5wgr5pl3s) PMID:21371988

Incorporating Erlotinib or Irinotecan Plus Cisplatin into Chemoradiotherapy for Stage III Non-small Cell Lung Cancer According to EGFR Mutation Status.

PubMed

Lee, Youngjoo; Han, Ji-Youn; Moon, Sung Ho; Nam, Byung-Ho; Lim, Kun Young; Lee, Geon Kook; Kim, Heung Tae; Yun, Tak; An, Hye Jin; Lee, Jin Soo

2017-10-01

Concurrent chemoradiotherapy (CCRT) is the standard care for stage III non-small cell lung cancer (NSCLC) patients; however, a more effective regimen is needed to improve the outcome by better controlling occult metastases. We conducted two parallel randomized phase II studies to incorporate erlotinib or irinotecan-cisplatin (IP) into CCRT for stage III NSCLC depending on epidermal growth factor receptor (EGFR) mutation status. Patients with EGFR-mutant tumors were randomized to receive three cycles of erlotinib first and then either CCRT with erlotinib followed by erlotinib (arm A) or CCRT with IP only (arm B). Patients with EGFR unknown or wild-type tumors were randomized to receive either three cycles of IP before (arm C) or after CCRT with IP (arm D). Seventy-three patients were screened and the study was closed early because of slow accrual after 59 patients were randomized. Overall, there were seven patients in arm A, five in arm B, 22 in arm C, and 25 in arm D. The response rate was 71.4% and 80.0% for arm A and B, and 70.0% and 73.9% for arm C and D. The median overall survival (OS) was 39.3 months versus 31.2 months for arm A and B (p=0.442), and 16.3 months versus 25.3 months for arm C and D (p=0.050). Patients with sensitive EGFR mutations had significantly longer OS than EGFR-wild patients (74.8 months vs. 25.3 months, p=0.034). There were no unexpected toxicities. Combined-modality treatment by molecular diagnostics is feasible in stage III NSCLC. EGFR-mutant patients appear to be a distinct subset with longer survival.

Efficacy of a Multi-level Intervention to Reduce Injecting and Sexual Risk Behaviors among HIV-Infected People Who Inject Drugs in Vietnam: A Four-Arm Randomized Controlled Trial

PubMed Central

Go, Vivian F.; Frangakis, Constantine; Minh, Nguyen Le; Latkin, Carl; Ha, Tran Viet; Mo, Tran Thi; Sripaipan, Teerada; Davis, Wendy W.; Zelaya, Carla; Vu, Pham The; Celentano, David D.; Quan, Vu Minh

2015-01-01

Introduction Injecting drug use is a primary driver of HIV epidemics in many countries. People who inject drugs (PWID) and are HIV infected are often doubly stigmatized and many encounter difficulties reducing risk behaviors. Prevention interventions for HIV-infected PWID that provide enhanced support at the individual, family, and community level to facilitate risk-reduction are needed. Methods 455 HIV-infected PWID and 355 of their HIV negative injecting network members living in 32 sub-districts in Thai Nguyen Province were enrolled. We conducted a two-stage randomization: First, sub-districts were randomized to either a community video screening and house-to-house visits or standard of care educational pamphlets. Second, within each sub-district, participants were randomized to receive either enhanced individual level post-test counseling and group support sessions or standard of care HIV testing and counseling. This resulted in four arms: 1) standard of care; 2) community level intervention; 3) individual level intervention; and 4) community plus individual intervention. Follow-up was conducted at 6, 12, 18, and 24 months. Primary outcomes were self-reported HIV injecting and sexual risk behaviors. Secondary outcomes included HIV incidence among HIV negative network members. Results Fewer participants reported sharing injecting equipment and unprotected sex from baseline to 24 months in all arms (77% to 4% and 24% to 5% respectively). There were no significant differences at the 24-month visit among the 4 arms (Wald = 3.40 (3 df); p = 0.33; Wald = 6.73 (3 df); p = 0.08). There were a total of 4 HIV seroconversions over 24 months with no significant difference between intervention and control arms. Discussion Understanding the mechanisms through which all arms, particularly the control arm, demonstrated both low risk behaviors and low HIV incidence has important implications for policy and prevention programming. Trial Registration ClinicalTrials.gov NCT01689545 PMID:26011427

Efficacy of a Multi-level Intervention to Reduce Injecting and Sexual Risk Behaviors among HIV-Infected People Who Inject Drugs in Vietnam: A Four-Arm Randomized Controlled Trial.

PubMed

Go, Vivian F; Frangakis, Constantine; Minh, Nguyen Le; Latkin, Carl; Ha, Tran Viet; Mo, Tran Thi; Sripaipan, Teerada; Davis, Wendy W; Zelaya, Carla; Vu, Pham The; Celentano, David D; Quan, Vu Minh

2015-01-01

Injecting drug use is a primary driver of HIV epidemics in many countries. People who inject drugs (PWID) and are HIV infected are often doubly stigmatized and many encounter difficulties reducing risk behaviors. Prevention interventions for HIV-infected PWID that provide enhanced support at the individual, family, and community level to facilitate risk-reduction are needed. 455 HIV-infected PWID and 355 of their HIV negative injecting network members living in 32 sub-districts in Thai Nguyen Province were enrolled. We conducted a two-stage randomization: First, sub-districts were randomized to either a community video screening and house-to-house visits or standard of care educational pamphlets. Second, within each sub-district, participants were randomized to receive either enhanced individual level post-test counseling and group support sessions or standard of care HIV testing and counseling. This resulted in four arms: 1) standard of care; 2) community level intervention; 3) individual level intervention; and 4) community plus individual intervention. Follow-up was conducted at 6, 12, 18, and 24 months. Primary outcomes were self-reported HIV injecting and sexual risk behaviors. Secondary outcomes included HIV incidence among HIV negative network members. Fewer participants reported sharing injecting equipment and unprotected sex from baseline to 24 months in all arms (77% to 4% and 24% to 5% respectively). There were no significant differences at the 24-month visit among the 4 arms (Wald = 3.40 (3 df); p = 0.33; Wald = 6.73 (3 df); p = 0.08). There were a total of 4 HIV seroconversions over 24 months with no significant difference between intervention and control arms. Understanding the mechanisms through which all arms, particularly the control arm, demonstrated both low risk behaviors and low HIV incidence has important implications for policy and prevention programming. ClinicalTrials.gov NCT01689545.

A cluster randomized controlled trial of a brief tobacco cessation intervention for low-income communities in India: study protocol.

PubMed

Sarkar, Bidyut K; Shahab, Lion; Arora, Monika; Lorencatto, Fabiana; Reddy, K Srinath; West, Robert

2014-03-01

India has 275 million adult tobacco users and tobacco use is estimated to contribute to more than a million deaths in the country each year. There is an urgent need to develop and evaluate affordable, practicable and scalable interventions to promote cessation of tobacco use. Because tobacco use is so harmful, an increase of as little as 1 percentage point in long-term quit success rates can have an important public health impact. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of a brief scalable smoking cessation intervention delivered by trained health professionals as an outreach programme in poor urban communities in India. This is a pragmatic, two-arm, community-based cluster randomized controlled trial focused on tobacco users in low-income communities. The treatment arm is a brief intervention comprising brief advice including training in craving control using simple yogic breathing exercises (BA-YBA) and the control arm is very brief advice (VBA). Of a total of 32 clusters, 16 will be allocated to the intervention arm and 16 to the control arm. Each cluster will have 31 participants, making a total of 992 participants. The primary outcome measure will follow the Russell Standard: self-report of sustained abstinence for at least 6 months following the intervention confirmed at the final follow-up by salivary cotinine. This trial will inform national and international policy on delivery of scalable and affordable brief outreach interventions to promote tobacco use cessation in low resource settings where tobacco users have limited access to physicians and medications. © 2014 Society for the Study of Addiction.

Capacity-building and clinical competence in infectious disease in Uganda: a mixed-design study with pre/post and cluster-randomized trial components.

PubMed

Weaver, Marcia R; Crozier, Ian; Eleku, Simon; Makanga, Gyaviira; Mpanga Sebuyira, Lydia; Nyakake, Janepher; Thompson, MaryLou; Willis, Kelly

2012-01-01

Best practices for training mid-level practitioners (MLPs) to improve global health-services are not well-characterized. Two hypotheses were: 1) Integrated Management of Infectious Disease (IMID) training would improve clinical competence as tested with a single arm, pre-post design, and 2) on-site support (OSS) would yield additional improvements as tested with a cluster-randomized trial. Thirty-six Ugandan health facilities (randomized 1∶1 to parallel OSS and control arms) enrolled two MLPs each. All MLPs participated in IMID (3-week core course, two 1-week boost sessions, distance learning). After the 3-week course, OSS-arm trainees participated in monthly OSS. Twelve written case scenarios tested clinical competencies in HIV/AIDS, tuberculosis, malaria, and other infectious diseases. Each participant completed different randomly-assigned blocks of four scenarios before IMID (t0), after 3-week course (t1), and after second boost course (t2, 24 weeks after t1). Scoring guides were harmonized with IMID content and Ugandan national policy. Score analyses used a linear mixed-effects model. The primary outcome measure was longitudinal change in scenario scores. Scores were available for 856 scenarios. Mean correct scores at t0, t1, and t2 were 39.3%, 49.1%, and 49.6%, respectively. Mean score increases (95% CI, p-value) for t0-t1 (pre-post period) and t1-t2 (parallel-arm period) were 12.1 ((9.6, 14.6), p<0.001) and -0.6 ((-3.1, +1.9), p = 0.647) percent for OSS arm and 7.5 ((5.0, 10.0), p<0.001) and 1.6 ((-1.0, +4.1), p = 0.225) for control arm. The estimated mean difference in t1 to t2 score change, comparing arm A (participated in OSS) vs. arm B was -2.2 ((-5.8, +1.4), p = 0.237). From t0-t2, mean scores increased for all 12 scenarios. Clinical competence increased significantly after a 3-week core course; improvement persisted for 24 weeks. No additional impact of OSS was observed. Data on clinical practice, facility-level performance and health outcomes will complete assessment of overall impact of IMID and OSS. ClinicalTrials.gov NCT01190540.

Bobath Concept versus constraint-induced movement therapy to improve arm functional recovery in stroke patients: a randomized controlled trial.

PubMed

Huseyinsinoglu, Burcu Ersoz; Ozdincler, Arzu Razak; Krespi, Yakup

2012-08-01

To compare the effects of the Bobath Concept and constraint-induced movement therapy on arm functional recovery among stroke patients with a high level of function on the affected side. A single-blinded, randomized controlled trial. Outpatient physiotherapy department of a stroke unit. A total of 24 patients were randomized to constraint-induced movement therapy or Bobath Concept group. The Bobath Concept group was treated for 1 hour whereas the constraint-induced movement therapy group received training for 3 hours per day during 10 consecutive weekdays. Main measures were the Motor Activity Log-28, the Wolf Motor Function Test, the Motor Evaluation Scale for Arm in Stroke Patients and the Functional Independence Measure. The two groups were found to be homogeneous based on demographic variables and baseline measurements. Significant improvements were seen after treatment only in the 'Amount of use' and 'Quality of movement' subscales of the Motor Activity Log-28 in the constraint-induced movement therapy group over the the Bobath Concept group (P = 0.003; P = 0.01 respectively). There were no significant differences in Wolf Motor Function Test 'Functional ability' (P = 0.137) and 'Performance time' (P = 0.922), Motor Evaluation Scale for Arm in Stroke Patients (P = 0.947) and Functional Independence Measure scores (P = 0.259) between the two intervention groups. Constraint-induced movement therapy and the Bobath Concept have similar efficiencies in improving functional ability, speed and quality of movement in the paretic arm among stroke patients with a high level of function. Constraint-induced movement therapy seems to be slightly more efficient than the Bobath Concept in improving the amount and quality of affected arm use.

Combined effects of sensory cueing and limb activation on unilateral neglect in subacute left hemiplegic stroke patients: a randomized controlled pilot study.

PubMed

Fong, Kenneth N K; Yang, Nicole Y H; Chan, Marko K L; Chan, Dora Y L; Lau, Andy F C; Chan, Dick Y W; Cheung, Joyce T Y; Cheung, Hobby K Y; Chung, Raymond C K; Chan, Chetwyn C H

2013-07-01

To compare the effects of contralesional sensory cueing and limb activation with that of sham control in the treatment of unilateral neglect after stroke. A randomized, single-blinded, sham-controlled pilot study. Two rehabilitation hospitals. Forty subacute left hemiplegic stroke inpatients with unilateral neglect. Participants were assigned randomly to 1 of 2 groups. The experimental group wore a wristwatch cueing device over the hemiplegic arm for three hours a day, five days per week, for three weeks, and also underwent conventional rehabilitation. Patients were encouraged to move their hemiplegic arm five consecutive times after each prompt. The sham group underwent the same rehabilitation process, except they wore a sham device. Neglect, arm motor performance, and overall functioning were assessed pre- and posttraining, and at follow-up. There were no significant differences between groups in outcome measures except the neglect drawing tasks (p = 0.034) (the mean gain score from baseline to follow-up assessment was 5.2 (3.7) in the experimental group and 1.9 (3.5) in the sham group), across three time intervals. The experimental group showed greater improvement in arm motor performance than did the sham group. The results did not confirm that sensory cueing and limb activation treatment is effective when compared with those receiving placebo to reduce unilateral neglect, but it might be useful for promoting hemiplegic arm performance in stroke patients.

Tailored Behavioral Intervention Among Blacks With Metabolic Syndrome and Sleep Apnea: Results of the MetSO Trial.

PubMed

Jean-Louis, Girardin; Newsome, Valerie; Williams, Natasha J; Zizi, Ferdinand; Ravenell, Joseph; Ogedegbe, Gbenga

2017-01-01

To assess effectiveness of a culturally and linguistically tailored telephone-delivered intervention to increase adherence to physician-recommended evaluation and treatment of obstructive sleep apnea (OSA) among blacks. In a two-arm randomized controlled trial, we evaluated effectiveness of the tailored intervention among blacks with metabolic syndrome, relative to those in an attention control arm (n = 380; mean age = 58 ± 13; female = 71%). The intervention was designed to enhance adherence using culturally and linguistically tailored OSA health messages delivered by a trained health educator based on patients' readiness to change and unique barriers preventing desired behavior changes. Analysis showed 69.4% of the patients in the intervention arm attended initial consultation with a sleep specialist, compared to 36.7% in the control arm; 74.7% of those in the intervention arm and 66.7% in the control arm completed diagnostic evaluation; and 86.4% in the intervention arm and 88.9% in the control arm adhered to PAP treatment based on subjective report. Logistic regression analyses adjusting for sociodemographic factors indicated patients in the intervention arm were 3.17 times more likely to attend initial consultation, compared to those in the control arm. Adjusted models revealed no significant differences between the two arms regarding adherence to OSA evaluation or treatment. The intervention was successful in promoting importance of sleep consultation and evaluation of OSA among blacks, while there was no significant group difference in laboratory-based evaluation and treatment adherence rates. It seems that the fundamental barrier to OSA care in that population may be the importance of seeking OSA care. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

A Bayesian pick-the-winner design in a randomized phase II clinical trial.

PubMed

Chen, Dung-Tsa; Huang, Po-Yu; Lin, Hui-Yi; Chiappori, Alberto A; Gabrilovich, Dmitry I; Haura, Eric B; Antonia, Scott J; Gray, Jhanelle E

2017-10-24

Many phase II clinical trials evaluate unique experimental drugs/combinations through multi-arm design to expedite the screening process (early termination of ineffective drugs) and to identify the most effective drug (pick the winner) to warrant a phase III trial. Various statistical approaches have been developed for the pick-the-winner design but have been criticized for lack of objective comparison among the drug agents. We developed a Bayesian pick-the-winner design by integrating a Bayesian posterior probability with Simon two-stage design in a randomized two-arm clinical trial. The Bayesian posterior probability, as the rule to pick the winner, is defined as probability of the response rate in one arm higher than in the other arm. The posterior probability aims to determine the winner when both arms pass the second stage of the Simon two-stage design. When both arms are competitive (i.e., both passing the second stage), the Bayesian posterior probability performs better to correctly identify the winner compared with the Fisher exact test in the simulation study. In comparison to a standard two-arm randomized design, the Bayesian pick-the-winner design has a higher power to determine a clear winner. In application to two studies, the approach is able to perform statistical comparison of two treatment arms and provides a winner probability (Bayesian posterior probability) to statistically justify the winning arm. We developed an integrated design that utilizes Bayesian posterior probability, Simon two-stage design, and randomization into a unique setting. It gives objective comparisons between the arms to determine the winner.

Assessment and Implication of Prognostic Imbalance in Randomized Controlled Trials with a Binary Outcome – A Simulation Study

PubMed Central

Chu, Rong; Walter, Stephen D.; Guyatt, Gordon; Devereaux, P. J.; Walsh, Michael; Thorlund, Kristian; Thabane, Lehana

2012-01-01

Background Chance imbalance in baseline prognosis of a randomized controlled trial can lead to over or underestimation of treatment effects, particularly in trials with small sample sizes. Our study aimed to (1) evaluate the probability of imbalance in a binary prognostic factor (PF) between two treatment arms, (2) investigate the impact of prognostic imbalance on the estimation of a treatment effect, and (3) examine the effect of sample size (n) in relation to the first two objectives. Methods We simulated data from parallel-group trials evaluating a binary outcome by varying the risk of the outcome, effect of the treatment, power and prevalence of the PF, and n. Logistic regression models with and without adjustment for the PF were compared in terms of bias, standard error, coverage of confidence interval and statistical power. Results For a PF with a prevalence of 0.5, the probability of a difference in the frequency of the PF≥5% reaches 0.42 with 125/arm. Ignoring a strong PF (relative risk = 5) leads to underestimating the strength of a moderate treatment effect, and the underestimate is independent of n when n is >50/arm. Adjusting for such PF increases statistical power. If the PF is weak (RR = 2), adjustment makes little difference in statistical inference. Conditional on a 5% imbalance of a powerful PF, adjustment reduces the likelihood of large bias. If an absolute measure of imbalance ≥5% is deemed important, including 1000 patients/arm provides sufficient protection against such an imbalance. Two thousand patients/arm may provide an adequate control against large random deviations in treatment effect estimation in the presence of a powerful PF. Conclusions The probability of prognostic imbalance in small trials can be substantial. Covariate adjustment improves estimation accuracy and statistical power, and hence should be performed when strong PFs are observed. PMID:22629322

A phase III, open label, randomized multicenter controlled trial of oral versus intravenous treosulfan in heavily pretreated recurrent ovarian cancer: a study of the North-Eastern German Society of Gynecological Oncology (NOGGO).

PubMed

Sehouli, Jalid; Tomè, Oliver; Dimitrova, Desislava; Camara, Oumar; Runnebaum, Ingo Bernhard; Tessen, Hans Werner; Rautenberg, Beate; Chekerov, Radoslav; Muallem, Mustafa Zelal; Lux, Michael Patrick; Trarbach, Tanja; Gitsch, Gerald

2017-03-01

In recurrent ovarian cancer (ROC), there is a high demand on effective therapies with a mild toxicity profile. Treosulfan is an alkylating agent approved as oral (p.o.) and intravenous (i.v.) formulation for the treatment of recurrent ovarian cancer. Data on safety and efficacy for either formulation are rare. For the first time we conducted a randomized phase III study comparing both formulations in women with ROC. Patients having received at least two previous lines of chemotherapy were randomly assigned to one of two treatment arms: treosulfan i.v. 7000 mg/m 2 d1 q4w or treosulfan p.o. 600 mg/m 2 d1-28 q8w. Primary endpoint was safety regarding hematological and gastrointestinal toxicity grade III/IV, secondary endpoints were other toxicities, clinical benefit rate (CBR), time to progression (TTP), overall survival (OS) and quality of life. 250 patients were treated with treosulfan i.v. (128) or treosulfan p.o. (122). In general treosulfan therapy was well tolerated in both treatment arms. Leukopenia grade III/IV occurred significantly more frequently in the p.o. arm (3.9% i.v. arm, 14.8% p.o. arm, p = 0.002). Other toxicities were similar in both arms. CBR was comparable between arms (41.4% i.v. arm, 36.9% p.o. arm). No difference in TTP (3.7 months i.v. arm, 3.5 months p.o. arm) or OS (13.6 months i.v. arm, 10.4 months p.o. arm, p = 0.087) occurred. Given the safety and efficacy results treosulfan is an acceptable option for heavily pretreated OC patients. Regarding the toxicity profile the i.v. application was better tolerated with less grade III and IV toxicities.

Dietary Weight Loss and Exercise Effects on Serum Biomarkers of Angiogenesis in Overweight Postmenopausal Women: A Randomized Controlled Trial.

PubMed

Duggan, Catherine; Tapsoba, Jean de Dieu; Wang, Ching-Yun; McTiernan, Anne

2016-07-15

Obese and sedentary persons have an increased risk for cancer, but underlying mechanisms are poorly understood. Angiogenesis is common to adipose tissue formation and remodeling, and to tumor vascularization. A total of 439 overweight/obese, healthy, postmenopausal women [body mass index (BMI) > 25 kg/m(2)] ages 50-75 years, recruited between 2005 and 2008 were randomized to a 4-arm 12-month randomized controlled trial, comparing a caloric restriction diet arm (goal: 10% weight loss, N = 118), aerobic exercise arm (225 minutes/week of moderate-to-vigorous activity, N = 117), a combined diet + exercise arm (N = 117), or control (N = 87) on circulating levels of angiogenic biomarkers. VEGF, plasminogen activator inhibitor-1 (PAI-1), and pigment epithelium-derived factor (PEDF) were measured by immunoassay at baseline and 12 months. Changes were compared using generalized estimating equations, adjusting for baseline BMI, age, and race/ethnicity. Participants randomized to the diet + exercise arms had statistically significantly greater reductions in PAI-1 at 12 months compared with controls (-19.3% vs. +3.48%, respectively, P < 0.0001). Participants randomized to the diet and diet + exercise arms had statistically significantly greater reductions in PEDF (-9.20%, -9.90%, respectively, both P < 0.0001) and VEGF (-8.25%, P = 0.0005; -9.98%, P < 0.0001, respectively) compared with controls. There were no differences in any of the analytes in participants randomized to the exercise arm compared with controls. Increasing weight loss was statistically significantly associated with linear trends of greater reductions in PAI-1, PEDF, and VEGF. Weight loss is significantly associated with reduced circulating VEGF, PEDF, and PAI-1, and could provide incentive for reducing weight as a cancer prevention method in overweight and obese individuals. Cancer Res; 76(14); 4226-35. ©2016 AACR. ©2016 American Association for Cancer Research.

Effectiveness of home-based nutritional counselling and support on exclusive breastfeeding in urban poor settings in Nairobi: a cluster randomized controlled trial.

PubMed

Kimani-Murage, Elizabeth W; Griffiths, Paula L; Wekesah, Frederick Murunga; Wanjohi, Milka; Muhia, Nelson; Muriuki, Peter; Egondi, Thaddaeus; Kyobutungi, Catherine; Ezeh, Alex C; McGarvey, Stephen T; Musoke, Rachel N; Norris, Shane A; Madise, Nyovani J

2017-12-19

Exclusive breastfeeding (EBF) improves infant health and survival. We tested the effectiveness of a home-based intervention using Community Health Workers (CHWs) on EBF for six months in urban poor settings in Kenya. We conducted a cluster-randomized controlled trial in Korogocho and Viwandani slums in Nairobi. We recruited pregnant women and followed them until the infant's first birthday. Fourteen community clusters were randomized to intervention or control arm. The intervention arm received home-based nutritional counselling during scheduled visits by CHWs trained to provide specific maternal infant and young child nutrition (MIYCN) messages and standard care. The control arm was visited by CHWs who were not trained in MIYCN and they provided standard care (which included aspects of ante-natal and post-natal care, family planning, water, sanitation and hygiene, delivery with skilled attendance, immunization and community nutrition). CHWs in both groups distributed similar information materials on MIYCN. Differences in EBF by intervention status were tested using chi square and logistic regression, employing intention-to-treat analysis. A total of 1110 mother-child pairs were involved, about half in each arm. At baseline, demographic and socioeconomic factors were similar between the two arms. The rates of EBF for 6 months increased from 2% pre-intervention to 55.2% (95% CI 50.4-59.9) in the intervention group and 54.6% (95% CI 50.0-59.1) in the control group. The adjusted odds of EBF (after adjusting for baseline characteristics) were slightly higher in the intervention arm compared to the control arm but not significantly different: for 0-2 months (OR 1.27, 95% CI 0.55 to 2.96; p = 0.550); 0-4 months (OR 1.15; 95% CI 0.54 to 2.42; p = 0.696), and 0-6 months (OR 1.11, 95% CI 0.61 to 2.02; p = 0.718). EBF for six months significantly increased in both arms indicating potential effectiveness of using CHWs to provide home-based counselling to mothers. The lack of any difference in EBF rates in the two groups suggests potential contamination of the control arm by information reserved for the intervention arm. Nevertheless, this study indicates a great potential for use of CHWs when they are incentivized and monitored as an effective model of promotion of EBF, particularly in urban poor settings. Given the equivalence of the results in both arms, the study suggests that the basic nutritional training given to CHWs in the basic primary health care training, and/or provision of information materials may be adequate in improving EBF rates in communities. However, further investigations on this may be needed. One contribution of these findings to implementation science is the difficulty in finding an appropriate counterfactual for community-based educational interventions. ISRCTN ISRCTN83692672 . Registered 11 November 2012. Retrospectively registered.

Subcutaneous Crotaline Fab antivenom for the treatment of rattlesnake envenomation in a porcine model.

PubMed

Offerman, Steven R; Barry, J David; Richardson, William H; Tong, Tri; Tanen, Dave; Bush, Sean P; Clark, Richard F

2009-01-01

This study was designed to investigate whether the local, subcutaneous injection of Crotaline Fab antivenom (CroFab) at the rattlesnake envenomation site would result in less extremity edema when compared to intravenous (i.v.) antivenom infusion alone. This is a randomized, three-arm laboratory experiment using a porcine model. Each animal was anesthetized, intubated, and maintained on mechanical ventilation. About 6 mg/kg of Crotalus atrox venom was injected subcutaneously at the hock of the right hind leg. Animals were then randomized to immediately receive subcutaneous and i.v. antivenom (SC/IV), i.v. antivenom only, or saline control. SC/IV animals received two vials of CroFab subcutaneously at the envenomation site and two vials intravenously. IV animals received four vials of CroFab intravenously. Limb edema was tracked by serial circumference and volumetric measurements over an 8-h period. Limb circumference was measured at four pre-determined locations hourly. Limb volume was measured by a water displacement method at baseline, 4, and 8 h. Twenty-six animals were randomized to the three treatment groups. The SC/IV and IV arms included nine animals each. Two animals in the SC/IV group died suddenly during the study, leaving seven animals for data analysis. There were eight controls. Increasing limb edema was observed in all groups. No differences were detected in limb circumferences or limb volumes between control and either treatment arms. In this porcine model of crotaline envenomation, no differences in limb edema were found between animals treated with SC/IV or IV CroFab when compared to saline controls.

Process Evaluation of a Multi-Component Intervention to Reduce Infectious Diseases and Improve Hygiene and Well-Being among School Children: The Hi Five Study

ERIC Educational Resources Information Center

Bonnesen, C. T.; Plauborg, R.; Denbaek, A. M.; Due, P.; Johansen, A.

2015-01-01

The Hi Five study was a three-armed cluster randomized controlled trial designed to reduce infections and improve hygiene and well-being among pupils. Participating schools (n = 43) were randomized into either control (n = 15) or one of two intervention groups (n = 28). The intervention consisted of three components: (i) a curriculum (ii)…

Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial

PubMed Central

2012-01-01

Background Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) is a randomized controlled trial that follows a novel multi-arm, multi-stage (MAMS) design. We describe methodological and practical issues arising with (1) stopping recruitment to research arms following a pre-planned intermediate analysis and (2) adding a new research arm during the trial. Methods STAMPEDE recruits men who have locally advanced or metastatic prostate cancer who are starting standard long-term hormone therapy. Originally there were five research and one control arms, each undergoing a pilot stage (focus: safety, feasibility), three intermediate ‘activity’ stages (focus: failure-free survival), and a final ‘efficacy’ stage (focus: overall survival). Lack-of-sufficient-activity guidelines support the pairwise interim comparisons of each research arm against the control arm; these pre-defined activity cut-off becomes increasingly stringent over the stages. Accrual of further patients continues to the control arm and to those research arms showing activity and an acceptable safety profile. The design facilitates adding new research arms should sufficiently interesting agents emerge. These new arms are compared only to contemporaneously recruited control arm patients using the same intermediate guidelines in a time-delayed manner. The addition of new research arms is subject to adequate recruitment rates to support the overall trial aims. Results (1) Stopping Existing Therapy: After the second intermediate activity analysis, recruitment was discontinued to two research arms for lack-of-sufficient activity. Detailed preparations meant that changes were implemented swiftly at 100 international centers and recruitment continued seamlessly into Activity Stage III with 3 remaining research arms and the control arm. Further regulatory and ethical approvals were not required because this was already included in the initial trial design. (2) Adding New Therapy: An application to add a new research arm was approved by the funder, (who also organized peer review), industrial partner and regulatory and ethical bodies. This was all done in advance of any decision to stop current therapies. Conclusions The STAMPEDE experience shows that recruitment to a MAMS trial and mid-flow changes its design are achievable with good planning. This benefits patients and the scientific community as research treatments are evaluated in a more efficient and cost-effective manner. Trial registration ISRCTN78818544, NCT00268476 First patient into trial: 17 October 2005 First patient into abiraterone comparison: 15 November 2011 PMID:22978443

Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial.

PubMed

Sydes, Matthew R; Parmar, Mahesh K B; Mason, Malcolm D; Clarke, Noel W; Amos, Claire; Anderson, John; de Bono, Johann; Dearnaley, David P; Dwyer, John; Green, Charlene; Jovic, Gordana; Ritchie, Alastair W S; Russell, J Martin; Sanders, Karen; Thalmann, George; James, Nicholas D

2012-09-15

Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) is a randomized controlled trial that follows a novel multi-arm, multi-stage (MAMS) design. We describe methodological and practical issues arising with (1) stopping recruitment to research arms following a pre-planned intermediate analysis and (2) adding a new research arm during the trial. STAMPEDE recruits men who have locally advanced or metastatic prostate cancer who are starting standard long-term hormone therapy. Originally there were five research and one control arms, each undergoing a pilot stage (focus: safety, feasibility), three intermediate 'activity' stages (focus: failure-free survival), and a final 'efficacy' stage (focus: overall survival). Lack-of-sufficient-activity guidelines support the pairwise interim comparisons of each research arm against the control arm; these pre-defined activity cut-off becomes increasingly stringent over the stages. Accrual of further patients continues to the control arm and to those research arms showing activity and an acceptable safety profile. The design facilitates adding new research arms should sufficiently interesting agents emerge. These new arms are compared only to contemporaneously recruited control arm patients using the same intermediate guidelines in a time-delayed manner. The addition of new research arms is subject to adequate recruitment rates to support the overall trial aims. (1) Stopping Existing Therapy: After the second intermediate activity analysis, recruitment was discontinued to two research arms for lack-of-sufficient activity. Detailed preparations meant that changes were implemented swiftly at 100 international centers and recruitment continued seamlessly into Activity Stage III with 3 remaining research arms and the control arm. Further regulatory and ethical approvals were not required because this was already included in the initial trial design.(2) Adding New Therapy: An application to add a new research arm was approved by the funder, (who also organized peer review), industrial partner and regulatory and ethical bodies. This was all done in advance of any decision to stop current therapies. The STAMPEDE experience shows that recruitment to a MAMS trial and mid-flow changes its design are achievable with good planning. This benefits patients and the scientific community as research treatments are evaluated in a more efficient and cost-effective manner. ISRCTN78818544, NCT00268476. First patient into trial: 17 October 2005. First patient into abiraterone comparison: 15 November 2011.

The RAndomized Placebo Phase Study Of Rilonacept in the Treatment of Systemic Juvenile Idiopathic Arthritis (RAPPORT)

PubMed Central

Ilowite, Norman T.; Prather, Kristi; Lokhnygina, Yuliya; Schanberg, Laura E.; Elder, Melissa; Milojevic, Diana; Verbsky, James W.; Spalding, Steven J.; Kimura, Yukiko; Imundo, Lisa F.; Punaro, Marilynn G.; Sherry, David D.; Tarvin, Stacey E.; Zemel, Lawrence S.; Birmingham, James D.; Gottlieb, Beth S.; Miller, Michael L.; O'Neil, Kathleen; Ruth, Natasha M.; Wallace, Carol A.; Singer, Nora G.; Sandborg, Christy I.

2015-01-01

Background Interleukin-1 plays a pivotal role in in the pathogenesis of systemic juvenile idiopathic arthritis (sJIA). We assessed the efficacy and safety of rilonacept (IL-1 trap), an IL-1 inhibitor, in a randomized, double-blind, placebo-controlled trial. Methods An initial 4-week double-blind placebo phase was incorporated into a 24-week randomized multi-center design, followed by an open label phase. We randomized 71 children with at least 2 active joints 1:1 to 2 arms of the study. Patients in the rilonacept arm received rilonacept (4.4mg/kg loading dose followed by 2.2mg/kg weekly, subcutaneously) from day 0; patients in the placebo arm received placebo for 4 weeks followed by a loading dose of rilonacept at week 4 followed by weekly maintenance doses. The primary endpoint was time to response, using adapted JIA ACR30 response criteria coupled with absence of fever and taper of systemic corticosteroids using pre-specified criteria. Results Time to response was shorter in the rilonacept arm than in the placebo arm (Chi-square 7.235, P=.007). Secondary analysis showed 20/35 (57%) of patients in the rilonacept arm responded at week 4 compared to 9/33 (27%) in the placebo arm (P=.016) using the same response criteria. Exacerbation of sJIA (4) was the most common SAE. More patients in the rilonacept arm had elevated liver transaminases, including more than three times the upper limits of normal, as compared to those in the placebo arm. Adverse events were similar in the two arms of the study. Conclusions Rilonacept was generally well tolerated and demonstrated efficacy in active sJIA. PMID:24839206

Consequences of Frequent Hemodialysis: Comparison to Conventional Hemodialysis and Transplantation

PubMed Central

Stokes, John B.

2011-01-01

The average life expectancy of a person on hemodialysis is less than 3 years and hasn't changed in 20 years. The Hemodialysis (HEMO) trial, a randomized trial to determine whether increasing urea removal to the maximum practical degree through a 3-times-a-week schedule, showed no difference in mortality in the treatment and control groups. Investigators speculated that the increment in functional waste removal in the HEMO study was too small to produce improvements in mortality. To test this hypothesis, the NIDDK funded the Frequent Hemodialysis Network, a consortium of centers testing whether patients randomized to intensive dialysis would demonstrate improved (reduced) left ventricular LV mass and quality of life. The trial has two arms: the daily (in-center) and the home (nocturnal) arms. Each arm has patients randomized to conventional dialysis or 6 days (or nights) of dialysis. The results of the HEMO trial will be reported in the fall of 2010. PMID:21686215

Steps to Health employee weight management randomized control trial: short-term follow-up results.

PubMed

Østbye, Truls; Stroo, Marissa; Brouwer, Rebecca J N; Peterson, Bercedis L; Eisenstein, Eric L; Fuemmeler, Bernard F; Joyner, Julie; Gulley, Libby; Dement, John M

2015-02-01

To present the short-term follow-up findings of the Steps to Health study, a randomized trial to evaluate the effectiveness of two employee weight management programs offered within Duke University and the Health System. A total of 550 obese (body mass index, ≥30 kg/m2) employees were randomized 1:1 between January 2011 and June 2012 to the education-based Weight Management (WM) or the WM+ arm, which focused on behavior modification. Employees were contacted to complete a follow-up visit approximately 14 months after baseline. There were no clinically, or statistically, meaningful differences between arms, but there were modest reductions in body mass index, and positive, meaningful changes in diet and physical activity for both arms. The modest positive effects observed in this study may suggest that to achieve weight loss through the workplace more intensive interventions may be required.

Effectiveness of a multimodal standard nursing program on health-related quality of life in Chinese mainland female patients with breast cancer: protocol for a single-blind cluster randomized controlled trial.

PubMed

Zhou, Kaina; Wang, Duolao; He, Xiaole; Huo, Lanting; An, Jinghua; Li, Minjie; Wang, Wen; Li, Xiaomei

2016-08-31

Breast cancer and its treatment-related adverse effects are harmful to physical, psychological, and social functioning, leading to health-related quality of life (HRQoL) impairment in patients. Many programs have been used with this population for HRQoL improvement; however, few studies have considered the physical, psychological, and social health domains comprehensively, and few have constructed multimodal standard nursing interventions based on specific theories. The purpose of this trial is to examine the effect of a health belief model (HBM)-based multimodal standard nursing program (MSNP) on HRQoL in female patients with breast cancer. This is a two-arm single-blind cluster randomized controlled trial (cRCT) in clinical settings. Twelve tertiary hospitals will be randomly selected from the 24 tertiary hospitals in Xi'an, China, and allocated to the intervention arm and control arm using a computer-generated random numbers table. Inpatient female patients with breast cancer from each hospital will receive either MSNP plus routine nursing care immediately after recruitment (intervention arm), or only routine nursing care (control arm). The intervention will be conducted by trained nurses for 12 months. All recruited female patients with breast cancer, participating clinical staff, and trained data collectors from the 12 hospitals will be blind with respect to group allocation. Patients of the control arm will not be offered any information about the MSNP during the study period to prevent bias. The primary outcome is HRQoL measured through the Functional Assessment of Cancer Therapy-Breast version 4.0 at 12 months. Secondary outcomes include pain, fatigue, sleep, breast cancer-related lymphedema, and upper limb function, which are evaluated by a visual analogue scale, the circumference method, and the Constant-Murley Score. This trial will provide important evidence on the effectiveness of multimodal nursing interventions delivered by nurses in clinical settings. Study findings will inform strategies for scaling up comprehensive standard intervention programs on health management in the population of female patients with breast cancer. Chictr.org.cn ChiCTR-IOR-16008253 (April 9, 2016).

An Intergroup Randomized Phase II Study of Bevacizumab or Cetuximab in Combination with Gemcitabine and in Combination with Chemoradiation in Patients with Resected Pancreatic Carcinoma: A Trial of the ECOG-ACRIN Cancer Research Group (E2204).

PubMed

Berlin, Jordan D; Feng, Yang; Catalano, Paul; Abbruzzese, James L; Philip, Philip A; McWilliams, Robert R; Lowy, Andrew M; Benson, Al B; Blackstock, A William

2018-01-01

Evaluate toxicity of two treatment arms, A (cetuximab) and B (bevacizumab), when combined with gemcitabine, and chemoradiation in patients with completely resected pancreatic carcinoma. Secondary objectives included overall survival (OS) and disease-free survival (DFS). Patients with R0/R1 resection were randomized 1:1 to cetuximab or bevacizumab administered in combination with gemcitabine for two treatment cycles. Next three cycles included concurrent cetuximab/bevacizumab plus chemoradiation, followed by one cycle of cetuximab/bevacizumab. Cycles 7-12 included cetuximab/bevacizumab with gemcitabine. Cycles were 2 weeks. Frequency of specific toxicities was summarized for each treatment arm at two times during the study, after chemotherapy but prior to chemoradiation and after all therapy. A total of 127 patients were randomized (A, n = 65; B, n = 62). Prior to chemoradiation, the overall rate for toxicities of interest was 10% for arm A and 2% for arm B. After all therapy, the overall rates for toxicities of interest were 30 and 25% for arms A and B, respectively. Overall median OS and DFS were 17 and 11 months, respectively, which is not a significant improvement over expected survival rates for historical controls. Both treatments were tolerable with manageable toxicities, and were safe enough for a phase III trial had this been indicated. © 2017 S. Karger AG, Basel.

Do early changes in the HAM-D-17 anxiety/somatization factor items affect the treatment outcome among depressed outpatients? Comparison of two controlled trials of St John's wort (Hypericum perforatum) versus a SSRI.

PubMed

Bitran, Stella; Farabaugh, Amy H; Ameral, Victoria E; LaRocca, Rachel A; Clain, Alisabet J; Fava, Maurizio; Mischoulon, David

2011-07-01

To assess whether early changes in Hamilton Depression Rating Scale-17 anxiety/somatization items predict remission in two controlled studies of Hypericum perforatum (St John's wort) versus selective serotonin reuptake inhibitors for major depressive disorder. The Hypericum Depression Trial Study Group (National Institute of Mental Health) randomized 340 patients to Hypericum, sertraline, or placebo for 8 weeks, whereas the Massachusetts General Hospital study randomized 135 patients to Hypericum, fluoxetine, or placebo for 12 weeks. The investigators examined whether remission was associated with early changes in anxiety/somatization symptoms. In the National Institute of Mental Health study, significant associations were observed between remission and early improvement in the anxiety (psychic) item (sertraline arm), somatic (gastrointestinal item; Hypericum arm), and somatic (general) symptoms (placebo arm). None of the three treatment arms of the Massachusetts General Hospital study showed significant associations between anxiety/somatization symptoms and remission. When both study samples were pooled, we found associations for anxiety (psychic; selective serotonin reuptake inhibitors arm), somatic (gastrointestinal), and hypochondriasis (Hypericum arm), and anxiety (psychic) and somatic (general) symptoms (placebo arm). In the entire sample, remission was associated with the improvement in the anxiety (psychic), somatic (gastrointestinal), and somatic (general) items. The number and the type of anxiety/somatization items associated with remission varied depending on the intervention. Early scrutiny of the Hamilton Depression Rating Scale-17 anxiety/somatization items may help to predict remission of major depressive disorder.

A randomized study to compare sequential chemoradiotherapy with concurrent chemoradiotherapy for unresectable locally advanced esophageal cancer.

PubMed

Gupta, Arunima; Roy, Somnath; Majumdar, Anup; Hazra, Avijit; Mallik, Chandrani

2014-01-01

Chemotherapy combined with radiotherapy can improve outcome in locally advanced esophageal cancer. This study aimed to compare efficacy and toxicity between concurrent chemoradiotherapy (CCRT) and sequential chemoradiotherapy (SCRT) in unresectable, locally advanced, esophageal squamous cell carcinoma (ESSC). Forty-one patients with unresectable, locally advanced ESCC were randomized into two arms. In the CCRT arm (Arm A), 17 patients received 50.4 Gy at 1.8 Gy per fraction over 5.6 weeks along with concurrent cisplatin (75 mg m(-2) intravenously on day 1 and 5-fluorouracil (1000 mg m(-2) continuous intravenous infusion on days 1-4 starting on the first day of irradiation and given after 28 days. In the SCRT arm (Arm B), 20 patients received two cycles of chemotherapy, using the same schedule, followed by radiotherapy fractionated in a similar manner. The endpoints were tumor response, acute and late toxicities, and disease-free survival. With a median follow up of 12.5 months, the complete response rate was 82.4% in Arm A and 35% in Arm B (P = 0.003). Statistically significant differences in frequencies of acute skin toxicity (P = 0.016), gastrointestinal toxicity (P = 0.005) and late radiation pneumonitis (P = 0.002) were found, with greater in the CCRT arm. A modest but non-significant difference was observed in median time to recurrence among complete responders in the two arms (Arm A 13 months and Arm B 15.5 months, P = 0.167) and there was also no significant difference between the Kaplan Meier survival plots (P = 0.641) of disease-free survival. Compared to sequential chemoradiotherapy, concurrent chemoradiotherapy can significantly improve local control rate but with greater risk of adverse reactions.

A cluster randomized trial to determine the effectiveness of a novel, digital pendant and voice reminder platform on increasing infant immunization adherence in rural Udaipur, India.

PubMed

Nagar, Ruchit; Venkat, Preethi; Stone, Logan D; Engel, Kyle A; Sadda, Praneeth; Shahnawaz, Mohammed

2017-11-18

Five hundred thousand children under the age of 5 die from vaccine preventable diseases in India every year. More than just improving coverage, increasing timeliness of immunizations is critical to ensuring infant health in the first year of life. Novel, culturally appropriate community engagement strategies are worth exploring to close the immunization gap. In our study, a digital NFC (Near Field Communication) pendant worn on black thread and voice call reminder system was tested for the effectiveness in improving DTP3 adherence within 2 monthly camps from DTP1 administration. A cluster randomized controlled trial was conducted in which 96 village health camps were randomized to 3 arms: NFC sticker, NFC pendant, and NFC pendant with voice call reminder in local dialect. Randomization was done across 5 blocks in the Udaipur District serviced by Seva Mandir from August 2015 to April 2016. In terms of our three primary outcomes related to DTP3 adherence, point estimates show conflicting results. Two outcomes presented adherence in the control. DTP3 completion within two camps after DTP1 showed higher adherence in the Control (Sticker) (74.2%) arm compared to the Pendant (67.2%) and Pendant and Voice arms (69.3%). Likewise, the estimate for DTP3 completion within 180 days of birth in the Control (Sticker) (69.4%) arm was higher than estimates in the Pendant (57.4%) and Pendant and Voice arms (58.7%). However, one outcome displayed higher adherence in the intervention. DTP3 completion within two months from the time of registration was higher in the Pendant (37.7%) and Pendant and Voice arms (38.7%) compared to the Control (Sticker) arm (27.4%). In all primary outcomes, differences in adherence were statistically insignificant both before and after controlling for confounding factors. In terms of secondary outcomes, our results suggest that providing a necklace generated significant community discussion (H = 8.8796, df = 2, p = .0118), had strong satisfaction among users (χ2=26.039, df = 4, p < .0001), and resulted in increased visibility within families (grandmothers:χ2=34.023, df = 2, p < .0001, fathers: χ2=34.588, df = 2, p < .0001). Neither the NFC necklace nor the necklace with additional voice call reminders in the local dialect directly resulted in an increase in infant immunization timeliness through DTP3, the primary outcome. Still our process outcomes suggest that our culturally symbolic necklace has potential to be an assistive tool in immunization campaigns. Follow-on work will seek to examine whether positive behavior change towards vaccines can be fostered with earlier engagement of this platform beginning in the prenatal stage, under a continuum of care framework. Copyright © 2017. Published by Elsevier Ltd.

Social Media and Peer-Reviewed Medical Journal Readership: A Randomized Prospective Controlled Trial.

PubMed

Hawkins, C Matthew; Hunter, Makeba; Kolenic, Giselle E; Carlos, Ruth C

2017-05-01

To prospectively evaluate the impact of increasing levels of social media engagement on page visits and web-link clicks for content published in the Journal of the American College of Radiology. A three-arm prospective trial was designed using a control group, a basic Twitter intervention group (using only the Journal's @JACRJournal Twitter account), and an enhanced Twitter intervention group (using the personal Twitter accounts of editorial board members and trainees). Overall, 428 articles published between June 2013 and July 2015 were randomly assigned to the three groups. Article-specific tweets for both intervention arms were sent between September 14, 2015, and October 28, 2015. Primary end points included article-specific weekly and monthly page visits on the journal's Elsevier website (Amsterdam, Netherlands). For the two intervention groups, additional end points included 7-day and 30-day Twitter link clicks. Weekly page visits for the enhanced Twitter arm (mean 18.2; 95% confidence interval [CI] 15.6-20.7) were significantly higher when compared with the weekly page visits for the control arm (mean 7.6; 95% CI 1.7-13.6). However, there was no demonstrable increase in weekly page visits (mean 9.4; 95% CI 7.4-11.5) for the basic Twitter arm compared with the control arm. No intervention effects over control, regardless of Twitter arm assignment, were demonstrated for monthly page visits. The enhanced Twitter intervention resulted in a statistically significant increase in both 7-day and 30-day Twitter link clicks compared with the basic Twitter intervention group. An organized social media strategy, with focused social media activity from editorial board members, increased engagement with content published in a peer-reviewed radiology journal. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Enhancing activities of daily living of chronic stroke patients in primary health care by modified constraint-induced movement therapy (HOMECIMT): study protocol for a cluster randomized controlled trial

PubMed Central

2013-01-01

Background Stroke leads to constant rehabilitation needs even at the chronic stage. However, although many stroke patients receive physical or occupational therapy in primary health care, treatment prescriptions do not generally specify therapeutic goals; in particular, participation is not established as an explicit therapeutic goal in the ambulatory setting. The primary aim of this study is to evaluate the efficacy of a therapy regimen for chronic stroke patients (modified ‘constraint-induced movement therapy (CIMT) at home’) with impaired hand or arm function with regard to the prerequisites of participation in everyday activities: a sufficient arm and hand function. ‘CIMT at home’ will be compared with conventional physical and occupational therapy (‘therapy as usual’). Methods/design The study is a parallel cluster randomized controlled trial with therapy practices as clusters (n = 48). After written consent from the patients (n = 144), the therapists will be randomly assigned to treat either the intervention or the control group. Blinded external assessors will evaluate the patients using standardized outcome measures before and after the intervention, and six months later. The two coprimary endpoint assessments of arm and hand function as prerequisites for participation (defined as equal involvement in activities of daily living) are the motor activity log (quality of arm and hand use) and the Wolf motor function test (arm and hand function). These assessments are made four weeks post-treatment and relativized to baseline performance. Changes in primary outcomes will be analyzed with mixed models, which consider the hierarchical structure of the data and will be adjusted to the baseline measurements and sex. The primary analysis will be the comparison of the two randomized groups, with respect to the adjusted averages for each of the two coprimary endpoints. To keep an overall significance level of 5%, the two endpoints will be tested at the significance level of 5% each in hierarchical order. Discussion A modification of the CIMT, feasible in the patients’ homes (CIMT at home), appears to be a promising therapeutic approach in the ambulatory care of chronic stroke patients. With proven efficacy and practicality, a participation-oriented, stroke-specific treatment would be available in primary care. Trial registration ClinicalTrials.gov NCT01343602 PMID:24124993

Video on Diet Before Outpatient Colonoscopy Does Not Improve Quality of Bowel Preparation: A Prospective, Randomized, Controlled Trial.

PubMed

Rice, Sean C; Higginbotham, Tina; Dean, Melanie J; Slaughter, James C; Yachimski, Patrick S; Obstein, Keith L

2016-11-01

Successful outpatient colonoscopy (CLS) depends on many factors including the quality of a patient's bowel preparation. Although education on consumption of the pre-CLS purgative can improve bowel preparation quality, no study has evaluated dietary education alone. We have created an educational video on pre-CLS dietary instructions to determine whether dietary education would improve outpatient bowel preparation quality. A prospective randomized, blinded, controlled study of patients undergoing outpatient CLS was performed. All patients received a 4 l polyethylene glycol-based split-dose bowel preparation and standard institutional pre-procedure instructions. Patients were then randomly assigned to an intervention arm or to a no intervention arm. A 4-min educational video detailing clear liquid diet restriction was made available to patients in the intervention arm, whereas those randomized to no intervention did not have access to the video. Patients randomized to the video were provided with the YouTube video link 48-72 h before CLS. An attending endoscopist blinded to randomization performed the CLS. Bowel preparation quality was scored using the Boston Bowel Preparation Scale (BBPS). Adequate preparation was defined as a BBPS total score of ≥6 with all segment scores ≥2. Wilcoxon rank-sum and Pearson's χ 2 -tests were performed to assess differences between groups. Ninety-two patients were randomized (video: n=42; control: n=50) with 47 total video views being tallied. There were no demographic differences between groups. There was no statistically significant difference in adequate preparation between groups (video=74%; control=68%; P=0.54). The availability of a supplementary patient educational video on clear liquid diet alone was insufficient to improve bowel preparation quality when compared with standard pre-procedure instruction at our institution.

Mobile critical care recovery program (m-CCRP) for acute respiratory failure survivors: study protocol for a randomized controlled trial.

PubMed

Khan, Sikandar; Biju, Ashok; Wang, Sophia; Gao, Sujuan; Irfan, Omar; Harrawood, Amanda; Martinez, Stephanie; Brewer, Emily; Perkins, Anthony; Unverzagt, Frederick W; Lasiter, Sue; Zarzaur, Ben; Rahman, Omar; Boustani, Malaz; Khan, Babar

2018-02-07

Patients admitted to intensive care units (ICU) with acute respiratory failure (ARF) face chronic complications that can impede return to normal daily function. A mobile, collaborative critical care model may enhance the recovery of ARF survivors. The Mobile Critical Care Recovery Program (m-CCRP) study is a two arm, randomized clinical trial. We will randomize 620 patients admitted to the ICU with acute respiratory failure requiring mechanical ventilation in a 1:1 ratio to one of two arms (310 patients per arm) - m-CCRP intervention versus attention control. Those in the intervention group will meet with a care coordinator after hospital discharge in predetermined intervals to aid in the recovery process. Baseline assessments and personalized goal setting will be used to develop an individualized care plan for each patient after discussion with an interdisciplinary team. The attention control arm will receive printed material and telephone reminders emphasizing mobility and management of chronic conditions. Duration of the intervention and follow-up is 12 months post-randomization. Our primary aim is to assess the efficacy of m-CCRP in improving the quality of life of ARF survivors at 12 months. Secondary aims of the study are to evaluate the efficacy of m-CCRP in improving function (cognitive, physical, and psychological) of ARF survivors and to determine the efficacy of m-CCRP in reducing acute healthcare utilization. The proposed randomized controlled trial will evaluate the efficacy of a collaborative critical care recovery program in accomplishing the Institute of Healthcare Improvement's triple aims of better health, better care, at lower cost. We have developed a collaborative critical care model to promote ARF survivors' recovery from the physical, psychological, and cognitive impacts of critical illness. In contrast to a single disease focus and clinic-based access, m-CCRP represents a comprehensive, accessible, mobile, ahead of the curve intervention, focused on the multiple aspects of the unique recovery needs of ARF survivors. NCT03053245 , clinicaltrials.gov, registered February 1, 2017.

Strengthening malaria service delivery through supportive supervision and community mobilization in an endemic Indian setting: an evaluation of nested delivery models.

PubMed

Das, Ashis; Friedman, Jed; Kandpal, Eeshani; Ramana, Gandham N V; Gupta, Rudra Kumar Das; Pradhan, Madan M; Govindaraj, Ramesh

2014-12-08

Malaria continues to be a prominent global public health challenge. This study tested the effectiveness of two service delivery models for reducing the malaria burden, e.g. supportive supervision of community health workers (CHW) and community mobilization in promoting appropriate health-seeking behaviour for febrile illnesses in Odisha, India. The study population comprised 120 villages from two purposively chosen malaria-endemic districts, with 40 villages randomly assigned to each of the two treatment arms, one with both supportive supervision and community mobilization and one with community mobilization alone, as well as an observational control arm. Outcome measures included changes in the utilization of bed nets and timely care-seeking for fever from a trained provider compared to the control group. Analysis was by intention-to-treat. Significant improvements were observed in the reported utilization of bed nets in both intervention arms (84.5% in arm A and 82.4% in arm B versus 78.6% in the control arm; p < 0.001). While overall rates of treatment-seeking were equal across study arms, treatment-seeking from a CHW was higher in both intervention arms (28%; p = 0.005 and 27.6%; p = 0.007) than in the control arm (19.2%). Fever cases were significantly more likely to visit a CHW and receive a timely diagnosis of fever in the combined interventions arm than in the control arm (82.1% vs. 67.1%; p = 0.025). Care-seeking from trained providers also increased with a substitution away from untrained providers. Further, fever cases from the combined interventions arm (60.6%; p = 0.004) and the community mobilization arm (59.3%; p = 0.012) were more likely to have received treatment from a skilled provider within 24 hours than fever cases from the control arm (50.1%). In particular, women from the combined interventions arm were more likely to have received timely treatment from a skilled provider (61.6% vs. 47.2%; p = 0.028). A community-based intervention combining the supportive supervision of community health workers with intensive community mobilization and can be effective in improving care-seeking and preventive behaviour and may be used to strengthen the national malaria control programme.

Evaluation of a spirituality informed e-mental health tool as an intervention for major depressive disorder in adolescents and young adults - a randomized controlled pilot trial.

PubMed

Rickhi, Badri; Kania-Richmond, Ania; Moritz, Sabine; Cohen, Jordan; Paccagnan, Patricia; Dennis, Charlotte; Liu, Mingfu; Malhotra, Sonya; Steele, Patricia; Toews, John

2015-12-24

Depression in adolescents and young adults is a major mental health condition that requires attention. Research suggests that approaches that include spiritual concepts and are delivered through an online platform are a potentially beneficial approach to treating/managing depression in this population. The purpose of this study was to evaluate the effectiveness of an 8-week online spirituality informed e-mental health intervention (the LEAP Project) on depression severity, and secondary outcomes of spiritual well-being and self-concept, in adolescents and young adults with major depressive disorder of mild to moderate severity. A parallel group, randomized, waitlist controlled, assessor-blinded clinical pilot trial was conducted in Calgary, Alberta, Canada. The sample of 62 participants with major depressive disorder (DSM-IV-TR) was defined by two age subgroups: adolescents (ages 13 to 18 years; n = 31) and young adults (ages 19 to 24 years; n = 31). Participants in each age subgroup were randomized into the study arm (intervention initiated upon enrolment) or the waitlist control arm (intervention initiated after an 8-week wait period). Comparisons were made between the study and waitlist control arms at week 8 (the point where study arm had completed the intervention and the waitlist control arm had not) and within each arm at four time points over 24-week follow-up period. At baseline, there was no statistical difference between study and waitlist participants for both age subgroups for all three outcomes of interest. After the intervention, depression severity was significantly reduced; comparison across arms at week 8 and over time within each arm and both age subgroups. Spiritual well-being changes were not significant, with the exception of an improvement over time for the younger participants in the study arm (p = 0.01 at week 16 and p = 0.0305 at week 24). Self-concept improved significantly for younger participants immediately after the intervention (p = 0.045 comparison across arms at week 8; p = 0.0175 in the waitlist control arm) and over time in the study arm (p = 0.0025 at week 16). In the older participants, change was minimal, with the exception of a significant improvement in one of six factors (vulnerability) in study arm over time (p = 0.025 at week 24). The results of the LEAP Project pilot trial suggest that it is an effective, online intervention for youth ages 13 to 24 with mild to moderate major depressive disorder with various life situations and in a limited way on spiritual well-being and self-concept. ClinicalTrials.gov NCT00985686. Registered 24 September 2009.

Effects of 6 months of resveratrol versus placebo on pentraxin 3 in patients with type 2 diabetes mellitus: a double-blind randomized controlled trial.

PubMed

Bo, S; Ponzo, V; Evangelista, A; Ciccone, G; Goitre, I; Saba, F; Procopio, M; Cassader, M; Gambino, R

2017-05-01

The anti-inflammatory effects of the polyphenol resveratrol in patients with type 2 diabetes mellitus (T2DM) are controversial. Its role on pentraxin 3 (PTX3) concentrations, a human acute phase protein, has never been evaluated. Our aim was to determine whether a two-dosage resveratrol supplementation (500 and 40 mg/day) has an impact on PTX3 values in T2DM patients from a double-blind randomized placebo-controlled trial. Variations in total antioxidant status (TAS) were evaluated too. A total of 192 T2DM patients were randomized to receive resveratrol 500 mg/day (Resv 500 arm), resveratrol 40 mg/day (Resv 40 arm) or placebo for 6 months. At baseline and at the trial end, PTX3 and TAS values were determined. A dose-dependent increase in PTX3 concentrations of 4.7% (Resv 40 arm) and 26.3% (Resv 500 arm), and 8.0% reduction after placebo were found. Adjusted mean differences of change versus placebo were 0.16 (95% CI 0.01-0.32) and 0.25 (0.09-0.42) in the Resv 40 and Resv 500 arms, respectively. At subgroup analyses, lower diabetes duration, aspirin, alcohol use, younger age, female gender, smoking (Resv 500 arm) and female gender and aspirin use (Resv 40 arm) were associated with higher PTX3 increments. A dose-dependent increment in TAS values in the resveratrol arms (1.4 and 6.4% for Resv 40 and Resv 500, respectively), and a reduction in placebo arm (-8.9%) were observed. Adjusted mean differences of change were 28.5 (95% CI 10.1-46.8) and 44.8 (25.4-64.1) in the Resv 40 and Resv 500 arms, respectively. Resveratrol supplementation increased PTX3 and TAS levels in a dose-dependent manner in T2DM patients. At present, potential clinical implications of these results remain unclear. CLINICALTRIALS. NCT02244879.

Impact of advance care planning on the care of patients with heart failure: study protocol for a randomized controlled trial.

PubMed

Malhotra, Chetna; Sim, David Kheng Leng; Jaufeerally, Fazlur; Vikas, Nivedita Nadkarni; Sim, Genevieve Wong Cheng; Tan, Boon Cheng; Ng, Clarice Shu Hwa; Tho, Pei Leng; Lim, Jingfen; Chuang, Claire Ya-Ting; Fong, Florence Hui Mei; Liu, Joy; Finkelstein, Eric A

2016-06-10

Despite the promise and popularity of advance care planning, there is insufficient evidence that advance care planning helps patients to meet their end-of-life care preferences, especially in Asian settings. Thus, the proposed study aims to assess whether patients with advanced heart failure who are receiving advance care planning have a greater likelihood of receiving end-of-life care consistent with their preferences compared to patients receiving usual care. Secondary objectives are to compare differences in health care expenditures, quality of life, anxiety and depression, understanding of own illness, participation in decision-making and concordance with their caregiver's preferences for end-of-life care, between patients with advanced heart failure receiving advance care planning and usual care. This is a two-arm randomized controlled trial of advance care planning versus usual care (control) conducted at two institutions in Singapore. Two hundred and eighty-two patients with advanced heart failure (n = 94 in the advance care planning arm; n = 188 in the control arm receiving usual care) will be recruited from these centers and followed for 1 year or until they die, whichever is earlier. Additionally, the study will include up to one caregiver per patient enrolled. If advance care planning is proven to be effective, the results will help to promote its uptake among health care providers and patients both within Singapore and in other countries. NCT02299180 . Registered on 18 November 2014.

A novel community-based study to address disparities in hypertension and colorectal cancer: a study protocol for a randomized control trial

PubMed Central

2013-01-01

Background Black men have the greatest burden of premature death and disability from hypertension (HTN) in the United States, and the highest incidence and mortality from colorectal cancer (CRC). While several clinical trials have reported beneficial effects of lifestyle changes on blood pressure (BP) reduction, and improved CRC screening with patient navigation (PN), the effectiveness of these approaches in community-based settings remains understudied, particularly among Black men. Methods/design MISTER B is a two-parallel-arm randomized controlled trial that will compare the effect of a motivational interviewing tailored lifestyle intervention (MINT) versus a culturally targeted PN intervention on improvement of BP and CRC screening among black men aged ≥50 with uncontrolled HTN who are eligible for CRC screening. Approximately 480 self-identified black men will be randomly assigned to one of the two study conditions. This innovative research design allows each intervention to serve as the control for the other. Specifically, the MINT arm is the control condition for the PN arm, and vice-versa. This novel, simultaneous testing of two community-based interventions in a randomized fashion is an economical and yet rigorous strategy that also enhances the acceptability of the project. Participants will be recruited during scheduled screening events at barbershops in New York City. Trained research assistants will conduct the lifestyle intervention, while trained community health workers will deliver the PN intervention. The primary outcomes will be 1) within-patient change in systolic and diastolic BP from baseline to six months and 2) CRC screening rates at six months. Discussion This innovative study will provide a unique opportunity to test two interventions for two health disparities simultaneously in community-based settings. Our study is one of the first to test culturally targeted patient navigation for CRC screening among black men in barbershops. Thus, our study has the potential to improve the reach of hypertension control and cancer prevention efforts within a high-risk population that is under-represented in primary care settings. Trial registration ClinicalTrials.gov, NCT01092078 PMID:24011142

Efficacy of tandospirone in patients with irritable bowel syndrome-diarrhea and anxiety

PubMed Central

Lan, Ling; Chen, Yu-Long; Zhang, Hao; Jia, Bai-Ling; Chu, Yan-Jun; Wang, Jin; Tang, Shi-Xiao; Xia, Guo-Dong

2014-01-01

AIM: To investigate the efficacy of tandospirone in patients with irritable bowel syndrome-diarrhea (IBS-D) and anxiety in a prospective, randomized, controlled study. METHODS: Two hundred patients with IBS-D and moderate anxiety were randomized to receive pinaverium and tandospirone (arm A) or pinaverium and placebo (arm B). Tandospirone or placebo was given thrice daily at a fixed dose of 10 mg and pinaverium was given thrice daily at a fixed dose of 50 mg. The duration of treatment was 8 wk. Patients were assessed for abdominal pain and diarrhea. Anxiety was evaluated using the Hamilton Rating Scale for Anxiety (HAM-A). The primary study endpoints were response rates for abdominal pain and diarrhea. The secondary study endpoints were response rates for anxiety. Adverse events were also evaluated. RESULTS: One hundred and seventy of 200 patients (82 patients in arm A and 88 patients in arm B) completed the study. Demographic and baseline characteristics of the 200 participants were comparable in the two arms. At week 8, the overall response rate for abdominal pain and diarrhea was 52.0% for arm A and 37.0% for arm B (P < 0.05). The HAM-A score showed that the response rate was 61.0% for arm A and 21.0% for arm B (P < 0.01). The treatments were well tolerated and no significant adverse events were reported. CONCLUSION: Tandospirone is effective and can be combined with pinaverium in IBS-D patients with anxiety. PMID:25170231

The Impact of Peer Support and mp3 Messaging on Adherence to Inhaled Corticosteroids in Minority Adolescents with Asthma: A Randomized Controlled Trial

PubMed Central

Mosnaim, Giselle; Li, Hong; Martin, Molly; Richardson, DeJuran; Belice, Paula Jo; Avery, Elizabeth; Ryan, Norman; Bender, Bruce; Powell, Lynda

2013-01-01

Background Poor adherence to inhaled corticosteroids (ICS) is a critical risk factor contributing to asthma morbidity among low-income minority adolescents. Objective This trial tested whether peer support group meetings and peer asthma messages delivered via mp3 players improved adherence to ICS. Methods Low-income African American and/or Hispanic adolescents, ages 11–16, with persistent asthma, and poor (≤ 48%) adherence to prescription ICS during the 3-week run-in were randomized to intervention or attention control groups (ATG) for the 10-week treatment. During treatment, the intervention arm participated in weekly coping peer group support sessions and received mp3 peer-recorded asthma messages promoting adherence. The ATG participated in weekly meetings with a research assistant and received an equivalent number of mp3 doctor-recorded asthma messages. Adherence was measured using self-report and the DoserCT, (Meditrac, Inc.), an electronic dose counter. The primary outcome was the difference in adherence at 10 weeks between the two arms. Results Thirty-four subjects were randomized to each arm. At 10 weeks, no statistical difference in objectively measured adherence could be detected between the two arms adjusting for baseline adherence (P = 0.929). Adherence declined in both groups over the course of the active treatment period. Participants’ in both study arms self-reported adherence was significantly higher than their objectively measured adherence at week 10 (P < 0.0001). Conclusion Improving medication adherence in longitudinal studies is challenging. Peer support and mp3-delivered peer asthma messages may not be of sufficient dose to improve outcomes. PMID:24565620

Effects of repetitive transcranial magnetic stimulation combined with sensory cueing on unilateral neglect in subacute patients with right hemispheric stroke: a randomized controlled study.

PubMed

Yang, Nicole Yh; Fong, Kenneth Nk; Li-Tsang, Cecilia Wp; Zhou, D

2017-09-01

To compare the effects of rTMS combined with sensory cueing, rTMS alone, and conventional rehabilitation on unilateral neglect, hemiplegic arm functions and performance of activities of daily living. A single-blinded randomized controlled trial. A convalescent hospital. Sixty inpatients with left unilateral neglect after stroke. Patients were randomly assigned to three groups: rTMS combined with sensory cueing, rTMS, and conventional rehabilitation alone. rTMS at 1 Hz was applied over P5 of the contralesional hemisphere while vibration cueing was emitted using a wristwatch device on the hemiplegic arm, five days per week for two weeks. The first two groups received the same dosage of conventional rehabilitation on top of their experimental interventions. Blinded assessments were administered at baseline, 2 weeks postintervention, and 6 weeks follow-up. Neglect and arm motor performance. Both rTMS combined with sensory cueing (99.6±33.0) and rTMS alone (88.2±28.7) significantly reduced unilateral neglect than conventional rehabilitation (72.7±33.1) when measured using the conventional subtests of the Behavioural Inattention Test, but the combination was better than rTMS alone. Hemiplegic arm functions and activities of daily living improved in all patients across the three groups but no significant differences were found between the groups. The combination of inhibitory P5-rTMS with sensory cueing was better than either rTMS or conventional rehabilitation alone in producing a stronger and long-lasting improvement in unilateral neglect, but the improvement was not associated with improved arm function or independence in activities of daily living.

TROPICS 1: a phase III, randomized, double-blind, placebo-controlled study of tenecteplase for restoration of function in dysfunctional central venous catheters.

PubMed

Gabrail, Nashat; Sandler, Eric; Charu, Veena; Anas, Nick; Lim, Eduardo; Blaney, Martha; Ashby, Mark; Gillespie, Barbara S; Begelman, Susan M

2010-12-01

To evaluate the efficacy and safety of the thrombolytic tenecteplase, a fibrin-specific recombinant tissue plasminogen activator, for restoring function to dysfunctional central venous catheters (CVCs). In this double-blind, placebo-controlled study, eligible patients with dysfunctional nonhemodialysis CVCs were randomly assigned to two treatment arms. In the first arm (TNK-TNK-PBO), patients received an initial dose of intraluminal tenecteplase (TNK) (up to 2 mg), a second dose of tenecteplase if indicated, and a third placebo (PBO) dose. In the PBO-TNK-TNK arm, placebo was instilled first followed by up to two doses of tenecteplase, if needed, for restoration of catheter function. After administration of each dose, CVC function was assessed at 15, 30, and 120 minutes. There were 97 patients who received either TNK-TNK-PBO (n = 50) or PBO-TNK-TNK (n = 47). Within 120 minutes of initial study drug instillation, catheter function was restored to 30 patients (60%) in the TNK-TNK-PBO arm and 11 patients (23%) in the PBO-TNK-TNK arm, for a treatment difference of 37 percentage points (95% confidence interval 18-55; P = .0002). Cumulative restoration rates for CVC function increased to 87% after the second dose of tenecteplase in both study arms combined. Two patients developed a deep vein thrombosis (DVT) after exposure to tenecteplase; one DVT was considered to be drug related. No cases of intracranial hemorrhage, major bleeding, embolic events, catheter-related bloodstream infections, or catheter-related complications were reported. Tenecteplase was efficacious for restoration of catheter function in these study patients with dysfunctional CVCs. Copyright © 2010 SIR. Published by Elsevier Inc. All rights reserved.

Endometrial Injury May Increase the Pregnancy Rate in Patients Undergoing Intrauterine Insemination: An Interventional Randomized Clinical Trial.

PubMed

Bahaa Eldin, Ahmed M; Abdelmaabud, Karim H; Laban, Mohamed; Hassanin, Alaa S; Tharwat, Ahmed A; Aly, Tarek R; Elbohoty, Ahmed E; Elsayed, Helmy M; Ibrahim, Ahmed M; Ibrahim, Mohammed E; Sabaa, Haitham M; Abdelrazik, Azza A; Abdelhady, Ibrahim

2016-10-01

This study aimed to investigate the effect of endometrial injury using Pipelle catheter in the follicular phase (cycle day 5, 6, or 7) of the stimulation cycle on pregnancy rates in patients undergoing intrauterine insemination. This prospective randomized controlled study was carried out in the Assisted Reproductive Technology Unit of Ain Shams University Maternity Hospital, Cairo, Egypt, from July 1, 2013 to August 31, 2015. Three hundred sixty women, 20 to 35 years of age, with patent fallopian tubes, mild male factor infertility, or unexplained infertility were recruited. Participants were allocated randomly into 2 groups: experimental arm and control arm. Women in the experimental arm underwent endometrial biopsy using a Pipelle catheter on day 5, 6, or 7 of the stimulation cycle combined with intrauterine insemination. Women in the control group underwent intrauterine insemination with no endometrial biopsy done. The primary outcomes were the clinical and chemical pregnancy rates. Data of 344 participants were statistically analyzed. The chemical pregnancy rate was 23.66% in the experimental arm and 10.85% in the control arm (P = .002). The clinical pregnancy rate was 18.93% in the experimental arm and 7.42% in the control arm (P = .003). Endometrial injury using a Pipelle catheter in the stimulation cycle may improve pregnancy rates in women undergoing intrauterine insemination. © The Author(s) 2016.

Effects of anti-obesity drugs, diet, and exercise on weight-loss maintenance after a very-low-calorie diet or low-calorie diet: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Johansson, Kari; Neovius, Martin; Hemmingsson, Erik

2014-01-01

Weight-loss maintenance remains a major challenge in obesity treatment. The objective was to evaluate the effects of anti-obesity drugs, diet, or exercise on weight-loss maintenance after an initial very-low-calorie diet (VLCD)/low-calorie diet (LCD) period (<1000 kcal/d). We conducted a systematic review by using MEDLINE, the Cochrane Controlled Trial Register, and EMBASE from January 1981 to February 2013. We included randomized controlled trials that evaluated weight-loss maintenance strategies after a VLCD/LCD period. Two authors performed independent data extraction by using a predefined data template. All pooled analyses were based on random-effects models. Twenty studies with a total of 27 intervention arms and 3017 participants were included with the following treatment categories: anti-obesity drugs (3 arms; n = 658), meal replacements (4 arms; n = 322), high-protein diets (6 arms; n = 865), dietary supplements (6 arms; n = 261), other diets (3 arms; n = 564), and exercise (5 arms; n = 347). During the VLCD/LCD period, the pooled mean weight change was -12.3 kg (median duration: 8 wk; range 3-16 wk). Compared with controls, anti-obesity drugs improved weight-loss maintenance by 3.5 kg [95% CI: 1.5, 5.5 kg; median duration: 18 mo (12-36 mo)], meal replacements by 3.9 kg [95% CI: 2.8, 5.0 kg; median duration: 12 mo (10-26 mo)], and high-protein diets by 1.5 kg [95% CI: 0.8, 2.1 kg; median duration: 5 mo (3-12 mo)]. Exercise [0.8 kg; 95% CI: -1.2, 2.8 kg; median duration: 10 mo (6-12 mo)] and dietary supplements [0.0 kg; 95% CI: -1.4, 1.4 kg; median duration: 3 mo (3-14 mo)] did not significantly improve weight-loss maintenance compared with control. Anti-obesity drugs, meal replacements, and high-protein diets were associated with improved weight-loss maintenance after a VLCD/LCD period, whereas no significant improvements were seen for dietary supplements and exercise.

Children Learning About Second-Hand Smoking: A Feasibility Cluster Randomized Controlled Trial.

PubMed

Huque, Rumana; Dogar, Omara; Cameron, Ian; Thomson, Heather; Amos, Amanda; Siddiqi, Kamran

2015-12-01

Exposure to second-hand smoke is a threat to children's health. We developed a school-based smoke-free intervention (SFI) to support families in implementing smoke-free homes in Bangladesh, and gathered preliminary evidence of its effectiveness. A feasibility cluster randomized controlled trial of SFI was conducted in 24 schools in Mirpur, an urban area within Dhaka. Using simple stratified randomization, schools were allocated to: Arm A (SFI only), Arm B (SFI plus reminders), and Arm C (the control group). A total of 781 year-5 children (10-12 years old) in the consenting schools, participated in the study. Outcomes including "smoke-free homes" and "social visibility" that is, not smoking in front of children at home were assessed through questionnaire-based children's surveys, administered by researchers, at baseline and at weeks 1, 12, 27, and 52 in all arms. "Smoke-free homes" were significantly higher in Arm A (odds ratio [OR] = 4.8; 95% CI = 2.6-9.0) and in Arm B (OR = 3.9; 95% CI = 2.0-7.5) than in Arm C, when controlled for the baseline levels, at year 1. Similarly, "social visibility" was significantly reduced in Arm A (OR = 5.8; 95% CI = 2.8-11.7) and in Arm B (OR = 7.2; 95% CI = 3.3-15.9) than Arm C, when controlled for the baseline levels, at year 1. We observed an increasing trend (Cochrane Armitage test statistic [Z] = 3.8; p < .0001) in homes becoming smoke-free with increasing intensity of the intervention (control < Arm A < Arm B), and a decreasing trend (Z = -5.13; p < .0001) in social visibility at homes. SFI has the potential to encourage children to negotiate a smoke-free environment in their homes. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Economic evaluation of a task-shifting intervention for common mental disorders in India

PubMed Central

Buttorff, Christine; Hock, Rebecca S; Weiss, Helen A; Naik, Smita; Araya, Ricardo; Kirkwood, Betty R; Chisholm, Daniel

2012-01-01

Abstract Objective To carry out an economic evaluation of a task-shifting intervention for the treatment of depressive and anxiety disorders in primary-care settings in Goa, India. Methods Cost–utility and cost–effectiveness analyses based on generalized linear models were performed within a trial set in 24 public and private primary-care facilities. Subjects were randomly assigned to an intervention or a control arm. Eligible subjects in the intervention arm were given psycho-education, case management, interpersonal psychotherapy and/or antidepressants by lay health workers. Subjects in the control arm were treated by physicians. The use of health-care resources, the disability of each subject and degree of psychiatric morbidity, as measured by the Revised Clinical Interview Schedule, were determined at 2, 6 and 12 months. Findings Complete data, from all three follow-ups, were collected from 1243 (75.4%) and 938 (81.7%) of the subjects enrolled in the study facilities from the public and private sectors, respectively. Within the public facilities, subjects in the intervention arm showed greater improvement in all the health outcomes investigated than those in the control arm. Time costs were also significantly lower in the intervention arm than in the control arm, whereas health system costs in the two arms were similar. Within the private facilities, however, the effectiveness and costs recorded in the two arms were similar. Conclusion Within public primary-care facilities in Goa, the use of lay health workers in the care of subjects with common mental disorders was not only cost–effective but also cost-saving. PMID:23226893

Bilateral coupling facilitates recovery of rhythmical movements from perturbation in healthy and post-stroke subjects.

PubMed

Ustinova, Ksenia I; Feldman, Anatol G; Levin, Mindy F

2013-06-01

The paretic arm of subjects with stroke has a decreased ability to quickly adapt to and recover from perturbations during rhythmical arm swinging. We investigated whether bilateral coupling in the synchronous motion of two arms may facilitate the restoration of rhythmical movement of the paretic arm in subjects with chronic hemiparesis due to stroke. While standing, stroke and age-matched healthy (control) subjects swung one or both arms synchronously at ~0.8 Hz from the shoulder joints. In randomly selected cycles, one arm was transiently arrested by an electromagnetic device when moving forward or backward. In the control group, bilateral swinging resumed faster than unilateral swinging regardless of which arm was perturbed. In the stroke group, this effect was observed only when the perturbation was applied to the paretic arm, suggesting that the motion of the non-paretic arm accelerated the recovery from perturbation of the paretic arm. In addition, bilateral swinging resumed after reduced anterior-posterior excursions of both arms in stroke subjects. Results confirm previous findings that bilateral swinging is normally guided by central changes in the referent configuration of the two arms that function as a single unit. As a consequence, both arms cooperate in recovery from perturbation of motion applied to one arm. Results also suggest that stroke-related brain damage alters the symmetry of bilateral interaction, resulting in deficits of inter-manual cooperative action. The involvement of the non-paretic arm could be beneficial for the recovery of swinging of both arms and may also facilitate movements of the paretic arm in certain tasks.

Optimization and evaluation of a proportional derivative controller for planar arm movement.

PubMed

Jagodnik, Kathleen M; van den Bogert, Antonie J

2010-04-19

In most clinical applications of functional electrical stimulation (FES), the timing and amplitude of electrical stimuli have been controlled by open-loop pattern generators. The control of upper extremity reaching movements, however, will require feedback control to achieve the required precision. Here we present three controllers using proportional derivative (PD) feedback to stimulate six arm muscles, using two joint angle sensors. Controllers were first optimized and then evaluated on a computational arm model that includes musculoskeletal dynamics. Feedback gains were optimized by minimizing a weighted sum of position errors and muscle forces. Generalizability of the controllers was evaluated by performing movements for which the controller was not optimized, and robustness was tested via model simulations with randomly weakened muscles. Robustness was further evaluated by adding joint friction and doubling the arm mass. After optimization with a properly weighted cost function, all PD controllers performed fast, accurate, and robust reaching movements in simulation. Oscillatory behavior was seen after improper tuning. Performance improved slightly as the complexity of the feedback gain matrix increased. Copyright 2009 Elsevier Ltd. All rights reserved.

Optimization and evaluation of a proportional derivative controller for planar arm movement

PubMed Central

Jagodnik, Kathleen M.; van den Bogert, Antonie J.

2013-01-01

In most clinical applications of functional electrical stimulation (FES), the timing and amplitude of electrical stimuli have been controlled by open-loop pattern generators. The control of upper extremity reaching movements, however, will require feedback control to achieve the required precision. Here we present three controllers using proportional derivative (PD) feedback to stimulate six arm muscles, using two joint angle sensors. Controllers were first optimized and then evaluated on a computational arm model that includes musculoskeletal dynamics. Feedback gains were optimized by minimizing a weighted sum of position errors and muscle forces. Generalizability of the controllers was evaluated by performing movements for which the controller was not optimized, and robustness was tested via model simulations with randomly weakened muscles. Robustness was further evaluated by adding joint friction and doubling the arm mass. After optimization with a properly weighted cost function, all PD controllers performed fast, accurate, and robust reaching movements in simulation. Oscillatory behavior was seen after improper tuning. Performance improved slightly as the complexity of the feedback gain matrix increased. PMID:20097345

Effects of Natural Sounds on Pain: A Randomized Controlled Trial with Patients Receiving Mechanical Ventilation Support.

PubMed

Saadatmand, Vahid; Rejeh, Nahid; Heravi-Karimooi, Majideh; Tadrisi, Sayed Davood; Vaismoradi, Mojtaba; Jordan, Sue

2015-08-01

Nonpharmacologic pain management in patients receiving mechanical ventilation support in critical care units is under investigated. Natural sounds may help reduce the potentially harmful effects of anxiety and pain in hospitalized patients. The aim of this study was to examine the effect of pleasant, natural sounds on self-reported pain in patients receiving mechanical ventilation support, using a pragmatic parallel-arm, randomized controlled trial. The study was conducted in a general adult intensive care unit of a high-turnover teaching hospital, in Tehran, Iran. Between October 2011 and June 2012, we recruited 60 patients receiving mechanical ventilation support to the intervention (n = 30) and control arms (n = 30) of a pragmatic parallel-group, randomized controlled trial. Participants in both arms wore headphones for 90 minutes. Those in the intervention arm heard pleasant, natural sounds, whereas those in the control arm heard nothing. Outcome measures included the self-reported visual analog scale for pain at baseline; 30, 60, and 90 minutes into the intervention; and 30 minutes post-intervention. All patients approached agreed to participate. The trial arms were similar at baseline. Pain scores in the intervention arm fell and were significantly lower than in the control arm at each time point (p < .05). Administration of pleasant, natural sounds via headphones is a simple, safe, nonpharmacologic nursing intervention that may be used to allay pain for up to 120 minutes in patients receiving mechanical ventilation support. Copyright © 2015 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Two-Year Outcomes of a Randomized, Family-Based Substance Use Prevention Trial for Asian American Adolescent Girls

PubMed Central

Fang, Lin; Schinke, Steven P.

2014-01-01

Asian Americans have been largely ignored in the prevention outcome literature. In this study, we tested a parent-child program with a sample of Asian American adolescent girls and their mothers, and evaluated the program’s efficacy on decreasing girls’ substance use, and modifying risk and protective factors at individual, family, and peer levels. One hundred and eight Asian American mother-daughter dyads recruited through online advertisements and from community service agencies were randomly assigned to an intervention arm (n = 56) or to a test-only control arm (n = 52). The intervention consisted of a nine-session substance abuse prevention program, delivered entirely online. Guided by family interaction theory, the prevention program aimed to strengthen the quality of girls’ relationships with their mothers while increasing girls’ resilience to resist substance use. Intent-to-treat analyses showed that at 2-year follow-up, intervention-arm dyads had significantly higher levels of mother-daughter closeness, mother-daughter communication, maternal monitoring, and family rules against substance use compared to the control-arm dyads. Intervention-arm girls also showed sustained improvement in self-efficacy and refusal skills, and had lower intentions to use substances in the future. Most important, intervention-arm girls reported fewer instances of alcohol and marijuana use, and prescription drug misuse relative to the control-arm girls. The study suggests that a culturally generic, family-based prevention program was efficacious in enhancing parent-child relationships, improving girls’ resiliency, and preventing substance use behaviors among Asian American girls. PMID:23276322

Two-year outcomes of a randomized, family-based substance use prevention trial for Asian American adolescent girls.

PubMed

Fang, Lin; Schinke, Steven P

2013-09-01

Asian Americans have been largely ignored in the prevention outcome literature. In this study, we tested a parent-child program with a sample of Asian American adolescent girls and their mothers, and evaluated the program's efficacy on decreasing girls' substance use and modifying risk and protective factors at individual, family, and peer levels. A total of 108 Asian American mother-daughter dyads recruited through online advertisements and from community service agencies were randomly assigned to an intervention arm (n = 56) or to a test-only control arm (n = 52). The intervention consisted of a nine-session substance abuse prevention program, delivered entirely online. Guided by family interaction theory, the prevention program aimed to strengthen the quality of girls' relationships with their mothers while increasing girls' resilience to resist substance use. Intent-to-treat analyses showed that at 2-year follow-up, intervention-arm dyads had significantly higher levels of mother-daughter closeness, mother-daughter communication, maternal monitoring, and family rules against substance use compared with the control-arm dyads. Intervention-arm girls also showed sustained improvement in self-efficacy and refusal skills and had lower intentions to use substances in the future. Most important, intervention-arm girls reported fewer instances of alcohol and marijuana use and prescription drug misuse relative to the control-arm girls. The study suggests that a culturally generic, family-based prevention program was efficacious in enhancing parent-child relationships, improving girls' resiliency, and preventing substance use behaviors among Asian American girls. PsycINFO Database Record (c) 2013 APA, all rights reserved.

Effects of Action Observational Training Plus Brain-Computer Interface-Based Functional Electrical Stimulation on Paretic Arm Motor Recovery in Patient with Stroke: A Randomized Controlled Trial.

PubMed

Kim, TaeHoon; Kim, SeongSik; Lee, ByoungHee

2016-03-01

The purpose of this study was to investigate whether action observational training (AOT) plus brain-computer interface-based functional electrical stimulation (BCI-FES) has a positive influence on motor recovery of paretic upper extremity in patients with stroke. This was a hospital-based, randomized controlled trial with a blinded assessor. Thirty patients with a first-time stroke were randomly allocated to one of two groups: the BCI-FES group (n = 15) and the control group (n = 15). The BCI-FES group administered to AOT plus BCI-FES on the paretic upper extremity five times per week during 4 weeks while both groups received conventional therapy. The primary outcomes were the Fugl-Meyer Assessment of the Upper Extremity, Motor Activity Log (MAL), Modified Barthel Index and range of motion of paretic arm. A blinded assessor evaluated the outcomes at baseline and 4 weeks. All baseline outcomes did not differ significantly between the two groups. After 4 weeks, the Fugl-Meyer Assessment of the Upper Extremity sub-items (total, shoulder and wrist), MAL (MAL-Activity of Use and Quality of Movement), Modified Barthel Index and wrist flexion range of motion were significantly higher in the BCI-FES group (p < 0.05). AOT plus BCI-based FES is effective in paretic arm rehabilitation by improving the upper extremity performance. The motor improvements suggest that AOT plus BCI-based FES can be used as a therapeutic tool for stroke rehabilitation. The limitations of the study are that subjects had a certain limited level of upper arm function, and the sample size was comparatively small; hence, it is recommended that future large-scale trials should consider stratified and lager populations according to upper arm function. Copyright © 2015 John Wiley & Sons, Ltd.

Randomized Sequential Individual Assignment in Social Experiments: Evaluating the Design Options Prospectively

ERIC Educational Resources Information Center

Lohr, Sharon L.; Zhu, Xiaoshu

2017-01-01

Many randomized experiments in the social sciences allocate subjects to treatment arms at the time the subjects enroll. Desirable features of the mechanism used to assign subjects to treatment arms are often (1) equal numbers of subjects in intervention and control arms, (2) balanced allocation for population subgroups and across covariates, (3)…

Stress Management and Resiliency Training (SMART) program among Department of Radiology faculty: a pilot randomized clinical trial.

PubMed

Sood, Amit; Sharma, Varun; Schroeder, Darrell R; Gorman, Brian

2014-01-01

To test the efficacy of a Stress Management and Resiliency Training (SMART) program for decreasing stress and anxiety and improving resilience and quality of life among Department of Radiology physicians. The study was approved by the institutional review board. A total of 26 Department of Radiology physicians were randomized in a single-blind trial to either the SMART program or a wait-list control arm for 12 weeks. The program involved a single 90-min group session in the SMART training with two follow-up phone calls. Primary outcomes measured at baseline and week 12 included the Perceived Stress Scale, Linear Analog Self-Assessment Scale, Mindful Attention Awareness Scale, and Connor-Davidson Resilience Scale. A total of 22 physicians completed the study. A statistically significant improvement in perceived stress, anxiety, quality of life, and mindfulness at 12 weeks was observed in the study arm compared to the wait-list control arm; resilience also improved in the active arm, but the changes were not statistically significant when compared to the control arm. A single session to decrease stress among radiologists using the SMART program is feasible. Furthermore, the intervention afforded statistically significant and clinically meaningful improvement in anxiety, stress, quality of life, and mindful attention. Further studies including larger sample size and longer follow-up are warranted. Copyright © 2014. Published by Elsevier Inc.

Building research capacity in Botswana: a randomized trial comparing training methodologies in the Botswana ethics training initiative.

PubMed

Barchi, Francis H; Kasimatis-Singleton, Megan; Kasule, Mary; Khulumani, Pilate; Merz, Jon F

2013-02-01

Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post- and pre-test scores were highly correlated (r = 0.65, p < 0.0001). Group assignment alone did not have an effect on test scores (p > 0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Completion of the case-based intervention improved respondents' test scores, with those who completed all six email cases scoring roughly 10% better than those who failed to complete this task and those in the control arm. There was only suggestive evidence that intensive case work improved ethical issue identification, although there was limited ability to assess this outcome due to a high drop-out rate.

Building research capacity in Botswana: a randomized trial comparing training methodologies in the Botswana ethics training initiative

PubMed Central

2013-01-01

Background Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. Methods University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Results Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post- and pre-test scores were highly correlated (r = 0.65, p < 0.0001). Group assignment alone did not have an effect on test scores (p > 0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Conclusions Completion of the case-based intervention improved respondents’ test scores, with those who completed all six email cases scoring roughly 10% better than those who failed to complete this task and those in the control arm. There was only suggestive evidence that intensive case work improved ethical issue identification, although there was limited ability to assess this outcome due to a high drop-out rate. PMID:23368699

Recovery in the Severely Impaired Arm Post-stroke after Mirror Therapy - a Randomized Controlled Study.

PubMed

Chan, Wing Chiu; Au-Yeung, Stephanie Suk Yin

2018-03-09

This study aimed to examine the effectiveness of mirror therapy (MT) on recovery in the severely impaired arm after stroke. Using single-blind randomized controlled design, patients with severely impaired arm within 1-month post-stroke were assigned to received MT (n=20) or control therapy (CT) (n=21), 30min. twice daily for 4 weeks in addition to conventional rehabilitation. During MT and CT, subjects practiced similar structured exercises in both arms, except that mirror reflection of the unaffected arm was the visual feedback for MT, but mirror was absent for CT so that subjects could watch both arms in exercise. Fugl-Meyer Assessment (FMA) and Wolf Motor Function Test (WMFT) were the outcome measurements. After the intervention, both MT and CT groups had significant arm recovery similarly in FMA (p=0.867), WMFT-Time (p=0.947) and WMFT-Functional Ability Scale (p=0.676). MT or CT which involved exercises concurrently for the paretic and unaffected arms during subacute stroke promoted similar motor recovery in the severely impaired arm.

Aprepitant as an add-on therapy in children receiving highly emetogenic chemotherapy: a randomized, double-blind, placebo-controlled trial.

PubMed

Bakhshi, Sameer; Batra, Atul; Biswas, Bivas; Dhawan, Deepa; Paul, Reeja; Sreenivas, Vishnubhatla

2015-11-01

Aprepitant, a neurokinin-1 receptor antagonist, in combination with 5 HT-3 antagonist and dexamethasone is recommended in adults receiving moderately and highly emetogenic chemotherapy to reduce chemotherapy-induced vomiting (CIV). Data for use of aprepitant in children is limited and hence aprepitant is not recommended by Pediatric Oncology Group of Ontario guidelines for prevention of CIV in children <12 years. A randomized, double-blind, placebo-controlled trial was conducted at a single center in chemotherapy naïve children (5-18 years) receiving highly emetogenic chemotherapy. All patients received intravenous ondansetron (0.15 mg/kg) and dexamethasone (0.15 mg/kg) prior to chemotherapy followed by oral ondansetron and dexamethasone. Patients randomly assigned to aprepitant arm received oral aprepitant (15-40 kg = days 1-3, 80 mg; 41-65 kg = day 1, 125 mg and days 2-3, 80 mg) 1 h before chemotherapy. Control group received placebo as add-on therapy. Primary outcome measure was the incidence of acute moderate to severe vomiting, which was defined as more than two vomiting episodes within 24 h after the administration of the first chemotherapy dose until 24 h after the last chemotherapy dose in the block. Complete response (CR) was defined as absence of vomiting and retching during the specified phase. Of the 96 randomized patients, three were excluded from analysis; 93 patients were analyzed (50 in aprepitant arm and 43 in placebo arm). Acute moderate and severe vomiting was reported in 72 % patients receiving placebo and 38 % patients receiving aprepitant (p = 0.001). Complete response rates during acute phase were significantly higher in aprepitant arm (48 vs. 12 %, p < 0.001). No major adverse effects were reported by patients/guardians. This double-blind, randomized, placebo-controlled trial shows that aprepitant significantly decreases the incidence of CIV during acute phase when used as an add-on drug with ondansetron and dexamethasone in children receiving highly emetogenic chemotherapy.

Effects of a behavioral intervention to reduce serodiscordant unsafe sex among HIV positive men who have sex with men: the Positive Connections randomized controlled trial study.

PubMed

Rosser, B R Simon; Hatfield, Laura A; Miner, Michael H; Ghiselli, Margherita E; Lee, Brian R; Welles, Seth L

2010-04-01

Few behavioral interventions have been conducted to reduce high-risk sexual behavior among HIV-positive Men who have Sex with Men (HIV+ MSM). Hence, we lack well-proven interventions for this population. Positive Connections is a randomized controlled trial (n = 675 HIV+ MSM) comparing the effects of two sexual health seminars--for HIV+ MSM and all MSM--with a contrast prevention video arm. Baseline, 6-, 12- and 18-month follow-up surveys assessed psychosexual variables and frequency of serodiscordant unprotected anal intercourse (SDUAI). At post-test, intentions to avoid transmission were significantly higher in the sexual health arms. However, SDUAI frequency decreased equally across arms. HIV+ MSM engaging in SDUAI at baseline were more likely to leave the study. Tailoring interventions to HIV+ MSM did not increase their effectiveness in this study. A sexual health approach appeared as effective as an untailored video-based HIV prevention intervention in reducing SDUAI among HIV+ MSM.

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound.

PubMed

Cyr, Amy E; Tucker, Natalia; Ademuyiwa, Foluso; Margenthaler, Julie A; Aft, Rebecca L; Eberlein, Timothy J; Appleton, Catherine M; Zoberi, Imran; Thomas, Maria A; Gao, Feng; Gillanders, William E

2016-08-01

Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era in which tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesized that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (arm 1) vs SLNB (arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial. Sixty-eight subjects were enrolled in the pilot phase of the trial (34 subjects in arm 1, no further staging; 32 subjects in arm 2, SLNB; and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40 to 80 years) in arm 1 and 59 years (range 31 to 81 years) in arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1 to 32 months). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (>2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm. Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial. Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound

PubMed Central

Cyr, Amy E; Tucker, Natalia; Ademuyiwa, Foluso; Margenthaler, Julie A; Aft, Rebecca L; Eberlein, Timothy J; Appleton, Catherine M; Zoberi, Imran; Thomas, Maria A; Gao, Feng; Gillanders, William E

2016-01-01

Background Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era where tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesize that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. Study Design Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (Arm 1) versus SLNB (Arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial. Results 68 subjects were enrolled in the pilot phase of the trial (34 subjects in Arm 1, no further staging; 32 subjects in Arm 2, SLNB, and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40-80) in Arm 1 and 59 years (range 31-81) in Arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1-32). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (> 2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm. Conclusions Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial. PMID:27212005

Epilation for Minor Trachomatous Trichiasis: Four-Year Results of a Randomised Controlled Trial

PubMed Central

Habtamu, Esmael; Rajak, Saul N.; Tadesse, Zerihun; Wondie, Tariku; Zerihun, Mulat; Guadie, Birhan; Gebre, Teshome; Kello, Amir Bedri; Callahan, Kelly; Mabey, David C. W.; Khaw, Peng T.; Gilbert, Clare E.; Weiss, Helen A.; Emerson, Paul M.; Burton, Matthew J.

2015-01-01

Background Trachomatous trichiasis (TT) needs to be managed to reduce the risk of vision loss. The long-term impact of epilation (a common traditional practice of repeated plucking of lashes touching the eye) in preventing visual impairment and corneal opacity from TT is unknown. We conducted a randomized controlled trial of epilation versus surgery for the management of minor TT (fewer than six lashes touching the eye) in Ethiopia. Here we report the four-year outcome and the effect on vision and corneal opacity. Methodology/ Principal Findings 1300 individuals with minor TT were recruited and randomly assigned to quality trichiasis surgery or repeated epilation using high quality epilation forceps by a trained person with good near vision. Participants were examined six-monthly for two-years, and then at four-years after randomisation. At two-years all epilation arm participants were offered free surgery. At four-years 1151 (88.5%) were re-examined: 572 (88%) and 579 (89%) from epilation and surgery arms, respectively. At that time, 21.1% of the surgery arm participants had recurrent TT; 189/572 (33%) of the epilation arm had received surgery, while 383 (67%) declined surgery and had continued epilating (“epilation-only”). Among the epilation-only group, 207 (54.1%) fully controlled their TT, 166 (43.3%) had minor TT and 10 (2.6%) had major TT (>5 lashes). There were no differences between participants in the epilation-only, epilation-to-surgery and surgery arm participants in changes in visual acuity and corneal opacity between baseline and four-years. Conclusions/ Significance Most minor TT participants randomised to the epilation arm continued epilating and controlled their TT. Change in vision and corneal opacity was comparable between surgery and epilation-only participants. This suggests that good quality epilation with regular follow-up is a reasonable second-line alternative to surgery for minor TT for individuals who either decline surgery or do not have immediate access to surgical treatment. PMID:25768796

Home-based interventions for black patients with uncontrolled hypertension: a cluster randomized controlled trial

PubMed Central

Feldman, Penny H; McDonald, Margaret V; Barrón, Yolanda; Gerber, Linda M; Peng, Timothy R

2016-01-01

Aim: Assess the comparative effectiveness of two blood pressure (BP) control interventions for black patients with uncontrolled hypertension. Patients & methods: A total of 845 patients were enrolled in a three-arm cluster randomized trial. On admission of an eligible patient, field nurses were randomized to usual care, a basic or augmented intervention. Results: Across study arms there were no significant 12 months differences in BP control rates (primary outcome) (25% usual care, 26% basic intervention, 22% augmented intervention); systolic BP (143.8 millimeters of mercury [mmHg], 146.9 mmHG, 143.9 mmHG, respectively); medication intensification (47, 43, 54%, respectively); or self-management score (18.7, 18.7, 17.9, respectively). Adjusted systolic BP dropped more than 10 mmHg from baseline to 12 months (155.5–145.4 mmHg) among all study participants. Conclusion: Neither the augmented nor basic intervention was more effective than usual care in improving BP control, systolic BP, medication intensification or patient self-management. Usual home care yielded substantial improvements, creating a high comparative effectiveness threshold. Clinical Trial Registration: NCT00139490. PMID:26946952

Randomized trial comparing two methods of re-irradiation after salvage surgery in head and neck squamous cell carcinoma: Once daily split-course radiotherapy with concomitant chemotherapy or twice daily radiotherapy with cetuximab.

PubMed

Tao, Yungan; Faivre, Laura; Laprie, Anne; Boisselier, Pierre; Ferron, Christophe; Jung, Guy Michel; Racadot, Séverine; Gery, Bernard; Even, Caroline; Breuskin, Ingrid; Bourhis, Jean; Janot, François

2018-05-18

A previous randomized trial in recurrent Head and Neck squamous-cell carcinoma (HNSCC) has shown re-irradiation combined with chemotherapy after salvage surgery significantly improved disease-free survival (DFS). The objective of this randomized trial was to compare two methods of re-irradiation in terms of toxicity and survival. Patients with recurrence/second primary in previously irradiated area were randomly allocated to receive either 60 Gy over 11 weeks with concomitant 5FU - hydroxyurea (VP-arm), or 60 Gy (1.2 Gy twice daily) over 5 weeks with cetuximab (HFR-arm). Primary endpoint was treatment interruption >15 days (acute toxicity). Twenty-six patients were included in VP-arm and 27 in HFR-arm. One patient in VP-arm experienced >15 days interruption due to toxicity, and none in HFR-arm. In both arms, all patients received at least 60 Gy. In VP-arm, 8/26 patients had chemotherapy delay and/or dose reduction. In HFR-arm, 4/27 patients had <6 cycles cetuximab. There was no significant difference in overall survival (Median OS: 37.4 months vs 21.9 months, p = 0.12). Toxicities and DFS were not different between 2 arms. Twice daily schedule of re-irradiation of 60 Gy/5 weeks with cetuximab was tolerable and no significant difference in treatment delays occurred between two arms. Copyright © 2018 Elsevier B.V. All rights reserved.

Randomized clinical trial of postoperative strontium-90 radiation therapy for pterygia: treatment using 30 Gy/3 fractions vs. 40 Gy/4 fractions.

PubMed

Nakamatsu, Kiyoshi; Nishimura, Yasumasa; Kanamori, Shuichi; Koike, Ryuta; Tachibana, Izumi; Nishikawa, Tatsuyuki; Shibata, Toru

2011-07-01

Postoperative adjuvant treatment with strontium-90 radiation therapy (RT) is a proven technique for reducing the recurrence of pterygium. This randomized trial was conducted to evaluate whether a total dose of 40 Gy provides a better local control rate than a total dose of 30 Gy for surgically resected pterygia. A single institutional randomized trial was conducted. Between 1999 and 2003, 74 pterygia in 71 patients were randomly allocated to 30 Gy/3 fractions/15 days (arm A) or to 40 Gy/4 fractions/22 days (arm B). Only primary pterygia for which RT could be started within 3 days of surgical resection were included. Postoperative RT was given by a strontium-90 eye applicator, and a dose of 10 Gy per fraction was delivered in weekly fractions (day 1, 8, 15, 22). Of the 74 pterygia treated, 73 in 70 patients were analyzed. Of the 73 pterygia, 41 were allocated to arm A, and the remaining 32 to arm B. The 2-year local control rates for arm A and arm B were 85% and 75%, respectively, without significant difference. No serious acute and late complications were noted in either arm. Our new standard fractionation for postoperative RT for pterygia is 30 Gy/3 fractions.

Intensified hand-hygiene campaign including soap-and-water wash may prevent acute infections in office workers, as shown by a recognized-exposure -adjusted analysis of a randomized trial.

PubMed

Hovi, Tapani; Ollgren, Jukka; Savolainen-Kopra, Carita

2017-01-09

Variable exposure to causative agents of acute respiratory (RTI) or gastrointestinal tract infections (GTI) is a significant confounding factor in the analysis of the efficacy of interventions concerning these infections. We had an exceptional opportunity to reanalyze a previously published dataset from a trial assessing the effect of enhanced hand hygiene on the occurrence of RTI or GTI in adults, after adjustment for reported exposure and other covariates. Twenty-one working units (designated clusters) each including at least 50 office employees, totaling 1,270 persons, were randomized into two intervention arms (either using water-and-soap or alcohol-rub in hand cleansing), or in the control arm. Self-reported data was collected through weekly emails and included own symptoms of RTI or GTI, and exposures to other persons with similar symptoms. Differences in the weekly occurrences of RTI and GTI symptoms between the arms were analyzed using multilevel binary regression model with log link with personal and cluster specific random effects, self-reported exposure to homologous disease, randomization triplet, and seasonality as covariates in the Bayesian framework. Over the 16 months duration of the trial, 297 persons in the soap and water arm, 238 persons in the alcohol-based hand rub arm, and 230 controls sent reports. The arms were similar in age distribution and gender ratios. A temporally-associated reported exposure strongly increased the risk of both types of infection in all trial arms. Persons in the soap-and-water arm reported a significantly - about 24% lower weekly prevalence of GTI than the controls whether they had observed an exposure or not during the preceding week, while for RTI, this intervention reduced the prevalence only during weeks without a reported exposure. Alcohol-rub did not affect the symptom prevalence. We conclude that while frequent and careful hand washing with soap and water partially protected office-working adults from GTI, the effect on RTI was only marginal in this study. Potential reasons for this difference include partially different transmission routes and a difference in the virus load. In this trial, frequent standardized hand rubbing with ethanol-based disinfectant did not reduce the weekly prevalence of either type of infections. ClinicalTrials.gov Identifier: NCT00821509, 12 March 2009.

Two biomarker-directed randomized trials in European and Chinese patients with nonsmall-cell lung cancer: the BRCA1-RAP80 Expression Customization (BREC) studies.

PubMed

Moran, T; Wei, J; Cobo, M; Qian, X; Domine, M; Zou, Z; Bover, I; Wang, L; Provencio, M; Yu, L; Chaib, I; You, C; Massuti, B; Song, Y; Vergnenegre, A; Lu, H; Lopez-Vivanco, G; Hu, W; Robinet, G; Yan, J; Insa, A; Xu, X; Majem, M; Chen, X; de Las Peñas, R; Karachaliou, N; Sala, M A; Wu, Q; Isla, D; Zhou, Y; Baize, N; Zhang, F; Garde, J; Germonpre, P; Rauh, S; ALHusaini, H; Sanchez-Ronco, M; Drozdowskyj, A; Sanchez, J J; Camps, C; Liu, B; Rosell, R

2014-11-01

In a Spanish Lung Cancer Group (SLCG) phase II trial, the combination of BRCA1 and receptor-associated protein 80 (RAP80) expression was significantly associated with outcome in Caucasian patients with nonsmall-cell lung cancer (NSCLC). The SLCG therefore undertook an industry-independent collaborative randomized phase III trial comparing nonselected cisplatin-based chemotherapy with therapy customized according to BRCA1/RAP80 expression. An analogous randomized phase II trial was carried out in China under the auspices of the SLCG to evaluate the effect of BRCA1/RAP80 expression in Asian patients. Eligibility criteria included stage IIIB-IV NSCLC and sufficient tumor specimen for molecular analysis. Randomization to the control or experimental arm was 1 : 1 in the SLCG trial and 1 : 3 in the Chinese trial. In both trials, patients in the control arm received docetaxel/cisplatin; in the experimental arm, patients with low RAP80 expression received gemcitabine/cisplatin, those with intermediate/high RAP80 expression and low/intermediate BRCA1 expression received docetaxel/cisplatin, and those with intermediate/high RAP80 expression and high BRCA1 expression received docetaxel alone. The primary end point was progression-free survival (PFS). Two hundred and seventy-nine patients in the SLCG trial and 124 in the Chinese trial were assessable for PFS. PFS in the control and experimental arms in the SLCG trial was 5.49 and 4.38 months, respectively [log rank P = 0.07; hazard ratio (HR) 1.28; P = 0.03]. In the Chinese trial, PFS was 4.74 and 3.78 months, respectively (log rank P = 0.82; HR 0.95; P = 0.82). Accrual was prematurely closed on the SLCG trial due to the absence of clinical benefit in the experimental over the control arm. However, the BREC studies provide proof of concept that an international, nonindustry, biomarker-directed trial is feasible. Thanks to the groundwork laid by these studies, we expect that ongoing further research on alternative biomarkers to elucidate DNA repair mechanisms will help define novel therapeutic approaches. NCT00617656/GECP-BREC and ChiCTR-TRC-12001860/BREC-CHINA. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Financial Incentives for Chronic Disease Management: Results and Limitations of 2 Randomized Clinical Trials With New York Medicaid Patients.

PubMed

VanEpps, Eric M; Troxel, Andrea B; Villamil, Elizabeth; Saulsgiver, Kathryn A; Zhu, Jingsan; Chin, Jo-Yu; Matson, Jacqueline; Anarella, Joseph; Roohan, Patrick; Gesten, Foster; Volpp, Kevin G

2018-01-01

To identify whether financial incentives promote improved disease management in Medicaid recipients diagnosed with hypertension or diabetes, respectively. Four-group, multicenter, randomized clinical trials. Between 2013 and 2016, New York State Medicaid managed care members diagnosed with hypertension (N = 920) or with diabetes (N = 959). Participants in each 6-month trial were randomly assigned to 1 of 4 arms: (1) process incentives-earned by attending primary care visits and/or receiving prescription medication refills, (2) outcome incentives-earned by reducing systolic blood pressure (hypertension) or hemoglobin A 1c (HbA 1c ; diabetes) levels, (3) combined process and outcome incentives, and (4) control (no incentives). Systolic blood pressure (hypertension) and HbA 1c (diabetes) levels, primary care visits, and medication prescription refills. Analysis and Results: At 6 months, there were no statistically significant differences between intervention arms and the control arm in the change in systolic blood pressure, P = .531. Similarly, there were no significant differences in blood glucose control (HbA 1c ) between the intervention arms and control after 6 months, P = .939. The majority of participants had acceptable systolic blood pressure (<140 mm Hg) or blood glucose (<8.0%) levels at baseline and throughout the study. Financial incentives-regardless of whether they were delivered based on disease-relevant outcomes, process activities, or a combination of the two-have a negligible impact on health outcomes for Medicaid recipients diagnosed with either hypertension or diabetes in 2 studies in which, among other design and operational limitations, the majority of recipients had relatively well-controlled diseases at the time of enrollment.

The efficacy and safety of neoadjuvant chemotherapy +/- letrozole in postmenopausal women with locally advanced breast cancer: a randomized phase III clinical trial.

PubMed

Mohammadianpanah, Mohammad; Ashouri, Yaghoub; Hoseini, Sare; Amadloo, Niloofar; Talei, Abdolrasoul; Tahmasebi, Sedigheh; Nasrolahi, Hamid; Mosalaei, Ahmad; Omidvari, Shapour; Ansari, Mansour; Mosleh-Shirazi, Mohammad Amin

2012-04-01

This two-arm randomized clinical study aimed to evaluate the efficacy and safety of neoadjuvant concurrent chemotherapy and letrozole in postmenopausal women with locally advanced breast carcinoma. One hundred and one postmenopausal women aged 50-83 years with pathologically proven locally advanced (clinical stage T3, T4 and/or N2, N3) breast cancer were randomly assigned to receive neoadjuvant chemotherapy alone (control arm, n = 51) or neoadjuvant chemotherapy concurrent with letrozole 2.5 mg (study arm, n = 50). Chemotherapy consisted of a median 4 (range 3-5) cycles of intravenous 5-fluorouracil 600 mg/m(2), doxorubicin 60 mg/m(2), and cyclophosphamide 600 mg/m(2), every three weeks. All patients subsequently underwent modified radical mastectomy approximately two weeks after the last cycle of chemotherapy. Pathologic complete response rates were 25.5% and 10.2% in the study and the control group, respectively (P = 0.049). Similarly, clinical complete response rates were 27.6% and 10.2% in the study and the control group, respectively (P = 0.037). In the subgroup analysis of hormone receptor-positive cases, the complete response rates were more prominent in study group compared with control group. Common treatment-related side effects such as nausea, vomiting, bone marrow suppression, and mucositis were similar in both groups, but hot flush was more prevalent in study group compared with control group (P = 0.023). The addition of letrozole concurrently with neoadjuvant chemotherapy provides a higher clinical and pathologic response rates with acceptable toxicity compared with chemotherapy alone in postmenopausal women with locally advanced sensitive breast cancer.

Repetitive facilitative exercise under continuous electrical stimulation for severe arm impairment after sub-acute stroke: a randomized controlled pilot study.

PubMed

Shimodozono, Megumi; Noma, Tomokazu; Matsumoto, Shuji; Miyata, Ryuji; Etoh, Seiji; Kawahira, Kazumi

2014-01-01

To investigate the effectiveness of repetitive facilitative exercise (RFE) under surface neuromuscular electrical stimulation (NMES) in patients with post-stroke hemiplegia. This randomized, controlled, observer-blinded, pilot trial randomized 27 adults with severe arm impairment [Fugl-Meyer Arm scale (FMA) ≤ 20] due to stroke of 3-13 weeks duration into three groups and provided treatment on a 4-week, 40 minutes/day, 5 days/week schedule. The RFE-under-NMES group were given 100-150 repetitions of standardized movements of shoulder, elbow and wrist joints of their affected arm with concurrent low-amplitude NMES for each corresponding musculature. The RFE group was given the same exercise regimen but without NMES. The control group was treated with a conventional arm rehabilitation programme without NMES. FMA was assessed at baseline and 4 weeks. All 27 participants (nine in each group) completed the trial. At 4 weeks, the RFE-under-NMES group evidenced significantly greater improvement compared with the control group on the FMA (p = 0.003), but not with the RFE group (p = 0.092). The RFE group showed improvement compared with the control group, but it was not significant (p = 0.199). RFE under NMES is feasible in clinical settings and may be more effective than conventional rehabilitation in lessening arm impairment after sub-acute stroke.

An randomized controlled trial of Post-it® notes did not increase postal response rates in older depressed participants.

PubMed

Lewis, Helen; Keding, Ada; Bosanquet, Katharine; Gilbody, Simon; Torgerson, David

2017-02-01

Our aim was to evaluate the effectiveness of a Post-it® note to increase response rates and shorten response times to a 4-month postal follow-up questionnaire sent to participants taking part in the Collaborative Care in Screen-Positive Elders (CASPER) trials. Our trial was a two-arm randomized controlled trial comparing response rates to questionnaires with a printed Post-it® note (intervention) and without (control), nested in multi centred randomized controlled trials of older people with varying levels of depressive symptoms; the CASPER + and CASPER Self Help for those At Risk of Depression (SHARD) trials. A total of 611 participants were eligible and randomized. The primary outcome was response rates, secondary outcomes were time to response and need for a reminder. Of 297 participants, 266 (89.6%) returned their 4-month questionnaire in the post-it note arm, compared with 282 of 314 participants (89.8%) in the control arm (OR = 0.97, 95% CI: 0.57, 1.65, P = 0.913). There were no statistically significant differences in time to respond or the need to be sent a reminder. Patients with a major depressive episode were more likely to return questionnaires with post-it notes (P of interaction = .019). There was no significant difference in response rates, time to response, or the need for a reminder between the intervention and control at 4-month follow up for older people with depressive symptoms. However, there was a significant interaction between the Post-it® note group and level of depression. © 2016 John Wiley & Sons, Ltd.

Improving mental health among ultra-poor children: Two-year outcomes of a cluster-randomized trial in Burkina Faso.

PubMed

Ismayilova, Leyla; Karimli, Leyla; Sanson, Jo; Gaveras, Eleni; Nanema, Rachel; Tô-Camier, Alexice; Chaffin, Josh

2018-07-01

There is limited evidence about interventions improving child mental health in francophone West Africa. Behavioral mental health interventions alone may have limited effects on children's emotional well-being in families living in abject poverty, especially in low-income countries. This study tests the effects of economic intervention, alone and in combination with a family-focused component, on the mental health of children from ultra-poor households in rural Burkina Faso. The three-arm cluster randomized trial included children in the age range of 10-15 years old (N = 360), from twelve villages in Nord region of Burkina Faso (ClinicalTrial.gov ID: NCT02415933). Villages were randomized (4 villages/120 households per arm) to the waitlist arm, the economic intervention utilizing the Graduation approach (Trickle Up/TU arm), or to the economic strengthening plus family coaching component (TU + arm). Intervention effects were tested using repeated-measures mixed-effects regressions that account for the clustered nature of the data. Children from the TU + arm showed a reduction in depressive symptoms at 12 months (medium effect size Cohen's d = -0.41, p = .001) and 24 months (d = -0.39, p = .025), compared to the control condition and the economic intervention alone (at 12 months d = -0.22, p = .020). Small effect size improvements in self-esteem were detected in the TU + group, compared to the control arm at 12 months (d = 0.21) and to the TU arm at 24 months (d = 0.21). Trauma symptoms significantly reduced in the TU + group at 12 months (Incidence Risk Ratio/IRR = 0.62, 95% CI = 0.41, 0.92, p = .042), compared to the control group. Integrating psychosocial intervention involving all family members with economic empowerment strategies may be an innovative approach for improving emotional well-being among children living in extreme poverty. Copyright © 2018 Elsevier Ltd. All rights reserved.

Human papillomavirus-based cervical cancer prevention: long-term results of a randomized screening trial.

PubMed

Denny, Lynette; Kuhn, Louise; Hu, Chih-Chi; Tsai, Wei-Yann; Wright, Thomas C

2010-10-20

Screen-and-treat approaches to cervical cancer prevention are an attractive option for low-resource settings, but data on their long-term efficacy are lacking. We evaluated the efficacy of two screen-and-treat approaches through 36 months of follow-up in a randomized trial. A total of 6637 unscreened South African women aged 35-65 years who were tested for the presence of high-risk human papillomavirus (HPV) DNA in cervical samples underwent visual inspection of the cervix using acetic acid staining and HIV serotesting. Of these, 6555 were randomly assigned to three study arms: 1) HPV-and-treat, in which all women with a positive HPV DNA test result underwent cryotherapy; 2) visual inspection-and-treat, in which all women with a positive visual inspection test result underwent cryotherapy; or 3) control, in which further evaluation or treatment was delayed for 6 months. All women underwent colposcopy with biopsy at 6 months. All women who were HPV DNA- or visual inspection-positive at enrollment, and a subset of all other women had extended follow-up to 36 months (n = 3639) with yearly colposcopy. The endpoint-cervical intraepithelial neoplasia grade 2 or worse (CIN2+)-was analyzed using actuarial life-table methods. All statistical tests were two-sided. After 36 months, there was a sustained statistically significant decrease in the cumulative detection of CIN2+ in the HPV-and-treat arm compared with the control arm (1.5% vs 5.6%, difference = 4.1%, 95% confidence interval [CI] = 2.8% to 5.3%, P < .001). The difference in the cumulative detection of CIN2+ in the visual inspection-and-treat arm compared with the control was less (3.8% vs 5.6%, difference = 1.8%, 95% CI = 0.4% to 3.2%, P = .002). Incident cases of CIN2+ (identified more than 12 months after enrollment) were less common in the HPV-and-treat arm (0.3%, 95% CI = 0.05% to 1.02%) than in the control (1.0%, 95% CI = 0.5% to 1.7%) or visual inspection-and-treat (1.3%, 95% CI = 0.8% to 2.1%) arms. In this trial, a screen-and-treat approach using HPV DNA testing identified and treated prevalent cases of CIN2+ and appeared to reduce the number of incident cases of CIN2+ that developed more than 12 months after cryotherapy.

Mediation of Short and Longer Term Effects of an Intervention Program to Enhance Resilience in Immigrants from Mainland China to Hong Kong

PubMed Central

Yu, Nancy X.; Lam, T. H.; Liu, Iris K. F.; Stewart, Sunita M.

2015-01-01

Few clinical trials report on the active intervention components that result in outcome changes, although this is relevant to further improving efficacy and adapting effective programs to other populations. This paper presents follow-up analyses of a randomized controlled trial to enhance adaptation by increasing knowledge and personal resilience in two separate brief interventions with immigrants from Mainland China to Hong Kong (Yu et al., 2014b). The present paper extends our previous one by reporting on the longer term effect of the interventions on personal resilience, and examining whether the Resilience intervention worked as designed to enhance personal resilience. The four-session intervention targeted at self-efficacy, positive thinking, altruism, and goal setting. In this randomized controlled trial, 220 immigrants were randomly allocated to three arms: Resilience, Information (an active control arm), and Control arms. Participants completed measures of the four active components (self-efficacy, positive thinking, altruism, and goal setting) at baseline and immediately after the intervention. Personal resilience was assessed at baseline, post-intervention, and 3- and 6-month follow-ups. The results showed that the Resilience arm had greater increases in the four active components post-intervention. Changes in each of the four active components at the post-intervention assessment mediated enhanced personal resilience at the 3-month follow-up in the Resilience arm. Changes in self-efficacy and goal setting showed the largest effect size, and altruism showed the smallest. The arm effects of the Resilience intervention on enhanced personal resilience at the 6-month follow-up were mediated by increases of personal resilience post-intervention (Resilience vs. Control) and at the 3-month follow-up (Resilience vs. Information). These findings showed that these four active components were all mediators in this Resilience intervention. Our results of the effects of short term increases in personal resilience on longer term increase in personal resilience in some models suggest how changes in intervention outcomes might persist over time. PMID:26640446

Effects of Periodontal Therapy on Rate of Preterm Delivery A Randomized Controlled Trial

PubMed Central

Offenbacher, Steven; Beck, James D.; Jared, Heather L.; Mauriello, Sally M.; Mendoza, Luisto C.; Couper, David J.; Stewart, Dawn D.; Murtha, Amy P.; Cochran, David L.; Dudley, Donald J.; Reddy, Michael S.; Geurs, Nicolaas C.; Hauth, John C.

2010-01-01

OBJECTIVE To test the effects of maternal periodontal disease treatment on the incidence of preterm birth (delivery before 37 weeks of gestation). METHODS The Maternal Oral Therapy to Reduce Obstetric Risk Study was a randomized, treatment-masked, controlled clinical trial of pregnant women with periodontal disease who were receiving standard obstetric care. Participants were assigned to either a periodontal treatment arm, consisting of scaling and root planing early in the second trimester, or a delayed treatment arm that provided periodontal care after delivery. Pregnancy and maternal periodontal status were followed to delivery and neonatal outcomes until discharge. The primary outcome (gestational age less than 37 weeks) and the secondary outcome (gestational age less than 35 weeks) were analyzed using a χ2 test of equality of two proportions. RESULTS The study randomized 1,806 patients at three performance sites and completed 1,760 evaluable patients. At baseline, there were no differences comparing the treatment and control arms for any of the periodontal or obstetric measures. The rate of preterm delivery for the treatment group was 13.1% and 11.5% for the control group (P=.316). There were no significant differences when comparing women in the treatment group with those in the control group with regard to the adverse event rate or the major obstetric and neonatal outcomes. CONCLUSION Periodontal therapy did not reduce the incidence of preterm delivery. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, www.clinicaltrials.gov, NCT00097656. LEVEL OF EVIDENCE I PMID:19701034

How much is not enough? A Community Randomized trial of a Water and Health Education program for Trachoma and Ocular C. trachomatis infection in Niger

PubMed Central

Abdou, Amza; Munoz, Beatriz E; Nassirou, Baido; Kadri, Boubacar; Moussa, Fati; Baarè, Ibrahim; Riverson, Joseph; Opong, Emmanuel; West, Sheila K

2009-01-01

Summary Objective To determine the impact after two years of a water and health education (W/HE) program on ocular C. trachomatis infection and trachoma. Methods We randomized 12 trachoma-endemic communities in Maradi, Niger 1:1 to W/HE intervention and control arms and collected data on 10 of the 12 villages. In the intervention villages, at least one clean water well was constructed, and a three-month, modest health education program was provided immediately prior to the two year survey. We censused all households, and 557 children ages 1 to 5 years were randomly selected as sentinel children and examined at baseline and at one and two years from baseline. Trachoma was clinically assessed and a swab taken and analyzed for C. trachomatis. Tetracycline eye ointment was provided to all children in either arm during the surveys who had signs of trachoma. Results Infection with C. trachomatis declined slightly, and not significantly, in the children in the control villages over the two years, from 15% to 11%. The decline in infection was more pronounced, and significant, in the children in the intervention villages, from 26% to 15%. However, the change in infection rates in the intervention villages was not significantly different from the change in infection rates in the control villages (p=0.39, and 0.11 for change from baseline to one year and two year respectively). There was also no difference in the change in overall trachoma rates between the two arms. Conclusion These data suggest that the provision of water plus a modest health education program did not result in a significant difference in trachoma or ocular C. trachomatis infection in endemic communities in Niger. A more substantial health education intervention is likely necessary to produce change. PMID:20409284

Correction to: The effectiveness of a life style modification and peer support home blood pressure monitoring in control of hypertension: protocol for a cluster randomized controlled trial.

PubMed

Su, Tin Tin; Majid, Hazreen Abdul; Nahar, Azmi Mohamed; Azizan, Nurul Ain; Hairi, Farizah Mohd; Thangiah, Nithiah; Dahlui, Maznah; Bulgiba, Awang; Murray, Liam J

2017-11-06

After publication of the article [1], it has been brought to our attention that the methodology outlined in the original article was not able to be fully carried out. The article planned a two armed randomized control trial. However, due to a lower response than expected and one housing complex dropping out from the study, the method was changed to pre- and post-intervention with no control group. All other methods were conducted as outlined in the original article.

The effects of mirror therapy on arm and hand function in subacute stroke in patients.

PubMed

Radajewska, Alina; Opara, Józef A; Kucio, Cezary; Błaszczyszyn, Monika; Mehlich, Krzysztof; Szczygiel, Jarosław

2013-09-01

The aim of this study was to evaluate the effect of mirror therapy on arm and hand function in subacute stroke in patients. The study included 60 hemiparetic right-handed patients after ischemic stroke 8-10 weeks after onset. They underwent stationary comprehensive rehabilitation in the rehabilitation centre. They were divided into two randomly assigned groups: mirror (n=30) and control (n=30). For both groups, two subgroups were created: one that included patients with right arm paresis (n=15) and the other that included patients with left arm paresis (n=15). The mirror group received an additional intervention: training with a mirror for 5 days/week, 2 sessions/day, for 21 days. Each single session lasted for 15 min. The control group (n=30) underwent a conventional rehabilitation program without mirror therapy. To evaluate self-care in performing activities of daily living, the Functional Index 'Repty' was used. To evaluate hand and arm function, the Frenchay Arm Test and the Motor Status Score were used. Measurements were performed twice: before and after 21 days of applied rehabilitation. No significant improvement in hand and arm function in both subgroups in Frenchay Arm Test and Motor Status Score scales was observed. However, there was a significant improvement in self-care of activities of daily living in the right arm paresis subgroup in the mirror group measured using the Functional Index 'Repty'. Mirror therapy improves self-care of activities of daily living for patients with right arm paresis after stroke.

Central Fetal Monitoring With and Without Computer Analysis: A Randomized Controlled Trial.

PubMed

Nunes, Inês; Ayres-de-Campos, Diogo; Ugwumadu, Austin; Amin, Pina; Banfield, Philip; Nicoll, Antony; Cunningham, Simon; Sousa, Paulo; Costa-Santos, Cristina; Bernardes, João

2017-01-01

To evaluate whether intrapartum fetal monitoring with computer analysis and real-time alerts decreases the rate of newborn metabolic acidosis or obstetric intervention when compared with visual analysis. A randomized clinical trial carried out in five hospitals in the United Kingdom evaluated women with singleton, vertex fetuses of 36 weeks of gestation or greater during labor. Continuous central fetal monitoring by computer analysis and online alerts (experimental arm) was compared with visual analysis (control arm). Fetal blood sampling and electrocardiographic ST waveform analysis were available in both arms. The primary outcome was incidence of newborn metabolic acidosis (pH less than 7.05 and base deficit greater than 12 mmol/L). Prespecified secondary outcomes included operative delivery, use of fetal blood sampling, low 5-minute Apgar score, neonatal intensive care unit admission, hypoxic-ischemic encephalopathy, and perinatal death. A sample size of 3,660 per group (N=7,320) was planned to be able to detect a reduction in the rate of metabolic acidosis from 2.8% to 1.8% (two-tailed α of 0.05 with 80% power). From August 2011 through July 2014, 32,306 women were assessed for eligibility and 7,730 were randomized: 3,961 to computer analysis and online alerts, and 3,769 to visual analysis. Baseline characteristics were similar in both groups. Metabolic acidosis occurred in 16 participants (0.40%) in the experimental arm and 22 participants (0.58%) in the control arm (relative risk 0.69 [0.36-1.31]). No statistically significant differences were found in the incidence of secondary outcomes. Compared with visual analysis, computer analysis of fetal monitoring signals with real-time alerts did not significantly reduce the rate of metabolic acidosis or obstetric intervention. A lower-than-expected rate of newborn metabolic acidosis was observed in both arms of the trial. ISRCTN Registry, http://www.isrctn.com, ISRCTN42314164.

Telephone-Based Physical Activity Counseling for Major Depression in People with Multiple Sclerosis

ERIC Educational Resources Information Center

Bombardier, Charles H.; Ehde, Dawn M.; Gibbons, Laura E.; Wadhwani, Roini; Sullivan, Mark D.; Rosenberg, Dori E.; Kraft, George H.

2013-01-01

Objective: Physical activity represents a promising treatment for major depressive disorder (MDD) in people with multiple sclerosis (MS). We conducted a single-blind, two-arm randomized controlled trial comparing a 12-week physical activity counseling intervention delivered primarily by telephone (n = 44) to a wait-list control group (N = 48).…

A randomized controlled trial on the efficacy of thoracic CT screening for lung cancer in non-smokers and smokers of <30 pack-years aged 50-64 years (JECS study): research design.

PubMed

Sagawa, Motoyasu; Nakayama, Tomio; Tanaka, Makoto; Sakuma, Tsutomu; Sobue, Tomotaka

2012-12-01

In order to assess the efficacy of lung cancer screening using low-dose thoracic computed tomography, compared with chest roentgenography, in people aged 50-64 years with a smoking history of <30 pack-years, a randomized controlled trial is being conducted in Japan. The screening methods are randomly assigned individually. The duration of this trial is 10 years. In the intervention arm, low-dose thoracic computed tomography is performed for each participant in the first and the sixth years. In the control arm, chest roentgenography is performed for each participant in the first year. The participants in both arms are also encouraged to receive routine lung cancer screening using chest roentgenography annually. The interpretation of radiological findings and the follow-up of undiagnosed nodules are to be carried out according to the guidelines published in Japan. The required sample size is calculated to be 17 500 subjects for each arm.

Celecoxib plus hormone therapy versus hormone therapy alone for hormone-sensitive prostate cancer: first results from the STAMPEDE multiarm, multistage, randomised controlled trial

PubMed Central

James, Nicholas D; Sydes, Matthew R; Mason, Malcolm D; Clarke, Noel W; Anderson, John; Dearnaley, David P; Dwyer, John; Jovic, Gordana; Ritchie, Alastair WS; Russell, J Martin; Sanders, Karen; Thalmann, George N; Bertelli, Gianfilippo; Birtle, Alison J; O'Sullivan, Joe M; Protheroe, Andrew; Sheehan, Denise; Srihari, Narayanan; Parmar, Mahesh KB

2012-01-01

Summary Background Long-term hormone therapy alone is standard care for metastatic or high-risk, non-metastatic prostate cancer. STAMPEDE—an international, open-label, randomised controlled trial—uses a novel multiarm, multistage design to assess whether the early additional use of one or two drugs (docetaxel, zoledronic acid, celecoxib, zoledronic acid and docetaxel, or zoledronic acid and celecoxib) improves survival in men starting first-line, long-term hormone therapy. Here, we report the preplanned, second intermediate analysis comparing hormone therapy plus celecoxib (arm D) with hormone therapy alone (control arm A). Methods Eligible patients were men with newly diagnosed or rapidly relapsing prostate cancer who were starting long-term hormone therapy for the first time. Hormone therapy was given as standard care in all trial arms, with local radiotherapy encouraged for newly diagnosed patients without distant metastasis. Randomisation was done using minimisation with a random element across seven stratification factors. Patients randomly allocated to arm D received celecoxib 400 mg twice daily, given orally, until 1 year or disease progression (including prostate-specific antigen [PSA] failure). The intermediate outcome was failure-free survival (FFS) in three activity stages; the primary outcome was overall survival in a subsequent efficacy stage. Research arms were compared pairwise against the control arm on an intention-to-treat basis. Accrual of further patients was discontinued in any research arm showing safety concerns or insufficient evidence of activity (lack of benefit) compared with the control arm. The minimum targeted activity at the second intermediate activity stage was a hazard ratio (HR) of 0·92. This trial is registered with ClinicalTrials.gov, number NCT00268476, and with Current Controlled Trials, number ISRCTN78818544. Findings 2043 patients were enrolled in the trial from Oct 17, 2005, to Jan 31, 2011, of whom 584 were randomly allocated to receive hormone therapy alone (control group; arm A) and 291 to receive hormone therapy plus celecoxib (arm D). At the preplanned analysis of the second intermediate activity stage, with 305 FFS events (209 in arm A, 96 in arm D), there was no evidence of an advantage for hormone therapy plus celecoxib over hormone therapy alone: HR 0·98 (95% CI 0·90–1·06). 2-year FFS was 51% (95% CI 46–56) in arm A and 51% (95% CI 43–58) in arm D. There was no evidence of differences in the incidence of adverse events between groups (events of grade 3 or higher were noted at any time in 123 [23%, 95% CI 20–27] patients in arm A and 64 [25%, 19–30] in arm D). The most common grade 3–5 events adverse effects in both groups were endocrine disorders (55 [11%] of patients in arm A vs 19 [7%] in arm D) and musculoskeletal disorders (30 [6%] of patients in arm A vs 15 [6%] in arm D). The independent data monitoring committee recommended stopping accrual to both celecoxib-containing arms on grounds of lack of benefit and discontinuing celecoxib for patients currently on treatment, which was endorsed by the trial steering committee. Interpretation Celecoxib 400 mg twice daily for up to 1 year is insufficiently active in patients starting hormone therapy for high-risk prostate cancer, and we do not recommend its use in this setting. Accrual continues seamlessly to the other research arms and follow-up of all arms will continue to assess effects on overall survival. Funding Cancer Research UK, Pfizer, Novartis, Sanofi-Aventis, Medical Research Council (London, UK). PMID:22452894

Lack of significant anti-inflammatory activity with clindamycin in the treatment of rosacea: results of 2 randomized, vehicle-controlled trials.

PubMed

Martel, Philippe; Jarratt, Michael; Weiss, Jonathan; Carlavan, Isabelle

2017-07-01

Rosacea is a chronic inflammatory skin disease of the face. The objective of the studies described here was to evaluate the efficacy of clindamycin in the treatment of rosacea. Two multicenter, randomized, vehicle-controlled, phase 2 studies were conducted in participants with moderate to severe rosacea. Study A was a 12-week dose-comparison, 5-arm, parallel group comparison of clindamycin cream 1% or vehicle once or twice daily and clindamycin cream 0.3% once daily. Study B was a 2-arm comparison of twice daily clindamycin gel 1% versus vehicle gel. A total of 629 participants (study A, N=416; study B, N=213) were randomized. The results of these studies indicated that clindamycin cream 0.3% and 1% and clindamycin gel 1% were no more effective than the vehicle in the treatment of moderate to severe rosacea, suggesting clindamycin has no intrinsic anti-inflammatory activity in rosacea.

A pilot study of activity-based therapy in the arm motor recovery post stroke: a randomized controlled trial.

PubMed

Rabadi, Mh; Galgano, M; Lynch, D; Akerman, M; Lesser, M; Volpe, Bt

2008-12-01

To determine the efficacy of activity-based therapies using arm ergometer or robotic or group occupational therapy for motor recovery of the paretic arm in patients with an acute stroke (< or =4 weeks) admitted to an inpatient rehabilitation facility, and to obtain information to plan a large randomized controlled trial. Prospective, randomized controlled study. Stroke unit in a rehabilitation hospital. Thirty patients with an acute stroke (< or =4 weeks) who had arm weakness (Medical Research Council grade 2 or less at the shoulder joint). Occupational therapy (OT) group (control) (n = 10), arm ergometer (n = 10) or robotic (n = 10) therapy group. All patients received standard, inpatient, post-stroke rehabilitation training for 3 hours a day, plus 12 additional 40-minute sessions of the activity-based therapy. The primary outcome measures were discharge scores in the Fugl-Meyer Assessment Scale for upper limb impairment, Motor Status Scale, total Functional Independence Measure (FIM) and FIM-motor and FIM-cognition subscores. The three groups (OT group versus arm ergometer versus robotic) were comparable on clinical demographic measures except the robotic group was significantly older and there were more haemorrhagic stroke patients in the arm ergometer group. After adjusting for age, stroke type and outcome measures at baseline, a similar degree of improvement in the discharge scores was found in all of the primary outcome measures. This study suggests that activity-based therapies using an arm ergometer or robot when used over shortened training periods have the same effect as OT group therapy in decreasing impairment and improving disability in the paretic arm of severely affected stroke patients in the subacute phase.

Effects of anti-obesity drugs, diet, and exercise on weight-loss maintenance after a very-low-calorie diet or low-calorie diet: a systematic review and meta-analysis of randomized controlled trials123

PubMed Central

Neovius, Martin; Hemmingsson, Erik

2014-01-01

Background: Weight-loss maintenance remains a major challenge in obesity treatment. Objective: The objective was to evaluate the effects of anti-obesity drugs, diet, or exercise on weight-loss maintenance after an initial very-low-calorie diet (VLCD)/low-calorie diet (LCD) period (<1000 kcal/d). Design: We conducted a systematic review by using MEDLINE, the Cochrane Controlled Trial Register, and EMBASE from January 1981 to February 2013. We included randomized controlled trials that evaluated weight-loss maintenance strategies after a VLCD/LCD period. Two authors performed independent data extraction by using a predefined data template. All pooled analyses were based on random-effects models. Results: Twenty studies with a total of 27 intervention arms and 3017 participants were included with the following treatment categories: anti-obesity drugs (3 arms; n = 658), meal replacements (4 arms; n = 322), high-protein diets (6 arms; n = 865), dietary supplements (6 arms; n = 261), other diets (3 arms; n = 564), and exercise (5 arms; n = 347). During the VLCD/LCD period, the pooled mean weight change was −12.3 kg (median duration: 8 wk; range 3–16 wk). Compared with controls, anti-obesity drugs improved weight-loss maintenance by 3.5 kg [95% CI: 1.5, 5.5 kg; median duration: 18 mo (12–36 mo)], meal replacements by 3.9 kg [95% CI: 2.8, 5.0 kg; median duration: 12 mo (10–26 mo)], and high-protein diets by 1.5 kg [95% CI: 0.8, 2.1 kg; median duration: 5 mo (3–12 mo)]. Exercise [0.8 kg; 95% CI: −1.2, 2.8 kg; median duration: 10 mo (6–12 mo)] and dietary supplements [0.0 kg; 95% CI: −1.4, 1.4 kg; median duration: 3 mo (3–14 mo)] did not significantly improve weight-loss maintenance compared with control. Conclusion: Anti-obesity drugs, meal replacements, and high-protein diets were associated with improved weight-loss maintenance after a VLCD/LCD period, whereas no significant improvements were seen for dietary supplements and exercise. PMID:24172297

Effect of prandial treatment timing adjustment, based on continuous glucose monitoring, in patients with type 2 diabetes uncontrolled with once-daily basal insulin: A randomized, phase IV study.

PubMed

Ilany, Jacob; Bhandari, Hamad; Nabriski, Dan; Toledano, Yoel; Konvalina, Noa; Cohen, Ohad

2018-05-01

To evaluate the glycaemic control achieved by prandial once-daily insulin glulisine injection timing adjustment, based on a continuous glucose monitoring sensor, in comparison to once-daily insulin glulisine injection before breakfast in patients with type 2 diabetes who are uncontrolled with once-daily basal insulin glargine. This was a 24-week open-label, randomized, controlled, multicentre trial. At the end of an 8-week period of basal insulin optimization, patients with HbA1c ≥ 7.5% and FPG < 130 mg/dL were randomized (1:1) to either arm A (no sensor) or arm B (sensor) to receive 16-week intensified prandial glulisine treatment. Patients in arm A received pre-breakfast glulisine, and patients in arm B received glulisine before the meal with the highest glucose elevation based on sensor data. The primary outcome was mean HbA1c at week 24 and secondary outcomes included rates of hypoglycaemic events and insulin dosage. A total of 121 patients were randomized to arm A (n = 61) or arm B (n = 60). There was no difference in mean HbA1c at week 24 between arms A and B (8.5% ± 1.2% vs 8.4% ± 1.0%; P = .66). The prandial insulin glulisine dosage for arm A and arm B was 9.3 and 10.1 units, respectively (P = .39). The frequency of hypoglycaemic events did not differ between study arms (36.1% vs 51.7%; P = .08). Using a CGM sensor to identify the meal with the highest glucose excursion and adjusting the timing of prandial insulin treatment did not show any advantage in terms of glycaemic control or safety in our patients. © 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Effects of Source- versus Household Contamination of Tubewell Water on Child Diarrhea in Rural Bangladesh: A Randomized Controlled Trial

PubMed Central

Unicomb, Leanne; Arnold, Benjamin F.; Colford Jr., John M.; Luby, Stephen P.

2015-01-01

Background Shallow tubewells are the primary drinking water source for most rural Bangladeshis. Fecal contamination has been detected in tubewells, at low concentrations at the source and at higher levels at the point of use. We conducted a randomized controlled trial to assess whether improving the microbiological quality of tubewell drinking water by household water treatment and safe storage would reduce diarrhea in children <2 years in rural Bangladesh. Methods We randomly assigned 1800 households with a child aged 6-18 months (index child) into one of three arms: chlorine plus safe storage, safe storage and control. We followed households with monthly visits for one year to promote the interventions, track their uptake, test participants’ source and stored water for fecal contamination, and record caregiver-reported child diarrhea prevalence (primary outcome). To assess reporting bias, we also collected data on health outcomes that are not expected to be impacted by our interventions. Findings Both interventions had high uptake. Safe storage, alone or combined with chlorination, reduced heavy contamination of stored water. Compared to controls, diarrhea in index children was reduced by 36% in the chlorine plus safe storage arm (prevalence ratio, PR = 0.64, 0.55-0.73) and 31% in the safe storage arm (PR = 0.69, 0.60-0.80), with no difference between the two intervention arms. One limitation of the study was the non-blinded design with self-reported outcomes. However, the prevalence of health outcomes not expected to be impacted by water interventions did not differ between study arms, suggesting minimal reporting bias. Conclusions Safe storage significantly improved drinking water quality at the point of use and reduced child diarrhea in rural Bangladesh. There was no added benefit from combining safe storage with chlorination. Efforts should be undertaken to implement and evaluate long-term efforts for safe water storage in Bangladesh. Trial Registration ClinicalTrials.gov NCT01350063 PMID:25816342

Affect school and script analysis versus basic body awareness therapy in the treatment of psychological symptoms in patients with diabetes and high HbA1c concentrations: two study protocols for two randomized controlled trials.

PubMed

Melin, Eva O; Svensson, Ralph; Gustavsson, Sven-Åke; Winberg, Agneta; Denward-Olah, Ewa; Landin-Olsson, Mona; Thulesius, Hans O

2016-04-27

Depression is linked with alexithymia, anxiety, high HbA1c concentrations, disturbances of cortisol secretion, increased prevalence of diabetes complications and all-cause mortality. The psycho-educational method 'affect school with script analysis' and the mind-body therapy 'basic body awareness treatment' will be trialled in patients with diabetes, high HbA1c concentrations and psychological symptoms. The primary outcome measure is change in symptoms of depression. Secondary outcome measures are changes in HbA1c concentrations, midnight salivary cortisol concentration, symptoms of alexithymia, anxiety, self-image measures, use of antidepressants, incidence of diabetes complications and mortality. Two studies will be performed. Study I is an open-labeled parallel-group study with a two-arm randomized controlled trial design. Patients are randomized to either affect school with script analysis or to basic body awareness treatment. According to power calculations, 64 persons are required in each intervention arm at the last follow-up session. Patients with type 1 or type 2 diabetes were recruited from one hospital diabetes outpatient clinic in 2009. The trial will be completed in 2016. Study II is a multicentre open-labeled parallel-group three-arm randomized controlled trial. Patients will be randomized to affect school with script analysis, to basic body awareness treatment, or to treatment as usual. Power calculations show that 70 persons are required in each arm at the last follow-up session. Patients with type 2 diabetes will be recruited from primary care. This study will start in 2016 and finish in 2023. For both studies, the inclusion criteria are: HbA1c concentration ≥62.5 mmol/mol; depression, alexithymia, anxiety or a negative self-image; age 18-59 years; and diabetes duration ≥1 year. The exclusion criteria are pregnancy, severe comorbidities, cognitive deficiencies or inadequate Swedish. Depression, anxiety, alexithymia and self-image are assessed using self-report instruments. HbA1c concentration, midnight salivary cortisol concentration, blood pressure, serum lipid concentrations and anthropometrics are measured. Data are collected from computerized medical records and the Swedish national diabetes and causes of death registers. Whether the "affect school with script analysis" will reduce psychological symptoms, increase emotional awareness and improve diabetes related factors will be tried, and compared to "basic body awareness treatment" and treatment as usual. ClinicalTrials.gov: NCT01714986.

Vaccination With Patient-Specific Tumor-Derived Antigen in First Remission Improves Disease-Free Survival in Follicular Lymphoma

PubMed Central

Schuster, Stephen J.; Neelapu, Sattva S.; Gause, Barry L.; Janik, John E.; Muggia, Franco M.; Gockerman, Jon P.; Winter, Jane N.; Flowers, Christopher R.; Nikcevich, Daniel A.; Sotomayor, Eduardo M.; McGaughey, Dean S.; Jaffe, Elaine S.; Chong, Elise A.; Reynolds, Craig W.; Berry, Donald A.; Santos, Carlos F.; Popa, Mihaela A.; McCord, Amy M.; Kwak, Larry W.

2011-01-01

Purpose Vaccination with hybridoma-derived autologous tumor immunoglobulin (Ig) idiotype (Id) conjugated to keyhole limpet hemocyanin (KLH) and administered with granulocyte-monocyte colony-stimulating factor (GM-CSF) induces follicular lymphoma (FL) –specific immune responses. To determine the clinical benefit of this vaccine, we conducted a double-blind multicenter controlled phase III trial. Patients and Methods Treatment-naive patients with advanced stage FL achieving complete response (CR) or CR unconfirmed (CRu) after chemotherapy were randomly assigned two to one to receive either Id vaccine (Id-KLH + GM-CSF) or control (KLH + GM-CSF). Primary efficacy end points were disease-free survival (DFS) for all randomly assigned patients and DFS for randomly assigned patients receiving at least one dose of Id vaccine or control. Results Of 234 patients enrolled, 177 (81%) achieved CR/CRu after chemotherapy and were randomly assigned. For 177 randomly assigned patients, including 60 patients not vaccinated because of relapse (n = 55) or other reasons (n = 5), median DFS between Id-vaccine and control arms was 23.0 versus 20.6 months, respectively (hazard ratio [HR], 0.81; 95% CI, 0.56 to 1.16; P = .256). For 117 patients who received Id vaccine (n = 76) or control (n = 41), median DFS after randomization was 44.2 months for Id-vaccine arm versus 30.6 months for control arm (HR, 0.62; 95% CI, 0.39 to 0.99; P = .047) at median follow-up of 56.6 months (range, 12.6 to 89.3 months). In an unplanned subgroup analysis, median DFS was significantly prolonged for patients receiving IgM-Id (52.9 v 28.7 months; P = .001) but not IgG-Id vaccine (35.1 v 32.4 months; P = .807) compared with isotype-matched control-treated patients. Conclusion Vaccination with patient-specific hybridoma-derived Id vaccine after chemotherapy-induced CR/CRu may prolong DFS in patients with FL. Vaccine isotype may affect clinical outcome and explain differing results between this and other controlled Id-vaccine trials. PMID:21632504

Comparison of patient comprehension of rapid HIV pre-test fundamentals by information delivery format in an emergency department setting

PubMed Central

Merchant, Roland C; Gee, Erin M; Clark, Melissa A; Mayer, Kenneth H; Seage, George R; DeGruttola, Victor G

2007-01-01

Background Two trials were conducted to compare emergency department patient comprehension of rapid HIV pre-test information using different methods to deliver this information. Methods Patients were enrolled for these two trials at a US emergency department between February 2005 and January 2006. In Trial One, patients were randomized to a no pre-test information or an in-person discussion arm. In Trial Two, a separate group of patients were randomized to an in-person discussion arm or a Tablet PC-based video arm. The video, "Do you know about rapid HIV testing?", and the in-person discussion contained identical Centers for Disease Control and Prevention-suggested pre-test information components as well as information on rapid HIV testing with OraQuick®. Participants were compared by information arm on their comprehension of the pre-test information by their score on a 26-item questionnaire using the Wilcoxon rank-sum test. Results In Trial One, 38 patients completed the no-information arm and 31 completed the in-person discussion arm. Of these 69 patients, 63.8% had twelve years or fewer of formal education and 66.7% had previously been tested for HIV. The mean score on the questionnaire for the in-person discussion arm was higher than for the no information arm (18.7 vs. 13.3, p ≤ 0.0001). In Trial Two, 59 patients completed the in-person discussion and 55 completed the video arms. Of these 114 patients, 50.9% had twelve years or fewer of formal education and 68.4% had previously been tested for HIV. The mean score on the questionnaire for the video arm was similar to the in-person discussion arm (20.0 vs. 19.2; p ≤ 0.33). Conclusion The video "Do you know about rapid HIV testing?" appears to be an acceptable substitute for an in-person pre-test discussion on rapid HIV testing with OraQuick®. In terms of adequately informing ED patients about rapid HIV testing, either form of pre-test information is preferable than for patients to receive no pre-test information. PMID:17850670

Randomized comparison of whole brain radiotherapy, 20 Gy in four daily fractions versus 40 Gy in 20 twice-daily fractions, for brain metastases.

PubMed

Graham, P H; Bucci, J; Browne, L

2010-07-01

The present study compared the intracranial control rate and quality of life for two radiation fractionation schemes for cerebral metastases. A total of 113 patients with a Eastern Cooperative Oncology Group performance status <3; and stable (>2 months), absent, or concurrent presentation of extracranial disease were randomized to 40 Gy in 20 twice-daily fractions (Arm A) or 20 Gy in four daily fractions (Arm B), stratified by resection status. The European Organization for Research and Treatment of Cancer Quality of Life 30-item questionnaire was administered monthly during Year 1, bimonthly during Year 2, and then every 6 months to Year 5. The patient age range was 28-83 years (mean 62). Of the 113 patients, 41 had undergone surgical resection, and 74 patients had extracranial disease (31 concurrent and 43 stable). The median survival time was 6.1 months in Arm A and 6.6 months in Arm B, and the overall 5-year survival rate was 3.5%. Intracranial progression occurred in 44% of Arm A and 64% of Arm B patients (p = .03). Salvage surgery or radiotherapy was used in 4% of Arm A patients and 21% of Arm B patients (p = .004). Death was attributed to central nervous system progression in 32% of patients in Arm A and 52% of patients in Arm B (p = .03). The toxicity was minimal, with a minor increase in short-term cutaneous reactions in Arm A. The patients' quality of life was not impaired by the more intense treatment in Arm A. Intracranial disease control was improved and the quality of life was maintained with 40 Gy in 20 twice-daily fractions. This schema should be considered for better prognosis subgroups of patients with cerebral metastases. (c) 2010 Elsevier Inc. All rights reserved.

Doxycycline for prevention of erlotinib-induced rash in patients with non-small-cell lung cancer (NSCLC) after failure of first-line chemotherapy: A randomized, open-label trial.

PubMed

Deplanque, Gaël; Gervais, Radj; Vergnenegre, Alain; Falchero, Lionel; Souquet, Pierre-Jean; Chavaillon, Jean-Michel; Taviot, Bruno; Fraboulet, Ghislaine; Saal, Hakim; Robert, Caroline; Chosidow, Olivier

2016-06-01

Rash is a common epidermal growth factor receptor inhibitor-induced toxicity that can impair quality of life and treatment compliance. We sought to evaluate the efficacy of doxycycline in preventing erlotinib-induced rash (folliculitis) in patients with non-small-cell lung cancer. This open-label, randomized, prospective, phase II trial was conducted in 147 patients with locally advanced or metastatic non-small-cell lung cancer progressing after first-line chemotherapy, randomized for 4 months with erlotinib alone 150 mg/d per os (control arm) or combined with doxycycline 100 mg/d (doxycycline arm). Incidence and severity of rash, compliance, survival, and safety were assessed. Baseline characteristics of the 147 patients were well balanced in the intent-to-treat population. Folliculitis occurred in 71% of patients in the doxycycline arm and 81% in the control arm (P = .175). The severity of folliculitis and other skin lesions was lower in the doxycycline arm compared with the control arm. Other adverse events were reported at a similar frequency across arms. There was no significant difference in survival between treatment arms. The open-label design of the study and the duration of the treatment with doxycycline are limitations. Doxycycline did not reduce the incidence of erlotinib-induced folliculitis, but significantly reduced its severity. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Gaming and Conventional Exercises for Improvement of Arm Function After Stroke: A Randomized Controlled Pilot Study.

PubMed

Kottink, Anke I R; Prange, Gerdienke B; Krabben, Thijs; Rietman, Johan S; Buurke, Jaap H

2014-06-01

The use of new technologies in rehabilitation, such as virtual reality and/or computerized gaming exercises, may be useful to enable patients to practice intensively in a motivating way. The objective of the present randomized controlled pilot study was to compare the effect of reach training using a target group specific-designed rehabilitation game to time-matched standardized conventional reach training on arm function after stroke. Twenty chronic stroke patients were randomized to either the rehabilitation game group or the conventional training group. Both groups received three arm training sessions of 30 minutes each week, during a period of 6 weeks. Arm (the upper extremity part of Fugl-Meyer [FM] assessment) and hand (the Action Research Arm [ARA] test) functions were tested 1 week before (T0) and 1 week after (T1) training. A follow-up measurement was performed at 1 month after T1 (T2). ARA and FM scores improved significantly within both groups. Post hoc comparisons revealed significant increases in test scores between T0 and T1 and between T0 and T2 for both ARA and FM, but not for changes from T1 to T2. There were no significant differences between both groups for either clinical test. The present randomized controlled pilot study showed that both arm and hand function improved as much after training with a rehabilitation game as after time-matched conventional training.

Impact of Two Adolescent Pregnancy Prevention Interventions on Risky Sexual Behavior: A Three-Arm Cluster Randomized Control Trial.

PubMed

Barbee, Anita P; Cunningham, Michael R; van Zyl, Michiel A; Antle, Becky F; Langley, Cheri N

2016-09-01

To test the efficacy of Reducing the Risk (RTR) and Love Notes (LN) on reducing risky sexual behavior among youths yet to experience or cause a pregnancy. The four dependent variables were ever had sex, condom use, birth control use, and number of sexual partners at 3- and 6-month follow-up in a 3-arm cluster randomized controlled trial of 1448 impoverished youths, aged 14 to 19 years, in 23 community-based organizations in Louisville, Kentucky, from September 2011 through March 2014. At 3 and 6 months, compared with the control condition, youths in RTR reported fewer sexual partners and greater use of birth control. At 6 months, LN participants reported greater use of birth control and condoms, fewer sexual partners, and were less likely to have ever had sex compared with the control condition. We provided additional evidence for the continued efficacy of RTR and the first rigorous study of LN, which embeds sex education into a larger curriculum on healthy relationships and violence prevention.

Results of a pilot test of a brief computer-assisted tailored HIV prevention intervention for use with a range of demographic and risk groups.

PubMed

Zule, William A; Bobashev, Georgiy V; Reif, Susan M; Poulton, Winona; Coomes, Curtis M; Wechsberg, Wendee M

2013-11-01

There is a need for brief HIV prevention interventions that can be disseminated and implemented widely. This article reports the results of a small randomized field experiment that compared the relative effects of a brief two-session counselor-delivered computer-tailored intervention and a control condition. The intervention is designed for use with African-American, non-Hispanic white and Hispanic males and females who may be at risk of HIV through unprotected sex, selling sex, male to male sex, injecting drug use or use of stimulants. Participants (n = 120) were recruited using a quota sampling approach and randomized using block randomization, which resulted in ten male and ten female participants of each racial/ethnic group (i.e. African-American, non-Hispanic white and Hispanic) being assigned to either the intervention or a control arm. In logistic regression analyses using a generalized estimating equations approach, at 3-month followup, participants in the intervention arm were more likely than participants in the control arm to report condom use at last sex (Odds ratio [OR] = 4.75; 95 % Confidence interval [CI] = 1.70-13.26; p = 0.003). The findings suggest that a brief tailored intervention may increase condom use. Larger studies with longer followups are needed to determine if these results can be replicated.

DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial

PubMed Central

Chaillous, Lucy; Franc, Sylvia; Benhamou, Pierre-Yves; Schaepelynck, Pauline; Hanaire, Hélène; Catargi, Bogdan; Farret, Anne; Fontaine, Pierre; Guerci, Bruno; Reznik, Yves; Penfornis, Alfred; Borot, Sophie; Serusclat, Pierre; Kherbachi, Yacine; D'Orsay, Geneviève; Detournay, Bruno; Simon, Pierre; Charpentier, Guillaume

2018-01-01

Background Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a smartphone app (downloaded via the internet) used to calculate bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO was associated with a significant improvement in glycemic control in patients with poorly controlled type 1 diabetes mellitus, particularly when combined with teleconsultations with physicians. Objective Here, we present the protocol for a new study (Suivi A Grande Echelle d’une cohorte de diabétiques de type 1 et de type 2 sous schéma insulinique basal bolus par la TELEmédecine; abbreviated TELESAGE), conducted in a larger population of diabetic patients with poorly controlled basal-bolus insulin levels. Methods TELESAGE is a multicenter, double-randomized, open-label, three parallel–arms study, conducted in approximately 100 centers in France. The study will compare a control group (arm 1: usual follow-up) with two DIABEO telemedicine systems: (1) physician-assisted telemedicine (arm 2), and (2) nurse-assisted telemonitoring and teleconsultations by a diabetologist’s task delegation (arm 3). Initial randomization will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE will be to investigate the effect of the DIABEO telemedicine system versus usual follow-up, with respect to improvements in the glycated hemoglobin levels of approximately 696 diabetic patients with poorly controlled basal-bolus insulin levels. Results The TELESAGE study is sponsored by Sanofi (Gentilly, France). A primary completion date is expected in June 2018, and publication of results is expected within 6 months of work completion. Conclusions The TELESAGE study is expected to confirm the previous results of the TELEDIAB 1 study using a larger sample of diabetic patients. It is also expected to evaluate a nurse-assisted telemonitoring system. We will assess the potential of the DIABEO telemedicine service in terms of its utility and explore whether it can become an integral part of diabetes care for patients. Trial Registration ClinicalTrials.gov NCT02287532; https://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd) PMID:29674306

A Single-Blind randomized controlled trial to evaluate the effect of extended counseling on uptake of pre-antiretroviral care in eastern uganda

PubMed Central

2011-01-01

Background Many newly screened people living with HIV (PLHIV) in Sub-Saharan Africa do not understand the importance of regular pre-antiretroviral (ARV) care because most of them have been counseled by staff who lack basic counseling skills. This results in low uptake of pre-ARV care and late treatment initiation in resource-poor settings. The effect of providing post-test counseling by staff equipped with basic counseling skills, combined with home visits by community support agents on uptake of pre-ARV care for newly diagnosed PLHIV was evaluated through a randomized intervention trial in Uganda. Methods An intervention trial was performed consisting of post-test counseling by trained counselors, combined with monthly home visits by community support agents for continued counseling to newly screened PLHIV in Iganga district, Uganda between July 2009 and June 2010, Participants (N = 400) from three public recruitment centres were randomized to receive either the intervention, or the standard care (the existing post-test counseling by ARV clinic staff who lack basic training in counseling skills), the control arm. The outcome measure was the proportion of newly screened and counseled PLHIV in either arm who had been to their nearest health center for clinical check-up in the subsequent three months +2 months. Treatment was randomly assigned using computer-generated random numbers. The statistical significance of differences between the two study arms was assessed using chi-square and t-tests for categorical and quantitative data respectively. Risk ratios and 95% confidence intervals were used to assess the effect of the intervention. Results Participants in the intervention arm were 80% more likely to accept (take up) pre-ARV care compared to those in the control arm (RR 1.8, 95% CI 1.4-2.1). No adverse events were reported. Conclusions Provision of post-test counseling by staff trained in basic counseling skills, combined with home visits by community support agents had a significant effect on uptake of pre-ARV care and appears to be a cost-effective way to increase the prerequisites for timely ARV initiation. Trial registration The trial was registered by Current Controlled Trials Ltd C/OBioMed Central Ltd as ISRCTN94133652 and received financial support from Sida and logistical support from the European Commission. PMID:21794162

Shamba Maisha: Pilot agricultural intervention for food security and HIV health outcomes in Kenya: design, methods, baseline results and process evaluation of a cluster-randomized controlled trial.

PubMed

Cohen, Craig R; Steinfeld, Rachel L; Weke, Elly; Bukusi, Elizabeth A; Hatcher, Abigail M; Shiboski, Stephen; Rheingans, Richard; Scow, Kate M; Butler, Lisa M; Otieno, Phelgona; Dworkin, Shari L; Weiser, Sheri D

2015-01-01

Despite advances in treatment of people living with HIV, morbidity and mortality remains unacceptably high in sub-Saharan Africa, largely due to parallel epidemics of poverty and food insecurity. We conducted a pilot cluster randomized controlled trial (RCT) of a multisectoral agricultural and microfinance intervention (entitled Shamba Maisha) designed to improve food security, household wealth, HIV clinical outcomes and women's empowerment. The intervention was carried out at two HIV clinics in Kenya, one randomized to the intervention arm and one to the control arm. HIV-infected patients >18 years, on antiretroviral therapy, with moderate/severe food insecurity and/or body mass index (BMI) <18.5, and access to land and surface water were eligible for enrollment. The intervention included: 1) a microfinance loan (~$150) to purchase the farming commodities, 2) a micro-irrigation pump, seeds, and fertilizer, and 3) trainings in sustainable agricultural practices and financial literacy. Enrollment of 140 participants took four months, and the screening-to-enrollment ratio was similar between arms. We followed participants for 12 months and conducted structured questionnaires. We also conducted a process evaluation with participants and stakeholders 3-5 months after study start and at study end. Baseline results revealed that participants at the two sites were similar in age, gender and marital status. A greater proportion of participants at the intervention site had a low BMI in comparison to participants at the control site (18% vs. 7%, p = 0.054). While median CD4 count was similar between arms, a greater proportion of participants enrolled at the intervention arm had a detectable HIV viral load compared with control participants (49% vs. 28%, respectively, p < 0.010). Process evaluation findings suggested that Shamba Maisha had high acceptability in recruitment, delivered strong agricultural and financial training, and led to labor saving due to use of the water pump. Implementation challenges included participant concerns about repaying loans, agricultural challenges due to weather patterns, and a challenging partnership with the microfinance institution. We expect the results from this pilot study to provide useful data on the impacts of livelihood interventions and will help in the design of a definitive cluster RCT. This trial is registered at ClinicalTrials.gov, NCT01548599.

A multi-faceted tailored strategy to implement an electronic clinical decision support system for pressure ulcer prevention in nursing homes: a two-armed randomized controlled trial.

PubMed

Beeckman, Dimitri; Clays, Els; Van Hecke, Ann; Vanderwee, Katrien; Schoonhoven, Lisette; Verhaeghe, Sofie

2013-04-01

Frail older people admitted to nursing homes are at risk of a range of adverse outcomes, including pressure ulcers. Clinical decision support systems are believed to have the potential to improve care and to change the behaviour of healthcare professionals. To determine whether a multi-faceted tailored strategy to implement an electronic clinical decision support system for pressure ulcer prevention improves adherence to recommendations for pressure ulcer prevention in nursing homes. Two-armed randomized controlled trial in a nursing home setting in Belgium. The trial consisted of a 16-week implementation intervention between February and June 2010, including one baseline, four intermediate, and one post-testing measurement. Primary outcome was the adherence to guideline-based care recommendations (in terms of allocating adequate pressure ulcer prevention in residents at risk). Secondary outcomes were the change in resident outcomes (pressure ulcer prevalence) and intermediate outcomes (knowledge and attitudes of healthcare professionals). Random sample of 11 wards (6 experimental; 5 control) in a convenience sample of 4 nursing homes in Belgium. In total, 464 nursing home residents and 118 healthcare professionals participated. The experimental arm was involved in a multi-faceted tailored implementation intervention of a clinical decision support system, including interactive education, reminders, monitoring, feedback and leadership. The control arm received a hard-copy of the pressure ulcer prevention protocol, supported by standardized 30 min group lecture. Patients in the intervention arm were significantly more likely to receive fully adequate pressure ulcer prevention when seated in a chair (F=16.4, P=0.003). No significant improvement was observed on pressure ulcer prevalence and knowledge of the professionals. While baseline attitude scores were comparable between both groups [exp. 74.3% vs. contr. 74.5% (P=0.92)], the mean score after the intervention was 83.5% in the experimental group vs. 72.1% in the control group (F=15.12, P<0.001). The intervention was only partially successful to improve the primary outcome. Attitudes improved significantly while the knowledge of the healthcare workers remained unsatisfactorily low. Further research should focus on the underlying reasons for these findings. Copyright © 2012 Elsevier Ltd. All rights reserved.

Evaluation of a Cluster-Randomized Controlled Trial of a Package of Community-Based Maternal and Newborn Interventions in Mirzapur, Bangladesh

PubMed Central

Darmstadt, Gary L.; Choi, Yoonjoung; Arifeen, Shams E.; Bari, Sanwarul; Rahman, Syed M.; Mannan, Ishtiaq; Seraji, Habibur Rahman; Winch, Peter J.; Saha, Samir K.; Ahmed, A. S. M. Nawshad Uddin; Ahmed, Saifuddin; Begum, Nazma; Lee, Anne C. C.; Black, Robert E.; Santosham, Mathuram; Crook, Derrick; Baqui, Abdullah H.

2010-01-01

Background To evaluate a delivery strategy for newborn interventions in rural Bangladesh. Methods A cluster-randomized controlled trial was conducted in Mirzapur, Bangladesh. Twelve unions were randomized to intervention or comparison arm. All women of reproductive age were eligible to participate. In the intervention arm, community health workers identified pregnant women; made two antenatal home visits to promote birth and newborn care preparedness; made four postnatal home visits to negotiate preventive care practices and to assess newborns for illness; and referred sick neonates to a hospital and facilitated compliance. Primary outcome measures were antenatal and immediate newborn care behaviours, knowledge of danger signs, care seeking for neonatal complications, and neonatal mortality. Findings A total of 4616 and 5241 live births were recorded from 9987 and 11153 participants in the intervention and comparison arm, respectively. High coverage of antenatal (91% visited twice) and postnatal (69% visited on days 0 or 1) home visitations was achieved. Indicators of care practices and knowledge of maternal and neonatal danger signs improved. Adjusted mortality hazard ratio in the intervention arm, compared to the comparison arm, was 1.02 (95% CI: 0.80–1.30) at baseline and 0.87 (95% CI: 0.68–1.12) at endline. Primary causes of death were birth asphyxia (49%) and prematurity (26%). No adverse events associated with interventions were reported. Conclusion Lack of evidence for mortality impact despite high program coverage and quality assurance of implementation, and improvements in targeted newborn care practices suggests the intervention did not adequately address risk factors for mortality. The level and cause-structure of neonatal mortality in the local population must be considered in developing interventions. Programs must ensure skilled care during childbirth, including management of birth asphyxia and prematurity, and curative postnatal care during the first two days of life, in addition to essential newborn care and infection prevention and management. Trial Registration Clinicaltrials.gov NCT00198627 PMID:20352087

Change in Functional Arm Use Is Associated With Somatosensory Skills After Sensory Retraining Poststroke.

PubMed

Turville, Megan; Carey, Leeanne M; Matyas, Thomas A; Blennerhassett, Jannette

We investigated changes in functional arm use after retraining for stroke-related somatosensory loss and identified whether such changes are associated with somatosensory discrimination skills. Data were pooled (N = 80) from two randomized controlled trials of somatosensory retraining. We used the Motor Activity Log to measure perceived amount of arm use in daily activities and the Action Research Arm Test to measure performance capacity. Somatosensory discrimination skills were measured using standardized modality-specific measures. Participants' arm use improved after somatosensory retraining (z = -6.80, p < .01). Change in arm use was weakly associated with somatosensation (tactile, β = 0.31, p < .01; proprioception, β = -0.17, p > .05; object recognition, β = 0.13, p < .05). Change in daily arm use was related to a small amount of variance in somatosensory outcomes. Stroke survivors' functional arm use can increase after somatosensory retraining, with change varying among survivors. Copyright © 2017 by the American Occupational Therapy Association, Inc.

A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home.

PubMed

Fife, Caroline E; Davey, Suzanne; Maus, Erik A; Guilliod, Renie; Mayrovitz, Harvey N

2012-12-01

Pneumatic compression devices (PCDs) are used in the home setting as adjunctive treatment for lymphedema after acute treatment in a clinical setting. PCDs range in complexity from simple to technologically advanced. The objective of this prospective, randomized study was to determine whether an advanced PCD (APCD) provides better outcomes as measured by arm edema and tissue water reductions compared to a standard PCD (SPCD) in patients with arm lymphedema after breast cancer treatment. Subjects were randomized to an APCD (Flexitouch system, HCPCS E0652) or SPCD (Bio Compression 2004, HCPCS E0651) used for home treatment 1 h/day for 12 weeks. Pressure settings were 30 mmHg for the SPCD and upper extremity treatment program (UE01) with standard pressure for the APCD. Thirty-six subjects (18 per group) with unilateral upper extremity lymphedema with at least 5% arm edema volume at the time of enrollment, completed treatments over the 12-week period. Arm volumes were determined from arm girth measurements and suitable model calculations, and tissue water was determined based on measurements of the arm tissue dielectric constant (TDC). The APCD-treated group experienced an average of 29% reduction in edema compared to a 16% increase in the SPCD group. Mean changes in TDC values were a 5.8% reduction for the APCD group and a 1.9% increase for the SPCD group. This study suggests that for the home maintenance phase of treatment of arm lymphedema secondary to breast cancer therapy, the adjuvant treatment with an APCD provides better outcomes than with a SPCD.

Reducing the Mental Health-Related Stigma of Social Work Students: A Cluster RCT

ERIC Educational Resources Information Center

Rubio-Valera, Maria; Aznar-Lou, Ignacio; Vives-Collet, Mireia; Fernández, Ana; Gil-Girbau, Montserrat; Serrano-Blanco, Antoni

2018-01-01

The aim of this study was to evaluate the impact of a social contact and education intervention to improve attitudes to mental illness in first-year social work students. This was a 3-month cluster randomized controlled trial with two parallel arms: intervention (87) and control group (79). The intervention was a workshop led by an OBERTAMENT…

Design of healthy hearts in the heartland (H3): A practice-randomized, comparative effectiveness study.

PubMed

Ciolino, Jody D; Jackson, Kathryn L; Liss, David T; Brown, Tiffany; Walunas, Theresa L; Murakami, Linda; Chung, Isabel; Persell, Stephen D; Kho, Abel N

2018-06-02

The Healthy Hearts in the Heartland (H3) study is part of a nationwide effort, EvidenceNOW, seeking to better understand the ability of small primary care practices to improve "ABCS" clinical quality measures: appropriate Aspirin therapy, Blood pressure control, Cholesterol management, and Smoking cessation. H3 aimed to assess feasibility of implementing Point-of-Care (POC) or POC plus Population Management (POC + PM) quality improvement (QI) strategies to improve ABCS at practices in Illinois, Indiana, and Wisconsin. We describe the design and randomization of the H3 study. We conducted a two-arm (1:1, POC:POC + PM), practice-randomized, comparative effectiveness study in 226 primary care practices across four "waves" of randomization with a 12-month intervention period, followed by a six-month sustainability period. Randomization controlled imbalance in nine baseline variables through a modified constrained algorithm. Among others, we used initial, unverified estimates of baseline ABCS values. We randomized 112 and 114 practices to POC and POC + PM arms, respectively. Randomization ensured baseline comparability for all nine key variables, including the ABCS measures indicating proportion of patients at the practice level meeting each quality measure. Median(Inner Quartile Range) values were A: 0.78(0.66-0.86) in POC arm vs. 0.77(0.63-0.86) in POC + PM arm, B: 0.64(0.53-0.73) vs. 0.64(0.53-0.75), C: 0.78(0.63-0.86) vs. 0.75(0.64-0.81), S: 0.80(0.65-0.81) vs. 0.79(0.61-0.91). Surrogate estimates for the true ABCS at baseline coupled with the unique randomization logic achieved adequate baseline balance on these outcomes. Similar practice- or cluster-randomized trials may consider adaptations of this design. Final analyses on 12- and 18-month ABCS outcomes for the H3 study are forthcoming. This trial is registered on ClinicalTrials.gov (Initial post: 11/05/2015; identifier: NCT02598284; https://clinicaltrials.gov/ct2/show/NCT02598284?term=NCT02598284&rank=1). Copyright © 2018 Elsevier Inc. All rights reserved.

Phase II randomized study of trabectedin given as two different every 3 weeks dose schedules (1.5 mg/m2 24 h or 1.3 mg/m2 3 h) to patients with relapsed, platinum-sensitive, advanced ovarian cancer.

PubMed

Del Campo, J M; Roszak, A; Bidzinski, M; Ciuleanu, T E; Hogberg, T; Wojtukiewicz, M Z; Poveda, A; Boman, K; Westermann, A M; Lebedinsky, C

2009-11-01

This randomized, open-label, phase II clinical trial evaluated the optimal regimen of trabectedin administered every 3 weeks in patients with platinum-sensitive, relapsed, advanced ovarian cancer (AOC). Patients previously treated with less than two or two previous chemotherapy lines were randomized to receive trabectedin 1.5 mg/m(2) 24 h (arm A, n = 54) or 1.3 mg/m(2) 3 h (arm B, n = 53). Objective response rate (ORR) per RECIST was the primary efficacy end point. Toxic effects were graded according to the National Cancer Institute-Common Toxicity Criteria v. 2.0. ORR was 38.9% [95% confidence interval (CI) 25.9% to 53.1%; arm A] and 35.8% (95% CI 23.1% to 50.2%; arm B) (intention-to-treat primary analysis). Median time to progression was 6.2 months (95% CI 5.3-8.6 months; arm A) and 6.8 months (95% CI 4.6-7.4 months; arm B). Frequent severe adverse events were nausea/vomiting (24%, arm A; 15%, arm B) and fatigue (15%, arm A; 10%, arm B). Common severe laboratory abnormalities were transient, noncumulative neutropenia (55%, arm A; 37%, arm B) and transaminase increases (alanine aminotransferase, 55%, arm A; 59%, arm B). Both every-3-weeks trabectedin regimes, 1.5 mg/m(2) 24 h and 1.3 mg/m(2) 3 h, were active and reasonably well tolerated in AOC platinum-sensitive patients. Trabectedin every-3-weeks has promising activity and deserves to be further evaluated in relapsed AOC.

The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers - study protocol for a randomized controlled trial.

PubMed

Zahid, Raana; Dogar, Omara; Mansoor, Sonia; Khan, Amina; Kanaan, Mona; Jawad, Mohammed; Ahluwalia, Jasjit S; Siddiqi, Kamran

2017-01-11

Waterpipe tobacco smoking has increased among youth across the globe including in the US, and it continues as a common and traditional form of smoking tobacco in Pakistan. A range of behavioral and pharmacological therapies are available to support people in quitting cigarette smoking; however, little evidence exists for the efficacy of these therapies in achieving abstinence among waterpipe tobacco smokers. The objective of this study is to assess the efficacy of varenicline when added to behavioral support for waterpipe tobacco smoking cessation, by measuring biochemically validated continuous abstinence in waterpipe tobacco smokers. This is a two-arm, double-blind, placebo-controlled randomized trial conducted in four districts in Punjab, Pakistan. Study participants include adults using a waterpipe (with or without concomitant cigarette, bidi or other forms of tobacco smoking) on a daily basis for at least 6 months and who are willing to quit. We will individually randomize 510 participants to one of the two arms of the trial. Participants in the intervention arm will receive varenicline and behavioral support and those in the control arm will receive placebo and behavioral support. The primary outcome will be continuous abstinence for at least 6 months (week 25) which is biochemically verified by a carbon monoxide level of <10 ppm. Secondary outcomes will include biochemically verified 7-day point abstinence at 5, 12 and 25 weeks and any lapses and relapses between the different assessment points. Tertiary outcomes will include assessment of withdrawal symptoms using the Mood and Physical Symptoms Scale (MPSS), smoking dependency using the Lebanon Waterpipe Dependency Scale (LWDS-11) and monitoring adverse outcomes. This is an efficacy trial and would require a subsequent effectiveness trial for a definitive evaluation of the intervention. ISRCTN, ISRCTN94103375 . Registered on 1 December 2015.

Entertainment education for breast cancer surgery decisions: a randomized trial among patients with low health literacy.

PubMed

Jibaja-Weiss, Maria L; Volk, Robert J; Granchi, Thomas S; Neff, Nancy E; Robinson, Emily K; Spann, Stephen J; Aoki, Noriaki; Friedman, Lois C; Beck, J Robert

2011-07-01

To evaluate an entertainment-based patient decision aid for early stage breast cancer surgery in low health literacy patients. Newly diagnosed female patients with early stage breast cancer from two public hospitals were randomized to receive an entertainment-based decision aid for breast cancer treatment along with usual care (intervention arm) or to receive usual care only (control arm). Pre-decision (baseline), pre-surgery, and 1-year follow-up assessments were conducted. Patients assigned to the intervention arm of the study were more likely than the controls to choose mastectomy rather than breast-conserving surgery; however, they appeared better informed and clearer about their surgical options than women assigned to the control group. No differences in satisfaction with the surgical decision or the decision-making process were observed between the patients who viewed the intervention and those assigned to the control group. Entertainment education may be a desirable strategy for informing lower health literate women about breast cancer surgery options. Incorporating patient decision aids, particularly computer-based decision aids, into standard clinical practice remains a challenge; however, patients may be directed to view programs at home or at public locations (e.g., libraries, community centers). Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

A randomized controlled trial of a nurse-led case management programme for hospital-discharged older adults with co-morbidities

PubMed Central

Chow, Susan Ka Yee; Wong, Frances Kam Yuet

2014-01-01

Aim To examine the effects of a nurse-led case management programme for hospital-discharged older adults with co-morbidities. Background The most significant chronic conditions today involve diseases of the cardiovascular, respiratory, endocrine and renal systems. Previous studies have suggested that a nurse-led case management approach using either telephone follow-ups or home visits was able to improve clinical and patient outcomes for patients having a single, chronic disease, while the effects for older patients having at least two long-term conditions are unknown. A self-help programme using motivation and empowerment approaches is the framework of care in the study. Design Randomized controlled trial. Method The study was conducted from 2010–2012. Older patients having at least two chronic diseases were included for analysis. The participants were randomized into three arms: two study groups and one control group. Data were collected at baseline and at 4 and 12 weeks later. Results Two hundred and eighty-one patients completed the study. The interventions demonstrated significant differences in hospital readmission rates within 84 days post discharge. The two intervention groups had lower readmission rates than the control group. Patients in the two study arms had significantly better self-rated health and self-efficacy. There was significant difference between the groups in the physical composite score, but no significant difference in mental component score in SF-36 scale. Conclusion The postdischarge interventions led by the nurse case managers on self-management of disease using the empowerment approach were able to provide effective clinical and patient outcomes for older patients having co-morbidities. PMID:24617755

A randomized clinical trial comparing metabolic parameters after 48 weeks of standard- and low-dose stavudine therapy and tenofovir disoproxil fumarate therapy in HIV-infected South African patients.

PubMed

Menezes, C N; Crowther, N J; Duarte, R; Van Amsterdam, D; Evans, D; Dickens, C; Dix-Peek, T; Rassool, M; Prinsloo, A; Raal, F; Sanne, I

2014-01-01

Low-dose stavudine therapy may have a lower toxicity profile compared with standard dose. A randomized controlled trial comparing these two doses of stavudine with tenofovir disoproxil fumarate (tenofovir DF) was performed to assess the effects on anthropometry, markers of inflammation, and lipid and glucose metabolism in Black South African patients. Sixty patients were randomized 1:1:1 to either standard-dose (30-40 mg) or low-dose (20-30 mg) stavudine or tenofovir DF (300 mg), each combined with lamivudine and efavirenz, for 48 weeks. Anthropometry, markers of inflammation, and lipid and glucose metabolism were assessed using standard techniques. In all three treatment arms, there was a significant increase in lipid levels over the study period. At 48 weeks, fasting glucose level (P < 0.005) and homeostasis model assessment (HOMA) score (P < 0.05) increased significantly in the standard-dose stavudine arm, as did insulin and C-peptide levels in both the standard- and low-dose stavudine arms. At week 48, a significant decrease (P < 0.05) in adiponectin was noted in the standard-dose stavudine arm, but there was an increase (P < 0.005) in the tenofovir DF arm. In both the stavudine arms, significant increases in anthropometric measures occurred at 24 weeks but these decreased by week 48. Mitochondrial toxicities occurred in both the stavudine arms. Immunological and virological outcomes were similar for all three arms. This study highlights the occurrence of metabolic abnormalities with both stavudine and tenofovir DF treatment. Awareness of the potential increased cardiovascular risk should be of concern with the use of both these therapies. © 2013 British HIV Association.

An RCT Investigating Patient-Driven Versus Physician-Driven Titration of BIAsp 30 in Patients with Type 2 Diabetes Uncontrolled Using NPH Insulin.

PubMed

Chraibi, Abdelmjid; Al-Herz, Shoorook; Nguyen, Bich Dao; Soeatmadji, Djoko W; Shinde, Anil; Lakshmivenkataraman, Balasubramanian; Assaad-Khalil, Samir H

2017-08-01

The aim of this study was to confirm the efficacy of patient-driven titration of BIAsp 30 in terms of glycemic control, by comparing it to physician-driven titration of BIAsp 30, in patients with type 2 diabetes in North Africa, the Middle East, and Asia. A 20-week, open-label, randomized, two-armed, parallel-group, multicenter study in Egypt, Indonesia, Morocco, Saudi Arabia, and Vietnam. Patients (n = 155) with type 2 diabetes inadequately controlled using neutral protamine Hagedorn (NPH) insulin were randomized to either patient-driven or physician-driven BIAsp 30 titration. The noninferiority of patient-driven compared to physician-driven titration with respect to the reduction in HbA1c was confirmed. The estimated mean change in HbA1c from baseline to week 20 was -1.27% in the patient-driven arm and -1.04% in the physician-driven arm, with an estimated treatment difference of -0.23% (95% confidence interval: -0.54; 0.08). After 20 weeks of treatment, the proportions of patients achieving the target of HbA1c <7.5% were similar between titration arms; the proportions of patients achieving the target of ≤6.5% were also similar. Both titration algorithms were well tolerated, and hypoglycemic episode rates were similar in both arms. Patient-driven titration of BIAsp 30 can be as effective and safe as physician-driven titration in non-Western populations. Overall, the switch from NPH insulin to BIAsp 30 was well tolerated in both titration arms and led to improved glycemic control. A limitation of the study was the relatively small number of patients recruited in each country. ClinicalTrials.gov NCT01589653. Novo Nordisk A/S, Denmark.

Hand washing with soap and water together with behavioural recommendations prevents infections in common work environment: an open cluster-randomized trial

PubMed Central

2012-01-01

Background Hand hygiene is considered as an important means of infection control. We explored whether guided hand hygiene together with transmission-limiting behaviour reduces infection episodes and lost days of work in a common work environment in an open cluster-randomized 3-arm intervention trial. Methods A total of 21 clusters (683 persons) were randomized to implement hand hygiene with soap and water (257 persons), with alcohol-based hand rub (202 persons), or to serve as a control (224 persons). Participants in both intervention arms also received standardized instructions on how to limit the transmission of infections. The intervention period (16 months) included the emergence of the 2009 influenza pandemic and the subsequent national hand hygiene campaign influencing also the control arm. Results In the total follow-up period there was a 6.7% reduction of infection episodes in the soap-and water arm (p = 0.04). Before the onset of the anti-pandemic campaign, a statistically significant (p = 0.002) difference in the mean occurrence of infection episodes was observed between the control (6.0 per year) and the soap-and-water arm (5.0 per year) but not between the control and the alcohol-rub arm (5.6 per year). Neither intervention had a decreasing effect on absence from work. Conclusions We conclude that intensified hand hygiene using water and soap together with behavioural recommendations can reduce the occurrence of self-reported acute illnesses in common work environment. Surprisingly, the occurrence of reported sick leaves also increased in the soap-and water-arm. Trial Registration ClinicalTrials.gov: NCT00981877 Source of funding The Finnish Work Environment Fund and the National Institute for Health and Welfare. PMID:22243622

Hand washing with soap and water together with behavioural recommendations prevents infections in common work environment: an open cluster-randomized trial.

PubMed

Savolainen-Kopra, Carita; Haapakoski, Jaason; Peltola, Piia A; Ziegler, Thedi; Korpela, Terttu; Anttila, Pirjo; Amiryousefi, Ali; Huovinen, Pentti; Huvinen, Markku; Noronen, Heikki; Riikkala, Pia; Roivainen, Merja; Ruutu, Petri; Teirilä, Juha; Vartiainen, Erkki; Hovi, Tapani

2012-01-16

Hand hygiene is considered as an important means of infection control. We explored whether guided hand hygiene together with transmission-limiting behaviour reduces infection episodes and lost days of work in a common work environment in an open cluster-randomized 3-arm intervention trial. A total of 21 clusters (683 persons) were randomized to implement hand hygiene with soap and water (257 persons), with alcohol-based hand rub (202 persons), or to serve as a control (224 persons). Participants in both intervention arms also received standardized instructions on how to limit the transmission of infections. The intervention period (16 months) included the emergence of the 2009 influenza pandemic and the subsequent national hand hygiene campaign influencing also the control arm. In the total follow-up period there was a 6.7% reduction of infection episodes in the soap-and water arm (p = 0.04). Before the onset of the anti-pandemic campaign, a statistically significant (p = 0.002) difference in the mean occurrence of infection episodes was observed between the control (6.0 per year) and the soap-and-water arm (5.0 per year) but not between the control and the alcohol-rub arm (5.6 per year). Neither intervention had a decreasing effect on absence from work. We conclude that intensified hand hygiene using water and soap together with behavioural recommendations can reduce the occurrence of self-reported acute illnesses in common work environment. Surprisingly, the occurrence of reported sick leaves also increased in the soap-and water-arm. ClinicalTrials.gov: NCT00981877 The Finnish Work Environment Fund and the National Institute for Health and Welfare.

The feasibility, time savings and economic impact of a designated time appointment system at a busy HIV care clinic in Kenya: a randomized controlled trial.

PubMed

Kwena, Zachary A; Njoroge, Betty W; Cohen, Craig R; Oyaro, Patrick; Shikari, Rosemary; Kibaara, Charles K; Bukusi, Elizabeth A

2015-01-01

As efforts are made to reach universal access to ART in Kenya, the problem of congestion at HIV care clinics is likely to worsen. We evaluated the feasibility and the economic benefits of a designated time appointment system as a solution to decongest HIV care clinics. This was an explanatory two-arm open-label randomized controlled trial that enrolled 354 consenting participants during their normal clinic days and followed-up at subsequent clinic appointments for up to nine months. Intervention arm participants were given specific dates and times to arrive at the clinic for their next appointment while those in the control arm were only given the date and had the discretion to decide on the time to arrive as is the standard practice. At follow-up visits, we recorded arrival and departure times and asked the monetary value of work participants engaged in before and after clinic. We conducted multiple imputation to replace missing data in our primary outcome variables to allow for intention-to-treat analysis; and analyzed the data using Mann-Whitney U test. Overall, 72.1% of the intervention participants arrived on time, 13.3% arrived ahead of time and 14.6% arrived past scheduled time. Intervention arm participants spent a median of 65 [interquartile range (IQR), 52-87] minutes at the clinic compared to 197 (IQR, 173-225) minutes for control participants (p<0.01). Furthermore, intervention arm participants were more productively engaged on their clinic days valuing their cumulative work at a median of USD 10.5 (IQR, 60.0-16.8) compared to participants enrolled in the control arm who valued their work at USD 8.3 (IQR, 5.5-12.9; p=0.02). A designated time appointment system is feasible and provides substantial time savings associated with greater economic productivity for HIV patients attending a busy HIV care clinic.

The effect of referral for genetic counseling on genetic testing and surgical prevention in women at high risk for ovarian cancer: Results from a randomized controlled trial.

PubMed

Drescher, Charles W; Beatty, J David; Resta, Robert; Andersen, M Robyn; Watabayashi, Kate; Thorpe, Jason; Hawley, Sarah; Purkey, Hannah; Chubak, Jessica; Hanson, Nancy; Buist, Diana S M; Urban, Nicole

2016-07-22

Guidelines recommend genetic counseling and testing for women who have a pedigree suggestive of an inherited susceptibility for ovarian cancer. The authors evaluated the effect of referral to genetic counseling on genetic testing and prophylactic oophorectomy in a randomized controlled trial. Data from an electronic mammography reporting system identified 12,919 women with a pedigree that included breast cancer, of whom 625 were identified who had a high risk for inherited susceptibility to ovarian cancer using a risk-assessment questionnaire. Of these, 458 women provided informed consent and were randomized 1:1 to intervention consisting of a genetic counseling referral (n = 228) or standard clinical care (n = 230). Participants were predominantly aged 45 to 65 years, and 30% and 20% reported a personal history of breast cancer or a family history of ovarian cancer, respectively. Eighty-five percent of women in the intervention group participated in a genetic counseling session. Genetic testing was reported by 74 (33%) and 20 (9%) women in the intervention and control arms (P < .005), respectively. Five women in the intervention arm and 2 in the control arm were identified as germline mutation carriers. Ten women in the intervention arm and 3 in the control arm underwent prophylactic bilateral salpingo-oophorectomy (P < .05). Routine referral of women at high risk for ovarian cancer to genetic counseling promotes genetic testing and prophylactic surgery. The findings from the current randomized controlled trial demonstrate the value of implementing strategies that target women at high risk for ovarian cancer to ensure they are offered access to recommended care. CA Cancer J Clin 2016. © 2016 American Cancer Society, Inc. © 2016 American Cancer Society.

Unilateral versus bilateral robot-assisted rehabilitation on arm-trunk control and functions post stroke: a randomized controlled trial.

PubMed

Wu, Ching-Yi; Yang, Chieh-Ling; Chen, Ming-de; Lin, Keh-Chung; Wu, Li-Ling

2013-04-12

Although the effects of robot-assisted arm training after stroke are promising, the relative effects of unilateral (URT) vs. bilateral (BRT) robot-assisted arm training remain uncertain. This study compared the effects of URT vs. BRT on upper extremity (UE) control, trunk compensation, and function in patients with chronic stroke. This was a single-blinded, randomized controlled trial. The intervention was implemented at 4 hospitals. Fifty-three patients with stroke were randomly assigned to URT, BRT, or control treatment (CT). Each group received UE training for 90 to 105 min/day, 5 days/week, for 4 weeks. The kinematic variables for arm motor control and trunk compensation included normalized movement time, normalized movement units, and the arm-trunk contribution slope in unilateral and bilateral tasks. Motor function and daily function were measured by the Wolf Motor Function Test (WMFT), Motor Activity Log (MAL), and ABILHAND Questionnaire. The BRT and CT groups elicited significantly larger slope values (i.e., less trunk compensation) at the start of bilateral reaching than the URT group. URT led to significantly better effects on WMFT-Time than BRT. Differences in arm control kinematics and performance on the MAL and ABILHAND among the 3 groups were not significant. BRT and URT resulted in differential improvements in specific UE/trunk performance in patients with stroke. BRT elicited larger benefits than URT on reducing compensatory trunk movements at the beginning of reaching. In contrast, URT produced better improvements in UE temporal efficiency. These relative effects on movement kinematics, however, did not translate into differential benefits in daily functions. ClinicalTrials.gov: NCT00917605.

Shamba Maisha: Randomized controlled trial of an agricultural and finance intervention to improve HIV health outcomes in Kenya

PubMed Central

WEISER, Sheri D.; BUKUSI, Elizabeth A.; STEINFELD, Rachel L.; FRONGILLO, Edward A.; WEKE, Elly; DWORKIN, Shari L.; PUSATERI, Kyle; SHIBOSKI, Stephen; SCOW, Kate; BUTLER, Lisa M.; COHEN, Craig R.

2015-01-01

Objectives Food insecurity and HIV/AIDS outcomes are inextricably linked in sub-Saharan Africa. We report on health and nutritional outcomes of a multisectoral agricultural intervention trial among HIV-infected adults in rural Kenya. Design Pilot cluster randomized controlled trial Methods The intervention included a human-powered water pump, a microfinance loan to purchase farm commodities, and education in sustainable farming practices and financial management. Two health facilities in Nyanza Region, Kenya were randomly assigned as intervention or control. HIV-infected adults 18 to 49 years old who were on antiretroviral therapy and had access to surface water and land were enrolled beginning in April 2012 and followed quarterly for one year. Data were collected on nutritional parameters, CD4 T lymphocyte counts, and HIV RNA. Difference in difference fixed-effects regression models were used to test whether patterns in health outcomes differed over time from baseline between the intervention and control arms. Results We enrolled 72 and 68 participants in the intervention and control groups, respectively. At 12 months follow-up, we found a statistically significant increase in CD4 cell counts (165 cells/mm3, p<0.001) and proportion virologically suppressed in the intervention arm compared to the control arm (comparative improvement in proportion of 0.33 suppressed, OR 7.6, 95% CI: 2.2–26.8). Intervention participants experienced significant improvements in food security (3.6 scale points higher, p<0.001) and frequency of food consumption (9.4 times per week greater frequency, p=0.013) compared to controls. Conclusion Livelihood interventions may be a promising approach to tackle the intersecting problems of food insecurity, poverty and HIV/AIDS morbidity. PMID:26214684

Shamba Maisha: randomized controlled trial of an agricultural and finance intervention to improve HIV health outcomes.

PubMed

Weiser, Sheri D; Bukusi, Elizabeth A; Steinfeld, Rachel L; Frongillo, Edward A; Weke, Elly; Dworkin, Shari L; Pusateri, Kyle; Shiboski, Stephen; Scow, Kate; Butler, Lisa M; Cohen, Craig R

2015-09-10

Food insecurity and HIV/AIDS outcomes are inextricably linked in sub-Saharan Africa. We report on health and nutritional outcomes of a multisectoral agricultural intervention trial among HIV-infected adults in rural Kenya. This is a pilot cluster randomized controlled trial. The intervention included a human-powered water pump, a microfinance loan to purchase farm commodities, and education in sustainable farming practices and financial management. Two health facilities in Nyanza Region, Kenya were randomly assigned as intervention or control. HIV-infected adults 18 to 49 years' old who were on antiretroviral therapy and had access to surface water and land were enrolled beginning in April 2012 and followed quarterly for 1 year. Data were collected on nutritional parameters, CD4 T-lymphocyte counts, and HIV RNA. Differences in fixed-effects regression models were used to test whether patterns in health outcomes differed over time from baseline between the intervention and control arms. We enrolled 72 and 68 participants in the intervention and control groups, respectively. At 12 months follow-up, we found a statistically significant increase in CD4 cell counts (165 cells/μl, P < 0.001) and proportion virologically suppressed in the intervention arm compared with the control arm (comparative improvement in proportion of 0.33 suppressed, odds ratio 7.6, 95% confidence interval: 2.2-26.8). Intervention participants experienced significant improvements in food security (3.6 scale points higher, P < 0.001) and frequency of food consumption (9.4 times per week greater frequency, P = 0.013) compared to controls. Livelihood interventions may be a promising approach to tackle the intersecting problems of food insecurity, poverty and HIV/AIDS morbidity.

Rural providers' access to online resources: a randomized controlled trial

PubMed Central

Hall, Laura J.; McElfresh, Karen R.; Warner, Teddy D.; Stromberg, Tiffany L.; Trost, Jaren; Jelinek, Devin A.

2016-01-01

Objective The research determined the usage and satisfaction levels with one of two point-of-care (PoC) resources among health care providers in a rural state. Methods In this randomized controlled trial, twenty-eight health care providers in rural areas were stratified by occupation and region, then randomized into either the DynaMed or the AccessMedicine study arm. Study participants were physicians, physician assistants, and nurses. A pre- and post-study survey measured participants' attitudes toward different information resources and their information-seeking activities. Medical student investigators provided training and technical support for participants. Data analyses consisted of analysis of variance (ANOVA), paired t tests, and Cohen's d statistic to compare pre- and post-study effects sizes. Results Participants in both the DynaMed and the AccessMedicine arms of the study reported increased satisfaction with their respective PoC resource, as expected. Participants in both arms also reported that they saved time in finding needed information. At baseline, both arms reported too little information available, which increased to “about right amounts of information” at the completion of the study. DynaMed users reported a Cohen's d increase of +1.50 compared to AccessMedicine users' reported use of 0.82. DynaMed users reported d2 satisfaction increases of 9.48 versus AccessMedicine satisfaction increases of 0.59 using a Cohen's d. Conclusion Participants in the DynaMed arm of the study used this clinically oriented PoC more heavily than the users of the textbook-based AccessMedicine. In terms of user satisfaction, DynaMed users reported higher levels of satisfaction than the users of AccessMedicine. PMID:26807050

Offering self-administered oral HIV testing to truck drivers in Kenya to increase testing: a randomized controlled trial.

PubMed

Kelvin, Elizabeth A; George, Gavin; Mwai, Eva; Nyaga, Eston; Mantell, Joanne E; Romo, Matthew L; Odhiambo, Jacob O; Starbuck, Lila; Govender, Kaymarlin

2018-01-01

We conducted a randomized controlled trial among 305 truck drivers from two North Star Alliance roadside wellness clinics in Kenya to see if offering HIV testing choices would increase HIV testing uptake. Participants were randomized to be offered (1) a provider-administered rapid blood (finger-prick) HIV test (i.e., standard of care [SOC]) or (2) a Choice between SOC or a self-administered oral rapid HIV test with provider supervision in the clinic. Participants in the Choice arm who refused HIV testing in the clinic were offered a test kit for home use with phone-based posttest counseling. We compared HIV test uptake using the Mantel Haenszel odds ratio (OR) adjusting for clinic. Those in the Choice arm had higher odds of HIV test uptake than those in the SOC arm (OR = 1.5), but the difference was not statistically significant (p = 0.189). When adding the option to take an HIV test kit for home use, the Choice arm had significantly greater odds of testing uptake (OR = 2.8, p = 0.002). Of those in the Choice arm who tested, 26.9% selected the SOC test, 64.6% chose supervised self-testing in the clinic, and 8.5% took a test kit for home use. Participants varied in the HIV test they selected when given choices. Importantly, when participants who refused HIV testing in the clinic were offered a test kit for home use, an additional 8.5% tested. Offering truck drivers a variety of HIV testing choices may increase HIV testing uptake in this key population.

The Efficacy of Fast ForWord-Language Intervention in School-Age Children with Language Impairment: A Randomized Controlled Trial

PubMed Central

Gillam, Ronald B.; Loeb, Diane Frome; Hoffman, LaVae M.; Bohman, Thomas; Champlin, Craig A.; Thibodeau, Linda; Widen, Judith; Brandel, Jayne; Friel-Patti, Sandy

2008-01-01

Purpose A randomized controlled trial (RCT) was conducted to compare the language and auditory processing outcomes of children assigned to Fast ForWord-Language (FFW-L) to the outcomes of children assigned to nonspecific or specific language intervention comparison treatments that did not contain modified speech. Method Two hundred and sixteen children between the ages of 6 and 9 years with language impairments were randomly assigned to one of four arms: Fast ForWord-Language (FFW-L), academic enrichment (AE), computer-assisted language intervention (CALI), or individualized language intervention (ILI) provided by a speech-language pathologist. All children received 1 hour and 40 minutes of treatment, 5 days per week, for 6 weeks. Language and auditory processing measures were administered to the children by blinded examiners before treatment, immediately after treatment, 3 months after treatment, and 6 months after treatment. Results The children in all four arms improved significantly on a global language test and a test of backward masking. Children with poor backward masking scores who were randomized to the FFW-L arm did not present greater improvement on the language measures than children with poor backward masking scores who were randomized to the other three arms. Effect sizes, analyses of standard error of measurement, and normalization percentages supported the clinical significance of the improvements on the CASL. There was a treatment effect for the Blending Words subtest on the Comprehensive Test of Phonological Processing (Wagner, Torgesen, & Rashotte, 1999). Participants in the FFW-L and CALI arms earned higher phonological awareness scores than children in the ILI and AE arms at the six-month follow-up testing. Conclusion Fast ForWord-Language, the language intervention that provided modified speech to address a hypothesized underlying auditory processing deficit, was not more effective at improving general language skills or temporal processing skills than a nonspecific comparison treatment (AE) or specific language intervention comparison treatments (CALI and ILI) that did not contain modified speech stimuli. These findings call into question the temporal processing hypothesis of language impairment and the hypothesized benefits of using acoustically modified speech to improve language skills. The finding that children in the three treatment arms and the active comparison arm made clinically relevant gains on measures of language and temporal auditory processing informs our understanding of the variety of intervention activities that can facilitate development. PMID:18230858

A cluster randomized trial of routine HIV-1 viral load monitoring in Zambia: study design, implementation, and baseline cohort characteristics.

PubMed

Koethe, John R; Westfall, Andrew O; Luhanga, Dora K; Clark, Gina M; Goldman, Jason D; Mulenga, Priscilla L; Cantrell, Ronald A; Chi, Benjamin H; Zulu, Isaac; Saag, Michael S; Stringer, Jeffrey S A

2010-03-12

The benefit of routine HIV-1 viral load (VL) monitoring of patients on antiretroviral therapy (ART) in resource-constrained settings is uncertain because of the high costs associated with the test and the limited treatment options. We designed a cluster randomized controlled trial to compare the use of routine VL testing at ART-initiation and at 3, 6, 12, and 18 months, versus our local standard of care (which uses immunological and clinical criteria to diagnose treatment failure, with discretionary VL testing when the two do not agree). Dedicated study personnel were integrated into public-sector ART clinics. We collected participant information in a dedicated research database. Twelve ART clinics in Lusaka, Zambia constituted the units of randomization. Study clinics were stratified into pairs according to matching criteria (historical mortality rate, size, and duration of operation) to limit the effect of clustering, and independently randomized to the intervention and control arms. The study was powered to detect a 36% reduction in mortality at 18 months. From December 2006 to May 2008, we completed enrollment of 1973 participants. Measured baseline characteristics did not differ significantly between the study arms. Enrollment was staggered by clinic pair and truncated at two matched sites. A large clinical trial of routing VL monitoring was successfully implemented in a dynamic and rapidly growing national ART program. Close collaboration with local health authorities and adequate reserve staff were critical to success. Randomized controlled trials such as this will likely prove valuable in determining long-term outcomes in resource-constrained settings. Clinicaltrials.gov NCT00929604.

Randomized controlled trial of the tolerability and completion of maraviroc compared with Kaletra® in combination with Truvada® for HIV post-exposure prophylaxis (MiPEP Trial).

PubMed

Milinkovic, Ana; Benn, Paul; Arenas-Pinto, Alejandro; Brima, Nataliya; Copas, Andrew; Clarke, Amanda; Fisher, Martin; Schembri, Gabriel; Hawkins, David; Williams, Andy; Gilson, Richard

2017-06-01

Post-exposure prophylaxis (PEP) for HIV is often poorly tolerated and not completed. Alternative PEP regimens may improve adherence and completion, aiding HIV prevention. We conducted a randomized controlled trial of a maraviroc-based PEP regimen compared with a standard-of-care regimen using ritonavir-boosted lopinavir. Patients meeting criteria for PEP were randomized to tenofovir disoproxil/emtricitabine (200/245 mg) once daily plus ritonavir-boosted lopinavir (Kaletra ® 400/100 mg) or maraviroc 300 mg twice daily. The composite primary endpoint was completion of 28 days of the allocated PEP regimen without grade 3 or 4 clinical or laboratory adverse events (AEs) related to the PEP medication. Two hundred and thirteen individuals were randomized (107 to maraviroc; 106 to Kaletra ® arm). Follow-up rates were high in both groups. There was no difference in the primary endpoint; 70 (71%) in the maraviroc and 64 (65%) in the Kaletra ® arm ( P  =   0.36) completed PEP without grade 3 or 4 AEs. Discontinuation of PEP was the same (18%) in both groups. There were no grade 3 or 4 clinical AEs in either arm, but more grade 1 or 2 clinical AEs in the Kaletra ® arm (91% versus 70%; P  < 0.001). Antidiarrhoeal medication use was higher in the Kaletra ® arm (67% versus 25%; P  < 0.001). There were no HIV seroconversions in the study period. The completion rate in the absence of grade 3 or 4 AEs was similar with both regimens. Maraviroc-based PEP was better tolerated, supporting its use as an option for non-occupational PEP. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Randomized controlled trial on postoperative pulmonary humidification after total laryngectomy: external humidifier versus heat and moisture exchanger.

PubMed

Mérol, Jean-Claude; Charpiot, Anne; Langagne, Thibault; Hémar, Patrick; Ackerstaff, Annemieke H; Hilgers, Frans J M

2012-02-01

Assessment of immediate postoperative airway humidification after total laryngectomy (TLE), comparing the use of an external humidifier (EH) with humidification through a heat and moisture exchanger (HME). Randomized controlled trial (RCT). Fifty-three patients were randomized into the standard (control) EH (N = 26) or the experimental HME arm (N = 27). Compliance, pulmonary and sleeping problems, patients' and nursing staff satisfaction, nursing time, and cost-effectiveness were assessed with trial-specific structured questionnaires and tally sheets. In the EH arm data were available for all patients, whereas in the HME arm data were incomplete for four patients. The 24/7 compliance rate in the EH arm was 12% and in the HME arm 87% (77% if the four nonevaluable patients are considered noncompliant). Compliance and patients' satisfaction were significantly better, and the number of coughing episodes, mucus expectoration for clearing the trachea, and sleeping disturbances were significantly less in the HME arm (P < .001). This was also the case for nursing time and nursing staff satisfaction and preference. This RCT clearly shows the benefits of immediate postoperative airway humidification by means of an HME over the use of an EH after TLE. This study therefore underlines that HMEs presently can be considered the better option for early postoperative airway humidification after TLE. Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc.

Effects of task-oriented robot training on arm function, activity, and quality of life in chronic stroke patients: a randomized controlled trial.

PubMed

Timmermans, Annick A A; Lemmens, Ryanne J M; Monfrance, Maurice; Geers, Richard P J; Bakx, Wilbert; Smeets, Rob J E M; Seelen, Henk A M

2014-03-31

Over fifty percent of stroke patients experience chronic arm hand performance problems, compromising independence in daily life activities and quality of life. Task-oriented training may improve arm hand performance after stroke, whereby augmented therapy may lead to a better treatment outcome. Technology-supported training holds opportunities for increasing training intensity. However, the effects of robot-supported task-oriented training with real life objects in stroke patients are not known to date. The aim of the present study was to investigate the effectiveness and added value of the Haptic Master robot combined with task-oriented arm hand training in chronic stroke patients. In a single-blind randomized controlled trial, 22 chronic stroke patients were randomly allocated to receive either task-oriented robot-assisted arm-hand training (experimental group) or task-oriented non-robotic arm-hand training (control group). For training, the T-TOAT (Technology-supported Task-Oriented Arm Training) method was applied. Training was provided during 8 weeks, 4 times/week, 2 × 30 min/day. A significant improvement after training on the Action Research Arm Test (ARAT) was demonstrated in the experimental group (p = 0.008). Results were maintained until 6 months after cessation of the training. On the perceived performance measure (Motor Activity Log (MAL)), both, the experimental and control group improved significantly after training (control group p = 0.008; experimental group p = 0.013). The improvements on MAL in both groups were maintained until 6 months after cessation of the training. With regard to quality of life, only in the control group a significant improvement after training was found (EuroQol-5D p = 0.015, SF-36 physical p = 0.01). However, the improvement on SF-36 in the control group was not maintained (p = 0.012). No between-group differences could be demonstrated on any of the outcome measures. Arm hand performance improved in chronic stroke patients, after eight weeks of task oriented training. The use of a Haptic Master robot in support of task-oriented arm training did not show additional value over the video-instructed task-oriented exercises in highly functional stroke patients. Current Controlled Trials ISRCTN82787126.

Effect of an environmental school-based obesity prevention program on changes in body fat and body weight: a randomized trial.

PubMed

Williamson, Donald A; Champagne, Catherine M; Harsha, David W; Han, Hongmei; Martin, Corby K; Newton, Robert L; Sothern, Melinda S; Stewart, Tiffany M; Webber, Larry S; Ryan, Donna H

2012-08-01

This study tested the efficacy of two school-based programs for prevention of body weight/fat gain in comparison to a control group, in all participants and in overweight children. The Louisiana (LA) Health study utilized a longitudinal, cluster randomized three-arm controlled design, with 28 months of follow-up. Children (N = 2,060; mean age = 10.5 years, SD = 1.2) from rural communities in grades 4-6 participated in the study. Seventeen school clusters (mean = 123 children/cluster) were randomly assigned to one of three prevention arms: (i) primary prevention (PP), an environmental modification (EM) program, (ii) primary + secondary prevention (PP+SP), the environmental program with an added classroom and internet education component, or (iii) control (C). Primary outcomes were changes in percent body fat and BMI z scores. Secondary outcomes were changes in behaviors related to energy balance. Comparisons of PP, PP+SP, and C on changes in body fat and BMI z scores found no differences. PP and PP+SP study arms were combined to create an EM arm. Relative to C, EM decreased body fat for boys (-1.7 ± 0.38% vs. -0.14 ± 0.69%) and attenuated fat gain for girls (2.9 ± 0.22% vs. 3.93 ± 0.37%), but standardized effect sizes were relatively small (<0.30). In conclusion, this school-based EM programs had modest beneficial effects on changes in percent body fat. Addition of a classroom/internet program to the environmental program did not enhance weight/fat gain prevention, but did impact physical activity and social support in overweight children.

Effect of an Environmental School-based Obesity Prevention Program On Changes in Body Fat and Body Weight: A Randomized Trial

PubMed Central

Williamson, D.A.; Champagne, C.M.; Harsha, D.; Han, H.; Martin, C.K.; Newton, R.L.; Sothern, M.; Stewart, T.M.; Webber, L.S.; Ryan, D.

2012-01-01

This study tested the efficacy of two school-based programs for prevention of body weight/fat gain in comparison to a control group, in all participants and in overweight children. The Louisiana (LA) Health study utilized a longitudinal, cluster randomized 3-arm controlled design, with 28 months of follow-up. Children (N=2060; M age = 10.5 years, SD = 1.2) from rural communities in Grades 4 to 6 participated in the study. 17 school clusters (M = 123 children/cluster) were randomly assigned to one of three prevention arms: 1) Primary Prevention (PP), an environmental modification program, 2) Primary + Secondary Prevention (PP+SP), the environmental program with an added classroom and internet education component, or 3) Control (C). Primary outcomes were changes in percent body fat and body mass index z scores. Secondary outcomes were changes in behaviors related to energy balance. Comparisons of PP, PP+SP, and C on changes in body fat and BMI z scores found no differences. PP and PP+SP study arms were combined to create an environmental modification arm (EM). Relative to C, EM decreased body fat for boys (−1.7% ± 0.38% versus −0.14% ± 0.69%) and attenuated fat gain for girls (2.9% ± 0.22% versus 3.93% ± 0.37%), but standardized effect sizes were relatively small (< 0.30). In conclusion, this school-based environmental modification programs had modest beneficial effects on changes in percent body fat. Addition of a classroom/internet program to the environmental program did not enhance weight/fat gain prevention, but did impact physical activity and social support in overweight children. PMID:22402733

Intravitreal ranibizumab as an adjunct for Ahmed valve surgery in open-angle glaucoma: a pilot study.

PubMed

Desai, Rajen U; Singh, Kuldev; Lin, Shan C

2013-03-01

To determine the safety and efficacy of intravitreal ranibizumab therapy before and after Ahmed tube insertion for open-angle glaucoma as a means of optimizing postoperative intraocular pressure control. Randomized, controlled trial. Open-angle glaucoma patients scheduled for Ahmed tube insertion, randomized to ranibizumab or control groups. Ranibizumab (0.5 mg in 0.05 mL) was administered intravitreally at three time points: 9 days prior to surgery, 1 month post-surgery and 2 months post-surgery. Control patients underwent the same procedure without ranibizumab. Success at 6 months postoperatively was defined as intraocular pressure <18 mmHg with no adjunctive medications or intraocular pressure <15 mmHg with one adjunctive medication. The study and control arms included six and five subjects, respectively, with four in each arm undergoing combined cataract surgery. In the ranibizumab arm, the preoperative and postoperative intraocular pressure/medication usage was 21.0 ± 6.7 mmHg on 3.2 ± 1.5 medications and 14.7 ± 1.9 mmHg on 0.5 ± 0.8 medications, respectively. In the control arm, preoperative and postoperative intraocular pressure/medication usage was 18.8 ± 3.8 mmHg on 2.8 ± 1.3 medications and 16.2 ± 3.6 mmHg with 1.8 ± 1.6 medications, respectively. Success was achieved in 83% of subjects in the ranibizumab group compared with 40% in the control group (two-tailed Fisher's exact test, P = 0.24). The findings from this small pilot comparative study suggest that intravitreal ranibizumab use may be a safe and potentially effective adjunctive treatment modality in improving success after Ahmed tube placement. © 2012 The Authors. Clinical and Experimental Ophthalmology © 2012 Royal Australian and New Zealand College of Ophthalmologists.

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial.

PubMed

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2018-01-01

To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Participants' homes across Cambridgeshire, UK. Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation. Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. ClinicalTrials.gov identifier NCT 02310438.

Intensification of antiretroviral therapy through addition of enfuvirtide in naive HIV-1-infected patients with severe immunosuppression does not improve immunological response: results of a randomized multicenter trial (ANRS 130 Apollo).

PubMed

Joly, Véronique; Fagard, Catherine; Grondin, Carine; Descamps, Diane; Yazdanpanah, Yazdan; Charpentier, Charlotte; Colin de Verdiere, Nathalie; Tabuteau, Sophie; Raffi, François; Cabie, André; Chene, Geneviève; Yeni, Patrick

2013-02-01

We studied whether addition of enfuvirtide (ENF) to a background combination antiretroviral therapy (cART) would improve the CD4 cell count response at week 24 in naive patients with advanced HIV disease. ANRS 130 Apollo is a randomized study, conducted in naive HIV-1-infected patients, either asymptomatic with CD4 counts of <100/mm(3) or stage B/C disease with CD4 counts of <200/mm(3). Patients received tenofovir-emtricitabine with lopinavir-ritonavir (LPV/r) or efavirenz and were randomized to receive ENF for 24 weeks (ENF arm) or not (control arm). The primary endpoint was the proportion of patients with CD4 counts of ≥ 200/mm(3) at week 24. A total of 195 patients were randomized: 73% had stage C disease, 78% were male, the mean age was 44 years, the median CD4 count was 30/mm(3), and the median HIV-1 RNA load was 5.4 log(10) copies/ml. Eighty-one percent of patients received LPV/r. One patient was lost to follow-up, and eight discontinued the study (four in each arm). The proportions of patients with CD4 counts of ≥ 200/mm(3) at week 24 were 34% and 38% in the ENF and control arms, respectively (P = 0.53). The proportions of patients with HIV-1 RNA loads of <50 copies/ml were 74% and 58% at week 24 in the ENF and control arms, respectively (P < 0.02), and the proportion reached 79% in both arms at week 48. Twenty (20%) and 12 patients (13%) in the ENF and control arms, respectively, experienced at least one AIDS event during follow-up (P = 0.17). Although inducing a more rapid virological response, addition of ENF to a standard cART does not improve the immunological outcome in naive HIV-infected patients with severe immunosuppression.

Intensification of Antiretroviral Therapy through Addition of Enfuvirtide in Naive HIV-1-Infected Patients with Severe Immunosuppression Does Not Improve Immunological Response: Results of a Randomized Multicenter Trial (ANRS 130 Apollo)

PubMed Central

Fagard, Catherine; Grondin, Carine; Descamps, Diane; Yazdanpanah, Yazdan; Charpentier, Charlotte; Colin de Verdiere, Nathalie; Tabuteau, Sophie; Raffi, François; Cabie, André; Chene, Geneviève; Yeni, Patrick

2013-01-01

We studied whether addition of enfuvirtide (ENF) to a background combination antiretroviral therapy (cART) would improve the CD4 cell count response at week 24 in naive patients with advanced HIV disease. ANRS 130 Apollo is a randomized study, conducted in naive HIV-1-infected patients, either asymptomatic with CD4 counts of <100/mm3 or stage B/C disease with CD4 counts of <200/mm3. Patients received tenofovir-emtricitabine with lopinavir-ritonavir (LPV/r) or efavirenz and were randomized to receive ENF for 24 weeks (ENF arm) or not (control arm). The primary endpoint was the proportion of patients with CD4 counts of ≥200/mm3 at week 24. A total of 195 patients were randomized: 73% had stage C disease, 78% were male, the mean age was 44 years, the median CD4 count was 30/mm3, and the median HIV-1 RNA load was 5.4 log10 copies/ml. Eighty-one percent of patients received LPV/r. One patient was lost to follow-up, and eight discontinued the study (four in each arm). The proportions of patients with CD4 counts of ≥200/mm3 at week 24 were 34% and 38% in the ENF and control arms, respectively (P = 0.53). The proportions of patients with HIV-1 RNA loads of <50 copies/ml were 74% and 58% at week 24 in the ENF and control arms, respectively (P < 0.02), and the proportion reached 79% in both arms at week 48. Twenty (20%) and 12 patients (13%) in the ENF and control arms, respectively, experienced at least one AIDS event during follow-up (P = 0.17). Although inducing a more rapid virological response, addition of ENF to a standard cART does not improve the immunological outcome in naive HIV-infected patients with severe immunosuppression. PMID:23165467

Applying a Family-Level Economic Strengthening Intervention to Improve Education and Health-Related Outcomes of School-Going AIDS-Orphaned Children: Lessons from a Randomized Experiment in Southern Uganda.

PubMed

Ssewamala, Fred M; Karimli, Leyla; Torsten, Neilands; Wang, Julia Shu-Huah; Han, Chang-Keun; Ilic, Vilma; Nabunya, Proscovia

2016-01-01

Children comprise the largest proportion of the population in sub-Saharan Africa. Of these, millions are orphaned. Orphanhood increases the likelihood of growing up in poverty, dropping out of school, and becoming infected with HIV. Therefore, programs aimed at securing a healthy developmental trajectory for these orphaned children are desperately needed. We conducted a two-arm cluster-randomized controlled trial to evaluate the effectiveness of a family-level economic strengthening intervention with regard to school attendance, school grades, and self-esteem in AIDS-orphaned adolescents aged 12-16 years from 10 public rural primary schools in southern Uganda. Children were randomly assigned to receive usual care (counseling, school uniforms, school lunch, notebooks, and textbooks), "bolstered" with mentorship from a near-peer (control condition, n = 167), or to receive bolstered usual care plus a family-level economic strengthening intervention in the form of a matched Child Savings Account (Suubi-Maka treatment arm, n = 179). The two groups did not differ at baseline, but 24 months later, children in the Suubi-Maka treatment arm reported significantly better educational outcomes, lower levels of hopelessness, and higher levels of self-concept compared to participants in the control condition. Our study contributes to the ongoing debate on how to address the developmental impacts of the increasing numbers of orphaned and vulnerable children and adolescents in sub-Saharan Africa, especially those affected by HIV/AIDS. Our findings indicate that innovative family-level economic strengthening programs, over and above bolstered usual care that includes psychosocial interventions for young people, may have positive developmental impacts related to education, health, and psychosocial functioning.

Applying a Family-Level Economic Strengthening Intervention to Improve Education and Health-Related Outcomes of School-going AIDS-Orphaned Children: Lessons from a Randomized Experiment in Southern Uganda

PubMed Central

Ssewamala, Fred M.; Leyla, Karimli; Neilands, Torsten; Julia Shu-Huah, Wang; Chang-Keun, Han; Vilma, Ilic; Proscovia, Nabunya

2015-01-01

Children comprise the largest proportion of the population in sub-Saharan Africa. Of these, millions are orphaned. Orphanhood increases the likelihood of growing up in poverty, dropping out of school, and becoming infected with HIV. Therefore, programs aimed at securing a healthy developmental trajectory for these orphaned children are desperately needed. We conducted a two-arm cluster-randomized controlled trial to evaluate the effectiveness of a family-level economic strengthening intervention with regard to school-attendance, school grades, and self-esteem in AIDS-orphaned adolescents aged 12–16 years from 10 public rural primary schools in southern Uganda. Children were randomly assigned to receive usual care (counseling, school uniforms, school lunch, notebooks and textbooks), “bolstered” with mentorship from a near-peer (control condition, n=167), or to receive bolstered usual care plus a family-level economic strengthening intervention in the form of a matched Child Savings Account (Suubi-Maka treatment arm, n = 179). The two groups did not differ at baseline, but 24-months later, children in the Suubi-Maka treatment arm reported significantly better educational outcomes, lower levels of hopelessness, and higher levels of self-concept compared to participants in the control condition. Our study contributes to the ongoing debate on how to address the developmental impacts of the increasing numbers of orphaned, and vulnerable children and adolescents in sub-Saharan Africa, especially those affected by HIV/AIDS. Our findings indicate that innovative family-level economic strengthening programs, over and above bolstered usual care that includes psychosocial interventions for young people, may have positive developmental impacts related to education, health, and psychosocial functioning. PMID:26228480

Effects of Three Motivationally Targeted Mobile Device Applications on Initial Physical Activity and Sedentary Behavior Change in Midlife and Older Adults: A Randomized Trial.

PubMed

King, Abby C; Hekler, Eric B; Grieco, Lauren A; Winter, Sandra J; Sheats, Jylana L; Buman, Matthew P; Banerjee, Banny; Robinson, Thomas N; Cirimele, Jesse

2016-01-01

While there has been an explosion of mobile device applications (apps) promoting healthful behaviors, including physical activity and sedentary patterns, surprisingly few have been based explicitly on strategies drawn from behavioral theory and evidence. This study provided an initial 8-week evaluation of three different customized physical activity-sedentary behavior apps drawn from conceptually distinct motivational frames in comparison with a commercially available control app. Ninety-five underactive adults ages 45 years and older with no prior smartphone experience were randomized to use an analytically framed app, a socially framed app, an affectively framed app, or a diet-tracker control app. Daily physical activity and sedentary behavior were measured using the smartphone's built-in accelerometer and daily self-report measures. Mixed-effects models indicated that, over the 8-week period, the social app users showed significantly greater overall increases in weekly accelerometry-derived moderate to vigorous physical activity relative to the other three arms (P values for between-arm differences = .04-.005; Social vs. Control app: d = 1.05, CI = 0.44,1.67; Social vs. Affect app: d = 0.89, CI = 0.27,1.51; Social vs. Analytic app: d = 0.89, CI = 0.27,1.51), while more variable responses were observed among users of the other two motivationally framed apps. Social app users also had significantly lower overall amounts of accelerometry-derived sedentary behavior relative to the other three arms (P values for between-arm differences = .02-.001; Social vs. Control app: d = 1.10,CI = 0.48,1.72; Social vs. Affect app: d = 0.94, CI = 0.32,1.56; Social vs. Analytic app: d = 1.24, CI = 0.59,1.89). Additionally, Social and Affect app users reported lower overall sitting time compared to the other two arms (P values for between-arm differences < .001; Social vs. Control app: d = 1.59,CI = 0.92, 2.25; Social vs. Analytic app: d = 1.89,CI = 1.17, 2.61; Affect vs. Control app: d = 1.19,CI = 0.56, 1.81; Affect vs. Analytic app: d = 1.41,CI = 0.74, 2.07). The results provide initial support for the use of a smartphone-delivered social frame in the early induction of both physical activity and sedentary behavior changes. The information obtained also sets the stage for further investigation of subgroups that might particularly benefit from different motivationally framed apps in these two key health promotion areas. ClinicalTrials.gov NCT01516411.

A household randomized, controlled trial of the efficacy of 0.03% transfluthrin coils alone and in combination with long-lasting insecticidal nets on the incidence of Plasmodium falciparum and Plasmodium vivax malaria in Western Yunnan Province, China.

PubMed

Hill, Nigel; Zhou, Hong Ning; Wang, Piyu; Guo, Xiaofang; Carneiro, Ilona; Moore, Sarah J

2014-05-31

Mosquito coils are the most commonly used household insecticidal product in the world with sales exceeding 50 billion coils, used by two billion people worldwide annually. Despite strong evidence that coils prevent mosquito bites a systematic review concluded that there is no evidence that burning mosquito coils prevents malaria acquisition. Therefore, the current trial was designed to measure and compare prevention of malaria infection by mosquito coils or long-lasting insecticidal net (LLIN) or a combination of the two in Yunnan, China in the Greater Mekong sub-region. A four-arm single blind household-randomized design was chosen as coils emanate insecticide throughout the household. Households enrolled at baseline were randomly allocated by the lottery method to one of the four intervention arms: (i) nothing, (ii) 0.03% transfluthrin coils alone, (iii) deltamethrin long-lasting insecticide treated nets, (LLINs) alone or (iv) a combination of transfluthrin coils and deltamethrin LLINs. All household members were recruited to the study, with only those households excluded with pregnant or breastfeeding mothers, members with chest complaints or allergies or members that regularly slept away from home. The main outcome of interest was Plasmodium falciparum malaria prevalence detected by rapid diagnostic tests (RDTs) during six repeated monthly cross-sectional surveys. The secondary outcome of interest was the effect on Plasmodium vivax prevalence detected in the same way. A total of 2,052 households were recruited into the study, comprising 7,341 individuals The odds ratios of testing positive by RDT with P. falciparum or P. vivax were >75% lower for all intervention arms compared with the control arm. Coils alone provided 77% protection (95% CI: 50%-89%), LLINs provided 91% protection (95% CI: 72%-97%) and the combination of coils and LLINs provided 94% protection (95% CI: 77%-99%) against P. falciparum compared with the control arm. There was no statistically significant difference between the protective efficacies of the different interventions. This is the first robust clinical evaluation of transfluthrin mosquito coils as a means to reduce malaria and the high degree of infection prevented would indicate they represent a potentially highly effective tool, which could be integrated into larger vector control programmes. ClinicalTrials.gov Identifier: NCT00442442, March 2007.

Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial.

PubMed

Alfawal, Alaa M H; Hajeer, Mohammad Y; Ajaj, Mowaffak A; Hamadah, Omar; Brad, Bassel

2018-02-17

To evaluate the effectiveness of two minimally invasive surgical procedures in the acceleration of canine retraction: piezocision and laser-assisted flapless corticotomy (LAFC). Trial design: A single-centre randomized controlled trial with a compound design (two-arm parallel-group design and a split-mouth design for each arm). 36 Class II division I patients (12 males, 24 females; age range: 15 to 27 years) requiring first upper premolars extraction followed by canine retraction. piezocision group (PG; n = 18) and laser-assisted flapless corticotomy group (LG; n = 18). A split-mouth design was applied for each group where the flapless surgical intervention was randomly allocated to one side and the other side served as a control side. the rate of canine retraction (primary outcome), anchorage loss and canine rotation, which were assessed at 1, 2, 3 and 4 months following the onset of canine retraction. Also the duration of canine retraction was recorded. Random sequence: Computer-generated random numbers. Allocation concealment: sequentially numbered, opaque, sealed envelopes. Blinding: Single blinded (outcomes' assessor). Seventeen patients in each group were enrolled in the statistical analysis. The rate of canine retraction was significantly greater in the experimental side than in the control side in both groups by two-fold in the first month and 1.5-fold in the second month (p < 0.001). Also the overall canine retraction duration was significantly reduced in the experimental side as compared with control side in both groups about 25% (p ≤ 0.001). There were no significant differences between the experimental and the control sides regarding loss of anchorage and upper canine rotation in both groups (p > 0.05). There were no significant differences between the two flapless techniques regarding the studied variables during all evaluation times (p > 0.05). Piezocision and laser-assisted flapless corticotomy appeared to be effective treatment methods for accelerating canine retraction without any significant untoward effect on anchorage or canine rotation during rapid retraction. ClinicalTrials.gov (Identifier: NCT02606331 ).

A novel telemonitoring device for improving diabetes control: protocol and results from a randomized clinical trial.

PubMed

Pressman, Alice R; Kinoshita, Linda; Kirk, Susan; Barbosa, Gina Monraz; Chou, Cathy; Minkoff, Jerome

2014-02-01

Telemedicine is one approach to managing patients with chronic illness. Several telephone-based monitoring studies of diabetes patients have shown improved glycosylated hemoglobin (HbA1c), blood pressure (BP), and low-density lipoprotein (LDL) levels. The purpose of this study was to evaluate an investigational in-home telemetry device for improving glucose and BP control over 6 months for patients with type 2 diabetes. The device was used to transmit weekly blood glucose, weight, and BP readings to a diabetes care manager. We conducted a two-arm, parallel-comparison, single-blind, randomized controlled trial among Kaiser Permanente Northern California members 18-75 years old with type 2 diabetes mellitus and entry HbA1c levels between 7.5% and 10.0%. Participants were randomly assigned to either the telemonitoring arm or the usual care arm. We observed very small, nonsignificant changes in fructosamine (telemonitoring, -54.9 μmol; usual care, -59.4 μmol) and systolic BP (telemonitoring, -6.3 mm Hg; usual care, -3.2 mm Hg) from baseline to 6 weeks in both groups. At 6 months, we observed no significant intergroup differences in change from baseline for HbA1c, fructosamine, or self-efficacy. However, LDL cholesterol in the telemonitoring arm decreased more than in the usual care arm (-17.1 mg/dL versus -5.4 mg/dL; P=0.045). Although HbA1c improved significantly over 6 months in both groups, the difference in improvement between the groups was not significant. This lack of significance may be due to the relatively healthy status of the volunteers in our study and to the high level of care provided by the care managers in the Santa Rosa, CA clinic. Further study in subgroups of less healthy diabetes patients is recommended.

Rehabilitation of traumatic brain injury in active duty military personnel and veterans: Defense and Veterans Brain Injury Center randomized controlled trial of two rehabilitation approaches.

PubMed

Vanderploeg, Rodney D; Schwab, Karen; Walker, William C; Fraser, Jamie A; Sigford, Barbara J; Date, Elaine S; Scott, Steven G; Curtiss, Glenn; Salazar, Andres M; Warden, Deborah L

2008-12-01

To determine the relative efficacy of 2 different acute traumatic brain injury (TBI) rehabilitation approaches: cognitive didactic versus functional-experiential, and secondarily to determine relative efficacy for different patient subpopulations. Randomized, controlled, intent-to-treat trial comparing 2 alternative TBI treatment approaches. Four Veterans Administration acute inpatient TBI rehabilitation programs. Adult veterans or active duty military service members (N=360) with moderate to severe TBI. One and a half to 2.5 hours of protocol-specific cognitive-didactic versus functional-experiential rehabilitation therapy integrated into interdisciplinary acute Commission for Accreditation of Rehabilitation Facilities-accredited inpatient TBI rehabilitation programs with another 2 to 2.5 hours daily of occupational and physical therapy. Duration of protocol treatment varied from 20 to 60 days depending on the clinical needs and progress of each participant. The 2 primary outcome measures were functional independence in living and return to work and/or school assessed by independent evaluators at 1-year follow-up. Secondary outcome measures consisted of the FIM, Disability Rating Scale score, and items from the Present State Exam, Apathy Evaluation Scale, and Neurobehavioral Rating Scale. The cognitive-didactic and functional-experiential treatments did not result in overall group differences in the broad 1-year primary outcomes. However, analysis of secondary outcomes found differentially better immediate posttreatment cognitive function (mean+/-SD cognitive FIM) in participants randomized to cognitive-didactic treatment (27.3+/-6.2) than to functional treatment (25.6+/-6.0, t332=2.56, P=.01). Exploratory subgroup analyses found that younger participants in the cognitive arm had a higher rate of returning to work or school than younger patients in the functional arm, whereas participants older than 30 years and those with more years of education in the functional arm had higher rates of independent living status at 1 year posttreatment than similar patients in the cognitive arm. Results from this large multicenter randomized controlled trial comparing cognitive-didactic and functional-experiential approaches to brain injury rehabilitation indicated improved but similar long-term global functional outcome. Participants in the cognitive treatment arm achieved better short-term functional cognitive performance than patients in the functional treatment arm. The current increase in war-related brain injuries provides added urgency for rigorous study of rehabilitation treatments. (http://ClinicalTrials.gov ID# NCT00540020.).

Web-Based Just-in-Time Information and Feedback on Antibiotic Use for Village Doctors in Rural Anhui, China: Randomized Controlled Trial

PubMed Central

Shen, XingRong; Lu, Manman; Feng, Rui; Cheng, Jing; Chai, Jing; Xie, Maomao; Dong, Xuemeng; Jiang, Tao

2018-01-01

Background Excessive use of antibiotics is very common worldwide, especially in rural China; various measures that have been used in curbing the problem have shown only marginal effects. Objective The objective of this study was to test an innovative intervention that provided just-in-time information and feedback (JITIF) to village doctors on care of common infectious diseases. Methods The information component of JITIF consisted of a set of theory or evidence-based ingredients, including operation guideline, public commitment, and takeaway information, whereas the feedback component tells each participating doctor about his or her performance scores and percentages of antibiotic prescriptions. These ingredients were incorporated together in a synergetic way via a Web-based aid. Evaluation of JITIF adopted a randomized controlled trial design involving 24 village clinics randomized into equal control and intervention arms. Measures used included changes between baseline and endpoint (1 year after baseline) in terms of: percentages of patients with symptomatic respiratory or gastrointestinal tract infections (RTIs or GTIs) being prescribed antibiotics, delivery of essential service procedures, and patients’ beliefs and knowledge about antibiotics and infection prevention. Two researchers worked as a group in collecting the data at each site clinic. One performed nonparticipative observation of the service process, while the other performed structured exit interviews about patients’ beliefs and knowledge. Data analysis comprised mainly of: (1) descriptive estimations of beliefs or knowledge, practice of indicative procedures, and use of antibiotics at baseline and endpoint for intervention and control groups and (2) chi-square tests for the differences between these groups. Results A total of 1048 patients completed the evaluation, including 532 at baseline (intervention=269, control=263) and 516 at endpoint (intervention=262, control=254). Patients diagnosed with RTIs and GTIs accounted for 76.5% (407/532) and 23.5% (125/352), respectively, at baseline and 80.8% (417/532) and 19.2% (99/532) at endpoint. JITIF resulted in substantial improvement in delivery of essential service procedures (2.6%-24.8% at baseline on both arms and at endpoint on the control arm vs 88.5%-95.0% at endpoint on the intervention arm, P<.001), beliefs favoring rational antibiotics use (11.5%-39.8% at baseline on both arms and at endpoint on the control arm vs 19.8%-62.6% at endpoint on the intervention arm, P<.001) and knowledge about side effects of antibiotics (35.7% on the control arm vs 73.7% on the intervention arm, P<.001), measures for managing or preventing RTIs (39.1% vs 66.7%, P=.02), and measures for managing or preventing GTIs (46.8% vs 69.2%, P<.001). It also reduced antibiotics prescription (from 88.8%-62.3%, P<.001), and this decrease was consistent for RTIs (87.1% vs 64.3%, P<.001) and GTIs (94.7% vs 52.4%, P<.001). Conclusions JITIF is effective in controlling antibiotics prescription at least in the short term and may provide a low-cost and sustainable solution to the widespread excessive use of antibiotics in rural China. PMID:29444768

Intermanual transfer in training with an upper-limb myoelectric prosthesis simulator: a mechanistic, randomized, pretest-posttest study.

PubMed

Romkema, Sietske; Bongers, Raoul M; van der Sluis, Corry K

2013-01-01

Intermanual transfer may improve prosthetic handling and acceptance if used in training soon after an amputation. The purpose of this study was to determine whether intermanual transfer effects can be detected after training with a myoelectric upper-limb prosthesis simulator. A mechanistic, randomized, pretest-posttest design was used. A total of 48 right-handed participants (25 women, 23 men) who were able-bodied were randomly assigned to an experimental group or a control group. The experimental group performed a training program of 5 days' duration using the prosthesis simulator. To determine the improvement in skill, a test was administered before, immediately after, and 6 days after training. The control group only performed the tests. Training was performed with the unaffected arm, and tests were performed with the affected arm (the affected arm simulating an amputated limb). Half of the participants were tested with the dominant arm and half with the nondominant arm. Initiation time was defined as the time from starting signal until start of the movement, movement time was defined as the time from the beginning of the movement until completion of the task, and force control was defined as the maximal applied force on a deformable object. The movement time decreased significantly more in the experimental group (F₂,₉₂=7.42, P=.001, η²(G)=.028) when compared with the control group. This finding is indicative of faster handling of the prosthesis. No statistically significant differences were found between groups with regard to initiation time and force control. We did not find a difference in intermanual transfer between the dominant and nondominant arms. The training utilized participants who were able-bodied in a laboratory setting and focused only on transradial amputations. Intermanual transfer was present in the affected arm after training the unaffected arm with a myoelectric prosthesis simulator, and this effect did not depend on laterality. This effect may improve rehabilitation of patients with an upper-limb amputation.

Phase II randomized trial of radiation therapy, cetuximab, and pemetrexed with or without bevacizumab in patients with locally advanced head and neck cancer.

PubMed

Argiris, A; Bauman, J E; Ohr, J; Gooding, W E; Heron, D E; Duvvuri, U; Kubicek, G J; Posluszny, D M; Vassilakopoulou, M; Kim, S; Grandis, J R; Johnson, J T; Gibson, M K; Clump, D A; Flaherty, J T; Chiosea, S I; Branstetter, B; Ferris, R L

2016-08-01

We previously reported the safety of concurrent cetuximab, an antibody against epidermal growth factor receptor (EGFR), pemetrexed, and radiation therapy (RT) in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). In this non-comparative phase II randomized trial, we evaluated this non-platinum combination with or without bevacizumab, an inhibitor of vascular endothelial growth factor (VEGF). Patients with previously untreated stage III-IVB SCCHN were randomized to receive: conventionally fractionated radiation (70 Gy), concurrent cetuximab, and concurrent pemetrexed (arm A); or the identical regimen plus concurrent bevacizumab followed by bevacizumab maintenance for 24 weeks (arm B). The primary end point was 2-year progression-free survival (PFS), with each arm compared with historical control. Exploratory analyses included the relationship of established prognostic factors to PFS and quality of life (QoL). Seventy-eight patients were randomized: 66 oropharynx (42 HPV-positive, 15 HPV-negative, 9 unknown) and 12 larynx; 38 (49%) had heavy tobacco exposure. Two-year PFS was 79% [90% confidence interval (CI) 0.69-0.92; P < 0.0001] for arm A and 75% (90% CI 0.64-0.88; P < 0.0001) for arm B, both higher than historical control. No differences in PFS were observed for stage, tobacco history, HPV status, or type of center (community versus academic). A significantly increased rate of hemorrhage occurred in arm B. SCCHN-specific QoL declined acutely, with marked improvement but residual symptom burden 1 year post-treatment. RT with a concurrent non-platinum regimen of cetuximab and pemetrexed is feasible in academic and community settings, demonstrating expected toxicities and promising efficacy. Adding bevacizumab increased toxicity without apparent improvement in efficacy, countering the hypothesis that dual EGFR-VEGF targeting would overcome radiation resistance, and enhance clinical benefit. Further development of cetuximab, pemetrexed, and RT will require additional prospective study in defined, high-risk populations where treatment intensification is justified. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Telephone-delivered behavioral intervention among blacks with sleep apnea and metabolic syndrome: study protocol for a randomized controlled trial.

PubMed

Williams, Natasha J; Jean-Louis, Girardin; Brown, Clinton D; McFarlane, Samy I; Boutin-Foster, Carla; Ogedegbe, Gbenga

2014-06-12

Lack of adherence to recommended treatment for obstructive sleep apnea remains an ongoing public health challenge. Despite evidence that continuous positive airway pressure (CPAP) is effective and improves overall quality of life, adherence with the use of CPAP in certain racial/ethnic groups, especially blacks, is suboptimal. Evidence indicates that the incidence and prevalence of obstructive sleep apnea are higher among blacks, relative to whites, and blacks are less likely to adhere to recommended treatment compared with other racial/ethnic groups. Using a two-arm randomized controlled design, this study will evaluate the effectiveness of a culturally and linguistically tailored telephone-delivered intervention to promote adherence to physician-recommended sleep apnea assessment and treatment among blacks with metabolic syndrome, versus an attention-control arm. The intervention is designed to foster adherence to recommended sleep apnea care using the stages-of-change model. The intervention will be delivered entirely over the telephone. Participants in the intervention arm will receive 10 phone calls to address challenges and barriers to recommended care. Outcomes will be assessed at baseline, and at 6- and 12-months post-randomization. This tailored behavioral intervention will improve adherence to sleep apnea assessment and treatment among blacks with metabolic syndrome. We expect to demonstrate that this intervention modality is feasible in terms of time and cost and can be replicated in populations with similar racial/ethnic backgrounds. The study is registered at clinicaltrials.gov NCT01946659 (February 2013).

Improving Breast Cancer Surgical Treatment Decision Making: The iCanDecide Randomized Clinical Trial.

PubMed

Hawley, Sarah T; Li, Yun; An, Lawrence C; Resnicow, Kenneth; Janz, Nancy K; Sabel, Michael S; Ward, Kevin C; Fagerlin, Angela; Morrow, Monica; Jagsi, Reshma; Hofer, Timothy P; Katz, Steven J

2018-03-01

Purpose This study was conducted to determine the effect of iCanDecide, an interactive and tailored breast cancer treatment decision tool, on the rate of high-quality patient decisions-both informed and values concordant-regarding locoregional breast cancer treatment and on patient appraisal of decision making. Methods We conducted a randomized clinical trial of newly diagnosed patients with early-stage breast cancer making locoregional treatment decisions. From 22 surgical practices, 537 patients were recruited and randomly assigned online to the iCanDecide interactive and tailored Web site (intervention) or the iCanDecide static Web site (control). Participants completed a baseline survey and were mailed a follow-up survey 4 to 5 weeks after enrollment to assess the primary outcome of a high-quality decision, which consisted of two components, high knowledge and values-concordant treatment, and secondary outcomes (decision preparation, deliberation, and subjective decision quality). Results Patients in the intervention arm had higher odds of making a high-quality decision than did those in the control arm (odds ratio, 2.00; 95% CI, 1.37 to 2.92; P = .0004), which was driven primarily by differences in the rates of high knowledge between groups. The majority of patients in both arms made values-concordant treatment decisions (78.6% in the intervention arm and 81.4% in the control arm). More patients in the intervention arm had high decision preparation (estimate, 0.18; 95% CI, 0.02 to 0.34; P = .027), but there were no significant differences in the other decision appraisal outcomes. The effect of the intervention was similar for women who were leaning strongly toward a treatment option at enrollment compared with those who were not. Conclusion The tailored and interactive iCanDecide Web site, which focused on knowledge building and values clarification, positively affected high-quality decisions largely by improving knowledge compared with static online information. To be effective, future patient-facing decision tools should be integrated into the clinical workflow to improve decision making.

Effects of diabetes self-management programs on time-to-hospitalization among patients with type 2 diabetes: a survival analysis model.

PubMed

Adepoju, Omolola E; Bolin, Jane N; Phillips, Charles D; Zhao, Hongwei; Ohsfeldt, Robert L; McMaughan, Darcy K; Helduser, Janet W; Forjuoh, Samuel N

2014-04-01

This study compared time-to-hospitalization among subjects enrolled in different diabetes self-management programs (DSMP). We sought to determine whether the interventions delayed the occurrence of any acute event necessitating hospitalization. Electronic medical records (EMR) were obtained for 376 adults enrolled in a randomized controlled trial (RCT) of Type 2 diabetes (T2DM) self-management programs. All study participants had uncontrolled diabetes and were randomized into either: personal digital assistant (PDA), Chronic Disease Self-Management Program (CDSMP), combined PDA and CDSMP (COM), or usual care (UC) groups. Subjects were followed for a maximum of two years. Time-to-hospitalization was measured as the interval between study enrollment and the occurrence of a diabetes-related hospitalization. Subjects enrolled in the CDSMP-only arm had significantly prolonged time-to-hospitalization (Hazard ratio: 0.10; p=0.002) when compared to subjects in the control arm. Subjects in the PDA-only and combined PDA and CDSMP arms showed no improvements in comparison to the control arm. CDSMP can be effective in delaying time-to-hospitalization among patients with T2DM. Reducing unnecessary healthcare utilization, particularly inpatient hospitalization is a key strategy to improving the quality of health care and lowering associated health care costs. The CDSMP offers the potential to reduce time-to-hospitalization among T2DM patients. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Effect of integrated capacity-building interventions on malaria case management by health professionals in Uganda: a mixed design study with pre/post and cluster randomized trial components.

PubMed

Mbonye, Martin Kayitale; Burnett, Sarah M; Burua, Aldomoro; Colebunders, Robert; Crozier, Ian; Kinoti, Stephen N; Ronald, Allan; Naikoba, Sarah; Rubashembusya, Timothy; Van Geertruyden, Jean-Pierre; Willis, Kelly S; Weaver, Marcia R

2014-01-01

The Integrated Infectious Diseases Capacity Building Evaluation (IDCAP) designed two interventions: Integrated Management of Infectious Disease (IMID) training program and On-Site Support (OSS). We evaluated their effects on 23 facility performance indicators, including malaria case management. IMID, a three-week training with two follow-up booster courses, was for two mid- level practitioners, primarily clinical officers and registered nurses, from 36 primary care facilities. OSS was two days of training and continuous quality improvement activities for nine months at 18 facilities, to which all health workers were invited to participate. Facilities were randomized as clusters 1∶1 to parallel OSS "arm A" or control "arm B". Outpatient data on four malaria case management indicators were collected for 14 months. Analysis compared changes before and during the interventions within arms (relative risk = RR). The effect of OSS was measured with the difference in changes across arms (ratio of RR = RRR). The proportion of patients with suspected malaria for whom a diagnostic test result for malaria was recorded decreased in arm B (adjusted RR (aRR) = 0.97; 99%CI: 0.82,1.14) during IMID, but increased 25% in arm A (aRR = 1.25; 99%CI:0.94, 1.65) during IMID and OSS relative to baseline; (aRRR = 1.28; 99%CI:0.93, 1.78). The estimated proportion of patients that received an appropriate antimalarial among those prescribed any antimalarial increased in arm B (aRR = 1.09; 99%CI: 0.87, 1.36) and arm A (aRR = 1.50; 99%CI: 1.04, 2.17); (aRRR = 1.38; 99%CI: 0.89, 2.13). The proportion of patients with a negative diagnostic test result for malaria prescribed an antimalarial decreased in arm B (aRR = 0.96; 99%CI: 0.84, 1.10) and arm A (aRR = 0.67; 99%CI: 0.46, 0.97); (aRRR = 0.70; 99%CI: 0.48, 1.00). The proportion of patients with a positive diagnostic test result for malaria prescribed an antibiotic did not change significantly in either arm. The combination of IMID and OSS was associated with statistically significant improvements in malaria case management.

A blinded, randomized controlled trial of high-dose vitamin D supplementation to reduce recurrence of bacterial vaginosis.

PubMed

Turner, Abigail Norris; Carr Reese, Patricia; Fields, Karen S; Anderson, Julie; Ervin, Melissa; Davis, John A; Fichorova, Raina N; Roberts, Mysheika Williams; Klebanoff, Mark A; Jackson, Rebecca D

2014-11-01

Low serum vitamin D levels have been associated with increased prevalence of the reproductive tract condition bacterial vaginosis (BV). The objective of this trial was to evaluate the effect of high-dose vitamin D supplementation on BV recurrence. This randomized, placebo-controlled, double-blinded trial enrolled 118 women with symptomatic BV from an urban sexually transmitted disease clinic (clinicaltrials.gov registration NCT01450462). All participants received 500 mg of oral metronidazole twice daily for 7 days. Intervention participants (n = 59) also received 9 doses of 50,000 IU of cholecalciferol (vitamin D3) over 24 weeks; control women (n = 59) received matching placebo. Recurrent BV was assessed via Nugent scoring after 4, 12, and 24 weeks. We assessed the effect of the intervention using an intention-to-treat approach, fitting Cox proportional hazards models to evaluate recurrent BV over the follow-up period. Most participants (74%) were black, with a median age of 26 years. Median presupplementation serum 25-hydroxyvitamin D [25(OH)D] was similar across randomization arms: 16.6 ng/mL in the vitamin D arm and 15.8 ng/mL in the control arm. At trial completion, median 25(OH)D among women receiving vitamin D was 30.5 ng/mL, vs 17.8 ng/mL in control women; 16% of women receiving vitamin D and 57% receiving placebo remained vitamin D deficient (<20 ng/mL). BV prevalence among women randomized to vitamin D was very similar to those randomized to placebo at the 4- and 12-week visits, but by the 24-week visit, BV prevalence was 65% among women in the vitamin D arm and 48% among control women. BV recurrence was not reduced by vitamin D supplementation (intention-to-treat hazard ratio, 1.11; 95% confidence interval, 0.68-1.81). Among women experiencing recurrent BV, median time to recurrence was 13.7 weeks in the vitamin D arm and 14.3 weeks in the control arm. Women receiving vitamin D experienced significant increases in serum 25(OH)D, but this increase was not associated with decreased BV recurrence in this high-risk sexually transmitted disease clinic population. Copyright © 2014 Elsevier Inc. All rights reserved.

A blinded, randomized controlled trial of high-dose vitamin D supplementation to reduce recurrence of bacterial vaginosis

PubMed Central

TURNER, Abigail Norris; REESE, Patricia CARR; FIELDS, Karen S.; ANDERSON, Julie; ERVIN, Melissa; DAVIS, John A.; FICHOROVA, Raina N.; ROBERTS, Mysheika Williams; KLEBANOFF, Mark A.; JACKSON, Rebecca D.

2014-01-01

Objective Low serum vitamin D levels have been associated with increased prevalence of the reproductive tract condition bacterial vaginosis (BV). The objective of this trial was to evaluate the effect of high-dose vitamin D supplementation on BV recurrence. Study design This randomized, placebo-controlled, double-blinded trial enrolled 118 women with symptomatic BV from an urban STD clinic (clinicaltrials.gov registration NCT01450462). All participants received 500mg oral metronidazole twice daily for seven days. Intervention participants (n=59) also received nine doses of 50,000 international units of cholecalciferol (vitamin D3) over 24 weeks; control women (n=59) received matching placebo. Recurrent BV was assessed via Nugent scoring after 4, 12 and 24 weeks. We assessed the effect of the intervention using an intention-to-treat approach, fitting Cox proportional hazards models to evaluate recurrent BV over the follow-up period. Results Most participants (74%) were black, with a median age of 26 years. Median presupplementation serum 25-hydroxyvitamin D [25(OH)D] was similar across randomization arms: 16.6 ng/mL in the vitamin D arm and 15.8 ng/mL in the control arm. At trial completion, median 25(OH)D among women receiving vitamin D was 30.5 ng/mL, vs 17.8 ng/mL in control women; 16% of women receiving vitamin D and 57% receiving placebo remained vitamin D deficient (<20 ng/mL). BV prevalence among women randomized to vitamin D was very similar to those randomized to placebo at the 4- and 12-week visits, but by the 24-week visit, BV prevalence was 65% among women in the vitamin D arm and 48% among control women. BV recurrence was not reduced by vitamin D supplementation (intention-to-treat hazard ratio, 1.11; 95% confidence interval, 0.68-1.81). Among women experiencing recurrent BV, median time to recurrence was 13.7 weeks in the vitamin D arm and 14.3 weeks in the control arm. Conclusions Women receiving vitamin D experienced significant increases in serum 25(OH)D, but this increase was not associated with decreased BV recurrence in this high-risk STD clinic population. PMID:24949544

Isometric arm counter-pressure maneuvers to abort impending vasovagal syncope.

PubMed

Brignole, Michele; Croci, Francesco; Menozzi, Carlo; Solano, Alberto; Donateo, Paolo; Oddone, Daniele; Puggioni, Enrico; Lolli, Gino

2002-12-04

We hypothesized that isometric arm exercises were able to increase blood pressure (BP) during the phase of impending vasovagal syncope and allow the patient to avoid losing consciousness. Hypotension is always present during the prodromal phase of vasovagal syncope. We evaluated the effect of handgrip (HG) and arm-tensing in 19 patients affected by tilt-induced vasovagal syncope. The study consisted of an acute single-blind, placebo-controlled, randomized, cross-over tilt-table efficacy study and a clinical follow-up feasibility study. In the acute tilt study, HG was administered for 2 min, starting at the time of onset of symptoms of impending syncope. In the active arm, HG caused an increase in systolic blood pressure (SBP) from 92 +/- 10 mm Hg to 105 +/- 38 mm Hg, whereas in the placebo arm SBP decreased from 91 +/- 11 mm Hg to 73 +/- 21 mm Hg (p = 0.008). Heart rate behavior was similar in the two arms. In the active arm, 63% of patients became asymptomatic, versus 11% in the control arm (p = 0.02); conversely, only 5% of patients developed syncope, versus 47% in the control arm (p = 0.01). The patients were trained to self-administer arm-tensing treatment as soon as symptoms of impending syncope occurred. During 9 +/- 3 months of follow-up, the treatment was actually performed in 95/97 episodes of impending syncope (98%) and was successful in 94/95 (99%). No patients suffered injury or other adverse morbidity related to the relapses. Isometric arm contraction is able to abort impending vasovagal syncope by increasing systemic BP. Arm counter-pressure maneuvers can be proposed as a new, feasible, safe, and well accepted first-line treatment for vasovagal syncope.

Effect of Motivational Interviewing on Weight Efficacy Lifestyle among Women with Overweight and Obesity: A Randomized Controlled Trial.

PubMed

Mirkarimi, Kamal; Kabir, Mohammad Javad; Honarvar, Mohammad Reza; Ozouni-Davaji, Rahman Berdi; Eri, Maryam

2017-03-01

Obesity and overweight have become increasingly a major public health problem across the world. This study aimed at exploring the effects of motivational interviewing on weight efficacy lifestyle among women with obesity and overweight. A single-blind randomized clinical trial study was conducted on 100 overweight and obese women who attended a nutrition clinic. The samples were selected based on the clinical records and assigned into two groups, namely motivational interviewing arm (50 samples) and nutrition education arm (50 samples). Data were collected using a standard validated questionnaire entitled "weight efficacy lifestyle". The intervention was designed according to five motivation sessions and four nutrition education programs, such that the participants of the nutrition education arm were also provided with the nutrition pamphlets related to weight control. Data were finally analyzed using the SPSS statistical software by performing the independent t-test, chi-square, LSD and repeated measures ANOVA tests. P<0.05 were considered statistically significant. The mean age of women was 39.9±9.1 and 36.3±8.9 years in the control and motivational interviewing arms, respectively. Compared with the control group, the score of the motivational interviewing group was statistically significant in terms of weight efficacy lifestyle P=0.0001) and all subscales including social pressure (P=0.0001), physical discomfort (P=0.005), food accessibility (P=0.0001), positive and entertainment activities (P=0.0001), as well as negative emotions (P=0.003). Motivational interviewing appeared to be effective in increasing weight efficacy lifestyle among women with overweight and obesity. IRCT2014051817736N1.

Targeting young drinkers online: the effectiveness of a web-based brief alcohol intervention in reducing heavy drinking among college students: study protocol of a two-arm parallel group randomized controlled trial.

PubMed

Voogt, Carmen V; Poelen, Evelien A P; Kleinjan, Marloes; Lemmers, Lex A C J; Engels, Rutger C M E

2011-04-14

The prevalence of heavy drinking among college students and its associated health related consequences highlights an urgent need for alcohol prevention programs targeting 18 to 24 year olds. Nevertheless, current alcohol prevention programs in the Netherlands pay surprisingly little attention to the drinking patterns of this specific age group. The study described in this protocol will test the effectiveness of a web-based brief alcohol intervention that is aimed at reducing alcohol use among heavy drinking college students aged 18 to 24 years old. The effectiveness of the What Do You Drink web-based brief alcohol intervention will be tested among 908 heavy drinking college students in a two-arm parallel group randomized controlled trial. Participants will be allocated at random to either the experimental (N=454: web-based brief alcohol intervention) or control condition (N=454: no intervention). The primary outcome measure will be the percentage of participants who drink within the normative limits of the Dutch National Health Council for low-risk drinking. These limits specify that, for heavy alcohol use, the mean consumption cannot exceed 14 or 21 glasses of standard alcohol units per week for females and males, respectively, while for binge drinking, the consumption cannot exceed five or more glasses of standard alcohol units on one drinking occasion at least once per week within one month and six months after the intervention. Reductions in mean weekly alcohol consumption and frequency of binge drinking are also primary outcome measures. Weekly Ecological Momentary Assessment will measure alcohol-related cognitions, that is, attitudes, self-efficacy, subjective norms and alcohol expectancies, which will be included as the secondary outcome measures. This study protocol describes the two-arm parallel group randomized controlled trial developed to evaluate the effectiveness of a web-based brief alcohol intervention. We expect a reduction of mean weekly alcohol consumption and frequency of binge drinking in the experimental condition compared to the control condition as a direct result of the intervention. If the website is effective, it will be implemented in alcohol prevention initiatives, which will facilitate the implementation of the protocol. Netherlands Trial Register NTR2665.

Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.

PubMed

Martínez-Lavín, Manuel; Amezcua-Guerra, Luis

2017-10-01

This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 79–653) [DOSAGE ERROR CORRECTED] . The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related. Pre-clinical trials, post-marketing case series, and the global drug adverse reaction database (VigiBase) describe similar post-HPV immunization symptom clusters. Two of the largest randomized HPV vaccine trials unveiled more severe adverse events in the tested HPV vaccine arm of the study. Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Pre-clinical trials and post-marketing case series describe similar post-HPV immunization symptoms.

Two Randomized Controlled Pilot Trials of Social Forces to Improve Statin Adherence among Patients with Diabetes.

PubMed

Reese, Peter P; Kessler, Judd B; Doshi, Jalpa A; Friedman, Joelle; Mussell, Adam S; Carney, Caroline; Zhu, Jingsan; Wang, Wenli; Troxel, Andrea; Young, Peinie; Lawnicki, Victor; Rajpathak, Swapnil; Volpp, Kevin

2016-04-01

Medication nonadherence is an important obstacle to cardiovascular disease management. To improve adherence through real-time feedback based on theories of how social forces influence behavior. Two randomized controlled pilot trials called PROMOTE and SUPPORT. Participants stored statin medication in wireless-enabled pill bottles that transmitted adherence data to researchers. Adults with diabetes and a history of low statin adherence based on pharmacy refills (i.e., Medication Possession Ratio [MPR] <80% in the pre-randomization screening period). In PROMOTE, each participant was randomized to 1) weekly messages in which that participant's statin adherence was compared to that of other participants (comparison), 2) weekly summaries of that participant's statin adherence (summary), or 3) control. In SUPPORT, each participant identified another person (the Medication Adherence Partner [MAP]) to receive reports about that participant's adherence, and was randomized to 1) daily reports to MAP, 2) weekly reports to MAP, 3) reports to MAP only if dose was missed, or 4) control. Adherence measured by pill bottle. Among 45,000 health plan members contacted by mail, <1% joined the trial. Participants had low baseline MPRs (median = 60%, IQR 41-72%) but high pill-bottle adherence (90% in PROMOTE, 92% in SUPPORT) during the trial. In PROMOTE (n = 201) and SUPPORT (n = 200), no intervention demonstrated significantly better adherence vs. In a subgroup of PROMOTE participants with the lowest pre-study MPR, pill-bottle-measured adherence in the comparison arm (89%) was higher than the control (86%) and summary (76%) arms, but differences were non-significant (p = 0.10). Interventions based on social forces did not improve medication adherence vs. control over a 3-month period. Given the low percentage of invited individuals who enrolled, the studies may have attracted participants who required little encouragement to improve adherence other than study participation.

Baby Shampoo to Relieve the Discomfort of Tear Gas and Pepper Spray Exposure: A Randomized Controlled Trial.

PubMed

Stopyra, Jason P; Winslow, James E; Johnson, James C; Hill, Keith D; Bozeman, William P

2018-03-01

Oleoresin capsicum (OC) or pepper spray, and tear gas (CS) are used by police and the military and produce severe discomfort. Some have proposed that washing with baby shampoo helps reduce this discomfort. We conducted a prospective, randomized, controlled study to determine if baby shampoo is effective in reducing the severity and duration of these effects. Study subjects included volunteers undergoing OC or CS exposure as part of their police or military training. After standardized exposure to OC or CS all subjects were allowed to irrigate their eyes and skin ad lib with water. Those randomized to the intervention group were provided with baby shampoo for application to their head, neck, and face. Participants rated their subjective discomfort in two domains on a scale of 0-10 at 0, 3, 5, 10, and 15 minutes. We performed statistical analysis using a two-tailed Mann-Whitney Test. There were 58 participants. Of 40 subjects in the OC arm of the study, there were no significant differences in the ocular or respiratory discomfort at any of the time points between control (n=19) and intervention (n=21) groups. Of 18 subjects in the CS arm, there were no significant differences in the ocular or skin discomfort at any of the time points between control (n=8) and intervention (n=10) groups. Irrigation with water and baby shampoo provides no better relief from OC- or CS-induced discomfort than irrigation with water alone.

Reconciling the effects of screening on prostate cancer mortality in the ERSPC and PLCO trials

PubMed Central

Tsodikov, Alex; Gulati, Roman; Heijnsdijk, Eveline AM; Pinsky, Paul F; Moss, Sue M; Qiu, Sheng; de Carvalho, Tiago M; Hugosson, Jonas; Berg, Christine D; Auvinen, Anssi; Andriole, Gerald L; Roobol, Monique J; Crawford, E David; Nelen, Vera; Kwiatkowski, Maciej; Zappa, Marco; Luján, Marcos; Villers, Arnauld; Feuer, Eric J; de Koning, Harry J; Mariotto, Angela B; Etzioni, Ruth

2017-01-01

Background The European Randomized Study of Screening for Prostate Cancer (ERSPC) found screening reduced prostate cancer (PC) mortality, but the Prostate, Lung, Colorectal, and Ovarian trial (PLCO) found no reduction. Objective To evaluate whether effects of screening on PC mortality relative to no screening differed between the ERSPC and PLCO. Design Cox regression of PC death in each trial arm adjusted for age and trial, and extended analyses that accounted for increased incidence due to screening and diagnostic workup on each arm via mean lead times (MLTs). MLTs were estimated empirically and using analytic or microsimulation models. Setting Randomized controlled trials in Europe and the US. Participants Men aged 55–69 (ERSPC) or 55–74 (PLCO) at randomization. Intervention Prostate cancer screening. Measurements PC incidence and survival from randomization; PC incidence in the US before screening began. Results Estimated MLTs were similar in the ERSPC and PLCO intervention arms but were longer in the PLCO control arm than the ERSPC control arm. Extended analyses found no evidence that effects of screening differed between trials (P=0.37–0.47, range across MLT estimation approaches) but strong evidence that benefit increased with MLT (P=0.0027–0.0032). Screening was estimated to confer a 7–9% reduction in PC death per year of MLT. This translated into an estimated 25–31% and 27–32% lower risk of PC death under screening as performed in the ERSPC and PLCO intervention arms, respectively, relative to no screening. Limitations MLT is a simple metric of screening and diagnostic workup. Conclusion After accounting for differences in implementation and settings, the ERSPC and PLCO provide compatible evidence that screening reduces PC mortality. PMID:28869989

The advance care planning PREPARE study among older Veterans with serious and chronic illness: study protocol for a randomized controlled trial.

PubMed

Sudore, Rebecca; Le, Gem M; McMahan, Ryan; McMahon, Ryan; Feuz, Mariko; Katen, Mary; Barnes, Deborah E

2015-12-12

Advance care planning (ACP) is a process whereby patients prepare for medical decision-making. The traditional objective of ACP has focused on the completion of advance directives. We have developed a new paradigm of ACP focused on preparing patients and their loved ones for communication and informed medical decision-making. To operationalize this new paradigm of ACP, we created an interactive, patient-centered website called PREPARE ( www.prepareforyourcare.org ) designed for diverse older adults. This randomized controlled trial with blinded outcome assessment is designed to determine the efficacy of PREPARE to engage older Veterans in the ACP process. Veterans who are ≥ 60 years of age, have ≥ two medical conditions, and have seen a primary care physician ≥ two times in the last year are being randomized to one of two study arms. The PREPARE study arm reviews the PREPARE website and an easy-to-read advance directive. The control arm only reviews the advance directive. The primary outcome is documentation of an advance directive and ACP discussions. Other clinically important outcomes using validated surveys include ACP behavior change process measures (knowledge, contemplation, self-efficacy, and readiness) and a full range of ACP action measures (identifying a surrogate, identifying values and goals, choosing leeway or flexibility for the surrogate, communicating with clinicians and surrogates, and documenting one's wishes). We will also assess satisfaction with decision-making and Veteran activation within primary care visits by direct audio recording. To examine the outcomes at 1 week, 3 months, and 6 months between the two study arms, we will use mixed effects linear, Poisson, or negative binomial regression and mixed effects logistic regression. This study will determine whether PREPARE increases advance directive completion rates and engagement with the ACP process. If PREPARE is efficacious, it could prove to be an easy and effective intervention to help older adults engage in the ACP process within or outside of the medical environment. PREPARE may also help older adults communicate their medical wishes and goals to their loved ones and clinicians, improve medical decision-making, and ensure their wishes are honored over the life course. ClinicalTrials.gov NCT01550731 . Registered on 8 December 2011.

Effect of the emotional freedom technique on perceived stress, quality of life, and cortisol salivary levels in tension-type headache sufferers: a randomized controlled trial.

PubMed

Bougea, Anastasia M; Spandideas, Nick; Alexopoulos, Evangelos C; Thomaides, Thomas; Chrousos, George P; Darviri, Christina

2013-01-01

To evaluate the short-term effects of the emotional freedom technique (EFT) on tension-type headache (TTH) sufferers. We used a parallel-group design, with participants randomly assigned to the emotional freedom intervention (n = 19) or a control arm (standard care n = 16). The study was conducted at the outpatient Headache Clinic at the Korgialenio Benakio Hospital of Athens. Thirty-five patients meeting criteria for frequent TTH according to International Headache Society guidelines were enrolled. Participants were instructed to use the EFT method twice a day for two months. Study measures included the Perceived Stress Scale, the Multidimensional Health Locus of Control Scale, and the Short-Form questionnaire-36. Salivary cortisol levels and the frequency and intensity of headache episodes were also assessed. Within the treatment arm, perceived stress, scores for all Short-Form questionnaire-36 subscales, and the frequency and intensity of the headache episodes were all significantly reduced. No differences in cortisol levels were found in any group before and after the intervention. EFT was reported to benefit patients with TTH. This randomized controlled trial shows promising results for not only the frequency and severity of headaches but also other lifestyle parameters. Copyright © 2013 Elsevier Inc. All rights reserved.

A controlled, randomized, comparative study of a radiant heat bandage on the healing of stage 3-4 pressure ulcers: a pilot study.

PubMed

Thomas, David R; Diebold, Marilyn R; Eggemeyer, Linda M

2005-01-01

Pressure ulcers, like other chronic wounds, fail to proceed through an orderly and timely process to produce anatomical or functional integrity. Treatment of pressure ulcers is directed to improving host factors and providing an optimum wound environment. In addition to providing a moist wound environment, it has been theorized that preventing hypothermia in a wound and maintaining a normothermic state might improve wound healing. Forty-one subjects with a stage 3 or stage 4 truncal pressure ulcer >1.0 cm(2) were recruited from outpatient clinics, long-term care nursing homes, and a rehabilitation center. The experimental group was randomized to a radiant-heat dressing device and the control group was randomized to a hydrocolloid dressing, with or without a calcium alginate filler. Subjects were followed until healed or for 12 weeks. Eight subjects (57%) in the experimental group had complete healing of their pressure ulcer compared with 7 subjects (44%) with complete healing in the control group (P = .46). Although a 13% difference in healing rate between the two arms of the study was found, this difference was not statistically significant. At almost all points along the healing curve, the proportion not healed was higher in the control arm.

Randomized controlled trial of a computer-based module to improve contraceptive method choice.

PubMed

Garbers, Samantha; Meserve, Allison; Kottke, Melissa; Hatcher, Robert; Ventura, Alicia; Chiasson, Mary Ann

2012-10-01

Unintended pregnancy is common in the United States, and interventions are needed to improve contraceptive use among women at higher risk of unintended pregnancy, including Latinas and women with low educational attainment. A three-arm randomized controlled trial was conducted at two family planning sites serving low-income, predominantly Latina populations. The trial tested the efficacy of a computer-based contraceptive assessment module in increasing the proportion of patients choosing an effective method of contraception (<10 pregnancies/100 women per year, typical use). Participants were randomized to complete the module and receive tailored health materials, to complete the module and receive generic health materials, or to a control condition. In intent-to-treat analyses adjusted for recruitment site (n=2231), family planning patients who used the module were significantly more likely to choose an effective contraceptive method: 75% among those who received tailored materials [odds ratio (OR)=1.56; 95% confidence interval (CI): 1.23-1.98] and 78% among those who received generic materials (OR=1.74; 95% CI: 1.35-2.25), compared to 65% among control arm participants. The findings support prior research suggesting that patient-centered interventions can positively influence contraceptive method choice. Copyright © 2012 Elsevier Inc. All rights reserved.

Randomized controlled trial of supervised patient self-testing of warfarin therapy using an internet-based expert system.

PubMed

Ryan, F; Byrne, S; O'Shea, S

2009-08-01

Increased frequency of prothrombin time testing, facilitated by patient self-testing (PST) of the International Normalized Ratio (INR) can improve the clinical outcomes of oral anticoagulation therapy (OAT). However, oversight of this type of management is often difficult and time-consuming for healthcare professionals. This study reports the first randomized controlled trial of an automated direct-to-patient expert system, enabling remote and effective management of patients on OAT. A prospective, randomized controlled cross-over study was performed to test the hypothesis that supervised PST using an internet-based, direct-to-patient expert system could provide improved anticoagulation control as compared with that provided by an anticoagulation management service (AMS). During the 6 months of supervised PST, patients measured their INR at home using a portable meter and entered this result, along with other information, onto the internet web page. Patients received instant feedback from the system as to what dose to take and when the next test was due. During the routine care arm, patients attended the AMS at least every 4-6 weeks and were dosed by the anticoagulation pharmacist or physician. The primary outcome variable was the difference in the time in therapeutic range (TTR) between both arms. One hundred and sixty-two patients were enrolled (male 61.6%, mean age 58.7 years), and 132 patients (81.5%) completed both arms. TTR was significantly higher during PST management than during AMS management (median TTR 74% vs 58.6%; z=5.67, P < 0.001). The use of an internet-based, direct-to-patient expert system for the management of PST improves the control of OAT as compared with AMS management.

Transcranial direct current stimulation (tDCS) of the primary motor cortex and robot-assisted arm training in chronic incomplete cervical spinal cord injury: A proof of concept sham-randomized clinical study.

PubMed

Yozbatiran, Nuray; Keser, Zafer; Davis, Matthew; Stampas, Argyrios; O'Malley, Marcia K; Cooper-Hay, Catherine; Frontera, Joel; Fregni, Felipe; Francisco, Gerard E

2016-07-15

After cervical spinal cord injury, current options for treatment of upper extremity motor functions have been limited to traditional approaches. However, there is a substantial need to explore more rigorous alternative treatments to facilitate motor recovery. To demonstrate whether anodal-primary motor cortex (M1) excitability enhancement (with cathodal-supra orbital area) (atDCS) combined with robot-assisted arm training (R-AAT) will provide greater improvement in contralateral arm and hand motor functions compared to sham stimulation (stDCS) and R-AAT in patients with chronic, incomplete cervical spinal cord injury (iCSCI). In this parallel-group, double-blinded, randomized and sham-controlled trial, nine participants with chronic iCSCI (AIS C and D level) were randomized to receive 10 sessions of atDCS or stDSC combined with R-AAT. Feasibility and tolerability was assessed with attrition rate and occurrence of adverse events, Changes in arm and hand function were assessed with Jebson Taylor Hand Function Test (JTHFT). Amount of Use Scale of Motor Activity Log (AOU-MAL), American Spinal Injury Association Upper Extremity Motor Score and Modified Ashworth Scale (MAS) at baseline, after treatment, and at two-month follow-up. None of the participants missed a treatment session or dropped-out due to adverse events related to the treatment protocol. Participants tended to perform better in JTHFT and AOU-MAL after treatment. Active group at post-treatment and two-month follow-up demonstrated better arm and hand performance compared to sham group. These preliminary findings support that modulating excitatory input of the corticospinal tracts on spinal circuits may be a promising strategy in improving arm and hand functions in persons with incomplete tetraplegia. Further study is needed to explore the underlying mechanisms of recovery.

Randomized Controlled Trial of Social Media: Effect of Increased Intensity of the Intervention.

PubMed

Fox, Caroline S; Gurary, Ellen B; Ryan, John; Bonaca, Marc; Barry, Karen; Loscalzo, Joseph; Massaro, Joseph

2016-04-27

A prior randomized controlled trial of social media exposure at Circulation determined that social media did not increase 30-day page views. Whether insufficient social media intensity contributed to these results is uncertain. Original article manuscripts were randomized to social media exposure compared with no social media exposure (control) at Circulation beginning in January 2015. Social media exposure consisted of Facebook and Twitter posts on the journal's accounts. To increase social media intensity, a larger base of followers was built using advertising and organic growth, and posts were presented in triplicate and boosted on Facebook and retweeted on Twitter. The primary outcome was 30-day page views. Stopping rules were established at the point that 50% of the manuscripts were randomized and had 30-day follow-up to compare groups on 30-day page views. The trial was stopped for futility on September 26, 2015. Overall, 74 manuscripts were randomized to receive social media exposure, and 78 manuscripts were randomized to the control arm. The intervention and control arms were similar based on article type (P=0.85), geographic location of the corresponding author (P=0.33), and whether the manuscript had an editorial (P=0.80). Median number of 30-day page views was 499.5 in the social media arm and 450.5 in the control arm; there was no evidence of a treatment effect (P=0.38). There were no statistically significant interactions of treatment by manuscript type (P=0.86), by corresponding author (P=0.35), by trimester of publication date (P=0.34), or by editorial status (P=0.79). A more intensive social media strategy did not result in increased 30-day page views of original research. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Effects of Gyejibongnyeong-hwan on dysmenorrhea caused by blood stagnation: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Gyejibongnyeong-hwan (GJBNH) is one of the most popular Korean medicine formulas for menstrual pain of dysmenorrhea. The concept of blood stagnation in Korean medicine is considered the main factor of causing abdominal pain, or cramps, during menstrual periods. To treat the symptoms, GJBNH is used to fluidify the stagnated blood and induce the blood flow to be smooth, reducing pain as the result. The purpose of this trial is to identify the efficacy of GJBNH in dysmenorrhea caused by blood stagnation. Methods This study is a multi-centre, randomised, double-blind, controlled trial with two parallel arms: the group taking GJBNH and the group taking placebo. 100 patients (women from age 18 to 35) will be enrolled to the trial. Through randomization 50 patients will be in experiment arm, and the other 50 patients will be in control arm. At the second visit (baseline), all participants who were already screened that they fulfil both the inclusion and the exclusion criteria will be randomised into two groups. Each group will take the intervention three times per day during two menstrual cycles. After the treatment for two cycles, each patient will be followed up during their 3rd, 4th and 5th menstrual cycles. From the screening (Visit 1) through the second follow-up (Visit 6) the entire process will take 25 weeks. Discussion This trial will provide evidence for the effectiveness of GJBNH in treating periodical pain due to dysmenorrhea that is caused by blood stagnation. The primary outcome between the two groups will be measured by changes in the Visual Analogue Score (VAS) of pain. The secondary outcome will be measured by the Blood Stagnation Scale, the Short-form McGill questionnaire and the COX menstrual symptom scale. Analysis of covariance (ANCOVA) and repeated measured ANOVA will be used to analyze the data analysis. Trial registration Current Controlled Trials: ISRCTN30426947 PMID:22217258

The SHAZ! Project: Results from a Pilot Randomized Trial of a Structural Intervention to Prevent HIV among Adolescent Women in Zimbabwe

PubMed Central

Dunbar, Megan S.; Kang Dufour, Mi-Suk; Lambdin, Barrot; Mudekunye-Mahaka, Imelda; Nhamo, Definate; Padian, Nancy S.

2014-01-01

Adolescent females in Zimbabwe are at high risk for HIV acquisition. Shaping the Health of Adolescents in Zimbabwe (SHAZ!) was a randomized controlled trial of a combined intervention package including life-skills and health education, vocational training, micro-grants and social supports compared to life-skills and health education alone. SHAZ! was originally envisioned as a larger effectiveness trial, however, the intervention was scaled back due to contextual and economic conditions in the country at the time. SHAZ! enrolled 315 participants randomly assigned to study arm within blocks of 50 participants (158 intervention and 157 control). The intervention arm participants showed statistically significant differences from the control arm participants for several outcomes during the two years of follow up including; reduced food insecurity [IOR = 0.83 vs. COR = 0.68, p-0.02], and having their own income [IOR = 2.05 vs. COR = 1.67, p = 0.02]. Additionally, within the Intervention arm there was a lower risk of transactional sex [IOR = 0.64, 95% CI (0.50, 0.83)], and a higher likelihood of using a condom with their current partner [IOR = 1.79, 95% CI (1.23, 2.62)] over time compared to baseline. There was also evidence of fewer unintended pregnancies among intervention participants [HR = 0.61, 95% CI (0.37, 1.01)], although this relationship achieved only marginal statistical significance. Several important challenges in this study included the coordination with vocational training programs, the political and economic instability of the area at the time of the study, and the difficulty in creating a true standard of care control arm. Overall the results of the SHAZ! study suggest important potential for HIV prevention intervention packages that include vocational training and micro-grants, and lessons for further economic livelihoods interventions with adolescent females. Further work is needed to refine the intervention model, and test the impact of the intervention at scale on biological outcomes. Trial Registration ClinicalTrials.gov NCT02034214 PMID:25415455

The SHAZ! project: results from a pilot randomized trial of a structural intervention to prevent HIV among adolescent women in Zimbabwe.

PubMed

Dunbar, Megan S; Kang Dufour, Mi-Suk; Lambdin, Barrot; Mudekunye-Mahaka, Imelda; Nhamo, Definate; Padian, Nancy S

2014-01-01

Adolescent females in Zimbabwe are at high risk for HIV acquisition. Shaping the Health of Adolescents in Zimbabwe (SHAZ!) was a randomized controlled trial of a combined intervention package including life-skills and health education, vocational training, micro-grants and social supports compared to life-skills and health education alone. SHAZ! was originally envisioned as a larger effectiveness trial, however, the intervention was scaled back due to contextual and economic conditions in the country at the time. SHAZ! enrolled 315 participants randomly assigned to study arm within blocks of 50 participants (158 intervention and 157 control). The intervention arm participants showed statistically significant differences from the control arm participants for several outcomes during the two years of follow up including; reduced food insecurity [IOR = 0.83 vs. COR = 0.68, p-0.02], and having their own income [IOR = 2.05 vs. COR = 1.67, p = 0.02]. Additionally, within the Intervention arm there was a lower risk of transactional sex [IOR = 0.64, 95% CI (0.50, 0.83)], and a higher likelihood of using a condom with their current partner [IOR = 1.79, 95% CI (1.23, 2.62)] over time compared to baseline. There was also evidence of fewer unintended pregnancies among intervention participants [HR = 0.61, 95% CI (0.37, 1.01)], although this relationship achieved only marginal statistical significance. Several important challenges in this study included the coordination with vocational training programs, the political and economic instability of the area at the time of the study, and the difficulty in creating a true standard of care control arm. Overall the results of the SHAZ! study suggest important potential for HIV prevention intervention packages that include vocational training and micro-grants, and lessons for further economic livelihoods interventions with adolescent females. Further work is needed to refine the intervention model, and test the impact of the intervention at scale on biological outcomes. ClinicalTrials.gov NCT02034214.

'TXT2BFiT' a mobile phone-based healthy lifestyle program for preventing unhealthy weight gain in young adults: study protocol for a randomized controlled trial.

PubMed

Hebden, Lana; Balestracci, Kate; McGeechan, Kevin; Denney-Wilson, Elizabeth; Harris, Mark; Bauman, Adrian; Allman-Farinelli, Margaret

2013-03-18

Despite international efforts to arrest increasing rates of overweight and obesity, many population strategies have neglected young adults as a target group. Young adults are at high risk for unhealthy weight gain which tends to persist throughout adulthood with associated chronic disease health risks. TXT2BFiT is a nine month two-arm parallel-group randomized controlled trial aimed at improving weight management and weight-related dietary and physical activity behaviors among young adults. Participants are recruited via general practice (primary medical care) clinics in Sydney, New South Wales, Australia. All participants receive a mailed resource outlining national physical activity and dietary guidelines and access to the study website. Additional resources accessible to the intervention arm via the study website include Smartphone mobile applications, printable handouts, an interactive healthy weight tracker chart, and a community blog. The study consists of two phases: (1) Intensive phase (weeks 1 to 12): the control arm receives four short message service (SMS) text messages; the intervention arm receives eight SMS messages/week tailored to their baseline stage-of-change, one Email/week, and personalized coaching calls during weeks 0, 2, 5, 8, and 11; and (2) Maintenance phase (weeks 14 to 36): the intervention arm receives one SMS message/month, one Email/month and booster coaching calls during months 5 and 8. A sample of N = 354 (177 per arm) is required to detect differences in primary outcomes: body weight (kg) and body mass index (kg/m2), and secondary outcomes: physical activity, sitting time, intake of specific foods, beverages and nutrients, stage-of-change, self-efficacy and participant well-being, at three and nine months. Program reach, costs, implementation and participant engagement will also be assessed. This mobile phone based program addresses an important gap in obesity prevention efforts to date. The method of intervention delivery is via platforms that are highly accessible and appropriate for this population group. If effective, further translational research will be required to assess how this program might operate in the broader community. Australian New Zealand Clinical Trials Registry ACTRN12612000924853.

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial

PubMed Central

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2017-01-01

Objective: To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. Design: A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Setting: Participants’ homes across Cambridgeshire, UK. Subjects: Eleven people with stroke and arm hemiparesis, 3–60 months post stroke, following discharge from community rehabilitation. Interventions: Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Main measures: Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. Results: A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. Conclusion: It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. Trial registration: ClinicalTrials.gov identifier NCT 02310438. PMID:28643570

Color record in self-monitoring of blood glucose improves glycemic control by better self-management.

PubMed

Nishimura, Akiko; Harashima, Shin-ichi; Honda, Ikumi; Shimizu, Yoshiyuki; Harada, Norio; Nagashima, Kazuaki; Hamasaki, Akihiro; Hosoda, Kiminori; Inagaki, Nobuya

2014-07-01

Color affects emotions, feelings, and behaviors. We hypothesized that color used in self-monitoring of blood glucose (SMBG) is helpful for patients to recognize and act on their glucose levels to improve glycemic control. Here, two color-indication methods, color record (CR) and color display (CD), were independently compared for their effects on glycemic control in less frequently insulin-treated type 2 diabetes. One hundred twenty outpatients were randomly allocated to four groups with 2×2 factorial design: CR or non-CR and CD or non-CD. Blood glucose levels were recorded in red or blue pencil in the CR arm, and a red or blue indicator light on the SMBG meter was lit in the CD arm, under hyperglycemia or hypoglycemia, respectively. The primary end point was difference in glycated hemoglobin (HbA1c) reduction in 24 weeks. Secondary end points were self-management performance change and psychological state change. HbA1c levels at 24 weeks were significantly decreased in the CR arm by -0.28% but were increased by 0.03% in the non-CR arm (P=0.044). In addition, diet and exercise scores were significantly improved in the CR arm compared with the non-CR arm. The exercise score showed significant improvement in the CD arm compared with the non-CD arm but without a significant difference in HbA1c reduction. Changes in psychological states were not altered between the arms. CR has a favorable effect on self-management performance without any influence on psychological stress, resulting in improved glycemic control in type 2 diabetes patients using less frequent insulin injection. Thus, active but not passive usage of color-indication methods by patients is important in successful SMBG.

Management of Chemoradiation-Induced Mucositis in Head and Neck Cancers With Oral Glutamine

PubMed Central

Panda, Niharika; Dash, Manoj Kumar; Mohanty, Sumita; Samantaray, Sagarika

2016-01-01

Purpose Head and neck cancers are the third most common cancers worldwide. Oral mucositis is the most common toxicity seen in patients who receive chemoradiation to treat head and neck cancer. The aim of this study was to evaluate the efficacy and safety of oral glutamine supplementation in these patients. Materials and Methods From December 2013 to December 2014, we randomly assigned to two arms 162 patients who had squamous cell carcinoma of the head and neck. Patients in arm A were given oral glutamine once per day, whereas those in arm B served as negative control subjects. All patients received radiotherapy given as 70 Gy in 35 fractions over 7 weeks with an injection of cisplatin once per week. Patients were assessed once per week to evaluate for the onset and severity of mucositis, pain, use of analgesics, and for Ryle tube feeding. Results We observed that 53.1% of patients developed mucositis toward the fifth week in the glutamine arm compared with 55.5% of patients in the control arm at the third week. None in the glutamine arm compared with 92.35% of patients in the control arm developed G3 mucositis. Rates of adverse events like pain, dysphagia, nausea, edema, and cough, as well as use of analgesics and Ryle tube feeding, were significantly lower in the glutamine arm than in the control arm. Conclusion This study highlights that the onset as well as the severity of mucositis in patients receiving glutamine was significantly delayed. None of the patients receiving glutamine developed G3 mucositis. Hence, the findings emphasize the use of oral glutamine supplementation as a feasible and affordable treatment option for mucositis in patients with head and neck cancers who are receiving chemoradiation. PMID:28717702

An exercise trial targeting African-American women with metabolic syndrome and at high risk for breast cancer: Rationale, design, and methods.

PubMed

Dash, Chiranjeev; Makambi, Kepher; Wallington, Sherrie F; Sheppard, Vanessa; Taylor, Teletia R; Hicks, Jennifer S; Adams-Campbell, Lucile L

2015-07-01

Metabolic syndrome and obesity are known risk factors for breast cancers. Exercise interventions can potentially modify circulating biomarkers of breast cancer risk but evidence in African-Americans and women with metabolic syndrome is lacking. The Focused Intervention on Exercise to Reduce CancEr (FIERCE) trial is a prospective, 6-month, 3-arm, randomized controlled trial to examine the effect of exercise on obesity, metabolic syndrome components, and breast cancer biomarkers among African-American women at high risk of breast cancer. Two hundred-forty inactive women with metabolic syndrome and absolute risk of breast cancer ≥ 1.40 will be randomized to one of the three trial arms: 1) a supervised, facility-based exercise arm; 2) a home-based exercise arm; and 3) a control group that maintains physical activity levels through the course of the trial. Assessments will be conducted at baseline, 3 months, and 6 months. The primary outcome variables are anthropometric indicators of obesity, metabolic syndrome components, and inflammatory, insulin-pathway, and hormonal biomarkers of breast cancer risk. The FIERCE trial will provide evidence on whether a short-term exercise intervention might be effective in reducing breast cancer risk among African-American women with comorbidities and high breast cancer risk--a group traditionally under-represented in non-therapeutic breast cancer trials. NCT02103140. Copyright © 2015. Published by Elsevier Inc.

Mechanical arm trainer for the treatment of the severely affected arm after a stroke: a single-blinded randomized trial in two centers.

PubMed

Hesse, S; Werner, C; Pohl, M; Mehrholz, J; Puzich, U; Krebs, H I

2008-10-01

To test whether training with a new mechanical arm trainer leads to better outcomes than electrical stimulation of the paretic wrist extensors in subacute stroke patients with severe upper limb paresis. Electrical stimulation is a standard and reimbursable form of therapy in Germany. Randomized controlled trial of 54 inpatients enrolled 4-8 wks from stroke onset, mean upper-extremity subsection of Fugl-Meyer assessment (0-66) at admission less than 18. In addition to standard care, all patients practiced 20-30 mins arm trainer or electrical stimulation every workday for 6 wks, totaling 30 sessions. Primary outcome was the Fugl-Meyer assessment, secondary outcomes were the Box and Block test, the Medical Research Council and the modified Ashworth scale, blindly assessed at enrollment, after 6 wks, and at 3-mo follow-up. Both groups were homogeneous at study onset. Shoulder pain occurred in two arm trainer patients. The primary Fugl-Meyer assessment outcome improved for both groups over time (P < 0.001), but this improvement did not differ between groups. The initial (terminal) mean Fugl-Meyer assessment scores were 8.8 +/- 4.8 (19.2 +/- 14.5) for the arm trainer and 8.6 +/- 3.5 (13.6 +/- 7.9) for the electrical stimulation group. No patient could transport a block initially, but at completion significantly more arm trainer patients were able to transport at least three blocks (five vs. zero, P = 0.023). No significant differences were observed between the groups on the secondary Box and Block outcome at follow-up (eight vs. four patients). All Box and Block responders had an initial Fugl-Meyer assessment > or =10. Arm trainer training did not lead to a superior primary outcome over electrical stimulation training. However, "good performers" on the secondary outcome seemed to benefit more from the arm trainer training.

Effectiveness of Provider and Community Interventions to Improve Treatment of Uncomplicated Malaria in Nigeria: A Cluster Randomized Controlled Trial.

PubMed

Onwujekwe, Obinna; Mangham-Jefferies, Lindsay; Cundill, Bonnie; Alexander, Neal; Langham, Julia; Ibe, Ogochukwu; Uzochukwu, Benjamin; Wiseman, Virginia

2015-01-01

The World Health Organization recommends that malaria be confirmed by parasitological diagnosis before treatment using Artemisinin-based Combination Therapy (ACT). Despite this, many health workers in malaria endemic countries continue to diagnose malaria based on symptoms alone. This study evaluates interventions to help bridge this gap between guidelines and provider practice. A stratified cluster-randomized trial in 42 communities in Enugu state compared 3 scenarios: Rapid Diagnostic Tests (RDTs) with basic instruction (control); RDTs with provider training (provider arm); and RDTs with provider training plus a school-based community intervention (provider-school arm). The primary outcome was the proportion of patients treated according to guidelines, a composite indicator requiring patients to be tested for malaria and given treatment consistent with the test result. The primary outcome was evaluated among 4946 (93%) of the 5311 patients invited to participate. A total of 40 communities (12 in control, 14 per intervention arm) were included in the analysis. There was no evidence of differences between the three arms in terms of our composite indicator (p = 0.36): stratified risk difference was 14% (95% CI -8.3%, 35.8%; p = 0.26) in the provider arm and 1% (95% CI -21.1%, 22.9%; p = 0.19) in the provider-school arm, compared with control. The level of testing was low across all arms (34% in control; 48% provider arm; 37% provider-school arm; p = 0.47). Presumptive treatment of uncomplicated malaria remains an ingrained behaviour that is difficult to change. With or without extensive supporting interventions, levels of testing in this study remained critically low. Governments and researchers must continue to explore alternative ways of encouraging providers to deliver appropriate treatment and avoid the misuse of valuable medicines. ClinicalTrials.gov NCT01350752.

Randomized controlled trial of a dose consolidation program.

PubMed

Delate, Thomas; Fairman, Kathleen A; Carey, Shelly M; Motheral, Brenda R

2004-01-01

To evaluate the effectiveness and financial impact of a drug dose consolidation (optimization) program using letter intervention. This pilot program in a large, mid-Atlantic health plan utilized a randomized controlled trial research design. A review of adjudicated pharmacy claims records was performed monthly for 3 consecutive months from November 2002 through February 2003 to identify inefficient (i.e., >once-daily) regimens for any one of 68 dosage strengths of 37 single-source maintenance drugs with once-daily dosing recommendations. Prescribers who had prescribed one or more inefficient regimens were identified and randomized to one of the 2 intervention arms or a control arm. Prescribers in both intervention arms were sent personalized letters with information on their patients. inefficient regimens and suggested dose consolidation options. Patients of prescribers in one intervention arm received a complementary, patient-oriented letter. Pharmacy claims for patients in all arms were examined at 180 days after the date of the letter mailing for conversion to an efficient (once-daily) regimen. Financial modeling analysis calculated net savings as changes in pharmacy expenditures minus administrative costs. A total of 2,614 inefficient regimens, representing 6.7% of claims for the targeted medications, were identified. The rate of consolidation to a suggested dosing option was lower for the Physician Letter arm (7.3%) than for the Physician/Member Letter arm (10.2%) (P = 0.046). Both intervention arms had higher consolidation rates than the Control arm (3.9%) (P = 0.018 and P = 0.000, respectively.). Approximately 30% of the regimens in each study arm were never refilled after being targeted. Financial modeling indicated that a dose consolidation intervention could save 0.03 dollars to 0.07 dollars per member per month (PMPM) in 2003 dollars with full medication compliance but only 0.02 dollars to 0.03 dollars PMPM when savings were calculated with realistic, partial compliance rates. Subanalyses performed at the drug therapy class level revealed few opportunities to justify implementing a dose consolidation program. After taking into consideration program administrative costs, high rates of refill discontinuation, and dose consolidation that occurs naturally without intervention, the results indicated that a letter-based dose consolidation program did not appreciably decrease pharmacy expenditures.

The effect of arm support combined with rehabilitation games on upper-extremity function in subacute stroke: a randomized controlled trial.

PubMed

Prange, Gerdienke B; Kottink, Anke I R; Buurke, Jaap H; Eckhardt, Martine M E M; van Keulen-Rouweler, Bianca J; Ribbers, Gerard M; Rietman, Johan S

2015-02-01

Use of rehabilitation technology, such as (electro)mechanical devices or robotics, could partly relieve the increasing strain on stroke rehabilitation caused by an increasing prevalence of stroke. Arm support (AS) training showed improvement of unsupported arm function in chronic stroke. To examine the effect of weight-supported arm training combined with computerized exercises on arm function and capacity, compared with dose-matched conventional reach training in subacute stroke patients. In a single-blind, multicenter, randomized controlled trial, 70 subacute stroke patients received 6 weeks of training with either an AS device combined with computerized exercises or dose-matched conventional training (CON). Arm function was evaluated pretraining and posttraining by Fugl-Meyer assessment (FM), maximal reach distance, Stroke Upper Limb Capacity Scale (SULCS), and arm pain via Visual Analogue Scale, in addition to perceived motivation by Intrinsic Motivation Inventory posttraining. FM and SULCS scores and reach distance improved significantly within both groups. These improvements and experienced pain did not differ between groups. The AS group reported higher interest/enjoyment during training than the CON group. AS training with computerized exercises is as effective as conventional therapy dedicated to the arm to improve arm function and activity in subacute stroke rehabilitation, when applied at the same dose. © The Author(s) 2014.

Mirror therapy for patients with severe arm paresis after stroke--a randomized controlled trial.

PubMed

Thieme, Holm; Bayn, Maria; Wurg, Marco; Zange, Christian; Pohl, Marcus; Behrens, Johann

2013-04-01

To evaluate the effects of individual or group mirror therapy on sensorimotor function, activities of daily living, quality of life and visuospatial neglect in patients with a severe arm paresis after stroke. Randomized controlled trial. Inpatient rehabilitation centre. Sixty patients with a severe paresis of the arm within three months after stroke. Three groups: (1) individual mirror therapy, (2) group mirror therapy and (3) control intervention with restricted view on the affected arm. Motor function on impairment (Fugl-Meyer Test) and activity level (Action Research Arm Test), independence in activities of daily living (Barthel Index), quality of life (Stroke Impact Scale) and visuospatial neglect (Star Cancellation Test). After five weeks, no significant group differences for motor function were found (P > 0.05). Pre-post differences for the Action Research Arm Test and Fugl-Meyer Test: individual mirror therapy: 3.4 (7.1) and 3.2 (3.8), group mirror therapy: 1.1 (3.1) and 5.1 (10.0) and control therapy: 2.8 (6.7) and 5.2 (8.7). However, a significant effect on visuospatial neglect for patients in the individual mirror therapy compared to control group could be shown (P < 0.01). Furthermore, it was possible to integrate a mirror therapy group intervention for severely affected patients after stroke. This study showed no effect on sensorimotor function of the arm, activities of daily living and quality of life of mirror therapy compared to a control intervention after stroke. However, a positive effect on visuospatial neglect was indicated.

Applying economic incentives to increase effectiveness of an outpatient weight loss program (TRIO) - A randomized controlled trial.

PubMed

Finkelstein, Eric A; Tham, Kwang-Wei; Haaland, Benjamin A; Sahasranaman, Aarti

2017-07-01

The prevalence of overweight and obesity has more than doubled in the past three decades, leading to rising rates of non-communicable diseases. This study tests whether adding a payment/rewards (term reward) program to an existing evidence-based weight loss program can increase weight loss and weight loss maintenance. We conducted a parallel-group randomized controlled trial from October 2012 to October 2015 with 161 overweight or obese individuals randomized to either control or reward arm in a 1:2 ratio. Control and reward arm participants received a four month weight loss program at the LIFE (Lifestyle Improvement and Fitness Enhancement) Centre at Singapore General Hospital. Those in the reward arm paid a fee of S$165.00 (1US$ = 1.35S$) to access a program that provided rewards of up to S$660 for meeting weight loss and physical activity goals. Participants could choose to receive rewards as guaranteed cash payments or a lottery ticket with a 1 in 10 chance of winning but with the same expected value. The primary outcome was weight loss at months 4, 8, and 12. 161 participants were randomized to control (n = 54) or reward (n = 107) arms. Average weight loss was more than twice as great in the reward arm compared to the control arm at month 4 when the program concluded (3.4 kg vs 1.4 kg, p < 0.01), month 8 when rewards concluded (3.3 kg vs 1.8 kg, p < 0.05), and at month 12 (2.3 kg vs 0.8 kg, p < 0.05). These results reveal that a payment/rewards program can be used to improve weight loss and weight loss maintenance when combined with an evidence-based weight loss program. Future efforts should attempt to replicate this approach and identify how to cost effectively expand these programs to maximize their reach. This study is registered at www.clinicaltrials.gov (Identifier: NCT01533454). Copyright © 2017 Elsevier Ltd. All rights reserved.

Recombinant human growth hormone and rosiglitazone for abdominal fat accumulation in HIV-infected patients with insulin resistance: a randomized, double-blind, placebo-controlled, factorial trial.

PubMed

Glesby, Marshall J; Albu, Jeanine; Chiu, Ya-Lin; Ham, Kirsis; Engelson, Ellen; He, Qing; Muthukrishnan, Varalakshmi; Ginsberg, Henry N; Donovan, Daniel; Ernst, Jerry; Lesser, Martin; Kotler, Donald P

2013-01-01

Recombinant human growth hormone (rhGH) reduces visceral adipose tissue (VAT) volume in HIV-infected patients but can worsen glucose homeostasis and lipoatrophy. We aimed to determine if adding rosiglitazone to rhGH would abrogate the adverse effects of rhGH on insulin sensitivity (SI) and subcutaneous adipose tissue (SAT) volume. Randomized, double-blind, placebo-controlled, multicenter trial using a 2×2 factorial design in which HIV-infected subjects with abdominal obesity and insulin resistance were randomized to rhGH 3 mg daily, rosiglitazone 4 mg twice daily, combination rhGH + rosiglitazone, or double placebo (control) for 12 weeks. The primary endpoint was change in SI by frequently sampled intravenous glucose tolerance test from entry to week 12. Body composition was assessed by whole body magnetic resonance imaging (MRI) and dual Xray absorptiometry (DEXA). Seventy-seven subjects were randomized of whom 72 initiated study drugs. Change in SI from entry to week 12 differed across the 4 arms by 1-way ANCOVA (P = 0.02); by pair-wise comparisons, only rhGH (decreasing SI; P = 0.03) differed significantly from control. Changes from entry to week 12 in fasting glucose and glucose area under the curve on 2-hour oral glucose tolerance test differed across arms (1-way ANCOVA P = 0.004), increasing in the rhGH arm relative to control. VAT decreased significantly in the rhGH arms (-17.5% in rhGH/rosiglitazone and -22.7% in rhGH) but not in the rosiglitazone alone (-2.5%) or control arms (-1.9%). SAT did not change significantly in any arm. DEXA results were consistent with the MRI data. There was no significant rhGH x rosiglitazone interaction for any body composition parameter. The addition of rosiglitazone abrogated the adverse effects of rhGH on insulin sensitivity and glucose tolerance while not significantly modifying the lowering effect of rhGH on VAT. Clinicaltrials.gov NCT00130286.

Recombinant Human Growth Hormone and Rosiglitazone for Abdominal Fat Accumulation in HIV-Infected Patients with Insulin Resistance: A Randomized, Double-Blind, Placebo-Controlled, Factorial Trial

PubMed Central

Glesby, Marshall J.; Albu, Jeanine; Chiu, Ya-Lin; Ham, Kirsis; Engelson, Ellen; He, Qing; Muthukrishnan, Varalakshmi; Ginsberg, Henry N.; Donovan, Daniel; Ernst, Jerry; Lesser, Martin; Kotler, Donald P.

2013-01-01

Background Recombinant human growth hormone (rhGH) reduces visceral adipose tissue (VAT) volume in HIV-infected patients but can worsen glucose homeostasis and lipoatrophy. We aimed to determine if adding rosiglitazone to rhGH would abrogate the adverse effects of rhGH on insulin sensitivity (SI) and subcutaneous adipose tissue (SAT) volume. Methodology/Principal Findings Randomized, double-blind, placebo-controlled, multicenter trial using a 2×2 factorial design in which HIV-infected subjects with abdominal obesity and insulin resistance were randomized to rhGH 3 mg daily, rosiglitazone 4 mg twice daily, combination rhGH + rosiglitazone, or double placebo (control) for 12 weeks. The primary endpoint was change in SI by frequently sampled intravenous glucose tolerance test from entry to week 12. Body composition was assessed by whole body magnetic resonance imaging (MRI) and dual Xray absorptiometry (DEXA). Seventy-seven subjects were randomized of whom 72 initiated study drugs. Change in SI from entry to week 12 differed across the 4 arms by 1-way ANCOVA (P = 0.02); by pair-wise comparisons, only rhGH (decreasing SI; P = 0.03) differed significantly from control. Changes from entry to week 12 in fasting glucose and glucose area under the curve on 2-hour oral glucose tolerance test differed across arms (1-way ANCOVA P = 0.004), increasing in the rhGH arm relative to control. VAT decreased significantly in the rhGH arms (−17.5% in rhGH/rosiglitazone and −22.7% in rhGH) but not in the rosiglitazone alone (−2.5%) or control arms (−1.9%). SAT did not change significantly in any arm. DEXA results were consistent with the MRI data. There was no significant rhGH x rosiglitazone interaction for any body composition parameter. Conclusions/Significance The addition of rosiglitazone abrogated the adverse effects of rhGH on insulin sensitivity and glucose tolerance while not significantly modifying the lowering effect of rhGH on VAT. Trial Registration Clinicaltrials.gov NCT00130286 PMID:23593417

Ethical Issues for Control-Arm Patients After Revelation of Benefits of Experimental Therapy: A Framework Modeled in Neuroblastoma

PubMed Central

Unguru, Yoram; Joffe, Steven; Fernandez, Conrad V.; Yu, Alice L.

2013-01-01

In 2009, the Children's Oncology Group (COG) phase III randomized controlled trial, ANBL0032, found that adding immunotherapy (Ch14.18) to standard therapy significantly improved outcomes in patients with high-risk neuroblastoma when administered within 110 days after autologous stem-cell transplantation (SCT). After careful deliberation and consultation, the COG Neuroblastoma Committee decided to offer Ch14.18 to prior trial participants who had been randomly assigned to the control arm (no immunotherapy), regardless of the time that had elapsed since SCT. This decision occurred in the context of a limited supply of Ch14.18 and no data regarding its role when administered beyond 110 days. In this article, we analyze the numerous ethical challenges highlighted by the ANBL0032 trial, including the limits of researchers' reciprocity-based obligations to study participants, post-trial access to beneficial therapies, and the balance between scientific knowledge and parental hope. These deliberations may be useful to other researchers when considering their ethical obligations to control-arm participants in the wake of a positive randomized trial. PMID:23295797

Quality of life outcomes from the Exercise and Nutrition Enhance Recovery and Good Health for You (ENERGY)-randomized weight loss trial among breast cancer survivors

PubMed Central

Colditz, Graham A.; Rock, Cheryl L.; Sedjo, Rebecca L.; Liu, Jingxia; Wolin, Kathleen Y.; Krontiras, Helen; Byers, Tim; Pakiz, Bilgé; Parker, Barbara A.; Naughton, Michael; Elias, Anthony; Ganz, Patricia A.

2015-01-01

Obesity is a poor prognostic factor and is negatively related to quality of life (QOL) in breast cancer survivors. Exercise and Nutrition to Enhance Recovery and Good Health for You is the largest weight loss trial completed among cancer survivors. Percent losses in body weight with an intensive group-based intervention versus an attention control were 6.0 versus 1.5 % (p < 0.0001) and 3.7 versus 1.3 % (p<0.0001) at 12 and 24 months, respectively. ENERGY also was designed to answer the research question: Does weight loss significantly improve vitality and physical function (key components of QOL)? 692 breast cancer survivors (BMI: 25–45 kg/m2) at 4 US sites were randomized to a year-long intensive intervention of 52 group sessions and telephone counseling contacts versus a non-intensive (control) of two in-person counseling sessions. Weight, self-reported QOL, and symptoms were measured semi-annually for two years. Significant decreases in physical function and increases in symptoms were observed among controls from baseline to 6 months, but not in the intervention arm, −3.45 (95 % Confidence Interval [CI] −6.10, –0.79, p = 0.0109) and 0.10 (95 %CI 0.04, 0.16, p = 0.0021), respectively. Improvements in vitality were seen in both arms but trended toward greater improvement in the intervention arm −2.72 (95 % CI −5.45, 0.01, p = 0.0508). These differences diminished over time; however, depressive symptoms increased in the intervention versus control arms and became significant at 24 months, −1.64 (95 % CI −3.13, –0.15, p = 0.0308). Increased QOL has been reported in shorter term diet and exercise trials among cancer survivors. These longer term data suggest that diet and exercise interventions improve some aspects of QOL, but these benefits may diminish over time. PMID:26518022

Brick tunnel randomization and the momentum of the probability mass.

PubMed

Kuznetsova, Olga M

2015-12-30

The allocation space of an unequal-allocation permuted block randomization can be quite wide. The development of unequal-allocation procedures with a narrower allocation space, however, is complicated by the need to preserve the unconditional allocation ratio at every step (the allocation ratio preserving (ARP) property). When the allocation paths are depicted on the K-dimensional unitary grid, where allocation to the l-th treatment is represented by a step along the l-th axis, l = 1 to K, the ARP property can be expressed in terms of the center of the probability mass after i allocations. Specifically, for an ARP allocation procedure that randomizes subjects to K treatment groups in w1 :⋯:wK ratio, w1 +⋯+wK =1, the coordinates of the center of the mass are (w1 i,…,wK i). In this paper, the momentum with respect to the center of the probability mass (expected imbalance in treatment assignments) is used to compare ARP procedures in how closely they approximate the target allocation ratio. It is shown that the two-arm and three-arm brick tunnel randomizations (BTR) are the ARP allocation procedures with the tightest allocation space among all allocation procedures with the same allocation ratio; the two-arm BTR is the minimum-momentum two-arm ARP allocation procedure. Resident probabilities of two-arm and three-arm BTR are analytically derived from the coordinates of the center of the probability mass; the existence of the respective transition probabilities is proven. Probability of deterministic assignments with BTR is found generally acceptable. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Clinical effectiveness of decongestive treatments on excess arm volume and patient-centered outcomes in women with early breast cancer-related arm lymphedema: a systematic review

PubMed Central

Jeffs, Eunice; Ream, Emma; Taylor, Cath; Bick, Debra

2018-01-01

ABSTRACT Objective: To identify the effect of decongestive lymphedema treatment on excess arm volume or patient-centered outcomes in women presenting within either 12 months or a mean nine months of developing arm lymphedema following breast cancer treatment. Introduction: Lymphedema is a common consequence of breast cancer treatment requiring life-long treatment to reduce symptoms and prevent complications. Currently, evidence to inform the optimal decongestive lymphedema treatment package is lacking. Inclusion criteria: The review included studies on women who received lymphedema treatment within either 12 months or a mean of nine months of developing unilateral breast cancer-related arm lymphedema. The intervention was any decongestive lymphedema treatment delivered with the purpose of reducing arm lymphedema, compared to another form of lymphedema treatment (whether self or practitioner-administered), placebo or no treatment. The clinical outcome was excess arm volume; patient-centered outcomes were health-related quality of life, arm heaviness, arm function, patient-perceived benefit and satisfaction with treatment. Experimental study designs were eligible, including randomized and non-randomized controlled trials, quasi-experimental, prospective and retrospective before and after studies were considered. Methods: A three-step search strategy was utilized to find published and unpublished studies. The search identified studies published from the inception of each database to July 6, 2016. Reference lists were scanned to identify further eligible studies. Studies were critically appraised using appropriate standardized critical appraisal instruments from the Joanna Briggs Institute. Details describing each study and treatment results regarding outcomes of interest were extracted from papers included in the review using appropriate standardized data extraction tools from the Joanna Briggs Institute. Due to heterogeneity in included studies, results for similar outcome measures were not pooled in statistical meta-analysis. A narrative and tabular format was used to synthesize results from identified and included studies. Results: Seven studies reporting results for outcomes of interest were critically appraised and included in the review: five randomized controlled trials and two descriptive (uncontrolled) studies. Reported outcomes included excess arm volume (five studies), health-related quality of life (three studies), arm heaviness (one study), arm function (two studies) and patient-perceived benefit (two studies). There was some evidence that decongestive treatments were effective for women presenting within either 12 months or a mean of nine months of developing breast cancer-related arm lymphedema, but the wide range of data prevented comparison of treatment findings which limited our ability to answer the review questions. Conclusions: Weak evidence (grade B) for the impact of decongestive lymphedema treatment on women with early lymphedema (i.e. less than 12 months duration of BCRL symptoms) did not allow any conclusions to be drawn about the most effective treatment to be offered when these women first present for treatment. Findings provided no justification to support change to current practice. Future primary research needs to focus on the most effective treatment for women when they first present with lymphedema symptoms, e.g. treatment provided within 12 months of developing symptoms. Studies should be adequately powered and recruit women exclusively with less than 12 months duration of breast cancer-related lymphedema symptoms, provide longer follow-up to monitor treatment effect over time, with comparable treatment protocols, outcome measures and reporting methods. PMID:29419623

Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol.

PubMed

Winstein, Carolee J; Wolf, Steven L; Dromerick, Alexander W; Lane, Christianne J; Nelsen, Monica A; Lewthwaite, Rebecca; Blanton, Sarah; Scott, Charro; Reiss, Aimee; Cen, Steven Yong; Holley, Rahsaan; Azen, Stanley P

2013-01-11

Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting.The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP), compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC). Two secondary objectives are to compare ASAP to a true (active monitoring only) usual and customary (UCC) therapy group and to compare DEUCC and UCC. Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure.The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the improvement in log-transformed WMFT time will be greater for the ASAP than the DEUCC group. This pre-planned hypothesis will be tested at a significance level of 0.05. ICARE will test whether ASAP is superior to the same number of hours of usual therapy. Pre-specified secondary analyses will test whether 30 hours of usual therapy is superior to current usual and customary therapy not controlled for dose. www.ClinicalTrials.gov Identifier: NCT00871715

Web-Based Just-in-Time Information and Feedback on Antibiotic Use for Village Doctors in Rural Anhui, China: Randomized Controlled Trial.

PubMed

Shen, XingRong; Lu, Manman; Feng, Rui; Cheng, Jing; Chai, Jing; Xie, Maomao; Dong, Xuemeng; Jiang, Tao; Wang, Debin

2018-02-14

Excessive use of antibiotics is very common worldwide, especially in rural China; various measures that have been used in curbing the problem have shown only marginal effects. The objective of this study was to test an innovative intervention that provided just-in-time information and feedback (JITIF) to village doctors on care of common infectious diseases. The information component of JITIF consisted of a set of theory or evidence-based ingredients, including operation guideline, public commitment, and takeaway information, whereas the feedback component tells each participating doctor about his or her performance scores and percentages of antibiotic prescriptions. These ingredients were incorporated together in a synergetic way via a Web-based aid. Evaluation of JITIF adopted a randomized controlled trial design involving 24 village clinics randomized into equal control and intervention arms. Measures used included changes between baseline and endpoint (1 year after baseline) in terms of: percentages of patients with symptomatic respiratory or gastrointestinal tract infections (RTIs or GTIs) being prescribed antibiotics, delivery of essential service procedures, and patients' beliefs and knowledge about antibiotics and infection prevention. Two researchers worked as a group in collecting the data at each site clinic. One performed nonparticipative observation of the service process, while the other performed structured exit interviews about patients' beliefs and knowledge. Data analysis comprised mainly of: (1) descriptive estimations of beliefs or knowledge, practice of indicative procedures, and use of antibiotics at baseline and endpoint for intervention and control groups and (2) chi-square tests for the differences between these groups. A total of 1048 patients completed the evaluation, including 532 at baseline (intervention=269, control=263) and 516 at endpoint (intervention=262, control=254). Patients diagnosed with RTIs and GTIs accounted for 76.5% (407/532) and 23.5% (125/352), respectively, at baseline and 80.8% (417/532) and 19.2% (99/532) at endpoint. JITIF resulted in substantial improvement in delivery of essential service procedures (2.6%-24.8% at baseline on both arms and at endpoint on the control arm vs 88.5%-95.0% at endpoint on the intervention arm, P<.001), beliefs favoring rational antibiotics use (11.5%-39.8% at baseline on both arms and at endpoint on the control arm vs 19.8%-62.6% at endpoint on the intervention arm, P<.001) and knowledge about side effects of antibiotics (35.7% on the control arm vs 73.7% on the intervention arm, P<.001), measures for managing or preventing RTIs (39.1% vs 66.7%, P=.02), and measures for managing or preventing GTIs (46.8% vs 69.2%, P<.001). It also reduced antibiotics prescription (from 88.8%-62.3%, P<.001), and this decrease was consistent for RTIs (87.1% vs 64.3%, P<.001) and GTIs (94.7% vs 52.4%, P<.001). JITIF is effective in controlling antibiotics prescription at least in the short term and may provide a low-cost and sustainable solution to the widespread excessive use of antibiotics in rural China. ©XingRong Shen, Manman Lu, Rui Feng, Jing Cheng, Jing Chai, Maomao Xie, Xuemeng Dong, Tao Jiang, Debin Wang. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 14.02.2018.

Assessing the effectiveness and cost-effectiveness of audit and feedback on physician’s prescribing indicators: study protocol of a randomized controlled trial with economic evaluation

PubMed Central

2012-01-01

Background Physician prescribing is the most frequent medical intervention with a highest impact on healthcare costs and outcomes. Therefore improving and promoting rational drug use is a great interest. We aimed to assess the effectiveness and cost-effectiveness of two forms of conducting prescribing audit and feedback interventions and a printed educational material intervention in improving physician prescribing. Method/design A four-arm randomized trial with economic evaluation will be conducted in Tehran. Three interventions (routine feedback, revised feedback, and printed educational material) and a no intervention control arm will be compared. Physicians working in outpatient practices are randomly allocated to one of the four arms using stratified randomized sampling. The interventions are developed based on a review of literature, physician interviews, current experiences in Iran and with theoretical insights from the Theory of Planned Behavior. Effects of the interventions on improving antibiotics and corticosteroids prescribing will be assessed in regression analyses. Cost data will be assessed from a health care provider’s perspective and incremental cost-effectiveness ratios will be calculated. Discussion This study will determine the effectiveness and cost-effectiveness of three interventions and allow us to determine the most effective interventions in improving prescribing pattern. If the interventions are cost-effective, they will likely be applied nationwide. Trial registration Iranian Registry of Clinical Trials Registration Number: IRCT201106086740N1Pharmaceutical Sciences Research Center of TUMS Ethics Committee Registration Number: 90-02-27-07 PMID:23351564

Ambulatory Treatment of Fast Breathing in Young Infants Aged <60 Days: A Double-Blind, Randomized, Placebo-Controlled Equivalence Trial in Low-Income Settlements of Karachi

PubMed Central

Muhammad, Amber A.; Shafiq, Yasir; Shah, Saima; Kumar, Naresh; Ahmed, Imran; Azam, Iqbal; Pasha, Omrana; Zaidi, Anita K. M.

2017-01-01

Abstract Background. Integrated Management of Childhood Illness recommends that young infants with isolated fast breathing be referred to a hospital for antibiotic treatment, which is often impractical in resource-limited settings. Additionally, antibiotics may be unnecessary for physiologic tachypnea in otherwise well newborns. We tested the hypothesis that ambulatory treatment with oral amoxicillin for 7 days was equivalent (similarity margin of 3%) to placebo in young infants with isolated fast breathing in primary care settings where hospital referral is often unfeasible. Methods. This randomized equivalence trial was conducted in 4 primary health centers of Karachi, Pakistan. Infants presenting with isolated fast breathing and oxygen saturation ≥90% were randomly assigned to receive either oral amoxicillin or placebo twice daily for 7 days. Enrolled infants were followed on days 1–8, 11, and 14. The primary outcome was treatment failure by day 8, analyzed per protocol. The trial was stopped by the data safety monitoring board due to higher treatment failure rate and the occurrence of 2 deaths in the placebo arm in an interim analysis. Results. Four hundred twenty-three infants fulfilled per protocol criteria in the amoxicillin arm and 426 in the placebo arm. Twelve infants (2.8%) had treatment failure in the amoxicillin arm and 25 (5.9%) in the placebo arm (risk difference, 3.1; P value .04). Two infants in the placebo arm died, whereas no deaths occurred in the amoxicillin arm. Other adverse outcomes, as well as the proportions of relapse, were evenly distributed across both study arms. Conclusions. This trial failed to show equivalence of placebo to amoxicillin in the management of isolated fast breathing without hypoxemia or other clinical signs of illness in term young infants. Clinical Trials Registration. NCT01533818. PMID:27941119

Results of Clinicians Using a Therapeutic Robotic System in an Inpatient Stroke Rehabilitation Unit

PubMed Central

2011-01-01

Background Physical rehabilitation is an area where robotics could contribute significantly to improved motor return for individuals following a stroke. This paper presents the results of a preliminary randomized controlled trial (RCT) of a robot system used in the rehabilitation of the paretic arm following a stroke. Methods The study's objectives were to explore the efficacy of this new type of robotic therapy as compared to standard physiotherapy treatment in treating the post-stroke arm; to evaluate client satisfaction with the proposed robotic system; and to provide data for sample size calculations for a proposed larger multicenter RCT. Twenty clients admitted to an inpatient stroke rehabilitation unit were randomly allocated to one of two groups, an experimental (robotic arm therapy) group or a control group (conventional therapy). An occupational therapist blinded to patient allocation administered two reliable measures, the Chedoke Arm and Hand Activity Inventory (CAHAI-7) and the Chedoke McMaster Stroke Assessment of the Arm and Hand (CMSA) at admission and discharge. For both groups, at admission, the CMSA motor impairment stage of the affected arm was between 1 and 3. Results Data were compared to determine the effectiveness of robot-assisted versus conventional therapy treatments. At the functional level, both groups performed well, with improvement in scores on the CAHAI-7 showing clinical and statistical significance. The CAHAI-7 (range7-49) is a measure of motor performance using functional items. Individuals in the robotic therapy group, on average, improved by 62% (95% CI: 26% to 107%) while those in the conventional therapy group changed by 30% (95% CI: 4% to 61%). Although performance on this measure is influenced by hand recovery, our results showed that both groups had similar stages of motor impairment in the hand. Furthermore, the degree of shoulder pain, as measured by the CMSA pain inventory scale, did not worsen for either group over the course of treatment. Conclusion Our findings indicated that robotic arm therapy alone, without additional physical therapy interventions tailored to the paretic arm, was as effective as standard physiotherapy treatment for all responses and more effective than conventional treatment for the CMSA Arm (p = 0.04) and Hand (p = 0.04). At the functional level, both groups performed equally well. PMID:21871095

Results of clinicians using a therapeutic robotic system in an inpatient stroke rehabilitation unit.

PubMed

Abdullah, Hussein A; Tarry, Cole; Lambert, Cynthia; Barreca, Susan; Allen, Brian O

2011-08-26

Physical rehabilitation is an area where robotics could contribute significantly to improved motor return for individuals following a stroke. This paper presents the results of a preliminary randomized controlled trial (RCT) of a robot system used in the rehabilitation of the paretic arm following a stroke. The study's objectives were to explore the efficacy of this new type of robotic therapy as compared to standard physiotherapy treatment in treating the post-stroke arm; to evaluate client satisfaction with the proposed robotic system; and to provide data for sample size calculations for a proposed larger multicenter RCT. Twenty clients admitted to an inpatient stroke rehabilitation unit were randomly allocated to one of two groups, an experimental (robotic arm therapy) group or a control group (conventional therapy). An occupational therapist blinded to patient allocation administered two reliable measures, the Chedoke Arm and Hand Activity Inventory (CAHAI-7) and the Chedoke McMaster Stroke Assessment of the Arm and Hand (CMSA) at admission and discharge. For both groups, at admission, the CMSA motor impairment stage of the affected arm was between 1 and 3. Data were compared to determine the effectiveness of robot-assisted versus conventional therapy treatments. At the functional level, both groups performed well, with improvement in scores on the CAHAI-7 showing clinical and statistical significance. The CAHAI-7 (range7-49) is a measure of motor performance using functional items. Individuals in the robotic therapy group, on average, improved by 62% (95% CI: 26% to 107%) while those in the conventional therapy group changed by 30% (95% CI: 4% to 61%). Although performance on this measure is influenced by hand recovery, our results showed that both groups had similar stages of motor impairment in the hand. Furthermore, the degree of shoulder pain, as measured by the CMSA pain inventory scale, did not worsen for either group over the course of treatment. Our findings indicated that robotic arm therapy alone, without additional physical therapy interventions tailored to the paretic arm, was as effective as standard physiotherapy treatment for all responses and more effective than conventional treatment for the CMSA Arm (p = 0.04) and Hand (p = 0.04). At the functional level, both groups performed equally well.

Figure-of-eight bandage versus arm sling for treating middle-third clavicle fractures in adults: study protocol for a randomised controlled trial.

PubMed

Lenza, Mario; Taniguchi, Luiz Fabiano Presente; Ferretti, Mario

2016-05-04

Fracture of the clavicle is common, accounting for 2.6 to 4.0 % of all fractures, with an overall incidence of 36.5 to 64 per 100,000 per year. Around 80 % of clavicle fractures occur in the middle third of the clavicle. Randomised controlled trials comparing treatment interventions have failed to indicate the best therapeutic practices for these fractures. The objective of this study is to evaluate the effects (benefits and harms) of two commonly-used conservative interventions: the figure-of-eight bandage versus the arm sling as treatments of middle-third clavicle fractures. This project has been designed as a single-centre, two-arm randomised controlled trial that will compare two interventions: figure-of-eight bandage versus the arm sling. We propose to recruit 110 adults, aged 18 years or older, with an acute (less than 10 days since injury) middle-third clavicle fracture. The primary outcomes to be evaluated will be function and/or disability measured by the Disability of the Arm, Shoulder, and Hand (DASH) questionnaire. In order to assess the secondary outcomes, the Modified University of California at Los Angeles (modified - UCLA) Shoulder Rating Scale will be used. The occurrence of pain (Visual Analogue Scale for pain (VAS)), treatment failure, adverse events and the ability to return to previous activities will also be recorded and evaluated as secondary outcomes. the primary outcome DASH score and the secondary outcomes - modified UCLA and VAS scores - will be analysed graphically. We will apply generalised mixed models with the intervention groups (two levels), and time-point assessments (seven levels) as fixed effects and patients as a random effect. According to the current literature there is very limited evidence from two small trials regarding the effectiveness of different methods of conservative interventions for treating clavicle fractures. This is the first randomised controlled trial comparing the figure-of-eight bandage versus the arm sling for treating clavicle fractures that follows the CONSORT Statement guidelines. ClinicalTrials.gov NCT02398006 .

Effect of Transcranial Direct Current Stimulation on Severely Affected Arm-Hand Motor Function in Patients After an Acute Ischemic Stroke: A Pilot Randomized Control Trial.

PubMed

Rabadi, Meheroz H; Aston, Christopher E

2017-10-01

The aim of this article was to determine whether cathodal transcranial direct current stimulation (c-tDCS) to unaffected primary motor cortex (PMC) plus conventional occupational therapy (OT) improves functional motor recovery of the affected arm hand in patients after an acute ischemic stroke compared with sham transcranial direct current stimulation plus conventional OT. In this prospective, randomized, double-blinded, sham-controlled trial of 16 severe, acute ischemic stroke patients with severe arm-hand weakness were randomly assigned to either experimental (c-tDCS plus OT; n = 8) or control (sham transcranial direct current stimulation plus OT; n = 8) groups. All patients received a standard 3-hr in-patient rehabilitation therapy, plus an additional ten 30-min sessions of tDCS. During each session, 1 mA of cathodal stimulation to the unaffected PMC is performed followed by the patient's scheduled OT. The primary outcome measure was change in Action Research Arm Test (ARAT) total and subscores on discharge. Application of c-tDCS to unaffected PMC resulted in a clinically relevant 10-point improvement in the affected arm-hand function based on ARAT total score compared with a 2-point improvement in the control group. Application of 30-min of c-tDCS to the unaffected PMC showed a 10-point improvement in the ARAT score. This corresponds to a large effect size in improvement of affected arm-hand function in patients with severe, acute ischemic stroke. Although not statistically significant, this suggests that larger studies, enrolling at least 25 patients in each group, and with a longer follow-up are warranted.

Comparison of intra-articular injections of hyaluronic acid and corticosteroid in the treatment of osteoarthritis of the hip in comparison with intra-articular injections of bupivacaine. Design of a prospective, randomized, controlled study with blinding of the patients and outcome assessors.

PubMed

Colen, Sascha; van den Bekerom, Michel P J; Bellemans, Johan; Mulier, Michiel

2010-11-16

Although intra-articular hyaluronic acid is well established as a treatment for osteoarthritis of the knee, its use in hip osteoarthritis is not based on large randomized controlled trials. There is a need for more rigorously designed studies on hip osteoarthritis treatment as this subject is still very much under debate. Randomized, controlled trial with a three-armed, parallel-group design. Approximately 315 patients complying with the inclusion and exclusion criteria will be randomized into one of the following treatment groups: infiltration of the hip joint with hyaluronic acid, with a corticosteroid or with 0.125% bupivacaine.The following outcome measure instruments will be assessed at baseline, i.e. before the intra-articular injection of one of the study products, and then again at six weeks, 3 and 6 months after the initial injection: Pain (100 mm VAS), Harris Hip Score and HOOS, patient assessment of their clinical status (worse, stable or better then at the time of enrollment) and intake of pain rescue medication (number per week). In addition patients will be asked if they have complications/adverse events. The six-month follow-up period for all patients will begin on the date the first injection is administered. This randomized, controlled, three-arm study will hopefully provide robust information on two of the intra-articular treatments used in hip osteoarthritis, in comparison to bupivacaine. NCT01079455.

A randomized study comparing outcomes of stapled and hand-sutured anastomoses in patients undergoing open gastrointestinal surgery.

PubMed

Chandramohan, S M; Gajbhiye, Raj Narenda; Agwarwal, Anil; Creedon, Erin; Schwiers, Michael L; Waggoner, Jason R; Tatla, Daljit

2013-08-01

Although stapling is an alternative to hand-suturing in gastrointestinal surgery, recent trials specifically designed to evaluate differences between the two in surgery time, anastomosis time, and return to bowel activity are lacking. This trial compared the outcomes of the two in subjects undergoing open gastrointestinal surgery. Adult subjects undergoing emergency or elective surgery requiring a single gastric, small, or large bowel anastomosis were enrolled into this open-label, prospective, randomized, interventional, parallel, multicenter, controlled trial. Randomization was assigned in a 1:1 ratio between the hand-sutured group (n = 138) and the stapled group (n = 142). Anastomosis time, surgery time, and time to bowel activity were collected and compared as primary endpoints. A total of 280 subjects were enrolled from April 2009 to September 2010. Only the time of anastomosis was significantly different between the two arms: 17.6 ± 1.90 min (stapled) and 20.6 ± 1.90 min (hand-sutured). This difference was deemed not clinically or economically meaningful. Safety outcomes and other secondary endpoints were similar between the two arms. Mechanical stapling is faster than hand-suturing for the construction of gastrointestinal anastomoses. Apart from this, stapling and hand-suturing are similar with respect to the outcomes measured in this trial.

Community-based intermittent mass testing and treatment for malaria in an area of high transmission intensity, western Kenya: study design and methodology for a cluster randomized controlled trial.

PubMed

Samuels, Aaron M; Awino, Nobert; Odongo, Wycliffe; Abong'o, Benard; Gimnig, John; Otieno, Kephas; Shi, Ya Ping; Were, Vincent; Allen, Denise Roth; Were, Florence; Sang, Tony; Obor, David; Williamson, John; Hamel, Mary J; Patrick Kachur, S; Slutsker, Laurence; Lindblade, Kim A; Kariuki, Simon; Desai, Meghna

2017-06-07

Most human Plasmodium infections in western Kenya are asymptomatic and are believed to contribute importantly to malaria transmission. Elimination of asymptomatic infections requires active treatment approaches, such as mass testing and treatment (MTaT) or mass drug administration (MDA), as infected persons do not seek care for their infection. Evaluations of community-based approaches that are designed to reduce malaria transmission require careful attention to study design to ensure that important effects can be measured accurately. This manuscript describes the study design and methodology of a cluster-randomized controlled trial to evaluate a MTaT approach for malaria transmission reduction in an area of high malaria transmission. Ten health facilities in western Kenya were purposively selected for inclusion. The communities within 3 km of each health facility were divided into three clusters of approximately equal population size. Two clusters around each health facility were randomly assigned to the control arm, and one to the intervention arm. Three times per year for 2 years, after the long and short rains, and again before the long rains, teams of community health volunteers visited every household within the intervention arm, tested all consenting individuals with malaria rapid diagnostic tests, and treated all positive individuals with an effective anti-malarial. The effect of mass testing and treatment on malaria transmission was measured through population-based longitudinal cohorts, outpatient visits for clinical malaria, periodic population-based cross-sectional surveys, and entomological indices.

The SPORTSMART study: a pilot randomised controlled trial of sexually transmitted infection screening interventions targeting men in football club settings

PubMed Central

Fuller, Sebastian S; Mercer, Catherine H; Copas, Andrew J; Saunders, John; Sutcliffe, Lorna J; Cassell, Jackie A; Hart, Graham; Johnson, Anne M; Roberts, Tracy E; Jackson, Louise J; Muniina, Pamela; Estcourt, Claudia S

2015-01-01

Background Uptake of chlamydia screening by men in England has been substantially lower than by women. Non-traditional settings such as sports clubs offer opportunities to widen access. Involving people who are not medically trained to promote screening could optimise acceptability. Methods We developed two interventions to explore the acceptability and feasibility of urine-based sexually transmitted infection (STI) screening interventions targeting men in football clubs. We tested these interventions in a pilot cluster randomised control trial. Six clubs were randomly allocated, two to each of three trial arms: team captain-led and poster STI screening promotion; sexual health adviser-led and poster STI screening promotion; and poster-only STI screening promotion (control/comparator). Primary outcome was test uptake. Results Across the three arms, 153 men participated in the trial and 90 accepted the offer of screening (59%, 95% CI 35% to 79%). Acceptance rates were broadly comparable across the arms: captain-led: 28/56 (50%); health professional-led: 31/46 (67%); and control: 31/51 (61%). However, rates varied appreciably by club, precluding formal comparison of arms. No infections were identified. Process evaluation confirmed that interventions were delivered in a standardised way but the control arm was unintentionally ‘enhanced’ by some team captains actively publicising screening events. Conclusions Compared with other UK-based community screening models, uptake was high but gaining access to clubs was not always easy. Use of sexual health advisers and team captains to promote screening did not appear to confer additional benefit over a poster-promoted approach. Although the interventions show potential, the broader implications of this strategy for UK male STI screening policy require further investigation. PMID:25512674

A tailored multicomponent program to reduce discomfort in critically ill patients: a cluster-randomized controlled trial.

PubMed

Kalfon, Pierre; Baumstarck, Karine; Estagnasie, Philippe; Geantot, Marie-Agnès; Berric, Audrey; Simon, Georges; Floccard, Bernard; Signouret, Thomas; Boucekine, Mohamed; Fromentin, Mélanie; Nyunga, Martine; Sossou, Achille; Venot, Marion; Robert, René; Follin, Arnaud; Audibert, Juliette; Renault, Anne; Garrouste-Orgeas, Maïté; Collange, Olivier; Levrat, Quentin; Villard, Isabelle; Thevenin, Didier; Pottecher, Julien; Patrigeon, René-Gilles; Revel, Nathalie; Vigne, Coralie; Azoulay, Elie; Mimoz, Olivier; Auquier, Pascal

2017-12-01

Critically ill patients are exposed to stressful conditions and experience several discomforts. The primary objective was to assess whether a tailored multicomponent program is effective for reducing self-perceived discomfort. In a cluster-randomized two-arm parallel trial, 34 French adult intensive care units (ICUs) without planned interventions to reduce discomfort were randomized, 17 to the arm including a 6-month period of program implementation followed by a 6-month period without the program (experimental group), and 17 to the arm with an inversed sequence (control group). The tailored multicomponent program consisted of assessment of ICU-related self-perceived discomforts, immediate and monthly feedback to healthcare teams, and site-specific tailored interventions. The primary outcome was the overall discomfort score derived from the 16-item IPREA questionnaire (0, minimal, 100, maximal overall discomfort) and the secondary outcomes were the discomfort scores of each IPREA item. IPREA was administered on the day of ICU discharge with a considered timeframe from the ICU admission until ICU discharge. During a 1-month assessment period, 398 and 360 patients were included in the experimental group and the control group, respectively. The difference (experimental minus control) of the overall discomfort score between groups was - 7.00 (95% CI - 9.89 to - 4.11, p < 0.001). After adjustment (age, gender, ICU duration, mechanical ventilation duration, and type of admission), the program effect was still positive for the overall discomfort score (difference - 6.35, SE 1.23, p < 0.001) and for 12 out of 16 items. This tailored multicomponent program decreased self-perceived discomfort in adult critically ill patients. Clinicaltrials.gov Identifier NCT02442934.

Testing a counselling intervention in antenatal care for women experiencing partner violence: a study protocol for a randomized controlled trial in Johannesburg, South Africa.

PubMed

Pallitto, Christina; García-Moreno, Claudia; Stöeckl, Heidi; Hatcher, Abigail; MacPhail, Catherine; Mokoatle, Keneoue; Woollett, Nataly

2016-11-05

Intimate partner violence (IPV) during or before pregnancy is associated with many adverse health outcomes. Pregnancy-related complications or poor infant health outcomes can arise from direct trauma as well as physiological effects of stress, both of which impact maternal health and fetal growth and development. Antenatal care can be a key entry point within the health system for many women, particularly in low-resource settings. Interventions to identify violence during pregnancy and offer women support and counselling may reduce the occurrence of violence and mitigate its consequences. Following a formative research phase, a randomized controlled trial will be conducted to test a nurse-led empowerment counselling intervention, originally developed for high-income settings and adapted for urban South Africa. The primary outcome is reduction of partner violence, and secondary outcomes include improvement in women's mental health, safety and self-efficacy. The study aims to recruit 504 pregnant women from three antenatal clinics in Johannesburg who will be randomized to the nurse-led empowerment arm (two 30-min counselling sessions) or enhanced control condition (a referral list) to determine whether participants in the intervention arm have better outcomes as compared to the those in the control arm. This research will provide much needed evidence on whether a short counselling intervention delivered by nurses is efficacious and feasible in low resource settings that have high prevalence of IPV and HIV. The study was registered in the South African Clinical Trials Registry (DOH-27-0414-4720) on 11 August 2014 and in the ISRCTN Registry ( ISRCTN35969343 ) on 23 May 2016).

Predictors of Study Attrition in a Randomized Controlled Trial Evaluating a Perinatal Home-Visiting Program with Mothers with Psychosocial Vulnerabilities

PubMed Central

Foulon, Stéphanie; Greacen, Tim; Pasquet, Blandine; Dugravier, Romain; Saïas, Thomas; Guedeney, Nicole; Guedeney, Antoine; Tubach, Florence

2015-01-01

Objective Randomised controlled trials evaluating perinatal home-visiting programs are frequently confronted with the problem of high attrition rates. The aim of the present study is to identify predictors of study attrition in a trial evaluating a perinatal home-visiting program in France. Materials and Methods CAPEDP is a French randomized trial comparing a perinatal home-visiting program using psychologists versus usual care (N = 440). The first assessment was at inclusion into the trial at the 27th week of pregnancy and the final assessment when the child reached the age of two. Attrition rates were calculated at 3 and 24 months postpartum. Stepwise logistic regression was used to identify predictors of early (between inclusion and 3 months postpartum) and later (between 3 and 24 months postpartum) attrition among social, psychological and parenting factors. Results Attrition rates were 17% and 63% at 3 and 24 months respectively. At 24 months, there was significantly more attrition in the control arm (70.6%) compared to the intervention arm (55.2%). Five independent predictors of early attrition were identified: having already had an abortion; having greater attachment insecurity as measured with the Vulnerable Attachment Style Questionnaire (VASQ); having lower global severity of psychiatric symptoms as assessed with the Symptom Check-List (SCL-90) at inclusion, being neither currently employed nor studying; and declaring no tobacco consumption during pregnancy. Being randomized into the control arm, having undergone early parental loss before age 11 and having lower global severity of psychiatric symptoms (SCL-90) at 3 months postpartum were the only variables associated with later attrition. Conclusion This study provides key information for identifying mothers who may require specific support to avoid study attrition in trials evaluating a home-visiting program. PMID:26554839

Moxifloxacin in Pediatric Patients with Complicated Intra-Abdominal Infections: Results of the MOXIPEDIA Randomized Controlled Study.

PubMed

Wirth, Stefan; Emil, Sherif G S; Engelis, Arnis; Digtyar, Valeri; Criollo, Margarita; DiCasoli, Carl; Stass, Heino; Willmann, Stefan; Nkulikiyinka, Richard; Grossmann, Ulrike

2018-01-18

This study was designed to evaluate primarily the safety and also the efficacy of moxifloxacin (MXF) in children with complicated intra-abdominal infections (cIAIs). In this multicenter, randomized, double-blind, controlled study, 451 pediatric patients aged 3 months to 17 years with cIAIs were treated with intravenous/oral MXF (N = 301) or comparator (COMP, intravenous ertapenem followed by oral amoxicillin/clavulanate; N = 150) for 5 to 14 days. Doses of MXF were selected based on the results of a Phase 1 study in pediatric patients (NCT01049022). The primary endpoint was safety, with particular focus on cardiac and musculoskeletal safety; clinical and bacteriological efficacy at test of cure were also investigated. The proportion of patients with adverse events (AEs) was comparable between the two treatment arms (MXF: 58.1% and COMP: 54.7%). The incidence of drug-related AEs was higher in the MXF arm than the COMP arm (14.3% and 6.7%, respectively). No cases of QTc interval prolongation-related morbidity or mortality were observed. The proportion of patients with musculoskeletal AEs was comparable between treatment arms; no drug-related events were reported. Clinical cure rates were 84.6% and 95.5% in the MXF and COMP arms, respectively, in patients with confirmed pathogen(s) at baseline. MXF treatment was well tolerated in children with cIAIs. However, a lower clinical cure rate was observed with MXF treatment compared with COMP. This study does not support a recommendation of MXF for children with cIAIs when alternative more efficacious antibiotics with better safety profile are available.

The effectiveness of a Web-based personalized feedback and social norms alcohol intervention on United Kingdom university students: randomized controlled trial.

PubMed

Bewick, Bridgette M; West, Robert M; Barkham, Michael; Mulhern, Brendan; Marlow, Robert; Traviss, Gemma; Hill, Andrew J

2013-07-24

Alcohol consumption in the student population continues to be cause for concern. Building on the established evidence base for traditional brief interventions, interventions using the Internet as a mode of delivery are being developed. Published evidence of replication of initial findings and ongoing development and modification of Web-based personalized feedback interventions for student alcohol use is relatively rare. The current paper reports on the replication of the initial Unitcheck feasibility trial. To evaluate the effectiveness of Unitcheck, a Web-based intervention that provides instant personalized feedback on alcohol consumption. It was hypothesized that use of Unitcheck would be associated with a reduction in alcohol consumption. A randomized control trial with two arms (control=assessment only; intervention=fully automated personalized feedback delivered using a Web-based intervention). The intervention was available week 1 through to week 15. Students at a UK university who were completing a university-wide annual student union electronic survey were invited to participate in the current study. Participants (n=1618) were stratified by sex, age group, year of study, self-reported alcohol consumption, then randomly assigned to one of the two arms, and invited to participate in the current trial. Participants were not blind to allocation. In total, n=1478 (n=723 intervention, n=755 control) participants accepted the invitation. Of these, 70% were female, the age ranged from 17-50 years old, and 88% were white/white British. Data were collected electronically via two websites: one for each treatment arm. Participants completed assessments at weeks 1, 16, and 34. Assessment included CAGE, a 7-day retrospective drinking diary, and drinks consumed per drinking occasion. The regression model predicted a monitoring effect, with participants who completed assessments reducing alcohol consumption over the final week. Further reductions were predicted for those allocated to receive the intervention, and additional reductions were predicted as the number of visits to the intervention website increased. Unitcheck can reduce the amount of alcohol consumed, and the reduction can be sustained in the medium term (ie, 19 weeks after intervention was withdrawn). The findings suggest self-monitoring is an active ingredient to Web-based personalized feedback.

Pharmacodynamic and pharmacokinetic neoadjuvant study of hedgehog pathway inhibitor Sonidegib (LDE-225) in men with high-risk localized prostate cancer undergoing prostatectomy.

PubMed

Ross, Ashley E; Hughes, Robert M; Glavaris, Stephanie; Ghabili, Kamyar; He, Ping; Anders, Nicole M; Harb, Rana; Tosoian, Jeffrey J; Marchionni, Luigi; Schaeffer, Edward M; Partin, Alan W; Allaf, Mohamad E; Bivalacqua, Trinity J; Chapman, Carolyn; O'Neal, Tanya; DeMarzo, Angelo M; Hurley, Paula J; Rudek, Michelle A; Antonarakis, Emmanuel S

2017-11-28

To determine the pharmacodynamic effects of Sonidegib (LDE-225) in prostate tumor tissue from men with high-risk localized prostate cancer, by comparing pre-surgical core-biopsy specimens to tumor tissue harvested post-treatment at prostatectomy. We conducted a prospective randomized (Sonidegib vs. observation) open-label translational clinical trial in men with high-risk localized prostate cancer undergoing radical prostatectomy. The primary endpoint was the proportion of patients in each arm who achieved at least a two-fold reduction in GLI1 mRNA expression in post-treatment versus pre-treatment tumor tissue. Secondary endpoints included the effect of pre-surgical treatment with Sonidegib on disease progression following radical prostatectomy, and safety. Fourteen men were equally randomized (7 per arm) to either neoadjuvant Sonidegib or observation for 4 weeks prior to prostatectomy. Six of seven men (86%) in the Sonidegib arm (and none in the control group) achieved a GLI1 suppression of at least two-fold. In the Sonidegib arm, drug was detectable in plasma and in prostatic tissue; and median intra-patient GLI1 expression decreased by 63-fold, indicating potent suppression of Hedgehog signaling. Sonidegib was well tolerated, without any Grade 3-4 adverse events observed. Disease-free survival was comparable among the two arms (HR = 1.50, 95% CI 0.26-8.69, P = 0.65). Hedgehog pathway activity (as measured by GLI1 expression) was detectable at baseline in men with localized high-risk prostate cancer. Sonidegib penetrated into prostatic tissue and induced a >60-fold suppression of the Hedgehog pathway. The oncological benefit of Hedgehog pathway inhibition in prostate cancer remains unclear.

Night glucose control with MD-Logic artificial pancreas in home setting: a single blind, randomized crossover trial-interim analysis.

PubMed

Nimri, Revital; Muller, Ido; Atlas, Eran; Miller, Shahar; Kordonouri, Olga; Bratina, Natasa; Tsioli, Christiana; Stefanija, Magdalena A; Danne, Thomas; Battelino, Tadej; Phillip, Moshe

2014-03-01

Artificial pancreas (AP) systems have shown an improvement in glucose control and a reduced risk of nocturnal hypoglycemia under controlled conditions but remain to be evaluated under daily-life conditions. To assess the feasibility, safety, and efficacy of the MD-Logic AP in controlling nocturnal glucose levels in the patient's home. Two-arm study, each covering four consecutive nights comparing the MD-Logic AP ('closed-loop' arm) with sensor-augmented pump therapy ('control' arm). Fifteen patients (mean age 19 ± 10.4 yr, A1c 7.5 ± 0.5% or 58 ± 5.9 mmol/mol, diabetes duration 9.9 ± 8.2 yr) were randomly assigned either to 'Group A' (first 'closed-loop', then 'control' arm) or to 'Group B' (vice versa). Investigators were masked to treatment intervention. Primary endpoints were the time spent with glucose levels below 70 mg/dL and the percentage of nights in which the mean overnight glucose levels were within 90-140 mg/dL. Endpoint analyses were based on unmodified sensor glucose readings of the four study nights. Time of glucose levels spent below 70 mg/dL was significantly shorter on the closed-loop nights than on control nights, median and interquartile range 3.8 (0, 11.6) and 48.7 (0.6, 67.9) min, respectively; p = 0.0034. The percentage of individual nights in which mean overnight glucose level was within 90-140 mg/dL was 67 (33, 88), and 50 (25, 75), under closed-loop and control nights, respectively, with no statistical difference. Secondary endpoint analyses demonstrated significant improvements in hypoglycemia parameters. No serious adverse events were reported. This interim analysis demonstrates the feasibility, safety, and efficiency of the MD-Logic AP system in home use, and demonstrates an improvement over sensor-augmented pump therapy. (ClinicalTrials.gov identifier NCT01726829). © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Effectiveness of an Activity Tracker- and Internet-Based Adaptive Walking Program for Adults: A Randomized Controlled Trial.

PubMed

Poirier, Josée; Bennett, Wendy L; Jerome, Gerald J; Shah, Nina G; Lazo, Mariana; Yeh, Hsin-Chieh; Clark, Jeanne M; Cobb, Nathan K

2016-02-09

The benefits of physical activity are well documented, but scalable programs to promote activity are needed. Interventions that assign tailored and dynamically adjusting goals could effect significant increases in physical activity but have not yet been implemented at scale. Our aim was to examine the effectiveness of an open access, Internet-based walking program that assigns daily step goals tailored to each participant. A two-arm, pragmatic randomized controlled trial compared the intervention to no treatment. Participants were recruited from a workplace setting and randomized to a no-treatment control (n=133) or to treatment (n=132). Treatment participants received a free wireless activity tracker and enrolled in the walking program, Walkadoo. Assessments were fully automated: activity tracker recorded primary outcomes (steps) without intervention by the participant or investigators. The two arms were compared on change in steps per day from baseline to follow-up (after 6 weeks of treatment) using a two-tailed independent samples t test. Participants (N=265) were 66.0% (175/265) female with an average age of 39.9 years. Over half of the participants (142/265, 53.6%) were sedentary (<5000 steps/day) and 44.9% (119/265) were low to somewhat active (5000-9999 steps/day). The intervention group significantly increased their steps by 970 steps/day over control (P<.001), with treatment effects observed in sedentary (P=.04) and low-to-somewhat active (P=.004) participants alike. The program is effective in increasing daily steps. Participants benefited from the program regardless of their initial activity level. A tailored, adaptive approach using wireless activity trackers is realistically implementable and scalable. Clinicaltrials.gov NCT02229409, https://clinicaltrials.gov/ct2/show/NCT02229409 (Archived by WebCite at http://www.webcitation.org/6eiWCvBYe).

Effect of Two or Six Doses 800 mg of Albendazole Every Two Months on Loa loa Microfilaraemia: A Double Blind, Randomized, Placebo-Controlled Trial.

PubMed

Kamgno, Joseph; Nguipdop-Djomo, Patrick; Gounoue, Raceline; Téjiokem, Mathurin; Kuesel, Annette C

2016-03-01

Loiasis is a parasitic infection endemic in the African rain forest caused by the filarial nematode Loa loa. Loiasis can be co-endemic with onchocerciasis and/or lymphatic filariasis. Ivermectin, the drug used in the control of these diseases, can induce serious adverse reactions in patients with high L loa microfilaraemia (LLM). A drug is needed which can lower LLM below the level that represents a risk so that ivermectin mass treatment to support onchocerciasis and lymphatic filariasis elimination can be implemented safely. Sixty men and women from a loiasis endemic area in Cameroon were randomized after stratification by screening LLM (≤ 30000, 30001-50000, >50000) to three treatment arms: two doses albendazole followed by 4 doses matching placebo (n = 20), six doses albendazole (n = 20) albendazole or 6 doses matching placebo (n = 20) administered every two months. LLM was measured before each treatment and 14, 18, 21 and 24 months after the first treatment. Monitoring for adverse events occurred three and seven days as well as 2 months after each treatment. None of the adverse events recorded were considered treatment related. The percentages of participants with ≥ 50% decrease in LLM from pre-treatment for ≥ 4 months were 53%, 17% and 11% in the 6-dose, 2-dose and placebo treatment arms, respectively. The difference between the 6-dose and the placebo arm was significant (p = 0.01). The percentages of participants with LLM < 8100 mf/ml for ≥ 4 months were 21%, 11% and 0% in the 6-dose, 2-dose and placebo treatment arms, respectively. The 6-dose regimen reduced LLM significantly, but the reduction was insufficient to eliminate the risk of severe and/or serious adverse reactions during ivermectin mass drug administration in loiasis co-endemic areas.

Effect of Two or Six Doses 800 mg of Albendazole Every Two Months on Loa loa Microfilaraemia: A Double Blind, Randomized, Placebo-Controlled Trial

PubMed Central

Kamgno, Joseph; Nguipdop-Djomo, Patrick; Gounoue, Raceline; Téjiokem, Mathurin; Kuesel, Annette C.

2016-01-01

Background Loiasis is a parasitic infection endemic in the African rain forest caused by the filarial nematode Loa loa. Loiasis can be co-endemic with onchocerciasis and/or lymphatic filariasis. Ivermectin, the drug used in the control of these diseases, can induce serious adverse reactions in patients with high L loa microfilaraemia (LLM). A drug is needed which can lower LLM below the level that represents a risk so that ivermectin mass treatment to support onchocerciasis and lymphatic filariasis elimination can be implemented safely. Methodology Sixty men and women from a loiasis endemic area in Cameroon were randomized after stratification by screening LLM (≤30000, 30001–50000, >50000) to three treatment arms: two doses albendazole followed by 4 doses matching placebo (n = 20), six doses albendazole (n = 20) albendazole or 6 doses matching placebo (n = 20) administered every two months. LLM was measured before each treatment and 14, 18, 21 and 24 months after the first treatment. Monitoring for adverse events occurred three and seven days as well as 2 months after each treatment. Principal Findings None of the adverse events recorded were considered treatment related. The percentages of participants with ≥ 50% decrease in LLM from pre-treatment for ≥ 4 months were 53%, 17% and 11% in the 6-dose, 2-dose and placebo treatment arms, respectively. The difference between the 6-dose and the placebo arm was significant (p = 0.01). The percentages of participants with LLM < 8100 mf/ml for ≥4 months were 21%, 11% and 0% in the 6-dose, 2-dose and placebo treatment arms, respectively. Conclusions/ Significance The 6-dose regimen reduced LLM significantly, but the reduction was insufficient to eliminate the risk of severe and/or serious adverse reactions during ivermectin mass drug administration in loiasis co-endemic areas. PMID:26967331

Wide brick tunnel randomization - an unequal allocation procedure that limits the imbalance in treatment totals.

PubMed

Kuznetsova, Olga M; Tymofyeyev, Yevgen

2014-04-30

In open-label studies, partial predictability of permuted block randomization provides potential for selection bias. To lessen the selection bias in two-arm studies with equal allocation, a number of allocation procedures that limit the imbalance in treatment totals at a pre-specified level but do not require the exact balance at the ends of the blocks were developed. In studies with unequal allocation, however, the task of designing a randomization procedure that sets a pre-specified limit on imbalance in group totals is not resolved. Existing allocation procedures either do not preserve the allocation ratio at every allocation or do not include all allocation sequences that comply with the pre-specified imbalance threshold. Kuznetsova and Tymofyeyev described the brick tunnel randomization for studies with unequal allocation that preserves the allocation ratio at every step and, in the two-arm case, includes all sequences that satisfy the smallest possible imbalance threshold. This article introduces wide brick tunnel randomization for studies with unequal allocation that allows all allocation sequences with imbalance not exceeding any pre-specified threshold while preserving the allocation ratio at every step. In open-label studies, allowing a larger imbalance in treatment totals lowers selection bias because of the predictability of treatment assignments. The applications of the technique in two-arm and multi-arm open-label studies with unequal allocation are described. Copyright © 2013 John Wiley & Sons, Ltd.

A pilot, randomized controlled trial to examine the health outcomes of raisin consumption in patients with diabetes.

PubMed

Kanellos, P T; Kaliora, A C; Tentolouris, N K; Argiana, V; Perrea, D; Kalogeropoulos, N; Kountouri, A M; Karathanos, V T

2014-03-01

Dried fruits, like their fresh homologues, contain relatively high concentrations of antioxidants. The aim of this study was to determine the health outcomes of raisin consumption on patients with diabetes. We examined the effects of dried grapes (Vitis vinifera) cultivated in Greece, namely Corinthian Raisins (CR) on blood pressure, fasting glucose, glucated hemoglobin (HbA1c), lipid peroxidation, high-sensitivity C-reactive protein, antioxidant status, and cytokines in patients with type 2 diabetes mellitus (T2DM). Forty-eight well-controlled patients with T2DM from the diabetes outpatient clinic of our hospital were recruited to a two-armed, randomized, controlled, 24-wk prospective intervention trial in order to examine the health outcomes of CR consumption. All participants were reported to consume less fruits and vegetables than the recommended amount of five servings daily. Participants in the intervention were instructed to consume CR equal to two fruit servings (36 g/d), replacing snacks with similar energy density twice during the day. Anthropometric and blood pressure measurements, assessment of dietary intake, and fasting blood draws were conducted at baseline and at week 24. Also, phenolic compounds present in CR were analyzed in plasma of the patients. t Test for parametric data and Mann-Whitney test or Wilcoxon test for non-parametric data were performed. Significance was set at P < 0.05. Body weight, glycemic control, and lipid profile were not affected in either arm. Patients in the CR arm reduced their diastolic blood pressure and increased their total antioxidant potential significantly compared with baseline. The differences between the two groups at week 24 were significant. No change in high-sensitivity C-reactive protein was observed. A significant difference in plasma circulating p-hydroxybenzoic acid was observed between groups at the end of the trial. Our study shows that naturally CR may improve health features in patients with well-controlled T2DM. Copyright © 2014 Elsevier Inc. All rights reserved.

Induction of a pathological complete response by four courses of neoadjuvant chemotherapy for gastric cancer: early results of the randomized phase II COMPASS trial.

PubMed

Yoshikawa, Takaki; Tanabe, Kazuaki; Nishikawa, Kazuhiro; Ito, Yuichi; Matsui, Takanori; Kimura, Yutaka; Hirabayashi, Naoki; Mikata, Shoki; Iwahashi, Makoto; Fukushima, Ryoji; Takiguchi, Nobuhiro; Miyashiro, Isao; Morita, Satoshi; Miyashita, Yumi; Tsuburaya, Aakira; Sakamoto, Junichi

2014-01-01

The prognosis for stage 3 gastric cancer is not satisfactory, even with S-1 adjuvant chemotherapy. A randomized phase II trial was conducted to compare two and four courses of neoadjuvant S-1/cisplatin (SC) and paclitaxel/cisplatin (PC) using a two-by-two factorial design for locally advanced gastric cancer. The primary endpoint was overall survival. We clarified the impact of these regimens on the secondary endpoints, including the clinical and pathological responses, chemotherapy-related toxicities, and surgical results. Patients received S-1 (80 mg/m(2) for 21 days with 1 week's rest)/cisplatin (60 mg/m(2) at day 8) or paclitaxel/cisplatin (80 and 25 mg/m(2), respectively, on days 1, 8, and 15 with 1 week's rest) as neoadjuvant chemotherapy. Eighty-three patients were assigned to arm A (two courses of SC, n = 21), arm B (four courses of SC, n = 20), arm C (two courses of PC, n = 21), and arm D (four courses of PC, n = 21). Pathological response rate was 43 % in arm A, 40 % in arm B, 29 % in arm C, and 38 % in arm D. Pathological complete response was only observed in arms B (10 %) and D (10 %). Most bone marrow toxicities, nausea, vomiting, alopecia, and fatigue were slightly higher but acceptable in arms B and D. Grade 3/4 surgical morbidities were not commonly observed in all four arms. Pathological complete response could be induced by four courses of neoadjuvant chemotherapy without a marked increase of toxicities, regardless of a SC or PC regimen.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lin, Shinn-Yn; Department of Medical Imaging and Radiological Sciences, College of Medicine, Chang Gung University, Taiwan; Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taiwan

Purpose: This report is the second analysis of a prospective randomized trial to investigate the impact of {sup 18}F-fluorodeoxyglucose positron emission tomography (FDG-PET) on cervical cancer patients with enlarged pelvic lymph nodes identified by magnetic resonance imaging. Methods and Materials: Patients with newly diagnosed cervical cancer with enlarged pelvic lymph nodes but free of enlarged para-aortic lymph nodes (PALN) were eligible. Patients were randomized to receive either pretreatment FDG-PET (PET arm) or not (control arm). The whole pelvis was the standard irradiation field for all patients except those with FDG-avid extrapelvic findings. Results: In all, 129 patients were enrolled. Pretreatmentmore » PET detected extrapelvic metastases in 7 patients. No new patient experienced treatment failure during the additional 4-year follow-up period. There were no significant differences between the PET arm and the control arm regarding overall survival, disease-free survival, and freedom from extrapelvic metastasis. In the control arm, 8 of 10 patients with PALN relapse had limited extrapelvic nodal failures; their 5-year disease-specific survival was 34.3%. By contrast, only 1 of 5 patients with PALN relapse in the PET arm experienced such limited failures; their 5-year survival rate was 0%. Conclusions: Although the pretreatment detection of PALN did not translate into survival benefit, it indeed decreased the need for extended-field concurrent chemoradiation therapy.« less

Effect of vertical active vibration isolation on tracking performance and on ride qualities

NASA Technical Reports Server (NTRS)

Dimasi, F. P.; Allen, R. E.; Calcaterra, P. C.

1972-01-01

An investigation to determine the effect on pilot performance and comfort of an active vibration isolation system for a commercial transport pilot seat is reported. The test setup consisted of: a hydraulic shaker which produced random vertical vibration inputs; the active vibration isolation system; the pilot seat; the pilot control wheel and column; the side-arm controller; and a two-axis compensatory tracking task. The effects of various degrees of pilot isolation on short-term (two-minute) tracking performance and comfort were determined.

Intensified hyperfractionated accelerated radiotherapy limits the additional benefit of simultaneous chemotherapy--results of a multicentric randomized German trial in advanced head-and-neck cancer.

PubMed

Staar, S; Rudat, V; Stuetzer, H; Dietz, A; Volling, P; Schroeder, M; Flentje, M; Eckel, H E; Mueller, R P

2001-08-01

To demonstrate the efficacy of radiochemotherapy (RCT) as the first choice of treatment for advanced unresectable head-and-neck cancer. To prove an expected benefit of simultaneously given chemotherapy, a two-arm randomized study with hyperfractionated accelerated radiochemotherapy (HF-ACC-RCT) vs. hyperfractionated accelerated radiotherapy (HF-ACC-RT) was initiated. The primary endpoint was 1-year survival with local control (SLC). Patients with Stage III and IV (UICC) unresectable oro- and hypopharyngeal carcinomas were randomized for HF-ACC-RCT with 2 cycles of 5-FU (600 mg/m(2)/day)/carboplatinum (70 mg/m(2)) on days 1--5 and 29--33 (arm A) or HF-ACC-RT alone (arm B). In both arms, there was a second randomization for testing the effect of prophylactically given G-CSF (263 microg, days 15--19) on mucosal toxicity. Total RT dose in both arms was 69.9 Gy in 38 days, with a concomitant boost regimen (weeks 1--3: 1.8 Gy/day, weeks 4 and 5: b.i.d. RT with 1.8 Gy/1.5 Gy). Between July 1995 and May 1999, 263 patients were randomized (median age 56 years; 96% Stage IV tumors, 4% Stage III tumors). This analysis is based on 240 patients: 113 patients with RCT and 127 patients with RT, qualified for protocol and starting treatment. There were 178 oropharyngeal and 62 hypopharyngeal carcinomas. Treatment was tolerable in both arms, with a higher mucosal toxicity after RCT. Restaging showed comparable nonsignificant different CR + PR rates of 92.4% after RCT and 87.9% after RT (p = 0.29). After a median observed time of 22.3 months, l- and 2-year local-regional control (LRC) rates were 69% and 51% after RCT and 58% and 45% after RT (p = 0.14). There was a significantly better 1-year SLC after RCT (58%) compared with RT (44%, p = 0.05). Patients with oropharyngeal carcinomas showed significantly better SLC after RCT (60%) vs. RT (40%, p = 0.01); the smaller group of hypopharyngeal carcinomas had no statistical benefit of RCT (p = 0.84). For both tumor locations, prophylactically given G-CSF was a poor prognostic factor (Cox regression), and resulted in reduced LRC (log-rank test: +/- G-CSF, p = 0.0072). With accelerated radiotherapy, the efficiency of simultaneously given chemotherapy may be not as high as expected when compared to standard fractionated RT. Oropharyngeal carcinomas showed better LRC after HF-ACC-RCT vs. HF-ACC-RT; hypopharyngeal carcinomas did not. Prophylactic G-CSF resulted in an unexpected reduced local control and should be given in radiotherapy regimen only with strong hematologic indication.

Impact of Calcium and Two Doses of Vitamin D on Bone Metabolism in the Elderly: A Randomized Controlled Trial.

PubMed

Rahme, Maya; Sharara, Sima Lynn; Baddoura, Rafic; Habib, Robert H; Halaby, Georges; Arabi, Asma; Singh, Ravinder J; Kassem, Moustapha; Mahfoud, Ziyad; Hoteit, Maha; Daher, Rose T; Bassil, Darina; El Ferkh, Karim; El-Hajj Fuleihan, Ghada

2017-07-01

The optimal dose of vitamin D to optimize bone metabolism in the elderly is unclear. We tested the hypothesis that vitamin D, at a dose higher than recommended by the Institute of Medicine (IOM), has a beneficial effect on bone remodeling and mass. In this double-blind trial we randomized 257 overweight elderly subjects to receive 1000 mg of elemental calcium citrate/day, and the daily equivalent of 3750 IU/day or 600 IU/day of vitamin D3 for 1 year. The subjects' mean age was 71 ± 4 years, body mass index 30 ± 4 kg/m 2 , 55% were women, and 222 completed the 12-month follow-up. Mean serum 25 hydroxyvitamin D (25OHD) was 20 ng/mL, and rose to 26 ng/mL in the low-dose arm, and 36 ng/mL in the high-dose arm, at 1 year (p < 0.05). Plasma parathyroid hormone, osteocalcin, and C-terminal telopeptide (Cross Laps) levels decreased significantly by 20% to 22% in both arms, but there were no differences between the two groups for any variable, at 6 or 12 months, with the exception of serum calcitriol, which was higher in the high-dose group at 12 months. Bone mineral density (BMD) increased significantly at the total hip and lumbar spine, but not the femoral neck, in both study arms, whereas subtotal body BMD increased in the high-dose group only, at 1 year. However, there were no significant differences in percent change BMD between the two study arms at any skeletal site. Subjects with serum 25OHD <20 ng/mL and PTH level >76 pg/mL showed a trend for higher BMD increments at all skeletal sites, in the high-dose group, that reached significance at the hip. Adverse events were comparable in the two study arms. This controlled trial shows little additional benefit in vitamin D supplementation at a dose exceeding the IOM recommendation of 600 IU/day on BMD and bone markers, in overweight elderly individuals. © 2017 American Society for Bone and Mineral Research. © 2017 American Society for Bone and Mineral Research.

Implementation of an evidence-based intervention to promote colorectal cancer screening in community organizations: a cluster randomized trial.

PubMed

Maxwell, Annette E; Danao, Leda L; Cayetano, Reggie T; Crespi, Catherine M; Bastani, Roshan

2016-06-01

The implementation of evidence-based strategies to promote colorectal cancer (CRC) screening remains challenging. The aim of this study is to evaluate two strategies to implement an evidence-based intervention to promote CRC screening in Filipino American community organizations. Twenty-two community organizations were randomized to either a basic or enhanced implementation strategy. In both arms, community health advisors recruited participants non-adherent to CRC screening guidelines, conducted educational sessions, distributed print materials and free fecal occult blood test kits, reminded participants to get screened, and mailed letters to participants' providers. In the enhanced arm, leaders of the organizations participated in implementation efforts. While the effectiveness was similar in both arms of the study (screening rate at 6-month follow-up was 53 % in the enhanced arm, 49 % in the basic arm), 223 participants were screened in the enhanced arm versus 122 in the basic arm. The enhanced implementation strategy reached 83 % more participants and achieved a higher public health impact. NCT01351220 (ClinicalTrials.gov).

An elevated plus-maze in mixed reality for studying human anxiety-related behavior.

PubMed

Biedermann, Sarah V; Biedermann, Daniel G; Wenzlaff, Frederike; Kurjak, Tim; Nouri, Sawis; Auer, Matthias K; Wiedemann, Klaus; Briken, Peer; Haaker, Jan; Lonsdorf, Tina B; Fuss, Johannes

2017-12-21

A dearth of laboratory tests to study actual human approach-avoidance behavior has complicated translational research on anxiety. The elevated plus-maze (EPM) is the gold standard to assess approach-avoidance behavior in rodents. Here, we translated the EPM to humans using mixed reality through a combination of virtual and real-world elements. In two validation studies, we observed participants' anxiety on a behavioral, physiological, and subjective level. Participants reported higher anxiety on open arms, avoided open arms, and showed an activation of endogenous stress systems. Participants' with high anxiety exhibited higher avoidance. Moreover, open arm avoidance was moderately predicted by participants' acrophobia and sensation seeking, with opposing influences. In a randomized, double blind, placebo controlled experiment, GABAergic stimulation decreased avoidance of open arms while alpha-2-adrenergic antagonism increased avoidance. These findings demonstrate cross-species validity of open arm avoidance as a translational measure of anxiety. We thus introduce the first ecologically valid assay to track actual human approach-avoidance behavior under laboratory conditions.

Baby Shampoo to Relieve the Discomfort of Tear Gas and Pepper Spray Exposure: A Randomized Controlled Trial

PubMed Central

Winslow, James E.; Johnson, James C.; Hill, Keith D.; Bozeman, William P.

2018-01-01

Introduction Oleoresin capsicum (OC) or pepper spray, and tear gas (CS) are used by police and the military and produce severe discomfort. Some have proposed that washing with baby shampoo helps reduce this discomfort. Methods We conducted a prospective, randomized, controlled study to determine if baby shampoo is effective in reducing the severity and duration of these effects. Study subjects included volunteers undergoing OC or CS exposure as part of their police or military training. After standardized exposure to OC or CS all subjects were allowed to irrigate their eyes and skin ad lib with water. Those randomized to the intervention group were provided with baby shampoo for application to their head, neck, and face. Participants rated their subjective discomfort in two domains on a scale of 0–10 at 0, 3, 5, 10, and 15 minutes. We performed statistical analysis using a two-tailed Mann-Whitney Test. Results There were 58 participants. Of 40 subjects in the OC arm of the study, there were no significant differences in the ocular or respiratory discomfort at any of the time points between control (n=19) and intervention (n=21) groups. Of 18 subjects in the CS arm, there were no significant differences in the ocular or skin discomfort at any of the time points between control (n=8) and intervention (n=10) groups. Conclusion Irrigation with water and baby shampoo provides no better relief from OC- or CS-induced discomfort than irrigation with water alone. PMID:29560057

Evaluation of mHealth strategies to optimize adherence and efficacy of Option B+ prevention of mother-to-child HIV transmission: rationale, design and methods of a 3-armed randomized controlled trial

PubMed Central

Drake, Alison L.; Unger, Jennifer A.; Ronen, Keshet; Matemo, Daniel; Perrier, Trevor; DeRenzi, Brian; Richardson, Barbra A.; Kinuthia, John; John-Stewart, Grace

2017-01-01

Background Lifelong antiretroviral therapy (ART) (Option B+) is recommended for all HIV-infected pregnant/postpartum women, but high adherence is required to maximize HIV prevention potential and maintain maternal health. Mobile health (mHealth) interventions may provide treatment adherence support for women during, and beyond, the pregnancy and postpartum periods. Methods and Design We are conducting an unblinded, triple-arm randomized clinical trial (Mobile WACh X) of one-way short message service (SMS) versus two-way SMS versus control (no SMS) to improve maternal ART adherence and retention in care by 2 years postpartum. We will enroll 825 women from Nairobi and Western Kenya. Women in the intervention arms receive weekly, semi-automated motivational and educational SMS and visit reminders via an interactive, human-computer hybrid communication system. Participants in the two-way SMS arm are also asked to respond to a question related to the message. SMS are based in behavioral theory, are tailored to participant characteristics through SMS tracks, and are timed along the pregnancy/postpartum continuum. After enrollment, follow-up visits are scheduled at 6 weeks; 6, 12, 18, and 24 months postpartum. The primary outcomes, virological failure (HIV viral load ≥1000 copies/mL), maternal retention in care, and infant HIV-free survival, will be compared in an intent to treat analysis. We will also measure ART adherence and drug resistance. Discussion Personalized and tailored SMS to support HIV-infected women during and after pregnancy may be an effective strategy to motivate women to adhere to ART and remain in care and improve maternal and infant outcomes. PMID:28315480

Evaluation of mHealth strategies to optimize adherence and efficacy of Option B+ prevention of mother-to-child HIV transmission: Rationale, design and methods of a 3-armed randomized controlled trial.

PubMed

Drake, Alison L; Unger, Jennifer A; Ronen, Keshet; Matemo, Daniel; Perrier, Trevor; DeRenzi, Brian; Richardson, Barbra A; Kinuthia, John; John-Stewart, Grace

2017-06-01

Lifelong antiretroviral therapy (ART) (Option B+) is recommended for all HIV-infected pregnant/postpartum women, but high adherence is required to maximize HIV prevention potential and maintain maternal health. Mobile health (mHealth) interventions may provide treatment adherence support for women during, and beyond, the pregnancy and postpartum periods. We are conducting an unblinded, triple-arm randomized clinical trial (Mobile WACh X) of one-way short message service (SMS) vs. two-way SMS vs. control (no SMS) to improve maternal ART adherence and retention in care by 2years postpartum. We will enroll 825 women from Nairobi and Western Kenya. Women in the intervention arms receive weekly, semi-automated motivational and educational SMS and visit reminders via an interactive, human-computer hybrid communication system. Participants in the two-way SMS arm are also asked to respond to a question related to the message. SMS are based in behavioral theory, are tailored to participant characteristics through SMS tracks, and are timed along the pregnancy/postpartum continuum. After enrollment, follow-up visits are scheduled at 6weeks; 6, 12, 18, and 24months postpartum. The primary outcomes, virological failure (HIV viral load ≥1000copies/mL), maternal retention in care, and infant HIV infection or death, will be compared in an intent to treat analysis. We will also measure ART adherence and drug resistance. Personalized and tailored SMS to support HIV-infected women during and after pregnancy may be an effective strategy to motivate women to adhere to ART and remain in care and improve maternal and infant outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

Influence of arm crank ergometry on development of lymphedema in breast cancer patients after axillary dissection: A randomized controlled trail.

PubMed

Schmidt, Thorsten; Berner, Jette; Jonat, Walter; Weisser, Burkhard; Röcken, Christioph; van Mackelenbergh, Marion; Mundhenke, Christoph

2017-01-19

To investigate the safety and efficacy of arm crank ergometry in breast cancer patients after axillary lymph node dissection, with regard to changes in bioelectrical impedance analysis, arm circumference, muscular strength, quality of life and fatigue. Randomized controlled clinical intervention trial. Forty-nine patients with breast cancer after axillary lymph node dissection. Arm crank ergometer training twice-weekly was compared with usual care over 12 weeks. The arm crank ergometer group improved significantly in terms of lean body mass and skeletal muscle mass, and showed a significant decrease in body fat. In the arm crank ergometer group, as well as the usual care group, a significant increase in armpit circumference was detected during the training period. The magnitude of the gain was higher in the usual care group. For all other measured regions of the arm a significant decrease in circumference was seen in both groups. Muscular strength of the upper extremity increased significantly in both groups, with a greater improvement in the arm crank ergometer group. In both groups a non-significant trend towards improvement in quality of life was observed. The arm crank ergometer group showed significant improvements in physical functioning, general fatigue and physical fatigue. These results confirm the feasibility of arm crank ergometer training after axillary lymph node dissection and highlight improvements in strength, quality of life and reduced arm symptoms with this training.

A randomized phase 2 study comparing two doses of delafloxacin with tigecycline in adults with complicated skin and skin-structure infections.

PubMed

O'Riordan, William; Mehra, Purvi; Manos, Paul; Kingsley, Jeff; Lawrence, Laura; Cammarata, Sue

2015-01-01

A randomized, double-blind, multicenter trial was done to compare two doses of delafloxacin with tigecycline in patients with various complicated skin and skin-structure infections (wound infections following surgery, trauma, burns, or animal/insect bites, abscesses, and cellulitis). Patients were randomized 1:1:1 to receive delafloxacin 300mg intravenous (IV) every 12h, delafloxacin 450mg IV every 12h, or tigecycline 100mg IV×1, followed by 50mg IV every 12h; randomization was stratified by infection type. Duration of therapy was 5-14 days. The primary efficacy analysis, performed on the clinically evaluable (CE) population at the test-of-cure (TOC) visit (14-21 days after the final dose of study drug), compared clinical response rates in the delafloxacin and tigecycline arms. Clinical response rates in the two delafloxacin arms were also compared. Among CE patients, clinical cure rates at TOC visit were similar in the delafloxacin and tigecycline arms (94.3%, 92.5%, and 91.2%, respectively in delafloxacin 300-mg, delafloxacin 450-mg, and tigecycline arms). Overall, the most frequent adverse events were nausea, vomiting, and diarrhea; the 300-mg delafloxacin arm was the best-tolerated regimen. Delafloxacin was similarly effective as tigecycline for a variety of complicated skin and skin-structure infections and was well tolerated. (Clinicaltrials.gov NCT 0719810). Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Effects of a Home-Based Upper Limb Training Program in Patients With Multiple Sclerosis: A Randomized Controlled Trial.

PubMed

Ortiz-Rubio, Araceli; Cabrera-Martos, Irene; Rodríguez-Torres, Janet; Fajardo-Contreras, Waldo; Díaz-Pelegrina, Ana; Valenza, Marie Carmen

2016-12-01

To evaluate the effects of a home-based upper limb training program on arm function in patients with multiple sclerosis (MS). Additionally, the effects of this program on manual dexterity, handgrip strength, and finger prehension force were analyzed. Randomized, single-blind controlled trial. Home based. Patients with a clinical diagnosis of MS acknowledging impaired manual ability (N=37) were randomized into 2 groups. Patients in the experimental group were included in a supervised home-based upper limb training program for 8 weeks twice a week. Patients in the control group received information in the form of a leaflet with a schedule of upper limb exercise training. The primary outcome measure was arm function (motor functioning assessed using the finger tapping test and a functional measure, the Action Research Arm Test). The secondary outcome measures were manual dexterity assessed with the Purdue Pegboard Test and handgrip strength and finger prehension force evaluated with a handgrip and a pinch dynamometer, respectively. After 8 weeks, a significant between-group improvement (P<.05) was found on the Action Research Arm Test bilaterally and the finger tapping test in the most affected upper limb. The secondary outcomes also improved in the most affected limb in the experimental group. An 8-week home-based intervention program focused on upper limbs twice a week improved arm function and physiologic variables with a primary focus on the more affected extremity in patients with MS compared with the control group. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Weight change among people randomized to minimal intervention control groups in weight loss trials.

PubMed

Johns, David J; Hartmann-Boyce, Jamie; Jebb, Susan A; Aveyard, Paul

2016-04-01

Evidence on the effectiveness of behavioral weight management programs often comes from uncontrolled program evaluations. These frequently make the assumption that, without intervention, people will gain weight. The aim of this study was to use data from minimal intervention control groups in randomized controlled trials to examine the evidence for this assumption and the effect of frequency of weighing on weight change. Data were extracted from minimal intervention control arms in a systematic review of multicomponent behavioral weight management programs. Two reviewers classified control arms into three categories based on intensity of minimal intervention and calculated 12-month mean weight change using baseline observation carried forward. Meta-regression was conducted in STATA v12. Thirty studies met the inclusion criteria, twenty-nine of which had usable data, representing 5,963 participants allocated to control arms. Control arms were categorized according to intensity, as offering leaflets only, a single session of advice, or more than one session of advice from someone without specialist skills in supporting weight loss. Mean weight change at 12 months across all categories was -0.8 kg (95% CI -1.1 to -0.4). In an unadjusted model, increasing intensity by moving up a category was associated with an additional weight loss of -0.53 kg (95% CI -0.96 to -0.09). Also in an unadjusted model, each additional weigh-in was associated with a weight change of -0.42 kg (95% CI -0.81 to -0.03). However, when both variables were placed in the same model, neither intervention category nor number of weigh-ins was associated with weight change. Uncontrolled evaluations of weight loss programs should assume that, in the absence of intervention, their population would weigh up to a kilogram on average less than baseline at the end of the first year of follow-up. © 2016 The Authors Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

Perspectives of health care professionals on the facilitators and barriers to the implementation of a stroke rehabilitation guidelines cluster randomized controlled trial.

PubMed

Munce, Sarah E P; Graham, Ian D; Salbach, Nancy M; Jaglal, Susan B; Richards, Carol L; Eng, Janice J; Desrosiers, Johanne; MacKay-Lyons, Marilyn; Wood-Dauphinee, Sharon; Korner-Bitensky, Nicol; Mayo, Nancy E; Teasell, Robert W; Zwarenstein, Merrick; Mokry, Jennifer; Black, Sandra; Bayley, Mark T

2017-06-26

The Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial (SCORE-IT) was a cluster randomized controlled trial that evaluated two knowledge translation (KT) interventions for the promotion of the uptake of best practice recommendations for interventions targeting upper and lower extremity function, postural control, and mobility. Twenty rehabilitation centers across Canada were randomly assigned to either the facilitated or passive KT intervention. The objective of the current study was to understand the factors influencing the implementation of the recommended treatments and KT interventions from the perspective of nurses, occupational therapists and physical therapists, and clinical managers following completion of the trial. A qualitative descriptive approach involving focus groups was used. Thematic analysis was used to understand the factors influencing the implementation of the recommended treatments and KT interventions. The Clinical Practice Guidelines Framework for Improvement guided the analysis. Thirty-three participants were interviewed from 11 of the 20 study sites (6 sites from the facilitated KT arm and 5 sites from the passive KT arm). The following factors influencing the implementation of the recommended treatments and KT interventions emerged: facilitation, agreement with the intervention - practical, familiarity with the recommended treatments, and environmental factors, including time and resources. Each of these themes includes the sub-themes of facilitator and/or barrier. Improved team communication and interdisciplinary collaboration emerged as an unintended outcome of the trial across both arms in addition to a facilitator to the implementation of the treatment recommendations. Facilitation was identified as a facilitator to implementation of the KT interventions in the passive KT intervention arm despite the lack of formally instituted facilitators in this arm of the trial. This is one of the first studies to examine the factors influencing the implementation of stroke recommendations and associated KT interventions within the context of a trial. Findings highlight the important role of self-selected facilitators to implementation efforts. Future research should seek to better understand the specific characteristics of facilitators that are associated with successful implementation and clinical outcomes, especially within the context of stroke rehabilitation.

Does Provider Self-Reporting of Etiquette Behaviors Improve Patient Experience? A Randomized Controlled Trial.

PubMed

Siddiqui, Zishan; Qayyum, Rehan; Bertram, Amanda; Durkin, Nowella; Kebede, Sosena; Ponor, Lucia; Oduyebo, Ibironke; Allen, Lisa; Brotman, Daniel J

2017-06-01

There is a glaring lack of published evidence-based strategies to improve the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient experience scores on the physician domain. Strategies that have been used are resource intensive and difficult to sustain. We hypothesized that prompting providers to assess their own etiquette-based practices every 2 weeks over the course of 1 year would improve patient experience on the physician domain. Randomized controlled trial. 4 acute care hospitals. Hospitalists. Hospitalists were randomized to the study or the control arm. The study arm was prompted every 2 weeks for 12 months to report how frequently they engaged in 7 best-practice bedside etiquette behaviors. Control arm participants received similarly worded questions on quality improvement behaviors. Provider experience scores were calculated from the physician HCAHPS and Press Ganey survey provider items. Physicians reported high rates of etiquette-based behavior at baseline, and this changed modestly over the study period. Self-reported etiquette behaviors were not associated with experience scores. The difference in difference analysis of the baseline and postintervention physician experience scores between the intervention arm and the control arm was not statistically significant (P = 0.71). In this 12-month study, biweekly reflection and reporting of best-practice bedside etiquette behaviors did not result in significant improvement on physician domain experience scores. It is likely that hospitalists' self-assessment of their bedside etiquette may not reflect patient perception of these behaviors. Furthermore, hospitalists may be resistant to improvement in this area since they rate themselves highly at baseline. Journal of Hospital Medicine 2017;12:402-406. © 2017 Society of Hospital Medicine

Hemodialysis Infection Prevention Protocols Ontario-Shower Technique (HIPPO-ST): A Pilot Randomized Trial.

PubMed

Kosa, S Daisy; Gafni, Amiram; House, Andrew A; Lawrence, JulieAnn; Moist, Louise; Nathoo, Bharat; Tam, Paul; Sarabia, Alicia; Thabane, Lehana; Wu, George; Lok, Charmaine E

2017-03-01

We developed the Hemodialysis Infection Prevention Protocols Ontario-Shower Technique (HIPPO-ST) to permit hemodialysis (HD) patients with central venous catheters (catheters) to shower without additional infection risk. Our primary objective was to determine the feasibility of conducting a parallel randomized controlled trial (RCT) to evaluate the impact of HIPPO-ST on catheter-related bacteremia (CRB) in adult HD patients. Adult HD patients using catheters were recruited from 11 HD units. Patients were randomized to receive HIPPO-ST or standard care and were followed up for 6 months. Only CRB-outcome assessors were blinded. For the study to be considered feasible, 4 of 5 feasibility outcomes, each with its own statistical threshold for success, must have been achieved. A total of 68 patients were randomized (33 HIPPO-ST and 35 control) and were followed up to 6 months. Of 5 measures of feasibility, 4 were achieved: (1) accurate CRB rate documented (threshold: κ level >0.80); (2) 97.8% (279/285) of satellite HD patients with catheters were screened (threshold: >95%); (3) 88% (23/26) in the HIPPO-ST arm were successfully educated by 6 months (threshold: >80%); and (4) 0% (0/29) patients in the control arm were "contaminated," that is, using HIPPO-ST (threshold: <5%). However, only 44.2% (72/163) of eligible patients consented to participate (threshold: >80%). The rate of CRB was similarly low in HIPPO-ST and control groups (0.68 vs. 0.88/1000 catheter days). This HIPPO-ST pilot study demonstrated the feasibility of the larger HIPPO-ST study, especially given the high levels of education success with the HIPPO-ST arm and the low levels of contamination in the control arm.

Communication style and exercise compliance in physiotherapy (CONNECT): a cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients' adherence to physiotherapists' recommendations: study rationale, design, and methods.

PubMed

Lonsdale, Chris; Hall, Amanda M; Williams, Geoffrey C; McDonough, Suzanne M; Ntoumanis, Nikos; Murray, Aileen; Hurley, Deirdre A

2012-06-15

Physical activity and exercise therapy are among the accepted clinical rehabilitation guidelines and are recommended self-management strategies for chronic low back pain. However, many back pain sufferers do not adhere to their physiotherapist's recommendations. Poor patient adherence may decrease the effectiveness of advice and home-based rehabilitation exercises. According to self-determination theory, support from health care practitioners can promote patients' autonomous motivation and greater long-term behavioral persistence (e.g., adherence to physiotherapists' recommendations). The aim of this trial is to assess the effect of an intervention designed to increase physiotherapists' autonomy-supportive communication on low back pain patients' adherence to physical activity and exercise therapy recommendations. This study will be a single-blinded cluster randomized controlled trial. Outpatient physiotherapy centers (N =12) in Dublin, Ireland (population = 1.25 million) will be randomly assigned using a computer-generated algorithm to either the experimental or control arm. Physiotherapists in the experimental arm (two hospitals and four primary care clinics) will attend eight hours of communication skills training. Training will include handouts, workbooks, video examples, role-play, and discussion designed to teach physiotherapists how to communicate in a manner that promotes autonomous patient motivation. Physiotherapists in the waitlist control arm (two hospitals and four primary care clinics) will not receive this training. Participants (N = 292) with chronic low back pain will complete assessments at baseline, as well as 1 week, 4 weeks, 12 weeks, and 24 weeks after their first physiotherapy appointment. Primary outcomes will include adherence to physiotherapy recommendations, as well as low back pain, function, and well-being. Participants will be blinded to treatment allocation, as they will not be told if their physiotherapist has received the communication skills training. Outcome assessors will also be blinded.We will use linear mixed modeling to test between arm differences both in the mean levels and the rates of change of the outcome variables. We will employ structural equation modeling to examine the process of change, including hypothesized mediation effects. This trial will be the first to test the effect of a self-determination theory-based communication skills training program for physiotherapists on their low back pain patients' adherence to rehabilitation recommendations.

Dual-Arm Generalized Compliant Motion With Shared Control

NASA Technical Reports Server (NTRS)

Backes, Paul G.

1994-01-01

Dual-Arm Generalized Compliant Motion (DAGCM) primitive computer program implementing improved unified control scheme for two manipulator arms cooperating in task in which both grasp same object. Provides capabilities for autonomous, teleoperation, and shared control of two robot arms. Unifies cooperative dual-arm control with multi-sensor-based task control and makes complete task-control capability available to higher-level task-planning computer system via large set of input parameters used to describe desired force and position trajectories followed by manipulator arms. Some concepts discussed in "A Generalized-Compliant-Motion Primitive" (NPO-18134).

Effect of a brief smoking cessation intervention on adult tobacco smokers with pulmonary tuberculosis: A cluster randomized controlled trial from North India.

PubMed

Goel, Sonu; Kathiresan, Jeyashree; Singh, Preeti; Singh, Rana J

2017-09-01

An association between smoking and poor tuberculosis (TB) treatment outcomes has been globally established. Various smoking cessation interventions (SCIs) have been proven worldwide to curb smoking behavior. There is a need for evidence to assess if SCI increases the chance of successful treatment outcome among TB patients. To assess the effectiveness of a brief SCI; The Ask, Brief, Cessation support (ABC) package, on treatment outcomes and smoking cessation in smear-positive adult pulmonary TB patients. A cluster, randomized controlled trial was conducted wherein 17 designated microscopic centers of Chandigarh, India were randomly assigned using a computer-generated randomization sequence to receive SCI within directly observed treatment, short (DOTS) services, or existing standard of care. Eligible and consenting smokers (15 + years) registered as smear-positive pulmonary TB for DOTS (n = 156) between January and June 2013 were enrolled. Smoking cessation (self-reported) was assessed at intervals till the end of treatment. End TB treatment outcomes were extracted from patient records. Treatment success was lower in intervention arm (83.6%) as compared control arm (88.2%), but the difference was statistically insignificant (P = 0.427). Smoking cessation was higher in intervention arm (80.2%) compared to comparison arm (57.5%) (adjusted incidence risk ratio = 1.56; 95% confidence interval = 1.24-1.93; P < 0.0001). SCI is effective in inducing smoking cessation among TB patients. No association of SCI with TB treatment outcomes could be detected.

Randomized, Placebo-Controlled Trial of Green Tea Catechins for Prostate Cancer Prevention

PubMed Central

Kumar, Nagi B.; Pow-Sang, Julio; Egan, Kathleen M.; Spiess, Philippe E.; Dickinson, Shohreh; Salup, Raoul; Helal, Mohamed; McLarty, Jerry; Williams, Christopher R.; Schreiber, Fred; Parnes, Howard L.; Sebti, Said; Kazi, Aslam; Kang, Loveleen; Quinn, Gwen; Smith, Tiffany; Yue, Binglin; Diaz, Karen; Chornokur, Ganna; Crocker, Theresa; Schell, Michael J.

2015-01-01

Preclinical, epidemiological and prior clinical trial data suggest that green tea catechins (GTCs) may reduce prostate cancer (PCa) risk. We conducted a placebo-controlled, randomized clinical trial of Polyphenon E® (PolyE), a proprietary mixture of GTCs, containing 400 mg (–)-epigallocatechin-3-gallate (EGCG) per day, in 97 men with high-grade prostatic intraepithelial neoplasia (HGPIN) and/or atypical small acinar proliferation (ASAP). The primary study endpoint was a comparison of the cumulative one-year PCa rates on the two study arms. No differences in the number of PCa cases were observed: 5/49 (PolyE) versus 9/48 (placebo), P=0.25. A secondary endpoint comparing the cumulative rate of PCa plus ASAP among men with HGPIN without ASAP at baseline, revealed a decrease in this composite endpoint: 3/26 (PolyE) versus 10/25 (placebo), P<0.024. This finding was driven by a decrease in ASAP diagnoses on the Poly E (0/26) compared to the placebo arm (5/25). A decrease in serum prostate specific antigen (PSA) was observed on the PolyE arm [−0.87 ng/ml (95%CI: −1.66, −0.09)]. Adverse events related to the study agent did not significantly differ between the two study groups. Daily intake of a standardized, decaffeinated catechin mixture containing 400 mg EGCG per day for 1 year accumulated in plasma and was well tolerated but did not reduce the likelihood of PCa in men with baseline HGPIN or ASAP. PMID:25873370

DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial.

PubMed

Jeandidier, Nathalie; Chaillous, Lucy; Franc, Sylvia; Benhamou, Pierre-Yves; Schaepelynck, Pauline; Hanaire, Hélène; Catargi, Bogdan; Farret, Anne; Fontaine, Pierre; Guerci, Bruno; Reznik, Yves; Penfornis, Alfred; Borot, Sophie; Serusclat, Pierre; Kherbachi, Yacine; D'Orsay, Geneviève; Detournay, Bruno; Simon, Pierre; Charpentier, Guillaume

2018-04-19

Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a smartphone app (downloaded via the internet) used to calculate bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO was associated with a significant improvement in glycemic control in patients with poorly controlled type 1 diabetes mellitus, particularly when combined with teleconsultations with physicians. Here, we present the protocol for a new study (Suivi A Grande Echelle d'une cohorte de diabétiques de type 1 et de type 2 sous schéma insulinique basal bolus par la TELEmédecine; abbreviated TELESAGE), conducted in a larger population of diabetic patients with poorly controlled basal-bolus insulin levels. TELESAGE is a multicenter, double-randomized, open-label, three parallel-arms study, conducted in approximately 100 centers in France. The study will compare a control group (arm 1: usual follow-up) with two DIABEO telemedicine systems: (1) physician-assisted telemedicine (arm 2), and (2) nurse-assisted telemonitoring and teleconsultations by a diabetologist's task delegation (arm 3). Initial randomization will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE will be to investigate the effect of the DIABEO telemedicine system versus usual follow-up, with respect to improvements in the glycated hemoglobin levels of approximately 696 diabetic patients with poorly controlled basal-bolus insulin levels. The TELESAGE study is sponsored by Sanofi (Gentilly, France). A primary completion date is expected in June 2018, and publication of results is expected within 6 months of work completion. The TELESAGE study is expected to confirm the previous results of the TELEDIAB 1 study using a larger sample of diabetic patients. It is also expected to evaluate a nurse-assisted telemonitoring system. We will assess the potential of the DIABEO telemedicine service in terms of its utility and explore whether it can become an integral part of diabetes care for patients. ClinicalTrials.gov NCT02287532; https://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd). ©Nathalie Jeandidier, Lucy Chaillous, Sylvia Franc, Pierre-Yves Benhamou, Pauline Schaepelynck, Hélène Hanaire, Bogdan Catargi, Anne Farret, Pierre Fontaine, Bruno Guerci, Yves Reznik, Alfred Penfornis, Sophie Borot, Pierre Serusclat, Yacine Kherbachi, Geneviève D'Orsay, Bruno Detournay, Pierre Simon, Guillaume Charpentier. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.04.2018.

A cluster randomized controlled trial to assess the impact of SAFE on spousal violence against women and girls in slums of Dhaka, Bangladesh.

PubMed

Naved, Ruchira Tabassum; Mamun, Mahfuz Al; Mourin, Sanjida Akhter; Parvin, Kausar

2018-01-01

Bangladesh reports one of the highest rates of intimate partner violence (IPV) in the world. Despite wide recognition of IPV as an important public health and human rights issue, evidence for IPV prevention is still inadequate. Lack of guidance on effective IPV prevention in Bangladesh resulted in targeting only women in most of the programmes. This paper assesses impact of SAFE, a 20-month intervention (March 2012 to October 2013) in slums of Dhaka on IPV and tests effectiveness of female only groups vs. no groups; and female + male groups vs. female only groups on IPV in the community using a three-arm cluster randomized controlled trial. SAFE's core activities included interactive group sessions, community mobilisation, and services. The last two activities were common across arms. Regression analyses (female survey: baseline n = 2,666; endline n = 2,670) showed no effect of SAFE on IPV against women aged 15-29. However, sub-group analyses demonstrated 21% risk reduction of physical IPV against adolescent girls aged 15-19 in the female + male group intervention arm. A consistent reduction in sexual violence was observed in both female and female + male arms for both groups of women, but the results were not statistically significant. The findings emphasise the importance of combining male and female interventions for reducing physical IPV against adolescent girls. Implications for future research have been discussed.

Virtual patients in the acquisition of clinical reasoning skills: does presentation mode matter? A quasi-randomized controlled trial.

PubMed

Schubach, Fabian; Goos, Matthias; Fabry, Götz; Vach, Werner; Boeker, Martin

2017-09-15

The objective of this study is to compare two different instructional methods in the curricular use of computerized virtual patients in undergraduate medical education. We aim to investigate whether using many short and focused cases - the key feature principle - is more effective for the learning of clinical reasoning skills than using few long and systematic cases. We conducted a quasi-randomized, non-blinded, controlled parallel-group intervention trial in a large medical school in Southwestern Germany. During two seminar sessions, fourth- and fifth-year medical students (n = 56) worked on the differential diagnosis of the acute abdomen. The educational tool - virtual patients - was the same, but the instructional method differed: In one trial arm, students worked on multiple short cases, with the instruction being focused only on important elements ("key feature arm", n = 30). In the other trial arm, students worked on few long cases, with the instruction being comprehensive and systematic ("systematic arm", n = 26). The overall training time was the same in both arms. The students' clinical reasoning capacity was measured by a specifically developed instrument, a script concordance test. Their motivation and the perceived effectiveness of the instruction were assessed using a structured evaluation questionnaire. Upon completion of the script concordance test with a reference score of 80 points and a standard deviation of 5 for experts, students in the key feature arm attained a mean of 57.4 points (95% confidence interval: 50.9-63.9), and in the systematic arm, 62.7 points (57.2-68.2), with Cohen's d at 0.337. The difference is statistically non-significant (p = 0.214). In the evaluation survey, students in the key feature arm indicated that they experienced more time pressure and perceived the material as more difficult. In this study powered for a medium effect, we could not provide empirical evidence for the hypothesis that a key feature-based instruction on multiple short cases is superior to a systematic instruction on few long cases in the curricular implementation of virtual patients. The results of the evaluation survey suggest that learners should be given enough time to work through case examples, and that caution should be taken to prevent cognitive overload.

Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects.

PubMed

Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

2017-01-01

An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention) studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called "cluster randomization"). Compared with studies with individual randomization, studies with cluster randomization normally require (significantly) larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies. Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies.

Hombre Seguro (Safe Men): a sexual risk reduction intervention for male clients of female sex workers

PubMed Central

2014-01-01

Background Male clients of female sex workers (FSWs) are at risk of HIV and other sexually transmitted infections (STIs). We conducted a two-arm randomized controlled trial to test the efficacy of a sexual risk reduction intervention for male clients of FSWs in Tijuana, Mexico. Methods/Design Male clients of FSWs who were at least 18, were HIV-negative at baseline, and reported recent unprotected sex with FSWs were randomized to the Hombre Seguro sexual risk reduction intervention, or a time-attention didactic control condition. Each condition lasted approximately one hour. Participants underwent interviewer-administered surveys and testing for HIV and other STIs at baseline, and at 4, 8, and 12 month follow-ups. Combined HIV/STI incidence and unprotected vaginal and anal sex acts with FSWs were the primary outcomes. Discussion A total of 400 participants were randomized to one of the two conditions. Analyses indicated that randomization was successful; there were no significant differences between the participants in the two conditions at baseline. Average follow-up was 84% across both conditions. This is the first study to test the efficacy of a sexual risk reduction intervention for male clients of FSWs using the rigor of a randomized controlled trial. Trial registration NCT01280838, Date of registration: January 19, 2011. PMID:24885949

Enhanced invitation methods to increase uptake of NHS health checks: study protocol for a randomized controlled trial.

PubMed

Forster, Alice S; Burgess, Caroline; McDermott, Lisa; Wright, Alison J; Dodhia, Hiten; Conner, Mark; Miller, Jane; Rudisill, Caroline; Cornelius, Victoria; Gulliford, Martin C

2014-08-30

NHS Health Checks is a new program for primary prevention of heart disease, stroke, diabetes, chronic kidney disease, and vascular dementia in adults aged 40 to 74 years in England. Individuals without existing cardiovascular disease or diabetes are invited for a Health Check every 5 years. Uptake among those invited is lower than anticipated. The project is a three-arm randomized controlled trial to test the hypothesis that enhanced invitation methods, using the Question-Behaviour Effect (QBE), will increase uptake of NHS Health Checks compared with a standard invitation. Participants comprise individuals eligible for an NHS Health Check registered in two London boroughs. Participants are randomized into one of three arms. Group A receives the standard NHS Health Check invitation letter, information sheet, and reminder letter at 12 weeks for nonattenders. Group B receives a QBE questionnaire 1 week before receiving the standard invitation, information sheet, and reminder letter where appropriate. Group C is the same as Group B, but participants are offered a £5 retail voucher if they return the questionnaire. Participants are randomized in equal proportions, stratified by general practice. The primary outcome is uptake of NHS Health Checks 6 months after invitation from electronic health records. We will estimate the incremental health service cost per additional completed Health Check for trial groups B and C versus trial arm A, as well as evaluating the impact of the QBE questionnaire, and questionnaire plus voucher, on the socioeconomic inequality in uptake of Health Checks.The trial includes a nested comparison of two methods for implementing allocation, one implemented manually at general practices and the other implemented automatically through the information systems used to generate invitations for the Health Check. The research will provide evidence on whether asking individuals to complete a preliminary questionnaire, by using the QBE, is effective in increasing uptake of Health Checks and whether an incentive alters questionnaire return rates as well as uptake of Health Checks. The trial interventions can be readily translated into routine service delivery if they are shown to be cost-effective. Current Controlled Trials ISRCTN42856343. Date registered: 21.03.2013.

Web-based Social Media Intervention to Increase Vaccine Acceptance: A Randomized Controlled Trial.

PubMed

Glanz, Jason M; Wagner, Nicole M; Narwaney, Komal J; Kraus, Courtney R; Shoup, Jo Ann; Xu, Stanley; O'Leary, Sean T; Omer, Saad B; Gleason, Kathy S; Daley, Matthew F

2017-12-01

Interventions to address vaccine hesitancy and increase vaccine acceptance are needed. This study sought to determine if a Web-based, social media intervention increases early childhood immunization. A 3-arm, randomized controlled trial was conducted in Colorado from September 2013 to July 2016. Participants were pregnant women, randomly assigned (3:2:1) to a Web site with vaccine information and interactive social media components (VSM), a Web site with vaccine information (VI), or usual care (UC). Vaccination was assessed in infants of participants from birth to age 200 days. The primary outcome was days undervaccinated, measured as a continuous and dichotomous variable. Infants of 888 participants were managed for 200 days. By using a nonparametric rank-based analysis, mean ranks for days undervaccinated were significantly lower in the VSM arm versus UC ( P = .02) but not statistically different between the VI and UC ( P = .08) or between VSM and VI arms ( P = .63). The proportions of infants up-to-date at age 200 days were 92.5, 91.3, and 86.6 in the VSM, VI, and UC arms, respectively. Infants in the VSM arm were more likely to be up-to-date than infants in the UC arm (odds ratio [OR] = 1.92; 95% confidence interval [CI], 1.07-3.47). Up-to-date status was not statistically different between VI and UC arms (OR = 1.62; 95% CI, 0.87-3.00) or between the VSM and VI arms (OR = 1.19, 95% CI, 0.70-2.03). Providing Web-based vaccine information with social media applications during pregnancy can positively influence parental vaccine behaviors. Copyright © 2017 by the American Academy of Pediatrics.

Using the MEDiPORT humanoid robot to reduce procedural pain and distress in children with cancer: A pilot randomized controlled trial.

PubMed

Jibb, Lindsay A; Birnie, Kathryn A; Nathan, Paul C; Beran, Tanya N; Hum, Vanessa; Victor, J Charles; Stinson, Jennifer N

2018-06-12

Subcutaneous port needle insertions are painful and distressing for children with cancer. The interactive MEDiPORT robot has been programmed to implement psychological strategies to decrease pain and distress during this procedure. This study assessed the feasibility of a future MEDiPORT trial. The secondary aim was to determine the preliminary effectiveness of MEDiPORT in reducing child pain and distress during subcutaneous port accesses. This 5-month pilot randomized controlled trial used a web-based service to randomize 4- to 9-year-olds with cancer to the MEDiPORT cognitive-behavioral arm (robot using evidence-based cognitive-behavioral interventions) or active distraction arm (robot dancing and singing) while a nurse conducted a needle insertion. We assessed accrual and retention; technical difficulties; outcome measure completion by children, parents, and nurses; time taken to complete the study and clinical procedure; and child-, parent-, and nurse-rated acceptability. Descriptive analyses, with exploratory inferential testing of child pain and distress data, were used to address study aims. Forty children were randomized across study arms. Most (85%) eligible children participated and no children withdrew. Technical difficulties were more common in the cognitive-behavioral arm. Completion times for the study and needle insertion were acceptable and >96% of outcome measure items were completed. Overall, MEDiPORT and the study were acceptable to participants. There was no difference in pain between arms, but distress during the procedure was less pronounced in the active distraction arm. The MEDiPORT study appears feasible to implement as an adequately-powered effectiveness-assessing trial following modifications to the intervention and study protocol. ClinicalTrials.gov NCT02611739. © 2018 Wiley Periodicals, Inc.

A cluster randomized controlled trial to reduce childhood diarrhea using hollow fiber water filter and/or hygiene-sanitation educational interventions.

PubMed

Lindquist, Erik D; George, C M; Perin, Jamie; Neiswender de Calani, Karen J; Norman, W Ray; Davis, Thomas P; Perry, Henry

2014-07-01

Safe domestic potable water supplies are urgently needed to reduce childhood diarrheal disease. In periurban neighborhoods in Cochabamba, Bolivia, we conducted a cluster randomized controlled trial to evaluate the efficacy of a household-level hollow fiber filter and/or behavior change communication (BCC) on water, sanitation, and hygiene (WASH) to reduce the diarrheal disease in children less than 5 years of age. In total, 952 households were followed for a period of 12 weeks post-distribution of the study interventions. Households using Sawyer PointONE filters had significantly less diarrheal disease compared with the control arm during the intervention period, which was shown by diarrheal prevalence ratios of 0.21 (95% confidence interval [95% CI] = 0.15-0.30) for the filter arm and 0.27 (95% CI = 0.22-0.34) for the filter and WASH BCC arm. A non-significant reduction in diarrhea prevalence was reported in the WASH BCC study arm households (0.71, 95% CI = 0.59-0.86). © The American Society of Tropical Medicine and Hygiene.

A Cluster Randomized Controlled Trial to Reduce Childhood Diarrhea Using Hollow Fiber Water Filter and/or Hygiene–Sanitation Educational Interventions

PubMed Central

Lindquist, Erik D.; George, C. M.; Perin, Jamie; Neiswender de Calani, Karen J.; Norman, W. Ray; Davis, Thomas P.; Perry, Henry

2014-01-01

Safe domestic potable water supplies are urgently needed to reduce childhood diarrheal disease. In periurban neighborhoods in Cochabamba, Bolivia, we conducted a cluster randomized controlled trial to evaluate the efficacy of a household-level hollow fiber filter and/or behavior change communication (BCC) on water, sanitation, and hygiene (WASH) to reduce the diarrheal disease in children less than 5 years of age. In total, 952 households were followed for a period of 12 weeks post-distribution of the study interventions. Households using Sawyer PointONE filters had significantly less diarrheal disease compared with the control arm during the intervention period, which was shown by diarrheal prevalence ratios of 0.21 (95% confidence interval [95% CI] = 0.15–0.30) for the filter arm and 0.27 (95% CI = 0.22–0.34) for the filter and WASH BCC arm. A non-significant reduction in diarrhea prevalence was reported in the WASH BCC study arm households (0.71, 95% CI = 0.59–0.86). PMID:24865680

Group versus individual family planning counseling in Ghana: a randomized, noninferiority trial.

PubMed

Schwandt, Hilary M; Creanga, Andreea A; Danso, Kwabena A; Adanu, Richard M K; Agbenyega, Tsiri; Hindin, Michelle J

2013-08-01

Group, rather than individual, family planning counseling has the potential to increase family planning knowledge and use through more efficient use of limited human resources. A randomized, noninferiority study design was utilized to identify whether group family planning counseling is as effective as individual family planning counseling in Ghana. Female gynecology patients were enrolled from two teaching hospitals in Ghana in June and July 2008. Patients were randomized to receive either group or individual family planning counseling. The primary outcome in this study was change in modern contraceptive method knowledge. Changes in family planning use intention before and after the intervention and intended method type were also explored. Comparisons between the two study arms suggest that randomization was successful. The difference in change in modern contraceptive methods known from baseline to follow-up between the two study arms (group-individual), adjusted for study site, was -0.21, (95% confidence interval: -0.53 to 0.12) suggesting no difference between the two arms. Group family planning counseling was as effective as individual family planning counseling in increasing modern contraceptive knowledge among female gynecology patients in Ghana. Copyright © 2013 Elsevier Inc. All rights reserved.

High-Resolution Manometry Improves the Diagnosis of Esophageal Motility Disorders in Patients With Dysphagia: A Randomized Multicenter Study.

PubMed

Roman, Sabine; Huot, Laure; Zerbib, Frank; Bruley des Varannes, Stanislas; Gourcerol, Guillaume; Coffin, Benoit; Ropert, Alain; Roux, Adeline; Mion, François

2016-03-01

High-resolution manometry (HRM) might be superior to conventional manometry (CM) to diagnose esophageal motility disorders. We aimed to compare the diagnosis performed with HRM and CM and confirmed at 6 months in a multicenter randomized trial. Patients with unexplained dysphagia were randomized to undergo either CM or HRM. Motility disorders were diagnosed using the Castell and Spechler classification for CM and the Chicago classification for HRM. Diagnosis confirmation was based on clinical outcome and response to treatment after 6-month follow-up. The initial diagnosis and percentage of confirmed diagnoses were compared between the two arms (CM and HRM). In total, 247 patients were randomized and 245 analyzed: 122 in the CM arm and 123 in the HRM arm. A manometric diagnosis was more frequently initially achieved with HRM than with CM (97% vs. 84%; P<0.01). Achalasia was more frequent in the HRM arm (26% vs. 12% in the CM arm; P<0.01) while normal examinations were more frequent in the CM arm (52% vs. 28% in the HRM arm; P<0.05). After follow-up, the initial diagnosis was confirmed in 89% of patients in the HRM arm vs. 81% in the CM arm (P=0.07). Finally, overall procedure tolerance was better with CM than with HRM (P<0.01). This randomized trial demonstrated an improved diagnostic yield for achalasia with HRM compared with CM. Diagnoses tended to be more frequently confirmed in patients who underwent HRM, suggesting that esophageal motility disorders could be identified earlier with HRM than with CM (ClinicalTrial.gov, NCT01284894).

Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects

PubMed Central

Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

2017-01-01

An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention) studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called “cluster randomization”). Compared with studies with individual randomization, studies with cluster randomization normally require (significantly) larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies. Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies. PMID:28584874

Randomized controlled trial of a video decision support tool for cardiopulmonary resuscitation decision making in advanced cancer.

PubMed

Volandes, Angelo E; Paasche-Orlow, Michael K; Mitchell, Susan L; El-Jawahri, Areej; Davis, Aretha Delight; Barry, Michael J; Hartshorn, Kevan L; Jackson, Vicki Ann; Gillick, Muriel R; Walker-Corkery, Elizabeth S; Chang, Yuchiao; López, Lenny; Kemeny, Margaret; Bulone, Linda; Mann, Eileen; Misra, Sumi; Peachey, Matt; Abbo, Elmer D; Eichler, April F; Epstein, Andrew S; Noy, Ariela; Levin, Tomer T; Temel, Jennifer S

2013-01-20

Decision making regarding cardiopulmonary resuscitation (CPR) is challenging. This study examined the effect of a video decision support tool on CPR preferences among patients with advanced cancer. We performed a randomized controlled trial of 150 patients with advanced cancer from four oncology centers. Participants in the control arm (n = 80) listened to a verbal narrative describing CPR and the likelihood of successful resuscitation. Participants in the intervention arm (n = 70) listened to the identical narrative and viewed a 3-minute video depicting a patient on a ventilator and CPR being performed on a simulated patient. The primary outcome was participants' preference for or against CPR measured immediately after exposure to either modality. Secondary outcomes were participants' knowledge of CPR (score range of 0 to 4, with higher score indicating more knowledge) and comfort with video. The mean age of participants was 62 years (standard deviation, 11 years); 49% were women, 44% were African American or Latino, and 47% had lung or colon cancer. After the verbal narrative, in the control arm, 38 participants (48%) wanted CPR, 41 (51%) wanted no CPR, and one (1%) was uncertain. In contrast, in the intervention arm, 14 participants (20%) wanted CPR, 55 (79%) wanted no CPR, and 1 (1%) was uncertain (unadjusted odds ratio, 3.5; 95% CI, 1.7 to 7.2; P < .001). Mean knowledge scores were higher in the intervention arm than in the control arm (3.3 ± 1.0 v 2.6 ± 1.3, respectively; P < .001), and 65 participants (93%) in the intervention arm were comfortable watching the video. Participants with advanced cancer who viewed a video of CPR were less likely to opt for CPR than those who listened to a verbal narrative.

Ethinylestradiol 20 μg/drospirenone 3 mg in a flexible extended regimen for the management of endometriosis-associated pelvic pain: a randomized controlled trial.

PubMed

Harada, Tasuku; Kosaka, Saori; Elliesen, Joerg; Yasuda, Masanobu; Ito, Makoto; Momoeda, Mikio

2017-11-01

To investigate the efficacy and safety of ethinylestradiol 20 μg/drospirenone 3 mg in a flexible extended regimen (Flexible MIB ) compared with placebo to treat endometriosis-associated pelvic pain (EAPP). A phase 3, randomized, double-blind, placebo-controlled, parallel-group study, consisting of a 24-week double-blind treatment phase followed by a 28-week open-label extension phase with an unblinded reference arm. Thirty-two centers. A total of 312 patients with endometriosis. Patients were randomized to Flexible MIB , placebo, or dienogest. The Flexible MIB and placebo arms received 1 tablet per day continuously for 120 days, with a 4-day tablet-free interval either after 120 days or after ≥3 consecutive days of spotting and/or bleeding on days 25-120. After 24 weeks, placebo recipients were changed to Flexible MIB . Patients randomized to dienogest received 2 mg/d for 52 weeks in an unblinded reference arm. Absolute change in the most severe EAPP based on visual analog scale scores from the baseline observation phase to the end of the double-blind treatment phase. Compared with placebo, Flexible MIB significantly reduced the most severe EAPP (mean difference in visual analog scale score: -26.3 mm). Flexible MIB also improved other endometriosis-associated pain and gynecologic findings and reduced the size of endometriomas. Flexible MIB improved EAPP and was well tolerated, suggesting it may be a new alternative for managing endometriosis. NCT01697111. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

A Double-Blind Placebo-Controlled Randomized Clinical Trial With Magnesium Oxide to Reduce Intrafraction Prostate Motion for Prostate Cancer Radiotherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lips, Irene M., E-mail: i.m.lips@umcutrecht.nl; Gils, Carla H. van; Kotte, Alexis N.T.J.

2012-06-01

Purpose: To investigate whether magnesium oxide during external-beam radiotherapy for prostate cancer reduces intrafraction prostate motion in a double-blind, placebo-controlled randomized trial. Methods and Materials: At the Department of Radiotherapy, prostate cancer patients scheduled for intensity-modulated radiotherapy (77 Gy in 35 fractions) using fiducial marker-based position verification were randomly assigned to receive magnesium oxide (500 mg twice a day) or placebo during radiotherapy. The primary outcome was the proportion of patients with clinically relevant intrafraction prostate motion, defined as the proportion of patients who demonstrated in {>=}50% of the fractions an intrafraction motion outside a range of 2 mm. Secondarymore » outcome measures included quality of life and acute toxicity. Results: In total, 46 patients per treatment arm were enrolled. The primary endpoint did not show a statistically significant difference between the treatment arms with a percentage of patients with clinically relevant intrafraction motion of 83% in the magnesium oxide arm as compared with 80% in the placebo arm (p = 1.00). Concerning the secondary endpoints, exploratory analyses demonstrated a trend towards worsened quality of life and slightly more toxicity in the magnesium oxide arm than in the placebo arm; however, these differences were not statistically significant. Conclusions: Magnesium oxide is not effective in reducing the intrafraction prostate motion during external-beam radiotherapy, and therefore there is no indication to use it in clinical practice for this purpose.« less

Oral language supports early literacy: a pilot cluster randomized trial in disadvantaged schools.

PubMed

Snow, Pamela C; Eadie, Patricia A; Connell, Judy; Dalheim, Brenda; McCusker, Hugh J; Munro, John K

2014-10-01

This study examined the impact of teacher professional development aimed at improving the capacity of primary teachers in disadvantaged schools to strengthen children's expressive and receptive oral language skills and early literacy success in the first 2 years of school. Fourteen low-SES schools in Victoria, Australia were randomly allocated to a research (n = 8) or control arm (n = 6), resulting in an initial sample of 1254 students, (n = 602 in research arm and n = 652 in control arm). The intervention comprised 6 days of teacher and principal professional development (delivered by language and literacy experts), school-based continuing contact with the research team and completion by one staff member of each research school of a postgraduate unit on early language and literacy. Schools in the control arm received standard teaching according to state auspiced curriculum guidelines. Full data were available on 979 students at follow-up (time 2). Students in the research arm performed significantly better on Test of Language Development: Primary (Fourth Edition) sub-tests (p ≤ .002) and the Reading Progress Test (F = 10.4(1); p = .001) than students in the control arm at time 2. Narrative scores were not significantly different at time 2, although students in research schools showed greater gains. Findings provide "proof of concept" for this approach, and are discussed with respect to implications for teacher professional development and pre-service education concerning the psycholinguistic competencies that underpin the transition to literacy.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cooper, Benjamin T.; Formenti-Ujlaki, George F.; Li, Xiaochun

Purpose: To report the results of a prospective randomized trial comparing a daily versus weekly boost to the tumor cavity during the course of accelerated radiation to the breast with patients in the prone position. Methods and Materials: From 2009 to 2012, 400 patients with stage 0 to II breast cancer who had undergone segmental mastectomy participated in an institutional review board–approved trial testing prone breast radiation therapy to 40.5 Gy in 15 fractions 5 d/wk to the whole breast, after randomization to a concomitant daily boost to the tumor bed of 0.5 Gy, or a weekly boost of 2 Gy, on Friday.more » The present noninferiority trial tested the primary hypothesis that a weekly boost produced no more acute toxicity than did a daily boost. The recurrence-free survival was estimated for both treatment arms using the Kaplan-Meier method; the relative risk of recurrence or death was estimated, and the 2 arms were compared using the log-rank test. Results: At a median follow-up period of 45 months, no deaths related to breast cancer had occurred. The weekly boost regimen produced no more grade ≥2 acute toxicity than did the daily boost regimen (8.1% vs 10.4%; noninferiority Z = −2.52; P=.006). No statistically significant difference was found in the cumulative incidence of long-term fibrosis or telangiectasia of grade ≥2 between the 2 arms (log-rank P=.923). Two local and two distant recurrences developed in the daily treatment arm and three local and one distant developed in the weekly arm. The 4-year recurrence-free survival rate was not different between the 2 treatment arms (98% for both arms). Conclusions: A tumor bed boost delivered either daily or weekly was tolerated similarly during accelerated prone breast radiation therapy, with excellent control of disease and comparable cosmetic results.« less

Utility and Cost-Effectiveness of Motivational Messaging to Increase Survey Response in Physicians: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Chan, Randolph C. H.; Mak, Winnie W. S.; Pang, Ingrid H. Y.; Wong, Samuel Y. S.; Tang, Wai Kwong; Lau, Joseph T. F.; Woo, Jean; Lee, Diana T. F.; Cheung, Fanny M.

2018-01-01

The present study examined whether, when, and how motivational messaging can boost the response rate of postal surveys for physicians based on Higgin's regulatory focus theory, accounting for its cost-effectiveness. A three-arm, blinded, randomized controlled design was used. A total of 3,270 doctors were randomly selected from the registration…

Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes.

PubMed

Feldblum, Paul J; Zulu, Robert; Linyama, David; Long, Sarah; Nonde, Thikazi Jere; Lai, Jaim Jou; Kashitala, Joshua; Veena, Valentine; Kasonde, Prisca

2016-06-01

To assess the safety, effectiveness, and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia. We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing. Four hundred and ninety-six men comprised the analysis population, with 255 in the Standard Sizing arm and 241 in the Modified Sizing arm. Three men experienced a moderate or severe AEs (0.6%), including 2 in the Standard Sizing arm (0.8%) and 1 in the Modified Sizing arm (0.4%). 73.2% of participants were completely healed at the scheduled day 42 healing check visit, with similar percentages across study arms. Virtually all (99.6%) men, regardless of study arm, stated that they were very satisfied or satisfied with the appearance of their circumcised penis, and 98.6% stated that they would recommend ShangRing circumcision to family/friends. The moderate/severe AE rate was low and similar in the 2 study arms, suggesting that provision of one-half the number of adult device sizes is sufficient for safe service delivery. Effectiveness, time to healing, and acceptability were similar in the study arms. The simplicity of the ShangRing technique, and its relative speed, could facilitate VMMC program goals. In addition, sufficiency of fewer device sizes would simplify logistics and inventory.

Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia

PubMed Central

Macciò, Antonio; Madeddu, Clelia; Serpe, Roberto; Massa, Elena; Dessì, Mariele; Panzone, Filomena; Contu, Paolo

2010-01-01

Purpose. A phase III, randomized study was carried out to establish the most effective and safest treatment to improve the primary endpoints of cancer cachexia—lean body mass (LBM), resting energy expenditure (REE), and fatigue—and relevant secondary endpoints: appetite, quality of life, grip strength, Glasgow Prognostic Score (GPS) and proinflammatory cytokines. Patients and Methods. Three hundred thirty-two assessable patients with cancer-related anorexia/cachexia syndrome were randomly assigned to one of five treatment arms: arm 1, medroxyprogesterone (500 mg/day) or megestrol acetate (320 mg/day); arm 2, oral supplementation with eicosapentaenoic acid; arm 3, L-carnitine (4 g/day); arm 4, thalidomide (200 mg/day); and arm 5, a combination of the above. Treatment duration was 4 months. Results. Analysis of variance showed a significant difference between treatment arms. A post hoc analysis showed the superiority of arm 5 over the others for all primary endpoints. An analysis of changes from baseline showed that LBM (by dual-energy X-ray absorptiometry and by L3 computed tomography) significantly increased in arm 5. REE decreased significantly and fatigue improved significantly in arm 5. Appetite increased significantly in arm 5; interleukin (IL)-6 decreased significantly in arm 5 and arm 4; GPS and Eastern Cooperative Oncology Group performance status (ECOG PS) score decreased significantly in arm 5, arm 4, and arm 3. Toxicity was quite negligible, and was comparable between arms. Conclusion. The most effective treatment in terms of all three primary efficacy endpoints and the secondary endpoints appetite, IL-6, GPS, and ECOG PS score was the combination regimen that included all selected agents. PMID:20156909

The effectiveness of a web-based brief alcohol intervention in reducing heavy drinking among adolescents aged 15 to 20 years with a low educational background: study protocol for a randomized controlled trial.

PubMed

Voogt, Carmen V; Poelen, Evelien A P; Lemmers, Lex A C J; Engels, Rutger C M E

2012-06-15

The serious negative health consequences of heavy drinking among adolescents is cause for concern, especially among adolescents aged 15 to 20 years with a low educational background. In the Netherlands, there is a lack of alcohol prevention programs directed to the drinking patterns of this specific target group. The study described in this protocol will test the effectiveness of a web-based brief alcohol intervention that aims to reduce alcohol use among heavy drinking adolescents aged 15 to 20 years with a low educational background. The effectiveness of the What Do You Drink (WDYD) web-based brief alcohol intervention will be tested among 750 low-educated, heavy drinking adolescents. It will use a two-arm parallel group cluster randomized controlled trial. Classes of adolescents from educational institutions will be randomly assigned to either the experimental (n = 375: web-based brief alcohol intervention) or control condition (n = 375: no intervention). Primary outcomes measures will be: 1) the percentage of participants who drink within the normative limits of the Dutch National Health Council for low-risk drinking, 2) reductions in mean weekly alcohol consumption, and 3) frequency of binge drinking. The secondary outcome measures include the alcohol-related cognitions, attitudes, self-efficacy, and subjective norms, which will be measured at baseline and at one and six months after the intervention. This study protocol presents the study design of a two-arm parallel-group randomized controlled trial to evaluate the effectiveness of the WDYD web-based brief alcohol intervention. We hypothesized a reduction in mean weekly alcohol consumption and in the frequency of binge drinking in the experimental condition, resulting from the web-based brief alcohol intervention, compared to the control condition. Netherlands Trial Register NTR2971.

Efficacy of a new sealant to prevent white spot lesions during fixed orthodontic treatment : A 12-month, single-center, randomized controlled clinical trial.

PubMed

Hammad, Shaza M; Knösel, Michael

2016-11-01

White spot lesions (WSLs) are an undesirable side effect of fixed orthodontic appliance therapy and are reported to occur in 2-96 % of orthodontic patients. In this study, the efficacy of a new sealant to prevent WSLs during fixed orthodontic treatment was compared to a control group that did not receive sealant. For this 2-arm parallel-group randomized trial, 50 subjects aged 12-18 years (mean age 14.57 ± 2.04 years) were recruited from the orthodontics department at Mansoura University, Egypt. Eligibility criteria were no restorations, no active WSLs or caries, and adequate oral hygiene. Subjects were randomized in a 1:1 ratio to one of the two arms prior to undergoing fixed orthodontic treatment, namely a single application of SeLECT Defense™ sealant during the bracketing appointment or no sealant (control arm). Instructions and dentifrices for local home fluoridation regimen were identical in both groups. Oral hygiene was assessed using the Approximal Plaque Index (API) at specified time intervals. Dental photographs were taken for blinded WSLs assessment; inter- and intra-operator error were also calculated. Categorical data were tested using the χ 2 test, and a logistic regression model was adopted to detect associations between decalcification (WSLs), sealant application, and oral hygiene status. Only excellent or good oral hygiene were independent prognostic factors for preventing severe WSLs (p = 0.035). No significant effect on caries incidence was observed for the sealant. In combination with adequate oral hygiene SeLECT Defense™ helps to reduced the frequency of WSLs. However, the sealat showed no significant effect as sole preventive strategy.

Effect of two contrasting interventions on upper limb chronic pain and disability: a randomized controlled trial.

PubMed

Sundstrup, Emil; Jakobsen, Markus D; Andersen, Christoffer H; Jay, Kenneth; Persson, Roger; Aagaard, Per; Andersen, Lars L

2014-01-01

Chronic pain and disability of the arm, shoulder, and hand severely affect labor market participation. Ergonomic training and education is the default strategy to reduce physical exposure and thereby prevent aggravation of pain. An alternative strategy could be to increase physical capacity of the worker by physical conditioning. To investigate the effect of 2 contrasting interventions, conventional ergonomic training (usual care) versus resistance training, on pain and disability in individuals with upper limb chronic pain exposed to highly repetitive and forceful manual work. Examiner-blinded, parallel-group randomized controlled trial with allocation concealment. Slaughterhouses located in Denmark, Europe. Sixty-six adults with chronic pain in the shoulder, elbow/forearm, or hand/wrist and work disability were randomly allocated to 10 weeks of specific resistance training for the shoulder, arm, and hand muscles for 3 x 10 minutes per week, or ergonomic training and education (usual care control group). Pain intensity (average of shoulder, arm, and hand, scale 0 - 10) was the primary outcome, and disability (Work module of DASH questionnaire) as well as isometric shoulder and wrist muscle strength were secondary outcomes. Pain intensity, disability, and muscle strength improved more following resistance training than usual care (P < 0.001, P = 0.05, P <0.0001, respectively [corrected]). Pain intensity decreased by 1.5 points (95% confidence interval -2.0 to -0.9) following resistance training compared with usual care, corresponding to an effect size of 0.91 (Cohen's d). Blinding of participants is not possible in behavioral interventions. However, at baseline outcome expectations of the 2 interventions were similar. Resistance training at the workplace results in clinical relevant improvements in pain, disability, and muscle strength in adults with upper limb chronic pain exposed to highly repetitive and forceful manual work. NCT01671267.

Protocol of the impact of alternative social assistance disbursement on drug-related harm (TASA) study: a randomized controlled trial to evaluate changes to payment timing and frequency among people who use illicit drugs.

PubMed

Richardson, Lindsey; Laing, Allison; Milloy, M-J; Maynard, Russ; Nosyk, Bohdan; Marshall, Brandon; Grafstein, Eric; Daly, Patricia; Wood, Evan; Montaner, Julio; Kerr, Thomas

2016-07-29

Government social assistance payments seek to alleviate poverty and address survival needs, but their monthly disbursement may cue increases in illicit drug use. This cue may be magnified when assistance is disbursed simultaneously across the population. Synchronized payments have been linked to escalations in drug use and unintended but severe drug-related harms, including overdose, as well as spikes in demand for health, social, financial and police services. The TASA study examines whether changing payment timing and frequency can mitigate drug-related harm associated with synchronized social assistance disbursement. The study is a parallel arm multi-group randomized controlled trial in which 273 participants are randomly allocated for six assistance cycles to a control or one of two intervention arms on a 1:1:1 basis. Intervention arm participants receive their payments: (1) monthly; or (2) semi-monthly, in each case on days that are not during the week when cheques are normally issued. The study partners with a community-based credit union that has developed a system to vary social assistance payment timing. The primary outcome is a 40 % increase in drug use during the 3 days beginning with cheque issue day compared to other days of the month. Bi-weekly follow-up interviews collect participant information on this and secondary outcomes of interest, including drug-related harm (e.g. non-fatal overdose), exposure to violence and health service utilization. Self-reported data will be supplemented with participant information from health, financial, police and government administrative databases. A longitudinal, nested, qualitative parallel process evaluation explores participant experiences, and a cost-effectiveness evaluation of different disbursement scenarios will be undertaken. Outcomes will be compared between control and intervention arms to identify the impacts of alternative disbursement schedules on drug-related harm resulting from synchronized income assistance. This structural RCT benefits from strong community partnerships, highly detailed outcome measurement, robust methods of randomization and data triangulation with third party administrative databases. The study will provide evidence regarding the potential importance of social assistance program design as a lever to support population health outcomes and service provision for populations with a high prevalence of substance use. NCT02457949 Registered 13 May 2015.

The BATTLE-2 Study: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer.

PubMed

Papadimitrakopoulou, Vassiliki; Lee, J Jack; Wistuba, Ignacio I; Tsao, Anne S; Fossella, Frank V; Kalhor, Neda; Gupta, Sanjay; Byers, Lauren Averett; Izzo, Julie G; Gettinger, Scott N; Goldberg, Sarah B; Tang, Ximing; Miller, Vincent A; Skoulidis, Ferdinandos; Gibbons, Don L; Shen, Li; Wei, Caimiao; Diao, Lixia; Peng, S Andrew; Wang, Jing; Tam, Alda L; Coombes, Kevin R; Koo, Ja Seok; Mauro, David J; Rubin, Eric H; Heymach, John V; Hong, Waun Ki; Herbst, Roy S

2016-08-01

By applying the principles of real-time biopsy, biomarker-based, adaptively randomized studies in non-small-cell lung cancer (NSCLC) established by the Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) trial, we conducted BATTLE-2 (BATTLE-2 Program: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer), an umbrella study to evaluate the effects of targeted therapies focusing on KRAS-mutated cancers. Patients with advanced NSCLC (excluding sensitizing EGFR mutations and ALK gene fusions) refractory to more than one prior therapy were randomly assigned, stratified by KRAS status, to four arms: (1) erlotinib, (2) erlotinib plus MK-2206, (3) MK-2206 plus AZD6244, or (4) sorafenib. Tumor gene expression profiling-targeted next-generation sequencing was performed to evaluate predictive and prognostic biomarkers. Two hundred patients, 27% with KRAS-mutated (KRAS mut+) tumors, were adaptively randomly assigned to erlotinib (n = 22), erlotinib plus MK-2206 (n = 42), MK-2206 plus AZD6244 (n = 75), or sorafenib (n = 61). In all, 186 patients were evaluable, and the primary end point of an 8-week disease control rate (DCR) was 48% (arm 1, 32%; arm 2, 50%; arm 3, 53%; and arm 4, 46%). For KRAS mut+ patients, DCR was 20%, 25%, 62%, and 44% whereas for KRAS wild-type patients, DCR was 36%, 57%, 49%, and 47% for arms 1, 2, 3, and 4, respectively. Median progression-free survival was 2.0 months, not different by KRAS status, 1.8 months for arm 1, and 2.5 months for arms 2 versus arms 3 and 4 in KRAS mut+ patients (P = .04). Median overall survival was 6.5 months, 9.0 and 5.1 months for arms 1 and 2 versus arms 3 and 4 in KRAS wild-type patients (P = .03). Median overall survival was 7.5 months in mesenchymal versus 5 months in epithelial tumors (P = .02). Despite improved progression-free survival on therapy that did not contain erlotinib for KRAS mut+ patients and improved prognosis for mesenchymal tumors, better biomarker-driven treatment strategies are still needed. © 2016 by American Society of Clinical Oncology.

The BATTLE-2 Study: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer

PubMed Central

Lee, J. Jack; Wistuba, Ignacio I.; Tsao, Anne S.; Fossella, Frank V.; Kalhor, Neda; Gupta, Sanjay; Byers, Lauren Averett; Izzo, Julie G.; Gettinger, Scott N.; Goldberg, Sarah B.; Tang, Ximing; Miller, Vincent A.; Skoulidis, Ferdinandos; Gibbons, Don L.; Shen, Li; Wei, Caimiao; Diao, Lixia; Peng, S. Andrew; Wang, Jing; Tam, Alda L.; Coombes, Kevin R.; Koo, Ja Seok; Mauro, David J.; Rubin, Eric H.; Heymach, John V.; Hong, Waun Ki; Herbst, Roy S.

2016-01-01

Purpose By applying the principles of real-time biopsy, biomarker-based, adaptively randomized studies in non–small-cell lung cancer (NSCLC) established by the Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) trial, we conducted BATTLE-2 (BATTLE-2 Program: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer), an umbrella study to evaluate the effects of targeted therapies focusing on KRAS-mutated cancers. Patients and Methods Patients with advanced NSCLC (excluding sensitizing EGFR mutations and ALK gene fusions) refractory to more than one prior therapy were randomly assigned, stratified by KRAS status, to four arms: (1) erlotinib, (2) erlotinib plus MK-2206, (3) MK-2206 plus AZD6244, or (4) sorafenib. Tumor gene expression profiling–targeted next-generation sequencing was performed to evaluate predictive and prognostic biomarkers. Results Two hundred patients, 27% with KRAS-mutated (KRAS mut+) tumors, were adaptively randomly assigned to erlotinib (n = 22), erlotinib plus MK-2206 (n = 42), MK-2206 plus AZD6244 (n = 75), or sorafenib (n = 61). In all, 186 patients were evaluable, and the primary end point of an 8-week disease control rate (DCR) was 48% (arm 1, 32%; arm 2, 50%; arm 3, 53%; and arm 4, 46%). For KRAS mut+ patients, DCR was 20%, 25%, 62%, and 44% whereas for KRAS wild-type patients, DCR was 36%, 57%, 49%, and 47% for arms 1, 2, 3, and 4, respectively. Median progression-free survival was 2.0 months, not different by KRAS status, 1.8 months for arm 1, and 2.5 months for arms 2 versus arms 3 and 4 in KRAS mut+ patients (P = .04). Median overall survival was 6.5 months, 9.0 and 5.1 months for arms 1 and 2 versus arms 3 and 4 in KRAS wild-type patients (P = .03). Median overall survival was 7.5 months in mesenchymal versus 5 months in epithelial tumors (P = .02). Conclusion Despite improved progression-free survival on therapy that did not contain erlotinib for KRAS mut+ patients and improved prognosis for mesenchymal tumors, better biomarker-driven treatment strategies are still needed. PMID:27480147

Treatment of Vitamin D Insufficiency in Children and Adolescents with Inflammatory Bowel Disease: A Randomized Clinical Trial Comparing Three Regimens

PubMed Central

Mitchell, Paul D.; Jiang, Hongyu; Kassiff, Sivan; Filip-Dhima, Rajna; DiFabio, Diane; Quinn, Nicolle; Lawton, Rachel C.; Varvaris, Mark; Van Straaten, Stephanie; Gordon, Catherine M.

2012-01-01

Context: Vitamin D insufficiency [serum 25-hydroxyvitamin D (25OHD) concentration less than 20 ng/ml] is prevalent among children with inflammatory bowel disease (IBD), and its treatment has not been studied. Objective: The aim of this study was to compare the efficacy and safety of three vitamin D repletion regimens. Design and Setting: We conducted a randomized, controlled clinical trial from November 2007 to June 2010 at the Clinical and Translational Study Unit of Children's Hospital Boston. The study was not blinded to participants and investigators. Patients: Eligibility criteria included diagnosis of IBD, age 5–21, and serum 25OHD concentration below 20 ng/ml. Seventy-one patients enrolled, 61 completed the trial, and two withdrew due to adverse events. Intervention: Patients received orally for 6 wk: vitamin D2, 2,000 IU daily (arm A, control); vitamin D3, 2,000 IU daily (arm B); vitamin D2, 50,000 IU weekly (arm C); and an age-appropriate calcium supplement. Main Outcome Measure: We measured the change in serum 25OHD concentration (Δ25OHD) (ng/ml). Secondary outcomes included change in serum intact PTH concentration (ΔPTH) (pg/ml) and the adverse event occurrence rate. Results: After 6 wk, Δ25OHD ± se was: 9.3 ± 1.8 (arm A); 16.4 ± 2.0 (arm B); 25.4 ± 2.5 (arm C); P (A vs. C) = 0.0004; P (A vs. B) = 0.03. ΔPTH ± se was −5.6 ± 5.5 (arm A); −0.1 ± 4.2 (arm B); −4.4 ± 3.9 (arm C); P = 0.57. No participant experienced hypercalcemia or hyperphosphatemia, and the prevalence of hypercalciuria did not differ among arms at follow-up. Conclusions: Oral doses of 2,000 IU vitamin D3 daily and 50,000 IU vitamin D2 weekly for 6 wk are superior to 2,000 IU vitamin D2 daily for 6 wk in raising serum 25OHD concentration and are well-tolerated among children and adolescents with IBD. The change in serum PTH concentration did not differ among arms. PMID:22456619

Evaluation of Two Interventions to Reduce Aggressive and Antisocial Behavior in First and Second Graders in a Resource-Poor Setting

ERIC Educational Resources Information Center

Klevens, Joanne; Martinez, Jose William; Le, Brenda; Rojas, Carlos; Duque, Adriana; Tovar, Rafael

2009-01-01

We conducted a three-arm cluster randomized controlled trial (n = 2491) to evaluate a teacher delivered intervention to reduce aggressive and antisocial behavior and increase prosocial behavior in the classroom. A second aim of this trial was to establish whether combining this intervention with an intervention for parents was better than the…

A two-arm cluster randomized control trial to determine the effectiveness of a pressure ulcer prevention bundle for critically ill patients.

PubMed

Tayyib, Nahla; Coyer, Fiona; Lewis, Peter A

2015-05-01

This study tested the effectiveness of a pressure ulcer (PU) prevention bundle in reducing the incidence of PUs in critically ill patients in two Saudi intensive care units (ICUs). A two-arm cluster randomized experimental control trial. Participants in the intervention group received the PU prevention bundle, while the control group received standard skin care as per the local ICU policies. Data collected included demographic variables (age, diagnosis, comorbidities, admission trajectory, length of stay) and clinical variables (Braden Scale score, severity of organ function score, mechanical ventilation, PU presence, and staging). All patients were followed every two days from admission through to discharge, death, or up to a maximum of 28 days. Data were analyzed with descriptive correlation statistics, Kaplan-Meier survival analysis, and Poisson regression. The total number of participants recruited was 140: 70 control participants (with a total of 728 days of observation) and 70 intervention participants (784 days of observation). PU cumulative incidence was significantly lower in the intervention group (7.14%) compared to the control group (32.86%). Poisson regression revealed the likelihood of PU development was 70% lower in the intervention group. The intervention group had significantly less Stage I (p = .002) and Stage II PU development (p = .026). Significant improvements were observed in PU-related outcomes with the implementation of the PU prevention bundle in the ICU; PU incidence, severity, and total number of PUs per patient were reduced. Utilizing a bundle approach and standardized nursing language through skin assessment and translation of the knowledge to practice has the potential to impact positively on the quality of care and patient outcome. © 2015 Sigma Theta Tau International.

A Randomized controlled trial of the effect of yoga and peer support on glycaemic outcomes in women with type 2 diabetes mellitus: a feasibility study.

PubMed

Sreedevi, Aswathy; Gopalakrishnan, Unnikrishnan Ambika; Karimassery Ramaiyer, Sundaram; Kamalamma, Leelamoni

2017-02-07

Type two diabetes is a complex and demanding chronic disease and its impact in a state (Kerala) which leads India in terms of the number of people with Diabetes is profound. Though the male to female ratio among the people with diabetes is roughly equal, women are uniquely and more severely affected. Management of type two Diabetes requires considerable dexterity on the part of the patient to manage drugs, diet and exercise. Therefore, in a low middle-income country like India it is necessary to look at low cost interventions that can empower the patient and build on available resources to help manage diabetes. Hence, we studied the feasibility and effect of two low cost interventions; yoga and peer support on glycaemic and other outcomes among women with type two diabetes. An open label parallel three armed randomized control trial was conducted among 124 recruited women with Diabetes for three months. Block randomization with a block length of six was carried out with each group having at least 41 women. In the Yoga arm, sessions by an instructor, consisting of a group of postures coordinated with breathing were conducted for an hour, two days a week. In the peer support arm each peer mentor after training visited 13-14 women with diabetes every week followed by a phone call. The meeting was about applying disease management or prevention plans in daily life. There was a trend in decline of fasting plasma glucose in the peer and yoga group and of glycosylated haemoglobin (HbA1c) in the yoga group only, though not significant. A significant decrease was observed in diastolic blood pressure and hip circumference in the yoga group. The process indicated that most (80%) of the women in the yoga group attended classes regularly and 90% of the women in the peer group reported that peer mentoring was useful. The effect of yoga and peer support on glycaemic outcomes was incremental. Longer term studies are necessary to ascertain the benefits shown by this feasibility study. CTRI/2011/12/002227 dated 14/12/2011.

Experiences of being a control group: lessons from a UK-based randomized controlled trial of group singing as a health promotion initiative for older people.

PubMed

Skingley, Ann; Bungay, Hilary; Clift, Stephen; Warden, June

2014-12-01

Existing randomized controlled trials within the health field suggest that the concept of randomization is not always well understood and that feelings of disappointment may occur when participants are not placed in their preferred arm. This may affect a study's rigour and ethical integrity if not addressed. We aimed to test whether these issues apply to a healthy volunteer sample within a health promotion trial of singing for older people. Written comments from control group participants at two points during the trial were analysed, together with individual semi-structured interviews with a small sample (n = 11) of this group. We found that motivation to participate in the trial was largely due to the appeal of singing and disappointment resulted from allocation to the control group. Understanding of randomization was generally good and feelings of disappointment lessened over time and with a post-research opportunity to sing. Findings suggest that measures should be put in place to minimize the potential negative impacts of randomized controlled trials in health promotion research. © The Author (2013). Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Developing a Video-Based eHealth Intervention for HIV-Positive Gay, Bisexual, and Other Men Who Have Sex with Men: Study Protocol for a Randomized Controlled Trial.

PubMed

Hirshfield, Sabina; Downing, Martin J; Parsons, Jeffrey T; Grov, Christian; Gordon, Rachel J; Houang, Steven T; Scheinmann, Roberta; Sullivan, Patrick S; Yoon, Irene S; Anderson, Ian; Chiasson, Mary Ann

2016-06-17

Gay, bisexual, and other men who have sex with men (GBMSM) accounted for 67% of new US human immunodeficiency virus (HIV) infections in 2012; however, less than 40% of HIV-positive GBMSM are virally suppressed. Preventing transmission from virally unsuppressed men who have condomless anal sex (CAS) with serodiscordant partners is a public health imperative. New HIV infections in GBMSM are attributed in part to online access to sex partners; therefore, low-cost eHealth interventions are a unique opportunity to reach men where they meet partners. To describe the protocol of a randomized controlled trial evaluating whether video-based messaging delivered online may lead to reductions in serodiscordant CAS and increased HIV disclosure. Sex Positive!([+]) is a two-arm, phase III, video-based randomized controlled trial delivered online to GBMSM living with HIV. Participants in the intervention arm receive 10 video vignettes grounded in social learning and social cognitive theories that are designed to elicit critical thinking around issues of HIV transmission and disclosure. Participants in the attention control arm receive 10 video vignettes that focus on healthy living. All videos are optimized for mobile viewing. The study protocol includes five online assessments conducted over a 1-year period among 1500 US white, black, or Hispanic/Latino GBMSM living with HIV who report suboptimal antiretroviral therapy (ART) adherence or a detectable viral load in the past 12 months and recent CAS (past 6 months) with HIV-negative or unknown status male partners. Compared to the control arm, we hypothesize that men who watch the intervention videos will report at 12-month follow-up significantly fewer serodiscordant CAS partners, increased HIV disclosure, and improved social cognition (eg, condom use self-efficacy, perceived responsibility). Participant recruitment began in June 2015 and ended in December 2015. This protocol describes the underlying theoretical framework and measures, study design, recruitment challenges, and antifraud measures for an online, video-based randomized controlled trial that has the potential to decrease HIV transmission risk behaviors among HIV-positive GBMSM who struggle with ART adherence. The Sex Positive!([+]) intervention allows for participation through multiple Internet-based mediums and has the potential to reach and engage a broader population of HIV-positive GBMSM who are virally unsuppressed. ClinicalTrials.gov NCT02023580; https://clinicaltrials.gov/ct2/show/NCT02023580 (Archived by WebCite at http://www.webcitation.org/6iHzA8wRG).

Developing a Video-Based eHealth Intervention for HIV-Positive Gay, Bisexual, and Other Men Who Have Sex with Men: Study Protocol for a Randomized Controlled Trial

PubMed Central

Downing Jr, Martin J; Parsons, Jeffrey T; Grov, Christian; Gordon, Rachel J; Houang, Steven T; Scheinmann, Roberta; Sullivan, Patrick S; Yoon, Irene S; Anderson, Ian; Chiasson, Mary Ann

2016-01-01

Background Gay, bisexual, and other men who have sex with men (GBMSM) accounted for 67% of new US human immunodeficiency virus (HIV) infections in 2012; however, less than 40% of HIV-positive GBMSM are virally suppressed. Preventing transmission from virally unsuppressed men who have condomless anal sex (CAS) with serodiscordant partners is a public health imperative. New HIV infections in GBMSM are attributed in part to online access to sex partners; therefore, low-cost eHealth interventions are a unique opportunity to reach men where they meet partners. Objective To describe the protocol of a randomized controlled trial evaluating whether video-based messaging delivered online may lead to reductions in serodiscordant CAS and increased HIV disclosure. Methods Sex Positive![+] is a two-arm, phase III, video-based randomized controlled trial delivered online to GBMSM living with HIV. Participants in the intervention arm receive 10 video vignettes grounded in social learning and social cognitive theories that are designed to elicit critical thinking around issues of HIV transmission and disclosure. Participants in the attention control arm receive 10 video vignettes that focus on healthy living. All videos are optimized for mobile viewing. The study protocol includes five online assessments conducted over a 1-year period among 1500 US white, black, or Hispanic/Latino GBMSM living with HIV who report suboptimal antiretroviral therapy (ART) adherence or a detectable viral load in the past 12 months and recent CAS (past 6 months) with HIV-negative or unknown status male partners. Compared to the control arm, we hypothesize that men who watch the intervention videos will report at 12-month follow-up significantly fewer serodiscordant CAS partners, increased HIV disclosure, and improved social cognition (eg, condom use self-efficacy, perceived responsibility). Results Participant recruitment began in June 2015 and ended in December 2015. Conclusions This protocol describes the underlying theoretical framework and measures, study design, recruitment challenges, and antifraud measures for an online, video-based randomized controlled trial that has the potential to decrease HIV transmission risk behaviors among HIV-positive GBMSM who struggle with ART adherence. The Sex Positive![+] intervention allows for participation through multiple Internet-based mediums and has the potential to reach and engage a broader population of HIV-positive GBMSM who are virally unsuppressed. ClinicalTrial ClinicalTrials.gov NCT02023580; https://clinicaltrials.gov/ct2/show/NCT02023580 (Archived by WebCite at http://www.webcitation.org/6iHzA8wRG) PMID:27315764

Effectiveness of a one-year multi-component day-camp intervention for overweight children: study protocol of the Odense overweight intervention study (OOIS).

PubMed

Larsen, Kristian Traberg; Huang, Tao; Møller, Niels Christian; Andersen, Lars Bo; Ried-Larsen, Mathias

2014-04-05

Childhood overweight has noticeable psychological and social consequences for the child and leads to an increased risk of mortality and morbidity later in life. With the high prevalence of overweight in children and adolescents, it is important to identify effective approaches for the prevention and treatment of overweight in children and young individuals. The primary aim of the study is to assess the effect of an intensive day-camp intervention on body mass index (BMI) in overweight children. The Odense Overweight Intervention Study is a semi-blinded randomized controlled trial. Overweight children from the Municipality of Odense, Denmark, were invited to participate in the trial. Based on power calculations 98 participants were found to be sufficient to randomize in order to find an effect of minimum 1.5 BMI points. Gender-stratified concealed block randomization with a ratio of 1:1 and random block sizes of two, four, and six ensured balance between study arms. The intervention consisted of a six-week multi-component day camp including increased physical activity, healthy diet and health education followed by 46 weeks of family-based habitual intervention. The standard care arm was offered two weekly hours of physical activity training for six weeks. The outcomes were measured at baseline and at six-week and 52-week follow-ups. Furthermore, BMI will be assessed again at 48-month follow-up. Test personnel were kept blinded. The intervention effect will be evaluated using mixed model analyses. During 2012 and 2013, 115 children were enrolled in the study. Fifty-nine children were randomized to the day-camp intervention arm and 56 to the standard intervention arm. This study will provide novel information about the long-term health effects of an intense day-camp intervention program on overweight children, due to the design and the follow-up period. Moreover, it will add to the knowledge on designing and implementing feasible camp settings for preventing overweight in children. NCT01574352 at http://clinicaltrials.gov on the 8th of March 2012.

RCT of an integrated CBT-HIV intervention on depressive symptoms and HIV risk.

PubMed

Tobin, Karin; Davey-Rothwell, Melissa A; Nonyane, Bareng A S; Knowlton, Amy; Wissow, Lawrence; Latkin, Carl A

2017-01-01

Depression and depressive symptoms mediate the association between drug use and HIV risk. Yet, there are few interventions that target depressive symptoms and HIV risk for people who use drugs (PWUD). This study was a randomized controlled trial of an integrated cognitive behavioral therapy and HIV prevention intervention to reduce depressive symptoms, injection risk behaviors and increase condom use in a sample of urban people who used heroin or cocaine in the prior 6 months. A total of 315 individuals aged 18-55, who self-reported at least one HIV drug and sex risk behavior and scored ≥16 and <40 on the Centers for Epidemiologic Studies-Depression (CES-D) scale were randomized using a two-block design, stratified by sex to ensure equivalent numbers, to a 10 session intervention arm (n = 162) or a single session control arm (n = 153). The outcomes of interest were decreases in CES-D score and injection risk behaviors and increases in condom use. The sample was majority African American (85%) and unemployed (94%). Nearly half (47%) reported injection in the prior 6 months and only 19% were taking medication for depression. Follow-up assessments were conducted at 6 and 12 months. Retention at 12 months was 94%. Intervention arm was associated with statistically significantly lower CES-D score at 12 month compared to control. No differences were observed between arms in injection risk. At 6 month, intervention was associated with greater odds of condom use with non-main partner. These findings suggest the potential role of the integrated intervention in reducing depressive symptoms, but weak impact on HIV risk. This trial is registered with ClinicalTrials.gov under the title "Neighborhoods, Networks, Depression, and HIV Risk" number NCT01380613.

The forgotten half of the equation: randomized controlled trial of a male invitation to attend couple voluntary counselling and testing.

PubMed

Mohlala, Boshishi K F; Boily, Marie-Claude; Gregson, Simon

2011-07-31

Increased male participation in antenatal care and uptake of couple voluntary counselling and testing (VCT) for HIV could reduce horizontal and vertical HIV transmission in sub-Saharan Africa. Randomized controlled trial to compare pregnant women's acceptance of written invitations for VCT and pregnancy information sessions (PISs) - the control group - for their male sexual partners (MSPs) and uptake of VCT among these pregnancy partners in Khayelitsha, South Africa. All women in the study accepted the invitation letters and agreed to invite their pregnancy partners to attend for VCT or PIS as requested. Thirty-five percent (175 of 500) pregnant women given VCT invitations for their partners brought their MSPs for antenatal clinic visit compared with 26% (129 of 500) given PIS invitations [relative risk (RR) 1.36, 95% confidence interval (CI) 1.12-1.64, P = 0.002]. Thirty-two percent (161 of 500) MSPs in the VCT arm underwent HIV testing compared with 11% (57/500) in the PIS arm (RR 2.82, 95% CI 2.14-3.72, P < 0.001). The proportions of women and men reporting unprotected sex during the pregnancy were lower in the MSP VCT arm than in the MSP PIS arm - 25 versus 81% (RR 0.30, 95% CI 0.22-0.42, P < 0.001) and 26 versus 76% (RR 0.34, 95% CI 0.25-0.47, P < 0.001), respectively. No differences were seen in intimate partner violence. Providing pregnant women with a written invitation for their partners increased male participation in antenatal care and uptake of couple VCT in a township in Cape Town, South Africa where community sensitization was conducted and antiretroviral therapy was available.

Effectiveness of multifaceted hand hygiene interventions in long-term care facilities in Hong Kong: a cluster-randomized controlled trial.

PubMed

Ho, Mei-lin; Seto, Wing-hong; Wong, Lai-chin; Wong, Tin-yau

2012-08-01

To determine the effectiveness of World Health Organization (WHO) multimodal strategy in promoting hand hygiene (HH) among healthcare workers (HCWs) in long-term care facilities (LTCFs). Cluster-randomized controlled trial. Eighteen homes for the elderly in Hong Kong were randomly allocated to 2 intervention arms and a control arm. Direct observation of HH practice was conducted by trained nurses. Either handrubbing with alcohol-based handrub (ABHR) or handwashing with liquid soap and water was counted as a compliant action. Disease notification data during 2007-2010 were used to calculate incidence rate ratio (IRR). Managers and HCWs of the participating homes. The WHO multimodal strategy was employed. All intervention homes were supplied with ABHR (WHO formulation I), ABHR racks, pull reels, HH posters and reminders, a health talk, video clips, training materials, and performance feedback. The only difference was that intervention arms 1 and 2 were provided with slightly powdered and powderless gloves, respectively. A total of 11,669 HH opportunities were observed. HH compliance increased from 27.0% to 60.6% and from 22.2% to 48.6% in intervention arms 1 and 2, respectively. Both intervention arms showed increased HH compliance after intervention compared to controls, at 21.6% compliance (both [Formula: see text]). Provision of slightly powdered versus powderless gloves did not have any significant impact on ABHR usage. Respiratory outbreaks (IRR, 0.12; 95% confidence interval [CI], 0.01-0.93; [Formula: see text]) and methicillin-resistant Staphylococcus aureus infections requiring hospital admission (IRR, 0.61; 95% CI, 0.38-0.97; [Formula: see text]) were reduced after intervention. A promotion program applying the WHO multimodal strategy was effective in improving HH among HCWs in LTCFs.

A Randomized Controlled Trial to Evaluate if Computerized Cognitive Rehabilitation Improves Neurocognition in Ugandan Children with HIV.

PubMed

Boivin, Michael J; Nakasujja, Noeline; Sikorskii, Alla; Opoka, Robert O; Giordani, Bruno

2016-08-01

Clinically stable children with HIV can have neuromotor, attention, memory, visual-spatial, and executive function impairments. We evaluated neuropsychological and behavioral benefits of computerized cognitive rehabilitation training (CCRT) in Ugandan HIV children. One hundred fifty-nine rural Ugandan children with WHO Stage I or II HIV disease (6 to 12 years; 77 boys, 82 girls; M = 8.9, SD = 1.86 years) were randomized to one of three treatment arms over a 2-month period. The CCRT arm received 24 one-hour sessions over 2 months, using Captain's Log (BrainTrain Corporation) programmed for games targeting working memory, attention, and visual-spatial analysis. These games progressed in difficulty as the child's performance improved. The second arm was a "limited CCRT" with the same games rotated randomly from simple to moderate levels of training. The third arm was a passive control group receiving no training. All children were assessed at enrollment, 2 months (immediately following CCRT), and 3 months after CCRT completion. The CCRT group had significantly greater gains through 3 months of follow-up compared to passive controls on overall Kaufman Assessment Battery for Children-second edition (KABC-II) mental processing index (p < .01), planning (p = .04), and knowledge (p = .03). The limited CCRT group performed better than controls on learning (p = .05). Both CCRT arms had significant improvements on CogState Groton maze learning (p < .01); although not on CogState attention/memory, TOVA/impulsivity, or behavior rating inventory for executive function and child behavior checklist (psychiatric behavior/symptom problems) ratings by caregiver. CCRT intervention can be effective for neurocognitive rehabilitation in children with HIV in low-resource settings, especially in children who are clinically stable on ARV treatment.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hatton, Matthew; Nankivell, Matthew, E-mail: mn@ctu.mrc.ac.uk; Lyn, Ethan

Purpose: Recent clinical trials and meta-analyses have shown that both CHART (continuous hyperfractionated accelerated radiation therapy) and induction chemotherapy offer a survival advantage over conventional radical radiotherapy for patients with inoperable non-small cell-lung cancer (NSCLC). This multicenter randomized controlled trial (INCH) was set up to assess the value of giving induction chemotherapy before CHART. Methods and Materials: Patients with histologically confirmed, inoperable, Stage I-III NSCLC were randomized to induction chemotherapy (ICT) (three cycles of cisplatin-based chemotherapy followed by CHART) or CHART alone. Results: Forty-six patients were randomized (23 in each treatment arm) from 9 UK centers. As a result ofmore » poor accrual, the trial was closed in December 2007. Twenty-eight patients were male, 28 had squamous cell histology, 34 were Stage IIIA or IIIB, and all baseline characteristics were well balanced between the two treatment arms. Seventeen (74%) of the 23 ICT patients completed the three cycles of chemotherapy. All 42 (22 CHART + 20 ICT) patients who received CHART completed the prescribed treatment. Median survival was 17 months in the CHART arm and 25 months in the ICT arm (hazard ratio of 0.60 [95% CI 0.31-1.16], p = 0.127). Grade 3 or 4 adverse events (mainly fatigue, dysphagia, breathlessness, and anorexia) were reported for 13 (57%) CHART and 13 (65%) ICT patients. Conclusions: This small randomized trial indicates that ICT followed by CHART is feasible and well tolerated. Despite closing early because of poor accrual, and so failing to show clear evidence of a survival benefit for the additional chemotherapy, the results suggest that CHART, and ICT before CHART, remain important options for the treatment of inoperable NSCLC and deserve further study.« less

Two-Year Outcomes of the Enabling Mothers to Prevent Pediatric Obesity Through Web-Based Education and Reciprocal Determinism (EMPOWER) Randomized Control Trial.

PubMed

Knowlden, Adam P; Conrad, Eric

2018-04-01

Childhood overweight and obesity is a public health epidemic with far-reaching medical, economic, and quality of life consequences. Brief, web-based interventions have received increased attention for their potential to combat childhood obesity. The purpose of our study was to evaluate a web-based, maternal-facilitated childhood obesity prevention intervention dubbed Enabling Mothers to Prevent Pediatric Obesity Through Web-Based Education and Reciprocal Determinism (EMPOWER), for its capacity to elicit sustained effects at the 2-year postintervention follow-up mark. Two interventions were evaluated using a randomized controlled trial design. The experimental, EMPOWER arm received a social cognitive theory intervention ( n = 29) designed to improve four maternal-facilitated behaviors in children (fruit and vegetable consumption, physical activity, sugar-free beverage intake, screen time). The active control arm received a knowledge-based intervention dubbed Healthy Lifestyles ( n = 28), which also targeted the same four behaviors. We identified a significant group-by-time interaction of small effect size for child fruit and vegetable consumption ( p = .033; Cohen's f = 0.139) in the EMPOWER group. The construct of maternal-facilitated environment was positively associated to improvements in child fruit and vegetable behavior. We also found significant main effects for child physical activity ( p = .024; Cohen's f = 0.124); sugar-free beverage intake ( p < .001; Cohen's f = 0.321); and screen time ( p < .001; Cohen's f = 0.303), suggesting both groups improved in these behaviors over time. The EMPOWER arm of the trial resulted in an overall increase of 1.680 daily cups of fruits and vegetables consumed by children, relative to the comparison group ( p < .001, 95% confidence interval = [1.113, 2.248]). Web-based maternal-facilitated interventions can induce sustained effects on child behaviors.

Advanced ovarian cancer: phase III randomized study of sequential cisplatin-topotecan and carboplatin-paclitaxel vs carboplatin-paclitaxel.

PubMed

Hoskins, P; Vergote, I; Cervantes, A; Tu, D; Stuart, G; Zola, P; Poveda, A; Provencher, D; Katsaros, D; Ojeda, B; Ghatage, P; Grimshaw, R; Casado, A; Elit, L; Mendiola, C; Sugimoto, A; D'Hondt, V; Oza, A; Germa, J R; Roy, M; Brotto, L; Chen, D; Eisenhauer, E A

2010-10-20

Topotecan has single-agent activity in recurrent ovarian cancer. It was evaluated in a novel combination compared with standard frontline therapy. Women aged 75 years or younger with newly diagnosed stage IIB or greater ovarian cancer, Eastern Cooperative Oncology Group Performance Status of 1 or less, were stratified by type of primary surgery and residual disease, treatment center, and age; then randomly assigned to one of the two 21-day intravenous regimens. Patients in arm 1 (n = 409) were administered four cycles of cisplatin 50 mg/m(2) on day 1 and topotecan 0.75 mg/m(2) on days 1-5, then four cycles of paclitaxel 175 mg/m(2) over 3 hours on day 1 followed by carboplatin (area under the curve = 5) on day 1. Patients in arm 2 (n = 410) were given paclitaxel plus carboplatin as in arm 1 for eight cycles. We compared progression-free survival (PFS), overall survival, and cancer antigen-125 normalization rates in the two treatment arms. A stratified log-rank test was used to assess the primary endpoint, PFS. All statistical tests were two-sided. A total of 819 patients were randomly assigned. At baseline, the median age of the patients was 57 years (range = 28-78); 81% had received debulking surgery, and of these, 55% had less than 1 cm residual disease; 66% of patients were stage III and 388 (47.4%) patients had measurable disease. After a median follow-up of 43 months, 650 patients had disease progression or died without documented progression and 406 had died. Patients in arm 1 had more hematological toxicity and hospitalizations than patients in arm 2; PFS was 14.6 months in arm 1 vs 16.2 months in arm 2 (hazard ratio = 1.10, 95% confidence interval = 0.94 to 1.28, P = .25). Among patients with elevated baseline cancer antigen-125, fewer in arm 1 than in arm 2 had levels return to normal by 3 months after random assignment (51.6% vs 63.3%, P = .007) Topotecan and cisplatin, followed by carboplatin and paclitaxel, were more toxic than carboplatin and paclitaxel alone, but without improved efficacy. Carboplatin plus paclitaxel remains the standard of care for advanced epithelial ovarian cancer.

Reaching the unreached through trained and skilled birth attendants in Ethiopia: a cluster randomized controlled trial study protocol.

PubMed

Zerfu, Taddese Alemu; Taddese, Henok; Nigatu, Tariku; Tenkolu, Girma; Vogel, Joshua P; Khan-Neelofur, Dina; Biadgilign, Sibhatu; Deribew, Amare

2017-01-26

Despite improvements since 1990 to 2014, maternal mortality ratio (MMR) remains high in Ethiopia. One of the key drivers of maternal mortality in Ethiopia is the very low coverage of Skilled Birth attendance (SBA) in rural Ethiopia. This cluster randomized trial piloted an innovative approach of deploying trained community reproductive nurses (CORN) to hard to reach/unreachable rural Ethiopia to improve the coverage of SBA. We used a three-arm cluster randomized trial to test the effect of deploying CORN in rural communities in South Ethiopia to improve SBA and other maternal health indicators. A total of 282 villages/clusters (94 from each arm) were randomly selected in the three districts of the zone for the study. The intervention was implemented in four consecutive phases that aimed at of provision of essential maternal, neonatal and child health (MNCH) services mainly focusing on SBA. The CORN were trained and deployed in health centres (arm 1) and in the community/health posts (arm2). A third arm (arm 3) consisting control villages without the intervention. A baseline and end line assessment was conducted to compare the difference in the proportion of SBA and other MNCH service uptake across the three arms Data was entered into computer, edited, cleaned, and analyzed using Epi-data statistical software. The presentation followed the Consolidated Standards of Reporting Trials (CONSORT) statement guidelines for cluster-randomized trials. This trial is designed to test the impact of an innovative and newly designed means of distribution for the national health extension program strategy with additional service package with no change to the target population. The focus is on effect of CORN in revitalizing the Health Extension Program (HEP) through improving SBA service uptake and other maternal health service uptake indicators. The study findings may guide national policy to strengthen and shape the already existing HEP that has certain limitations to improve maternal health indicators. The competency based training methodology could provide feedback for health science colleges to improve the national nursing or midwifery training curriculum. clinicaltrails.gov NCT02501252 dated on July 14, 2015.

Concomitant chemoradiotherapy versus induction docetaxel, cisplatin and 5 fluorouracil (TPF) followed by concomitant chemoradiotherapy in locally advanced head and neck cancer: a phase II randomized study.

PubMed

Paccagnella, A; Ghi, M G; Loreggian, L; Buffoli, A; Koussis, H; Mione, C A; Bonetti, A; Campostrini, F; Gardani, G; Ardizzoia, A; Dondi, D; Guaraldi, M; Cavallo, R; Tomio, L; Gava, A

2010-07-01

Concomitant chemoradiotherapy (CT/RT) is the standard treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN). We evaluated the efficacy of induction docetaxel (Taxotere), cisplatin, and 5-fluorouracil (TPF) before CT/RT versus CT/RT alone. Patients with stage III-IVM0 SCCHN, Eastern Cooperative Oncology Group performance status of zero to one, were randomly assigned to receive CT/RT alone (arm A: two cycles of cisplatin 20 mg/m(2), days1-4, plus 5-fluorouracil 800 mg/m(2)/day 96 h continuous infusion, during weeks 1 and 6 of radiotherapy) or three cycles of TPF (arm B: docetaxel 75 mg/m(2) and cisplatin 80 mg/m(2), day 1, and 5-fluorouracil 800 mg/m(2)/day 96 h continuous infusion, every 3 weeks) followed by the same CT/RT. The primary end point was the rate of radiologic complete response (CR) at 6-8 weeks after the end of CT/RT. A total of 101 patients were randomly allocated to the study (51 arm A; 50 arm B). CR rates were 21.2% (arm A) versus 50% (arm B). Median progression-free survival and overall survival were, respectively, 19.7 and 33.3 months (arm A) and 30.4 and 39.6 months (arm B). Hematologic and non-hematologic toxic effects during CT/RT were similar in the two arms. Induction TPF followed by CT/RT was associated with higher radiologic CR in patients with locally advanced SCCHN with no negative impact on CT/RT feasibility.

Randomized Clinical Trial of Weekly vs. Triweekly Cisplatin-Based Chemotherapy Concurrent With Radiotherapy in the Treatment of Locally Advanced Cervical Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ryu, Sang-Young, E-mail: ryu@kcch.re.kr; Lee, Won-Moo; Kim, Kidong

Purpose: To compare compliance, toxicity, and outcome of weekly and triweekly cisplatin administration concurrent with radiotherapy in locally advanced cervical cancer. Methods and Materials: In this open-label, randomized trial, 104 patients with histologically proven Stage IIB-IVA cervical cancer were randomly assigned by a computer-generated procedure to weekly (weekly cisplatin 40 mg/m{sup 2}, six cycles) and triweekly (cisplatin 75 mg/m{sup 2} every 3 weeks, three cycles) chemotherapy arms during concurrent radiotherapy. The difference of compliance and the toxicity profiles between the two arms were investigated, and the overall survival rate was analyzed after 5 years. Results: All patients tolerated both treatmentsmore » very well, with a high completion rate of scheduled chemotherapy cycles. There was no statistically significant difference in compliance between the two arms (86.3% in the weekly arm, 92.5% in the triweekly arm, p > 0.05). Grade 3-4 neutropenia was more frequent in the weekly arm (39.2%) than in the triweekly arm (22.6%) (p = 0.03). The overall 5-year survival rate was significantly higher in the triweekly arm (88.7%) than in the weekly arm (66.5%) (hazard ratio 0.375; 95% confidence interval 0.154-0.914; p = 0.03). Conclusions: Triweekly cisplatin 75-mg/m{sup 2} chemotherapy concurrent with radiotherapy is more effective and feasible than the conventional weekly cisplatin 40-mg/m{sup 2} regimen and may be a strong candidate for the optimal cisplatin dose and dosing schedule in the treatment of locally advanced cervical cancer.« less

Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: Study protocol for a randomized controlled trial.

PubMed

Cheng, Shi-Hui; Ismail, Amin; Anthony, Joseph; Ng, Ooi Chuan; Hamid, Azizah Abdul; Yusof, Barakatun-Nisak Mohd

2016-02-27

Type 2 diabetes mellitus is a major health threat worldwide. Cosmos caudatus is one of the medicinal plants used to treat type 2 diabetes. Therefore, this study aims to determine the effectiveness and safety of C. caudatus in patients with type 2 diabetes. Metabolomic approach will be carried out to compare the metabolite profiles between C. Caudatus treated diabetic patients and diabetic controls. This is a single-center, randomized, controlled, two-arm parallel design clinical trial that will be carried out in a tertiary hospital in Malaysia. In this study, 100 patients diagnosed with type 2 diabetes will be enrolled. Diabetic patients who meet the eligibility criteria will be randomly allocated to two groups, which are diabetic C. caudatus treated(U) group and diabetic control (C) group. Primary and secondary outcomes will be measured at baseline, 4, 8, and 12 weeks. The serum and urine metabolome of both groups will be examined using proton NMR spectroscopy. The study will be the first randomized controlled trial to assess whether C. caudatus can confer beneficial effect in patients with type 2 diabetes. The results of this trial will provide clinical evidence on the effectiveness and safety of C. caudatus in patients with type 2 diabetes. ClinicalTrials.gov identifier: NCT02322268.

The NULevel trial of a scalable, technology-assisted weight loss maintenance intervention for obese adults after clinically significant weight loss: study protocol for a randomised controlled trial.

PubMed

Evans, Elizabeth H; Araújo-Soares, Vera; Adamson, Ashley; Batterham, Alan M; Brown, Heather; Campbell, Miglena; Dombrowski, Stephan U; Guest, Alison; Jackson, Daniel; Kwasnicka, Dominika; Ladha, Karim; McColl, Elaine; Olivier, Patrick; Rothman, Alexander J; Sainsbury, Kirby; Steel, Alison J; Steen, Ian Nicholas; Vale, Luke; White, Martin; Wright, Peter; Sniehotta, Falko F

2015-09-22

Effective weight loss interventions are widely available but, after weight loss, most individuals regain weight. This article describes the protocol for the NULevel trial evaluating the effectiveness and cost-effectiveness of a systematically developed, inexpensive, scalable, technology-assisted, behavioural intervention for weight loss maintenance (WLM) in obese adults after initial weight loss. A 12-month single-centre, two-armed parallel group, participant randomised controlled superiority trial is underway, recruiting a total of 288 previously obese adults after weight loss of ≥5 % within the previous 12 months. Participants are randomly assigned to intervention or control arms, with a 1:1 allocation, stratified by sex and percentage of body weight lost (<10 % vs ≥10 %). Change in weight (kg) from baseline to 12 months is the primary outcome. Weight, other anthropometric variables and 7-day physical activity (assessed via accelerometer) measures are taken at 0 and 12 months. Questionnaires at 0, 6 and 12 months assess psychological process variables, health service use and participant costs. Participants in the intervention arm initially attend an individual face-to-face WLM consultation with an intervention facilitator and then use a mobile internet platform to self-monitor and report their diet, daily activity (via pedometer) and weight through daily weighing on wirelessly connected scales. Automated feedback via mobile phone, tailored to participants' weight regain and goal progress is provided. Participants in the control arm receive quarterly newsletters (via links embedded in text messages) and wirelessly connected scales. Qualitative process evaluation interviews are conducted with a subsample of up to 40 randomly chosen participants. Acceptability and feasibility of procedures, cost-effectiveness, and relationships among socioeconomic variables and WLM will also be assessed. It is hypothesised that participants allocated to the intervention arm will show significantly lower levels of weight regain from baseline than those in the control arm. To date, this is the first WLM trial using remote real-time weight monitoring and mobile internet platforms to deliver a flexible, efficient and scalable intervention, tailored to the individual. This trial addresses a key research need and has the potential to make a vital contribution to the evidence base to inform future WLM policy and provision. http://www.isrctn.com/ISRCTN14657176 (registration date 20 March 2014).

Randomized trial for superiority of high field strength intra-operative magnetic resonance imaging guided resection in pituitary surgery.

PubMed

Tandon, Vivek; Raheja, Amol; Suri, Ashish; Chandra, P Sarat; Kale, Shashank S; Kumar, Rajinder; Garg, Ajay; Kalaivani, Mani; Pandey, Ravindra M; Sharma, Bhawani S

2017-03-01

Till date there are no randomized trials to suggest the superiority of intra-operative magnetic resonance imaging (IOMRI) guided trans-sphenoidal pituitary resection over two dimensional fluoroscopic (2D-F) guided resections. We conducted this trial to establish the superiority of IOMRI in pituitary surgery. Primary objective was to compare extent of tumor resection between the two study arms. It was a prospective, randomized, outcome assessor and statistician blinded, two arm (A: IOMRI, n=25 and B: 2D-F, n=25), parallel group clinical trial. 4 patients from IOMRI group cross-over to 2D-F group and were consequently analyzed in latter group, based on modified intent to treat method. A total of 50 patients were enrolled till completion of trial (n=25 in each study arm). Demographic profile and baseline parameters were comparable among the two arms (p>0.05) except for higher number of endoscopic procedures and experienced neurosurgeons (>10years) in arm B (p=0.02, 0.002 respectively). Extent of resection was similar in both study arms (A, 94.9% vs B, 93.6%; p=0.78), despite adjusting for experience of operating surgeon and use of microscope/endoscope for surgical resection. We observed that use of IOMRI helped optimize the extent of resection in 5/20 patients (25%) for pituitary tumor resection in-group A. Present study failed to observe superiorty of IOMRI over conventional 2D-F guided resection in pituitary macroadenoma surgery. By use of this technology, younger surgeons could validate their results intra-operatively and hence could increase EOR without causing any increase in complications. Copyright © 2016 Elsevier Ltd. All rights reserved.

Community Case Management of Fever Due to Malaria and Pneumonia in Children Under Five in Zambia: A Cluster Randomized Controlled Trial

PubMed Central

Yeboah-Antwi, Kojo; Pilingana, Portipher; Macleod, William B.; Semrau, Katherine; Siazeele, Kazungu; Kalesha, Penelope; Hamainza, Busiku; Seidenberg, Phil; Mazimba, Arthur; Sabin, Lora; Kamholz, Karen; Thea, Donald M.; Hamer, Davidson H.

2010-01-01

Background Pneumonia and malaria, two of the leading causes of morbidity and mortality among children under five in Zambia, often have overlapping clinical manifestations. Zambia is piloting the use of artemether-lumefantrine (AL) by community health workers (CHWs) to treat uncomplicated malaria. Valid concerns about potential overuse of AL could be addressed by the use of malaria rapid diagnostics employed at the community level. Currently, CHWs in Zambia evaluate and treat children with suspected malaria in rural areas, but they refer children with suspected pneumonia to the nearest health facility. This study was designed to assess the effectiveness and feasibility of using CHWs to manage nonsevere pneumonia and uncomplicated malaria with the aid of rapid diagnostic tests (RDTs). Methods and Findings Community health posts staffed by CHWs were matched and randomly allocated to intervention and control arms. Children between the ages of 6 months and 5 years were managed according to the study protocol, as follows. Intervention CHWs performed RDTs, treated test-positive children with AL, and treated those with nonsevere pneumonia (increased respiratory rate) with amoxicillin. Control CHWs did not perform RDTs, treated all febrile children with AL, and referred those with signs of pneumonia to the health facility, as per Ministry of Health policy. The primary outcomes were the use of AL in children with fever and early and appropriate treatment with antibiotics for nonsevere pneumonia. A total of 3,125 children with fever and/or difficult/fast breathing were managed over a 12-month period. In the intervention arm, 27.5% (265/963) of children with fever received AL compared to 99.1% (2066/2084) of control children (risk ratio 0.23, 95% confidence interval 0.14–0.38). For children classified with nonsevere pneumonia, 68.2% (247/362) in the intervention arm and 13.3% (22/203) in the control arm received early and appropriate treatment (risk ratio 5.32, 95% confidence interval 2.19–8.94). There were two deaths in the intervention and one in the control arm. Conclusions The potential for CHWs to use RDTs, AL, and amoxicillin to manage both malaria and pneumonia at the community level is promising and might reduce overuse of AL, as well as provide early and appropriate treatment to children with nonsevere pneumonia. Trial registration ClinicalTrials.gov NCT00513500 Please see later in the article for the Editors' Summary PMID:20877714

Stroke of Known Cause and Underlying Atrial Fibrillation (STROKE-AF) randomized trial: Design and rationale.

PubMed

Bernstein, Richard A; Kamel, Hooman; Granger, Christopher B; Kowal, Robert C; Ziegler, Paul D; Schwamm, Lee H

2017-08-01

Approximately 20% of ischemic strokes are associated with clinically apparent atrial fibrillation (AF). Regardless of stroke etiology, detection of AF in patients with ischemic strokes often changes antithrombotic treatment from anti-platelet to oral anticoagulation therapy. The role and the optimum duration of cardiac monitoring to detect AF in patients with strokes presumed due to large vessel atherosclerosis or small vessel disease is unknown. This manuscript describes the design and rationale of the STROKE-AF trial. STROKE-AF is a randomized, controlled, open-label, post-market clinical trial. Detection of AF will be evaluated using continuous arrhythmia monitoring with an insertable cardiac monitor (ICM) compared with standard of care follow-up in patients with stroke (within the prior 10 days) that is presumed due to large vessel cervical or intracranial atherosclerosis, or to small vessel disease. Approximately 500 patients will be enrolled at approximately 40 centers in the United States. Patients will be randomized 1:1 to arrhythmia monitoring with an ICM (continuous monitoring arm) or standard of care follow-up (control arm). Subjects will be followed for ≥12 months and up to 3 years. The primary objective is to compare the incidence rate of detected AF through 12 months of follow-up between the two arms. This trial will provide information on the value of ICMs to detect subclinical AF in patients with stroke presumed due to large vessel atherosclerosis or small vessel disease, which will have implications for guiding treatment with oral anticoagulation for secondary stroke prevention. Copyright © 2017 Elsevier Inc. All rights reserved.

Evaluation of the immunogenicity and safety of different doses and formulations of a broad spectrum influenza vaccine (FLU-v) developed by SEEK: study protocol for a single-center, randomized, double-blind and placebo-controlled clinical phase IIb trial.

PubMed

van Doorn, Eva; Pleguezuelos, Olga; Liu, Heng; Fernandez, Ana; Bannister, Robin; Stoloff, Gregory; Oftung, Fredrik; Norley, Stephen; Huckriede, Anke; Frijlink, Henderik W; Hak, Eelko

2017-04-04

Current influenza vaccines, based on antibodies against surface antigens, are unable to provide protection against newly emerging virus strains which differ from the vaccine strains. Therefore the population has to be re-vaccinated annually. It is thus important to develop vaccines which induce protective immunity to a broad spectrum of influenza viruses. This trial is designed to evaluate the immunogenicity and safety of FLU-v, a vaccine composed of four synthetic peptides with conserved epitopes from influenza A and B strains expected to elicit both cell mediated immunity (CMI) and humoral immunity providing protection against a broad spectrum of influenza viruses. In a single-center, randomized, double-blind and placebo-controlled phase IIb trial, 222 healthy volunteers aged 18-60 years will be randomized (2:2:1:1) to receive two injections of a suspension of 500 μg FLU-v in saline (arm 1), one dose of emulsified 500 μg FLU-v in Montanide ISA-51 and water for injection (WFI) followed by one saline dose (arm 2), two saline doses (arm 3), or one dose of Montanide ISA-51 and WFI emulsion followed by one saline dose (arm 4). All injections will be given subcutaneously. Primary endpoints are safety and FLU-v induced CMI, evaluated by cytokine production by antigen specific T cell populations (flow-cytometry and ELISA). Secondary outcomes are measurements of antibody responses (ELISA and multiplex), whereas exploratory outcomes include clinical efficacy and additional CMI assays (ELISpot) to show cross-reactivity. Broadly protective influenza vaccines able to provide protection against multiple strains of influenza are urgently needed. FLU-v is a promising vaccine which has shown to trigger the cell-mediated immune response. The dosages and formulations tested in this current trial are also estimated to induce antibody response. Therefore, both cellular and humoral immune responses will be evaluated. EudraCT number 2015-001932-38 ; retrospectively registered clinicaltrials.gov NCT02962908 (November 7th 2016).

Reduced Reward-driven Eating Accounts for the Impact of a Mindfulness-Based Diet and Exercise Intervention on Weight Loss: Data from the SHINE Randomized Controlled Trial

PubMed Central

Mason, Ashley E.; Epel, Elissa S.; Aschbacher, Kirstin; Lustig, Robert H.; Acree, Michael; Kristeller, Jean; Cohn, Michael; Dallman, Mary; Moran, Patricia J.; Bacchetti, Peter; Laraia, Barbara; Hecht, Frederick M.; Daubenmier, Jennifer

2016-01-01

Many individuals with obesity report overeating despite intentions to maintain or lose weight. Two barriers to long-term weight loss are reward-driven eating, which is characterized by a lack of control over eating, a preoccupation with food, and a lack of satiety; and psychological stress. Mindfulness training may address these barriers by promoting awareness of hunger and satiety cues, self-regulatory control, and stress reduction. We examined these two barriers as potential mediators of weight loss in the Supporting Health by Integrating Nutrition and Exercise (SHINE) randomized controlled trial, which compared the effects of a 5.5-month diet and exercise intervention with or without mindfulness training on weight loss among adults with obesity. Intention-to-treat multiple mediation models tested whether post-intervention reward-driven eating and psychological stress mediated the impact of intervention arm on weight loss at 12-and 18-months post-baseline among 194 adults with obesity (BMI: 30–45). Mindfulness (relative to control) participants had significant reductions in reward-driven eating at 6 months (post-intervention), which, in turn, predicted weight loss at 12 months. Post-intervention reward-driven eating mediated 47.1% of the total intervention arm effect on weight loss at 12 months [β=-0.06, SE(β)=0.03, p=.030, 95% CI (−0.12, −0.01)]. This mediated effect was reduced when predicting weight loss at 18 months (p=.396), accounting for 23.0% of the total intervention effect, despite similar weight loss at 12 months. Psychological stress did not mediate the effect of intervention arm on weight loss at 12 or 18 months. In conclusion, reducing reward-driven eating, which can be achieved using a diet and exercise intervention that includes mindfulness training, may promote weight loss (clinicaltrials.gov registration: NCT00960414). PMID:26867697

Reduced reward-driven eating accounts for the impact of a mindfulness-based diet and exercise intervention on weight loss: Data from the SHINE randomized controlled trial.

PubMed

Mason, Ashley E; Epel, Elissa S; Aschbacher, Kirstin; Lustig, Robert H; Acree, Michael; Kristeller, Jean; Cohn, Michael; Dallman, Mary; Moran, Patricia J; Bacchetti, Peter; Laraia, Barbara; Hecht, Frederick M; Daubenmier, Jennifer

2016-05-01

Many individuals with obesity report over eating despite intentions to maintain or lose weight. Two barriers to long-term weight loss are reward-driven eating, which is characterized by a lack of control over eating, a preoccupation with food, and a lack of satiety; and psychological stress. Mindfulness training may address these barriers by promoting awareness of hunger and satiety cues, self-regulatory control, and stress reduction. We examined these two barriers as potential mediators of weight loss in the Supporting Health by Integrating Nutrition and Exercise (SHINE) randomized controlled trial, which compared the effects of a 5.5-month diet and exercise intervention with or without mindfulness training on weight loss among adults with obesity. Intention-to-treat multiple mediation models tested whether post-intervention reward-driven eating and psychological stress mediated the impact of intervention arm on weight loss at 12- and 18-months post-baseline among 194 adults with obesity (BMI: 30-45). Mindfulness (relative to control) participants had significant reductions in reward-driven eating at 6 months (post-intervention), which, in turn, predicted weight loss at 12 months. Post-intervention reward-driven eating mediated 47.1% of the total intervention arm effect on weight loss at 12 months [β = -0.06, SE(β) = 0.03, p = .030, 95% CI (-0.12, -0.01)]. This mediated effect was reduced when predicting weight loss at 18 months (p = .396), accounting for 23.0% of the total intervention effect, despite similar weight loss at 12 months. Psychological stress did not mediate the effect of intervention arm on weight loss at 12 or 18 months. In conclusion, reducing reward-driven eating, which can be achieved using a diet and exercise intervention that includes mindfulness training, may promote weight loss (clinicaltrials.gov registration: NCT00960414). Published by Elsevier Ltd.

Virtual temporal bone dissection system: OSU virtual temporal bone system: development and testing.

PubMed

Wiet, Gregory J; Stredney, Don; Kerwin, Thomas; Hittle, Bradley; Fernandez, Soledad A; Abdel-Rasoul, Mahmoud; Welling, D Bradley

2012-03-01

The objective of this project was to develop a virtual temporal bone dissection system that would provide an enhanced educational experience for the training of otologic surgeons. A randomized, controlled, multi-institutional, single-blinded validation study. The project encompassed four areas of emphasis: structural data acquisition, integration of the system, dissemination of the system, and validation. Structural acquisition was performed on multiple imaging platforms. Integration achieved a cost-effective system. Dissemination was achieved on different levels including casual interest, downloading of software, and full involvement in development and validation studies. A validation study was performed at eight different training institutions across the country using a two-arm randomized trial where study subjects were randomized to a 2-week practice session using either the virtual temporal bone or standard cadaveric temporal bones. Eighty subjects were enrolled and randomized to one of the two treatment arms; 65 completed the study. There was no difference between the two groups using a blinded rating tool to assess performance after training. A virtual temporal bone dissection system has been developed and compared to cadaveric temporal bones for practice using a multicenter trial. There was no statistical difference between practice on the current simulator compared to practice on human cadaveric temporal bones. Further refinements in structural acquisition and interface design have been identified, which can be implemented prior to full incorporation into training programs and used for objective skills assessment. Copyright © 2012 The American Laryngological, Rhinological, and Otological Society, Inc.

Effect of HIV self-testing on the number of sexual partners among female sex workers in Zambia

PubMed Central

Oldenburg, Catherine E.; Chanda, Michael M.; Ortblad, Katrina F.; Mwale, Magdalene; Chongo, Steven; Kamungoma, Nyambe; Kanchele, Catherine; Fullem, Andrew; Moe, Caitlin; Barresi, Leah G.; Harling, Guy D.; Bärnighausen, Till

2018-01-01

Objectives: To assess the effect of two health system approaches to distribute HIV self-tests on the number of female sex workers’ client and nonclient sexual partners. Design: Cluster randomized controlled trial. Methods: Peer educators recruited 965 participants. Peer educator–participant groups were randomized 1 : 1 : 1 to one of three arms: delivery of HIV self-tests directly from a peer educator, free facility-based delivery of HIV self-tests in exchange for coupons, or referral to standard-of-care HIV testing. Participants in all three arms completed four peer educator intervention sessions, which included counseling and condom distribution. Participants were asked the average number of client partners they had per night at baseline, 1 and 4 months, and the number of nonclient partners they had in the past 12 months (at baseline) and in the past month (at 1 month and 4 months). Results: At 4 months, participants reported significantly fewer clients per night in the direct delivery arm (mean difference −0.78 clients, 95% CI −1.28 to −0.28, P = 0.002) and the coupon arm (−0.71, 95% CI −1.21 to −0.21, P = 0.005) compared with standard of care. Similarly, they reported fewer nonclient partners in the direct delivery arm (−3.19, 95% CI −5.18 to −1.21, P = 0.002) and in the coupon arm (−1.84, 95% CI −3.81 to 0.14, P = 0.07) arm compared with standard of care. Conclusion: Expansion of HIV self-testing may have positive behavioral effects enhancing other HIV prevention efforts among female sex workers in Zambia. Trial Registration: ClinicalTrials.gov NCT02827240. PMID:29494424

Impact of continuous glucose monitoring on quality of life, treatment satisfaction, and use of medical care resources: analyses from the SWITCH study.

PubMed

Hommel, E; Olsen, B; Battelino, T; Conget, I; Schütz-Fuhrmann, I; Hoogma, R; Schierloh, U; Sulli, N; Gough, H; Castañeda, J; de Portu, S; Bolinder, J

2014-10-01

To investigate the impact of continuous glucose monitoring (CGM) on health-related quality of life (HRQOL), treatment satisfaction (TS) medical resource use, and indirect costs in the SWITCH study. SWITCH was a multicentre, randomized, crossover study. Patients with type 1 diabetes (n = 153) using continuous subcutaneous insulin infusion (CSII) were randomized to a 12 month sensor-On/Off or sensor-Off/On sequence (6 months each treatment), with a 4-month washout between periods. HRQOL in children and TS in adults were measured using validated questionnaires. Medical resource utilization data were collected. In adults, TS was significantly higher in the sensor-On arm, and there were significant improvements in ratings for treatment convenience and flexibility. There were no clinically significant differences in children's HRQOL or parents' proxy ratings. The incidence of severe hypoglycaemia, unscheduled visits, or diabetes-related hospitalizations did not differ significantly between the two arms. Adult patients made fewer telephone consultations during the sensor-On arm; children's caregivers made similar numbers of telephone consultations during both arms, and calls were on average only 3 min longer during the sensor-On arm. Regarding indirect costs, children with >70 % sensor usage missed fewer school days, compared with the sensor-Off arm (P = 0.0046) but there was no significant difference in the adults days of work off. The addition of CGM to CSII resulted in better metabolic control without imposing an additional burden on the patient or increased medical resource use, and offered the potential for cost offsets.

Effect of a Mobile Web App on Kidney Transplant Candidates' Knowledge About Increased Risk Donor Kidneys: A Randomized Controlled Trial.

PubMed

Gordon, Elisa J; Sohn, Min-Woong; Chang, Chih-Hung; McNatt, Gwen; Vera, Karina; Beauvais, Nicole; Warren, Emily; Mannon, Roslyn B; Ison, Michael G

2017-06-01

Kidney transplant candidates (KTCs) must provide informed consent to accept kidneys from increased risk donors (IRD), but poorly understand them. We conducted a multisite, randomized controlled trial to evaluate the efficacy of a mobile Web application, Inform Me, for increasing knowledge about IRDs. Kidney transplant candidates undergoing transplant evaluation at 2 transplant centers were randomized to use Inform Me after routine transplant education (intervention) or routine transplant education alone (control). Computer adaptive learning method reinforced learning by embedding educational material, and initial (test 1) and additional test questions (test 2) into each chapter. Knowledge (primary outcome) was assessed in person after education (tests 1 and 2), and 1 week later by telephone (test 3). Controls did not receive test 2. Willingness to accept an IRD kidney (secondary outcome) was assessed after tests 1 and 3. Linear regression test 1 knowledge scores were used to test the significance of Inform Me exposure after controlling for covariates. Multiple imputation was used for intention-to-treat analysis. Two hundred eighty-eight KTCs participated. Intervention participants had higher test 1 knowledge scores (mean difference, 6.61; 95% confidence interval [95% CI], 5.37-7.86) than control participants, representing a 44% higher score than control participants' scores. Intervention participants' knowledge scores increased with educational reinforcement (test 2) compared with control arm test 1 scores (mean difference, 9.50; 95% CI, 8.27-10.73). After 1 week, intervention participants' knowledge remained greater than controls' knowledge (mean difference, 3.63; 95% CI, 2.49-4.78) (test 3). Willingness to accept an IRD kidney did not differ between study arms at tests 1 and 3. Inform Me use was associated with greater KTC knowledge about IRD kidneys above routine transplant education alone.

Enhancing HIV Communication between Parents and Children: Efficacy of the Parents Matter! Program

ERIC Educational Resources Information Center

Miller, Kim S.; Lin, Carol Y.; Poulsen, Melissa N.; Fasula, Amy; Wyckoff, Sarah C.; Forehand, Rex; Long, Nicholas; Armistead, Lisa

2011-01-01

We examine efficacy of the Parents Matter! Program (PMP), a program to teach African-American parents of preadolescents sexual communication and HIV-prevention skills, through a multicenter, randomized control trial. A total of 1115 parent-child participants were randomized to one of three intervention arms (enhanced, brief, control). Percentages…

Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A.

PubMed

Welzel, Grit; Boch, Angela; Sperk, Elena; Hofmann, Frank; Kraus-Tiefenbacher, Uta; Gerhardt, Axel; Suetterlin, Marc; Wenz, Frederik

2013-01-07

Intraoperative radiotherapy (IORT) is a new treatment approach for early stage breast cancer. This study reports on the effects of IORT on radiation-related quality of life (QoL) parameters. Two hundred and thirty women with stage I-III breast cancer (age, 31 to 84 years) were entered into the study. A single-center subgroup of 87 women from the two arms of the randomized phase III trial TARGIT-A (TARGeted Intra-operative radioTherapy versus whole breast radiotherapy for breast cancer) was analyzed. Furthermore, results were compared to non-randomized control groups: n = 90 receiving IORT as a tumor bed boost followed by external beam whole breast radiotherapy (EBRT) outside of TARGIT-A (IORT-boost), and n = 53 treated with EBRT followed by an external-beam boost (EBRT-boost). QoL was collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires C30 (QLQ-C30) and BR23 (QLQ-BR23). The mean follow-up period in the TARGIT-A groups was 32 versus 39 months in the non-randomized control groups. Patients receiving IORT alone reported less general pain (21.3 points), breast (7.0 points) and arm (15.1 points) symptoms, and better role functioning (78.7 points) as patients receiving EBRT (40.9; 19.0; 32.8; and 60.5 points, respectively, P < 0.01). Patients receiving IORT alone also had fewer breast symptoms than TARGIT-A patients receiving IORT followed by EBRT for high risk features on final pathology (IORT-EBRT; 7.0 versus 29.7 points, P < 0.01). There were no significant differences between TARGIT-A patients receiving IORT-EBRT compared to non-randomized IORT-boost or EBRT-boost patients and patients receiving EBRT without a boost. In the randomized setting, important radiation-related QoL parameters after IORT were superior to EBRT. Non-randomized comparisons showed equivalent parameters in the IORT-EBRT group and the control groups.

Everolimus Is Associated With Less Weight Gain Than Tacrolimus 2 Years After Liver Transplantation: Results of a Randomized Multicenter Study

PubMed Central

Charlton, Michael; Rinella, Mary; Patel, Dharmesh; McCague, Kevin; Heimbach, Julie; Watt, Kymberly

2017-01-01

Background Weight gain early after transplant is a risk factor for posttransplant metabolic syndrome (PTMS), cardiovascular events, and renal insufficiency. The impact of mammalian target of rapamycin inhibition on posttransplant weight gain and the development of PTMS components postliver transplantation were examined in a randomized, controlled study. Methods After a run-in period, patients (N = 719) were randomized at 30 ± 5 days posttransplant in a 1:1:1 ratio to 3 treatment groups: (i) everolimus (EVR) + reduced tacrolimus (TAC) (n = 245); (ii) TAC control (n = 243) or (iii) TAC elimination (n = 231). In this post hoc analysis, weight change at 12 and 24 months was compared between groups. Vital signs, lipids, and laboratory parameters at 12 and 24 months and rates of PTMS were assessed. Results Mean increase in weight from baseline was higher at month 12 in the TAC control arm (8.15 ± 9.27 kg) than in the EVR + reduced TAC (5.88 ± 12.60 kg, P = 0.056) and the TAC elimination arms (4.76 ± 9.94 kg, P = 0.007). At month 24, the TAC control arm displayed a significantly greater weight increase (9.54 ± 10.21 kg) than either the EVR + reduced TAC (6.69 ± 8.37 kg, P = 0.011) or the TAC elimination groups (6.01 ± 9.98 kg, P = 0.024). Rates of PTMS were similar for the EVR + reduced TAC (71.8%), TAC elimination (70.3%) and TAC control (67.4%) arms (P = NS). Conclusions EVR with reduced-exposure TAC attenuated weight gain at 1 and 2 years posttransplant compared with a standard TAC immunosuppression regimen. Rates of PTMS were comparable between EVR-containing and TAC control regimens. PMID:28817434

Successful pharmacogenetics-based optimization of unboosted atazanavir plasma exposure in HIV-positive patients: a randomized, controlled, pilot study (the REYAGEN study).

PubMed

Bonora, S; Rusconi, S; Calcagno, A; Bracchi, M; Viganò, O; Cusato, J; Lanzafame, M; Trentalange, A; Marinaro, L; Siccardi, M; D'Avolio, A; Galli, M; Di Perri, G

2015-11-01

Atazanavir without ritonavir, despite efficacy and tolerability, shows low plasma concentrations that warrant optimization. In a randomized, controlled, pilot trial, stable HIV-positive patients on atazanavir/ritonavir (with tenofovir/emtricitabine) were switched to atazanavir. In the standard-dose arm, atazanavir was administered as 400 mg once daily, while according to patients' genetics (PXR, ABCB1 and SLCO1B1), in the pharmacogenetic arm: patients with unfavourable genotypes received 200 mg of atazanavir twice daily. EudraCT number: 2009-014216-35. Eighty patients were enrolled with balanced baseline characteristics. The average atazanavir exposure was 253 ng/mL (150-542) in the pharmacogenetic arm versus 111 ng/mL (64-190) in the standard-dose arm (P < 0.001); 28 patients in the pharmacogenetic arm (75.7%) had atazanavir exposure >150 ng/mL versus 14 patients (38.9%) in the standard-dose arm (P = 0.001). Immunovirological and laboratory parameters had a favourable outcome throughout the study with non-significant differences between study arms. Atazanavir plasma exposure is higher when the schedule is chosen according to the patient's genetic profile. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Rectal Diclofenac and Sublingual Nitroglycerin as a Combined Prophylactic Treatment for Post-ERCP Pancreatitis.

PubMed

Tomoda, Takeshi; Kato, Hironari; Mizukawa, Sho; Muro, Shinichiro; Akimoto, Yutaka; Uchida, Daisuke; Matsumoto, Kazuyuki; Yamamoto, Naoki; Horiguchi, Shigeru; Tsutsumi, Koichiro; Okada, Hiroyuki

2016-01-01

Acute pancreatitis is the major complication of endoscopic retrograde cholangiopancreatography (ERCP). A preliminary research suggested that the administration of nonsteroidal anti-inflammatory drugs (NSAIDs) with nitroglycerin might reduce the incidence of post-ERCP pancreatitis (PEP) more effectively than NSAIDs alone. We conduct a two-arm, multicenter, prospective, randomized, superiority trial to evaluate the additional effect of nitroglycerin for prevention of PEP. A total of 900 patients randomly receive 50 mg diclofenac suppository either alone or with 5 mg isosorbide dinitrate sublingual tablet. The primary endpoint is the occurrence of PEP. This study will clarify whether NSAIDs plus nitroglycerin can prevent PEP.

A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes

PubMed Central

Mathiesen, Elisabeth R; Jovanovič, Lois; McCance, David R; Ivanisevic, Marina; Durán-Garcia, Santiago; Brøndsted, Lise; Nazeri, Avideh; Damm, Peter

2014-01-01

Objective This randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented. Methods Subjects were randomized to IDet (n = 152) or NPH (n = 158) ≤12 months before pregnancy or at 8–12 gestational weeks. Results For IDet and NPH, there were 128 and 136 live births, 11 and 9 early fetal losses, and two and one perinatal deaths, respectively. Gestational age at delivery was greater for children from the IDet arm than the NPH arm (treatment difference: 0.49 weeks [95% CI 0.11;0.88], p = 0.012, linear regression). Sixteen children had a malformation (IDet: n = 8/142, 5.6%; NPH: n = 8/145, 5.5%). The incidence of adverse events was similar between treatments. Conclusion IDet is as well tolerated as NPH as regards perinatal outcomes in pregnant women with type 1 diabetes and no safety issues were identified. PMID:23617228

Long-Term Follow-up of Participants with Heart Failure in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

PubMed Central

Piller, Linda B.; Baraniuk, Sarah; Simpson, Lara M.; Cushman, William C.; Massie, Barry M.; Einhorn, Paula T.; Oparil, Suzanne; Ford, Charles E.; Graumlich, James F.; Dart, Richard A.; Parish, David C.; Retta, Tamrat M.; Cuyjet, Aloysius B.; Jafri, Syed Z.; Furberg, Curt D.; Saklayen, Mohammad G.; Thadani, Udho; Probstfield, Jeffrey L.; Davis, Barry R.

2011-01-01

Background In the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), a randomized, double-blind, practice-based, active-control, comparative effectiveness trial in high-risk hypertensive participants, risk of new-onset heart failure (HF) was higher in the amlodipine (2.5-10 mg/day) and lisinopril (10-40 mg/day) arms compared with the chlorthalidone (12.5-25 mg/day) arm . Similar to other studies, mortality rates following new-onset HF were very high (≥50% at 5 years), and were similar across randomized treatment arms. After the randomized phase of the trial ended in 2002, outcomes were determined from administrative databases. Methods and Results Using national databases, post-trial follow-up mortality through 2006 was obtained on participants who developed new-onset HF during the randomized (in-trial) phase of ALLHAT. Mean follow-up for the entire period was 8.9 years. Of 1761 participants with incident HF in-trial, 1348 died. Post-HF all-cause mortality was similar across treatment groups with adjusted hazard ratios (95% confidence intervals) of 0.95 (0.81-1.12) and 1.05 (0.89-1.25), respectively, for amlodipine and lisinopril compared with chlorthalidone, and 10-year adjusted rates of 86%, 87%, and 83%, respectively. All-cause mortality rates were also similar among those with reduced ejection fractions (84%) and preserved ejection fractions (81%) with no significant differences by randomized treatment arm. Conclusions Once HF develops, risk of death is high and consistent across randomized treatment groups. Measures to prevent the development of HF, especially blood pressure control, must be a priority if mortality associated with development of HF is to be addressed. PMID:21969009

Effects of Bladder Training and Pelvic Floor Muscle Training in Female Patients with Overactive Bladder Syndrome: A Randomized Controlled Trial.

PubMed

Rizvi, Raheela Mohsin; Chughtai, Novera Ghayoor; Kapadia, Naheed

2018-01-01

The purpose of our study was to see the efficacy of 3 different modes of treatment for overactive bladder (OAB) in symptoms reduction and quality of life improvement. We conducted a 12-week single-blinded randomized controlled trial of women aged 22-65 years with clinical diagnosis of OAB. Arm A (n = 47) received bladder training, arm B (n = 50) received pelvic floor muscle training (PFMT), and arm C (n = 50) received PFMT with biofeedback. Bladder diary was used to assess the difference in urinary frequency, urgency, and leak accidents before and after treatment. Initial and final assessment was made using -validated urogenital distress inventory short form 6 (UDI-SF6) and incontinence impact questionnaire short form 7 (IIQ-SF7). UDI-SF6 scores showed significant improvement in all arms. There was a reduction in UDI-6 scores from 8.38 ± 4.3 to 4.77 ± 5.5 with a mean difference of 3.61 ± 7.4 in patients in arm A (p = 0.002), arm B (p = 0.01), and arm C (p = 0.016). All patients in arms A, B, and C reported significant improvement in quality of life as assessed by IIQ-SF7 scores with significant p values of 0.009, 0.051, and 0.001, respectively. Bladder diary results using paired t test showed the significant difference in day time urinary frequency in arm A after treatment, as well as the reduction in both leak accidents and urgency score in all 3 arms. All 3 arms of study showed significant results and can be used as the first line of management. © 2018 S. Karger AG, Basel.

Naproxen Sodium for Pain Control With Intrauterine Device Insertion: A Randomized Controlled Trial.

PubMed

Ngo, Lynn L; Braaten, Kari P; Eichen, Eva; Fortin, Jennifer; Maurer, Rie; Goldberg, Alisa B

2016-12-01

To evaluate whether 550 mg oral naproxen sodium given 1 hour before intrauterine device (IUD) insertion is effective for pain relief as compared with placebo. This was a randomized, double-blind, placebo-controlled trial. The primary outcome was pain with IUD insertion measured on a 100-mm visual analog scale (VAS). Our sample size was calculated to detect a 15-mm difference in VAS scores with 80% power (α=0.05). Secondary outcomes included pain with tenaculum placement, uterine sounding, and 5 and 15 minutes postinsertion. A total of 118 women were enrolled and analyzed (58 in the naproxen sodium arm, 60 in the placebo arm, 97% nulliparous) between May 11, 2015, and March 25, 2016. There were no differences in baseline demographics or reproductive characteristics between arms. There were no differences in median VAS pain scores for the primary outcome of pain with IUD insertion between the naproxen sodium arm compared with the placebo arm (69 compared with 66 mm, P=.89). There were no differences in the secondary outcomes of median VAS pain scores with tenaculum placement (37 compared with 32 mm, P=.97) or uterine sounding (60 compared with 58 mm, P=.66). However, median pain scores postprocedure were lower in the naproxen arm as compared with the placebo arm: 17 compared with 26 mm (P=.01) at 5 minutes and 13 compared with 24 mm (P=.01) at 15 minutes postinsertion. Oral naproxen sodium does not reduce pain with IUD insertion but does reduce pain after insertion and should be considered as a premedication. ClinicalTrials.gov, http://clinicaltrials.gov, NCT02388191.

Cognitive function and neurodevelopmental outcomes in HIV-infected Children older than 1 year of age randomized to early versus deferred antiretroviral therapy: the PREDICT neurodevelopmental study.

PubMed

Puthanakit, Thanyawee; Ananworanich, Jintanat; Vonthanak, Saphonn; Kosalaraksa, Pope; Hansudewechakul, Rawiwan; van der Lugt, Jasper; Kerr, Stephen J; Kanjanavanit, Suparat; Ngampiyaskul, Chaiwat; Wongsawat, Jurai; Luesomboon, Wicharn; Vibol, Ung; Pruksakaew, Kanchana; Suwarnlerk, Tulathip; Apornpong, Tanakorn; Ratanadilok, Kattiya; Paul, Robert; Mofenson, Lynne M; Fox, Lawrence; Valcour, Victor; Brouwers, Pim; Ruxrungtham, Kiat

2013-05-01

We previously reported similar AIDS-free survival at 3 years in children who were >1 year old initiating antiretroviral therapy (ART) and randomized to early versus deferred ART in the Pediatric Randomized to Early versus Deferred Initiation in Cambodia and Thailand (PREDICT) study. We now report neurodevelopmental outcomes. Two hundred eighty-four HIV-infected Thai and Cambodian children aged 1-12 years with CD4 counts between 15% and 24% and no AIDS-defining illness were randomized to initiate ART at enrollment ("early," n = 139) or when CD4 count became <15% or a Centers for Disease Control (CDC) category C event developed ("deferred," n = 145). All underwent age-appropriate neurodevelopment testing including Beery Visual Motor Integration, Purdue Pegboard, Color Trails and Child Behavioral Checklist. Thai children (n = 170) also completed Wechsler Intelligence Scale (intelligence quotient) and Stanford Binet Memory test. We compared week 144 measures by randomized group and to HIV-uninfected children (n = 319). At week 144, the median age was 9 years and 69 (48%) of the deferred arm children had initiated ART. The early arm had a higher CD4 (33% versus 24%, P < 0.001) and a greater percentage of children with viral suppression (91% versus 40%, P < 0.001). Neurodevelopmental scores did not differ by arm, and there were no differences in changes between arms across repeated assessments in time-varying multivariate models. HIV-infected children performed worse than uninfected children on intelligence quotient, Beery Visual Motor Integration, Binet memory and Child Behavioral Checklist. In HIV-infected children surviving beyond 1 year of age without ART, neurodevelopmental outcomes were similar with ART initiation at CD4 15%-24% versus <15%, but both groups performed worse than HIV-uninfected children. The window of opportunity for a positive effect of ART initiation on neurodevelopment may remain in infancy.

A phase II study in advanced cancer patients to evaluate the early transition to palliative care (the PREPArE trial): protocol study for a randomized controlled trial.

PubMed

do Carmo, Thamires Monteiro; Paiva, Bianca Sakamoto Ribeiro; de Siqueira, Milena Ruas; da Rosa, Luciana de Toledo Bernardes; de Oliveira, Cleyton Zanardo; Nascimento, Maria Salete de Angelis; Paiva, Carlos Eduardo

2015-04-12

Previous studies have demonstrated the benefit of early integration of palliative care (PC) in oncology. However, patients continue to receive late referrals to PC even in comprehensive cancer centers. Patients and health professionals may perceive PC as 'a place to die,' and this stigma is a barrier to timely referrals and to patient acceptance of treatment. The primary objective is to evaluate the feasibility of psychosocial intervention and PC in patients with advanced cancer. The patients will be submitted to a series of brief psychosocial interventions that are based on cognitive behavioral therapy, and patient acceptance and satisfaction will be assessed. In addition, the impact of these interventions on depressive symptoms will be evaluated. A randomized, open-label, phase II trial with two intervention arms and a control group will be conducted. Patients who are started on palliative chemotherapy and who meet the inclusion criteria will be enrolled. The study participants will be recruited from the outpatient oncology clinics at Barretos Cancer Hospital and will be randomized into one of the following three treatment arms: Arm A, which will include five weekly psychosocial interventions based on CBT in combination with early PC; Arm B, which will include early PC only; and Arm C, which will include standard oncologic care. The Hospital Anxiety and Depression Scale (HADS), the Patient Health Questionnaire (PHQ-9), the Edmonton Symptom Assessment System (ESAS-br), the Family Satisfaction with End-of-Life Care (FAMCARE)-Patient scale, and the Disease Understanding Protocol will be used for data collection. The patients will answer these questionnaires at baseline and 45, 90, 120 and 180 days after randomization. Despite evidence of the positive impact of early PC, it is often provided to patients only at later stages. The inadequate awareness and stigmatization of PC as a place to die are barriers that complicate the early referral. Patients with advanced cancer may benefit from a psychosocial and educational strategy that adequately prepares them for initial PC appointments after an early referral to PC. We anticipate that benefits of psychological intervention shall be synergistic to secondary emotional benefits from the early integration of PC. This trial was registered on 6 May 2014 with ClinicalTrials.gov (identifier: NCT02133274).

Unaffected Arm Muscle Hypercatabolism in Dysphagic Subacute Stroke Patients: The Effects of Essential Amino Acid Supplementation

PubMed Central

Aquilani, Roberto; Boselli, Mirella; D'Antona, Giuseppe; Baiardi, Paola; Boschi, Federica; Viglio, Simona; Iadarola, Paolo; Pasini, Evasio; Barbieri, Annalisa; Dossena, Maurizia; Bongiorno, Andria Innocenza; Verri, Manuela

2014-01-01

Alterations in muscle protein turnover of the unaffected side of stroke patients could contribute to physical disability. We investigated whether hypercatabolic activity occurred in unaffected arm muscle and whether supplemented essential amino acids (EAAs) could limit muscle hypercatabolism (MH). Thirty-eight dysphagic subacute stroke subjects (<3 months after acute event) (29 males + 9 females; 69.7 ± 11.4 yrs) were enrolled and randomized to receive 8 g/day EAAs (n = 19; EAA group) or isocaloric placebo (maltodextrin; n = 19, Plac group). Before randomization, all patients had their arterial (A) and venous (V) amino acids measured and muscle (A − V) differences calculated in the unaffected arm. Eight matched and healthy subjects served as controls. When compared to healthy controls, the entire stroke population showed significant muscle release (= negative value A − V) of the amino acid phenylalanine (phenyl-) indicating a prevalence of MH. Moreover, randomized EAA and Plac groups had similar rates of MH. After 38 days from the start of the protocol, the EAA group but not the Plac group had MH converted to balanced protein turnover or anabolic activity. We concluded that muscle protein metabolism of the unaffected arm of dysphagic subacute stroke individuals could be characterized by MH which can be corrected by supplemented EAAs. PMID:25431770

Strategies and Opportunities to STOP Colon Cancer in Priority Populations: Design of a Cluster-Randomized Pragmatic Trial

PubMed Central

Coronado, Gloria D.; Vollmer, William M.; Petrik, Amanda; Taplin, Stephen H.; Burdick, Timothy E.; Meenan, Richard T.; Green, Beverly

2014-01-01

Background Colorectal cancer is the second-leading cause of cancer deaths in the United States. The Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) in Priority Populations study is a pragmatic trial and a collaboration between two research institutions and a network of more than 200 safety net clinics. The study will assess effectiveness of a systems-based intervention designed to improve rates of colorectal-cancer screening using fecal immunochemical testing (FIT) in federally qualified health centers in Oregon and Northern California. Material and Methods STOP CRC is a cluster-randomized comparative-effectiveness pragmatic trial enrolling 26 clinics. Clinics will be randomized to one of two arms. Clinics in the intervention arm (1) will use an automated, data-driven, electronic health record-embedded program to identify patients due for colorectal screening and mail FIT kits (with pictographic instructions) to them; (2) will conduct an improvement process (e.g. Plan-Do-Study-Act) to enhance the adoption, reach, and effectiveness of the program. Clinics in the control arm will provide opportunistic colorectal-cancer screening to patients at clinic visits. The primary outcomes are: proportion of age– and screening-eligible patients completing a FIT within 12 months; and cost, cost-effectiveness, and return on investment of the intervention. Conclusions This large-scale pragmatic trial will leverage electronic health record information and existing clinic staff to enroll a broad range of patients, including many with historically low colorectal-cancer screening rates. If successful, the program will provide a model for a cost-effective and scalable method to raise colorectal-cancer screening rates. PMID:24937017

Efficacy of Atorvastatin in Prevention of Contrast-induced Nephropathy in High-risk Patients Undergoing Angiography: A Double-blind Randomized Controlled Trial.

PubMed

Syed, Maaz Hussain; Khandelwal, Prakash Narayan; Thawani, Vijay R; Katare, S S

2017-01-01

To evaluate the efficacy and safety of atorvastatin (ATN) 80 mg in the prevention of contrast medium- induced nephropathy (CIN) in high risk patients undergoing angiograph. This was a prospective, double-blind, two-arm, parallel group RCT. A total of 216 patients undergoing coronary angiography were screened, and 188 eligible patients were randomized to two treatment arms. Patients in Group A received tablet N-acetylcysteine (NAC) 1200 mg once daily, and patients in Group B received tablet atorvastatin 80 mg + NAC 1200 mg once daily, for 3 days before, and 2 days after angiography. A total of 160 patients completed the trial. Postprocedure, nine and two CIN cases were found in Group A and B, respectively. The mean change in serum creatinine was 0.086 ± 0.168 in Group A and 0.021 ± 0.083 in Group B, which was statistically significant ( P = 0.0289). Postprocedure, the estimated glomerular filteration rate was reduced by 19.52 in Group A and 13.55 in Group B ( P = 0.003). This trial indicates the positive role of statins in preventive strategy against CIN along with NAC.

Efficacy of Atorvastatin in Prevention of Contrast-induced Nephropathy in High-risk Patients Undergoing Angiography: A Double-blind Randomized Controlled Trial

PubMed Central

Syed, Maaz Hussain; Khandelwal, Prakash Narayan; Thawani, Vijay R.; Katare, S. S.

2017-01-01

Objective: To evaluate the efficacy and safety of atorvastatin (ATN) 80 mg in the prevention of contrast medium- induced nephropathy (CIN) in high risk patients undergoing angiograph. Materials and Methods: This was a prospective, double-blind, two-arm, parallel group RCT. A total of 216 patients undergoing coronary angiography were screened, and 188 eligible patients were randomized to two treatment arms. Patients in Group A received tablet N-acetylcysteine (NAC) 1200 mg once daily, and patients in Group B received tablet atorvastatin 80 mg + NAC 1200 mg once daily, for 3 days before, and 2 days after angiography. Results: A total of 160 patients completed the trial. Postprocedure, nine and two CIN cases were found in Group A and B, respectively. The mean change in serum creatinine was 0.086 ± 0.168 in Group A and 0.021 ± 0.083 in Group B, which was statistically significant (P = 0.0289). Postprocedure, the estimated glomerular filteration rate was reduced by 19.52 in Group A and 13.55 in Group B (P = 0.003). Conclusion: This trial indicates the positive role of statins in preventive strategy against CIN along with NAC. PMID:28706398

[Multicentric prospective randomized and controlled study assessing effectiveness of intravaginal electrostimulation at home compared to usual care in female patients with urinary incontinence and prior perineal reeducation].

PubMed

Lopès, P; Rimbault, F; Scheffler, M; André, C; Cappelletti, M-C; Marès, P

2014-11-01

In order to maintain the benefits of perineal reeducation, patients with stress urinary incontinence need to perform self-retraining exercises of the perineal muscles at home. The aim of this randomized prospective multicentric study is to assess the effectiveness of GYNEFFIK(®), a perineal electrostimulator, during this home-care phase. Two parallel groups of women with stress urinary incontinence (UI) or with mixed UI (composed predominantly of stress UI), improved by physiotherapy, have followed a self-reeducation program, either with electrostimulation sessions (GYNEFFIK(®) or home perineal electrostimulation [HPES] arm) or with usual care (UC) only, without electrostimulation. The comparison of the two groups was based on the rate of women in which the benefit of the initial perineal reeducation was maintained (defined as the ICIQ and Ditrovie scales' score not worsening) at 2, 4 and 6 months. A total of 161 patients were analyzed (76 in the HPES arm and 85 in the UC arm). The therapeutic benefit of the initial perineal reeducation at the last available measure (6 months for a wide majority of patients) was maintained in 81.6% in the HPES arm versus 62.4% in the UC arm (P=0.007). This significant difference reflects a significant improvement both in clinical symptomatology and in quality of life. ICIQ score was improved in 44% of patients of HPES arm while it was improved in 14% of patients of UC arm (P<0.001) and daily number of urine leakage decreased of 1.2 leakage in the HPES arm versus 0.1 leakage in UC arm (P<0.05). Likewise, improvement of quality of life was superior in the HPES arm (48% improvement of Ditrovie score versus 19% in the UC group ; P<0.05). Investigator global impression was more favorable in the HPES arm (clinical improvement in 83% of patients versus 68% in the UC arm). At the last measure (i.e. endpoint), the benefit of initial physiotherapy was considered maintained or improved in all patients of the HPES arm while it was reported as worsened in 16.5% of the UC group. Using GYNEFFIK(®) favorably impacts quality of life, particularly physical activity and vitality and decreases emotional consequences of UI (i.e. anxiety and depression score as assessed by HAD scale). Copyright © 2014 Elsevier Masson SAS. All rights reserved.

A Randomized Controlled Trial of a Cardiopulmonary Resuscitation Video in Advance Care Planning for Progressive Pancreas and Hepatobiliary Cancer Patients

PubMed Central

Volandes, Angelo E.; Chen, Ling Y.; Gary, Kristen A.; Li, Yuelin; Agre, Patricia; Levin, Tomer T.; Reidy, Diane L.; Meng, Raymond D.; Segal, Neil H.; Yu, Kenneth H.; Abou-Alfa, Ghassan K.; Janjigian, Yelena Y.; Kelsen, David P.; O'Reilly, Eileen M.

2013-01-01

Abstract Background Cardiopulmonary resuscitation (CPR) is an important advance directive (AD) topic in patients with progressive cancer; however such discussions are challenging. Objective This study investigates whether video educational information about CPR engenders broader advance care planning (ACP) discourse. Methods Patients with progressive pancreas or hepatobiliary cancer were randomized to an educational CPR video or a similar CPR narrative. The primary end-point was the difference in ACP documentation one month posttest between arms. Secondary end-points included study impressions; pre- and post-intervention knowledge of and preferences for CPR and mechanical ventilation; and longitudinal patient outcomes. Results Fifty-six subjects were consented and analyzed. Rates of ACP documentation (either formal ADs or documented discussions) were 40% in the video arm (12/30) compared to 15% in the narrative arm (4/26), OR=3.6 [95% CI: 0.9–18.0], p=0.07. Post-intervention knowledge was higher in both arms. Posttest, preferences for CPR had changed in the video arm but not in the narrative arm. Preferences regarding mechanical ventilation did not change in either arm. The majority of subjects in both arms reported the information as helpful and comfortable to discuss, and they recommended it to others. More deaths occurred in the video arm compared to the narrative arm, and more subjects died in hospice settings in the video arm. Conclusions This pilot randomized trial addressing downstream ACP effects of video versus narrative decision tools demonstrated a trend towards more ACP documentation in video subjects. This trend, as well as other video effects, is the subject of ongoing study. PMID:23725233

Design and methodology of a community-based cluster-randomized controlled trial for dietary behaviour change in rural Kerala.

PubMed

Daivadanam, Meena; Wahlstrom, Rolf; Sundari Ravindran, T K; Sarma, P S; Sivasankaran, S; Thankappan, K R

2013-07-17

Interventions targeting lifestyle-related risk factors and non-communicable diseases have contributed to the mainstream knowledge necessary for action. However, there are gaps in how this knowledge can be translated for practical day-to-day use in complex multicultural settings like that in India. Here, we describe the design of the Behavioural Intervention for Diet study, which was developed as a community-based intervention to change dietary behaviour among middle-income households in rural Kerala. This was a cluster-randomized controlled trial to assess the effectiveness of a sequential stage-matched intervention to bring about dietary behaviour change by targeting the procurement and consumption of five dietary components: fruits, vegetables, salt, sugar, and oil. Following a step-wise process of pairing and exclusion of outliers, six out of 22 administrative units in the northern part of Trivandrum district, Kerala state were randomly selected and allocated to intervention or control arms. Trained community volunteers carried out the data collection and intervention delivery. An innovative tool was developed to assess household readiness-to-change, and a household measurement kit and easy formulas were introduced to facilitate the practical side of behaviour change. The 1-year intervention included a household component with sequential stage-matched intervention strategies at 0, 6, and 12 months along with counselling sessions, telephonic reminders, and home visits and a community component with general awareness sessions in the intervention arm. Households in the control arm received information on recommended levels of intake of the five dietary components and general dietary information leaflets. Formative research provided the knowledge to contextualise the design of the study in accordance with socio-cultural aspects, felt needs of the community, and the ground realities associated with existing dietary procurement, preparation, and consumption patterns. The study also addressed two key issues, namely the central role of the household as the decision unit and the long-term sustainability through the use of existing local and administrative networks and community volunteers.

Efficacy of a workplace osteoporosis prevention intervention: a cluster randomized trial.

PubMed

Tan, Ai May; LaMontagne, Anthony D; English, Dallas R; Howard, Peter

2016-08-24

Osteoporosis is a debilitating disease. Adequate calcium consumption and physical activity are the two major modifiable risk factors. This paper describes the major outcomes and efficacy of a workplace-based targeted behaviour change intervention to improve the dietary and physical activity behaviours of working women in sedentary occupations in Singapore. A cluster-randomized design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the units of randomization and intervention. Sixteen workplaces were recruited from a pool of 97, and randomly assigned to intervention and control arms (eight workplaces in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organization-wide educational activities. Workplaces in the control/standard care arm received print resources. Outcome measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, 4 weeks and 6 months post intervention. Adjusted cluster-level analyses were conducted comparing changes in intervention versus control groups, following intention-to-treat principles and CONSORT guidelines. Workplaces in the intervention group reported a significantly greater increase in calcium intake and duration of load-bearing moderate to vigorous physical activity (MVPA) compared with the standard care control group. Four weeks after intervention, the difference in adjusted mean calcium intake was 343.2 mg/day (95 % CI = 337.4 to 349.0, p < .0005) and the difference in adjusted mean load-bearing MVPA was 55.6 min/week (95 % CI = 54.5 to 56.6, p < .0005). Six months post intervention, the mean differences attenuated slightly to 290.5 mg/day (95 % CI = 285.3 to 295.7, p < .0005) and 50.9 min/week (95 % CI =49.3 to 52.6, p < .0005) respectively. This workplace-based intervention substantially improved calcium intake and load-bearing moderate to vigorous physical activity 6 months after the intervention began. Australia New Zealand Clinical Trial Registry ACTRN12616000079448 . Registered 25 January 2016 (retrospectively registered).

Strategies to retain participants in a long-term HIV prevention randomized controlled trial: Lessons from the MINTS-II study

PubMed Central

Horvath, Keith J.; Nygaard, Kate; Danilenko, Gene P.; Goknur, Sinan; Oakes, J. Michael; Rosser, B.R. Simon

2012-01-01

Achieving satisfactory retention in online HIV prevention trials typically have proved difficult, particularly over extended timeframes. The overall aim of this study was to assess factors associated with retention in the Men’s INTernet Study II (MINTS-II), a randomized controlled trial of a sexual risk reduction intervention for men who have sex with men. Participants were recruited via e-mails and banner advertisements in December, 2007 to participate in the MINTS-II Sexpulse intervention and followed over a 12-month period. Retention across the treatment and control arms was 85.2% at 12 months. Factors associated with higher retention included: randomization to the control arm, previous participation in a study by the research team, e-mail and telephone reminders to complete a survey once it was available to take, and fewer e-mail contacts between surveys. The results provide evidence that achieving satisfactory retention is possible in online HIV prevention trials, and suggest best practices for maximizing retention. PMID:21538084

Randomized Trial of Hypnosis as a Pain and Symptom Management Strategy in Adults with Sickle Cell Disease

PubMed Central

Wallen, Gwenyth R; Middleton, Kimberly R; Ames, Nancy; Brooks, Alyssa T; Handel, Daniel

2014-01-01

Sickle cell disease (SCD) is the most common genetic disease in African-Americans, characterized by recurrent painful vaso-occlusive crises. Medical therapies for controlling or preventing crises are limited because of efficacy and/or toxicity. This is a randomized, controlled, single-crossover protocol of hypnosis for managing pain in SCD patients. Participants receive hypnosis from a trained hypnosis therapist followed by six weeks of self-hypnosis using digital media. Those in the control arm receive SCD education followed by a six-week waiting period before crossing over to the hypnosis arm of the study. Outcome measures include assessments of pain (frequency, intensity and quality), anxiety, coping strategies, sleep, depression, and health care utilization. To date, there are no published randomized, controlled trials evaluating the efficacy of hypnosis on SCD pain modulation in adults. Self-hypnosis for pain management may be helpful in modulating chronic pain, improving sleep quality, and decreasing use of narcotics in patients with SCD. TRIAL REGISTRATION ClinicalTrials.gov: NCT00393250 PMID:25520557

Utility of optical facial feature and arm movement tracking systems to enable text communication in critically ill patients who cannot otherwise communicate.

PubMed

Muthuswamy, M B; Thomas, B N; Williams, D; Dingley, J

2014-09-01

Patients recovering from critical illness especially those with critical illness related neuropathy, myopathy, or burns to face, arms and hands are often unable to communicate by writing, speech (due to tracheostomy) or lip reading. This may frustrate both patient and staff. Two low cost movement tracking systems based around a laptop webcam and a laser/optical gaming system sensor were utilised as control inputs for on-screen text creation software and both were evaluated as communication tools in volunteers. Two methods were used to control an on-screen cursor to create short sentences via an on-screen keyboard: (i) webcam-based facial feature tracking, (ii) arm movement tracking by laser/camera gaming sensor and modified software. 16 volunteers with simulated tracheostomy and bandaged arms to simulate communication via gross movements of a burned limb, communicated 3 standard messages using each system (total 48 per system) in random sequence. Ten and 13 minor typographical errors occurred with each system respectively, however all messages were comprehensible. Speed of sentence formation ranged from 58 to 120s with the facial feature tracking system, and 60-160s with the arm movement tracking system. The average speed of sentence formation was 81s (range 58-120) and 104s (range 60-160) for facial feature and arm tracking systems respectively, (P<0.001, 2-tailed independent sample t-test). Both devices may be potentially useful communication aids in patients in general and burns critical care units who cannot communicate by conventional means, due to the nature of their injuries. Copyright © 2014 Elsevier Ltd and ISBI. All rights reserved.

A multi-stage drop-the-losers design for multi-arm clinical trials.

PubMed

Wason, James; Stallard, Nigel; Bowden, Jack; Jennison, Christopher

2017-02-01

Multi-arm multi-stage trials can improve the efficiency of the drug development process when multiple new treatments are available for testing. A group-sequential approach can be used in order to design multi-arm multi-stage trials, using an extension to Dunnett's multiple-testing procedure. The actual sample size used in such a trial is a random variable that has high variability. This can cause problems when applying for funding as the cost will also be generally highly variable. This motivates a type of design that provides the efficiency advantages of a group-sequential multi-arm multi-stage design, but has a fixed sample size. One such design is the two-stage drop-the-losers design, in which a number of experimental treatments, and a control treatment, are assessed at a prescheduled interim analysis. The best-performing experimental treatment and the control treatment then continue to a second stage. In this paper, we discuss extending this design to have more than two stages, which is shown to considerably reduce the sample size required. We also compare the resulting sample size requirements to the sample size distribution of analogous group-sequential multi-arm multi-stage designs. The sample size required for a multi-stage drop-the-losers design is usually higher than, but close to, the median sample size of a group-sequential multi-arm multi-stage trial. In many practical scenarios, the disadvantage of a slight loss in average efficiency would be overcome by the huge advantage of a fixed sample size. We assess the impact of delay between recruitment and assessment as well as unknown variance on the drop-the-losers designs.

Meta-analysis of randomized trials of effect of milrinone on mortality in cardiac surgery: an update.

PubMed

Majure, David T; Greco, Teresa; Greco, Massimiliano; Ponschab, Martin; Biondi-Zoccai, Giuseppe; Zangrillo, Alberto; Landoni, Giovanni

2013-04-01

The long-term use of milrinone is associated with increased mortality in chronic heart failure. A recent meta-analysis suggested that it might increase mortality in patients undergoing cardiac surgery. The authors conducted an updated meta-analysis of randomized trials in patients undergoing cardiac surgery to determine if milrinone impacted survival. A meta-analysis. Hospitals. One thousand thirty-seven patients from 20 randomized trials. None. Biomed, Central, PubMed, EMBASE, the Cochrane central register of clinical trials, and conference proceedings were searched for randomized trials that compared milrinone versus placebo or any other control in adult and pediatric patients undergoing cardiac surgery. Authors of trials that did not include mortality data were contacted. Only trials for which mortality data were available were included. Overall analysis showed no difference in mortality between patients receiving milrinone versus control (12/554 [2.2%] in the milrinone group v 10/483 [2.1%] in the control arm; relative risk [RR] = 1.15; 95% confidence interval [CI], 0.55-2.43; p = 0.7) or in analysis restricted to adults (11/364 [3%] in the milrinone group v 9/371 [2.4%] in the control arm; RR = 1.17; 95% CI, 0.54-2.53; p = 0.7). Sensitivity analyses in trials with a low risk of bias showed a trend toward an increase in mortality with milrinone (8/153 [5.2%] in the milrinone arm v 2/152 [1.3%] in the control arm; RR = 2.71; 95% CI, 0.82-9; p for effect = 0.10). Despite theoretic concerns for increased mortality with intravenous milrinone in patients undergoing cardiac surgery, the authors were unable to confirm an adverse effect on survival. However, sensitivity analysis of high-quality trials showed a trend toward increased mortality with milrinone. Copyright © 2013 Elsevier Inc. All rights reserved.

Does the Introduction of the Ranking Task in Valuation Studies Improve Data Quality and Reduce Inconsistencies? The Case of the EQ-5D-5L.

PubMed

Ramos-Goñi, Juan M; Rand-Hendriksen, Kim; Pinto-Prades, Jose Luis

2016-06-01

Time trade-off (TTO)-based valuation studies for the three-level version of the EuroQol five-dimensional questionnaire (EQ-5D) typically started off with a ranking task (ordering the health states by preference). This was not included in the protocol for the five-level EQ-5D (EQ-5D-5L) valuation study. To test whether reintroducing a ranking task before the composite TTO (C-TTO) could help to reduce inconsistencies in C-TTO responses and improve the data quality. Respondents were randomly assigned to three study arms. The control arm was the present EQ-5D-5L study protocol, without ranking. The second arm (ranking without sorting) preceded the present protocol by asking respondents to rank the target health states using physical cards. The states were then valued in random order using C-TTO. In the third arm (ranking and sorting), the ranked states remained visible through the C-TTO tasks and the order of valuation was determined by the ranking. The study used only 10 EQ-5D-5L health states. We compared the C-TTO-based inconsistent pairs of health states and ties. The final sample size was 196 in the control arm, 205 in the ranking without sorting arm, and 199 in the ranking and sorting arm. The percentages of ties by respondents were 15.1%, 12.5%, and 12.6% for the control arm, the ranking without sorting arm, and the ranking and sorting arm, respectively. The extra cost for adding the ranking task was about 15%. The benefit does not justify the effort involved in the ranking task. For this reason, the addition of the ranking task to the present EQ-5D-5L valuation protocol is not an attractive option. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Effect of the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation Therapy for Patients With Esophageal Cancer: The NRG Oncology RTOG 0436 Phase 3 Randomized Clinical Trial.

PubMed

Suntharalingam, Mohan; Winter, Kathryn; Ilson, David; Dicker, Adam P; Kachnic, Lisa; Konski, André; Chakravarthy, A Bapsi; Anker, Christopher J; Thakrar, Harish; Horiba, Naomi; Dubey, Ajay; Greenberger, Joel S; Raben, Adam; Giguere, Jeffrey; Roof, Kevin; Videtic, Gregory; Pollock, Jondavid; Safran, Howard; Crane, Christopher H

2017-11-01

The role of epidermal growth factor receptor (EGFR) inhibition in chemoradiation strategies in the nonoperative treatment of patients with esophageal cancer remains uncertain. To evaluate the benefit of cetuximab added to concurrent chemoradiation therapy for patients undergoing nonoperative treatment of esophageal carcinoma. A National Cancer Institute (NCI) sponsored, multicenter, phase 3, randomized clinical trial open to patients with biopsy-proven carcinoma of the esophagus. The study accrued 344 patients from 2008 to 2013. Patients were randomized to weekly concurrent cisplatin (50 mg/m2), paclitaxel (25 mg/m2), and daily radiation of 50.4 Gy/1.8 Gy fractions with or without weekly cetuximab (400 mg/m2 on day 1 then 250 mg/m2 weekly). Overall survival (OS) was the primary endpoint, with a study designed to detect an increase in 2-year OS from 41% to 53%; 80% power and 1-sided α = .025. Between June 30, 2008, and February 8, 2013, 344 patients were enrolled. This analysis used all data received at NRG Oncology through April 12, 2015. Sixteen patients were ineligible, resulting in 328 evaluable patients, 159 in the experimental arm and 169 in the control arm. Patients were well matched between the treatment arms for patient and tumor characteristics: 263 (80%) with T3 or T4 disease, 215 (66%) N1, and 62 (19%) with celiac nodal involvement. Incidence of grade 3, 4, or 5 treatment-related adverse events at any time was 71 (46%), 35 (23%), or 6 (4%) in the experimental arm and 83 (50%), 28 (17%), or 2 (1%) in the control arm, respectively. A clinical complete response (cCR) rate of 81 (56%) was observed in the experimental arm vs 92 (58%) in the control arm (Fisher exact test, P = .66). No differences were seen in cCR between treatment arms for either histology (adenocarcinoma or squamous cell). Median follow-up for all patients was 18.6 months. The 24- and 36-month local failure for the experimental arm was 47% (95% CI, 38%-57%) and 49% (95% CI, 40%-59%) vs 49% (95% CI, 41%-58%) and 49% (95% CI, 41%-58%) for the control arm (HR, 0.92; 95% CI, 0.66-1.28; P = .65). The 24- and 36-month OS rates for the experimental arm were 45% (95% CI, 37%-53%) and 34% (95% CI, 26%-41%) vs 44% (95% CI, 36%-51%) and 28% (95% CI, 21%-35%) for the control arm (HR, 0.90; 95% CI, 0.70-1.16; P = .47). The addition of cetuximab to concurrent chemoradiation did not improve OS. These phase 3 trial results point to little benefit to current EGFR-targeted agents in an unselected patient population, and highlight the need for predictive biomarkers in the treatment of esophageal cancer. clinicaltrials.gov Identifier: NCT00655876.

Irradiation with and without razoxane in the treatment of incompletely resected or inoperable recurrent rectal cancer. Results of a small randomized multicenter study.

PubMed

Rhomberg, Walter; Hammer, Josef; Sedlmayer, Felix; Eiter, Helmut; Seewald, Dieter; Schneider, Barbara

2007-07-01

In an earlier phase II study, irradiation together with razoxane was shown to improve local control in recurrent rectal cancer. Therefore, the Austrian Society of Radiooncology (OGRO) initiated a randomized controlled trial in 1992 to compare this combined treatment versus radiation therapy alone. Between 1992 and 1999, 36 patients with localized recurrences of rectal cancer were randomized to receive radiotherapy without (group A) or with razoxane (group B). The prognostic variables of the two groups were similar except for a longer median latency period from initial surgery to local recurrence in group A. High-energy photons with daily fractions between 170 and 200 cGy were used. The median total radiation dose was 60 Gy in each group. The patients in group B received a median razoxane dose of 9.6 g (range, 5-12 g). Main outcome measures were local control, overall survival, and toxicity. The combined treatment with razoxane increased the local control rate compared to radiotherapy alone (39% vs. 8%; p = 0.05). The median survival time was not different between the groups (20 months each). No patient in arm A but four of 18 patients in arm B survived 5 years. Acute toxic effects were of moderate degree in both groups. There were no substantial differences as to late side effects. Radiotherapy together with razoxane is superior to radiation treatment alone in recurrent rectal cancer as far as local control is concerned. In some patients, long-term survival was achieved with razoxane and radiotherapy.

Effect of Deploying Trained Community Based Reproductive Health Nurses (CORN) on Long-Acting Reversible Contraception (LARC) Use in Rural Ethiopia: A Cluster Randomized Community Trial.

PubMed

Zerfu, Taddese Alemu; Ayele, Henok Taddese; Bogale, Tariku Nigatu

2018-06-01

To investigate the effect of innovative means to distribute LARC on contraceptive use, we implemented a three arm, parallel groups, cluster randomized community trial design. The intervention consisted of placing trained community-based reproductive health nurses (CORN) within health centers or health posts. The nurses provided counseling to encourage women to use LARC and distributed all contraceptive methods. A total of 282 villages were randomly selected and assigned to a control arm (n = 94) or 1 of 2 treatment arms (n = 94 each). The treatment groups differed by where the new service providers were deployed, health post or health center. We calculated difference-in-difference (DID) estimates to assess program impacts on LARC use. After nine months of intervention, the use of LARC methods increased significantly by 72.3 percent, while the use of short acting methods declined by 19.6 percent. The proportion of women using LARC methods increased by 45.9 percent and 45.7 percent in the health post and health center based intervention arms, respectively. Compared to the control group, the DID estimates indicate that the use of LARC methods increased by 11.3 and 12.3 percentage points in the health post and health center based intervention arms. Given the low use of LARC methods in similar settings, deployment of contextually trained nurses at the grassroots level could substantially increase utilization of these methods. © 2018 The Population Council, Inc.

The Duration of Intestinal Immunity After an Inactivated Poliovirus Vaccine Booster Dose in Children Immunized With Oral Vaccine: A Randomized Controlled Trial.

PubMed

John, Jacob; Giri, Sidhartha; Karthikeyan, Arun S; Lata, Dipti; Jeyapaul, Shalini; Rajan, Anand K; Kumar, Nirmal; Dhanapal, Pavithra; Venkatesan, Jayalakshmi; Mani, Mohanraj; Hanusha, Janardhanan; Raman, Uma; Moses, Prabhakar D; Abraham, Asha; Bahl, Sunil; Bandyopadhyay, Ananda S; Ahmad, Mohammad; Grassly, Nicholas C; Kang, Gagandeep

2017-02-15

In 2014, 2 studies showed that inactivated poliovirus vaccine (IPV) boosts intestinal immunity in children previously immunized with oral poliovirus vaccine (OPV). As a result, IPV was introduced in mass campaigns to help achieve polio eradication. We conducted an open-label, randomized, controlled trial to assess the duration of the boost in intestinal immunity following a dose of IPV given to OPV-immunized children. Nine hundred healthy children in Vellore, India, aged 1-4 years were randomized (1:1:1) to receive IPV at 5 months (arm A), at enrollment (arm B), or no vaccine (arm C). The primary outcome was poliovirus shedding in stool 7 days after bivalent OPV challenge at 11 months. For children in arms A, B, and C, 284 (94.7%), 297 (99.0%), and 296 (98.7%), respectively, were eligible for primary per-protocol analysis. Poliovirus shedding 7 days after challenge was less prevalent in arms A and B compared with C (24.6%, 25.6%, and 36.4%, respectively; risk ratio 0.68 [95% confidence interval: 0.53-0.87] for A versus C, and 0.70 [0.55-0.90] for B versus C). Protection against poliovirus remained elevated 6 and 11 months after an IPV boost, although at a lower level than reported at 1 month. CTRI/2014/09/004979. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.

The Duration of Intestinal Immunity After an Inactivated Poliovirus Vaccine Booster Dose in Children Immunized With Oral Vaccine: A Randomized Controlled Trial

PubMed Central

John, Jacob; Giri, Sidhartha; Karthikeyan, Arun S; Lata, Dipti; Jeyapaul, Shalini; Rajan, Anand K; Kumar, Nirmal; Dhanapal, Pavithra; Venkatesan, Jayalakshmi; Mani, Mohanraj; Hanusha, Janardhanan; Raman, Uma; Moses, Prabhakar D; Abraham, Asha; Bahl, Sunil; Bandyopadhyay, Ananda S; Ahmad, Mohammad; Grassly, Nicholas C; Kang, Gagandeep

2017-01-01

Abstract Background In 2014, 2 studies showed that inactivated poliovirus vaccine (IPV) boosts intestinal immunity in children previously immunized with oral poliovirus vaccine (OPV). As a result, IPV was introduced in mass campaigns to help achieve polio eradication. Methods We conducted an open-label, randomized, controlled trial to assess the duration of the boost in intestinal immunity following a dose of IPV given to OPV-immunized children. Nine hundred healthy children in Vellore, India, aged 1–4 years were randomized (1:1:1) to receive IPV at 5 months (arm A), at enrollment (arm B), or no vaccine (arm C). The primary outcome was poliovirus shedding in stool 7 days after bivalent OPV challenge at 11 months. Results For children in arms A, B, and C, 284 (94.7%), 297 (99.0%), and 296 (98.7%), respectively, were eligible for primary per-protocol analysis. Poliovirus shedding 7 days after challenge was less prevalent in arms A and B compared with C (24.6%, 25.6%, and 36.4%, respectively; risk ratio 0.68 [95% confidence interval: 0.53–0.87] for A versus C, and 0.70 [0.55–0.90] for B versus C). Conclusions Protection against poliovirus remained elevated 6 and 11 months after an IPV boost, although at a lower level than reported at 1 month. Clinical Trials Registration CTRI/2014/09/004979. PMID:28003352

Gender-specific intervention to reduce underage drinking among early adolescent girls: a test of a computer-mediated, mother-daughter program.

PubMed

Schinke, Steven P; Cole, Kristin C A; Fang, Lin

2009-01-01

This study evaluated a gender-specific, computer-mediated intervention program to prevent underage drinking among early adolescent girls. Study participants were adolescent girls and their mothers from New York, New Jersey, and Connecticut. Participants completed pretests online and were randomly divided between intervention and control arms. Intervention-arm girls and their mothers interacted with a computer program aimed to enhance mother-daughter relationships and to teach girls skills for managing conflict, resisting media influences, refusing alcohol and drugs, and correcting peer norms about underage drinking, smoking, and drug use. After intervention, all participants (control and intervention) completed posttest and follow-up measurements. Two months following program delivery and relative to control-arm participants, intervention-arm girls and mothers had improved their mother-daughter communication skills and their perceptions and applications of parental monitoring and rule-setting relative to girls' alcohol use. Also at follow-up, intervention-arm girls had improved their conflict management and alcohol use-refusal skills; reported healthier normative beliefs about underage drinking; demonstrated greater self-efficacy about their ability to avoid underage drinking; reported less alcohol consumption in the past 7 days, 30 days, and year; and expressed lower intentions to drink as adults. Study findings modestly support the viability of a mother-daughter, computer-mediated program to prevent underage drinking among adolescent girls. The data have implications for the further development of gender-specific approaches to combat increases in alcohol and other substance use among American girls.

Generalized optimal design for two-arm, randomized phase II clinical trials with endpoints from the exponential dispersion family.

PubMed

Jiang, Wei; Mahnken, Jonathan D; He, Jianghua; Mayo, Matthew S

2016-11-01

For two-arm randomized phase II clinical trials, previous literature proposed an optimal design that minimizes the total sample sizes subject to multiple constraints on the standard errors of the estimated event rates and their difference. The original design is limited to trials with dichotomous endpoints. This paper extends the original approach to be applicable to phase II clinical trials with endpoints from the exponential dispersion family distributions. The proposed optimal design minimizes the total sample sizes needed to provide estimates of population means of both arms and their difference with pre-specified precision. Its applications on data from specific distribution families are discussed under multiple design considerations. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

An online community improves adherence in an internet-mediated walking program. Part 1: results of a randomized controlled trial.

PubMed

Richardson, Caroline R; Buis, Lorraine R; Janney, Adrienne W; Goodrich, David E; Sen, Ananda; Hess, Michael L; Mehari, Kathleen S; Fortlage, Laurie A; Resnick, Paul J; Zikmund-Fisher, Brian J; Strecher, Victor J; Piette, John D

2010-12-17

Approximately half of American adults do not meet recommended physical activity guidelines. Face-to-face lifestyle interventions improve health outcomes but are unlikely to yield population-level improvements because they can be difficult to disseminate, expensive to maintain, and inconvenient for the recipient. In contrast, Internet-based behavior change interventions can be disseminated widely at a lower cost. However, the impact of some Internet-mediated programs is limited by high attrition rates. Online communities that allow participants to communicate with each other by posting and reading messages may decrease participant attrition. Our objective was to measure the impact of adding online community features to an Internet-mediated walking program on participant attrition and average daily step counts. This randomized controlled trial included sedentary, ambulatory adults who used email regularly and had at least 1 of the following: overweight (body mass index [BMI] ≥ 25), type 2 diabetes, or coronary artery disease. All participants (n = 324) wore enhanced pedometers throughout the 16-week intervention and uploaded step-count data to the study server. Participants could log in to the study website to view graphs of their walking progress, individually-tailored motivational messages, and weekly calculated goals. Participants were randomized to 1 of 2 versions of a Web-based walking program. Those randomized to the "online community" arm could post and read messages with other participants while those randomized to the "no online community" arm could not read or post messages. The main outcome measures were participant attrition and average daily step counts over 16 weeks. Multiple regression analyses assessed the effect of the online community access controlling for age, sex, disease status, BMI, and baseline step counts. Both arms significantly increased their average daily steps between baseline and the end of the intervention period, but there were no significant differences in increase in step counts between arms using either intention-to-treat or completers analysis. In the intention-to-treat analysis, the average step count increase across both arms was 1888 ± 2400 steps. The percentage of completers was 13% higher in the online community arm than the no online community arm (online community arm, 79%, no online community arm, 66%, P = .02). In addition, online community arm participants remained engaged in the program longer than no online community arm participants (hazard ratio = 0.47, 95% CI = 0.25 - 0.90, P = .02). Participants with lower baseline social support posted more messages to the online community (P < .001) and viewed more posts (P < .001) than participants with higher baseline social support. Adding online community features to an Internet-mediated walking program did not increase average daily step counts but did reduce participant attrition. Participants with low baseline social support used the online community features more than those with high baseline social support. Thus, online communities may be a promising approach to reducing attrition from online health behavior change interventions, particularly in populations with low social support. NCT00729040; http://clinicaltrials.gov/ct2/show/NCT00729040 (Archived by WebCite at http://www.webcitation.org/5v1VH3n0A).

Once-a-Week Versus Once-Every-3-Weeks Cisplatin Chemoradiation for Locally Advanced Head and Neck Cancer: A Phase III Randomized Noninferiority Trial.

PubMed

Noronha, Vanita; Joshi, Amit; Patil, Vijay Maruti; Agarwal, Jaiprakash; Ghosh-Laskar, Sarbani; Budrukkar, Ashwini; Murthy, Vedang; Gupta, Tejpal; D'Cruz, Anil K; Banavali, Shripad; Pai, Prathamesh S; Chaturvedi, Pankaj; Chaukar, Devendra; Pande, Nikhil; Chandrasekharan, Arun; Talreja, Vikas; Vallathol, Dilip Harindran; Mathrudev, Vijayalakshmi; Manjrekar, Aparna; Maske, Kamesh; Bhelekar, Arati Sanjay; Nawale, Kavita; Kannan, Sadhana; Gota, Vikram; Bhattacharjee, Atanu; Kane, Shubhada; Juvekar, Shashikant L; Prabhash, Kumar

2018-04-10

Purpose Chemoradiation with cisplatin 100 mg/m 2 given once every 3 weeks is the standard of care in locally advanced head and neck squamous cell cancer (LAHNSCC). Increasingly, low-dose once-a-week cisplatin is substituted because of perceived lower toxicity and convenience. However, there is no level 1 evidence of comparable efficacy to cisplatin once every 3 weeks. Patients and Methods In this phase III randomized trial, we assessed the noninferiority of cisplatin 30 mg/m 2 given once a week compared with cisplatin 100 mg/m 2 given once every 3 weeks, both administered concurrently with curative intent radiotherapy in patients with LAHNSCC. The primary end point was locoregional control (LRC); secondary end points included toxicity, compliance, response, progression-free survival, and overall survival. Results Between 2013 and 2017, we randomly assigned 300 patients, 150 to each arm. Two hundred seventy-nine patients (93%) received chemoradiotherapy in the adjuvant setting. At a median follow-up of 22 months, the estimated cumulative 2-year LRC rate was 58.5% in the once-a-week arm and 73.1% in the once-every-3-weeks arm, leading to an absolute difference of 14.6% (95% CI, 5.7% to 23.5%); P = .014; hazard ratio (HR), 1.76 (95% CI, 1.11 to 2.79). Acute toxicities of grade 3 or higher occurred in 71.6% of patients in the once-a-week arm and in 84.6% of patients in the once-every-3-weeks arm ( P = .006). Estimated median progression-free survival in the once-a-week arm was 17.7 months (95% CI, 0.42 to 35.05 months) and in the once-every-3-weeks arm, 28.6 months (95% CI, 15.90 to 41.30 months); HR, 1.24 (95% CI, 0.89 to 1.73); P = .21. Estimated median overall survival in the once-a-week arm was 39.5 months and was not reached in the once-every-3-weeks arm (HR, 1.14 [95% CI, 0.79 to 1.65]; P = .48). Conclusion Once-every-3-weeks cisplatin at 100 mg/m 2 resulted in superior LRC, albeit with more toxicity, than did once-a-week cisplatin at 30 mg/m 2 , and should remain the preferred chemoradiotherapy regimen for LAHNSCC in the adjuvant setting.

HIV knowledge, stigma, and illness beliefs among pediatric caregivers in Ghana who have not disclosed their child's HIV status.

PubMed

Paintsil, Elijah; Renner, Lorna; Antwi, Sampson; Dame, Joycelyn; Enimil, Anthony; Ofori-Atta, Angela; Alhassan, Amina; Ofori, Irene Pokuaa; Cong, Xiangyu; Kyriakides, Tassos; Reynolds, Nancy R

2015-01-01

The majority of HIV-infected children in sub-Saharan Africa have not been informed of their HIV status. Caregivers are reluctant to disclose HIV status to their children because of concern about the child's ability to understand, parental sense of guilt, and fear of social rejection and isolation. We hypothesized that the low prevalence of pediatric HIV disclosure in Ghana is due to lack of accurate HIV information and high HIV stigma among caregivers. This is a preliminary analysis of baseline data of an HIV pediatric disclosure intervention study in Ghana ("Sankofa"). "Sankofa" - is a two-arm randomized controlled clinical trial comparing disclosure intervention plus usual care (intervention arm) vs usual care (control arm) at Korle-Bu Teaching Hospital (KBTH; control arm) and Komfo-Anokye Teaching Hospital (KATH; intervention arm). We enrolled HIV-infected children, ages 7-18 years who do not know their HIV status, and their caregivers. Baseline data of caregivers included demographic characteristics; Brief HIV Knowledge Questionnaire (HIV-KQ-18); Brief Illness Perception Questionnaire; and HIV Stigma Scale. Simple and multivariable linear regression analyses were used to assess the relationship between caregiver characteristics and HIV knowledge, stigma, and illness perception. Two hundred and ninety-eight caregivers were enrolled between January 2013 and July 2014 at the two study sites; KBTH (n = 167) and KATH (n = 131). The median age of caregivers was 41 years; 80.5% of them were female and about 60% of caregivers were HIV-positive. Seventy-eight percent of caregivers were self-employed with low household income. In both unadjusted and adjusted analyses, HIV negative status and lower level of education were associated with poor scores on HIV-KQ. HIV positive status remained significant for higher level of stigma in the adjusted analyses. None of the caregiver's characteristics predicted caregiver's illness perception. Intensification of HIV education in schools and targeted community campaigns are needed.

Feasibility, acceptability and preliminary psychological benefits of mindfulness meditation training in a sample of men diagnosed with prostate cancer on active surveillance: results from a randomized controlled pilot trial.

PubMed

Victorson, David; Hankin, Vered; Burns, James; Weiland, Rebecca; Maletich, Carly; Sufrin, Nathaniel; Schuette, Stephanie; Gutierrez, Bruriah; Brendler, Charles

2017-08-01

In a pilot randomized controlled trial, examine the feasibility and preliminary efficacy of an 8-week, mindfulness training program (Mindfulness Based Stress Reduction) in a sample of men on active surveillance on important psychological outcomes including prostate cancer anxiety, uncertainty intolerance and posttraumatic growth. Men were randomized to either mindfulness (n = 24) or an attention control arm (n = 19) and completed self-reported measures of prostate cancer anxiety, uncertainty intolerance, global quality of life, mindfulness and posttraumatic growth at baseline, 8 weeks, 6 months and 12 months. Participants in the mindfulness arm demonstrated significant decreases in prostate cancer anxiety and uncertainty intolerance, and significant increases in mindfulness, global mental health and posttraumatic growth. Participants in the control condition also demonstrated significant increases in mindfulness over time. Longitudinal increases in posttraumatic growth were significantly larger in the mindfulness arm than they were in the control arm. While mindfulness training was found to be generally feasible and acceptable among participants who enrolled in the 8-week intervention as determined by completion rates and open-ended survey responses, the response rate between initial enrollment and the total number of men approached was lower than desired (47%). While larger sample sizes are necessary to examine the efficacy of mindfulness training on important psychological outcomes, in this pilot study posttraumatic growth was shown to significantly increase over time for men in the treatment group. Mindfulness training has the potential to help men cope more effectively with some of the stressors and uncertainties associated with active surveillance. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Online distribution channel increases article usage on Mendeley: a randomized controlled trial.

PubMed

Kudlow, Paul; Cockerill, Matthew; Toccalino, Danielle; Dziadyk, Devin Bissky; Rutledge, Alan; Shachak, Aviv; McIntyre, Roger S; Ravindran, Arun; Eysenbach, Gunther

2017-01-01

Prior research shows that article reader counts (i.e. saves) on the online reference manager, Mendeley, correlate to future citations. There are currently no evidenced-based distribution strategies that have been shown to increase article saves on Mendeley. We conducted a 4-week randomized controlled trial to examine how promotion of article links in a novel online cross-publisher distribution channel (TrendMD) affect article saves on Mendeley. Four hundred articles published in the Journal of Medical Internet Research were randomized to either the TrendMD arm ( n  = 200) or the control arm ( n  = 200) of the study. Our primary outcome compares the 4-week mean Mendeley saves of articles randomized to TrendMD versus control. Articles randomized to TrendMD showed a 77% increase in article saves on Mendeley relative to control. The difference in mean Mendeley saves for TrendMD articles versus control was 2.7, 95% CI (2.63, 2.77), and statistically significant ( p  < 0.01). There was a positive correlation between pageviews driven by TrendMD and article saves on Mendeley (Spearman's rho r  = 0.60). This is the first randomized controlled trial to show how an online cross-publisher distribution channel (TrendMD) enhances article saves on Mendeley. While replication and further study are needed, these data suggest that cross-publisher article recommendations via TrendMD may enhance citations of scholarly articles.

Group Lidcombe Program Treatment for Early Stuttering: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Arnott, Simone; Onslow, Mark; O'Brian, Sue; Packman, Ann; Jones, Mark; Block, Susan

2014-01-01

Purpose: This study adds to the Lidcombe Program evidence base by comparing individual and group treatment of preschoolers who stutter. Method: A randomized controlled trial of 54 preschoolers was designed to establish whether group delivery outcomes were not inferior to the individual model. The group arm used a rolling group model, in which a…

Effects of providing personalized feedback of child's obesity risk on mothers' food choices using a virtual reality buffet.

PubMed

McBride, C M; Persky, S; Wagner, L K; Faith, M S; Ward, D S

2013-10-01

Providing personalized genetic-risk feedback of a child's susceptibility to adult-onset health conditions is a topic of considerable debate. Family health history (FHH), specifically parental overweight/obesity status, is a useful assessment for evaluating a child's genetic and environmental risk of becoming obese. It is unclear whether such risk information may influence parents' efforts to reduce their child's risk of obesity. To evaluate whether telling mothers the magnitude of their child's risk of becoming obese based on personal FHH influenced food choices for their young child from a virtual reality-based buffet restaurant. Overweight/obese mothers of a child aged 4-5 years who met eligibility criteria (N=221) were randomly assigned to one of three experimental arms, which emphasized different health information: arm 1, food safety control (Control); arm 2, behavioral-risk information (BRI) alone or arm 3, behavioral-risk information plus personal FHH-based risk assessment (BRI+FHH). Mothers donned a head-mounted display to be immersed in a virtual restaurant buffet, where they selected virtual food and beverages as a lunch for their child. Mothers who were randomized to BRI+FHH filled the index child's plate with an average of 45 fewer calories than those in the Control arm (P<0.05); those in the BRI arm filled the plate with 35 fewer calories than the Control arm, a non-significant difference. Calorie restriction was greatest among mothers in the BRI+FHH arm who received the weaker-risk message (that is, only one overweight parent). The influence of communicating a child's inherited risk of obesity on mothers' feeding practices may vary by the risk level conveyed. High-risk messages may best be coupled with strategies to increase mother's perceptions that efforts can be undertaken to reduce risk and build requisite behavioral skills to reduce risk.

Effectiveness and Cost of Insecticide-Treated Bed Nets and Indoor Residual Spraying for the Control of Cutaneous Leishmaniasis: A Cluster-Randomized Control Trial in Morocco

PubMed Central

Faraj, Chafika; Yukich, Joshua; Adlaoui, El Bachir; Wahabi, Rachid; Mnzava, Abraham Peter; Kaddaf, Mustapha; El Idrissi, Abderrahmane Laamrani; Ameur, Btissam; Kleinschmidt, Immo

2016-01-01

Cutaneous leishmaniasis (CL) remains an important public health problem in Morocco. A cluster-randomized trial was conducted with the following three study arms: 1) long-lasting insecticide-treated nets (LLINs) plus standard of care environmental management (SoC-EM), 2) indoor residual spraying (IRS) with α-cypermethrin plus SoC-EM, and 3) SoC-EM alone. Incidence of new CL cases by passive and active case detection, sandfly abundance, and cost and cost-effectiveness was compared between study arms over 5 years. Incidence of CL and sandfly abundance were significantly lower in the IRS arm compared with SoC-EM (CL incidence rate ratio = 0.32, 95% confidence interval [CI] = 0.15–0.69, P = 0.005 and sandfly abundance ratio = 0.39, 95% CI = 0.18–0.85, P = 0.022). Reductions in the LLIN arm of the study were not significant, possibly due to poor compliance. IRS was effective and more cost-effective for the prevention of CL in Morocco. PMID:26811431

Randomized phase III trial of concurrent chemoradiotherapy vs accelerated hyperfractionation radiotherapy in locally advanced head and neck cancer

PubMed Central

Chitapanarux, Imjai; Tharavichitkul, Ekkasit; Kamnerdsupaphon, Pimkhuan; Pukanhapan, Nantaka; Vongtama, Roy

2013-01-01

The aim of this study was to compare the efficacy and safety of concurrent chemoradiotherapy (CCRT) vs accelerated hyperfractionation with concomitant boost (CCB) as a primary treatment for patients with Stage III–IV squamous cell carcinoma of head and neck (SCCHN). A total of 85 non-metastatic advanced SCCHN patients were accrued from January 2003 to December 2007. Of these, 48 and 37 patients received CCRT and CCB, respectively. The patients were randomized to receive either three cycles of carboplatin and 5-fluorouracil plus conventional radiotherapy (CCRT, 66 Gy in 6.5 weeks) or hybrid accelerated radiotherapy (CCB, 70 Gy in 6 weeks). The primary endpoint was determined by locoregional control rate. The secondary endpoints were overall survival and toxicity. With a median follow-up of 43 months (range, 3–102), the 5-year locoregional control rate was 69.6% in the CCRT arm vs 55.0% in the CCB arm (P = 0.184). The 5-year overall survival rate was marginally significantly different (P = 0.05): 76.1% in the CCRT arm vs 63.5% in the CCB arm. Radiotherapy treatment interruptions of more than three days were 60.4% and 40.5% in the CCRT arm and CCB arm, respectively. The median total treatment time was 55.5 days in the CCRT arm and 49 days in the CCB arm. The rate of Grade 3–4 acute mucositis was significantly higher in the CCB arm (67.6% vs 41.7%, P = 0.01), but no high grade hematologic toxicities were found in the CCB arm (27.2% vs 0%). CCRT has shown a trend of improving outcome over CCB irradiation in locoregionally advanced head and neck cancer. PMID:23740894

Lopinavir/ritonavir, atazanavir/ritonavir, and efavirenz in antiretroviral-naïve HIV-1-infected individuals over 144 weeks: an open-label randomized controlled trial.

PubMed

Andersson, Lars-Magnus; Vesterbacka, Jan; Blaxhult, Anders; Flamholc, Leo; Nilsson, Staffan; Ormaasen, Vidar; Sönnerborg, Anders; Gisslén, Magnus

2013-07-01

The objective of this study was to compare the efficacy of ritonavir boosted atazanavir versus ritonavir boosted lopinavir or efavirenz, all in combination with 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs), over 144 weeks in antiretroviral-naïve HIV-1-infected individuals. A prospective open-label randomized controlled trial was conducted at 29 sites in Sweden and Norway between April 2004 and December 2009. Patients were randomized to receive either efavirenz 600 mg once daily (EFV), or atazanavir 300 mg and ritonavir 100 mg once daily (AZV/r), or lopinavir 400 mg and ritonavir 100 mg twice daily (LPV/r). The primary endpoints were the proportion of patients with HIV-1 RNA < 50 copies/ml at 48 and 144 weeks. Of 245 patients enrolled, 243 were randomized and 239 received the allocated intervention: 77 EFV, 81 AZV/r, and 81 LPV/r. Median (interquartile range) CD4 cell counts at baseline were 150 (80-200), 170 (80-220), and 150 (90-216) per microlitre, respectively. At week 48 the proportion (95% confidence interval (CI)) of patients achieving HIV-1 RNA < 50 copies/ml was 86 (78-94)% in the EFV arm, 78 (69-87)% in the AZV/r arm and, 69 (59-78)% in the LPV/r arm in the intention-to-treat analysis. There was a significant difference between the EFV and LPV/r arm (p = 0.014). At week 144, the proportion (95% CI) of patients achieving HIV-1 RNA < 50 copies/ml was 61 (50-72)%, 58 (47-69)%, 51 (41-63)%, respectively (p = 0.8). Patients with CD4 cell counts of ≤ 200/μl or HIV-1 RNA > 100,000 copies/ml at baseline had similar response rates in all arms. EFV was superior to LPV/r at week 48, but there were no significant differences between the 3 arms in the long-term (144 weeks) follow-up.

Two-sample binary phase 2 trials with low type I error and low sample size

PubMed Central

Litwin, Samuel; Basickes, Stanley; Ross, Eric A.

2017-01-01

Summary We address design of two-stage clinical trials comparing experimental and control patients. Our end-point is success or failure, however measured, with null hypothesis that the chance of success in both arms is p0 and alternative that it is p0 among controls and p1 > p0 among experimental patients. Standard rules will have the null hypothesis rejected when the number of successes in the (E)xperimental arm, E, sufficiently exceeds C, that among (C)ontrols. Here, we combine one-sample rejection decision rules, E ≥ m, with two-sample rules of the form E – C > r to achieve two-sample tests with low sample number and low type I error. We find designs with sample numbers not far from the minimum possible using standard two-sample rules, but with type I error of 5% rather than 15% or 20% associated with them, and of equal power. This level of type I error is achieved locally, near the stated null, and increases to 15% or 20% when the null is significantly higher than specified. We increase the attractiveness of these designs to patients by using 2:1 randomization. Examples of the application of this new design covering both high and low success rates under the null hypothesis are provided. PMID:28118686

Randomized Controlled Trial of a Video Decision Support Tool for Cardiopulmonary Resuscitation Decision Making in Advanced Cancer

PubMed Central

Volandes, Angelo E.; Paasche-Orlow, Michael K.; Mitchell, Susan L.; El-Jawahri, Areej; Davis, Aretha Delight; Barry, Michael J.; Hartshorn, Kevan L.; Jackson, Vicki Ann; Gillick, Muriel R.; Walker-Corkery, Elizabeth S.; Chang, Yuchiao; López, Lenny; Kemeny, Margaret; Bulone, Linda; Mann, Eileen; Misra, Sumi; Peachey, Matt; Abbo, Elmer D.; Eichler, April F.; Epstein, Andrew S.; Noy, Ariela; Levin, Tomer T.; Temel, Jennifer S.

2013-01-01

Purpose Decision making regarding cardiopulmonary resuscitation (CPR) is challenging. This study examined the effect of a video decision support tool on CPR preferences among patients with advanced cancer. Patients and Methods We performed a randomized controlled trial of 150 patients with advanced cancer from four oncology centers. Participants in the control arm (n = 80) listened to a verbal narrative describing CPR and the likelihood of successful resuscitation. Participants in the intervention arm (n = 70) listened to the identical narrative and viewed a 3-minute video depicting a patient on a ventilator and CPR being performed on a simulated patient. The primary outcome was participants' preference for or against CPR measured immediately after exposure to either modality. Secondary outcomes were participants' knowledge of CPR (score range of 0 to 4, with higher score indicating more knowledge) and comfort with video. Results The mean age of participants was 62 years (standard deviation, 11 years); 49% were women, 44% were African American or Latino, and 47% had lung or colon cancer. After the verbal narrative, in the control arm, 38 participants (48%) wanted CPR, 41 (51%) wanted no CPR, and one (1%) was uncertain. In contrast, in the intervention arm, 14 participants (20%) wanted CPR, 55 (79%) wanted no CPR, and 1 (1%) was uncertain (unadjusted odds ratio, 3.5; 95% CI, 1.7 to 7.2; P < .001). Mean knowledge scores were higher in the intervention arm than in the control arm (3.3 ± 1.0 v 2.6 ± 1.3, respectively; P < .001), and 65 participants (93%) in the intervention arm were comfortable watching the video. Conclusion Participants with advanced cancer who viewed a video of CPR were less likely to opt for CPR than those who listened to a verbal narrative. PMID:23233708

Evaluation of Cyavanaprāśa on Health and Immunity related Parameters in Healthy Children: A Two Arm, Randomized, Open Labeled, Prospective, Multicenter, Clinical Study.

PubMed

Gupta, Arun; Kumar, Sunil; Dole, Sanjeeva; Deshpande, Shailesh; Deshpande, Vaishali; Singh, Sudha; Sasibhushan, V

2017-01-01

Cyavanaprāśa (CP) is an Ayurvedic immune booster formulation that confers vigor and vitality while delaying the ageing process. Benefits of CP have been studied widely in adult population. Current study assessed beneficial effects of CP on health and immunity related parameters in healthy children. This study was a 6 month long two armed, randomized, open labeled, prospective clinical study. School going healthy children between ages of 5-12 years were randomized to receive orally daily either CP (approx. 6 g) followed by a cup of milk (100 - 200 ml) or cup of milk only twice a day while continuing with their normal/routine diet. Results were analyzed based on number of episodes, severity, duration of illness (infections and allergies) and number of absent days due to illness during the study duration and changes in levels of energy, physical fitness, strength, stamina and quality of life in children which were recorded in subject diary by their parents/Legally Acceptable Representative (LAR). 702 participants were randomized, out of which 627 completed the study (CP n = 313; Control n = 314). Results of immunity (episodes of infections or allergy related conditions) showed more than 2 times protection from immunity related illness in CP Group as compared to the control. CP also showed better percentage improvement in energy levels, physical fitness, strength, stamina and quality of life assessed through KIDSCREEN QOL-27 questionnaires in children. Regular consumption of CP for a period of six months could significantly improve immunity, energy levels, physical fitness, strength, stamina and quality of life in school going healthy children. Clinical Trail Registry of India vide CTRI/2015/02/005574, Dated 24 February 2015.

Evaluation of Cyavanaprāśa on Health and Immunity related Parameters in Healthy Children: A Two Arm, Randomized, Open Labeled, Prospective, Multicenter, Clinical Study

PubMed Central

Gupta, Arun; Kumar, Sunil; Dole, Sanjeeva; Deshpande, Shailesh; Deshpande, Vaishali; Singh, Sudha; Sasibhushan, V.

2017-01-01

Context: Cyavanaprāśa (CP) is an Ayurvedic immune booster formulation that confers vigor and vitality while delaying the ageing process. Benefits of CP have been studied widely in adult population. Objectives: Current study assessed beneficial effects of CP on health and immunity related parameters in healthy children. Methods: This study was a 6 month long two armed, randomized, open labeled, prospective clinical study. School going healthy children between ages of 5-12 years were randomized to receive orally daily either CP (approx. 6 g) followed by a cup of milk (100 – 200 ml) or cup of milk only twice a day while continuing with their normal/routine diet. Results were analyzed based on number of episodes, severity, duration of illness (infections and allergies) and number of absent days due to illness during the study duration and changes in levels of energy, physical fitness, strength, stamina and quality of life in children which were recorded in subject diary by their parents/Legally Acceptable Representative (LAR). Results: 702 participants were randomized, out of which 627 completed the study (CP n = 313; Control n = 314). Results of immunity (episodes of infections or allergy related conditions) showed more than 2 times protection from immunity related illness in CP Group as compared to the control. CP also showed better percentage improvement in energy levels, physical fitness, strength, stamina and quality of life assessed through KIDSCREEN QOL-27 questionnaires in children. Conclusion: Regular consumption of CP for a period of six months could significantly improve immunity, energy levels, physical fitness, strength, stamina and quality of life in school going healthy children. Study Registration: Clinical Trail Registry of India vide CTRI/2015/02/005574, Dated 24 February 2015. PMID:28867858

The Effect of Patient Choice of Intervention on Health Outcomes

PubMed Central

Clark, Noreen M.; Janz, Nancy K.; Dodge, Julia A.; Mosca, Lori; Lin, Xihong; Long, Qi; Little, Roderick J; Wheeler, John R.C.; Keteyian, Steven; Liang, Jersey

2008-01-01

Background Patient preference may influence intervention effects, but has not been extensively studied. Randomized controlled design (N=1075) assessed outcomes when women (60 years +) were given a choice of two formats of a program to enhance heart disease management. Methods Randomization to "no choice" or "choice" study arms. Further randomization of "no choice” to: 1) Group intervention program format, 2) Self-Directed program format, 3) Control Group. "Choice" arm selected their preferred program format. Baseline, four, twelve, and eighteen month follow-up data collected. Two analyses: health outcomes for choice compared to being randomized; and preference effect on treatment efficacy. Results Women who chose a format compared to being assigned a format had better psychosocial functioning at four months (p=0.02) and tended toward better physical functioning at twelve months (p=0.07). At eighteen months women who chose versus being assigned a format had more symptoms measured as: number (p=0.004), frequency (p=0.006) and bother (p=0.004). At four months women who preferred the Group format had better psychosocial functioning when assigned the Group format than when they were assigned the Self Directed format (p=0.03). At eighteen months women preferring a Group format had more symptoms: number (p=0.001), frequency (p=0.001), bother (p=0.001) when assigned the Group format than when assigned the Self Directed format. Conclusions Choice and preference for the Group format each enhanced psychosocial and physical functioning up to one year. Despite the preference for Group format, over the longer term (eighteen months) cardiac symptoms were fewer when assigned the Self-Directed format. PMID:18515187

Radiographic cup position following posterior and lateral approach to total hip arthroplasty. An explorative randomized controlled trial.

PubMed

Kruse, Christine; Rosenlund, Signe; Broeng, Leif; Overgaard, Søren

2018-01-01

The two most common surgical approaches to total hip arthroplasty are the posterior approach and lateral approach. The surgical approach may influence cup positioning and restoration of the offset, which may affect the biomechanical properties of the hip joint. The primary aim was to compare cup position between posterior approach and lateral approach. Secondary aims were to compare femoral offset, abductor moment arm and leg length discrepancy between the two approaches. Eighty patients with primary hip osteoarthritis were included in a randomized controlled trial and assigned to total hip arthroplasty using posterior approach or lateral approach. Postoperative radiographs from 38 patients in each group were included in this study for measurement of cup anteversion and inclination. Femoral offset, cup offset, total offset, abductor moment arm and leg length discrepancy were measured on preoperative and postoperative radiographs in 28 patients in each group. We found that mean anteversion was 5° larger in the posterior approach group (95% CI, -8.1 to -1.4; p = 0.006), while mean inclination was 5° less steep (95% CI, 2.7 to 7.2; p<0.001) compared with the lateral approach group. The posterior approach group had a larger mean femoral offset of 4.3mm (95% CI, -7.4 to -1.3, p = 0.006), mean total offset of 6.3mm (95% CI, -9.6 to -3; p<0.001) and mean abductor moment arm of 4.8mm (95% CI, -7.6 to -1.9; p = 0.001) compared with the lateral approach group. We found a larger cup anteversion but less steep cup inclination in the posterior approach group compared with the lateral approach group. Femoral offset and abductor moment arm were restored after total hip arthroplasty using lateral approach but significantly increased when using posterior approach.

Preoperative nutritional support in cancer patients with no clinical signs of malnutrition--prospective randomized controlled trial.

PubMed

Kabata, Paweł; Jastrzębski, Tomasz; Kąkol, Michał; Król, Karolina; Bobowicz, Maciej; Kosowska, Anna; Jaśkiewicz, Janusz

2015-02-01

Preoperative nutrition is beneficial for malnourished cancer patients. Yet, there is little evidence whether or not it should be given to nonmalnourished patients. The aim of this study was to assess the need to introduce preoperative nutritional support in patients without malnutrition at qualification for surgery. This was a prospective, two-arm, randomized, controlled, open-label study. Patients in interventional group received nutritional supplementation for 14 days before surgery, while control group kept on to their everyday diet. Each patient's nutritional status was assessed twice--at qualification (weight loss in 6 months, laboratory parameters: albumin, total protein, transferrin, and total lymphocyte count) and 1 day before surgery (change in body weight and laboratory parameters). After surgery, all patients were followed up for 30 days for postoperative complications. Fifty-four patients in interventional and 48 in control group were analyzed. In postoperative period, patients in control group suffered from significantly higher (p < 0.001) number of serious complications compared with patients receiving nutritional supplementation. Moreover, levels of all laboratory parameters declined significantly (p < 0.001) in these patients, while in interventional arm were stable (albumin and total protein) or raised (transferrin and total lymphocyte count). Preoperative nutritional support should be introduced for nonmalnourished patients as it helps to maintain proper nutritional status and reduce number and severity of postoperative complications compared with patients without such support.

Effect of homeopathy on analgesic intake following knee ligament reconstruction: a phase III monocentre randomized placebo controlled study

PubMed Central

Paris, A; Gonnet, N; Chaussard, C; Belon, P; Rocourt, F; Saragaglia, D; Cracowski, J L

2008-01-01

Aims The efficacy of homeopathy is still under debate. The objective of this study was to assess the efficacy of homeopathic treatment (Arnica montana 5 CH, Bryonia alba 5 CH, Hypericum perforatum 5 CH and Ruta graveolens 3 DH) on cumulated morphine intake delivered by PCA over 24 h after knee ligament reconstruction. Methods This was an add-on randomized controlled study with three parallel groups: a double-blind homeopathic or placebo arm and an open-label noninterventional control arm. Eligible patients were 18–60 years old candidates for surgery of the anterior cruciate ligament. Treatment was administered the evening before surgery and continued for 3 days. The primary end-point was cumulated morphine intake delivered by PCA during the first 24 h inferior or superior/equal to 10 mg day−1. Results One hundred and fifty-eight patients were randomized (66 in the placebo arm, 67 in the homeopathic arm and 25 in the noninterventional group). There was no difference between the treated and the placebo group for primary end-point (mean (95% CI) 48% (35.8, 56.3), and 56% (43.7, 68.3), required less than 10 mg day−1 of morphine in each group, respectively). The homeopathy treatment had no effect on morphine intake between 24 and 72 h or on the visual analogue pain scale, or on quality of life assessed by the SF-36 questionnaire. In addition, these parameters were not different in patients enrolled in the open-label noninterventional control arm. Conclusions The complex of homeopathy tested in this study was not superior to placebo in reducing 24 h morphine consumption after knee ligament reconstruction. What is already known about this subject The efficacy of homeopathy is still under debate and a recent meta-analysis recommended further randomized double-blind clinical trials to identify any clinical situation in which homeopathy might be effective. What this study adds The complex of homeopathy tested in this study (Arnica montana 5 CH, Bryonia alba 5 CH, Hypericum perforatum 5 CH and Ruta graveolens 3 DH) is not superior to placebo in reducing 24 h morphine consumption after knee ligament reconstruction. PMID:18251757

Cognitive-behavioral therapy as continuation treatment to sustain response after electroconvulsive therapy in depression: a randomized controlled trial.

PubMed

Brakemeier, Eva-Lotta; Merkl, Angela; Wilbertz, Gregor; Quante, Arnim; Regen, Francesca; Bührsch, Nicole; van Hall, Franziska; Kischkel, Eva; Danker-Hopfe, Heidi; Anghelescu, Ion; Heuser, Isabella; Kathmann, Norbert; Bajbouj, Malek

2014-08-01

Although electroconvulsive therapy (ECT) is the most effective acute antidepressant intervention, sustained response rates are low. It has never been systematically assessed whether psychotherapy, continuation ECT, or antidepressant medication is the most efficacious intervention to maintain initial treatment response. In a prospective, randomized clinical trial, 90 inpatients with major depressive disorder (MDD) were treated with right unilateral ultra-brief acute ECT. Electroconvulsive therapy responders received 6 months guideline-based antidepressant medication (MED) and were randomly assigned to add-on therapy with cognitive-behavioral group therapy (CBT-arm), add-on therapy with ultra-brief pulse continuation electroconvulsive therapy (ECT-arm), or no add-on therapy (MED-arm). After the 6 months of continuation treatment, patients were followed-up for another 6 months. The primary outcome parameter was the proportion of patients who remained well after 12 months. Of 90 MDD patients starting the acute phase, 70% responded and 47% remitted to acute ECT. After 6 months of continuation treatment, significant differences were observed in the three treatment arms with sustained response rates of 77% in the CBT-arm, 40% in the ECT-arm, and 44% in the MED-arm. After 12 months, these differences remained stable with sustained response rates of 65% in the CBT-arm, 28% in the ECT-arm, and 33% in the MED-arm. These results suggest that ultra-brief pulse ECT as a continuation treatment correlates with low sustained response rates. However, the main finding implicates cognitive-behavioral group therapy in combination with antidepressants might be an effective continuation treatment to sustain response after successful ECT in MDD patients. Copyright © 2014 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

A comparison of megestrol acetate, nandrolone decanoate and dietary counselling for HIV associated weight loss.

PubMed

Batterham, M J; Garsia, R

2001-08-01

This randomized, prospective study compared three treatments, nandrolone decanoate (ND), megestrol acetate (MA) or dietary counselling, for managing human immunodeficiency syndrome (HIV) associated weight loss. It was centred on a Tertiary referral hospital, Sydney, Australia. Fifteen patients were randomized to receive ND (100 mg/fortnight), or MA (400 mg/day) or dietary counselling for 12 weeks. Those patients randomized to dietary counselling were further randomized to receive nandrolone or megestrol after completing the dietary counselling arm. Weight, fat free mass (FFM), percentage body fat mass (FM), dietary intake and appetite were assessed before commencing and at the completion of each treatment arm. Weight increased significantly in all treatment arms (dietary counselling 1.13 kg +/- 0.36, nandrolone 4.01 kg +/- 1.68, megestrol 10.20 kg +/- 4.51, p < 0.05 paired t-test). FFM increased significantly in patients receiving ND (3.54 +/- 1.98 kg, p=0.001) and those receiving MA (2.76 +/- 0.55 kg, p=0.002), whereas the change in those receiving dietary counselling alone was not significant. Percentage body fat mass increased significantly only in those receiving MA (7.77 +/- 4.85%, p=0.049). The change in weight and percentage body fat mass was significantly greater in those receiving MA than the other two treatment arms. The increase in FFM was significantly greater in both the nandrolone and megestrol arms than the dietary counselling arm. It was concluded that ND and MA both resulted in an increase in FFM greater than dietary counselling alone. Megestrol produced a significantly greater increase in weight, percentage fat mass, intake and appetite than did the other two treatment arms, suggesting it may be the preferred agent, particularly in a palliative care setting in which weight, appetite and intake increase are desirable without regard to the composition of the body. The long-term use of these agents in people with HIV should be reviewed in the context of improved survival on highly active antiretroviral therapy regimens.

Feasibility study of the effects of art as a creative engagement intervention during stroke rehabilitation on improvement of psychosocial outcomes: study protocol for a single blind randomized controlled trial: the ACES study.

PubMed

Morris, Jacqui H; Kelly, Chris; Toma, Madalina; Kroll, Thilo; Joice, Sara; Mead, Gillian; Donnan, Peter; Williams, Brian

2014-09-28

Benefits of art participation after stroke are becoming increasingly recognized. Qualitative studies suggest that participation in visual arts creative engagement interventions (CEIs) during rehabilitation after stroke may improve mood, self-esteem, hope and some aspects of physical recovery. This study examines the feasibility of undertaking a randomized controlled trial of a CEI delivered by artists within in-patient stroke rehabilitation to test effectiveness. This trial is a two arm, single-blind, randomized controlled feasibility trial within in-patient stroke rehabilitation. We will recruit 80 patients receiving stroke rehabilitation in two stroke units in a health board area of Scotland (40 patients in each arm). Intervention arm participants will receive a visual-arts based CEI facilitated by experienced artists. Artists will follow an intervention protocol with specific components that enable participants to set, achieve and review artistic goals. Participants will receive up to eight intervention sessions, four within a group and four one-to-one with the artist. Control group participants will receive usual care only.Data collection will occur at baseline, post-intervention and three-month follow-up. Stroke-related health status is the primary outcome; mood, self-esteem, self-efficacy, perceived recovery control and hope are secondary outcomes. Semi-structured interviews will be conducted with purposively selected patients, artists and healthcare staff to elicit views and experiences of the intervention and feasibility and acceptability of trial processes. Recruitment rates, retention rates and patient preference for art participation will also be collected. Data will indicate, with confidence intervals, the proportion of patients choosing or refusing participation in the CEI and will allow calculation of recruitment rates for a future definitive trial. Summary data will indicate potential variability, magnitude and direction of difference between groups. Findings will inform sample size calculations for a definitive trial. Thematic analysis of qualitative data will be managed using the Framework Approach. Framework is an analytical approach for qualitative data, commonly used in policy and medical research. If shown to demonstrate effects, this intervention has the potential to address aspects of stroke recovery previously. Not routinely addressed in rehabilitation. Registered with Clinical Trials.Gov: NCT02085226 on 6th March 2014.

Recovery trajectories of vestibulopathic subjects after perturbations during locomotion

NASA Technical Reports Server (NTRS)

Wall, C. 3rd; Oddsson, L. I.; Patronik, N.; Sienko, K.; Kentala, E.

2002-01-01

We compared the mediolateral (M/L) responses to perturbations during locomotion of vestibulopathic (VP) subjects to those of controls. Eight subjects with unilateral vestibular loss (100% Reduced Vestibular Response from the caloric test) resulting from surgery for vestibular schwannoma and 11 controls were selected for this study. Despite their known vestibulopathy, all VP subjects scored within the normal range on computerized dynamic posturography Sensory Organization Tests. During gait, subjects were given surface perturbations of the right support-phase foot in two possible directions (forward-right and backward-left) at two possible magnitudes (5 and 10 cm) that were randomly mixed with trials having no perturbations. M/L stability was quantified by estimating the length of the M/L moment arm between the support foot and the trunk, and the M/L accelerations of the sternum and the head. The VP group had greater changes (p < 0.05) in their moment arm responses compared to controls. The number of steps that it took for the moment arm oscillations to return to normal and the variability in the moment arms were greater for the VP group. Differences in the sternum and head accelerations between VP and control groups were not as consistent, but there was a trend toward greater response deviations in the VP group for all 4 perturbation types. Increased response magnitude and variability of the VP group is consistent with an increase in their sensory noise of vestibular inputs due to the surgical lesion. Another possibility is a reduced sensitivity to motion inputs. This perturbation approach may prove useful for characterizing subtle vestibulopathies and similar changes in the human orientation mechanism after exposure to microgravity.

A brain-machine interface enables bimanual arm movements in monkeys.

PubMed

Ifft, Peter J; Shokur, Solaiman; Li, Zheng; Lebedev, Mikhail A; Nicolelis, Miguel A L

2013-11-06

Brain-machine interfaces (BMIs) are artificial systems that aim to restore sensation and movement to paralyzed patients. So far, BMIs have enabled only one arm to be moved at a time. Control of bimanual arm movements remains a major challenge. We have developed and tested a bimanual BMI that enables rhesus monkeys to control two avatar arms simultaneously. The bimanual BMI was based on the extracellular activity of 374 to 497 neurons recorded from several frontal and parietal cortical areas of both cerebral hemispheres. Cortical activity was transformed into movements of the two arms with a decoding algorithm called a fifth-order unscented Kalman filter (UKF). The UKF was trained either during a manual task performed with two joysticks or by having the monkeys passively observe the movements of avatar arms. Most cortical neurons changed their modulation patterns when both arms were engaged simultaneously. Representing the two arms jointly in a single UKF decoder resulted in improved decoding performance compared with using separate decoders for each arm. As the animals' performance in bimanual BMI control improved over time, we observed widespread plasticity in frontal and parietal cortical areas. Neuronal representation of the avatar and reach targets was enhanced with learning, whereas pairwise correlations between neurons initially increased and then decreased. These results suggest that cortical networks may assimilate the two avatar arms through BMI control. These findings should help in the design of more sophisticated BMIs capable of enabling bimanual motor control in human patients.

Ezetimibe for the Treatment of Nonalcoholic Steatohepatitis: Assessment by Novel Magnetic Resonance Imaging and Magnetic Resonance Elastography in a Randomized Trial (MOZART Trial)

PubMed Central

Loomba, Rohit; Sirlin, Claude B; Ang, Brandon; Bettencourt, Ricki; Jain, Rashmi; Salotti, Joanie; Soaft, Linda; Hooker, Jonathan; Kono, Yuko; Bhatt, Archana; Hernandez, Laura; Nguyen, Phirum; Noureddin, Mazen; Haufe, William; Hooker, Catherine; Yin, Meng; Ehman, Richard; Lin, Grace Y; Valasek, Mark A; Brenner, David A; Richards, Lisa

2015-01-01

Ezetimibe inhibits intestinal cholesterol absorption and lowers low-density lipoprotein cholesterol. Uncontrolled studies have suggested that it reduces liver fat as estimated by ultrasound in nonalcoholic steatohepatitis (NASH). Therefore, we aimed to examine the efficacy of ezetimibe versus placebo in reducing liver fat by the magnetic resonance imaging-derived proton density-fat fraction (MRI-PDFF) and liver histology in patients with biopsy-proven NASH. In this randomized, double-blind, placebo-controlled trial, 50 patients with biopsy-proven NASH were randomized to either ezetimibe 10 mg orally daily or placebo for 24 weeks. The primary outcome was a change in liver fat as measured by MRI-PDFF in colocalized regions of interest within each of the nine liver segments. Novel assessment by two-dimensional and three-dimensional magnetic resonance elastography was also performed. Ezetimibe was not significantly better than placebo at reducing liver fat as measured by MRI-PDFF (mean difference between the ezetimibe and placebo arms -1.3%, P = 0.4). Compared to baseline, however, end-of-treatment MRI-PDFF was significantly lower in the ezetimibe arm (15%-11.6%, P < 0.016) but not in the placebo arm (18.5%-16.4%, P = 0.15). There were no significant differences in histologic response rates, serum alanine aminotransferase and aspartate aminotransferase levels, or longitudinal changes in two-dimensional and three-dimensional magnetic resonance elastography-derived liver stiffness between the ezetimibe and placebo arms. Compared to histologic nonresponders (25/35), histologic responders (10/35) had a significantly greater reduction in MRI-PDFF (-4.35 ± 4.9% versus -0.30 ± 4.1%, P < 0.019). Conclusions: Ezetimibe did not significantly reduce liver fat in NASH. This trial demonstrates the application of colocalization of MRI-PDFF-derived fat maps and magnetic resonance elastography-derived stiffness maps of the liver before and after treatment to noninvasively assess treatment response in NASH. (Hepatology 2015;61:1239–1250) PMID:25482832

Does rating the operation videos with a checklist score improve the effect of E-learning for bariatric surgical training? Study protocol for a randomized controlled trial.

PubMed

De La Garza, Javier Rodrigo; Kowalewski, Karl-Friedrich; Friedrich, Mirco; Schmidt, Mona Wanda; Bruckner, Thomas; Kenngott, Hannes Götz; Fischer, Lars; Müller-Stich, Beat-Peter; Nickel, Felix

2017-03-21

Laparoscopic training has become an important part of surgical education. Laparoscopic Roux-en-Y gastric bypass (RYGB) is the most common bariatric procedure performed. Surgeons must be well trained prior to operating on a patient. Multimodality training is vital for bariatric surgery. E-learning with videos is a standard approach for training. The present study investigates whether scoring the operation videos with performance checklists improves learning effects and transfer to a simulated operation. This is a monocentric, two-arm, randomized controlled trial. The trainees are medical students from the University of Heidelberg in their clinical years with no prior laparoscopic experience. After a laparoscopic basic virtual reality (VR) training, 80 students are randomized into one of two arms in a 1:1 ratio to the checklist group (group A) and control group without a checklist (group B). After all students are given an introduction of the training center, VR trainer and laparoscopic instruments, they start with E-learning while watching explanations and videos of RYGB. Only group A will perform ratings with a modified Bariatric Objective Structured Assessment of Technical Skill (BOSATS) scale checklist for all videos watched. Group B watches the same videos without rating. Both groups will then perform an RYGB in the VR trainer as a primary endpoint and small bowel suturing as an additional test in the box trainer for evaluation. This study aims to assess if E-learning and rating bariatric surgical videos with a modified BOSATS checklist will improve the learning curve for medical students in an RYGB VR performance. This study may help in future laparoscopic and bariatric training courses. German Clinical Trials Register, DRKS00010493 . Registered on 20 May 2016.

[Arm rehabilitation : Current concepts and therapeutic options].

PubMed

Platz, T; Schmuck, L

2016-10-01

Arm paralysis after a stroke is a major cause of impairment. Presentation of therapeutic options and the efficacy in arm rehabilitation after stroke. Based on a systematic critical appraisal of randomized controlled trials (RCT) the therapeutic procedures for arm paralysis after stroke in the context of their effectiveness are introduced, including robotic therapy, mirror therapy, constraint-induced movement therapy (CIMT), arm basis training, arm ability training, neuromuscular electrical stimulation, bilateral and task-specific training, mental training and transcranial stimulation techniques, such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). Several therapeutic procedures with proven efficacy are currently available for arm rehabilitation after stroke. Their differential indications are presented and associated with conclusions for clinical practice.

Direct provision versus facility collection of HIV self-tests among female sex workers in Uganda: A cluster-randomized controlled health systems trial.

PubMed

Ortblad, Katrina; Kibuuka Musoke, Daniel; Ngabirano, Thomson; Nakitende, Aidah; Magoola, Jonathan; Kayiira, Prossy; Taasi, Geoffrey; Barresi, Leah G; Haberer, Jessica E; McConnell, Margaret A; Oldenburg, Catherine E; Bärnighausen, Till

2017-11-01

HIV self-testing allows HIV testing at any place and time and without health workers. HIV self-testing may thus be particularly useful for female sex workers (FSWs), who should test frequently but face stigma and financial and time barriers when accessing healthcare facilities. We conducted a cluster-randomized controlled health systems trial among FSWs in Kampala, Uganda, to measure the effect of 2 HIV self-testing delivery models on HIV testing and linkage to care outcomes. FSW peer educator groups (1 peer educator and 8 participants) were randomized to either (1) direct provision of HIV self-tests, (2) provision of coupons for free collection of HIV self-tests in a healthcare facility, or (3) standard of care HIV testing. We randomized 960 participants in 120 peer educator groups from October 18, 2016, to November 16, 2016. Participants' median age was 28 years (IQR 24-32). Our prespecified primary outcomes were self-report of any HIV testing at 1 month and at 4 months; our prespecified secondary outcomes were self-report of HIV self-test use, seeking HIV-related medical care and ART initiation. In addition, we analyzed 2 secondary outcomes that were not prespecified: self-report of repeat HIV testing-to understand the intervention effects on frequent testing-and self-reported facility-based testing-to quantify substitution effects. Participants in the direct provision arm were significantly more likely to have tested for HIV than those in the standard of care arm, both at 1 month (risk ratio [RR] 1.33, 95% CI 1.17-1.51, p < 0.001) and at 4 months (RR 1.14, 95% CI 1.07-1.22, p < 0.001). Participants in the direct provision arm were also significantly more likely to have tested for HIV than those in the facility collection arm, both at 1 month (RR 1.18, 95% CI 1.07-1.31, p = 0.001) and at 4 months (RR 1.03, 95% CI 1.01-1.05, p = 0.02). At 1 month, fewer participants in the intervention arms had sought medical care for HIV than in the standard of care arm, but these differences were not significant and were reduced in magnitude at 4 months. There were no statistically significant differences in ART initiation across study arms. At 4 months, participants in the direct provision arm were significantly more likely to have tested twice for HIV than those in the standard of care arm (RR 1.51, 95% CI 1.29-1.77, p < 0.001) and those in the facility collection arm (RR 1.22, 95% CI 1.08-1.37, p = 0.001). Participants in the HIV self-testing arms almost completely replaced facility-based testing with self-testing. Two adverse events related to HIV self-testing were reported: interpersonal violence and mental distress. Study limitations included self-reported outcomes and limited generalizability beyond FSWs in similar settings. In this study, HIV self-testing appeared to be safe and increased recent and repeat HIV testing among FSWs. We found that direct provision of HIV self-tests was significantly more effective in increasing HIV testing among FSWs than passively offering HIV self-tests for collection in healthcare facilities. HIV self-testing could play an important role in supporting HIV interventions that require frequent HIV testing, such as HIV treatment as prevention, behavior change for transmission reduction, and pre-exposure prophylaxis. ClinicalTrials.gov NCT02846402.

A randomized controlled trial of a pharmacist consultation program for family physicians and their elderly patients

PubMed Central

Sellors, John; Kaczorowski, Janusz; Sellors, Connie; Dolovich, Lisa; Woodward, Christel; Willan, Andrew; Goeree, Ron; Cosby, Roxanne; Trim, Kristina; Sebaldt, Rolf; Howard, Michelle; Hardcastle, Linda; Poston, Jeff

2003-01-01

Background Pharmacists can improve patient outcomes in institutional and pharmacy settings, but little is known about their effectiveness as consultants to primary care physicians. We examined whether an intervention by a specially trained pharmacist could reduce the number of daily medication units taken by elderly patients, as well as costs and health care use. Methods We conducted a randomized controlled trial in family practices in 24 sites in Ontario. We randomly allocated 48 randomly selected family physicians (69.6% participation rate) to the intervention or the control arm, along with 889 (69.5% participation rate) of their randomly selected community-dwelling, elderly patients who were taking 5 or more medications daily. In the intervention group, pharmacists conducted face-to-face medication reviews with the patients and then gave written recommendations to the physicians to resolve any drug-related problems. Process outcomes included the number of drug-related problems identified among the senior citizens in the intervention arm and the proportion of recommendations implemented by the physicians. Results After 5 months, seniors in the intervention and control groups were taking a mean of 12.4 and 12.2 medication units per day respectively (p = 0.50). There were no statistically significant differences in health care use or costs between groups. A mean of 2.5 drug-related problems per senior was identified in the intervention arm. Physicians implemented or attempted to implement 72.3% (790/1093) of the recommendations. Interpretation The intervention did not have a significant effect on patient outcomes. However, physicians were receptive to the recommendations to resolve drug-related problems, suggesting that collaboration between physicians and pharmacists is feasible. PMID:12847034

Contralesional arm preference depends on hemisphere of damage and target location in unilateral stroke patients

PubMed Central

Mani, Saandeep; Przybyla, Andrzej; Good, David C.; Haaland, Kathleen Y.; Sainburg, Robert L.

2014-01-01

Background Previous research has shown that during simulated activities of daily living right handed stroke patients use their contralesional arm more after left than right hemisphere stroke. These findings were attributed to a hand preference effect. However, these decisions about when to use the contralesional arm may be modulated by where in the work space the task is performed, a factor that could be used in physical rehabilitation to influence recovery by decreasing learned non-use. Objective To examine how target location and side of stroke influences arm selection choices for simple reaching movements. Methods Fourteen right-handed stroke patients (7 with left hemisphere damage, 7 with right hemisphere damage) with similar degree of hemiparesis (Fugl-Meyer motor score), and 16 right-handed control subjects participated in this experiment. Thirty-two targets were presented throughout the reachable horizontal plane workspace in a pseudo-random fashion, and the subjects were asked to select one hand to reach the target on each trial. Results The left hemisphere damaged group chose their contralesional arm significantly more often than the right hemisphere damaged group. Patients with right hemisphere damage also chose their left (contralesional) arm significantly less than the control group. However, these patterns of choice were most pronounced in the center of the workspace. Conclusion Both the side of hemisphere damage and workspace location played a significant role in the choice of whether to use the contralesional arm for reaching. These findings have implications for structuring rehabilitation for unilateral stroke patients. PMID:24523143

Promotion of early pediatric hearing detection through patient navigation: A randomized controlled clinical trial.

PubMed

Bush, Matthew L; Taylor, Zachary R; Noblitt, Bryce; Shackleford, Taylor; Gal, Thomas J; Shinn, Jennifer B; Creel, Liza M; Lester, Cathy; Westgate, Philip M; Jacobs, Julie A; Studts, Christina R

2017-11-01

To assess the efficacy of a patient navigator intervention to decrease nonadherence to obtain audiological testing following failed screening, compared to those receiving the standard of care. Using a randomized controlled design, guardian-infant dyads, in which the infants had abnormal newborn hearing screening, were recruited within the first week after birth. All participants were referred for definitive audiological diagnostic testing. Dyads were randomized into a patient navigator study arm or standard of care arm. The primary outcome was the percentage of patients with follow-up nonadherence to obtain diagnostic testing. Secondary outcomes were parental knowledge of infant hearing testing recommendations and barriers in obtaining follow-up testing. Sixty-one dyads were enrolled in the study (patient navigator arm = 27, standard of care arm = 34). The percentage of participants nonadherent to diagnostic follow-up during the first 6 months after birth was significantly lower in the patient navigator arm compared with the standard of care arm (7.4% vs. 38.2%) (P = .005). The timing of initial follow-up was significantly lower in the navigator arm compared with the standard of care arm (67.9 days after birth vs. 105.9 days, P = .010). Patient navigation increased baseline knowledge regarding infant hearing loss diagnosis recommendations compared with the standard of care (P = .004). Patient navigation decreases nonadherence rates following abnormal infant hearing screening and improves knowledge of follow-up recommendations. This intervention has the potential to improve the timeliness of delivery of infant hearing healthcare; future research is needed to assess the cost and feasibility of larger scale implementation. 1b. Laryngoscope, 127:S1-S13, 2017. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Eich, Hans Theodor; Gossmann, Axel; Engert, Andreas

Purpose: The role of radiotherapy (RT) after intensive chemotherapy in patients with advanced stage Hodgkin's lymphoma (HL) is still unclear. The German Hodgkin Study Group (GHSG) randomized HD12 trial was designed to test whether consolidative RT in the region of initial bulky disease and of residual disease is necessary after effective chemotherapy. A quality control program based on a multidisciplinary panel of radiation oncologists, radiologists, and medical oncologists who reviewed all patients' staging and restaging imaging was initiated. Methods and Materials: A total of 1661 patients aged 16 to 65 years with HL in Stage IIB (large mediastinal mass and/ormore » E-lesions) or Stage III to IV were randomized from January 1999 to January 2003 according to a factorial design between: 8 esc.BEACOPP + RT (arm A), 8 esc.BEACOPP non-RT (arm B), 4+4BEACOPP + RT (arm C), 4+4BEACOPP non-RT (arm D). Results: In the fifth interim analysis, 1449 patients were eligible for the arm comparison with regard to RT. After a median observation time of 48 months the FFTF rate was 86% and the OS 92%. The FFTF was 95% in the RT arms A+C and 88% in the non-RT arms B+D: no sequential significant difference. One thousand and eighty four patients were evaluated by the panel. The panel defined initial bulky disease in 800 patients and residual disease in 600 patients. The panel recommended continuation of therapy according to the randomization for 934 of 1084 patients and additive RT independently from the randomization arm for 145 of 1084 patients. Conclusions: The study showed that RT can be reduced substantially after effective chemotherapy. However, because of the irradiation of 10% of patients in the non-RT arms, equivalent effectiveness of a non-RT strategy cannot be proved. A substantial limitation of consolidative RT according to expert panel recommendations appears to be possible without reducing effectiveness.« less

A phase III randomized trial comparing adjuvant concomitant chemoradiotherapy versus standard adjuvant chemotherapy followed by radiotherapy in operable node-positive breast cancer: Final results

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rouesse, Jacques; Lande, Brigitte de la; Bertheault-Cvitkovic, Frederique

Purpose: To compare concomitant and sequential adjuvant chemoradiotherapy regimens in node-positive, operable breast cancer patients. Methods and Materials: This was a randomized, French, multicenter, phase III trial enrolling 638 eligible women with prior breast surgery and positive axillary dissection. Patients in Arm A received 500 mg/m{sup 2} 5-fluorouracil, 12 mg/m{sup 2} mitoxantrone, and 500 mg/m{sup 2} cyclophosphamide, with concomitant radiotherapy (50 Gy {+-} 10-20-Gy boost). Patients in Arm B received 500 mg/m{sup 2} 5-fluorouracil, 60 mg/m{sup 2} epirubicin, and 500 mg/m{sup 2} cyclophosphamide, with subsequent radiotherapy. Chemotherapy was administered on Day 1 every 21 days for 4 cycles. Results: Medianmore » treatment durations were 64 and 126 days (Arms A and B, respectively), with no significant difference in overall or disease-free survival. Five-year locoregional relapse-free survival favored patients with conservative surgery (two thirds of the population), with less local and/or regional recurrence in Arm A than in Arm B (3% vs. 9%; p 0.01). Multivariate analysis in this subgroup showed a 2.8-fold increased risk of locoregional recurrence with sequential chemoradiotherapy, independent of other prognostic factors (p = 0.027). Febrile neutropenia and Grade 3-4 leukopenia were significantly more frequent in Arm A. Subclinical left ventricular ejection fraction events at 1 year were more frequent with concomitant radiotherapy (p = 0.02). Conclusions: Concomitant radiotherapy with adjuvant fluorouracil, mitoxantrone, and cyclophosphamide has significantly better locoregional control in node-positive breast cancer after conservative surgery and 50% shorter treatment, albeit with slightly more acute toxicity. With mitoxantrone no longer available for adjuvant breast cancer treatment, alternative concomitant chemoradiotherapy studies are needed.« less

Integrating a Nurse-Midwife-Led Oral Health Intervention Into CenteringPregnancy Prenatal Care: Results of a Pilot Study.

PubMed

Adams, Sally H; Gregorich, Steven E; Rising, Sharon S; Hutchison, Margaret; Chung, Lisa H

2017-07-01

National and professional organizations recommend oral health promotion in prenatal care to improve women's oral health. However, few prenatal programs include education about oral health promotion. The objective of this study was to determine if women receiving a brief, low-cost, and sustainable educational intervention entitled CenteringPregnancy Oral Health Promotion had clinically improved oral health compared to women receiving standard CenteringPregnancy care. Women attending CenteringPregnancy, a group prenatal care model, at 4 health centers in the San Francisco Bay Area, participated in this nonrandomized controlled pilot study in 2010 to 2011. The intervention arm received the CenteringPregnancy Oral Health Promotion intervention consisting of two 15-minute skills-based educational modules addressing maternal and infant oral health, each module presented in a separate CenteringPregnancy prenatal care session. The present analysis focused on the maternal module that included facilitated discussions and skills-building activities including proper tooth brushing. The control arm received standard CenteringPregnancy prenatal care. Dental examinations and questionnaires were administered prior to and approximately 9 weeks postintervention. Primary outcomes included the Plaque Index, percent bleeding on probing, and percent of gingival pocket depths 4 mm or greater. Secondary outcomes were self-reported oral health knowledge, attitudes (importance and self-efficacy), and behaviors (tooth brushing and flossing). Regression models tested whether pre to post changes in outcomes differed between the intervention versus the control arms. One hundred and one women participated in the study; 49 were in the intervention arm, and 52 were in the control arm. The control and intervention arms did not vary significantly at baseline. Significant pre to post differences were noted between the arms with significant improvements in the intervention arm for the Plaque Index, bleeding on probing, and pocket depths 4 mm or greater. Providing brief oral health education and skills-building activities within prenatal care may be effective in improving women's oral health during pregnancy. These findings provide support for developing a full-scale randomized clinical trial of the CenteringPregnancy Oral Health Promotion intervention. © 2017 by the American College of Nurse-Midwives.

Does the use of Nintendo Wii Sports™ improve arm function and is it acceptable to patients after stroke? Publication of the Protocol of the Trial of Wii™ in Stroke - TWIST.

PubMed

Adie, Katja; Schofield, Christine; Berrow, Margie; Wingham, Jennifer; Freeman, Janet; Humfryes, John; Pritchard, Colin

2014-01-01

Many stroke patients experience loss of arm function requiring rehabilitation, which is expensive, repetitive, and does not always translate into "real life." Nintendo Wii Sports™ (Wii™) may offer task-specific training that is repetitive and motivating. The Trial of Wii™ in Stroke (TWIST) is designed to investigate feasibility, efficacy, and acceptability using Wii™ to improve affected arm function for patients after stroke. This is a randomized controlled trial (RCT), incorporating a qualitative study and health economics analysis that compares playing Wii™ versus arm exercises in patients receiving standard rehabilitation in a home setting within 6 months of stroke with a motor deficit of less than 5 on the MRC (Medical Research Council) scale (arm). In this study, we expect to randomize 240 participants. Primary outcome is change in affected arm function at 6 weeks follow-up in intervention and control group using the Action Research Arm Test. Secondary outcomes include occupational performance using the Canadian Occupational Performance Measure, quality of life using the Stroke Impact Scale, cost effectiveness analysis, and a qualitative study investigating factors that influence use of Wii™ for patients and carers. TWIST is the first UK RCT assessing the feasibility, cost effectiveness, and acceptability of Wii™ in stroke rehabilitation. The trial has been registered with ISRCTN 06807619 and UK CRN 11030. Results of the study will be published after completion of study in August 2014.

The efficacy of the Kampo medicine rikkunshito for chemotherapy-induced anorexia (RICH trial): study protocol for a randomized controlled trial.

PubMed

Inoue, Takuya; Takagi, Hironori; Owada, Yuki; Watanabe, Yuzuru; Yamaura, Takumi; Fukuhara, Mitsuro; Muto, Satoshi; Okabe, Naoyuki; Matsumura, Yuki; Hasegawa, Takeo; Osugi, Jun; Hoshino, Mika; Higuchi, Mitsunori; Shio, Yutaka; Yokouchi, Hiroshi; Kanazawa, Kenya; Ohbuchi, Katsuya; Fukushima, Takahisa; Munakata, Mitsuru; Suzuki, Hiroyuki

2017-10-18

Cisplatin is a key drug in lung cancer therapy. However, cisplatin is also well known to induce gastrointestinal disorders, such as chemotherapy-induced nausea and vomiting, anorexia, and weight loss. These symptoms sometimes affect patients' quality of life and make continuation of chemotherapy difficult. Anorexia is a cause of concern for patients with cancer because a persistent loss of appetite progresses to cancer cachexia. Although evidence-based management for chemotherapy has recently been established, there is room for improvement. This placebo-controlled, double-blind, randomized trial will aim to determine the efficacy of the traditional Japanese Kampo medicine rikkunshito (TJ-43) for preventing anorexia caused by cisplatin-including chemotherapy in patients with lung cancer. Patients with lung cancer who plan to receive cisplatin-including chemotherapy will be recruited. Patients who provide written consent will be randomly allocated to receive either TJ-43 (arm A) or placebo (arm B) for one course of chemotherapy (21 or 28 consecutive days). Investigators and patients will be masked to the treatment assignment throughout the trial. The primary endpoint will be evaluated as the change in dietary intake from day 0 (the day before the start of chemotherapy) to day 7 of cisplatin-including chemotherapy. The two arms of the trial will comprise 30 patients each. From November 2014, a total of 60 patients will be recruited, and recruitment for the study is planned to be complete by October 2017. This trial is designed to examine the efficacy of rikkunshito (TJ-43) for reducing anorexia and maintaining food intake caused by cisplatin-including chemotherapy in patients with lung cancer. Japan Pharmaceutical Information Center Clinical Trials Information (JAPIC CTI), trial registration: JAPIC CTI-142747 . Registered on 15 December 2014; the RICH trial.

Robust coordinated control of a dual-arm space robot

NASA Astrophysics Data System (ADS)

Shi, Lingling; Kayastha, Sharmila; Katupitiya, Jay

2017-09-01

Dual-arm space robots are more capable of implementing complex space tasks compared with single arm space robots. However, the dynamic coupling between the arms and the base will have a serious impact on the spacecraft attitude and the hand motion of each arm. Instead of considering one arm as the mission arm and the other as the balance arm, in this work two arms of the space robot perform as mission arms aimed at accomplishing secure capture of a floating target. The paper investigates coordinated control of the base's attitude and the arms' motion in the task space in the presence of system uncertainties. Two types of controllers, i.e. a Sliding Mode Controller (SMC) and a nonlinear Model Predictive Controller (MPC) are verified and compared with a conventional Computed-Torque Controller (CTC) through numerical simulations in terms of control accuracy and system robustness. Both controllers eliminate the need to linearly parameterize the dynamic equations. The MPC has been shown to achieve performance with higher accuracy than CTC and SMC in the absence of system uncertainties under the condition that they consume comparable energy. When the system uncertainties are included, SMC and CTC present advantageous robustness than MPC. Specifically, in a case where system inertia increases, SMC delivers higher accuracy than CTC and costs the least amount of energy.

A pragmatic randomized controlled trial of thiopurine methyltransferase genotyping prior to azathioprine treatment: the TARGET study.

PubMed

Newman, William G; Payne, Katherine; Tricker, Karen; Roberts, Stephen A; Fargher, Emily; Pushpakom, Sudeep; Alder, Jane E; Sidgwick, Gary P; Payne, Debbie; Elliott, Rachel A; Heise, Marco; Elles, Robert; Ramsden, Simon C; Andrews, Julie; Houston, J Brian; Qasim, Faeiza; Shaffer, Jon; Griffiths, Christopher E M; Ray, David W; Bruce, Ian; Ollier, William E R

2011-06-01

To conduct a pragmatic, randomized controlled trial to assess whether thiopurine methyltransferase (TPMT) genotyping prior to azathioprine reduces adverse drug reactions (ADRs). A total of 333 participants were randomized 1:1 to undergo TPMT genotyping prior to azathioprine or to commence treatment without genotyping. There was no difference in the primary outcome of stopping azathioprine due to an adverse reaction (ADR, p = 0.59) between the two study arms. ADRs were more common in older patients (p = 0.01). There was no increase in stopping azathioprine due to ADRs in TPMT heterozygotes compared with wild-type individuals. The single individual with TPMT variant homozygosity experienced severe neutropenia. Our work supports the strong evidence that individuals with TPMT variant homozygosity are at high risk of severe neutropenia, whereas TPMT heterozygotes are not at increased risk of ADRs at standard doses of azathioprine.

An interactive videogame for arm and hand exercise in people with Parkinson's disease: A randomized controlled trial.

PubMed

Allen, Natalie E; Song, Jooeun; Paul, Serene S; Smith, Stuart; O'Duffy, Jonathan; Schmidt, Matthew; Love, Rachelle; Sherrington, Catherine; Canning, Colleen G

2017-08-01

People with Parkinson's disease (PD) have difficulty performing upper extremity (UE) activities. The aim of this study was to investigate if exergames targeting the UE improve arm and hand activities and impairments and to establish the acceptability and feasibility of these games in people with PD. Two tablet-based exergames were developed which were controlled with finger movements or unimanual whole arm movements. Participants with PD were randomized to an exergame (n = 19) or control (n = 19) group. The exergame group performed UE exergames at home, 3 times per week for 12 weeks. The primary outcome measure was the nine hole peg test. Secondary outcomes included measures of UE activities and impairments, including the tapping test [speed (taps/60s), and error (weighted error score/speed)]. There were no between group differences in the nine hole peg test, or in any secondary outcome measures except for the tapping test. Horizontal tapping test results showed that exergame participants improved their speed (mean difference = 10.9 taps/60s, p < 0.001) but increased error (mean difference = 0.03, p = 0.03) compared to the control group. Participants enjoyed the games and improved in their ability to play the games. There were no adverse events. The UE exergames were acceptable and safe, but did not translate to improvement in functional activities. It is likely that the requirement of the games resulted in increased movement speed at the detriment of accuracy. The design of exergames should consider task specificity. Copyright © 2017 Elsevier Ltd. All rights reserved.

Control treatments in biologics trials of rheumatoid arthritis were often not deemed acceptable in the context of care.

PubMed

Estellat, Candice; Tubach, Florence; Seror, Raphaèle; Alfaiate, Toni; Hajage, David; De Rycke, Yann; Ravaud, Philippe

2016-01-01

Control treatments in randomized controlled trials (RCTs) should not deliberately disadvantage patients. The objectives of the study were to compare (1) willingness to include vs. (2) willingness to prescribe control treatment among physicians randomized to assess, respectively, either (1) enrollment in a trial or (2) appropriateness of control treatment in a care context for the same fictional patient. Physicians were authors of articles about rheumatoid arthritis (RA), involved in RA patient care, and used to enrolling patients in trials. The outcomes were willingness to give control treatment: trial enrollment or control-treatment appropriateness in care context. We derived three case vignettes of fictional standard eligible patients for each of 30 RCTs assessing biologics in RA. Physicians were randomly allocated to the "trial" or "care" arm. For each of the 90 fictional patients, physicians assigned to the trial arm were asked if they would enroll the patient in the RCT the patient was derived from. For the same 90 fictional patients, physicians assigned to the care arm were asked if the control treatment of the RCT was appropriate in a context of usual care. Of the 1,779 physicians invited to participate, 151 were randomized. Half of the fictional patients {41/90; 45% [95% confidence interval (CI): 37%, 53%]} would be enrolled in the RCT although the control-arm treatment of the RCT was not considered appropriate for them in the context of care. This rate differed by type of comparator [55% for non-head-to-head RCTs vs. 6% for head-to-head RCTs; adjusted odds ratio (aOR), 23.9 (95% CI: 5.5, 92.7)] and duration of trial control treatment [56% for ≤24 weeks and 15% for >24 weeks; aOR, 10.7 (95% CI: 2.8, 63.9)] but not patient RA activity [aOR, 2.5 (95% CI: 1.0, 6.6)]. The limitation of this study was that physicians gave their opinion on fictional patients with only RA. Control treatments in RCTs of biologics in RA are often deemed not acceptable in the context of usual care, especially those for non-head-to-head RCTs. These findings raise ethical concerns and challenge the choice of the comparator in RCTs. Copyright © 2016 Elsevier Inc. All rights reserved.

Structural Studies of Three-Arm Star Block Copolymers Exposed to Extreme Stretch Suggests a Persistent Polymer Tube

NASA Astrophysics Data System (ADS)

Mortensen, Kell; Borger, Anine L.; Kirkensgaard, Jacob J. K.; Garvey, Christopher J.; Almdal, Kristoffer; Dorokhin, Andriy; Huang, Qian; Hassager, Ole

2018-05-01

We present structural small-angle neutron scattering studies of a three-armed polystyrene star polymer with short deuterated segments at the end of each arm. We show that the form factor of the three-armed star molecules in the relaxed state agrees with that of the random phase approximation of Gaussian chains. Upon exposure to large extensional flow conditions, the star polymers change conformation resulting in a highly stretched structure that mimics a fully extended three-armed tube model. All three arms are parallel to the flow, one arm being either in positive or negative stretching direction, while the two other arms are oriented parallel, right next to each other in the direction opposite to the first arm.

Recommendations for choosing an analysis method that controls Type I error for unbalanced cluster sample designs with Gaussian outcomes.

PubMed

Johnson, Jacqueline L; Kreidler, Sarah M; Catellier, Diane J; Murray, David M; Muller, Keith E; Glueck, Deborah H

2015-11-30

We used theoretical and simulation-based approaches to study Type I error rates for one-stage and two-stage analytic methods for cluster-randomized designs. The one-stage approach uses the observed data as outcomes and accounts for within-cluster correlation using a general linear mixed model. The two-stage model uses the cluster specific means as the outcomes in a general linear univariate model. We demonstrate analytically that both one-stage and two-stage models achieve exact Type I error rates when cluster sizes are equal. With unbalanced data, an exact size α test does not exist, and Type I error inflation may occur. Via simulation, we compare the Type I error rates for four one-stage and six two-stage hypothesis testing approaches for unbalanced data. With unbalanced data, the two-stage model, weighted by the inverse of the estimated theoretical variance of the cluster means, and with variance constrained to be positive, provided the best Type I error control for studies having at least six clusters per arm. The one-stage model with Kenward-Roger degrees of freedom and unconstrained variance performed well for studies having at least 14 clusters per arm. The popular analytic method of using a one-stage model with denominator degrees of freedom appropriate for balanced data performed poorly for small sample sizes and low intracluster correlation. Because small sample sizes and low intracluster correlation are common features of cluster-randomized trials, the Kenward-Roger method is the preferred one-stage approach. Copyright © 2015 John Wiley & Sons, Ltd.

Comparison of Two Theory-Based, Fully Automated Telephone Interventions Designed to Maintain Dietary Change in Healthy Adults: Study Protocol of a Three-Arm Randomized Controlled Trial

PubMed Central

Quintiliani, Lisa M; Turner-McGrievy, Gabrielle M; Migneault, Jeffrey P; Heeren, Timothy; Friedman, Robert H

2014-01-01

Background Health behavior change interventions have focused on obtaining short-term intervention effects; few studies have evaluated mid-term and long-term outcomes, and even fewer have evaluated interventions that are designed to maintain and enhance initial intervention effects. Moreover, behavior theory has not been developed for maintenance or applied to maintenance intervention design to the degree that it has for behavior change initiation. Objective The objective of this paper is to describe a study that compared two theory-based interventions (social cognitive theory [SCT] vs goal systems theory [GST]) designed to maintain previously achieved improvements in fruit and vegetable (F&V) consumption. Methods The interventions used tailored, interactive conversations delivered by a fully automated telephony system (Telephone-Linked Care [TLC]) over a 6-month period. TLC maintenance intervention based on SCT used a skills-based approach to build self-efficacy. It assessed confidence in and barriers to eating F&V, provided feedback on how to overcome barriers, plan ahead, and set goals. The TLC maintenance intervention based on GST used a cognitive-based approach. Conversations trained participants in goal management to help them integrate their newly acquired dietary behavior into their hierarchical system of goals. Content included goal facilitation, conflict, shielding, and redundancy, and reflection on personal goals and priorities. To evaluate and compare the two approaches, a sample of adults whose F&V consumption was below public health goal levels were recruited from a large urban area to participate in a fully automated telephony intervention (TLC-EAT) for 3-6 months. Participants who increase their daily intake of F&V by ≥1 serving/day will be eligible for the three-arm randomized controlled trial. A sample of 405 participants will be randomized to one of three arms: (1) an assessment-only control, (2) TLC-SCT, and (3) TLC-GST. The maintenance interventions are 6 months. All 405 participants who qualify for the trial will complete surveys administered by blinded interviewers at baseline (randomization), 6, 12, 18, and 24 months. Results Data analysis is not yet complete, but we hypothesize that (1) TLC-GST > TLC-SCT > control at all follow-up time points for F&V consumption, and (2) intervention effects will be mediated by the theoretical constructs (eg, self-efficacy, goal pursuit, conflict, shielding, and facilitation). Conclusions This study used a novel study design to initiate and then promote the maintenance of dietary behavior change through the use of an evidence-based fully automated telephony intervention. After the first 6 months (the acquisition phase), we will examine whether two telephony interventions built using different underlying behavioral theories were more successful than an assessment-only control group in helping participants maintain their newly acquired health behavior change. Trial Registration Clinicaltrials.gov NCT00148525; http://clinicaltrials.gov/ct2/show/NCT00148525 (Archived by Webcite at http://www.webcitation.org/6TiRriJOs). PMID:25387065

A Randomized Controlled Trial to Evaluate if Computerized Cognitive Rehabilitation Improves Neurocognition in Ugandan Children with HIV

PubMed Central

Nakasujja, Noeline; Sikorskii, Alla; Opoka, Robert O.; Giordani, Bruno

2016-01-01

Abstract Objectives: Clinically stable children with HIV can have neuromotor, attention, memory, visual–spatial, and executive function impairments. We evaluated neuropsychological and behavioral benefits of computerized cognitive rehabilitation training (CCRT) in Ugandan HIV children. Design: One hundred fifty-nine rural Ugandan children with WHO Stage I or II HIV disease (6 to 12 years; 77 boys, 82 girls; M = 8.9, SD = 1.86 years) were randomized to one of three treatment arms over a 2-month period. Methods: The CCRT arm received 24 one-hour sessions over 2 months, using Captain's Log (BrainTrain Corporation) programmed for games targeting working memory, attention, and visual–spatial analysis. These games progressed in difficulty as the child's performance improved. The second arm was a “limited CCRT” with the same games rotated randomly from simple to moderate levels of training. The third arm was a passive control group receiving no training. All children were assessed at enrollment, 2 months (immediately following CCRT), and 3 months after CCRT completion. Results: The CCRT group had significantly greater gains through 3 months of follow-up compared to passive controls on overall Kaufman Assessment Battery for Children–second edition (KABC-II) mental processing index (p < .01), planning (p = .04), and knowledge (p = .03). The limited CCRT group performed better than controls on learning (p = .05). Both CCRT arms had significant improvements on CogState Groton maze learning (p < .01); although not on CogState attention/memory, TOVA/impulsivity, or behavior rating inventory for executive function and child behavior checklist (psychiatric behavior/symptom problems) ratings by caregiver. Conclusions: CCRT intervention can be effective for neurocognitive rehabilitation in children with HIV in low-resource settings, especially in children who are clinically stable on ARV treatment. PMID:27045714

Impact of a Daily SMS Medication Reminder System on Tuberculosis Treatment Outcomes: A Randomized Controlled Trial.

PubMed

Mohammed, Shama; Glennerster, Rachel; Khan, Aamir J

2016-01-01

The rapid uptake of mobile phones in low and middle-income countries over the past decade has provided public health programs unprecedented access to patients. While programs have used text messages to improve medication adherence, there have been no high-powered trials evaluating their impact on tuberculosis treatment outcomes. To measure the impact of Zindagi SMS, a two-way SMS reminder system, on treatment success of people with drug-sensitive tuberculosis. We conducted a two-arm, parallel design, effectiveness randomized controlled trial in Karachi, Pakistan. Individual participants were randomized to either Zindagi SMS or the control group. Zindagi SMS sent daily SMS reminders to participants and asked them to respond through SMS or missed (unbilled) calls after taking their medication. Non-respondents were sent up to three reminders a day. Public and private sector tuberculosis clinics in Karachi, Pakistan. Newly-diagnosed patients with smear or bacteriologically positive pulmonary tuberculosis who were on treatment for less than two weeks; 15 years of age or older; reported having access to a mobile phone; and intended to live in Karachi throughout treatment were eligible to participate. We enrolled 2,207 participants, with 1,110 randomized to Zindagi SMS and 1,097 to the control group. The primary outcome was clinically recorded treatment success based upon intention-to-treat. We found no significant difference between the Zindagi SMS or control groups for treatment success (719 or 83% vs. 903 or 83%, respectively, p = 0·782). There was no significant program effect on self-reported medication adherence reported during unannounced visits during treatment. In this large-scale randomized controlled effectiveness trial of SMS medication reminders for tuberculosis treatment, we found no significant impact. The trial was registered with ClinicalTrials.gov, NCT01690754.

Percutaneous lower-extremity arterial interventions with primary balloon angioplasty versus Silverhawk atherectomy and adjunctive balloon angioplasty: randomized trial.

PubMed

Shammas, Nicolas W; Coiner, Denise; Shammas, Gail A; Dippel, Eric J; Christensen, Lori; Jerin, Michael

2011-09-01

Target lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) versus SilverHawk atherectomy and adjunctive PTA of de novo infrainguinal disease has not been well defined. This study was conducted to compare the two approaches. In this prospective, two-center randomized trial of PTA versus atherectomy of infrainguinal vessels, the primary endpoint of TLR was evaluated at 1 year. Secondary endpoints included the rate of "bailout" stent placement for suboptimal acute angiographic results and the rate of target vessel revascularization (TVR). Fifty-eight patients were included in the study. Of these, 29 (36 vessels) were randomized to the atherectomy arm and 29 (48 vessels) to the PTA arm. Final acute angiographic success rates were 100% in the PTA arm and 97.2% in the atherectomy arm (P value not significant). There was no statistical difference in TLR (16.7% vs 11.1%) or TVR (21.4% vs 11.1%) between the PTA and atherectomy groups, respectively. Bailout stent placement was performed in 18 of 29 patients (62.1%) in the PTA arm and eight of 29 patients (27.6%) in the atherectomy arm (P = .017). Major adverse events were similar between the PTA and atherectomy arms. Finally, when embolic filter protection was used, distal macroembolization occurred in 11 of 17 patients (64.7%) treated with atherectomy versus none of 10 in the PTA group (P < .001). TLR and TVR at 1 year were statistically similar in atherectomy and primary PTA. Atherectomy reduced the need for bailout stent placement compared with primary PTA. Copyright © 2011 SIR. Published by Elsevier Inc. All rights reserved.

Efficacy of Continuing Education in Improving Pharmacists' Competencies for Providing Weight Management Service: Three-Arm Randomized Controlled Trial

ERIC Educational Resources Information Center

Sarayani, Amir; Rashidian, Arash; Gholami, Kheirollah; Torkamandi, Hassan; Javadi, Mohammadreza

2012-01-01

Introduction: Weight management is a new public health role for community pharmacists in many countries. Lack of expertise is one of the key barriers to counseling obese patients. We evaluated the comparative efficacy of three alternative continuing education (CE) meetings on weight management. Methods: We designed a randomized controlled trial…

Adjuvant Liraglutide and Insulin Versus Insulin Monotherapy in the Closed-Loop System in Type 1 Diabetes: A Randomized Open-Labeled Crossover Design Trial.

PubMed

Ilkowitz, Jeniece Trast; Katikaneni, Ranjitha; Cantwell, Martin; Ramchandani, Neesha; Heptulla, Rubina A

2016-09-01

The closed-loop (CL) system delivers insulin in a glucose-responsive manner and optimal postprandial glycemic control is difficult to achieve with the algorithm and insulin available. We hypothesized that adjunctive therapy with liraglutide, a once-daily glucagon-like peptide-1 agonist, would be more effective in normalizing postprandial hyperglycemia versus insulin monotherapy in the CL system, in patients with type 1 diabetes. This was a randomized, controlled, open-label, crossover design trial comparing insulin monotherapy versus adjuvant subcutaneous liraglutide 1.2 mg and insulin, using the CL system in 15 patients. Blood glucose (BG), insulin, and glucagon concentrations were analyzed. The liraglutide arm was associated with overall decreased mean BG levels (P = .0002). The average BG levels from 8:00 pm (day 1) to 9:00 pm (day 2) were lower in the liraglutide arm (144.6 ± 36.31 vs 159.7 ± 50.88 mg/dl respectively; P = .0002). Two-hour postbreakfast and lunch BG profiles were better in the liraglutide arm (P < .05) and the insulin and glucagon assay values were lower (P < .0001). Postprandially, the area under the curve (AUC) for 2-hour postbreakfast and lunch BG levels were significant (P = .01, P = .03) and the AUC for glucagon, postbreakfast (P < .0001) and lunch (P < .05), was also significant. The incidence of hypoglycemia did not differ between arms (P = .83, Fisher's exact test). Overall, adjunct liraglutide therapy plus CL was well tolerated even with expected side effects. This is a proof-of-concept study showing liraglutide can be a potential adjunctive therapy in addition to CL with insulin to reduce postprandial hyperglycemia in type 1 diabetes. © 2016 Diabetes Technology Society.

Improving outcomes for caregivers through treatment of young people affected by war: a randomized controlled trial in Sierra Leone.

PubMed

McBain, Ryan K; Salhi, Carmel; Hann, Katrina; Kellie, Jim; Kamara, Alimamy; Salomon, Joshua A; Kim, Jane J; Betancourt, Theresa S

2015-12-01

To measure the benefits to household caregivers of a psychotherapeutic intervention for adolescents and young adults living in a war-affected area. Between July 2012 and July 2013, we carried out a randomized controlled trial of the Youth Readiness Intervention--a cognitive-behavioural intervention for war-affected young people who exhibit depressive and anxiety symptoms and conduct problems--in Freetown, Sierra Leone. Overall, 436 participants aged 15-24 years were randomized to receive the intervention (n = 222) or care as usual (n = 214). Household caregivers for the participants in the intervention arm (n = 101) or control arm (n = 103) were interviewed during a baseline survey and again, if available (n = 155), 12 weeks later in a follow-up survey. We used a burden assessment scale to evaluate the burden of care placed on caregivers in terms of emotional distress and functional impairment. The caregivers' mental health--i.e. internalizing, externalizing and prosocial behaviour--was evaluated using the Oxford Measure of Psychosocial Adjustment. Difference-in-differences multiple regression analyses were used, within an intention-to-treat framework, to estimate the treatment effects. Compared with the caregivers of participants of the control group, the caregivers of participants of the intervention group reported greater reductions in emotional distress (scale difference: 0.252; 95% confidence interval, CI: 0.026-0.4782) and greater improvements in prosocial behaviour (scale difference: 0.249; 95% CI: 0.012-0.486) between the two surveys. A psychotherapeutic intervention for war-affected young people can improve the mental health of their caregivers.

Controller adherence following hospital discharge in high risk children: A pilot randomized trial of text message reminders.

PubMed

Kenyon, Chén C; Gruschow, Siobhan M; Quarshie, William O; Griffis, Heather; Leach, Michelle C; Zorc, Joseph J; Bryant-Stephens, Tyra C; Miller, Victoria A; Feudtner, Chris

2018-02-13

To assess the feasibility of a mobile health, inhaled corticosteroid (ICS) adherence reminder intervention and to characterize adherence trajectories immediately following severe asthma exacerbation in high-risk urban children with persistent asthma. Children aged 2-13 with persistent asthma were enrolled in this pilot randomized controlled trial during an asthma emergency department (ED) visit or hospitalization. Intervention arm participants received daily text message reminders for 30 days, and both arms received electronic sensors to measure ICS use. Primary outcomes were feasibility of sensor use and text message acceptability. Secondary outcomes included adherence to prescribed ICS regimen and 30-day adherence trajectories. Group-based trajectory modeling was used to examine adherence trajectories. Forty-one participants (mean age 5.9) were randomized to intervention (n = 21) or control (n = 20). Overall, 85% were Black, 88% had public insurance, and 51% of the caregivers had a high school education or less. Thirty-two participant families (78%) transmitted medication adherence data; of caregivers who completed the acceptability survey, 25 (96%) chose to receive daily reminders beyond that study interval. Secondary outcome analyses demonstrated similar average daily adherence between groups (intervention = 36%; control = 32%, P = 0.73). Three adherence trajectories were identified with none ever exceeding 80% adherence. Within a high-risk pediatric cohort, electronic monitoring of ICS use and adherence reminders delivered via text message were feasible for most participants, but there was no signal of effect. Adherence trajectories following severe exacerbation were suboptimal, demonstrating an important opportunity for asthma care improvement.

A multimedia consent tool for research participants in the Gambia: a randomized controlled trial.

PubMed

Afolabi, Muhammed Olanrewaju; McGrath, Nuala; D'Alessandro, Umberto; Kampmann, Beate; Imoukhuede, Egeruan B; Ravinetto, Raffaella M; Alexander, Neal; Larson, Heidi J; Chandramohan, Daniel; Bojang, Kalifa

2015-05-01

To assess the effectiveness of a multimedia informed consent tool for adults participating in a clinical trial in the Gambia. Adults eligible for inclusion in a malaria treatment trial (n = 311) were randomized to receive information needed for informed consent using either a multimedia tool (intervention arm) or a standard procedure (control arm). A computerized, audio questionnaire was used to assess participants' comprehension of informed consent. This was done immediately after consent had been obtained (at day 0) and at subsequent follow-up visits (days 7, 14, 21 and 28). The acceptability and ease of use of the multimedia tool were assessed in focus groups. On day 0, the median comprehension score in the intervention arm was 64% compared with 40% in the control arm (P = 0.042). The difference remained significant at all follow-up visits. Poorer comprehension was independently associated with female sex (odds ratio, OR: 0.29; 95% confidence interval, CI: 0.12-0.70) and residing in Jahaly rather than Basse province (OR: 0.33; 95% CI: 0.13-0.82). There was no significant independent association with educational level. The risk that a participant's comprehension score would drop to half of the initial value was lower in the intervention arm (hazard ratio 0.22, 95% CI: 0.16-0.31). Overall, 70% (42/60) of focus group participants from the intervention arm found the multimedia tool clear and easy to understand. A multimedia informed consent tool significantly improved comprehension and retention of consent information by research participants with low levels of literacy.

Increased Survival Among HIV-Infected PWID Receiving a Multi-Level HIV Risk and Stigma Reduction Intervention: Results From a Randomized Controlled Trial.

PubMed

Go, Vivian F; Frangakis, Constantine; Le Minh, Nguyen; Ha, Tran Viet; Latkin, Carl A; Sripaipan, Teerada; Zelaya, Carla E; Davis, Wendy W; Celentano, David D; Quan, Vu Minh

2017-02-01

In Vietnam, where 58% of prevalent HIV cases are attributed to people who inject drugs, we evaluated whether a multi-level intervention could improve care outcomes and increase survival. We enrolled 455 HIV-infected males who inject drugs from 32 communes in Thai Nguyen Province. Communes were randomized to a community stigma reduction intervention or standard of care and then within each commune, to an individual enhanced counseling intervention or standard of care, resulting into 4 arms: Arm 1 (standard of care); Arm 2 (community intervention alone); Arm 3 (individual intervention alone); and Arm 4 (community + individual interventions). Follow-up was conducted at 6, 12, 18, and 24 months to assess survival. Overall mortality was 23% (n = 103/455) more than 2 years. There were no losses to follow-up for the mortality endpoint. Survival at 24 months was different across arms: Arm 4 (87%) vs Arm 1 (82%) vs Arm 2 (68%) vs Arm 3 (73%); log-rank test for comparison among arms: P = 0.001. Among those with CD4 cell count <200 cells/mm and not on antiretroviral therapy at baseline (n = 162), survival at 24 months was higher in Arm 4 (84%) compared with other arms (Arm 1: 61%; Arm 2: 50%; Arm 3: 53%; P-value = 0.002). Overall, Arm 4 (community + individual interventions) had increased uptake of antiretroviral therapy compared with Arms 1, 2, and 3. This multi-level behavioral intervention seemed to increase survival of HIV-infected participants more than a 2-year period. Relative to the standard of care, the greatest intervention effect was among those with lower CD4 cell counts.

Postdeployment Battlemind Training for the U.K. Armed Forces: A Cluster Randomized Controlled Trial

ERIC Educational Resources Information Center

Mulligan, Kathleen; Fear, Nicola T.; Jones, Norman; Alvarez, Helen; Hull, Lisa; Naumann, Ulrike; Wessely, Simon; Greenberg, Neil

2012-01-01

Objective: Combat exposure can increase the risk of subsequent psychological ill-health in armed forces (AF) personnel. A U.S. postdeployment psycho-educational intervention, Battlemind, showed a beneficial effect on mental health in U.S. military personnel exposed to high combat levels. We evaluated the effectiveness of an anglicized version of…

Feasibility and Safety of Substituting Lung Ultrasonography for Chest Radiography When Diagnosing Pneumonia in Children: A Randomized Controlled Trial.

PubMed

Jones, Brittany Pardue; Tay, Ee Tein; Elikashvili, Inna; Sanders, Jennifer E; Paul, Audrey Z; Nelson, Bret P; Spina, Louis A; Tsung, James W

2016-07-01

Chest radiography (CXR) is the test of choice for diagnosing pneumonia. Lung ultrasonography (LUS) has been shown to be accurate for diagnosing pneumonia in children and may be an alternative to CXR. Our objective was to determine the feasibility and safety of substituting LUS for CXR when evaluating children suspected of having pneumonia. We conducted a randomized control trial comparing LUS with CXR in 191 children from birth to 21 years of age suspected of having pneumonia in an ED. Patients in the investigational arm underwent LUS. If there was clinical uncertainty after ultrasonography, physicians had the option to perform CXR. Patients in the control arm underwent sequential imaging with CXR followed by LUS. The primary outcome was the rate of CXR reduction; secondary outcomes were missed pneumonia, subsequent unscheduled health-care visits, and adverse events between the investigational and control arms. There was a 38.8% reduction (95% CI, 30.0%-48.9%) in CXR among investigational subjects compared with no reduction (95% CI, 0.0%-3.6%) in the control group. Novice and experienced physician-sonologists achieved 30.0% and 60.6% reduction in CXR use, respectively. There were no cases of missed pneumonia among all study participants (investigational arm, 0.0%: 95% CI, 0.0%-2.9%; control arm, 0.0%: 95% CI, 0.0%-3.0%), or differences in adverse events, or subsequent unscheduled health-care visits between arms. It may be feasible and safe to substitute LUS for CXR when evaluating children suspected of having pneumonia with no missed cases of pneumonia or increase in rates of adverse events. ClinicalTrials.gov; No.: NCT01654887; URL: www.clinicaltrials.gov. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Impact of fibrates on circulating cystatin C levels: a systematic review and meta-analysis of clinical trials.

PubMed

Sahebkar, Amirhossein; Simental-Mendía, Luis E; Pirro, Matteo; Montecucco, Fabrizio; Carbone, Federico; Banach, Maciej; Barreto, George E; Butler, Alexandra E

2018-06-29

To assess the effect of fibrates on circulating cystatin C levels. Clinical studies evaluating the effect of a fibrate on circulating cystatin C levels were searched in PubMed-Medline, SCOPUS, Web of Science and Google Scholar databases. A random-effect model and generic inverse variance method were used for quantitative data synthesis, sensitivity analysis conducted using the leave-one-out method, and weighted random-effects meta-regression performed to evaluate potential confounders on cystatin C levels. This meta-analysis of data from 9 published studies (16 treatment arms) involved a total of 2195 subjects. In a single-arm analysis of clinical trials (without control group; 8 studies comprising 14 treatment arms), fibrate therapy increased circulating cystatin C concentrations (WMD: 0.07 mg/dL, 95% CI: 0.04, 0.10, p <0.001; I 2 = 82.66%). When the analysis was restricted to randomized controlled trials (4 studies comprising 6 treatment arms), again elevation of circulating cystatin C levels was observed (WMD: 0.06 mg/L, 95% CI: 0.03, 0.09, p <0.001; I 2 = 42.98%). Elevated cystatin C levels were only seen with fenofibrate, not other fibrates. The results suggest that fenofibrate treatment adversely affects cystatin C levels and might partially explain the limited efficacy of fenofibrate in reducing cardiovascular events.

Effect of liposomes, vitamins A and E nasal spray in reducing the healing time after septoplasty with concurrent turbinate surgery in adolescents.

PubMed

Ricciardiello, Filippo; Cantone, Elena; Abate, Teresa; DI Lullo, Antonella M; Oliva, Flavia; Iengo, Maurizio; DE Bernardo, Giuseppe

2017-02-01

This study evaluates endoscopic and quality of life (QoL) outcomes in two groups, composed by both allergic (A) and non-allergic (N-A) adolescents undergoing septoplasty with concurrent turbinate surgery by radiofrequency treated after surgery with nasal spray containing liposomes and vitamins A and E. This double-blind randomized study was carried out on 40 patients (22 males, 18 females, mean age 15.5±1.0 years) undergoing septoplasty and volumetric tissue reduction of inferior turbinates by radiofrequency for post-traumatic deformities and severe nasal obstruction. We enrolled 20 subjects with positive skin prick tests and 20 with negative skin prick tests (SPT) to aeroallergens. All subjects underwent the Visual Analogue Scale (VAS) questionnaire and the nasal endoscopy score by Lund and Kennedy (LK) at baseline before surgery (T0) and 15 days (T15) and 21 days (T21) after treatment. After surgery, the nose was not packed and the day after surgery all subjects were randomized into two groups, experimental arm group I (GI) and control arm group II (GII) and given the treatment, nasal spray containing liposomes composed of phospholipids, fatty acids, and vitamin A and E for group I and saline solution (sodium chloride 0.9%) for group II. After therapy, the VAS and LK scores were better (P<0.05) in the investigational than in the control arm in both sub-groups (A and N-A). Our findings suggested that liposomal, vitamins A and E nasal spray improves the QoL in the early postoperative period, both in A and N-A sub-groups.

Assessing the benefits of five years of different approaches to treatment of urogenital schistosomiasis: A SCORE project in Northern Mozambique.

PubMed

Phillips, Anna E; Gazzinelli-Guimaraes, Pedro H; Aurelio, Herminio O; Ferro, Josefo; Nala, Rassul; Clements, Michelle; King, Charles H; Fenwick, Alan; Fleming, Fiona M; Dhanani, Neerav

2017-12-01

In Mozambique, schistosomiasis is highly endemic across the whole country. The Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) coordinates a five-year study that has been implemented in various African countries, including Mozambique. The overall goal of SCORE was to better understand how to best apply preventive chemotherapy with praziquantel (PZQ) for schistosomiasis control by evaluating the impact of alternative treatment approaches. This was a cluster-randomised trial that compared the impact of different treatment strategies in study areas with prevalence among school children of ≥21% S. haematobium infection by urine dipstick. Each village was randomly allocated to one of six possible combinations of community-wide treatment (CWT), school-based treatment (SBT), and/or drug holidays over a period of four years, followed by final data collection in the fifth year. The most intense intervention arm involved four years of CWT, while the least intensive arm involved two years of SBT followed by two consecutive years of PZQ holiday. Each study arm included 25 villages randomly assigned to one of the six treatment arms. The primary outcome of interest was change in prevalence and intensity of S. haematobium among 100 children aged 9-to-12-years that were sampled each year in every village. In addition to children aged 9-to-12 years, 100 children aged 5-8 years in their first-year of school and 50 adults (aged 20-55 years) were tested in the first and final fifth year of the study. Prevalence and intensity of S. haematobium infection was evaluated by two filtrations, each of 10mL, from a single urine specimen. In total, data was collected from 81,167 individuals across 149 villages in ten districts of Cabo Delgado province, Northern Mozambique. Overall PZQ treatment resulted in a significant reduction in the prevalence of S. haematobium infection from Year 1 to Year 5, where the average prevalence went from 60.5% to 38.8%, across all age groups and treatment arms. The proportion of those heavily infected also reduced from 17.6% to 11.9% over five years. There was a significantly higher likelihood of males being infected than females at baseline, but no significant difference between the sexes in their response to treatment. The only significant response based on a study arm was seen in both the 9-to-12-year-old and first-year cross sections, where two consecutive treatment holidays resulted in a significantly higher final prevalence of S. haematobium than no treatment holidays. When the arms were grouped together, four rounds of treatment (regardless of whether it was CWT or SBT), however, did result in a significantly greater reduction in S. haematobium prevalence than two rounds of treatment (i.e. with two intermittent or consecutive holiday years) over a five-year period. Although PC was successful in reducing the burden of active infection, even among those heavily infected, annual CWT did not have a significantly greater impact on disease prevalence or intensity than less intense treatment arms. This may be due to extremely high starting prevalence and intensity in the study area, with frequent exposure to reinfection, or related to challenges in achieving high treatment coverage More frequent treatment had a greater impact on prevalence and intensity of infection when arms were grouped by number of treatments, however, cost efficiency was greater in arms only receiving two treatments. Finally, a significant reduction in prevalence of S. haematobium was seen in adults even in the SBT arms implying the rate of transmission in the community had been decreased, even where only school children have been treated, which has significant logistical and cost-saving implications for a national control programme in justifying CWT.

Assessing the benefits of five years of different approaches to treatment of urogenital schistosomiasis: A SCORE project in Northern Mozambique

PubMed Central

Gazzinelli-Guimaraes, Pedro H.; Aurelio, Herminio O.; Ferro, Josefo; Nala, Rassul; Clements, Michelle; King, Charles H.; Fenwick, Alan; Fleming, Fiona M.; Dhanani, Neerav

2017-01-01

Background In Mozambique, schistosomiasis is highly endemic across the whole country. The Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) coordinates a five-year study that has been implemented in various African countries, including Mozambique. The overall goal of SCORE was to better understand how to best apply preventive chemotherapy with praziquantel (PZQ) for schistosomiasis control by evaluating the impact of alternative treatment approaches. Methods This was a cluster-randomised trial that compared the impact of different treatment strategies in study areas with prevalence among school children of ≥21% S. haematobium infection by urine dipstick. Each village was randomly allocated to one of six possible combinations of community-wide treatment (CWT), school-based treatment (SBT), and/or drug holidays over a period of four years, followed by final data collection in the fifth year. The most intense intervention arm involved four years of CWT, while the least intensive arm involved two years of SBT followed by two consecutive years of PZQ holiday. Each study arm included 25 villages randomly assigned to one of the six treatment arms. The primary outcome of interest was change in prevalence and intensity of S. haematobium among 100 children aged 9-to-12-years that were sampled each year in every village. In addition to children aged 9-to-12 years, 100 children aged 5–8 years in their first-year of school and 50 adults (aged 20–55 years) were tested in the first and final fifth year of the study. Prevalence and intensity of S. haematobium infection was evaluated by two filtrations, each of 10mL, from a single urine specimen. Principal findings In total, data was collected from 81,167 individuals across 149 villages in ten districts of Cabo Delgado province, Northern Mozambique. Overall PZQ treatment resulted in a significant reduction in the prevalence of S. haematobium infection from Year 1 to Year 5, where the average prevalence went from 60.5% to 38.8%, across all age groups and treatment arms. The proportion of those heavily infected also reduced from 17.6% to 11.9% over five years. There was a significantly higher likelihood of males being infected than females at baseline, but no significant difference between the sexes in their response to treatment. The only significant response based on a study arm was seen in both the 9-to-12-year-old and first-year cross sections, where two consecutive treatment holidays resulted in a significantly higher final prevalence of S. haematobium than no treatment holidays. When the arms were grouped together, four rounds of treatment (regardless of whether it was CWT or SBT), however, did result in a significantly greater reduction in S. haematobium prevalence than two rounds of treatment (i.e. with two intermittent or consecutive holiday years) over a five-year period. Conclusions Although PC was successful in reducing the burden of active infection, even among those heavily infected, annual CWT did not have a significantly greater impact on disease prevalence or intensity than less intense treatment arms. This may be due to extremely high starting prevalence and intensity in the study area, with frequent exposure to reinfection, or related to challenges in achieving high treatment coverage More frequent treatment had a greater impact on prevalence and intensity of infection when arms were grouped by number of treatments, however, cost efficiency was greater in arms only receiving two treatments. Finally, a significant reduction in prevalence of S. haematobium was seen in adults even in the SBT arms implying the rate of transmission in the community had been decreased, even where only school children have been treated, which has significant logistical and cost-saving implications for a national control programme in justifying CWT. PMID:29220347

Effect of Web-Based Versus Paper-Based Questionnaires and Follow-Up Strategies on Participation Rates of Dutch Childhood Cancer Survivors: A Randomized Controlled Trial

PubMed Central

van Dulmen-den Broeder, Eline; van der Pal, Helena J; Hollema, Nynke; Kremer, Leontien C; van den Heuvel-Eibrink, Marry M; van Leeuwen, Flora E

2015-01-01

Background Questionnaires are widely used in survey research, especially in cohort studies. However, participation in questionnaire studies has been declining over the past decades. Because high participation rates are needed to limit the risk of selection bias and produce valid results, it is important to investigate invitation strategies which may improve participation. Objectives The purpose of this study is to investigate the effect of Web-based versus paper-based questionnaires on participation rates in a questionnaire survey on late effects among childhood cancer survivors (CCSs). Methods A total of 750 CCSs were randomized across 3 study arms. The initial invitation in study arms 1 and 2 consisted of a Web-based questionnaire only, whereas in study arm 3 this invitation was complemented with a paper-based version of the questionnaire. The first postal reminder, sent to the nonresponding CCSs in all 3 study arms, consisted of either a reminder letter only (study arms 1 and 3) or a reminder letter complemented with a paper-based questionnaire (study arm 2). The second postal reminder was restricted to CCSs in study arms 1 and 2, with only those in study arm 1 also receiving a paper-based questionnaire. CCSs in study arm 3 received a second reminder by telephone instead of by mail. In contrast to CCSs in study arm 3, CCSs in study arms 1 and 2 received a third reminder, this time by telephone. Results: Overall, 58.1% (436/750) of the CCSs participated in the survey. Participation rates were equal in all 3 study arms with 57.4% (143/249) in arm 1, 60.6% (152/251) in arm 2, and 56.4% (141/250) in arm 3 (P=.09). Participation rates of CCSs who received an initial invitation for the Web-based questionnaire only and CCSs who received an invitation to complete either a paper-based or Web-based questionnaire did not differ (P=.55). After the first postal reminder, participation rates of CCSs invited for the Web-based questionnaire only also did not differ compared with CCSs invited for both the Web-based and paper-based questionnaires (P=.48). In general, CCSs preferred the paper-based over the Web-based questionnaire, and those completing the paper-based questionnaire were more often unemployed (P=.004) and lower educated (P<.001). Conclusion Invitation strategies offering a Web-based questionnaire without a paper-based alternative at first invitation can be used without compromising participation rates of CCS. Offering the choice between paper- and Web-based questionnaires seems to result in the highest accrual participation rate. Future research should look into the quality of the data delivered by both questionnaires filled in by respondents themselves. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 84711754; http://www.controlled-trials.com/ISRCTN84711754 (Archived by WebCite at http://www.webcitation.org/6c9ZB8paX) PMID:28410161

Noninferiority, randomized, controlled trial comparing embryo development using media developed for sequential or undisturbed culture in a time-lapse setup.

PubMed

Hardarson, Thorir; Bungum, Mona; Conaghan, Joe; Meintjes, Marius; Chantilis, Samuel J; Molnar, Laszlo; Gunnarsson, Kristina; Wikland, Matts

2015-12-01

To study whether a culture medium that allows undisturbed culture supports human embryo development to the blastocyst stage equivalently to a well-established sequential media. Randomized, double-blinded sibling trial. Independent in vitro fertilization (IVF) clinics. One hundred twenty-eight patients, with 1,356 zygotes randomized into two study arms. Embryos randomly allocated into two study arms to compare embryo development on a time-lapse system using a single-step medium or sequential media. Percentage of good-quality blastocysts on day 5. Percentage of day 5 good-quality blastocysts was 21.1% (standard deviation [SD] ± 21.6%) and 22.2% (SD ± 22.1%) in the single-step time-lapse medium (G-TL) and the sequential media (G-1/G-2) groups, respectively. The mean difference (-1.2; 95% CI, -6.0; 3.6) between the two media systems for the primary end point was less than the noninferiority margin of -8%. There was a statistically significantly lower number of good-quality embryos on day 3 in the G-TL group [50.7% (SD ± 30.6%) vs. 60.8% (SD ± 30.7%)]. Four out of the 11 measured morphokinetic parameters were statistically significantly different for the two media used. The mean levels of ammonium concentration in the media at the end of the culture period was statistically significantly lower in the G-TL group as compared with the G-2 group. We have shown that a single-step culture medium supports blastocyst development equivalently to established sequential media. The ammonium concentrations were lower in the single-step media, and the measured morphokinetic parameters were modified somewhat. NCT01939626. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Motivational Enhancement for Increasing Adherence to CPAP: A Randomized Controlled Trial.

PubMed

Bakker, Jessie P; Wang, Rui; Weng, Jia; Aloia, Mark S; Toth, Claudia; Morrical, Michael G; Gleason, Kevin J; Rueschman, Michael; Dorsey, Cynthia; Patel, Sanjay R; Ware, James H; Mittleman, Murray A; Redline, Susan

2016-08-01

Motivational enhancement (ME) shows promise as a means of increasing adherence to CPAP for OSA. We performed an open-label, parallel-arm, randomized controlled trial of CPAP only or CPAP + ME, recruiting individuals 45 to 75 years with moderate or severe OSA without marked sleepiness and with either established cardiovascular disease (CVD) or at risk for CVD. All participants received standardized CPAP support from a sleep technologist; those randomly assigned to CPAP + ME also received standardized ME delivered by a psychologist during two appointments and six phone calls over 32 weeks. Mixed-effect models with subject-specific intercepts and slopes were fitted to compare objective CPAP adherence between arms, adjusting for follow-up duration, randomization factors, and device manufacturer. All analyses were intention-to-treat. Overall, 83 participants (n = 42 CPAP only; n = 41 CPAP + ME) contributed 14,273 nights of data for 6 months. Participants were predominantly male (67%) and had a mean ± SD age of 63.9 ± 7.4 years, a BMI of 31.1 ± 5.2 kg/m(2), and an apnea-hypopnea index of 26.2 ± 12.9 events/h. In our fully adjusted model, average nightly adherence for 6 months was 99.0 min/night higher with CPAP + ME compared with CPAP only (P = .003; primary analysis). A subset of 52 participants remained in the study for 12 months; modeling these data yielded a consistent difference in adherence between arms of 97 min/night (P = .006) favoring CPAP + ME. ME delivered during brief appointments and phone calls resulted in a clinically significant increase in CPAP adherence. This strategy may represent a feasible approach for optimizing management of OSA. ClinicalTrials.gov; No.: NCT01261390; URL: www.clinicaltrials.gov. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

SAKK 24/09: safety and tolerability of bevacizumab plus paclitaxel vs. bevacizumab plus metronomic cyclophosphamide and capecitabine as first-line therapy in patients with HER2-negative advanced stage breast cancer - a multicenter, randomized phase III trial.

PubMed

Rochlitz, Christoph; Bigler, Martin; von Moos, Roger; Bernhard, Jürg; Matter-Walstra, Klazien; Wicki, Andreas; Zaman, Khalil; Anchisi, Sandro; Küng, Marc; Na, Kyung-Jae; Bärtschi, Daniela; Borner, Markus; Rordorf, Tamara; Rauch, Daniel; Müller, Andreas; Ruhstaller, Thomas; Vetter, Marcus; Trojan, Andreas; Hasler-Strub, Ursula; Cathomas, Richard; Winterhalder, Ralph

2016-10-10

Adding bevacizumab to chemotherapy improves response rates and progression-free survival (PFS) in metastatic breast cancer (mBC). We aimed to demonstrate decreased toxicity with metronomic chemotherapy/bevacizumab compared with paclitaxel/bevacizumab. This multicenter, randomized phase III trial compared bevacizumab with either paclitaxel (arm A) or daily oral capecitabine-cyclophosphamide (arm B) as first-line treatment in patients with HER2-negative advanced breast cancer. The primary endpoint was the incidence of selected grade 3-5 adverse events (AE) including: febrile neutropenia, infection, sensory/motor neuropathy, and mucositis. Secondary endpoints included objective response rate, disease control rate, PFS, overall survival (OS), quality of life (QoL), and pharmacoeconomics. The study was registered prospectively with ClinicalTrials.gov, number NCT01131195 on May 25, 2010. Between September 2010 and December 2012, 147 patients were included at 22 centers. The incidence of primary endpoint-defining AEs was similar in arm A (25 % [18/71]; 95 % CI 15-35 %) and arm B (24 % [16/68]; 95 % CI 13-34 %; P = 0.96). Objective response rates were 58 % (42/73; 95 % CI 0.46-0.69) and 50 % (37/74; 95 % CI 0.39-0.61) in arms A and B, respectively (P = 0.45). Median PFS was 10.3 months (95 % CI 8.7-11.3) in arm A and 8.5 months (95 % CI 6.5-11.9) in arm B (P = 0.90). Other secondary efficacy endpoints were not significantly different between study arms. The only statistically significant differences in QoL were less hair loss and less numbness in arm B. Treatment costs between the two arms were equivalent. This trial failed to meet its primary endpoint of a reduced rate of prespecified grade 3-5 AEs with metronomic bevacizumab, cyclophosphamide and capecitabine.

Does an outcome-based approach to continuing medical education improve physicians' competences in rational prescribing?

PubMed

Esmaily, Hamideh M; Savage, Carl; Vahidi, Rezagoli; Amini, Abolghasem; Dastgiri, Saeed; Hult, Hakan; Dahlgren, Lars Owe; Wahlstrom, Rolf

2009-11-01

Continuing medical education (CME) is compulsory in Iran, and traditionally it is lecture-based, which is mostly not successful. Outcome-based education has been proposed for CME programs. To evaluate the effectiveness of an outcome-based educational intervention with a new approach based on outcomes and aligned teaching methods, on knowledge and skills of general physicians (GPs) working in primary care compared with a concurrent CME program in the field of "Rational prescribing". The method used was cluster randomized controlled design. All GPs working in six cities in one province in Iran were invited to participate. The cities were matched and randomly divided into an intervention arm for education on rational prescribing with an outcome-based approach, and a control arm for a traditional program on the same topic. Knowledge and skills were assessed using a pre- and post-test, including case scenarios. In total, 112 GPs participated. There were significant improvements in knowledge and prescribing skills after the training in the intervention arm as well as in comparison with the changes in the control arm. The overall intervention effect was 26 percentage units. The introduction of an outcome-based approach in CME appears to be effective when creating programs to improve GPs' knowledge and skills.

Restaurant inspection frequency: The RestoFreq Study.

PubMed

Medu, Olanrewaju; Turner, Hollie; Cushon, Jennifer A; Melis, Deborah; Rea, Leslie; Abdellatif, Treena; Neudorf, Cory O; Schwandt, Michael

2017-03-01

Foodborne illness is an important contributor to morbidity and health system costs in Canada. Using number of critical hazards as a proxy for food safety, we sought to better understand how to improve food safety in restaurants. We compared the current standard of annual inspections to twice-yearly inspections among restaurants "at risk" for food safety infractions. These were restaurants that had three or more elevated-risk inspection ratings in the preceding 36 months. We conducted a two-arm randomized controlled trial between November 2012 and October 2014. The intervention was twice-yearly routine restaurant inspection compared to standard once-yearly routine inspection. Included were all restaurants within Saskatoon Health Region that were assessed as "at risk", with 73 restaurants in the intervention arm and 78 in the control arm. Independent sample t-tests were conducted between groups to compare: i) average number of critical hazards per inspection; and ii) proportion of inspections resulting in a rating indicating an elevated hazard. Over time we noted statistically significant improvements across both study arms, in number of both critical food safety hazards (decreased by 61%) and elevated-risk inspection ratings (decreased by 45%) (p < 0.0001). We observed no significant differences between the two groups pre- or post-intervention. Results suggest increasing the number of annual routine inspections in high-risk restaurants was not associated with a significant difference in measures of compliance with food safety regulations. Findings of this study do not provide evidence supporting increased frequency of restaurant inspection from annually to twice annually.

Correlations of Handgrip Strength with Selected Hand-Arm-Anthropometric Variables in Indian Inter-university Female Volleyball Players

PubMed Central

Koley, Shyamal; Pal Kaur, Satinder

2011-01-01

Purpose The purpose of this study was to estimate the dominant handgrip strength and its correlations with some hand and arm anthropometric variables in 101 randomly selected Indian inter-university female volleyball players aged 18-25 years (mean age 20.52±1.40) from six Indian universities. Methods Three anthropometric variables, i.e. height, weight, BMI, two hand anthropometric variables, viz. right and left hand width and length, four arm anthropometric variables, i.e. upper arm length, lower arm length, upper extremity length, upper arm circumference and dominant right and non-dominant handgrip strength were measured among Indian inter-university female volleyball players by standard anthropometric techniques. Results The findings of the present study indicated that Indian female volleyball players had higher mean values in eleven variables and lesser mean values in two variables than their control counterparts, showing significant differences (P<0.032-0.001) in height (t=2.63), weight (t=8.66), left hand width (t=2.10), left and right hand length (t=9.99 and 10.40 respectively), right upper arm length (t=8.48), right forearm length (t=5.41), dominant (right) and non-dominant (left) handgrip strength (t=9.37 and 6.76 respectively). In female volleyball players, dominant handgrip strength had significantly positive correlations (P=0.01) with all the variables studied. Conclusion It may be concluded that dominant handgrip strength had strong positive correlations with all the variables studied in Indian inter-university female volleyball players. PMID:22375242

Kinematically redundant arm formulations for coordinated multiple arm implementations

NASA Technical Reports Server (NTRS)

Bailey, Robert W.; Quiocho, Leslie J.; Cleghorn, Timothy F.

1990-01-01

Although control laws for kinematically redundant robotic arms were presented as early as 1969, redundant arms have only recently become recognized as viable solutions to limitations inherent to kinematically sufficient arms. The advantages of run-time control optimization and arm reconfiguration are becoming increasingly attractive as the complexity and criticality of robotic systems continues to progress. A generalized control law for a spatial arm with 7 or more degrees of freedom (DOF) based on Whitney's resolved rate formulation is given. Results from a simulation implementation utilizing this control law are presented. Furthermore, results from a two arm simulation are presented to demonstrate the coordinated control of multiple arms using this formulation.

Double-blind, placebo-controlled, randomized study of chlorhexidine prophylaxis for 5-fluorouracil-based chemotherapy-induced oral mucositis with nonblinded randomized comparison to oral cooling (cryotherapy) in gastrointestinal malignancies.

PubMed

Sorensen, Jens Benn; Skovsgaard, Torben; Bork, Ellen; Damstrup, Lars; Ingeberg, Sten

2008-04-01

The purpose was to evaluate prevention of oral mucositis (OM) using chlorhexidine compared with placebo and with oral cooling (cryotherapy) during fluorouracil (5-FU)-based chemotherapy in gastrointestinal (GI) cancer. Patients with previously untreated GI cancer receiving bolus 5-FU/leucovorin chemotherapy were randomized to chlorhexidine mouthrinse 3 times a day for 3 weeks (Arm A), double-blind placebo (normal saline) with the same dose and frequency (Arm B), or cryotherapy with crushed ice 45 minutes during chemotherapy (Arm C). Patients self-reported on severity (CTC-grading) and duration of OM. Among 225 patients randomized, 206 answered the questionnaire (70, 64, and 63 patients in Arms A, B, and C, respectively) and were well balanced with respect to diagnoses, stage, age, sex, smoking habits, and performance status. Mucositis grade 3-4 occurred more frequently in Arm B (33%) than in A (13%, P< .01) and C (11%, P< .005). Duration was significantly longer in B than in both A (P= .035) and C (P= .003). The frequency and duration of OM are significantly improved by prophylactic chlorhexidine and by cryotherapy. The latter is easy and inexpensive but has limited use, as it is drug- and schedule-dependent. The current study is the first double-blind randomized evaluation of prophylactic chlorhexidine in a large adult patient population with solid tumors receiving highly OM-inducing chemotherapy. A role for chlorhexidine in the prevention of OM is suggested, which should be evaluated further.

Effect of a pragmatic, cluster-randomized controlled trial on patient experience with care: The Transforming Outcomes for Patients through Medical home Evaluation and reDesign (TOPMED) study

PubMed Central

Dorr, David A.; Anastas, Tracy; Ramsey, Katrina; Wagner, Jesse; Sachdeva, Bhavaya; Michaels, LeAnn; Fagnan, Lyle

2016-01-01

Background Health reform programs like the Patient-Centered Medical Home (PCMH) are intended to improve the Triple Aim. Previous studies on PCMHs have shown mixed effects, but High Value Elements (HVEs) are expected to improve the Triple Aim. Objective To understand whether focusing on high value elements (HVEs) would improve patient experience with care. Methods Eight clinics were cluster-randomized in a year-long trial. Both arms received practice facilitation, IT-based reporting, and financial incentives. Intervention practices were encouraged to choose HVEs for QI goals. To assess patient experience, 1,597 Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys were sent pre- and post-trial to a stratified random sample of patients. Difference in difference multivariate analysis was used to compare patient responses from intervention and control practices, adjusting for confounders. Results The response rate was 43% (n=686). Non-respondent analysis showed no difference between arms, although differences were seen by risk status and age. The overall difference in difference was 2.8%, favoring the intervention. The intervention performed better in 9 of 11 composites. The intervention performed significantly better in Follow-up on test results (p=.091) and Patients’ rating of the provider (p=.091), while the control performed better in Access to care (p=.093). Both arms also had decreases, including 4 of 11 composites for the intervention, and 8 of 11 for the control. Discussion Practices that targeted HVEs showed significantly more improvement in patient experience of care. However, contemporaneous trends may have affected results, leading to declines in patient experience in both arms. PMID:27116107

Effects of Massage in Reducing the Pain and Anxiety of the Cardiac Surgery Critically Ill-a Randomized Controlled Trial.

PubMed

Boitor, Madalina; Martorella, Géraldine; Maheu, Christine; Laizner, Andréa Maria; Gélinas, Céline

2018-03-30

To evaluate the effectiveness of hand massage on the pain and anxiety of the cardiac surgery critically ill. A three-arm randomized controlled trial. This study was conducted in a medical-surgical intensive care unit in Canada. Adult patients who underwent elective cardiac surgery, who were able to speak French/English and to self-report symptoms, without a high risk of postoperative complications were eligible. Patients were randomly allocated to standard care plus either two 20-minute hand massages (experimental), two 20-minute hand holdings (active control), or two 20-minute rest periods (passive control/standard care). Pain intensity, pain unpleasantness, anxiety, muscle tension, and vital signs were evaluated before, after, and 30 minutes later for each intervention. From the 83 patients recruited, 60 were randomized (20 massage, 19 hand holding, 21 standard care). After controlling for baseline scores, the massage group reported significantly lower pain intensity, pain unpleasantness, and anxiety for the first data collection set compared with both hand holding and standard care (analysis of covariance, P < 0.02), with an average decrease of two points on a 0-10 scale. No statistically significant differences were noted between hand holding and standard care for any of the symptoms. Similar results were observed for the second data collection set (N = 43). Patients had decreased muscle tension post massage. Vital signs did not differ significantly between groups. Findings suggest that a 20-minute hand massage in addition to routine postoperative pain management can concomitantly reduce pain intensity, pain unpleasantness, and anxiety by two points on average on a 0-10 scale.

Design of a multi-arm randomized clinical trial with no control arm.

PubMed

Magaret, Amalia; Angus, Derek C; Adhikari, Neill K J; Banura, Patrick; Kissoon, Niranjan; Lawler, James V; Jacob, Shevin T

2016-01-01

Clinical trial designs that include multiple treatments are currently limited to those that perform pairwise comparisons of each investigational treatment to a single control. However, there are settings, such as the recent Ebola outbreak, in which no treatment has been demonstrated to be effective; and therefore, no standard of care exists which would serve as an appropriate control. For illustrative purposes, we focused on the care of patients presenting in austere settings with critically ill 'sepsis-like' syndromes. Our approach involves a novel algorithm for comparing mortality among arms without requiring a single fixed control. The algorithm allows poorly-performing arms to be dropped during interim analyses. Consequently, the study may be completed earlier than planned. We used simulation to determine operating characteristics for the trial and to estimate the required sample size. We present a potential study design targeting a minimal effect size of a 23% relative reduction in mortality between any pair of arms. Using estimated power and spurious significance rates from the simulated scenarios, we show that such a trial would require 2550 participants. Over a range of scenarios, our study has 80 to 99% power to select the optimal treatment. Using a fixed control design, if the control arm is least efficacious, 640 subjects would be enrolled into the least efficacious arm, while our algorithm would enroll between 170 and 430. This simulation method can be easily extended to other settings or other binary outcomes. Early dropping of arms is efficient and ethical when conducting clinical trials with multiple arms. Copyright © 2015 Elsevier Inc. All rights reserved.

Premium-Based Financial Incentives Did Not Promote Workplace Weight Loss In A 2013-15 Study.

PubMed

Patel, Mitesh S; Asch, David A; Troxel, Andrea B; Fletcher, Michele; Osman-Koss, Rosemary; Brady, Jennifer; Wesby, Lisa; Hilbert, Victoria; Zhu, Jingsan; Wang, Wenli; Volpp, Kevin G

2016-01-01

Employers commonly use adjustments to health insurance premiums as incentives to encourage healthy behavior, but the effectiveness of those adjustments is controversial. We gave 197 obese participants in a workplace wellness program a weight loss goal equivalent to 5 percent of their baseline weight. They were randomly assigned to a control arm, with no financial incentive for achieving the goal, or to one of three intervention arms offering an incentive valued at $550. Two intervention arms used health insurance premium adjustments, beginning the following year (delayed) or in the first pay period after achieving the goal (immediate). A third arm used a daily lottery incentive separate from premiums. At twelve months there were no statistically significant differences in mean weight change either between the control group (whose members had a mean gain of 0.1 pound) and any of the incentive groups (delayed premium adjustment, -1.2 pound; immediate premium adjustment, -1.4 pound; daily lottery incentive, -1.0 pound) or among the intervention groups. The apparent failure of the incentives to promote weight loss suggests that employers that encourage weight reduction through workplace wellness programs should test alternatives to the conventional premium adjustment approach by using alternative incentive designs, larger incentives, or both. Project HOPE—The People-to-People Health Foundation, Inc.

A randomized, double-blind, placebo-controlled trial of infliximab in refractory polymyositis and dermatomyositis.

PubMed

Schiffenbauer, Adam; Garg, Megha; Castro, Christine; Pokrovnichka, Angelina; Joe, Galen; Shrader, Joseph; Cabalar, Imelda Victoria; Faghihi-Kashani, Sara; Harris-Love, Michael O; Plotz, Paul H; Miller, Frederick W; Gourley, Mark

2018-06-01

To investigate in a pilot study the safety and efficacy of infliximab in patients with refractory dermatomyositis (DM) and polymyositis (PM). A randomized, double-blind, placebo-controlled trial including subjects with active DM or PM. Participants had stable doses of immunosuppressive medication and prednisone (≤0.5mg/kg/day), and exhibited clinical signs of muscle weakness for at least 4 weeks prior to study entry. Participants received infusions of either placebo or infliximab 5mg/kg at 0, 2, 6, and 14 weeks in blinded manner. The primary outcome was a ≥15% manual muscle strength (MMT) improvement at week 16 compared to week 0. The secondary outcome measures were improvement defined by the International Myositis Assessment and Clinical Studies Group (IMACS) criteria. At week 16, responders in each arm had the option of either continuing the same treatment or changing to the non-responder treatment for that study arm. Non-responders in the 5mg/kg infliximab arm were increased to infliximab 7.5mg/kg for weeks 22, 30, and 38. Non-responders in the placebo arm at week 16 received infliximab 5mg/kg at weeks 16, 18, 22, 30, and 38. Outcomes were reassessed at week 40. Twelve subjects completed the study to week 16. Six of the 12 subjects received infliximab treatment at the dose of 5mg/kg with only one subject meeting the responder criteria at that dose. Of the remaining five subjects on infliximab, three crossed over to the infliximab 7.5mg/kg dose. One of those three subjects responded. All six patients in the placebo arm crossed over to the 5mg/kg dosing regimen after week 16, and two of those responded to infliximab. Infliximab therapy for patients with refractory PM and DM was well tolerated and may benefit a subset of patients. Published by Elsevier Inc.

Strategies and Opportunities to STOP Colon Cancer in Priority Populations: design of a cluster-randomized pragmatic trial.

PubMed

Coronado, Gloria D; Vollmer, William M; Petrik, Amanda; Taplin, Stephen H; Burdick, Timothy E; Meenan, Richard T; Green, Beverly B

2014-07-01

Colorectal cancer is the second-leading cause of cancer deaths in the United States. The Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) in Priority Populations study is a pragmatic trial and a collaboration between two research institutions and a network of more than 200 safety net clinics. The study will assess the effectiveness of a system-based intervention designed to improve the rates of colorectal-cancer screening using fecal immunochemical testing (FIT) in federally qualified health centers in Oregon and Northern California. STOP CRC is a cluster-randomized comparative-effectiveness pragmatic trial enrolling 26 clinics. Clinics will be randomized to one of two arms. Clinics in the intervention arm (1) will use an automated, data-driven, electronic health record-embedded program to identify patients due for colorectal screening and mail FIT kits (with pictographic instructions) to them; (2) will conduct an improvement process (e.g. Plan-Do-Study-Act) to enhance the adoption, reach, and effectiveness of the program. Clinics in the control arm will provide opportunistic colorectal-cancer screening to patients at clinic visits. The primary outcomes are: proportion of age- and screening-eligible patients completing a FIT within 12months; and cost, cost-effectiveness, and return on investment of the intervention. This large-scale pragmatic trial will leverage electronic health record information and existing clinic staff to enroll a broad range of patients, including many with historically low colorectal-cancer screening rates. If successful, the program will provide a model for a cost-effective and scalable method to raise colorectal-cancer screening rates. Copyright © 2014 Elsevier Inc. All rights reserved.

A RCT comparing 7-year clinical outcomes of one level symptomatic cervical disc disease (SCDD) following ProDisc-C total disc arthroplasty (TDA) versus anterior cervical discectomy and fusion (ACDF).

PubMed

Loumeau, Thomas P; Darden, Bruce V; Kesman, Thomas J; Odum, Susan M; Van Doren, Bryce A; Laxer, Eric B; Murrey, Daniel B

2016-07-01

The objective of this trial was to compare the safety and efficacy of TDA using the ProDisc-C implant to ACDF in patients with single-level SCDD between C3 and C7. We report on the single-site results from a larger multicenter trial of 13 sites using an approved US Food and Drug Administration protocol (prospective, randomized controlled non-inferiority design). Patients were randomized one-to-one to either the ProDisc-C device or ACDF. All enrollees were evaluated pre- and post-operatively at regular intervals through month 84. Visual Analog Scale (VAS) for neck and arm pain/intensity, Neck Disability Index (NDI), Short-Form 36 (SF-36), and satisfaction were assessed. Twenty-two patients were randomized to each arm of the study. Nineteen additional patients received the ProDisc-C via continued access. NDI improved with the ProDisc-C more than with ACDF. Total range of motion was maintained with the ProDisc-C, but diminished with ACDF. Neck and arm pain improved more in the ProDisc-C than ACDF group. Patient satisfaction remained higher in the ProDisc-C group at 7 years. SF-36 scores were higher in the TDA group than ACDF group at 7 years; the difference was not clinically significant. Six additional operations (two at the same level; four at an adjacent level) were performed in the ACDF, but none in the ProDisc-C group. The ProDisc-C implant appears to be safe and effective for the treatment of SCDD. Patients with the implant retained motion at the involved segment and had a lower reoperation rate than those with an ACDF.

A cluster randomized pilot trial of a tailored worksite smoking cessation intervention targeting Hispanic/Latino construction workers: Intervention development and research design.

PubMed

Asfar, Taghrid; Caban-Martinez, Alberto J; McClure, Laura A; Ruano-Herreria, Estefania C; Sierra, Danielle; Gilford Clark, G; Samano, Daniel; Dietz, Noella A; Ward, Kenneth D; Arheart, Kristopher L; Lee, David J

2018-04-01

Construction workers have the highest smoking rate among all occupations (39%). Hispanic/Latino workers constitute a large and increasing group in the US construction industry (over 2.6 million; 23% of all workers). These minority workers have lower cessation rates compared to other groups due to their limited access to cessation services, and lack of smoking cessation interventions adapted to their culture and work/life circumstances. Formative research was conducted to create an intervention targeting Hispanic/Latino construction workers. This paper describes the intervention development and the design, methods, and data analysis plans for an ongoing cluster pilot two-arm randomized controlled trial comparing an Enhanced Care worksite cessation program to Standard Care. Fourteen construction sites will be randomized to either Enhanced Care or Standard Care and 126 participants (63/arm) will be recruited. In both arms, recruitment and intervention delivery occur around "food trucks" that regularly visit the construction sites. Participants at Enhanced Care sites will receive the developed intervention consisting of a single face-to-face group counseling session, 2 phone calls, and a fax referral to Florida tobacco quitline (QL). Participants at Standard Care sites will receive a fax referral to the QL. Both groups will receive eight weeks of nicotine replacement treatment and two follow-up assessments at three and six months. Feasibility outcomes are estimated recruitment yield, barriers to delivering the intervention onsite, and rates of adherence/compliance to the intervention, follow-ups, and QL enrollment. Efficacy outcomes are point-prevalence and prolonged abstinence rates at six month follow-up confirmed by saliva cotinine <15 ng/ml. Copyright © 2018. Published by Elsevier Inc.

Considering Patient Diet Preference to Optimize Weight Loss: Design Considerations of a Randomized Trial Investigating the Impact of Choice

PubMed Central

Yancy, William S.; Coffman, Cynthia J.; Geiselman, Paula J.; Kolotkin, Ronette L.; Almirall, Daniel; Oddone, Eugene Z.; Mayer, Stephanie B.; Gaillard, Leslie A.; Turner, Marsha; Smith, Valerie A.; Voils, Corrine I.

2015-01-01

A variety of diet approaches achieve moderate weight loss in many individuals. Yet, most diet interventions fail to achieve meaningful weight loss in more than a few individuals, likely due to inadequate adherence to the diet. It is widely conjectured that targeting the diet to an individual's food preferences will enhance adherence, thereby improving weight loss. This article describes the design considerations of a study protocol aimed at testing this hypothesis. The study is a 2-arm randomized trial recruiting 216 medical outpatients with BMI ≥30 kg/m2 followed for 48 weeks. Participants in the experimental arm (Choice) select from two of the most widely studied diets for weight loss, a low-carbohydrate, calorie-unrestricted diet (LCD) or a low-fat, reduced-calorie diet (LFD). The participant's choice is informed by results from a validated food preference questionnaire and a discussion of diet options with trained personnel. Choice participants are given the option to switch to the other diet after three months, if desired. Participants in the Control arm are randomly assigned to follow one of the two diets for the duration of follow-up. The primary outcome is weight assessed every 2-4 weeks for 48 weeks. Secondary outcomes include adherence to diet by food frequency questionnaire and obesity-specific health-related quality of life. If assisting patients to choose their diet enhances adherence and increases weight loss, the results will support the provision of diet options to patients who desire weight loss, and bring us one step closer to remediating the obesity epidemic faced by our healthcare systems. PMID:23506974

The effect of standard dose multivitamin supplementation on disease progression in HIV-infected adults initiating HAART: a randomized double blind placebo-controlled trial in Uganda.

PubMed

Guwatudde, David; Wang, Molin; Ezeamama, Amara E; Bagenda, Danstan; Kyeyune, Rachel; Wamani, Henry; Manabe, Yukari C; Fawzi, Wafaie W

2015-08-19

Efficacy trials investigating the effect of multivitamin (MV) supplementations among patients on Highly Active Antiretroviral Therapy (HAART) have so far been inconclusive. We conducted a randomized, double blind, placebo controlled trial to determine the effect of one recommended daily allowance (RDA) of MV supplementation on disease progression in patients initiating HAART. Eligible subjects were randomized to receive placebo or MV supplementation including vitamins B-complex, C and E. Participants were followed for up to 18 months. Primary endpoints were: change in CD4 cell count, weight and quality of life (QoL). Secondary endpoints were: i) development of a new or recurrent HIV disease progression event, including all-cause mortality; ii) switching from first- to second-line antiretroviral therapy (ART); and iii) occurrence of an adverse event. Intent-to-treat analysis, using linear regression mixed effects models were used to compare changes over time in the primary endpoints between the study arms. Kaplan-Meier time-to-event analysis and the log-rank test was used to compare HIV disease progression events and all-cause mortality. Four hundred participants were randomized, 200 onto MV and 200 onto placebo. By month 18, the average change in CD4 cell count in the MV arm was 141 cells/uL compared to 147 cells/uL in the placebo arm, a mean difference of -6 · 17 [95 % CI -29 · 3, 16 · 9]. The average change in weight in the MV arm was 3 · 9 kg compared to 3 · 3 kg in the placebo arm, a mean difference of 0 · 54 [95 % CI -0 · 40, 1 · 48]; whereas average change in QoL scores in the MV arm was 6 · 8 compared to 8 · 8 in the placebo arm, a mean difference of -2.16 [95 % CI -4 · 59,0 · 27]. No significant differences were observed in these primary endpoints, or in occurrence of adverse events between the trial arms. One RDA of MV supplementation was safe but did not have an effect on indicators of disease progression among HIV infected adults initiating HAART. Clinical trials NCT01228578 , registered on 15th October 2010.

“Smart” RCTs: Development of a Smartphone App for Fully Automated Nutrition-Labeling Intervention Trials

PubMed Central

Li, Nicole; Dunford, Elizabeth; Eyles, Helen; Crino, Michelle; Michie, Jo; Ni Mhurchu, Cliona

2016-01-01

Background There is substantial interest in the effects of nutrition labels on consumer food-purchasing behavior. However, conducting randomized controlled trials on the impact of nutrition labels in the real world presents a significant challenge. Objective The Food Label Trial (FLT) smartphone app was developed to enable conducting fully automated trials, delivering intervention remotely, and collecting individual-level data on food purchases for two nutrition-labeling randomized controlled trials (RCTs) in New Zealand and Australia. Methods Two versions of the smartphone app were developed: one for a 5-arm trial (Australian) and the other for a 3-arm trial (New Zealand). The RCT protocols guided requirements for app functionality, that is, obtaining informed consent, two-stage eligibility check, questionnaire administration, randomization, intervention delivery, and outcome assessment. Intervention delivery (nutrition labels) and outcome data collection (individual shopping data) used the smartphone camera technology, where a barcode scanner was used to identify a packaged food and link it with its corresponding match in a food composition database. Scanned products were either recorded in an electronic list (data collection mode) or allocated a nutrition label on screen if matched successfully with an existing product in the database (intervention delivery mode). All recorded data were transmitted to the RCT database hosted on a server. Results In total approximately 4000 users have downloaded the FLT app to date; 606 (Australia) and 1470 (New Zealand) users met the eligibility criteria and were randomized. Individual shopping data collected by participants currently comprise more than 96,000 (Australia) and 229,000 (New Zealand) packaged food and beverage products. Conclusions The FLT app is one of the first smartphone apps to enable conducting fully automated RCTs. Preliminary app usage statistics demonstrate large potential of such technology, both for intervention delivery and data collection. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12614000964617. New Zealand trial: Australian New Zealand Clinical Trials Registry ACTRN12614000644662. PMID:26988128

A multicenter randomized controlled evaluation of automated home monitoring and telephonic disease management in patients recently hospitalized for congestive heart failure: the SPAN-CHF II trial.

PubMed

Weintraub, Andrew; Gregory, Douglas; Patel, Ayan R; Levine, Daniel; Venesy, David; Perry, Kathleen; Delano, Christine; Konstam, Marvin A

2010-04-01

We performed a prospective, randomized investigation assessing the incremental effect of automated health monitoring (AHM) technology over and above that of a previously described nurse directed heart failure (HF) disease management program. The AHM system measured and transmitted body weight, blood pressure, and heart rate data as well as subjective patient self-assessments via a standard telephone line to a central server. A total of 188 consented and eligible patients were randomized between intervention and control groups in 1:1 ratio. Subjects randomized to the control arm received the Specialized Primary and Networked Care in Heart Failure (SPAN-CHF) heart failure disease management program. Subjects randomized to the intervention arm received the SPAN-CHF disease management program in conjunction with the AHM system. The primary end point was prespecified as the relative event rate of HF hospitalization between intervention and control groups at 90 days. The relative event rate of HF hospitalization for the intervention group compared with controls was 0.50 (95%CI [0.25-0.99], P = .05). Short-term reductions in the heart failure hospitalization rate were associated with the use of automated home monitoring equipment. Long-term benefits in this model remain to be studied. (c) 2010 Elsevier Inc. All rights reserved.

Polylactic acid vs. polyacrylamide hydrogel for treatment of facial lipoatrophy: a randomized controlled trial [Agence Nationale de Recherches sur le SIDA et les Hépatites Virales (ANRS) 132 SMILE].

PubMed

Lafaurie, M; Dolivo, M; Girard, P-M; May, T; Bouchaud, O; Carbonnel, E; Madelaine, I; Loze, B; Porcher, R; Molina, J-M

2013-08-01

The aim of the study was to demonstrate the noninferiority of polyacrylamide hydrogel (PH) vs. polylactic acid (PLA) for the treatment of facial lipoatrophy in HIV-infected adults. A randomized, blinded, multicentre, noninferiority 96-week study was carried out. Patients with facial lipoatrophy were randomly assigned to receive intradermal injections with PH or PLA, and were blinded to the filler. The primary efficacy endpoint was patient satisfaction at week 48 assessed using a visual analogue scale score (VAS). Secondary efficacy end-points included cheek thickness and skin-fold, lipoatrophy grading and quality of life. Safety was assessed by the reporting of adverse events. A total of 148 patients were included in the study; 93% were men, the median age was 47 years, the median CD4 count was 528 cells/μL, and the median duration of antiretroviral therapy was 12 years. Mean VAS increased from 2.8 at baseline to 7.1 and 7.5 in the PLA and PH arms, respectively, at week 48 (P=0.0002 for noninferiority) and was sustained at week 96 (6.7 and 7.9 in the PLA and PH arms, respectively; P=0.003 for noninferiority). Cheek thickness and skin-fold increases and lipoatrophy improvement were similar in the two arms. Quality of life remained unchanged or improved depending on the questionnaire used. In injected patients, subcutaneous nodules emerged in 28 (41%) and 26 (37%) patients in the PLA and PH arms, respectively (P=0.73). Four patients in the PH arm developed severe inflammatory nodules, a median of 17 months after the last injection. PH and PLA have similar efficacies in the treatment of facial lipoatrophy, but PH may be associated with more delayed inflammatory nodules. © 2013 British HIV Association.

Disclosing Pleiotropic Effects during Genetic Risk Assessment for Alzheimer’s Disease: A Randomized, Controlled Trial

PubMed Central

Christensen, Kurt D.; Roberts, J. Scott; Whitehouse, Peter J.; Royal, Charmaine D. M.; Obisesan, Thomas O.; Cupples, L. Adrienne; Vernarelli, Jacqueline A.; Bhatt, Deepak L.; Linnenbringer, Erin; Butson, Melissa B.; Fasaye, Grace-Ann; Uhlmann, Wendy R.; Hiraki, Susan; Wang, Na; Cook-Deegan, Robert; Green, Robert C.

2016-01-01

Background Increasing use of genetic testing raises questions about disclosing secondary findings, including pleiotropic information. Objective To determine the safety and behavioral impact of disclosing modest associations between APOE genotype and coronary artery disease (CAD) risk during APOE-based genetic risk assessments for Alzheimer’s disease (AD). Design Randomized, multicenter equivalence clinical trial Setting Four teaching hospitals Participants 257 asymptomatic adults enrolled, 69% with one AD-affected first degree relative Intervention Disclosing AD and CAD genetic risk information (AD+CAD) versus disclosing only AD genetic risk (AD-only) Measurements Co-primary outcomes were Beck Anxiety Index (BAI) and Center for Epidemiologic Studies Depression Scale (CES-D) scores at 12 months. Secondary outcomes included test-related distress at 12 months, all measures at 6 weeks and 6 months, and health behavior changes at 12 months. Results 12 months after disclosure, mean BAI scores were 3.5 and 3.5 in AD-only and AD+CAD arms (Δ=0.0, 95%CI: −1.0 to 1.0), and mean CES-D scores were 6.4 and 7.1 in AD-only and AD+CAD arms (Δ=0.7, 95%CI: −1.0 to 2.4). Both confidence bounds fell within the equivalence margin of +/−5 points. Among ε4-positive participants, distress was lower in AD+CAD arms than AD-only arms (Δ=−4.8, 95%CI: −8.6 to −1.0) (p=0.031 for disclosure arm x APOE genotype). AD+CAD participants also reported more health behavior changes, regardless of APOE genotype. Limitations Outcomes were self-reported from volunteers without severe anxiety, severe depression, or cognitive problems. Analyses omitted 33 randomized participants. Conclusion Disclosing pleiotropic information did not increase anxiety or depression, and may have decreased distress among those at increased risk for two conditions. Providing risk modification information regarding CAD improved health behaviors. Findings highlight potential benefits of secondary genetic findings disclosure when options exist for decreasing risk. PMID:26810768

[The interarm blood pressure difference in the critically ill patient].

PubMed

Valls Matarín, Josefa; del Cotillo Fuente, Mercedes; Quintana Riera, Salvador; de la Sierra Iserte, Alejandro

2014-02-04

To evaluate the prevalence of a difference in systolic blood pressure (SBPd) ≥ 10 mmHg between arms in patients admitted in a Critical Care Unit and to examine the clinical characteristics associated with such blood pressure difference. Observational cross-sectional study. Two blood pressure measurements in each arm were carried out at unit admission. The firstly measured arm was chosen at random. One-hundred and sixty-eight patients were studied, with a mean age of 61 (SD=16), 67.3% male and 45% with a previous hypertension diagnosis. On admission, 27.4% presented SBPd ≥ 10 mmHg. Among them, 54% had higher SBP in the right arm and 46% in the left one. A SBPd ≥ 10 mmHg was associated with a previous hypertension diagnosis (67.4 versus 36.9%; P<.001) and with reduced consciousness (76.1 versus 52.5%; P=.006). Over a quarter of critically ill patients have a SBPd ≥ 10 mmHg between arms. This feature is associated with a previous hypertension diagnosis and reduced consciousness. It should be assessed in the future if the choice of a control arm would help improve patient's care as it would become a more accurate guide for hemodynamic management. Copyright © 2012 Elsevier España, S.L. All rights reserved.

Incidence of herpes simplex virus type 2 infection in 5 sexually transmitted disease (STD) clinics and the effect of HIV/STD risk-reduction counseling.

PubMed

Gottlieb, Sami L; Douglas, John M; Foster, Mark; Schmid, D Scott; Newman, Daniel R; Baron, Anna E; Bolan, Gail; Iatesta, Michael; Malotte, C Kevin; Zenilman, Jonathan; Fishbein, Martin; Peterman, Thomas A; Kamb, Mary L

2004-09-15

The seroincidence of herpes simplex virus type 2 (HSV-2) infection was determined among 1766 patients attending sexually transmitted disease (STD) clinics and enrolled in a randomized, controlled trial of human immunodeficiency virus (HIV)/STD risk-reduction counseling (RRC). Arm 1 received enhanced RRC (4 sessions); arm 2, brief RRC (2 sessions); and arm 3, the control arm, brief informational messages. The overall incidence rate was 11.7 cases/100 person-years (py). Independent predictors of incidence of HSV-2 infection included female sex; black race; residence in Newark, New Jersey; <50% condom use with an occasional partner; and, in females, incident trichomoniasis and bacterial vaginosis. Only 10.8% of new HSV-2 infections were diagnosed clinically. Incidence rates were 12.9 cases/100 py in the control arm, 11.8 cases/100 py in arm 2, and 10.3 cases/100 py in arm 1 (hazard ratio, 0.8 [95% confidence interval, 0.6-1.1], vs. controls). The possible benefit of RRC in preventing acquisition of HSV-2 infection offers encouragement that interventions more specifically tailored to genital herpes may be useful and should be an important focus of future studies.

Gender-Specific Intervention to Reduce Underage Drinking Among Early Adolescent Girls: A Test of a Computer-Mediated, Mother-Daughter Program*

PubMed Central

Schinke, Steven P.; Cole, Kristin C. A.; Fang, Lin

2009-01-01

Objective: This study evaluated a gender-specific, computer-mediated intervention program to prevent underage drinking among early adolescent girls. Method: Study participants were adolescent girls and their mothers from New York, New Jersey, and Connecticut. Participants completed pretests online and were randomly divided between intervention and control arms. Intervention-arm girls and their mothers interacted with a computer program aimed to enhance mother-daughter relationships and to teach girls skills for managing conflict, resisting media influences, refusing alcohol and drugs, and correcting peer norms about underage drinking, smoking, and drug use. After intervention, all participants (control and intervention) completed posttest and follow-up measurements. Results: Two months following program delivery and relative to control-arm participants, intervention-arm girls and mothers had improved their mother-daughter communication skills and their perceptions and applications of parental monitoring and rule-setting relative to girls' alcohol use. Also at follow-up, intervention-arm girls had improved their conflict management and alcohol use-refusal skills; reported healthier normative beliefs about underage drinking; demonstrated greater self-efficacy about their ability to avoid underage drinking; reported less alcohol consumption in the past 7 days, 30 days, and year; and expressed lower intentions to drink as adults. Conclusions: Study findings modestly support the viability of a mother-daughter, computer-mediated program to prevent underage drinking among adolescent girls. The data have implications for the further development of gender-specific approaches to combat increases in alcohol and other substance use among American girls. PMID:19118394

PlanYourLifeSpan.org - an intervention to help seniors make choices for their fourth quarter of life: Results from the randomized clinical trial.

PubMed

Lindquist, Lee A; Ramirez-Zohfeld, Vanessa; Sunkara, Priya D; Forcucci, Chris; Campbell, Dianne S; Mitzen, Phyllis; Ciolino, Jody D; Gregory, Dyanna; Kricke, Gayle; Cameron, Kenzie A

2017-11-01

Few older adults contemplate their home support and health needs that may be required for aging-in-place. We sought to assess the efficacy of PlanYourLifespan.org (PYL), in influencing seniors' planning behaviors, perception of the importance of planning, and confidence accessing services. Randomized controlled trial, of adults, age ≥65 years in urban, suburban, rural areas of Texas, Illinois, Indiana. Among 385 participants, mean age was 71.9 years, 79.5% female. Between baseline and one-month follow-up, average planning behavior score increased 0.22 points in the PYL arm when compared to the attention control (AC) arm. After controlling for baseline, mean one-month planning behavior score was significantly higher in the PYL arm than in the AC arm (1.25 points, CI 0.37-2.12, p=0.005). Secondary analyses via longitudinal linear mixed modelling suggested a study arm-by-time interaction effect for both planning behavior (p=0.047 and perception of importance (p=0.05). Significant baseline covariates included self-efficacy, education, perceived social support, power of attorney, and history of stroke. PlanYourLifespan.org demonstrated efficacy in helping seniors plan for and communicate their health support needs. This free, nationally available tool may help individuals understand, plan, and communicate their options for their future support needs. Copyright © 2017 Elsevier B.V. All rights reserved.

Surgical site infections following colorectal cancer surgery: a randomized prospective trial comparing common and advanced antimicrobial dressing containing ionic silver.

PubMed

Biffi, Roberto; Fattori, Luca; Bertani, Emilio; Radice, Davide; Rotmensz, Nicole; Misitano, Pasquale; Cenciarelli, Sabine; Chiappa, Antonio; Tadini, Liliana; Mancini, Marina; Pesenti, Giovanni; Andreoni, Bruno; Nespoli, Angelo

2012-05-23

An antimicrobial dressing containing ionic silver was found effective in reducing surgical-site infection in a preliminary study of colorectal cancer elective surgery. We decided to test this finding in a randomized, double-blind trial. Adults undergoing elective colorectal cancer surgery at two university-affiliated hospitals were randomly assigned to have the surgical incision dressed with Aquacel Ag Hydrofiber dressing or a common dressing. To blind the patient and the nursing and medical staff to the nature of the dressing used, scrub nurses covered Aquacel Ag Hydrofiber with a common wound dressing in the experimental arm, whereas a double common dressing was applied to patients of control group. The primary end-point of the study was the occurrence of any surgical-site infection within 30 days of surgery. A total of 112 patients (58 in the experimental arm and 54 in the control group) qualified for primary end-point analysis. The characteristics of the patient population and their surgical procedures were similar. The overall rate of surgical-site infection was lower in the experimental group (11.1% center 1, 17.5% center 2; overall 15.5%) than in controls (14.3% center 1, 24.2% center 2, overall 20.4%), but the observed difference was not statistically significant (P = 0.451), even with respect to surgical-site infection grade 1 (superficial) versus grades 2 and 3, or grade 1 and 2 versus grade 3. This randomized trial did not confirm a statistically significant superiority of Aquacel Ag Hydrofiber dressing in reducing surgical-site infection after elective colorectal cancer surgery. Clinicaltrials.gov: NCT00981110.

Randomized controlled trial of video self-modeling following speech restructuring treatment for stuttering.

PubMed

Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

2010-08-01

In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech restructuring treatment. Post treatment, participants were randomly assigned to 2 trial arms: standard maintenance and standard maintenance plus VSM. Participants in the latter arm viewed stutter-free videos of themselves each day for 1 month. The addition of VSM did not improve speech outcomes, as measured by percent syllables stuttered, at either 1 or 6 months postrandomization. However, at the latter assessment, self-rating of worst stuttering severity by the VSM group was 10% better than that of the control group, and satisfaction with speech fluency was 20% better. Quality of life was also better for the VSM group, which was mildly to moderately impaired compared with moderate impairment in the control group. VSM intervention after treatment was associated with improvements in self-reported outcomes. The clinical implications of this finding are discussed.

Diagnostic Pathway with Multiparametric Magnetic Resonance Imaging Versus Standard Pathway: Results from a Randomized Prospective Study in Biopsy-naïve Patients with Suspected Prostate Cancer.

PubMed

Porpiglia, Francesco; Manfredi, Matteo; Mele, Fabrizio; Cossu, Marco; Bollito, Enrico; Veltri, Andrea; Cirillo, Stefano; Regge, Daniele; Faletti, Riccardo; Passera, Roberto; Fiori, Cristian; De Luca, Stefano

2017-08-01

An approach based on multiparametric magnetic resonance imaging (mpMRI) might increase the detection rate (DR) of clinically significant prostate cancer (csPCa). To compare an mpMRI-based pathway with the standard approach for the detection of prostate cancer (PCa) and csPCa. Between November 2014 and April 2016, 212 biopsy-naïve patients with suspected PCa (prostate specific antigen level ≤15 ng/ml and negative digital rectal examination results) were included in this randomized clinical trial. Patients were randomized into a prebiopsy mpMRI group (arm A, n=107) or a standard biopsy (SB) group (arm B, n=105). In arm A, patients with mpMRI evidence of lesions suspected for PCa underwent mpMRI/transrectal ultrasound fusion software-guided targeted biopsy (TB) (n=81). The remaining patients in arm A (n=26) with negative mpMRI results and patients in arm B underwent 12-core SB. The primary end point was comparison of the DR of PCa and csPCa between the two arms of the study; the secondary end point was comparison of the DR between TB and SB. The overall DRs were higher in arm A versus arm B for PCa (50.5% vs 29.5%, respectively; p=0.002) and csPCa (43.9% vs 18.1%, respectively; p<0.001). Concerning the biopsy approach, that is, TB in arm A, SB in arm A, and SB in arm B, the overall DRs were significantly different for PCa (60.5% vs 19.2% vs 29.5%, respectively; p<0.001) and for csPCa (56.8% vs 3.8% vs 18.1%, respectively; p<0.001). The reproducibility of the study could have been affected by the single-center nature. A diagnostic pathway based on mpMRI had a higher DR than the standard pathway in both PCa and csPCa. In this randomized trial, a pathway for the diagnosis of prostate cancer based on multiparametric magnetic resonance imaging (mpMRI) was compared with the standard pathway based on random biopsy. The mpMRI-based pathway had better performance than the standard pathway. Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Azacitidine in combination with intensive induction chemotherapy in older patients with acute myeloid leukemia: The AML-AZA trial of the Study Alliance Leukemia.

PubMed

Müller-Tidow, C; Tschanter, P; Röllig, C; Thiede, C; Koschmieder, A; Stelljes, M; Koschmieder, S; Dugas, M; Gerss, J; Butterfaß-Bahloul, T; Wagner, R; Eveslage, M; Thiem, U; Krause, S W; Kaiser, U; Kunzmann, V; Steffen, B; Noppeney, R; Herr, W; Baldus, C D; Schmitz, N; Götze, K; Reichle, A; Kaufmann, M; Neubauer, A; Schäfer-Eckart, K; Hänel, M; Peceny, R; Frickhofen, N; Kiehl, M; Giagounidis, A; Görner, M; Repp, R; Link, H; Kiani, A; Naumann, R; Brümmendorf, T H; Serve, H; Ehninger, G; Berdel, W E; Krug, U

2016-03-01

DNA methylation changes are a constant feature of acute myeloid leukemia. Hypomethylating drugs such as azacitidine are active in acute myeloid leukemia (AML) as monotherapy. Azacitidine monotherapy is not curative. The AML-AZA trial tested the hypothesis that DNA methyltransferase inhibitors such as azacitidine can improve chemotherapy outcome in AML. This randomized, controlled trial compared the efficacy of azacitidine applied before each cycle of intensive chemotherapy with chemotherapy alone in older patients with untreated AML. Event-free survival (EFS) was the primary end point. In total, 214 patients with a median age of 70 years were randomized to azacitidine/chemotherapy (arm-A) or chemotherapy (arm-B). More arm-A patients (39/105; 37%) than arm-B (25/109; 23%) showed adverse cytogenetics (P=0.057). Adverse events were more frequent in arm-A (15.44) versus 13.52 in arm-B, (P=0.26), but early death rates did not differ significantly (30-day mortality: 6% versus 5%, P=0.76). Median EFS was 6 months in both arms (P=0.96). Median overall survival was 15 months for patients in arm-A compared with 21 months in arm-B (P=0.35). Azacitidine added to standard chemotherapy increases toxicity in older patients with AML, but provides no additional benefit for unselected patients.

Phase II randomized trial of carboplatin, paclitaxel, bevacizumab with or without cixutumumab (IMC-A12) in patients with advanced non-squamous, non-small-cell lung cancer: a trial of the ECOG-ACRIN Cancer Research Group (E3508).

PubMed

Argiris, A; Lee, J W; Stevenson, J; Sulecki, M G; Hugec, V; Choong, N W; Saltzman, J N; Song, W; Hansen, R M; Evans, T L; Ramalingam, S S; Schiller, J H

2017-12-01

Cixutumumab is a fully human IgG1 monoclonal antibody to the insulin-like growth factor type I receptor that can potentially reverse resistance and enhance the efficacy of chemotherapy. Bevacizumab-eligible patients with stage IV or recurrent non-squamous, non-small-cell lung cancer and good performance status were randomized to receive standard doses of paclitaxel, carboplatin, and bevacizumab to a maximum of six cycles followed by bevacizumab maintenance (CPB) until progression (arm A) or CPB plus cixutumumab 6 mg/kg i.v. weekly (arm B). Of 175 patients randomized, 153 were eligible and treated (78 in arm A; 75 in arm B). The median progression-free survival was 5.8 months (95% CI 5.4-7.1) in arm A versus 7 months (95% CI 5.7-7.6) in arm B (P = 0.33); hazard ratio 0.92 (95% CI 0.65-1.31). Objective response was 46.2% versus 58.7% in arm A versus arm B (P = 0.15). The median overall survival was 16.2 months in arm A versus 16.1 months in arm B (P = 0.95). Grade 3/4 neutropenia and febrile neutropenia, thrombocytopenia, fatigue, and hyperglycemia were increased with cixutumumab. The addition of cixutumumab to CPB increased toxicity without improving efficacy and is not recommended for further development in non-small-cell lung cancer. Both treatment groups had longer OS than historical controls which may be attributed to several factors, and emphasizes the value of a comparator arm in phase II trials. NCT00955305. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Motivational interviewing and screening colonoscopy in high-risk individuals. A randomized controlled trial.

PubMed

Salimzadeh, Hamideh; Khabiri, Roghaye; Khazaee-Pool, Maryam; Salimzadeh, Somayeh; Delavari, Alireza

2018-06-01

To measure the impact of motivational interviewing (MI) on cancer knowledge and screening practice among first degree relatives (FDRs) of patients with colon cancer. This randomized controlled trial targeted patients with colon cancer first to recruit their possible FDRs. Digit randomization of the eligible index patients into intervention or control groups resulted in allocating their belonging FDRs to the same study arm. FDRs (n = 120) in intervention arm received MI counseling on phone by a trained oncology nurse and FDRs (n = 120) in control group received standard generic information by a physician on phone. Primary outcome was the rate of documented colonoscopy in FDRs within six months after the baseline. A total of 227 FDRs were followed up, 115 in the intervention and 112 in the control group. At follow-up, the uptake of screening colonoscopy in the intervention group was 83.5% versus 48.2% in controls (crude odds ratio, 5.4; 95% confidence interval, 2.9-10.0, P < .001). This was the first randomized controlled trial in Iran that confirmed the efficaciousness of a phone-based MI counseling in improving colonoscopy uptake among family members of patients with colon cancer. Phone-based motivational counseling that involves trained nurses or health providers seems to be feasible approach in Iran health system and enhances screening for colon cancer. Copyright © 2018 Elsevier B.V. All rights reserved.

Effectiveness and safety of misoprostol distributed to antenatal women to prevent postpartum haemorrhage after child-births: a stepped-wedge cluster-randomized trial.

PubMed

Ononge, Sam; Campbell, Oona M R; Kaharuza, Frank; Lewis, James J; Fielding, Katherine; Mirembe, Florence

2015-11-26

Oral misoprostol, administered by trained health-workers is effective and safe for preventing postpartum haemorrhage (PPH). There is interest in expanding administration of misoprostol by non-health workers, including task-shifting to pregnant women themselves. However, the use of misoprostol for preventing PPH in home-births remains controversial, due to the limited evidence to support self-administration or leaving it in the hands of non-health workers. This study aimed to determine if antenatally distributing misoprostol to pregnant women to self-administer at home birth reduces PPH. Between February 2013 and March 2014, we conducted a stepped-wedge cluster-randomized trial in six health facilities in Central Uganda. Women at 28+ weeks of gestation attending antenatal care were eligible. Women in the control-arm received the standard-of-care; while the intervention-arm were offered 600 mcg of misoprostol to swallow immediately after birth of baby, when oxytocin was not available. The primary outcome (PPH) was a drop in postpartum maternal haemoglobin (Hb) by ≥ 2 g/dl, lower than the prenatal Hb. Analysis was by intention-to-treat at the cluster level and we used a paired t-tests to assess whether the mean difference between the control and intervention groups was statistically significant. 97% (2466/2545) of eligible women consented to participate; 1430 and 1036 in the control and intervention arms respectively. Two thousand fifty-seven of the participants were successfully followed up and 271 (13.2%) delivered outside a health facility. There was no significant difference between the study group in number of women who received a uterotonic at birth (control 80.4% vs intervention 91.4%, mean difference = -11.0%, 95% confidence interval [CI] -25.7% to 3.6%, p = 0.11). No woman took misoprostol before their baby's birth. Shivering and fever were 14.9% in the control arm compared to 22.2% in the intervention arm (mean difference = -7.2%, 95% CI -11.1% to -3.7%), p = 0.005). There was a slight, but non-significant, reduction in the percentage of women with Hb drop ≥ 2g/dl from 18.5% in the control arm to 11.4% in the intervention arm (mean difference = 7.1%, 95% CI -3.1% to 17.3%, p = 0.14). Similarly, there was no significant difference between the groups in the primary outcome in the women who delivered at home (control 9.6% vs intervention 14.5%, mean difference -4.9; 95% CI -12.7 to 2.9), p = 0.17). This study was unable to detect a significant reduction in PPH following the antenatal distribution of misoprostol. The study was registered with Pan-African Clinical Trials Network ( PACTR201303000459148, on 19/11/2012).

Generalizability of causal inference in observational studies under retrospective convenience sampling.

PubMed

Hu, Zonghui; Qin, Jing

2018-05-20

Many observational studies adopt what we call retrospective convenience sampling (RCS). With the sample size in each arm prespecified, RCS randomly selects subjects from the treatment-inclined subpopulation into the treatment arm and those from the control-inclined into the control arm. Samples in each arm are representative of the respective subpopulation, but the proportion of the 2 subpopulations is usually not preserved in the sample data. We show in this work that, under RCS, existing causal effect estimators actually estimate the treatment effect over the sample population instead of the underlying study population. We investigate how to correct existing methods for consistent estimation of the treatment effect over the underlying population. Although RCS is adopted in medical studies for ethical and cost-effective purposes, it also has a big advantage for statistical inference: When the tendency to receive treatment is low in a study population, treatment effect estimators under RCS, with proper correction, are more efficient than their parallels under random sampling. These properties are investigated both theoretically and through numerical demonstration. Published 2018. This article is a U.S. Government work and is in the public domain in the USA.

Autologous transplantation in CLL patients with B and C Binet stages: final results of the prospective randomized GOELAMS LLC 98 trial.

PubMed

Brion, A; Mahé, B; Kolb, B; Audhuy, B; Colombat, P; Maisonneuve, H; Foussard, C; Bureau, A; Ferrand, C; Lesesve, J F; Béné, M C; Feugier, P

2012-04-01

The relevance of high-dose chemotherapy followed by auto-SCT in CLL remains to be defined. The aim of the prospective, randomized, GOELAMS LLC 98 trial was to compare two strategies in previously untreated CLL patients aged <60 years. Conventional chemotherapy (Arm A) consisted of six monthly courses of CHOP followed by six CHOP courses in every 3 months in those achieving a complete or PR. Arm A was compared with high-dose therapy with auto-SCT (Arm B), used as consolidation after three CHOP courses in case of CR or very good PR. A total of 86 patients were enrolled, of which 39 and 43 patients were evaluable in arm A and arm B, respectively. The primary endpoint was PFS. On an intent-to-treat basis and with a median follow-up time of 77.1 (range 1-135.5) months, the median PFS was 22 months in Arm A and 53 months in Arm B (P<0.0001). Median survival time was 104.7 months in arm A and 107.4 months in arm B. This trial demonstrates that frontline high-dose therapy with auto-SCT prolongs PFS but does not translate into a survival advantage in advanced CLL patients in the pre-rituximab era.

Phase III trial comparing 3-6 months of adjuvant FOLFOX4/XELOX in stage II-III colon cancer: safety and compliance in the TOSCA trial.

PubMed

Lonardi, S; Sobrero, A; Rosati, G; Di Bartolomeo, M; Ronzoni, M; Aprile, G; Massida, B; Scartozzi, M; Banzi, M; Zampino, M G; Pasini, F; Marchetti, P; Cantore, M; Zaniboni, A; Rimassa, L; Ciuffreda, L; Ferrari, D; Barni, S; Zagonel, V; Maiello, E; Rulli, E; Labianca, R

2016-11-01

Six months of oxaliplatin-based adjuvant chemotherapy is standard of care for radically resected stage III colon cancer and an accepted option for high-risk stage II. A shorter duration of therapy, if equally efficacious, would be advantageous for patients and Health-Care Systems. TOSCA ['Randomized trial investigating the role of FOLFOX-4 or XELOX (3 versus 6 months) regimen duration and bevacizumab as adjuvant therapy for patients with stage II/III colon cancer] is an open-label, phase III, multicenter, noninferiority trial randomizing patients with high-risk stage II or stage III radically resected colon cancer to receive 3 months (arm 3 m) versus 6 months (arm 6 m) of FOLFOX4/XELOX. Primary end-point was relapse-free survival. We present here safety and compliance data. From June 2007 to March 2013, 3759 patients were accrued from 130 Italian sites, 64% receiving FOLFOX4 and 36% XELOX in either arm. Treatment completion rate without any modification was 35% versus 12% and with delays or dose reduction 52% versus 44% in arm 3 and 6 m. Treatment was permanently discontinued in 8% (arm 3 m) and 33% (arm 6 m). In arm 6 m, 50% of patients discontinuing treatment did so after completing 80% of planned program. Grade 3+ toxicities were higher in arm 6 m than that in 3 m. Grade 2+ neuropathy was 31.2% versus 8.8% (P < 0.0001) while grade 3+ was 8.4 versus 1.3 (P < 0.0001), in arm 3 and 6 m. Seven deaths within 30 days from last treatment administration in arm 6 m and three deaths in arm 3 m were observed (0.3% versus 0.1%, P = 0.34). TOSCA is the first trial comparing 3 versus 6 months of adjuvant chemotherapy completing accrual within the international initiative of treatment duration evaluation (International Duration Evaluation of Adjuvant, IDEA). High compliance to treatment in control arm will allow a correct assessment of potential differences between the two treatment durations. NCT00646607. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

A Randomized Trial of Displaying Paid Price Information on Imaging Study and Procedure Ordering Rates.

PubMed

Chien, Alyna T; Lehmann, Lisa Soleymani; Hatfield, Laura A; Koplan, Kate E; Petty, Carter R; Sinaiko, Anna D; Rosenthal, Meredith B; Sequist, Thomas D

2017-04-01

Prior studies have demonstrated how price transparency lowers the test-ordering rates of trainees in hospitals, and physician-targeted price transparency efforts have been viewed as a promising cost-controlling strategy. To examine the effect of displaying paid-price information on test-ordering rates for common imaging studies and procedures within an accountable care organization (ACO). Block randomized controlled trial for 1 year. A total of 1205 fully licensed clinicians (728 primary care, 477 specialists). Starting January 2014, clinicians in the Control arm received no price display; those in the intervention arms received Single or Paired Internal/External Median Prices in the test-ordering screen of their electronic health record. Internal prices were the amounts paid by insurers for the ACO's services; external paid prices were the amounts paid by insurers for the same services when delivered by unaffiliated providers. Ordering rates (orders per 100 face-to-face encounters with adult patients): overall, designated to be completed internally within the ACO, considered "inappropriate" (e.g., MRI for simple headache), and thought to be "appropriate" (e.g., screening colonoscopy). We found no significant difference in overall ordering rates across the Control, Single Median Price, or Paired Internal/External Median Prices study arms. For every 100 encounters, clinicians in the Control arm ordered 15.0 (SD 31.1) tests, those in the Single Median Price arm ordered 15.0 (SD 16.2) tests, and those in the Paired Prices arms ordered 15.7 (SD 20.5) tests (one-way ANOVA p-value 0.88). There was no difference in ordering rates for tests designated to be completed internally or considered to be inappropriate or appropriate. Displaying paid-price information did not alter how frequently primary care and specialist clinicians ordered imaging studies and procedures within an ACO. Those with a particular interest in removing waste from the health care system may want to consider a variety of contextual factors that can affect physician-targeted price transparency.

Bridging glycated hemoglobin with quality of life and health state; a randomized case-control study among type 2 diabetes patients.

PubMed

Gillani, Syed Wasif; Ansari, Irfan Altaf; Zaghloul, Hisham A; Abdul, Mohi Iqbal Mohammad; Sulaiman, Syed Azhar Syed; Baig, Mirza R

2018-01-01

The aim of this study was to explore the predictors of QOL and health state and examine the relationship with glycemic control among type 2 diabetes mellitus (T2DM) patients. A randomized cross-sectional case-control study was conducted among n = 600 T2DM patients of Malaysia. Study population was distributed into three groups as: controls: patients with HbA1c ≤ 7 (n = 199), cases arm 1: with HbA1c 7-7.9 (n = 204) and cases arm 2 (n = 197): with HbA1c ≥ 8 consecutively last 3 times. Participants with diabetes history > 10 years exhibits higher mean QOL score among all the three groups. In contrast mean health status score significantly ( p  < 0.001) reduced with the exposure duration of diabetes both within and intergroup assessment that participants with poor glycemic control (arm 2) had significantly higher mean QOL score with knowledge and self-care dimensions as compared to others, however mean health state scores were significantly ( p  < 0.001) lower in all assessment dimensions as compared to controls. The F test of significance showed that demographic and clinical parameters were strong predictors of QOL, whereas self-care activities, comorbidities, ability of positive management and BMI were significant predictors to health state for consistent glycemic control (controls) as compared to poor glycemic control (arm 2) participants. This study suggested that poor glycemic index reported low self-care behavior, increase barriers to daily living activities and poor ability to manage diabetes positively, which cause poor QOL and decrease health state.

Randomized, Controlled Trial of the Effect of Dietary Potassium Restriction on Nerve Function in CKD.

PubMed

Arnold, Ria; Pianta, Timothy J; Pussell, Bruce A; Kirby, Adrienne; O'Brien, Kate; Sullivan, Karen; Holyday, Margaret; Cormack, Christine; Kiernan, Matthew C; Krishnan, Arun V

2017-10-06

Neuromuscular complications are almost universal in CKD by the time that a patient commences dialysis. Recent studies have indicated that chronic hyperkalemia may contribute to the development of neuropathy in CKD. This study was undertaken to determine whether dietary restriction of potassium intake may be a neuroprotective factor in CKD. A 24-month prospective, single-blind, randomized, controlled trial was undertaken in 47 consecutively recruited patients with stages 3 and 4 CKD. The intervention arm ( n =23) was prescribed a diet focusing on potassium restriction to meet a monthly serum potassium level of ≤4.5 mEq/L, with oral sodium polystyrene sulfonate provided if dietary advice failed to achieve the target. The control arm ( n =24) received dietary advice regarding general nutrition. The primary outcome was the change in the total neuropathy score evaluated by a blinded observer. Secondary outcomes included electrolyte levels, gait speed, neurophysiologic parameters, and health-related quality of life scores. Five patients withdrew before initiation of treatment, and final analysis consisted of n =21 in each group. There was a greater increase in total neuropathy score from baseline to final assessment in the control arm compared with the intervention arm (6.1±6.2-8.6±7.9 controls; 7.8±7.4-8.2±7.5 intervention; change 2.8±3.3-0.4±2.2, respectively; P <0.01). The intervention significantly reduced mean serum potassium compared with controls (4.6±0.1-4.8±0.1 mEq/L mean recorded every 6 months over the trial duration; P =0.03). There were no adverse changes in other nutritional parameters. Improved gait speed was also noted in the intervention arm compared with the control arm, with a mean increase of 0.15±0.17 m/s in the intervention group versus 0.02±0.16 m/s in the control group ( P =0.01). Our results provide important preliminary evidence that dietary potassium restriction confers neuroprotection in CKD and should be confirmed in a larger multicenter trial. Copyright © 2017 by the American Society of Nephrology.

Short video interventions to reduce mental health stigma: a multi-centre randomised controlled trial in nursing high schools.

PubMed

Winkler, Petr; Janoušková, Miroslava; Kožený, Jiří; Pasz, Jiří; Mladá, Karolína; Weissová, Aneta; Tušková, Eva; Evans-Lacko, Sara

2017-12-01

We aimed to assess whether short video interventions could reduce stigma among nursing students. A multi-centre, randomised controlled trial was conducted. Participating schools were randomly selected and randomly assigned to receive: (1) an informational leaflet, (2) a short video intervention or (3) a seminar involving direct contact with a service user. The Community Attitudes towards Mental Illness (CAMI) and Reported and Intended Behaviour Scale (RIBS) were selected as primary outcome measures. SPANOVA models were built and Cohen's d calculated to assess the overall effects in each of the trial arms. Compared to the baseline, effect sizes immediately after the intervention were small in the flyer arm (CAMI: d = 0.25; RIBS: d = 0.07), medium in the seminar arm (CAMI: d = 0.61; RIBS: d = 0.58), and medium in the video arm (CAMI: d = 0.49 RIBS: d = 0.26; n = 237). Effect sizes at the follow-up were vanishing in the flyer arm (CAMI: d = 0.05; RIBS: d = 0.04), medium in the seminar arm (CAMI: d = 0.43; RIBS: d = 0.26; n = 254), and small in the video arm (CAMI: d = 0.22 RIBS: d = 0.21; n = 237). Seminar had the strongest and relatively stable effect on students' attitudes and intended behaviour, but the effect of short video interventions was also considerable and stable over time. Since short effective video interventions are relatively cheap, conveniently accessible and easy to disseminate globally, we recommend them for further research and development.

Assessment of contamination and misclassification biases in a randomized controlled trial of a social network peer education intervention to reduce HIV risk behaviors among drug users and risk partners in Philadelphia, PA and Chiang Mai, Thailand.

PubMed

Simmons, Nicole; Donnell, Deborah; Ou, San-San; Celentano, David D; Aramrattana, Apinun; Davis-Vogel, Annet; Metzger, David; Latkin, Carl

2015-10-01

Controlled trials of HIV prevention and care interventions are susceptible to contamination. In a randomized controlled trial of a social network peer education intervention among people who inject drugs and their risk partners in Philadelphia, PA and Chiang Mai, Thailand, we tested a contamination measure based on recall of intervention terms. We assessed the recall of test, negative and positive control terms among intervention and control arm participants and compared the relative odds of recall of test versus negative control terms between study arms. The contamination measures showed good discriminant ability among participants in Chiang Mai. In Philadelphia there was no evidence of contamination and little evidence of diffusion. In Chiang Mai there was strong evidence of diffusion and contamination. Network structure and peer education in Chiang Mai likely led to contamination. Recall of intervention materials can be a useful method to detect contamination in experimental interventions.

Long-term effects of inhaled budesonide on screening-detected lung nodules

PubMed Central

Veronesi, G.; Lazzeroni, M.; Szabo, E.; Brown, P. H.; DeCensi, A.; Guerrieri-Gonzaga, A.; Bellomi, M.; Radice, D.; Grimaldi, M. C.; Spaggiari, L.; Bonanni, B.

2015-01-01

Background A previously carried out randomized phase IIb, placebo-controlled trial of 1 year of inhaled budesonide, which was nested in a lung cancer screening study, showed that non-solid and partially solid lung nodules detected by low-dose computed tomography (LDCT), and not immediately suspicious for lung cancer, tended to regress. Because some of these nodules may be slow-growing adenocarcinoma precursors, we evaluated long-term outcomes (after stopping the 1-year intervention) by annual LDCT. Patients and methods We analyzed the evolution of target and non-target trial nodules detected by LDCT in the budesonide and placebo arms up to 5 years after randomization. The numbers and characteristics of lung cancers diagnosed during follow-up were also analyzed. Results The mean maximum diameter of non-solid nodules reduced significantly (from 5.03 mm at baseline to 2.61 mm after 5 years) in the budesonide arm; there was no significant size change in the placebo arm. The mean diameter of partially solid lesions also decreased significantly, but only by 0.69 mm. The size of solid nodules did not change. Neither the number of new lesions nor the number of lung cancers differed in the two arms. Conclusions Inhaled budesonide given for 1 year significantly decreased the size of non-solid nodules detected by screening LDCT after 5 years. This is of potential importance since some of these nodules may progress slowly to adenocarcinoma. However, further studies are required to assess clinical implications. Clinical trial number NCT01540552. PMID:25672894

Mirror therapy for distal radial fractures: A pilot randomized controlled study.

PubMed

Bayon-Calatayud, Manuel; Benavente-Valdepeñas, Ana Maria; Del Prado Vazquez-Muñoz, Maria

2016-10-12

To investigate the efficacy of mirror therapy in reducing pain and disability in patients with distal radial fractures. Pilot randomized controlled study. Twenty-two patients with closed distal radial fracture. Patients were randomly assigned to experimental (= 11) or control (= 11) groups. Researchers were blinded to group allocation. Both groups received conventional physiotherapy. In addition, the experimental group had 15 sessions of mirror therapy (a daily session, 30 min). The control group received the same amount of conventional occupational therapy. Assessment was made from baseline to post-treatment. Pain was measured on a visual analogue scale (VAS). Active wrist extension and Quick-DASH (Disabilities of Arm, Shoulder and Hand) were used to assess functional recovery. Pain, disability, and range of motion improved for both groups after intervention. No significant post-treatment differences were found between groups in Quick-DASH (= 0.409), active wrist extension (= 0.191) and VAS scores (= 0.807). There was no significant difference in active wrist extension between groups. Mirror therapy was not superior to conventional occupational therapy in reducing pain and disability.

Adaptive adjustment of the randomization ratio using historical control data

PubMed Central

Hobbs, Brian P.; Carlin, Bradley P.; Sargent, Daniel J.

2013-01-01

Background Prospective trial design often occurs in the presence of “acceptable” [1] historical control data. Typically this data is only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. Purpose We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al. [2], succeeded a similar trial reported by Saltz et al. [3], and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. Methods The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS) characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors [4] are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial’s frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Results Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure leads to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal allocation of patients among the treatment arms. Using the proposed commensurate prior model to borrow strength from the historical data, after balancing total information with the adaptive randomization procedure, provides admissible estimators of the novel treatment effect with desirable bias-variance trade-offs. Limitations Adaptive randomization methods in general are sensitive to population drift and more suitable for trials that initiate with gradual enrollment. Balancing information among study arms in time-to-event analyses is difficult in the presence of informative right-censoring. Conclusions The proposed design could prove important in trials that follow recent evaluations of a control therapy. Efficient use of the historical controls is especially important in contexts where reliance on pre-existing information is unavoidable because the control therapy is exceptionally hazardous, expensive, or the disease is rare. PMID:23690095

Adaptive adjustment of the randomization ratio using historical control data.

PubMed

Hobbs, Brian P; Carlin, Bradley P; Sargent, Daniel J

2013-01-01

Prospective trial design often occurs in the presence of 'acceptable' historical control data. Typically, these data are only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al., succeeded a similar trial reported by Saltz et al., and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS), characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial's frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure lead to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal allocation of patients among the treatment arms. Using the proposed commensurate prior model to borrow strength from the historical data, after balancing total information with the adaptive randomization procedure, provides admissible estimators of the novel treatment effect with desirable bias-variance trade-offs. Adaptive randomization methods in general are sensitive to population drift and more suitable for trials that initiate with gradual enrollment. Balancing information among study arms in time-to-event analyses is difficult in the presence of informative right-censoring. The proposed design could prove important in trials that follow recent evaluations of a control therapy. Efficient use of the historical controls is especially important in contexts where reliance on preexisting information is unavoidable because the control therapy is exceptionally hazardous, expensive, or the disease is rare.

A randomized, placebo-controlled trial of repetitive spinal magnetic stimulation in lumbosacral spondylotic pain.

PubMed

Lo, Yew L; Fook-Chong, Stephanie; Huerto, Antonio P; George, Jane M

2011-07-01

Lumbar spondylosis is a degenerative disorder of the spine, whereby pain is a prominent feature that poses therapeutic challenges even after surgical intervention. There are no randomized, placebo-controlled studies utilizing repetitive spinal magnetic stimulation (SMS) in pain associated with lumbar spondylosis. In this study, we utilize SMS technique for patients with this condition in a pilot clinical trial. We randomized 20 patients into SMS treatment or placebo arms. All patients must have clinical and radiological evidence of lumbar spondylosis. Patients should present with pain in the lumbar region, localized or radiating down the lower limbs in a radicular distribution. SMS was delivered with a Medtronic R30 repetitive magnetic stimulator (Medtronic Corporation, Skovlunde, Denmark) connected to a C-B60 figure of eight coil capable of delivering a maximum output of 2 Tesla per pulse. The coil measured 90 mm in each wing and was centered over the surface landmark corresponding to the cauda equina region. The coil was placed flat over the back with the handle pointing cranially. Each patient on active treatment received 200 trains of five pulses delivered at 10 Hz, at an interval of 5 seconds between each train. "Sham" SMS was delivered with the coil angled vertically and one of the wing edges in contact with the stimulation point. All patients tolerated the procedure well and no side effects of SMS were reported. In the treatment arm, SMS had resulted in significant pain reduction immediately and at Day 4 after treatment (P < 0.05). In the placebo arm, however, no significant pain reduction was seen immediately and at Day 4 after SMS. SMS in the treatment arm had resulted in mean pain reduction of 62.3% postprocedure and 17.4% at Day 4. The placebo arm only achieved pain reduction of 6.1% postprocedure and 4.5% at Day 4. This is the first study to show that a single session of SMS resulted in significant improvement of pain associated with lumbar spondylosis in a randomized, double-blind, placebo-controlled setting. The novel findings support the potential of this technique for future studies pertaining to neuropathic pain. Wiley Periodicals, Inc.

Open-Label Randomized Trial of Titrated Disease Management for Patients with Hypertension: Study Design and Baseline Sample Characteristics

PubMed Central

Jackson, George L.; Weinberger, Morris; Kirshner, Miriam A.; Stechuchak, Karen M.; Melnyk, Stephanie D.; Bosworth, Hayden B.; Coffman, Cynthia J.; Neelon, Brian; Van Houtven, Courtney; Gentry, Pamela W.; Morris, Isis J.; Rose, Cynthia M.; Taylor, Jennifer P.; May, Carrie L.; Han, Byungjoo; Wainwright, Christi; Alkon, Aviel; Powell, Lesa; Edelman, David

2016-01-01

Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12 months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5 years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy. PMID:27417982

Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.

PubMed

Jackson, George L; Weinberger, Morris; Kirshner, Miriam A; Stechuchak, Karen M; Melnyk, Stephanie D; Bosworth, Hayden B; Coffman, Cynthia J; Neelon, Brian; Van Houtven, Courtney; Gentry, Pamela W; Morris, Isis J; Rose, Cynthia M; Taylor, Jennifer P; May, Carrie L; Han, Byungjoo; Wainwright, Christi; Alkon, Aviel; Powell, Lesa; Edelman, David

2016-09-01

Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy. Published by Elsevier Inc.

Role of metformin in oxaliplatin-induced peripheral neuropathy in patients with stage III colorectal cancer: randomized, controlled study.

PubMed

El-Fatatry, Basma Mahrous; Ibrahim, Osama Mohamed; Hussien, Fatma Zakaria; Mostafa, Tarek Mohamed

2018-06-21

Peripheral sensory neuropathy is the most prominently reported adverse effect of oxaliplatin. The purpose of this study was to evaluate metformin role in oxaliplatin-induced neuropathy. From November 2014 to May 2016, 40 patients with stage III colorectal cancer completed 12 cycles of FOLFOX-4 regimen. Twenty patients in the control arm received FOLFOX-4 regimen only, and 20 patients in the metformin arm, received the same regimen along with metformin 500 mg three times daily. The metformin efficacy was evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4.0), a12-item neurotoxicity questionnaire (Ntx-12) from the validated Functional Assessment of Cancer Therapy/Gynecologic Oncology Group and, the brief pain inventory short form "worst pain" item. In addition to neurotensin, malondialdehyde and interleukin-6 serum levels assessment. At the end of the 12th cycle, there were less patients with grade 2 and 3 neuropathy in metformin arm as compared to control arm. (60 versus 95%, P = 0.009) In addition, metformin arm showed significantly higher total scores of Ntx-12 questionnaire than control arm (24.0 versus 19.2, P < 0.001). Furthermore, the mean pain score in metformin arm was significantly lower than those of control arm, (6.7 versus 7.3, P = 0.005). Mean serum levels of malondialdehyde and neurotensin were significantly lower in metformin arm after the 6th and the 12th cycles. Metformin may be a promising drug in protecting colorectal cancer patients against oxaliplatin-induced chronic peripheral sensory neuropathy.

Effectiveness of a new dentifrice with baking soda and peroxide in removing extrinsic stain and whitening teeth.

PubMed

Ghassemi, A; Hooper, W; Vorwerk, L; Domke, T; DeSciscio, P; Nathoo, S

2012-01-01

The primary purpose of this randomized, controlled, six-week clinical trial was to determine the effectiveness and safety of a new whitening dentifrice in removing extrinsic tooth stain and whitening teeth. An additional two-week exploratory study was conducted to determine whether the whitening or stain-prevention activity of the dentifrice would persist following cessation of use. In the first study (Phase I), one-hundred and forty-six qualifying subjects were randomly assigned to either a sodium bicarbonate whitening dentifrice group (Arm & Hammer Advance White Extreme Whitening Baking Soda and Peroxide Toothpaste) or a silica-based negative control dentifrice group, and brushed twice daily with their assigned dentifrice for six weeks. Tooth shade on the labial surfaces of the eight incisors was assessed using a Vita Classic shade guide, and extrinsic tooth stain was scored using a Modified Lobene Stain Index (MLSI) at baseline, week 4, and week 6. In Phase II (after the week 6 examination), volunteers from the Arm & Hammer whitening dentifrice group were randomly assigned to continue using the whitening dentifrice or to use the negative control dentifrice twice daily for two weeks. The six-week shade and stain index scores served as the baseline for this exploratory phase and were rescored after two weeks. The whitening dentifrice group had statistically significant (p < 0.0001) mean shade score reductions of 1.82 and 2.57 from baseline to weeks 4 and 6, respectively. For the same periods, the negative control dentifrice group was virtually unchanged from baseline. For tooth stain, the MLSI total mean scores for the whitening dentifrice group showed statistically significant (p < 0.0001) decreases from baseline of 1.42 (41.6%) and 2.11 (61.6%) at weeks 4 and 6, respectively. In contrast, the negative control dentifrice group had a MLSI reduction of 0.07 at week 4 and a 0.06 increase at week 6. Between-group analyses using baseline-adjusted ANCOVA showed the whitening dentifrice to be statistically significantly more effective (p < 0.0001) than the negative control for shade and tooth stain reductions for all index comparisons. Compared to the six-week (baseline) scores, subjects who continued to use the whitening dentifrice for the additional two weeks experienced statistically significant (p < 0.0001) further mean reductions of 0.88 in shade score and 0.46 in MLSI score, while subjects who switched to the negative control dentifrice experienced smaller, statistically significant (p < 0.05) reductions of 0.34 in shade score and 0.13 in total MLSI score. The Arm & Hammer whitening dentifrice tested in this study is effective for removing extrinsic tooth stain and whitening teeth. While the results also suggest that this dentifrice may have stain-prevention activity that persists following cessation of product use, such activity would need to be confirmed with further studies.

Financial Incentives to Increase Advance Care Planning Among Medicaid Beneficiaries: Lessons Learned From Two Pragmatic Randomized Trials.

PubMed

Barnato, Amber E; Moore, Robert; Moore, Charity G; Kohatsu, Neal D; Sudore, Rebecca L

2017-07-01

Medicaid populations have low rates of advance care planning (ACP). Potential policy interventions include financial incentives. To test the effectiveness of patient plus provider financial incentive compared with provider financial incentive alone for increasing ACP discussions among Medicaid patients. Between April 2014 and July 2015, we conducted two sequential assessor-blinded pragmatic randomized trials in a health plan that pays primary care providers (PCPs) $100 to discuss ACP: 1) a parallel cluster trial (provider-delivered patient incentive) and 2) an individual-level trial (mail-delivered patient incentive). Control and intervention arms included encouragement to complete ACP, instructions for using an online ACP tool, and (in the intervention arm) $50 for completing the online ACP tool and a small probability of $1000 (i.e., lottery) for discussing ACP with their PCP. The primary outcome was provider-reported ACP discussion within three months. In the provider-delivered patient incentive study, 38 PCPs were randomized to the intervention (n = 18) or control (n = 20) and given 10 patient packets each to distribute. Using an intention-to-treat analysis, there were 27 of 180 ACP discussions (15%) in the intervention group and 5 of 200 (2.5%) in the control group (P = .0391). In the mail-delivered patient incentive study, there were 5 of 187 ACP discussions (2.7%) in the intervention group and 5 of 189 (2.6%) in the control group (P = .99). ACP rates were low despite an existing provider financial incentive. Adding a provider-delivered patient financial incentive, but not a mail-delivered patient incentive, modestly increased ACP discussions. PCP encouragement combined with a patient incentive may be more powerful than either encouragement or incentive alone. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Two-sample binary phase 2 trials with low type I error and low sample size.

PubMed

Litwin, Samuel; Basickes, Stanley; Ross, Eric A

2017-04-30

We address design of two-stage clinical trials comparing experimental and control patients. Our end point is success or failure, however measured, with null hypothesis that the chance of success in both arms is p 0 and alternative that it is p 0 among controls and p 1  > p 0 among experimental patients. Standard rules will have the null hypothesis rejected when the number of successes in the (E)xperimental arm, E, sufficiently exceeds C, that among (C)ontrols. Here, we combine one-sample rejection decision rules, E⩾m, with two-sample rules of the form E - C > r to achieve two-sample tests with low sample number and low type I error. We find designs with sample numbers not far from the minimum possible using standard two-sample rules, but with type I error of 5% rather than 15% or 20% associated with them, and of equal power. This level of type I error is achieved locally, near the stated null, and increases to 15% or 20% when the null is significantly higher than specified. We increase the attractiveness of these designs to patients by using 2:1 randomization. Examples of the application of this new design covering both high and low success rates under the null hypothesis are provided. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Randomized, Phase II Study of the Insulin-Like Growth Factor-1 Receptor Inhibitor IMC-A12, With or Without Cetuximab, in Patients With Cetuximab- or Panitumumab-Refractory Metastatic Colorectal Cancer

PubMed Central

Reidy, Diane Lauren; Vakiani, Efsevia; Fakih, Marwan G.; Saif, Muhammad Wasif; Hecht, Joel Randolph; Goodman-Davis, Noah; Hollywood, Ellen; Shia, Jinru; Schwartz, Jonathan; Chandrawansa, Kumari; Dontabhaktuni, Aruna; Youssoufian, Hagop; Solit, David B.; Saltz, Leonard B.

2010-01-01

Purpose To evaluate the safety and efficacy of IMC-A12, a human monoclonal antibody (mAb) that blocks insulin-like growth factor receptor-1 (IGF-1R), as monotherapy or in combination with cetuximab in patients with metastatic refractory anti–epidermal growth factor receptor (EGFR) mAb colorectal cancer. Methods A randomized, phase II study was performed in which patients in arm A received IMC-A12 10 mg/kg intravenously (IV) every 2 weeks, while patients in arm B received this same dose of IMC-A12 plus cetuximab 500 mg/m2 IV every 2 weeks. Subsequently, arm C (same combination treatment as arm B) was added to include patients who had disease control on a prior anti-EGFR mAb and wild-type KRAS tumors. Archived pretreatment tumor tissue was obtained when possible for KRAS, PIK3CA, and BRAF genotyping, and immunohistochemistry was obtained for pAKT as well as IGF-1R. Results Overall, 64 patients were treated (median age, 61 years; range, 40 to 84 years): 23 patients in arm A, 21 in arm B, and 20 in arm C. No antitumor activity was seen in the 23 patients treated with IMC-A12 monotherapy. Of the 21 patients randomly assigned to IMC-A12 plus cetuximab, one patient (with KRAS wild type) achieved a partial response, with disease control lasting 6.5 months. Arm C (all patients with KRAS wild type), however, showed no additional antitumor activity. Serious adverse events thought possibly related to IMC-A12 included a grade 2 infusion-related reaction (2%; one of 64 patients), thrombocytopenia (2%; one of 64 patients), grade 3 hyperglycemia (2%; one of 64 patients), and grade 1 pyrexia (2%, one of 64 patients). Conclusion IMC-A12 alone or in combination with cetuximab was insufficient to warrant additional study in patients with colorectal cancer refractory to EGFR inhibitors. PMID:20713879

Evaluation of HPV type-replacement in unvaccinated and vaccinated adolescent females-Post-hoc analysis of a community-randomized clinical trial (II).

PubMed

Gray, Penelope; Palmroth, Johanna; Luostarinen, Tapio; Apter, Dan; Dubin, Gary; Garnett, Geoff; Eriksson, Tiina; Natunen, Kari; Merikukka, Marko; Pimenoff, Ville; Söderlund-Strand, Anna; Vänskä, Simopekka; Paavonen, Jorma; Pukkala, Eero; Dillner, Joakim; Lehtinen, Matti

2018-06-15

Efficacy of human papillomavirus (HPV) vaccines promises to control HPV infections. However, HPV vaccination programs may lay bare an ecological niche for non-vaccine HPV types. We evaluated type-replacement by HPV type and vaccination strategy in a community-randomized trial executed in HPV vaccination naïve population. Thirty-three communities were randomized to gender-neutral vaccination with AS04-adjuvanted HPV16/18 vaccine (Arm A), HPV vaccination of girls and hepatitis B-virus (HBV) vaccination of boys (Arm B) and gender-neutral HBV vaccination (Arm C). Resident 1992-95 born boys (40,852) and girls (39,420) were invited. 11,662 boys and 20,513 girls were vaccinated with 20-30% and 45-48% coverage, respectively. HPV typing of 11,396 cervicovaginal samples was performed by high throughput PCR. Prevalence ratios (PR) between arms and ranked order of HPV types and odds ratio (OR) for having multiple HPV types in HPV16 or 18/45 positive individuals were calculated. The ranked order of HPV types did not significantly differ between arms or birth cohorts. For the non-HPV vaccinated 1992-1993 birth cohorts increased PR, between the gender-neutral intervention versus control arms for HPV39 (PR A 1.84, 95% CI 1.12-3.02) and HPV51 (PR A 1.56, 95% CI 1.11-2.19) were observed. In the gender-neutral arm, increased clustering between HPV39 and the vaccine-covered HPV types 16 or 18/45 (OR A16  = 5.1, OR A18/45  = 11.4) was observed in the non-HPV vaccinated 1994-1995 birth cohorts. Comparable clustering was seen between HPV51 and HPV16 or HPV18/45 (OR B16  = 4.7, OR B18/45  = 4.3), in the girls-only arm. In conclusion, definitively consistent postvaccination patterns of HPV type-replacement were not observed. Future occurrence of HPV39 and HPV51 warrant investigation. © 2018 UICC.

Randomized trial of standard pain control with or without gabapentin for pain related to radiation-induced mucositis in head and neck cancer.

PubMed

Kataoka, Tomoko; Kiyota, Naomi; Shimada, Takanobu; Funakoshi, Yohei; Chayahara, Naoko; Toyoda, Masanori; Fujiwara, Yutaka; Nibu, Ken-Ichi; Komori, Takahide; Sasaki, Ryohei; Mukohara, Toru; Minami, Hironobu

2016-12-01

Radiation-induced mucositis (RIM) in chemoradiotherapy (CRT) for head and neck cancer (HNC) causes severe pain and worsens CRT compliance, QOL and outcome. Following retrospective reports, we conducted a randomized trial of the safety and efficacy of gabapentin for RIM-associated pain during CRT. HNC patients (pts) receiving CRT were randomized to standard pain control (SPC) with acetaminophen and opioids, or SPC plus gabapentin (SPC+G). Gabapentin was maintained at 900mg/day for 4 weeks after CRT. Primary endpoint was maximum visual analogue scale (VAS) score during CRT, and secondary endpoints were total opioid dose, changes in QOL (EORTC QLQ-C30 and QLQ-HN 35) from baseline to 4 weeks after CRT, and adverse events. Twenty-two eligible Stage III or IV pts were randomly assigned to SPC or SPC+G (n=11 each). Twelve were treated in a locally advanced setting and 10 in a postoperative setting. Median maximum VAS scores, median total dose of opioids at maximum VAS and total dose of opioids at 4 weeks after CRT tended to be higher in the SPC+G arm (47 in SPC vs. 74 in SPC+G, p=0.517; 215mg vs. 745.3mg, p=0.880; and 1260mg vs. 1537.5mg, p=0.9438, respectively), without significance. QOL analysis showed significantly worse scores in the SPC+G arm for weight gain (p=0.005). Adverse events related to gabapentin were manageable. This pilot study is the first prospective randomized trial of gabapentin for RIM-related pain. Gabapentin had no apparent beneficial effect. Further research into agents for RIM-related pain is warranted. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Protective effects of Tualang honey on bone structure in experimental postmenopausal rats

PubMed Central

Zaid, Siti Sarah Mohamad; Sulaiman, Siti Amrah; Othman, Nor Hayati; Soelaiman, Ima-Nirwana; Shuid, Ahmad Nazrun; Mohamad, Norazlina; Muhamad, Norliza

2012-01-01

OBJECTIVE: The objective of this study was to evaluate the effects of Tualang honey on trabecular structure and compare these effects with those of calcium supplementation in ovariectomized rats. METHODS: Forty female, Sprague-Dawley rats were randomly divided into five groups (n = 8): four controls and one test arm. The control arm comprised a baseline control, sham-operated control, ovariectomized control, and ovariectomized calcium-treated rats (receiving 1% calcium in drinking water ad libitum). The test arm was composed of ovariectomized, Tualang honey-treated rats (received 0.2 g/kg body weight of Tualang honey). Both the sham-operated control and ovariectomized control groups received vehicle treatment (deionized water), and the baseline control group was sacrificed without treatment. RESULTS: All rats were orally gavaged daily for six weeks after day one post-surgery. The bone structural analysis of rats in the test arm group showed a significant increase in the bone volume per tissue volume (BV/TV), trabecular thickness (Tb.Th) and trabecular number (Tb.N) and a significant decrease in inter-trabecular space (Tb.Sp) compared with the ovariectomized control group. The trabecular thickness (Tb.Th) in the test arm group was significantly higher compared with the ovariectomized-calcium treated group, and the inter-trabecular space (Tb.Sp) in the test arm group was significantly narrower compared with the ovariectomized-calcium treated group. CONCLUSION: In conclusion, ovariectomized rats that received Tualang honey showed more improvements in trabecular bone structure than the rats that received calcium. PMID:22892923

Protective effects of Tualang honey on bone structure in experimental postmenopausal rats.

PubMed

Zaid, Siti Sarah Mohamad; Sulaiman, Siti Amrah; Othman, Nor Hayati; Soelaiman, Ima-Nirwana; Shuid, Ahmad Nazrun; Mohamad, Norazlina; Muhamad, Norliza

2012-07-01

The objective of this study was to evaluate the effects of Tualang honey on trabecular structure and compare these effects with those of calcium supplementation in ovariectomized rats. Forty female, Sprague-Dawley rats were randomly divided into five groups (n =8): four controls and one test arm. The control arm comprised a baseline control, sham-operated control, ovariectomized control, and ovariectomized calcium-treated rats (receiving 1% calcium in drinking water ad libitum). The test arm was composed of ovariectomized, Tualang honey-treated rats (received 0.2 g/kg body weight of Tualang honey). Both the sham-operated control and ovariectomized control groups received vehicle treatment (deionized water), and the baseline control group was sacrificed without treatment. All rats were orally gavaged daily for six weeks after day one post-surgery. The bone structural analysis of rats in the test arm group showed a significant increase in the bone volume per tissue volume (BV/TV), trabecular thickness (Tb.Th) and trabecular number (Tb.N) and a significant decrease in inter-trabecular space (Tb.Sp) compared with the ovariectomized control group. The trabecular thickness (Tb.Th) in the test arm group was significantly higher compared with the ovariectomized-calcium treated group, and the inter-trabecular space (Tb.Sp) in the test arm group was significantly narrower compared with the ovariectomized-calcium treated group. In conclusion, ovariectomized rats that received Tualang honey showed more improvements in trabecular bone structure than the rats that received calcium.

A comparison of two ambulatory blood pressure monitors worn at the same time.

PubMed

Kallem, Radhakrishna R; Meyers, Kevin E C; Sawinski, Deirdre L; Townsend, Raymond R

2013-05-01

There are limited data in the literature comparing two simultaneously worn ambulatory blood pressure (BP) monitoring (ABPM) devices. The authors compared BPs from two monitors (Mobil-O-Graph [I.E.M., Stolberg, Germany] and Spacelabs 90207 [Spacelabs Medical, Issequah, WA]). In the nonrandomized component of the study, simultaneous 8-hour BP and heart rate data were measured by Mobil-O-Graph, consistently applied to the nondominant arm, and Spacelabs to the dominant arm on 12 untreated adults. Simultaneous 8-hour BP and heart data were obtained by the same monitors randomly assigned to a dominant or nondominant arm on 12 other untreated adults. Oscillometric BP profiles were obtained in the dominant and nondominant arms of the above 24 patients using an Accutorr (Datascope, Mahwah, NJ) device. The Spacelabs monitor recorded a 10.2-mm Hg higher systolic pressure in the nonrandomized (P=.0016) and a 7.9-mm Hg higher systolic pressure in the randomized studies (P=.00008) compared with the Mobil-O-Graph. The mean arterial pressures were 1 mm Hg to 2 mm Hg different between monitors in the two studies, and heart rates were nearly identical. Our observations, if confirmed in larger cohorts, support the concern that ABPM device manufacturers consider developing normative databases for their devices. ©2013 Wiley Periodicals, Inc.

A multimedia consent tool for research participants in the Gambia: a randomized controlled trial

PubMed Central

McGrath, Nuala; D’Alessandro, Umberto; Kampmann, Beate; Imoukhuede, Egeruan B; Ravinetto, Raffaella M; Alexander, Neal; Larson, Heidi J; Chandramohan, Daniel; Bojang, Kalifa

2015-01-01

Abstract Objective To assess the effectiveness of a multimedia informed consent tool for adults participating in a clinical trial in the Gambia. Methods Adults eligible for inclusion in a malaria treatment trial (n = 311) were randomized to receive information needed for informed consent using either a multimedia tool (intervention arm) or a standard procedure (control arm). A computerized, audio questionnaire was used to assess participants’ comprehension of informed consent. This was done immediately after consent had been obtained (at day 0) and at subsequent follow-up visits (days 7, 14, 21 and 28). The acceptability and ease of use of the multimedia tool were assessed in focus groups. Findings On day 0, the median comprehension score in the intervention arm was 64% compared with 40% in the control arm (P = 0.042). The difference remained significant at all follow-up visits. Poorer comprehension was independently associated with female sex (odds ratio, OR: 0.29; 95% confidence interval, CI: 0.12–0.70) and residing in Jahaly rather than Basse province (OR: 0.33; 95% CI: 0.13–0.82). There was no significant independent association with educational level. The risk that a participant’s comprehension score would drop to half of the initial value was lower in the intervention arm (hazard ratio 0.22, 95% CI: 0.16–0.31). Overall, 70% (42/60) of focus group participants from the intervention arm found the multimedia tool clear and easy to understand. Conclusion A multimedia informed consent tool significantly improved comprehension and retention of consent information by research participants with low levels of literacy. PMID:26229203

Brain-Machine Interface Enables Bimanual Arm Movements in Monkeys

PubMed Central

Ifft, Peter J.; Shokur, Solaiman; Li, Zheng; Lebedev, Mikhail A.; Nicolelis, Miguel A. L.

2014-01-01

Brain-machine interfaces (BMIs) are artificial systems that aim to restore sensation and movement to severely paralyzed patients. However, previous BMIs enabled only single arm functionality, and control of bimanual movements was a major challenge. Here, we developed and tested a bimanual BMI that enabled rhesus monkeys to control two avatar arms simultaneously. The bimanual BMI was based on the extracellular activity of 374–497 neurons recorded from several frontal and parietal cortical areas of both cerebral hemispheres. Cortical activity was transformed into movements of the two arms with a decoding algorithm called a 5th order unscented Kalman filter (UKF). The UKF is well-suited for BMI decoding because it accounts for both characteristics of reaching movements and their representation by cortical neurons. The UKF was trained either during a manual task performed with two joysticks or by having the monkeys passively observe the movements of avatar arms. Most cortical neurons changed their modulation patterns when both arms were engaged simultaneously. Representing the two arms jointly in a single UKF decoder resulted in improved decoding performance compared with using separate decoders for each arm. As the animals’ performance in bimanual BMI control improved over time, we observed widespread plasticity in frontal and parietal cortical areas. Neuronal representation of the avatar and reach targets was enhanced with learning, whereas pairwise correlations between neurons initially increased and then decreased. These results suggest that cortical networks may assimilate the two avatar arms through BMI control. PMID:24197735

A 3-arm randomized controlled trial on the effects of dance movement intervention and exercises on elderly with early dementia.

PubMed

Ho, Rainbow Tin Hung; Cheung, Jacob Kai Ki; Chan, Wai Chi; Cheung, Irene Kit Man; Lam, Linda Chiu Wah

2015-10-19

Dementia is characterized by a progressive decline and deterioration of brain regions such as memory, spatial navigation and language, along with disturbances in daily functioning. Non-pharmacological interventions that offer a holistic approach by targeting cognitive functioning, prognosis and the psychological and social effects of dementia require rigorous investigation. The well-established benefits of physical activity for cognitive functioning and psychological support in dementia have been observed with dance-movement intervention. There is substantial evidence that dance-movement interventions provide emotional and social advantages. Thus, a randomized controlled trial (RCT) is planned to investigate the positive effects of a dance movement intervention, compared with mild physical exercise, on the physical and psychological well-being of elderly Chinese individuals with early dementia. A 3-arm RCT with waitlist control design will be used in this study. Two hundred and one elderly participants with very mild to mild dementia will be screened and randomized into the following groups: (i) dance movement based intervention, (ii) stretching and exercise intervention and (iii) no intervention waitlist-control group. The two intervention groups will receive a 1-h intervention, twice a week, for 12 weeks. The participants will be assessed four times over the course of 12 months: baseline before randomization, post-intervention (3 months), 6 months from baseline and 12 months from baseline. The primary outcomes will be compared between assessment points and between groups on neuropsychiatric symptoms, psychosocial well-being and cognitive and daily functioning. Secondary outcomes will assess the changes in salivary cortisol levels and their relationships with the primary outcome measures. This study will provide substantial evidence of the efficacy of a dance-movement-based intervention in slowing down dementia progression, due to its ability to act as a buffer against decline and improve areas affected by dementia. We also anticipate an association between cortisol levels and the outcome measures. The further development of this intervention into a structural program may be warranted for early psychosocial support among elderly populations. The trial has been registered in the Chinese Clinical Trial Registry ( ChiCTR-IOR-15006541 ).

Web-based screening and brief intervention for poly-drug use among teenagers: study protocol of a multicentre two-arm randomized controlled trial.

PubMed

Arnaud, Nicolas; Bröning, Sonja; Drechsel, Magdalena; Thomasius, Rainer; Baldus, Christiane

2012-09-26

Mid to late adolescence is characterised by a vulnerability to problematic substance use since the consumption of alcohol and illicit drugs is frequently initiated and increased in this life period. While the detrimental long- and short-term effects of problematic consumption patterns in adolescence pose a major public health concern, current prevention programs targeting alcohol- and other substance-using adolescents are scarce. The study described in this protocol will test the effectiveness of a web-based brief intervention aimed at reducing problematic alcohol use and promoting abstinence from illegal drugs in adolescents with risky substance use aged 16 to 18 years old in four EU-countries. To determine the effectiveness of our web-BI, we apply a two-arm randomized controlled trial (RCT) study design, with baseline assessment at study entry and a three month follow-up assessment. Adolescents aged 16 to 18 years from Belgium, the Czech Republic, Germany, and Sweden will be randomly assigned to either the fully electronically delivered brief intervention group (N = 400) or an assessment only control group (N = 400) depending on their screening for risky substance use (using the CRAFFT). Recruitment, informed consent, randomization, intervention and follow-up will be implemented online. Primary outcomes are reductions in frequency and quantity of use of alcohol and drugs other than alcohol over a 30 day period, as well as consumption per typical occasion. Secondary outcomes concern changes in substance use related cognitions including the constructs of the Theory of Planned Behaviour, implementation intentions, and stages of change. Moreover the study addresses a number of moderator variables, including age of first use, general psychopathology and quality of parent-child relationship. The trial is expected to contribute to the growing literature on theory- and web-based brief interventions for adolescents. We will explore the potential of using web-based technologies as means of delivering preventive interventions. In doing so we are among the first to target the relevant group of young poly-drug users in Europe. Current Controlled Trials ISRCTN95538913.

Design and Implementation of a Randomized Controlled Trial of Genomic Counseling for Patients with Chronic Disease

PubMed Central

Sweet, Kevin; Gordon, Erynn S.; Sturm, Amy C.; Schmidlen, Tara J.; Manickam, Kandamurugu; Toland, Amanda Ewart; Keller, Margaret A.; Stack, Catharine B.; García-España, J. Felipe; Bellafante, Mark; Tayal, Neeraj; Embi, Peter; Binkley, Philip; Hershberger, Ray E.; Sadee, Wolfgang; Christman, Michael; Marsh, Clay

2014-01-01

We describe the development and implementation of a randomized controlled trial to investigate the impact of genomic counseling on a cohort of patients with heart failure (HF) or hypertension (HTN), managed at a large academic medical center, the Ohio State University Wexner Medical Center (OSUWMC). Our study is built upon the existing Coriell Personalized Medicine Collaborative (CPMC®). OSUWMC patient participants with chronic disease (CD) receive eight actionable complex disease and one pharmacogenomic test report through the CPMC® web portal. Participants are randomized to either the in-person post-test genomic counseling—active arm, versus web-based only return of results—control arm. Study-specific surveys measure: (1) change in risk perception; (2) knowledge retention; (3) perceived personal control; (4) health behavior change; and, for the active arm (5), overall satisfaction with genomic counseling. This ongoing partnership has spurred creation of both infrastructure and procedures necessary for the implementation of genomics and genomic counseling in clinical care and clinical research. This included creation of a comprehensive informed consent document and processes for prospective return of actionable results for multiple complex diseases and pharmacogenomics (PGx) through a web portal, and integration of genomic data files and clinical decision support into an EPIC-based electronic medical record. We present this partnership, the infrastructure, genomic counseling approach, and the challenges that arose in the design and conduct of this ongoing trial to inform subsequent collaborative efforts and best genomic counseling practices. PMID:24926413

Preconception maternal nutrition: a multi-site randomized controlled trial

PubMed Central

2014-01-01

Background Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy. Methods/Study design This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none. 192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age; infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites. Discussion Positive results of this trial will support a paradigm shift in attention to nutrition of all females of child-bearing age. Trial registration ClinicalTrials.gov NCT01883193. PMID:24650219

Efficacy of a Carrageenan gel Against Transmission of Cervical HPV (CATCH): Interim analysis of a randomized, double-blind, placebo-controlled, phase 2B trial.

PubMed

Magnan, Sindy; Tota, Joseph E; El-Zein, Mariam; Burchell, Ann N; Schiller, John T; Ferenczy, Alex; Tellier, Pierre-Paul; Coutlée, François; Franco, Eduardo L

2018-04-20

We evaluated the efficacy of a carrageenan-based lubricant gel in reducing the risk of genital human papillomavirus (HPV) infections in women. We conducted a planned interim analysis of a randomized, double-blind, placebo-controlled, phase 2B trial. Women aged 18 years and older were randomly assigned (1:1) to a carrageenan-based or a placebo gel to be self-applied every other day for the first month and prior to and following each intercourse during follow-up. Assessments were done at 0·5, 1, 3, 6, 9, and 12 months. The primary outcome was incidence of a new infection by an HPV type that was not present at baseline. Analyses were performed by intention-to-treat. Between January 2013 and June 2017, 280 participants were randomly assigned to the carrageenan (n=141) or the placebo (n=139) arm. All participants were included in safety analyses, but 3 (1%) were excluded from efficacy analyses (HPV results unavailable: carrageenan=2, placebo=1). The median follow-up time was 9·2 months (inter-quartile range: 1·9-13·2). 59 (42%) of 139 participants in the carrageenan arm and 78 (57%) of 138 participants in the placebo arm got infected by at least one new HPV type (hazard ratio=0·64, 95% confidence interval=0·45-0·89, p=0·009). 62 (44%) of 141 participants in the carrageenan arm versus 43 (31%) of 139 participants in the placebo arm reported an adverse event (p=0.02); none of which were deemed related to the gels. Our trial's interim analysis suggests that using a carrageenan-based lubricant gel can reduce the risk of genital HPV infections in women. Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

A Phase 2 Randomized Study of Ramucirumab (IMC-1121B) with or without Dacarbazine in Patients with Metastatic Melanoma

PubMed Central

Carvajal, Richard D.; Wong, Michael K.; Thompson, John A.; Gordon, Michael S.; Lewis, Karl D.; Pavlick, Anna C.; Wolchok, Jedd D.; Rojas, Patrick B.; Schwartz, Jonathan D.; Bedikian, Agop Y.

2017-01-01

SUMMARY Background To evaluate the efficacy and safety of ramucirumab (IMC-1121B; LY3009806), a fully human monoclonal antibody targeting the vascular endothelial growth factor receptor-2, alone and in combination with dacarbazine in chemotherapy-naïve patients with metastatic melanoma (MM). Methods Eligible patients received ramucirumab (10 mg/kg) + dacarbazine (1000 mg/m2) (Arm A) or ramucirumab only (10 mg/kg) (Arm B) every 3 weeks. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), overall response, and safety. Findings Of 106 randomized patients, 102 received study treatment (Arm A, N = 52; Arm B, N = 50). Baseline characteristics were similar in both arms. Median PFS was 2·6 months (Arm A) and 1·7 months (Arm B); median 6-month PFS rates were 30·7% and 17·9% and 12-month PFS rates were 23·7% and 15·6%, respectively. In Arm A, 9 (17·3%) patients had partial response (PR) and 19 (36·5%), stable disease (SD); PR and SD in Arm B were 2 (4·0%) and 21 (42·0%), respectively. Median OS was 8·7 months in Arm A and 11·1 months in Arm B. Patients in both arms tolerated the treatment with limited grade 3/4 toxicities. Interpretation Ramucirumab alone or in combination with dacarbazine was associated with an acceptable safety profile in patients with MM. Although the study was not powered for comparison between treatment arms, PFS appeared greater with combination therapy. Sustained disease control was observed on both study arm Funding Funded by ImClone Systems LLC, a wholly-owned subsidiary of Eli Lilly and Company, Bridgewater, NJ PMID:24930625

Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial.

PubMed

Thiese, Matthew S; Hughes, Matthew; Biggs, Jeremy

2013-03-28

Non-invasive electrotherapy is commonly used for treatment of chronic low back pain. Evidence for efficacy of most electrotherapy modalities is weak or lacking. This study aims to execute a high-quality, double-blinded randomized controlled clinical trial comparing 1) H-Wave(®) Device stimulation plus usual care with 2) transcutaneous electrical nerve stimulation (TENS) plus usual care, and 3) Sham electrotherapy plus usual care to determine comparative efficacy for treatment of chronic non-specific low back pain patients. Chronic non-specific low back pain patients between ages of 18-65 years, with pain of at least 3 months duration and minimal current 5/10 VAS pain. Patients will have no significant signs or symptoms of lumbosacral nerve impingement, malignancy, spinal stenosis, or mood disorders. Double blind RCT with 3 arms and 38 subjects per arm. Randomization by permuted blocks of random length, stratified by Workers Compensation claim (yes vs. no), and use of opioids. The null hypothesis of this study is that there are no statistically significant differences in functional improvement between treatment types during and at the end of a 12-week week treatment period. Subjective data will be collected using Filemaker Pro™ database management collection tools. Objective data will be obtained through functional assessments. Data will be collected at enrollment and at 1, 4, 8, and 12 weeks for each participant by a blinded assessor. H-Wave(®) device stimulation (Intervention A) plus usual care, transcutaneous electrical nerve stimulation (TENS) (Intervention B) plus usual care, and sham electrotherapy plus usual care (control). Each treatment arm will have identical numbers of visits (4) and researcher contact time (approximately 15 hours). Oswestry Disability Index. Secondary measures include: Rowland Morris Instrument, VAS pain score, functional evaluation including strength when pushing and pulling, pain free range of motion in flexion and extension. Outcome measures assessed at baseline, 1, 4, 8, and 12 weeks. Treatment failure will be defined if patient terminates assigned treatment arm for non-efficacy or undergoes invasive procedure or other excluded cointerventions. Data will be analyzed using intention-to-treat analysis and adjusted for covariates related to LBP (e.g. age) as needed. Study strengths include complex randomization, treatment group allocation concealment, double blinding, controlling for co-interventions, rigorous inclusion criteria, assessment of compliance, plans for limiting dropout, identical assessment methods and timing for each treatment arm, and planned intention-to-treat analyses.

A randomized controlled trial of gabapentin for chronic low back pain with and without a radiating component

PubMed Central

Atkinson, J. Hampton; Slater, Mark A.; Capparelli, Edmund V.; Patel, Shetal M.; Wolfson, Tanya; Gamst, Anthony; Abramson, Ian S.; Wallace, Mark S.; Funk, Stephen D.; Rutledge, Thomas R.; Wetherell, Julie Loebach; Matthews, Scott C.; Zisook, Sidney; Garfin, Steven R.

2016-01-01

Gabapentin is prescribed for analgesia in chronic low back pain, yet there are no controlled trials supporting this practice. This randomized, two-arm, 12-week, parallel group study compared gabapentin (forced titration up to 3600 mg daily) to inert placebo. The primary efficacy measure was change in pain intensity from baseline to the last week on treatment measured by the Descriptor Differential Scale; the secondary outcome was disability (Oswestry Disability Index). The intention-to-treat analysis comprised 108 randomized chronic back pain patients (daily pain for ≥ 6 months) whose pain did (43%) or did not radiate into the lower extremity. Random effects regression models which did not impute missing scores were used to analyze outcome data. Pain intensity decreased significantly over time (p < .0001) with subjects on gabapentin or placebo reporting reductions of about 30% from baseline, but did not differ significantly between groups (p = .423). The same results pertained for disability scores. In responder analyses of those who completed 12 weeks (N=72), the proportion reporting at least 30% or 50% reduction in pain intensity, or at least “Minimal Improvement” on the Physician Clinical Global Impression of Change did not differ significantly between groups. There were no significant differences in analgesia between participants with radiating (n = 46) and non-radiating (n = 62) pain either within or between treatment arms. There was no significant correlation between gabapentin plasma concentration and pain intensity. Gabapentin appears to be ineffective for analgesia in chronic low back pain with or without a radiating component. PMID:26963844

Involving private practitioners in the Indian tuberculosis programme: a randomised trial.

PubMed

Yellappa, Vijayashree; Battaglioli, Tullia; Gurum, Sanath Kumar; Narayanan, Devadasan; Van der Stuyft, Patrick

2018-05-01

To assess a multicomponent intervention to improve private practitioners (PPs) involvement in referral of presumptive pulmonary TB (PTB) cases to the Revised National TB Control Programme (RNTCP) for sputum examination. Randomised controlled trial. We randomly allocated all 189 eligible PPs in Tumkur city, South India, to intervention or control arm. The intervention, implemented between December 2014 and January 2016, included two sets of activities, one targeted at health system strengthening (building RNTCP staff capacity to collaborate with PPs, provision of feedback on referrals through SMS) and one targeted at intervention PPs (training in RNTCP, provision of referral pads and education materials and monthly visits to PPs by RNTCP staff). Crude and adjusted referral and PTB case-finding rate ratios were calculated with negative binomial regression. PPs referred 836 individuals (548 from intervention and 169 from control arm PPs) of whom 176 were diagnosed with bacteriologically confirmed PTB. The proportion (95% confidence interval) of referring PPs [0.59 (0.49, 0.68) vs. 0.42 (0.32, 0.52) in the intervention and control arm, respectively], mean referral rate per PP-year [(5.7 (3.8, 8.7) vs. 1.8 (1.2, 2.8)] and smear-positive PTB case-finding rate per PP-year [(1.5 (0.9, 2.2) vs. 0.6 (0.3, 0.9)] were significantly higher in the intervention than the control arm. Stratifying by qualification, a statistically significant difference in the above indicators remained only among GPs and internists. Overall, surgeons, paediatricians and gynaecologists referred few patients. PP referrals contributed to 20% of the sputum smear positive PTB cases detected by RNTCP in Tumkur city (14% were from intervention arm PPs). We demonstrated the effectiveness of a health system-oriented intervention to improve PP's referrals of presumptive PTB cases to RNTCP. © 2018 John Wiley & Sons Ltd.

Comparative Effectiveness of an Internet-Based Smoking Cessation Intervention Versus Clinic-Based Specialty Care for Veterans.

PubMed

Calhoun, Patrick S; Datta, Santanu; Olsen, Maren; Smith, Valerie A; Moore, Scott D; Hair, Lauren P; Dedert, Eric A; Kirby, Angela; Dennis, Michelle; Beckham, Jean C; Bastian, Lori A

2016-10-01

The primary objective of this project was to examine the effectiveness of an Internet-based smoking cessation intervention combined with a tele-health medication clinic for nicotine replacement therapy (NRT) compared to referral to clinic-based smoking cessation care. A total of 413 patients were proactively recruited from the Durham VA Medical Center and followed for 12 months. Patients were randomized to receive either a referral to VA specialty smoking cessation care (control) or to the Internet intervention and tele-health medication clinic. Primary outcomes included (1) intervention reach, (2) self-reported 7-day point prevalence abstinence rates at 3 months and 12 months, and 3) relative cost-effectiveness. Reach of the Internet intervention and use of smoking cessation aids were significantly greater compared to the control. At 3 months-post randomization, however, there were no significant differences in quit rates: 17% (95% CI: 12%–23%) in the Internet-based intervention compared to 12% (95% CI: 8%–17%) in the control arm. Similarly, there were no differences in quit rates at 12 months (13% vs. 16%). While costs associated with the Internet arm were higher due to increased penetration and intensity of NRT use, there were no statistically significant differences in the relative cost effectiveness (e.g., life years gained, quality adjusted life years) between the two arms. Current results suggest that using an electronic medical record to identify smokers and proactively offering smoking cessation services that are consistent with US Public Health Guidelines can significantly reduce smoking in veterans. Novel interventions that increase the reach of intensive treatment are needed to maximize quit rates in this population.

Comparative Effectiveness of an Internet-Based Smoking Cessation Intervention versus Clinic-Based Specialty Care for Veterans

PubMed Central

Calhoun, Patrick S.; Datta, Santanu; Olsen, Maren; Smith, Valerie A.; Moore, Scott D.; Hair, Lauren P.; Dedert, Eric A.; Kirby, Angela; Dennis, Michelle; Beckham, Jean C.; Bastian, Lori A

2016-01-01

Introduction The primary objective of this project was to examine the effectiveness of an internet-based smoking cessation intervention combined with a tele-health medication clinic for nicotine replacement therapy (NRT) compared to referral to clinic-based smoking cessation care. Methods A total of 413 patients were proactively recruited from the Durham VA Medical Center and followed for 12 months. Patients were randomized to receive either a referral to VA specialty smoking cessation care (control) or to the internet intervention and tele-health medication clinic. Primary outcomes included (1) intervention reach, (2) self-reported 7-day point prevalence abstinence rates at 3 months and 12 months, and 3) relative cost-effectiveness. Results Reach of the internet intervention and use of smoking cessation aids were significantly greater compared to the control. At 3 months-post randomization, however, there were no significant differences in quit rates: 17% (95% CI: 12%–23%) in the internet-based intervention compared to 12% (95% CI: 8%–17%) in the control arm. Similarly, there were no differences in quit rates at 12 months (13% vs. 16%). While costs associated with the internet arm were higher due to increased penetration and intensity of NRT use, there were no statistically significant differences in the relative cost effectiveness (e.g., life years gained, quality adjusted life years) between the two arms. Conclusions Current results suggest that using an electronic medical record to identify smokers and proactively offering smoking cessation services that are consistent with US Public Health Guidelines can significantly reduce smoking in veterans. Novel interventions that increase the reach of intensive treatment are needed to maximize quit rates in this population. PMID:27568506

Potential surrogate endpoints for prostate cancer survival: analysis of a phase III randomized trial.

PubMed

Ray, Michael E; Bae, Kyounghwa; Hussain, Maha H A; Hanks, Gerald E; Shipley, William U; Sandler, Howard M

2009-02-18

The identification of surrogate endpoints for prostate cancer-specific survival may shorten the length of clinical trials for prostate cancer. We evaluated distant metastasis and general clinical treatment failure as potential surrogates for prostate cancer-specific survival by use of data from the Radiation Therapy and Oncology Group 92-02 randomized trial. Patients (n = 1554 randomly assigned and 1521 evaluable for this analysis) with locally advanced prostate cancer had been treated with 4 months of neoadjuvant and concurrent androgen deprivation therapy with external beam radiation therapy and then randomly assigned to no additional therapy (control arm) or 24 additional months of androgen deprivation therapy (experimental arm). Data from landmark analyses at 3 and 5 years for general clinical treatment failure (defined as documented local disease progression, regional or distant metastasis, initiation of androgen deprivation therapy, or a prostate-specific antigen level of 25 ng/mL or higher after radiation therapy) and/or distant metastasis were tested as surrogate endpoints for prostate cancer-specific survival at 10 years by use of Prentice's four criteria. All statistical tests were two-sided. At 3 years, 1364 patients were alive and contributed data for analysis. Both distant metastasis and general clinical treatment failure at 3 years were consistent with all four of Prentice's criteria for being surrogate endpoints for prostate cancer-specific survival at 10 years. At 5 years, 1178 patients were alive and contributed data for analysis. Although prostate cancer-specific survival was not statistically significantly different between treatment arms at 5 years (P = .08), both endpoints were consistent with Prentice's remaining criteria. Distant metastasis and general clinical treatment failure at 3 years may be candidate surrogate endpoints for prostate cancer-specific survival at 10 years. These endpoints, however, must be validated in other datasets.

HIV salvage therapy does not require nucleoside reverse transcriptase inhibitors: a randomized trial

PubMed Central

Tashima, Karen T; Smeaton, Laura M; Fichtenbaum, Carl J; Andrade, Adriana; Eron, Joseph J; Gandhi, Rajesh T; Johnson, Victoria A; Klingman, Karin L; Ritz, Justin; Hodder, Sally; Santana, Jorge L; Wilkin, Timothy; Haubrich, Richard H

2015-01-01

Background Nucleoside reverse transcriptase inhibitors (NRTIs) are often included in antiretroviral (ARV) regimens in treatment-experienced patients in the absence of data from randomized trials. Objective To compare treatment success between participants who omit versus Add NRTIs to an optimized ARV regimen of three or more agents. Design Multisite, randomized, controlled trial. Setting Outpatient HIV clinics. Participants HIV-infected patients with three-class ARV experience and/or viral resistance. Intervention Open-label optimized regimens (not including NRTIs) were selected based upon treatment history and susceptibility testing. Participants were randomized to Omit or Add NRTIs. Measurements The primary efficacy outcome was regimen failure through week 48, using a non-inferiority margin of 15%. The primary safety outcome was time to initial episode of severe sign/symptom or laboratory abnormality prior to discontinuation of NRTI assignment. Results 360 participants were randomized and 93% completed a week 48 visit. The cumulative probability of regimen failure was 29.8% in the Omit NRTI arm versus 25.9% in the Add NRTI arm (difference= 3.2%: 95% CI, −6.1 to 12.5). There were no significant differences in the primary safety endpoints or the proportion of participants with HIV RNA <50 copies/mL between arms. No deaths occurred in the Omit NRTIs arm, compared with 7 deaths in the Add NRTIs arm. Limitations Non-blinded study design and may not be applicable to resource poor settings. Conclusion HIV-infected treatment-experienced patients starting a new optimized regimen can safely omit NRTIs without compromising virologic efficacy. Omitting NRTIs will reduce pill burden, cost, and toxicity in this patient population. PMID:26595748

Pilot Randomized Controlled Trial of a Home Vegetable Gardening Intervention among Older Cancer Survivors Shows Feasibility, Satisfaction, and Promise in Improving Vegetable and Fruit Consumption, Reassurance of Worth, and the Trajectory of Central Adiposity.

PubMed

Demark-Wahnefried, Wendy; Cases, Mallory G; Cantor, Alan B; Frugé, Andrew D; Smith, Kerry P; Locher, Julie; Cohen, Harvey J; Tsuruta, Yuko; Daniel, Michael; Kala, Rishabh; De Los Santos, Jennifer F

2018-04-01

Holistic approaches are sought to improve lifestyle behaviors and health of cancer survivors long term. Our aim was to explore whether a home-based vegetable gardening intervention is feasible and whether it improves diet and other health-related outcomes among older cancer survivors. We conducted a feasibility trial in which cancer survivors were randomized to receive a year-long gardening intervention immediately or to a wait-list control arm. Home visits at baseline and 1 year assessed physical performance, anthropometric indices, behavioral and psychosocial outcomes, and biomarkers. Participants included 46 older (aged 60+ years) survivors of locoregionally staged cancers across Alabama from 2014 to 2016. Forty-two completed 1-year follow-up. Cooperative extension master gardeners delivered guidance to establish three seasonal vegetable gardens at survivors' homes. Plants, seeds, and gardening supplies were provided. Primary outcomes were feasibility targets of 80% accrual and retention, and an absence of serious adverse events; other outcomes were secondary and explored potential benefits. Baseline to follow-up changes were assessed within and between arms using paired t, McNemar's, and χ 2 tests. This trial proved to be safe and demonstrated 91.3% retention; 70% of intervention participants rated their experience as "excellent," and 85% would "do it again." Data suggest significantly increased reassurance of worth (+0.49 vs -0.45) and attenuated increases in waist circumference (+2.30 cm vs +7.96 cm) in the gardening vs control arms (P=0.02). Vegetable and fruit consumption increased by approximately 1 serving/day within the gardening arm from baseline to follow-up (mean [standard error]=1.34 [1.2] to 2.25 [1.9] servings/day; P=0.02)] compared to controls (1.22 [1.1] to 1.12 [0.7]; P=0.77; between-arm P=0.06). The home vegetable gardening intervention among older cancer survivors was feasible and suggested improvements in vegetable and fruit consumption and reassurance of worth; data also suggest attenuated increases in waist circumference. Continued study of vegetable gardening interventions is warranted to improve health, health behaviors, and well-being of older cancer survivors. Copyright © 2018 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

Efficacy of transfusion with granulocytes from G-CSF/dexamethasone–treated donors in neutropenic patients with infection

PubMed Central

Boeckh, Michael; Harrison, Ryan W.; McCullough, Jeffrey; Ness, Paul M.; Strauss, Ronald G.; Nichols, W. Garrett; Hamza, Taye H.; Cushing, Melissa M.; King, Karen E.; Young, Jo-Anne H.; Williams, Eliot; McFarland, Janice; Holter Chakrabarty, Jennifer; Sloan, Steven R.; Friedman, David; Parekh, Samir; Sachais, Bruce S.; Kiss, Joseph E.; Assmann, Susan F.

2015-01-01

High-dose granulocyte transfusion therapy has been available for 20 years, yet its clinical efficacy has never been conclusively demonstrated. We report here the results of RING (Resolving Infection in Neutropenia with Granulocytes), a multicenter randomized controlled trial designed to address this question. Eligible subjects were those with neutropenia (absolute neutrophil count <500/μL) and proven/probable/presumed infection. Subjects were randomized to receive either (1) standard antimicrobial therapy or (2) standard antimicrobial therapy plus daily granulocyte transfusions from donors stimulated with granulocyte colony-stimulating factor (G-CSF) and dexamethasone. The primary end point was a composite of survival plus microbial response, at 42 days after randomization. Microbial response was determined by a blinded adjudication panel. Fifty-six subjects were randomized to the granulocyte arm and 58 to the control arm. Transfused subjects received a median of 5 transfusions. Mean transfusion dose was 54.9 × 109 granulocytes. Overall success rates were 42% and 43% for the granulocyte and control groups, respectively (P > .99), and 49% and 41%, respectively, for subjects who received their assigned treatments (P = .64). Success rates for granulocyte and control arms did not differ within any infection type. In a post hoc analysis, subjects who received an average dose per transfusion of ≥0.6 × 109 granulocytes per kilogram tended to have better outcomes than those receiving a lower dose. In conclusion, there was no overall effect of granulocyte transfusion on the primary outcome, but because enrollment was half that planned, power to detect a true beneficial effect was low. RING was registered at www.clinicaltrials.gov as #NCT00627393. PMID:26333778

Randomized phase 3 trial comparing 2 cisplatin dose schedules in 326 patients with locally advanced squamous cell cervical carcinoma: long-term follow-up.

PubMed

Nagy, Viorica Magdalena; Ordeanu, Claudia; Coza, Ovidiu; Alin, Cristian Rancea; Traila, Alexandru; Todor, Nicolae

2012-11-01

The evaluation of 5-year results obtained through 2 radiochemotherapy (RCT) regimens: cisplatin (CDDP), 20 mg/m × 5 days every 21 days; and CDDP, 40 mg/m per week in locally advanced cervical carcinoma. In this single-institution prospective randomized phase 3 study, 326 patients with stage IIB to IIIB squamous cell cervical carcinoma treated from March 2003 to March 2005 were included. One hundred sixty patients (49%) had stage IIB cervical carcinoma, 103 patients (31.5%) had stage IIIA cervical carcinoma, and 63 patients (19.5%) had stage IIIB cervical carcinoma. The patients were randomly assigned to 2 therapeutic arms: 164 patients in arm A (5 days) concurrent RCT with CDDP, 20 mg/m per day, days 1 to 5 every 21 days; and 162 patients in arm B (weekly), concurrent RCT with CDDP, 40 mg/m per day weekly. All patients were treated with external beam radiotherapy on the abdominopelvic region using 15-MV x-rays and a cervical boost using the x-rays arch technique or medium-dose-rate intracavitary brachytherapy. The 5-year survival rate obtained through the 2 RCT regimens are not statistically different, even if a tendency of superiority can be observed in the 5-day arm as far as overall survival (78% in arm A vs 72% in arm B; p = 0.14) and disease-free survival (73% in arm A and 69% in arm B; p = 0.09) are concerned. Five-year local relapse-free survival was significantly superior in the 5-day CDDP arm (87%) in comparison with the weekly CDDP arm (77%); p < 0.01. In the 5-day arm, local relapse rate was twice lower, 21/164 (13%), compared with the weekly arm, 40/162 (25%); p < 0.01). Distance failures were identical in the 2 therapeutic groups: 22/164 (13%) and 21/162 (13%), respectively, which shows the superiority of arm A regarding local control. The results of our study demonstrate that RCT with cisplatin, 20 mg/m × 5 days every 21 days, is superior regarding local efficacy and is less toxic compared with the weekly chemotherapy regimen.

Network meta-analysis combining individual patient and aggregate data from a mixture of study designs with an application to pulmonary arterial hypertension.

PubMed

Thom, Howard H Z; Capkun, Gorana; Cerulli, Annamaria; Nixon, Richard M; Howard, Luke S

2015-04-12

Network meta-analysis (NMA) is a methodology for indirectly comparing, and strengthening direct comparisons of two or more treatments for the management of disease by combining evidence from multiple studies. It is sometimes not possible to perform treatment comparisons as evidence networks restricted to randomized controlled trials (RCTs) may be disconnected. We propose a Bayesian NMA model that allows to include single-arm, before-and-after, observational studies to complete these disconnected networks. We illustrate the method with an indirect comparison of treatments for pulmonary arterial hypertension (PAH). Our method uses a random effects model for placebo improvements to include single-arm observational studies into a general NMA. Building on recent research for binary outcomes, we develop a covariate-adjusted continuous-outcome NMA model that combines individual patient data (IPD) and aggregate data from two-arm RCTs with the single-arm observational studies. We apply this model to a complex comparison of therapies for PAH combining IPD from a phase-III RCT of imatinib as add-on therapy for PAH and aggregate data from RCTs and single-arm observational studies, both identified by a systematic review. Through the inclusion of observational studies, our method allowed the comparison of imatinib as add-on therapy for PAH with other treatments. This comparison had not been previously possible due to the limited RCT evidence available. However, the credible intervals of our posterior estimates were wide so the overall results were inconclusive. The comparison should be treated as exploratory and should not be used to guide clinical practice. Our method for the inclusion of single-arm observational studies allows the performance of indirect comparisons that had previously not been possible due to incomplete networks composed solely of available RCTs. We also built on many recent innovations to enable researchers to use both aggregate data and IPD. This method could be used in similar situations where treatment comparisons have not been possible due to restrictions to RCT evidence and where a mixture of aggregate data and IPD are available.

Effects of different doses of high-speed resistance training on physical performance and quality of life in older women: a randomized controlled trial

PubMed Central

Ramirez-Campillo, Rodrigo; Diaz, Daniela; Martinez-Salazar, Cristian; Valdés-Badilla, Pablo; Delgado-Floody, Pedro; Méndez-Rebolledo, Guillermo; Cañas-Jamet, Rodrigo; Cristi-Montero, Carlos; García-Hermoso, Antonio; Celis-Morales, Carlos; Moran, Jason; Buford, Thomas W; Rodriguez-Mañas, Leocadio; Alonso-Martinez, Alicia M; Izquierdo, Mikel

2016-01-01

Objective This study aimed to compare the effects of two frequencies of high-speed resistance training (HSRT) on physical performance and quality of life of older women. Methods A total of 24 older women participated in a 12-week HSRT program composed of either two or three sessions/week (equated for volume and intensity). Women were randomized into three arms: a control group (CG, n=8), a resistance training group performing two sessions/week (RT2, n=8), and a resistance training group performing three sessions/week (RT3, n=8). The training program for both experimental groups included exercises that required high-speed concentric muscle actions. Results No baseline differences were observed among groups. Compared with the CG, both training groups showed similar small to moderate improvements (P<0.05) in muscle strength, power, functional performance, balance, and quality of life. Conclusion These results suggest that equated for volume and intensity, two and three training sessions/week of HSRT are equally effective for improving physical performance and quality of life of older women. PMID:28008239

Effects of different doses of high-speed resistance training on physical performance and quality of life in older women: a randomized controlled trial.

PubMed

Ramirez-Campillo, Rodrigo; Diaz, Daniela; Martinez-Salazar, Cristian; Valdés-Badilla, Pablo; Delgado-Floody, Pedro; Méndez-Rebolledo, Guillermo; Cañas-Jamet, Rodrigo; Cristi-Montero, Carlos; García-Hermoso, Antonio; Celis-Morales, Carlos; Moran, Jason; Buford, Thomas W; Rodriguez-Mañas, Leocadio; Alonso-Martinez, Alicia M; Izquierdo, Mikel

2016-01-01

This study aimed to compare the effects of two frequencies of high-speed resistance training (HSRT) on physical performance and quality of life of older women. A total of 24 older women participated in a 12-week HSRT program composed of either two or three sessions/week (equated for volume and intensity). Women were randomized into three arms: a control group (CG, n=8), a resistance training group performing two sessions/week (RT2, n=8), and a resistance training group performing three sessions/week (RT3, n=8). The training program for both experimental groups included exercises that required high-speed concentric muscle actions. No baseline differences were observed among groups. Compared with the CG, both training groups showed similar small to moderate improvements ( P <0.05) in muscle strength, power, functional performance, balance, and quality of life. These results suggest that equated for volume and intensity, two and three training sessions/week of HSRT are equally effective for improving physical performance and quality of life of older women.

Acupressure Improves the Weaning Indices of Tidal Volumes and Rapid Shallow Breathing Index in Stable Coma Patients Receiving Mechanical Ventilation: Randomized Controlled Trial

PubMed Central

Maa, Suh-Hwa; Wang, Chiu-Hua; Hsu, Kuang-Hung; Lin, Horng-Chyuan; Yee, Brian; MacDonald, Karen

2013-01-01

Background. Acupressure has been shown to improve respiratory parameters. We investigated the effects of acupressure on weaning indices in stable coma patients receiving mechanical ventilation. Methods. Patients were randomly allocated to one of three treatments: standard care with adjunctive acupressure on one (n = 32) or two days (n = 31) and standard care (n = 31). Acupressure in the form of 10 minutes of bilateral stimulation at five acupoints was administered per treatment session. Weaning indices were collected on two days before, right after, and at 0.5 hrs, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, and 4 hrs after the start of treatment. Results. There were statistically significant improvements in tidal volumes and index of rapid shallow breathing in the one-day and two-day adjunctive acupressure study arms compared to the standard care arm immediately after acupressure and persisting until 0.5, 1 hr, and 2 hrs after adjustment for covariates. Conclusions. In the stable ventilated coma patient, adjunctive acupressure contributes to improvements in tidal volumes and the index of rapid shallow breathing, the two indices most critical for weaning patients from mechanical ventilation. These effects tend to be immediate and likely to be sustained for 1 to 2 hours. PMID:23710234

Pancreatic enzyme supplementation after gastrectomy for gastric cancer: a randomized controlled trial.

PubMed

Catarci, Marco; Berlanda, Manuele; Grassi, Giovanni Battista; Masedu, Francesco; Guadagni, Stefano

2018-05-01

Gastrectomy for gastric cancer is a significant cause of secondary exocrine pancreatic insufficiency. Pancreatic enzyme replacement therapy may influence nutritional status and quality of life after gastrectomy, but the pertinent clinical research to date remains controversial. A randomized controlled trial to test this hypothesis was carried out. After gastrectomy, 43 patients with gastric cancer were randomly assigned to a normal diet (Normal-d; n = 21) or to a pancreatic enzyme supplementation diet (PES-d; n = 22) and were followed up during a 12-month period, assessing nutritional status and quality of life through body mass index (BMI), instant nutritional assessment (INA) class status, serum pre-albumin (SPA) values, and GastroiIntestinal Quality of Life Index (GIQLI). BMI was not significantly influenced by the type of diet; INA class status was significantly improved in the PES-d arm, particularly during the first 3 months after gastrectomy; SPA levels increased in both arms at 6 months after gastrectomy, reaching significantly higher values in the PES-d arm at 12 months. GIQLI was not significantly influenced by the type of diet throughout the follow-up period; however, this index significantly improved in the PES-d arm between the first and third month after gastrectomy. PES-d improves nutritional status and quality of life after gastrectomy for gastric cancer, particularly within 3 months from the operation. A larger, multicenter trial is necessary to address the potential influence of several confounding variables such as disease stage and adjuvant treatments.

Interphase Chromosome Conformation and Chromatin-chromatin Interactions in Human Epithelial Cells Cultured Under Different Gravity Conditions

NASA Technical Reports Server (NTRS)

Zhang, Ye; Hada, Megumi; Wu, Honglu

2014-01-01

On a multi-mega base pair scale of the DNA, the arrangement of chromatin is non-random. In M10 epithelial cells, both telomere regions tend to be located towards the exterior of the chromosome domain, whereas the rest p-arm of the chromatin region towards the interior. In contrast, most of the q-arm of the chromatin is found in the peripheral of the domain. In lymphocytes, the p-arm chromatin regions towards the interior in close proximity with each other, whereas two q-arm regions are nearness in space. It indicates that G0 lymphocytes may lack secondary 3D chromatin folding. There chromatin folding patterns are consistent with our previous finding of non-random distribution of intra-chromosomal exchanges. In simulated microgravity conditions, the chromosome conformation may be altered and new regions in close proximity, especially to region 2 are suggested.

Vijana Vijiweni II: a cluster-randomized trial to evaluate the efficacy of a microfinance and peer health leadership intervention for HIV and intimate partner violence prevention among social networks of young men in Dar es Salaam.

PubMed

Kajula, Lusajo; Balvanz, Peter; Kilonzo, Mrema Noel; Mwikoko, Gema; Yamanis, Thespina; Mulawa, Marta; Kajuna, Deus; Hill, Lauren; Conserve, Donaldson; Reyes, Heathe Luz McNaughton; Leatherman, Sheila; Singh, Basant; Maman, Suzanne

2016-02-03

Intimate partner violence (IPV) and sexually transmitted infections (STIs), including HIV, remain important public health problems with devastating health effects for men and women in sub-Saharan Africa. There have been calls to engage men in prevention efforts, however, we lack effective approaches to reach and engage them. Social network approaches have demonstrated effective and sustained outcomes on changing risk behaviors in the U.S. Our team has identified and engaged naturally occurring social networks comprised mostly of young men in Dar es Salaam in an intervention designed to jointly reduce STI incidence and the perpetration of IPV. These stable networks are locally referred to as "camps." In a pilot study we demonstrated the feasibility and acceptability of a combined microfinance and peer health leadership intervention within these camp-based peer networks. We are implementing a cluster-randomized trial to evaluate the efficacy of an intervention combining microfinance with health leadership training in 60 camps in Dar es Salaam, Tanzania. Half of the camps have been randomized to the intervention arm, and half to a control arm. The camps in the intervention arm will receive a combined microfinance and health leadership intervention for a period of two years. The camps in the control arm will receive a delayed intervention. We have enrolled 1,258 men across the 60 study camps. Behavioral surveys will be conducted at baseline, 12-months post intervention launch and 30-month post intervention launch and biological samples will be drawn to test for Neisseria gonorrhea (NG), Chlamydia trachomatis (CT), and Trichomonas vaginalis (TV) at baseline and 30-months. The primary endpoints for assessing intervention impact are IPV perpetration and STI incidence. This is the first cluster-randomized trial targeting social networks of men in sub-Saharan Africa that jointly addresses HIV and IPV perpetration and has both biological and behavioral endpoints. Effective approaches to engage men in HIV and IPV prevention are needed in low resource, high prevalence settings like Tanzania. If we determine that this approach is effective, we will examine how to adapt and scale up this approach to other urban, sub-Saharan African settings. Clinical Trials.gov: NCT01865383 . Registration date: May 24, 2013.

PedVacc 002: a phase I/II randomized clinical trial of MVA.HIVA vaccine administered to infants born to human immunodeficiency virus type 1-positive mothers in Nairobi.

PubMed

Njuguna, Irene N; Ambler, Gwen; Reilly, Marie; Ondondo, Beatrice; Kanyugo, Mercy; Lohman-Payne, Barbara; Gichuhi, Christine; Borthwick, Nicola; Black, Antony; Mehedi, Shams-Rony; Sun, Jiyu; Maleche-Obimbo, Elizabeth; Chohan, Bhavna; John-Stewart, Grace C; Jaoko, Walter; Hanke, Tomáš

2014-10-07

A safe, effective vaccine for breastfeeding infants born to HIV-1-positive mothers could complement antiretroviral therapy (ART) for prevention of mother-to-child transmission of HIV-1. To date, only a few HIV-1 vaccine candidates have been tested in infants. A phase I/II randomized controlled trial PedVacc 002 was conducted to determine the safety and immunogenicity of a single, low dose of MVA.HIVA vaccine delivered intramuscularly to healthy 20-week-old infants born to HIV-1-positive mothers in Nairobi, Kenya. Pregnant HIV-1-positive women in the 2nd/3rd trimester of gestation were enrolled, provided with ART and self-selected their infant-feeding modality. Infants received nevirapine and cotrimoxazole prophylaxis. At 20 weeks of age, eligible HIV-1-negative infants were randomized to vaccine versus no-treatment arms and followed to 48 weeks of age for assessments of vaccine safety, HIV-1-specific T-cell responses and antibodies to routine childhood vaccines. Between February and November 2010, 182 mothers were screened, 104 were eligible and followed on ART during pregnancy/postpartum, of whom 73 had eligible infants at 20 weeks postpartum. Thirty-six infants were randomized to vaccine and 37 to no treatment. Eighty-four percent of infants breastfed, and retention at 48 weeks was 99%. Adverse events were rare and similar between the two arms. HIV-1-specific T-cell frequencies in interferon-γ ELISPOT assay were transiently higher in the MVA.HIVA arm (p=0.002), but not above the threshold for a positive assay. Protective antibody levels were adequate and similar between arms for all routine childhood vaccines except HBV, where 71% of MVA.HIVA subjects compared to 92% of control subjects were protected (p=0.05). This trial tested for the first time an MVA-vectored candidate HIV-1 vaccine in HIV-1-exposed infants in Africa, demonstrating trial feasibility and vaccine safety, low immunogenicity, and compatibility with routine childhood vaccinations. These results are reassuring for use of the MVA vector in more potent prime-boost regimens. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

A Randomized Controlled Trial of a Citywide Emergency Department Care Coordination Program to Reduce Prescription Opioid Related ED Visits

PubMed Central

Paulozzi, Leonard J.; Howell, Donelle; McPherson, Sterling; Murphy, Sean M.; Grohs, Becky; Marsh, Linda; Lederhos, Crystal; Roll, Jon

2017-01-01

Background Increasing prescription overdose deaths have demonstrated the need for safer ED prescribing practices for patients who are frequent ED users. Objectives We hypothesized that the care of frequent ED users would improve using a citywide care coordination program combined with an ED care coordination information system, as measured by fewer ED visits by and decreased controlled substance prescribing to these patients. Methods We conducted a multi-site randomized controlled trial (RCT) across all EDs in a metropolitan area. 165 patients with the most ED visits for complaints of pain were randomized. For the treatment arm, drivers of ED use were identified by medical record review. Patients and their primary care providers were contacted by phone. Each patient was discussed at a community multidisciplinary meeting where recommendations for ED care were formed. The ED care recommendations were stored in an ED information exchange system that faxed them to the treating ED provider when the patient presented to the ED. The control arm was subjected to treatment as usual. Results The intervention arm experienced a 34% decrease (IRR = 0.66, p < 0.001; 95% CI: 0.57 – 0.78) in ED visits and an 80% decrease (OR = 0.21, p = 0.001) in the odds of receiving an opioid prescription from the ED relative to the control group. Declines of 43.7%, 53.1%, 52.9%, and 53.1% were observed in the treatment group for morphine milligram equivalents, controlled substance pills, prescriptions, and prescribers. Conclusion This RCT showed the effectiveness of a citywide ED care coordination program in reducing ED visits and controlled substance prescribing. PMID:27624507

A Randomized Controlled Trial of a Citywide Emergency Department Care Coordination Program to Reduce Prescription Opioid Related Emergency Department Visits.

PubMed

Neven, Darin; Paulozzi, Leonard; Howell, Donelle; McPherson, Sterling; Murphy, Sean M; Grohs, Becky; Marsh, Linda; Lederhos, Crystal; Roll, John

2016-11-01

Increasing prescription overdose deaths have demonstrated the need for safer emergency department (ED) prescribing practices for patients who are frequent ED users. We hypothesized that the care of frequent ED users would improve using a citywide care coordination program combined with an ED care coordination information system, as measured by fewer ED visits by and decreased controlled substance prescribing to these patients. We conducted a multisite randomized controlled trial (RCT) across all EDs in a metropolitan area; 165 patients with the most ED visits for complaints of pain were randomized. For the treatment arm, drivers of ED use were identified by medical record review. Patients and their primary care providers were contacted by phone. Each patient was discussed at a community multidisciplinary meeting where recommendations for ED care were formed. The ED care recommendations were stored in an ED information exchange system that faxed them to the treating ED provider when the patient presented to the ED. The control arm was subjected to treatment as usual. The intervention arm experienced a 34% decrease (incident rate ratios = 0.66, p < 0.001; 95% confidence interval 0.57-0.78) in ED visits and an 80% decrease (odds ratio = 0.21, p = 0.001) in the odds of receiving an opioid prescription from the ED relative to the control group. Declines of 43.7%, 53.1%, 52.9%, and 53.1% were observed in the treatment group for morphine milligram equivalents, controlled substance pills, prescriptions, and prescribers, respectively. This RCT showed the effectiveness of a citywide ED care coordination program in reducing ED visits and controlled substance prescribing. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

The impact of peer support and mp3 messaging on adherence to inhaled corticosteroids in minority adolescents with asthma: a randomized, controlled trial.

PubMed

Mosnaim, Giselle; Li, Hong; Martin, Molly; Richardson, DeJuran; Belice, Paula Jo; Avery, Elizabeth; Ryan, Norman; Bender, Bruce; Powell, Lynda

2013-01-01

Poor adherence to inhaled corticosteroids (ICS) is a critical risk factor contributing to asthma morbidity among low-income minority adolescents. This trial tested whether peer support group meetings and peer asthma messages delivered via mp3 players improved adherence to ICS. Low-income African American and/or Hispanic adolescents, ages 11-16 years old, with persistent asthma, and poor (≤ 48%) adherence to prescription ICS during the 3-week run-in were randomized to intervention or attention control groups (ATG) for the 10-week treatment. During treatment, the intervention arm subjects participated in weekly coping peer group support sessions and received mp3 peer-recorded asthma messages that promoted adherence. The ATG participated in weekly meetings with a research assistant and received an equivalent number of mp3 physician-recorded asthma messages. Adherence was measured by using self-report and the Doser CT, an electronic dose counter. The primary outcome was the difference in adherence at 10 weeks between the 2 arms. Thirty-four subjects were randomized to each arm. At 10 weeks, no statistical difference in objectively measured adherence could be detected between the 2 arms when adjusting for baseline adherence (P = .929). Adherence declined in both groups over the course of the active treatment period. In both study arms, self-reported adherence by participants was significantly higher than their objectively measured adherence at week 10 (P < .0001). Improving medication adherence in longitudinal studies is challenging. Peer support and mp3-delivered peer asthma messages may not be of sufficient dose to improve outcomes. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Design and methodology of a community-based cluster-randomized controlled trial for dietary behaviour change in rural Kerala

PubMed Central

Daivadanam, Meena; Wahlstrom, Rolf; Ravindran, T.K. Sundari; Sarma, P.S.; Sivasankaran, S.; Thankappan, K.R.

2013-01-01

Background Interventions targeting lifestyle-related risk factors and non-communicable diseases have contributed to the mainstream knowledge necessary for action. However, there are gaps in how this knowledge can be translated for practical day-to-day use in complex multicultural settings like that in India. Here, we describe the design of the Behavioural Intervention for Diet study, which was developed as a community-based intervention to change dietary behaviour among middle-income households in rural Kerala. Methods This was a cluster-randomized controlled trial to assess the effectiveness of a sequential stage-matched intervention to bring about dietary behaviour change by targeting the procurement and consumption of five dietary components: fruits, vegetables, salt, sugar, and oil. Following a step-wise process of pairing and exclusion of outliers, six out of 22 administrative units in the northern part of Trivandrum district, Kerala state were randomly selected and allocated to intervention or control arms. Trained community volunteers carried out the data collection and intervention delivery. An innovative tool was developed to assess household readiness-to-change, and a household measurement kit and easy formulas were introduced to facilitate the practical side of behaviour change. The 1-year intervention included a household component with sequential stage-matched intervention strategies at 0, 6, and 12 months along with counselling sessions, telephonic reminders, and home visits and a community component with general awareness sessions in the intervention arm. Households in the control arm received information on recommended levels of intake of the five dietary components and general dietary information leaflets. Discussion Formative research provided the knowledge to contextualise the design of the study in accordance with socio-cultural aspects, felt needs of the community, and the ground realities associated with existing dietary procurement, preparation, and consumption patterns. The study also addressed two key issues, namely the central role of the household as the decision unit and the long-term sustainability through the use of existing local and administrative networks and community volunteers. PMID:23866917

Arm rehabilitation in post stroke subjects: A randomized controlled trial on the efficacy of myoelectrically driven FES applied in a task-oriented approach.

PubMed

Jonsdottir, Johanna; Thorsen, Rune; Aprile, Irene; Galeri, Silvia; Spannocchi, Giovanna; Beghi, Ettore; Bianchi, Elisa; Montesano, Angelo; Ferrarin, Maurizio

2017-01-01

Motor recovery of persons after stroke may be enhanced by a novel approach where residual muscle activity is facilitated by patient-controlled electrical muscle activation. Myoelectric activity from hemiparetic muscles is then used for continuous control of functional electrical stimulation (MeCFES) of same or synergic muscles to promote restoration of movements during task-oriented therapy (TOT). Use of MeCFES during TOT may help to obtain a larger functional and neurological recovery than otherwise possible. Multicenter randomized controlled trial. Eighty two acute and chronic stroke victims were recruited through the collaborating facilities and after signing an informed consent were randomized to receive either the experimental (MeCFES assisted TOT (M-TOT) or conventional rehabilitation care including TOT (C-TOT). Both groups received 45 minutes of rehabilitation over 25 sessions. Outcomes were Action Research Arm Test (ARAT), Upper Extremity Fugl-Meyer Assessment (FMA-UE) scores and Disability of the Arm Shoulder and Hand questionnaire. Sixty eight subjects completed the protocol (Mean age 66.2, range 36.5-88.7, onset months 12.7, range 0.8-19.1) of which 45 were seen at follow up 5 weeks later. There were significant improvements in both groups on ARAT (median improvement: MeCFES TOT group 3.0; C-TOT group 2.0) and FMA-UE (median improvement: M-TOT 4.5; C-TOT 3.5). Considering subacute subjects (time since stroke < 6 months), there was a trend for a larger proportion of improved patients in the M-TOT group following rehabilitation (57.9%) than in the C-TOT group (33.2%) (difference in proportion improved 24.7%; 95% CI -4.0; 48.6), though the study did not meet the planned sample size. This is the first large multicentre RCT to compare MeCFES assisted TOT with conventional care TOT for the upper extremity. No adverse events or negative outcomes were encountered, thus we conclude that MeCFES can be a safe adjunct to rehabilitation that could promote recovery of upper limb function in persons after stroke, particularly when applied in the subacute phase.

Financial incentive strategies for maintenance of weight loss: results from an internet-based randomized controlled trial.

PubMed

Yancy, William S; Shaw, Pamela A; Wesby, Lisa; Hilbert, Victoria; Yang, Lin; Zhu, Jingsan; Troxel, Andrea; Huffman, David; Foster, Gary D; Wojtanowski, Alexis C; Volpp, Kevin G

2018-05-25

Financial incentives can improve initial weight loss; we examined whether financial incentives can improve weight loss maintenance. Participants aged 30-80 years who lost at least 5 kg during the first 4-6 months in a nationally available commercial weight loss program were recruited via the internet into a three-arm randomized trial of two types of financial incentives versus active control during months 1-6 (Phase I) followed by passive monitoring during months 7-12 (Phase II). Interventions were daily self-weighing and text messaging feedback alone (control) or combined with a lottery-based incentive or a direct incentive. The primary outcome was weight change 6 months after initial weight loss. Secondary outcomes included weight change 12 months after initial weight loss (6 months after cessation of maintenance intervention), and self-reported physical activity and eating behaviors. Of 191 participants randomized, the mean age was 49.0 (SD = 10.5) years and weight loss prior to randomization was 11.4 (4.7) kg; 92% were women and 89% were White. Mean weight changes during the next 6 months (Phase I) were: lottery -3.0 (5.8) kg; direct -2.8 (5.8) kg; and control -1.4 (5.8) kg (all pairwise comparisons p > 0.1). Weight changes through the end of 12 months post-weight loss (Phase II) were: lottery -1.8 (10.5) kg; direct -0.7 (10.7) kg; and control -0.3 (9.4) kg (all pairwise comparisons p > 0.1). The percentages of participants who maintained their weight loss (defined as gaining ≤1.36 kg) were: lottery 79%, direct 76%, and control 67% at 6 months and lottery 66%, direct 62%, and control 59% at 12 months (all pairwise comparisons p > 0.1). At 6 and 12 months after initial weight loss, changes in self-reported physical activity or eating behaviors did not differ across arms. Compared with the active control of daily texting based on daily home weighing, lottery-based and direct monetary incentives provided no additional benefit for weight loss maintenance.