Randomized Face-to-Face vs. Home Exercise Interventions in Pregnant Women with Gestational Diabetes

PubMed Central

DOWNS, Danielle Symons; DINALLO, Jennifer M.; BIRCH, Leann L.; PAUL, Ian M.; ULBRECHT, Jan S.

2017-01-01

Objectives Evaluate effects of a theoretically-based, semi-intensive (Face-to-Face; F2F) exercise intervention and minimum-contact (Home) exercise intervention to the standard care (Control) on exercise, its motivational determinants, blood glucose levels, and insulin use of pregnant women with gestational diabetes mellitus (GDM). Design Randomized control trial with two intervention arms and control (standard care). Method Participants (N=65) were randomized to a Control (standard prenatal care/GDM dietary counseling), Home (standard care + phone education/support + home exercise), or F2F (standard care + on-site education/support + guided exercise with instructor on 2 days/week) group from ~20 weeks gestation to delivery. Assessments of exercise and motivational determinants were obtained at baseline (20-weeks gestation) and follow-up (32-weeks gestation). Blood glucose levels (fasting/postprandial mg/dL) and insulin use were extrapolated from medical records. Results At the 32-week follow-up, the F2F group had significantly higher exercise min, pedometer steps/day, and motivational determinants (attitude, subjective norm, perceived control, intention) than controls (p’s < .05) and significantly higher exercise min and subjective norm than the Home group (p’s < .05); these effect sizes were medium-large (η2 = .11–.23). There was a medium effect (η2 = .13) on postprandial blood glucose at 36-weeks gestation with the F2F group having lower values than controls. Although not significant, the F2F group started insulin later (33 weeks gestation) than the Home (27 weeks) and Control (31 weeks) groups. Conclusion A theoretically-based, F2F exercise intervention has multiple health benefits and may be the necessary approach for promoting exercise motivation and behavior among GDM women. PMID:28428728

Randomized Face-to-Face vs. Home Exercise Interventions in Pregnant Women with Gestational Diabetes.

PubMed

Downs, Danielle Symons; Dinallo, Jennifer M; Birch, Leann L; Paul, Ian M; Ulbrecht, Jan S

2017-05-01

Evaluate effects of a theoretically-based, semi-intensive (Face-to-Face; F2F) exercise intervention and minimum-contact (Home) exercise intervention to the standard care (Control) on exercise, its motivational determinants, blood glucose levels, and insulin use of pregnant women with gestational diabetes mellitus (GDM). Randomized control trial with two intervention arms and control (standard care). Participants ( N =65) were randomized to a Control (standard prenatal care/GDM dietary counseling), Home (standard care + phone education/support + home exercise), or F2F (standard care + on-site education/support + guided exercise with instructor on 2 days/week) group from ~20 weeks gestation to delivery. Assessments of exercise and motivational determinants were obtained at baseline (20-weeks gestation) and follow-up (32-weeks gestation). Blood glucose levels (fasting/postprandial mg/dL) and insulin use were extrapolated from medical records. At the 32-week follow-up, the F2F group had significantly higher exercise min, pedometer steps/day, and motivational determinants (attitude, subjective norm, perceived control, intention) than controls ( p 's < .05) and significantly higher exercise min and subjective norm than the Home group ( p 's < .05); these effect sizes were medium-large (η 2 = .11-.23). There was a medium effect (η 2 = .13) on postprandial blood glucose at 36-weeks gestation with the F2F group having lower values than controls. Although not significant, the F2F group started insulin later (33 weeks gestation) than the Home (27 weeks) and Control (31 weeks) groups. A theoretically-based, F2F exercise intervention has multiple health benefits and may be the necessary approach for promoting exercise motivation and behavior among GDM women.

Does therapeutic hypothermia reduce acute kidney injury among term neonates with perinatal asphyxia?--a randomized controlled trial.

PubMed

Tanigasalam, Vasanthan; Bhat, Vishnu; Adhisivam, Bethou; Sridhar, M G

2016-01-01

The objective of this study is to evaluate whether therapeutic hypothermia reduces the incidence of acute kidney injury (AKI) among term neonates perinatal asphyxia. This randomized controlled trial conducted in a tertiary care teaching hospital, south India included 120 term neonates with perinatal asphyxia who were randomized to receive either therapeutic hypothermia or standard supportive care. Renal parameters of neonates in both the groups were monitored and AKI was ascertained as per Acute Kidney Injury Network criteria. The incidence of AKI was less in therapeutic hypothermia group compared to standard treatment group (32% versus 60%, p < 0.05). The incidence of Stages 1, 2, and 3 AKI was 22%, 5%, and 5% in therapeutic hypothermia group compared with 52%, 5%, and 3%, respectively, in the standard treatment group. The mortality was less in therapeutic hypothermia group compared with the standard treatment group (26% versus 50%, p < 0.05). Therapeutic hypothermia reduces the incidence and severity of AKI among term neonates with perinatal asphyxia.

Exercise as an adjunct to nicotine gum in treating tobacco dependence among women.

PubMed

Kinnunen, Taru; Leeman, Robert F; Korhonen, Tellervo; Quiles, Zandra N; Terwal, Donna M; Garvey, Arthur J; Hartley, Howard L

2008-04-01

This was the first randomized, controlled smoking cessation trial assessing the efficacy of an exercise intervention as an adjunct to nicotine gum therapy in comparison with both equal contact control and standard care control conditions. Sedentary female smokers aged 18-55 years were provided with nicotine gum treatment along with brief behavioral counseling and were randomized into one of these three behavioral adjunct conditions. In the "intent-to-treat" sample (N = 182), at end of treatment and at 1-year follow-up, there were clear, but nonsignificant, trends in univariate analyses in which the exercise and equal contact control conditions both had higher rates of abstinence than the standard care control. However, when adjusting for other predictors of relapse in a multiple logistic regression, both exercise and equal contact control showed an advantage over standard care control in avoiding early relapse (i.e., after 1 week). In a multivariate survival model adjusting for other predictors, the equal contact condition had a significantly lower likelihood of relapse compared with the standard care condition and there was a near significant trend in which exercise offered an advantage over standard care as well. While these findings suggest a slightly improved likelihood of abstinence with exercise compared with standard care, exercise did not differ from equal contact control in its efficacy. Potential explanations for these equivalent levels of efficacy and implications for the findings are discussed.

Unannounced versus announced hospital surveys: a nationwide cluster-randomized controlled trial.

PubMed

Ehlers, Lars Holger; Simonsen, Katherina Beltoft; Jensen, Morten Berg; Rasmussen, Gitte Sand; Olesen, Anne Vingaard

2017-06-01

To evaluate the effectiveness of unannounced versus announced surveys in detecting non-compliance with accreditation standards in public hospitals. A nationwide cluster-randomized controlled trial. All public hospitals in Denmark were invited. Twenty-three hospitals (77%) (3 university hospitals, 5 psychiatric hospitals and 15 general hospitals) agreed to participate. Twelve hospitals were randomized to receive unannounced surveys (intervention group) and eleven hospitals to receive announced surveys (control group). We hypothesized that the hospitals receiving the unannounced surveys would reveal a higher degree of non-compliance with accreditation standards than the hospitals receiving announced surveys. Nine surveyors trained and employed by the Danish Institute for Quality and Accreditation in Healthcare (IKAS) were randomized into teams and conducted all surveys. The outcome was the surveyors' assessment of the hospitals' level of compliance with 113 performance indicators-an abbreviated set of the Danish Healthcare Quality Programme (DDKM) version 2, covering organizational standards, patient pathway standards and patient safety standards. Compliance with performance indicators was analyzed using binomial regression analysis with bootstrapped robust standard errors. In all, 16 202 measurements were acceptable for data analysis. The risk of observing non-compliance with performance indicators for the intervention group compared with the control group was statistically insignificant (risk difference (RD) = -0.6 percentage points [-2.51-1.31], P = 0.54). A converged analysis of the six patient safety critical standards, requiring 100% compliance to gain accreditation status revealed no statistically significant difference (RD = -0.78 percentage points [-4.01-2.44], P = 0.99). Unannounced hospital surveys were not more effective than announced surveys in detecting quality problems in Danish hospitals. ClinicalTrials.gov NCT02348567, https://clinicaltrials.gov/ct2/show/NCT02348567?term=NCT02348567. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care.

Does the addition of specific acupuncture to standard swallowing training improve outcomes in patients with dysphagia after stroke? a randomized controlled trial

PubMed Central

Xia, Wenguang; Zheng, Chanjuan; Zhu, Suiqiang; Tang, Zhouping

2015-01-01

Objective: To assess the effect of adding acupuncture to standard swallowing training for patients with dysphagia after stroke. Design: Single-blind randomized controlled trial. Setting: Inpatient and outpatient clinics. Subjects: A total of 124 patients with dysphagia after stroke were randomly divided into two groups: acupuncture and control. Interventions: The acupuncture group received standard swallowing training and acupuncture treatment. In comparison, the control group only received standard swallowing training. Participants in both groups received six days of therapy per week for a four-week period. Main measures: The primary outcome measures included the Standardized Swallowing Assessment and the Dysphagia Outcome Severity Scale. The secondary outcome measures included the Modified Barthel Index and Swallowing-Related Quality of Life, which were assessed before and after the four-week therapy period. Results: A total of 120 dysphagic subjects completed the study (60 in acupuncture group and 60 in control group). Significant differences existed in the Standardized Swallowing Assessment, Dysphagia Outcome Severity Scale, Modified Barthel Index, and Swallowing-Related Quality of Life scores of each group after the treatment (P < 0.01). After the four-week treatment, the Standardized Swallowing Assessment (mean difference − 2.9; 95% confidence interval (CI) – 5.0 to − 0.81; P < 0.01), Dysphagia Outcome Severity Scale (mean difference 2.3; 95% CI 0.7 to 1.2; P < 0.01), Modified Barthel Index (mean difference 17.2; 95% CI 2.6 to 9.3; P < 0.05) and Swallowing-Related Quality of Life scores (mean difference 31.4; 95% CI 3.2 to 11.4; P < 0.01) showed more significant improvement in the acupuncture group than the control group. Conclusions: Acupuncture combined with the standard swallowing training may be beneficial for dysphagic patients after stroke. PMID:25819076

Autologous Skin Cell Spray for Massive Soft Tissue War Injuries: A Prospective, Case-Control, Multicenter Trial

DTIC Science & Technology

2014-04-01

randomization design, after all patients are treated with dermal matrix, patients will be randomized to Arm 1 (control group; standard skin grafting with... grafts are often “meshed” or flattened and spread out to increase the size of the skin graft to better cover a large wound. Standard “meshing” increases...the size of the donor graft by 1.5 times (1:1.5). Problems with healing and skin irritation remain with such skin grafts when the injured areas are

Social stories: mechanisms of effectiveness in increasing game play skills in children diagnosed with autism spectrum disorder using a pretest posttest repeated measures randomized control group design.

PubMed

Quirmbach, Linda M; Lincoln, Alan J; Feinberg-Gizzo, Monica J; Ingersoll, Brooke R; Andrews, Siri M

2009-02-01

An increasing body of literature has indicated that social stories are an effective way to teach individuals diagnosed with autism appropriate social behavior. This study compared two formats of a social story targeting the improvement of social skills during game play using a pretest posttest repeated measures randomized control group design. A total of 45 children diagnosed with Autism Spectrum Disorder (ASD) ages 7-14 were randomly assigned to standard, directive, or control story conditions. Results demonstrated that the standard and directive story formats were equally as effective in eliciting, generalizing and maintaining the targeted social skills in participants who had prior game play experience and Verbal Comprehension Index (VCI) scores from the WISC-IV intelligence test in the borderline range or above.

A Randomized Controlled Design Investigating the Effects of Classroom-Based Physical Activity on Children's Fluid Intelligence and Achievement

ERIC Educational Resources Information Center

Fedewa, Alicia L.; Ahn, Soyeon; Erwin, Heather; Davis, Matthew C.

2015-01-01

Existing literature shows promising effects of physical activity on children's cognitive outcomes. This study assessed via a randomized, controlled design whether additional curricular physical activity during the school day resulted in gains for children's fluid intelligence and standardized achievement outcomes. Participants were children…

Effect of intervention programs in schools to reduce screen time: a meta-analysis.

PubMed

Friedrich, Roberta Roggia; Polet, Jéssica Pinto; Schuch, Ilaine; Wagner, Mário Bernardes

2014-01-01

to evaluate the effects of intervention program strategies on the time spent on activities such as watching television, playing videogames, and using the computer among schoolchildren. a search for randomized controlled trials available in the literature was performed in the following electronic databases: PubMed, Lilacs, Embase, Scopus, Web of Science, and Cochrane Library using the following Keywords randomized controlled trial, intervention studies, sedentary lifestyle, screen time, and school. A summary measure based on the standardized mean difference was used with a 95% confidence interval. a total of 1,552 studies were identified, of which 16 were included in the meta-analysis. The interventions in the randomized controlled trials (n=8,785) showed a significant effect in reducing screen time, with a standardized mean difference (random effect) of: -0.25 (-0.37, -0.13), p<0.01. interventions have demonstrated the positive effects of the decrease of screen time among schoolchildren. Copyright © 2014 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

Effects of a mixed media education intervention program on increasing knowledge, attitude, and compliance with standard precautions among nursing students: A randomized controlled trial.

PubMed

Xiong, Peng; Zhang, Jun; Wang, Xiaohui; Wu, Tat Leong; Hall, Brian J

2017-04-01

Standard precautions (SPs) are considered fundamental protective measures to manage health care-associated infections and to reduce occupational health hazards. This study intended to assess the effectiveness of a mixed media education intervention to enhance nursing students' knowledge, attitude, and compliance with SPs. A randomized controlled trial with 84 nursing students was conducted in a teaching hospital in Hubei, China. The intervention group (n = 42) attended 3 biweekly mixed media education sessions, consisting of lectures, videos, role-play, and feedback with 15-20 minutes of individual online supervision and feedback sessions following each class. The control group learned the same material through self-directed readings. Pre- and posttest assessments of knowledge, attitudes, and compliance were assessed with the Knowledge with Standard Precautions Questionnaire, Attitude with Standard Precautions Scale, and the Compliance with Standard Precautions Scale, respectively. The Standard Bacterial Colony Index was used to assess handwashing effectiveness. At 6-week follow-up, performance on the Knowledge with Standard Precautions Questionnaire, Attitude with Standard Precautions Scale, and Compliance with Standard Precautions Scale were significantly improved in the intervention group compared with the control group (P < .01). The hand hygiene standard in the intervention group (38 passed) outperformed the control group (23 passed) (P < .01). A mixed media education intervention is effective in improving knowledge, attitude, and compliance with SPs. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

From randomized controlled trials to observational studies.

PubMed

Silverman, Stuart L

2009-02-01

Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

Clinical performance of a new blood control peripheral intravenous catheter: A prospective, randomized, controlled study.

PubMed

Seiberlich, Laura E; Keay, Vanessa; Kallos, Stephane; Junghans, Tiffany; Lang, Eddy; McRae, Andrew D

2016-03-01

The performance of a new safety peripheral intravenous catheter (PIVC) that contains a blood control feature in the hub (blood control) was compared against the current hospital standard without blood control (standard). In this prospective, non-blinded trial, patients were randomized 1:1 to receive either device. Insertions were performed and rated by emergency room nurses. Primary endpoints included clinical acceptability, incidence of blood leakage, and risk of blood exposure. Secondary endpoints were digital compression, insertion success, and usability. 15 clinicians performed 152 PIVC insertions (73 blood control, 79 standard). Clinical acceptability of the blood control device (100%) was non-inferior to the standard (98.7%) (p < 0.0001). The blood control device had a lower incidence of blood leakage (14.1% vs 68.4%), was superior in eliminating the risk of blood exposure (93.9% vs 19.1%) and the need for digital compression (95.3% vs 19.1%), while maintaining non-inferior insertion success rates (95.9% vs 93.7%) and usability ratings (p < 0.0001). In comparison with the hospital-standard, the new safety PIVC with integrated blood control valve had similar clinical acceptability ratings yet demonstrated superior advantages to both clinicians and patients to decrease blood leakage and the clinician's risk of blood exposure, during the insertion process. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Effect of Intensive Versus Standard Blood Glucose Control in Patients With Type 2 Diabetes Mellitus in Different Regions of the World: Systematic Review and Meta-analysis of Randomized Controlled Trials.

PubMed

Sardar, Partha; Udell, Jacob A; Chatterjee, Saurav; Bansilal, Sameer; Mukherjee, Debabrata; Farkouh, Michael E

2015-05-05

Regional variation in type 2 diabetes mellitus care may affect outcomes in patients treated with intensive versus standard blood glucose control. We sought to evaluate these differences between North America and the rest of the world. Databases were searched from their inception through December 2013. Randomized controlled trials comparing the effects of intensive therapy with standard therapy for macro- and microvascular complications in adults with type 2 diabetes mellitus were selected. We calculated summary odds ratios (ORs) and 95% CIs with the random-effects model. The analysis included 34 967 patients from 17 randomized controlled trials (7 in North America and 10 in the rest of the world). There were no significant differences between intensive and standard therapy groups for all-cause mortality (OR 1.03, 95% CI 0.93 to 1.13) and cardiovascular mortality (OR 1.09, 95% CI 0.90 to 1.32). For trials conducted in North America, intensive therapy compared with standard glycemic control resulted in significantly higher all-cause mortality (OR 1.21, 95% CI 1.05 to 1.40) and cardiovascular mortality (OR 1.41, 95% CI 1.05 to 1.90) than trials conducted in the rest of the world (all-cause mortality OR 0.93, 95% CI 0.85 to 1.03; interaction P=0.006; cardiovascular mortality OR 0.89, 95% CI, 0.79 to 1.00; interaction P=0.007). Analysis of individual macro- and microvascular outcomes revealed no significant regional differences; however, the risk of severe hypoglycemia was significantly higher in trials of intensive therapy in North America (OR 3.52, 95% CI 3.07 to 4.03) compared with the rest of the world (OR 1.45, 95% CI 0.85 to 2.47; interaction P=0.001). Randomization to intensive glycemic control in type 2 diabetes mellitus patients was associated with increases in all-cause mortality, cardiovascular mortality, and severe hypoglycemia in North America compared with the rest of the world. Further investigation into the pathobiology or patient variability underlying these findings is warranted. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

[Effectiveness of the transparent sterile dressing vs standard to fix the peripheral venous catheter (PVC) on the incidence of phlebitis. A randomized controlled trial].

PubMed

Forni, Cristiana; D'Alessandro, Fabio; Gambino, Orazio; Amodeo, Alfredo; Pignotti, Elettra; Zanotti, Enrichetta; Tremosini, Morena; Trofa, Carmela; Sabattini, Tania; Matino, Federica; Genco, Rossana; Schiavone, Miguel; Bombino, Caterina; Mini, Sandra; Rocchegiani, Laura; Notarnicola, Teresa; Capezzali, Daniela; Boschi, Rita; Loro, Loretta

2012-01-01

Effectiveness of the transparent sterile dressing vs standard to fix the peripheral venous catheter (PVC), on the incidence of phlebitis. A randomized controlled trial. The type of dressing could contribute to the incidence of phlebitis, infiltration and accidental removals but the results of the studies are contrasting and samples are limited. To compare the effectiveness of a transparent polyurethane sterile dressing on the rate of phlebitis associated to peripheral venous catheter (PVC) vs a non sterile sticking plaster in use in current practice (standard dressing). Randomized controlled trial. Participants. 1061 PVCs (703 patients, adults and children) at a research orthopedic hospital in the north of Italy; 540 PVCs allocated to receive the sterile and 521 the standard dressing. 96 PVCs were excluded for phlebitis, 48 (9.6%) in the sterile and 48 (10.1%) in the standard dressing group, RR 0.96 (95%CI 0.697 - 1.335). Accidental removal of the PVCs was more frequent with the sterile dressing (9.6% vs 6.3%) but the number of catheters removed without complications was larger in the standard dressing group (48.9% vs 54.9% P=0.0503). Eighty-five PVCs were replaced for detachment of the dressing (50, 9.2% sterile and 35, 6.7% standard dressing). The cheapest transparent sterile dressing costs 32 cents while the standard 9 cents. A sticking non sterile plasters is not influential on the rate of phlebitis and ensures an good fix of the PVC compared the transparent sterile dressing to of polyurethane film.

Intensive glycemic control is not associated with fractures or falls in the ACCORD randomized trial.

PubMed

Schwartz, Ann V; Margolis, Karen L; Sellmeyer, Deborah E; Vittinghoff, Eric; Ambrosius, Walter T; Bonds, Denise E; Josse, Robert G; Schnall, Adrian M; Simmons, Debra L; Hue, Trisha F; Palermo, Lisa; Hamilton, Bruce P; Green, Jennifer B; Atkinson, Hal H; O'Connor, Patrick J; Force, Rex W; Bauer, Douglas C

2012-07-01

Older adults with type 2 diabetes are at high risk of fractures and falls, but the effect of glycemic control on these outcomes is unknown. To determine the effect of intensive versus standard glycemic control, we assessed fractures and falls as outcomes in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) randomized trial. ACCORD participants were randomized to intensive or standard glycemia strategies, with an achieved median A1C of 6.4 and 7.5%, respectively. In the ACCORD BONE ancillary study, fractures were assessed at 54 of the 77 ACCORD clinical sites that included 7,287 of the 10,251 ACCORD participants. At annual visits, 6,782 participants were asked about falls in the previous year. During an average follow-up of 3.8 (SD 1.3) years, 198 of 3,655 participants in the intensive glycemia and 189 of 3,632 participants in the standard glycemia group experienced at least one nonspine fracture. The average rate of first nonspine fracture was 13.9 and 13.3 per 1,000 person-years in the intensive and standard groups, respectively (hazard ratio 1.04 [95% CI 0.86-1.27]). During an average follow-up of 2.0 years, 1,122 of 3,364 intensive- and 1,133 of 3,418 standard-therapy participants reported at least one fall. The average rate of falls was 60.8 and 55.3 per 100 person-years in the intensive and standard glycemia groups, respectively (1.10 [0.84-1.43]). Compared with standard glycemia, intensive glycemia did not increase or decrease fracture or fall risk in ACCORD.

Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy | Division of Cancer Prevention

Cancer.gov

RATIONALE: Acupressure wristbands may prevent or reduce nausea and caused by chemotherapy. It is not yet known whether standard care is more effective with or without acupressure wristbands in controlling acute and delayed nausea. PURPOSE: This randomized phase III trial is studying how well acupressure wristbands work with or without standard care in controlling nausea in

Randomized Controlled Trial Comparing Collagen/Oxidized Regenerated Cellulose/Silver to Standard of Care in the Management of Venous Leg Ulcers.

PubMed

Cullen, Breda M; Serena, Thomas E; Gibson, Molly C; Snyder, Robert J; Hanft, Jason R; Yaakov, Raphael A

2017-10-01

To assess healing outcomes in venous leg ulcers (VLUs) treated with a combination of collagen, oxidized regenerated cellulose, and silver in conjunction with standard of care (SOC; intervention group) compared with SOC alone (control group). Standard of care included ADAPTIC nonadhering dressing (Acelity, San Antonio, Texas) and compression. Randomized controlled trial that followed patients in 3 US facilities for 12 weeks or until complete healing. Forty-nine patients with VLUs were randomized to either the intervention group (n = 22) or the control group (n = 27). Wound healing over 12 weeks. Intent-to-treat analysis showed a mean percentage wound area reduction at 12 weeks of 85.6% (SD, 28.6%) for the intervention group and 72.5% (SD, 77.8%) for the control group. There was a higher healing rate in the intervention group compared with patients who received SOC only at both week 4 (23% vs 11%) and week 12 (64% vs 59%). There were no adverse events related to the study therapy. Although the results were not significant, there was a trend toward faster healing in the intervention group. The results of this study indicate that collagen/oxidized regenerated cellulose/silver is a suitable and safe adjunctive intervention for use with SOC to manage VLUs.

Comparison of the Effectiveness of Transcutaneous Electrical Nerve Stimulation and Interferential Therapy on the Upper Trapezius in Myofascial Pain Syndrome: A Randomized Controlled Study.

PubMed

Dissanayaka, Thusharika Dilrukshi; Pallegama, Ranjith Wasantha; Suraweera, Hilari Justus; Johnson, Mark I; Kariyawasam, Anula Padma

2016-09-01

The aim of this study was to compare the effectiveness of transcutaneous electrical nerve stimulation and interferential therapy (IFT) both in combination with hot pack, myofascial release, active range of motion exercise, and a home exercise program on myofascial pain syndrome patients with upper trapezius myofascial trigger point. A total of 105 patients with an upper trapezius myofascial trigger point were recruited to this single-blind randomized controlled trial. Following random allocation of patients to three groups, three therapeutic regimens-control-standard care (hot pack, active range of motion exercises, myofascial release, and a home exercise program with postural advice), transcutaneous electrical nerve stimulation-standard care and IFT-standard care-were administered eight times during 4 wks at regular intervals. Pain intensity and cervical range of motions (cervical extension, lateral flexion to the contralateral side, and rotation to the ipsilateral side) were measured at baseline, immediately after the first treatment, before the eighth treatment, and 1 wk after the eighth treatment. Immediate and short-term improvements were marked in the transcutaneous electrical nerve stimulation group (n = 35) compared with the IFT group (n = 35) and the control group (n = 35) with respect to pain intensity and cervical range of motions (P < 0.05). The IFT group showed significant improvement on these outcome measurements than the control group did (P < 0.05). Transcutaneous electrical nerve stimulation with standard care facilitates recovery better than IFT does in the same combination.

Modeling of contact tracing in social networks

NASA Astrophysics Data System (ADS)

Tsimring, Lev S.; Huerta, Ramón

2003-07-01

Spreading of certain infections in complex networks is effectively suppressed by using intelligent strategies for epidemic control. One such standard epidemiological strategy consists in tracing contacts of infected individuals. In this paper, we use a recently introduced generalization of the standard susceptible-infectious-removed stochastic model for epidemics in sparse random networks which incorporates an additional (traced) state. We describe a deterministic mean-field description which yields quantitative agreement with stochastic simulations on random graphs. We also discuss the role of contact tracing in epidemics control in small-world and scale-free networks. Effectiveness of contact tracing grows as the rewiring probability is reduced.

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…

Nasal Continuous Positive Airway Pressure in Bronchiolitis: A Randomized Controlled Trial.

PubMed

Lal, Sandeep Narayan; Kaur, Jaspreet; Anthwal, Pooja; Goyal, Kanika; Bahl, Pinky; Puliyel, Jacob M

2018-01-15

To evaluate the efficacy of nasal continuous positive airway pressure (nCPAP) in decreasing respiratory distress in bronchiolitis. Randomized controlled trial. Tertiary-care hospital in New Delhi, India. Participants: 72 infants (age <1y) hospitalized with a clinical diagnosis of bronchiolitis were randomized to receive standard care, or nCPAP in addition to standard care, in the first hour after admission. 23 parents refused to give consent for participation. 2 infants did not tolerate nCPAP. 72 infants (age <1y) hospitalized with a clinical diagnosis of bronchiolitis were randomized to receive standard care, or nCPAP in addition to standard care, in the first hour after admission. 23 parents refused to give consent for participation. 2 infants did not tolerate nCPAP. The outcome was assessed after 60 minutes. If nCPAP was not tolerated or the distress increased, the infant was switched to standard care. Analysis was done on intention-to-treat basis. Change in respiratory rate, Silverman-Anderson score and a Modified Pediatric Society of New Zealand Severity Score. 14 out of 32 in nCPAP group and 5 out of 35 in standard care group had change in respiratory rate ≥10 (P=0.008). The mean (SD) change in respiratory rate [8.0 (5.8) vs 5.1 (4.0), P=0.02] in Silverman-Anderson score [0.78 (0.87) vs 0.39 (0.73), P=0.029] and in Modified Pediatric Society of New Zealand Severity Score [2.5 (3.01) vs. 1.08 (1.3), P=0.012] were significantly different in the nCPAP and standard care groups, respectively. nCPAP helped reduce respiratory distress significantly compared to standard care.

Thinking outside the Randomized Controlled Trials Experimental Box: Strategies for Enhancing Credibility and Social Justice

ERIC Educational Resources Information Center

Hesse-Biber, Sharlene

2013-01-01

Some evaluators employ randomized controlled trials (RCTs) as the gold standard of evidence-based practice (EBP). Critics of RCT designs argue that RCTs do not include the complexity of program participants' experiences or clinical expertise, and couple this with criticisms that it is difficult to transfer RCT findings from the laboratory to…

The Effects of Math Video Games on Learning: A Randomized Evaluation Study with Innovative Impact Estimation Techniques. CRESST Report 841

ERIC Educational Resources Information Center

Chung, Gregory K. W. K.; Choi, Kilchan; Baker, Eva L.; Cai, Li

2014-01-01

A large-scale randomized controlled trial tested the effects of researcher-developed learning games on a transfer measure of fractions knowledge. The measure contained items similar to standardized assessments. Thirty treatment and 29 control classrooms (~1500 students, 9 districts, 26 schools) participated in the study. Students in treatment…

Learning Mathematics in a Visuospatial Format: A Randomized, Controlled Trial of Mental Abacus Instruction.

PubMed

Barner, David; Alvarez, George; Sullivan, Jessica; Brooks, Neon; Srinivasan, Mahesh; Frank, Michael C

2016-07-01

Mental abacus (MA) is a technique of performing fast, accurate arithmetic using a mental image of an abacus; experts exhibit astonishing calculation abilities. Over 3 years, 204 elementary school students (age range at outset: 5-7 years old) participated in a randomized, controlled trial to test whether MA expertise (a) can be acquired in standard classroom settings, (b) improves students' mathematical abilities (beyond standard math curricula), and (c) is related to changes in basic cognitive capacities like working memory. MA students outperformed controls on arithmetic tasks, suggesting that MA expertise can be achieved by children in standard classrooms. MA training did not alter basic cognitive abilities; instead, differences in spatial working memory at the beginning of the study mediated MA learning. © 2016 The Authors. Child Development © 2016 Society for Research in Child Development, Inc.

Does the Internet assist clients to carry out contact tracing? A randomized controlled trial using web-based information.

PubMed

Tomnay, J E; Pitts, M K; Kuo, T C; Fairley, C K

2006-06-01

The primary outcome was to determine the acceptability of the Internet, specifically a website for use in standard partner notification. A secondary objective was to determine if a website would enhance the outcomes of currently used partner notification methods. In a randomized control trial, 105 participants diagnosed with chlamydia and non-gonoccocal urethritis (NGU) were randomized and 97 completed the study. About 30% of participants were provided a standard partner letter and 70% were provided the standard partner letter and website. All participants reported that their partners had no objections to the website (0%, 95% confidence interval [CI] 0-5%). There were no complaints received from any partner. The odds ratio for contacting partners was not significantly different between the two groups of participants. The results of this study indicate that providing a website with specific information about the infection to which a partner has been exposed is not harmful.

Assessment of the Reporting Quality of Placebo-controlled Randomized Trials on the Treatment of Type 2 Diabetes With Traditional Chinese Medicine in Mainland China: A PRISMA-Compliant Systematic Review.

PubMed

Zhao, Xiyan; Zhen, Zhong; Guo, Jing; Zhao, Tianyu; Ye, Ru; Guo, Yu; Chen, Hongdong; Lian, Fengmei; Tong, Xiaolin

2016-01-01

Placebo-controlled randomized trials are often used to evaluate the absolute effect of new treatments and are considered gold standard for clinical trials. No studies, however, have yet been conducted evaluating the reporting quality of placebo-controlled randomized trials. The current study aims to assess the reporting quality of placebo-controlled randomized trials on treatment of diabetes with Traditional Chinese Medicine (TCM) in Mainland China and to provide recommendations for improvements.China National Knowledge Infrastructure database, Wanfang database, China Biology Medicine database, and VIP database were searched for placebo-controlled randomized trials on treatment of diabetes with TCM. Review, animal experiment, and randomized controlled trials without placebo control were excluded. According to Consolidated Standards of Reporting Trials (CONSORT) 2010 checklists items, each item was given a yes or no depending on whether it was reported or not.A total of 68 articles were included. The reporting percentage in each article ranged from 24.3% to 73%, and 30.9% articles reported more than 50% of the items. Seven of the 37 items were reported more than 90% of the items, whereas 7 items were not mentioned at all. The average reporting for "title and abstract," "introduction," "methods," "results," "discussion," and "other information" was 43.4%, 78.7%, 40.1%, 49.9%, 71.1%, and 17.2%, respectively. The percentage of each section had increased after 2010. In addition, the reporting of multiple study centers, funding, placebo species, informed consent forms, and ethical approvals were 14.7%, 50%, 36.85%, 33.8%, and 4.4%, respectively.Although a scoring system was created according to the CONSORT 2010 checklist, it was not designed as an assessment tool. According to CONSORT 2010, the reporting quality of placebo-controlled randomized trials on the treatment of diabetes with TCM improved after 2010. Future improvements, however, are still needed, particularly in methods sections.

A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection

PubMed Central

2016-01-01

BACKGROUND Data from studies in nonhuman primates suggest that the triple monoclonal antibody cocktail ZMapp is a promising immune-based treatment for Ebola virus disease (EVD). METHODS Beginning in March 2015, we conducted a randomized, controlled trial of ZMapp plus the current standard of care as compared with the current standard of care alone in patients with EVD that was diagnosed in West Africa by polymerase-chain-reaction (PCR) assay. Eligible patients of any age were randomly assigned in a 1:1 ratio to receive either the current standard of care or the current standard of care plus three intravenous infusions of ZMapp (50 mg per kilogram of body weight, administered every third day). Patients were stratified according to baseline PCR cycle-threshold value for the virus (≤22 vs. >22) and country of enrollment. Oral favipiravir was part of the current standard of care in Guinea. The primary end point was mortality at 28 days. RESULTS A total of 72 patients were enrolled at sites in Liberia, Sierra Leone, Guinea, and the United States. Of the 71 patients who could be evaluated, 21 died, representing an overall case fatality rate of 30%. Death occurred in 13 of 35 patients (37%) who received the current standard of care alone and in 8 of 36 patients (22%) who received the current standard of care plus ZMapp. The observed posterior probability that ZMapp plus the current standard of care was superior to the current standard of care alone was 91.2%, falling short of the prespecified threshold of 97.5%. Frequentist analyses yielded similar results (absolute difference in mortality with ZMapp, −15 percentage points; 95% confidence interval, −36 to 7). Baseline viral load was strongly predictive of both mortality and duration of hospitalization in all age groups. CONCLUSIONS In this randomized, controlled trial of a putative therapeutic agent for EVD, although the estimated effect of ZMapp appeared to be beneficial, the result did not meet the prespecified statistical threshold for efficacy. (Funded by the National Institute of Allergy and Infectious Diseases and others; PREVAIL II ClinicalTrials.gov number, NCT02363322.) PMID:27732819

Theoretical and Empirical Underpinnings of the What Works Clearinghouse Attrition Standard for Randomized Controlled Trials

ERIC Educational Resources Information Center

Deke, John; Chiang, Hanley

2014-01-01

Meeting the What Works Clearinghouse (WWC) attrition standard (or one of the attrition standards based on the WWC standard) is now an important consideration for researchers conducting studies that could potentially be reviewed by the WWC (or other evidence reviews). Understanding the basis of this standard is valuable for anyone seeking to meet…

Transition from nonresonant to resonant random lasers by the geometrical confinement of disorder.

PubMed

Ghofraniha, N; Viola, I; Zacheo, A; Arima, V; Gigli, G; Conti, C

2013-12-01

We report on a transition in random lasers that is induced by the geometrical confinement of the emitting material. Different dye doped paper devices with controlled geometry are fabricated by soft lithography and show two distinguished behaviors in the stimulated emission: in the absence of boundary constraints, the energy threshold decreases for larger laser volumes showing the typical trend of diffusive nonresonant random lasers, while when the same material is lithographed into channels, the walls act as cavity and the resonant behavior typical of standard lasers is observed. The experimental results are consistent with the general theories of random and standard lasers and a clear phase diagram of the transition is reported.

The Treatment of Recurrent Abdominal Pain in Children: A Controlled Comparison of Cognitive-Behavioral Family Intervention and Standard Pediatric Care.

ERIC Educational Resources Information Center

Sanders, Matthew R.; And Others

1994-01-01

Conducted controlled clinical trial involving 44 children with recurrent abdominal pain randomly assigned to cognitive-behavioral family intervention (CBFI) or standard pediatric care (SPC). Both treatments resulted in significant improvements on measures of pain intensity and pain behavior. CBFI group had higher rate of complete elimination of…

Manual-guided psychosocial treatment. A new virtual requirement for pharmacotherapy trials?

PubMed

Carroll, K M

1997-10-01

The conduct of randomized clinical trials to evaluate the efficacy of pharmacotherapies for mental disorders is guided by research standards (at a high level of rigor) that govern most design elements, including randomization of subjects, use of placebo controls, formulation and dosage of the therapeutic agent, and monitoring of serum levels. In contrast, no such widely accepted guidelines are recognized for standardization of an essential, if unacknowledged, element of all such studies: the concomitant provision of at least a minimal form of psychosocial treatment. Standardized provision of psychosocial treatments in pharmacotherapy trials will foster replicability of findings and address several common problems (e.g., attrition, medication noncompliance, reduction of error variance, and ethical issues associated with placebo controls). Careful selection and standardization of the psychosocial context in which medications are delivered will improve the validity, precision, and power of pharmacotherapy efficacy research, and should be considered a virtual requirement in research design.

Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

PubMed

Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

2018-02-01

Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

A Derivation of the Long-Term Degradation of a Pulsed Atomic Frequency Standard from a Control-Loop Model

NASA Technical Reports Server (NTRS)

Greenhall, C. A.

1996-01-01

The phase of a frequency standard that uses periodic interrogation and control of a local oscillator (LO) is degraded by a long-term random-walk component induced by downconversion of LO noise into the loop passband. The Dick formula for the noise level of this degradation is derived from an explicit solution of an LO control-loop model.

On the evidentiary standards for nutrition advice.

PubMed

Jukola, Saana

2018-06-01

This paper evaluates the application of evidentiary standards originating from evidence-based medicine in nutrition advice. It shows that it is problematic to criticize nutrition recommendations for not being based on randomized controlled trials. Due to practical, ethical and methodological and reasons, it is difficult to conduct rigorous randomized controlled trials for acquiring evidence that is relevant for achieving the goals of population-level nutrition recommendations. Given the non-epistemic goals of the dietary recommendations, criteria of acceptable evidence should be adapted to the goals of the practice and the practical, ethical, and methodological constraints of the situation. Copyright © 2018 Elsevier Ltd. All rights reserved.

The effects of Alkanna tinctoria Tausch on split-thickness skin graft donor site management: a randomized, blinded placebo-controlled trial.

PubMed

Kheiri, Aliasghar; Amini, Shahideh; Javidan, Abbas Norouzi; Saghafi, Mohammad Mehdi; Khorasani, Ghasemali

2017-05-08

A prospective, randomized, placebo-controlled clinical trial was conducted to compare the healing effectiveness of Alkanna tinctoria (L.) Tausch (Boraginaceae) with standard dressing on wound healing at the donor site after removal of the skin graft. Enrolled patients were randomly allocated to receive topicalA. tinctoria extract ointment (20%) or standard dressing (dressing with base ointment) daily. Wound healing was assessed using the Bates-Jenson assessment tool at the 2 nd and 4 th weeks after intervention. Decreases in wound score were significantly greater in the A. tinctoria group compared with the placebo group (P <0.05). The surface areas of graft donor sites in the A. tinctoria group were significantly reduced as compared with the control group at day 28 of the intervention (P < 0.05). The proportion of patients in the A. tinctoria group achieving complete wound healing within 2 to 4 weeks was 50% and 96.66%, respectively, significantly higher than in patients receiving standard care: 0% and 23.3%, respectively. This clinical study showed that A. tinctoria dressing accelerates wound healing after graft harvesting. IRCT ID: IRCT201511165781N2 .

Comparison of Digital 12-Lead ECG and Digital 12-Lead Holter ECG Recordings in Healthy Male Subjects: Results from a Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.

PubMed

Wang, Duolao; Bakhai, Ameet; Arezina, Radivoj; Täubel, Jörg

2016-11-01

Electrocardiogram (ECG) variability is greatly affected by the ECG recording method. This study aims to compare Holter and standard ECG recording methods in terms of central locations and variations of ECG data. We used the ECG data from a double-blinded, placebo-controlled, randomized clinical trial and used a mixed model approach to assess the agreement between two methods in central locations and variations of eight ECG parameters (Heart Rate, PR, QRS, QT, RR, QTcB, QTcF, and QTcI intervals). A total of 34 heathy male subjects with mean age of 25.7 ± 4.78 years were randomized to receive either active drug or placebo. Digital 12-lead ECG and digital 12-lead Holter ECG recordings were performed to assess ECG variability. There are no significant differences in least square mean between the Holter and the standard method for all ECG parameters. The total variance is consistently higher for the Holter method than the standard method for all ECG parameters except for QRS. The intraclass correlation coefficient (ICC) values for the Holter method are consistently lower than those for the standard method for all ECG parameters except for QRS, in particular, the ICC for QTcF is reduced from 0.86 for the standard method to 0.67 for the Holter method. This study suggests that Holter ECGs recorded in a controlled environment are not significantly different but more variable than those from the standard method. © 2016 Wiley Periodicals, Inc.

NASA GSFC Mechanical Engineering Latest Inputs for Verification Standards (GEVS) Updates

NASA Technical Reports Server (NTRS)

Kaufman, Daniel

2003-01-01

This viewgraph presentation provides information on quality control standards in mechanical engineering. The presentation addresses safety, structural loads, nonmetallic composite structural elements, bonded structural joints, externally induced shock, random vibration, acoustic tests, and mechanical function.

Effects of voucher-based intervention on abstinence and retention in an outpatient treatment for cocaine addiction: a randomized controlled trial.

PubMed

Garcia-Rodriguez, Olaya; Secades-Villa, Roberto; Higgins, Stephen T; Fernandez-Hermida, Jose R; Carballo, Jose L; Errasti Perez, Jose M; Al-halabi Diaz, Susana

2009-06-01

The aims of this study were to assess whether voucher magnitude improved cocaine abstinence and retention in an outpatient treatment for cocaine dependence, and to determine the effectiveness of a contingency management intervention in a European cultural context. A randomized controlled trial was conducted in which 96 participants who were randomly assigned to 1 of 3 treatment conditions in a community setting: standard outpatient treatment, community reinforcement approach (CRA) plus low monetary value vouchers (each point earned was equivalent to 0.125 Euro, US$ 0.18), and CRA plus high monetary value vouchers (each point was worth 0.25 Euro, US$ 0.36). In the standard treatment group, mean percentage of cocaine-negative samples was 88.45%, versus 96.09% in the CRA plus low-vouchers group, and 97.07% in the CRA plus high-vouchers group. Retention rate at 6 months was 36.5% in the standard treatment group, 53.3% in the CRA plus low-vouchers group, and 69.0% in the CRA plus high-vouchers group. The CRA plus vouchers groups obtained better results than the standard program. This study showed that treating cocaine addiction by combining CRA with vouchers was more effective than standard treatment in community outpatient programs in Spain.

The Effect of Massage on Acute Postoperative Pain in Critically and Acutely Ill Adults Post-thoracic Surgery: Systematic Review and Meta-analysis of Randomized Controlled Trials.

PubMed

Boitor, Madalina; Gélinas, Céline; Richard-Lalonde, Melissa; Thombs, Brett D

Critical care practice guidelines identify a lack of clear evidence on the effectiveness of massage for pain control. To assess the effect of massage on acute pain in critically and acutely ill adults post-thoracic surgery. Medline, Embase, CINAHL, PsychInfo, Web of Science, Scopus and Cochrane Library databases were searched. Eligible studies were randomized controlled trials (RCTs) evaluating the effect of massage compared to attention control/sham massage or standard care alone on acute pain intensity post-thoracic surgery. Twelve RCTs were included. Of these, nine evaluated massage in addition to standard analgesia, including 2 that compared massage to attention control/sham massage in the intensive care unit (ICU), 6 that compared massage to standard analgesia alone early post-ICU discharge, and 1 that compared massage to both attention control and standard care in the ICU. Patients receiving massage with analgesia reported less pain (0-10 scale) compared to attention control/sham massage (3 RCTs; N = 462; mean difference -0.80, 95% confidence interval [CI] -1.25 to -0.35; p < 0.001; I 2  = 13%) and standard care (7 RCTs; N = 1087; mean difference -0.85, 95% CI -1.28 to -0.42; p < 0.001; I 2  = 70%). Massage, in addition to pharmacological analgesia, reduces acute post-cardiac surgery pain intensity. Copyright © 2017 Elsevier Inc. All rights reserved.

Improving Motor Control in Walking: A Randomized Clinical Trial in Older Adults with Subclinical Walking Difficulty

PubMed Central

Brach, Jennifer S.; Lowry, Kristin; Perera, Subashan; Hornyak, Victoria; Wert, David; Studenski, Stephanie A.; VanSwearingen, Jessie M.

2016-01-01

Objective The objective was to test the proposed mechanism of action of a task-specific motor learning intervention by examining its effect on measures of the motor control of gait. Design Single blinded randomized clinical trial. Setting University research laboratory. Participants Forty older adults 65 years of age and older, with gait speed >1.0 m/s and impaired motor skill (Figure of 8 walk time > 8 secs). Interventions The two interventions included a task-oriented motor learning and a standard exercise program. Both interventions lasted 12 weeks, with twice weekly one hour physical therapist supervised sessions. Main Outcome Measures Two measure of the motor control of gait, gait variability and smoothness of walking, were assessed pre and post intervention by assessors masked to treatment arm. Results Of 40 randomized subjects; 38 completed the trial (mean age 77.1±6.0 years). Motor control group improved more than standard group in double support time variability (0.13 vs. 0.05 m/s; adjusted difference, AD=0.006, p=0.03). Smoothness of walking in the anterior/posterior direction improved more in motor control than standard for all conditions (usual: AD=0.53, p=0.05; narrow: AD=0.56, p=0.01; dual task: AD=0.57, p=0.04). Conclusions Among older adults with subclinical walking difficulty, there is initial evidence that task-oriented motor learning exercise results in gains in the motor control of walking, while standard exercise does not. Task-oriented motor learning exercise is a promising intervention for improving timing and coordination deficits related to mobility difficulties in older adults, and needs to be evaluated in a definitive larger trial. PMID:25448244

Use of adjunctive mitomycin C in external dacryocystorhinostomy surgery compared with surgery alone in patients with nasolacrimal duct obstruction: A prospective, double-masked, randomized, controlled trial.

PubMed

Ari, Seyhmus; Gun, Ramazan; Surmeli, Serdar; Atay, Ahmet Engin; Caca, Ihsan

2009-08-01

The most common cause for the failure of external dacryocystorhinostomy (DCR) surgery is the formation of granulation tissue at the osteotomy site or common canaliculus. The aims of this study were to assess the efficacy of intraoperative adjunctive mitomycin C (MMC) treatment in external DCR surgery and to compare this procedure with the standard DCR procedure alone in the long term (1 year). In this prospective, double-masked, randomized, controlled trial, patients with primary acquired nasolacrimal duct obstruction were randomized (using a random number table) into 2 groups based on surgical procedure. In the MMC group, intraoperative adjunctive MMC 0.2 mg/mL was applied to the osteotomy site for 30 minutes. The control group underwent standard DCR procedure only. The results of the DCR surgeries were assessed using objective findings (eg, cessation of excessive tearing via nasolacrimal duct irrigation and the improvement in height of tear meniscus) and subjective symptoms (asking patients to describe the degree of tearing improvement). Both the patients and the researchers who were assessing the study outcomes were masked to treatment group. One hundred eyes of 100 Turkish patients were assessed and equally randomized to the MMC (27 women, 23 men; mean [SD] age, 47.0 [7.6] years) and control (26 women, 24 men; mean age, 46.6 [8.8] years) groups. The follow-up period was not significantly different between the MMC and the control groups (13.1 [1.1] vs 13.2 [1.4] months). Significantly more eyes in the MMC group than the control group remained symptom-free throughout the 1-year follow-up period (45/50 [90%] vs 33/50 [66%]; P=0.005). Significantly more patients in the control group than the MMC group had an improvement in symptoms at the 1-year follow-up (8/50 [16%] vs 2/50 [4%] eyes; P=0.005). Based on the patency of the drainage system, the success rate was significantly greater in the MMC group than the control group (48/50 [96%] vs 42/50 [84%]; P=0.005). Based on nasolacrimal duct irrigation, significantly fewer patients in the MMC group than the control group had an enclosed naso-lacrimal duct (2/50 [4%] vs 8/50 [16%]). No adverse effects (eg, abnormal nasal bleeding, mucosal necrosis, infection) or any other surgical adverse events were observed. In the management of these patients with primary acquired nasolacrimal duct obstruction, adjunctive intraoperative MMC application with standard DCR surgery had a significantly higher success rate than did standard DCR surgery alone. Further large, double-masked, randomized studies are needed to confirm these findings.

Use of adjunctive mitomycin C in external dacryocystorhinostomy surgery compared with surgery alone in patients with nasolacrimal duct obstruction: A prospective, double-masked, randomized, controlled trial

PubMed Central

Ari, Şeyhmus; Gun, Ramazan; Surmeli, Serdar; Atay, Ahmet Engin; Çaca, Îhsan

2009-01-01

Background: The most common cause for the failure of external dacryocystorhinostomy (DCR) surgery is the formation of granulation tissue at the osteotomy site or common canaliculus. Objectives: The aims of this study were to assess the efficacy of intraoperative adjunctive mitomycin C (MMC) treatment in external DCR surgery and to compare this procedure with the standard DCR procedure alone in the long term (1 year). Methods: In this prospective, double-masked, randomized, controlled trial, patients with primary acquired nasolacrimal duct obstruction were randomized (using a random number table) into 2 groups based on surgical procedure. In the MMC group, intraoperative adjunctive MMC 0.2 mg/mL was applied to the osteotomy site for 30 minutes. The control group underwent standard DCR procedure only. The results of the DCR surgeries were assessed using objective findings (eg, cessation of excessive tearing via nasolacrimal duct irrigation and the improvement in height of tear meniscus) and subjective symptoms (asking patients to describe the degree of tearing improvement). Both the patients and the researchers who were assessing the study outcomes were masked to treatment group. Results: One hundred eyes of 100 Turkish patients were assessed and equally randomized to the MMC (27 women, 23 men; mean [SD] age, 47.0 [7.6] years) and control (26 women, 24 men; mean age, 46.6 [8.8] years) groups. The follow-up period was not significantly different between the MMC and the control groups (13.1 [1.1] vs 13.2 [1.4] months). Significantly more eyes in the MMC group than the control group remained symptom-free throughout the 1-year follow-up period (45/50 [90%] vs 33/50 [66%]; P=0.005). Significantly more patients in the control group than the MMC group had an improvement in symptoms at the 1-year follow-up (8/50 [16%] vs 2/50 [4%] eyes; P=0.005). Based on the patency of the drainage system, the success rate was significantly greater in the MMC group than the control group (48/50 [96%] vs 42/50 [84%]; P=0.005). Based on nasolacrimal duct irrigation, significantly fewer patients in the MMC group than the control group had an enclosed naso-lacrimal duct (2/50 [4%] vs 8/50 [16%]). No adverse effects (eg, abnormal nasal bleeding, mucosal necrosis, infection) or any other surgical adverse events were observed. Conclusions: In the management of these patients with primary acquired nasolacrimal duct obstruction, adjunctive intraoperative MMC application with standard DCR surgery had a significantly higher success rate than did standard DCR surgery alone. Further large, double-masked, randomized studies are needed to confirm these findings. PMID:24683236

Comprehensive behavioral-motivational nutrition education improves depressive symptoms following bariatric surgery: a randomized, controlled trial of obese Hispanic Americans.

PubMed

Petasne Nijamkin, Monica; Campa, Adriana; Samiri Nijamkin, Shani; Sosa, Jorge

2013-01-01

To evaluate the effect of 2 post-bariatric support interventions on depressive symptoms of Hispanic Americans treated with gastric bypass for morbid or severe obesity. Prospective randomized, controlled trial conducted in a laparoscopic institution. During the Phase 1 clinical trial (from preoperative evaluation to 6 months after surgery), all participants received standard care. During Phase 2 (6-12 months after surgery), participants were randomly assigned to receive either standard care (n = 72) or comprehensive support (n = 72). Comprehensive group participants received 6 educational sessions focused on behavior change strategies and motivation with nutrition counseling. Depression scores and weight change over time. Independent samples t tests and regression analysis assessed relationships among depression scores and excess weight loss. Participants receiving behavioral-motivational intervention scored significantly lower on Beck's Depression Inventory questionnaire scores than those receiving standard care. For those with depressive symptoms at randomization, 24% of participants who received the comprehensive intervention reported no depressive symptoms at 12 months after surgery, compared with 6% of those who received standard care (P < .001). Patients' depressive mood improvement was significantly and positively associated with excess weight loss and attendance at educational sessions (P < .001). Findings support the importance of post-bariatric comprehensive behavioral-motivational nutrition education for decreasing risk for depression and improving weight loss. Copyright © 2013 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Clinical Trials in Vision Research

MedlinePlus

... the treatment group . If you are in the control group , you could receive the standard treatment for a ... Researchers randomly assign participants to the treatment and control groups. In most studies, you have an equal chance ...

Efficacy of Intensive Control of Glucose in Stroke Prevention: A Meta-Analysis of Data from 59197 Participants in 9 Randomized Controlled Trials

PubMed Central

Zhang, Chi; Zhou, Yu-Hao; Xu, Chun-Li; Chi, Feng-Ling; Ju, Hai-Ning

2013-01-01

Background The efficacy of treatments that lower glucose in reducing the risk of incident stroke remains unclear. We therefore did a systematic review and meta-analysis to evaluate the efficacy of intensive control of glucose in the prevention of stroke. Methodology/Principal Findings We systematically searched Medline, EmBase, and the Cochrane Library for trials published between 1950 and June, 2012. We included randomized controlled trials that reported on the effects of intensive control of glucose on incident stroke compared with standard care. Summary estimates of relative risk (RR) reductions were calculated with a random effects model, and the analysis was further stratified by factors that could affect the treatment effects. Of 649 identified studies, we included nine relevant trials, which provided data for 59197 patients and 2037 events of stroke. Overall, intensive control of glucose as compared to standard care had no effect on incident stroke (RR, 0.96; 95%CI 0.88–1.06; P = 0.445). In the stratified analyses, a beneficial effect was seen in those trials when body mass index (BMI) more than 30 (RR, 0.86; 95%CI: 0.75–0.99; P = 0.041). No other significant differences were detected between the effect of intensive control of glucose and standard care when based on other subset factors. Conclusions/Significance Our study indicated intensive control of glucose can effectively reduce the risk of incident stroke when patients with BMI more than 30. PMID:23372729

Delivering successful randomized controlled trials in surgery: Methods to optimize collaboration and study design.

PubMed

Blencowe, Natalie S; Cook, Jonathan A; Pinkney, Thomas; Rogers, Chris; Reeves, Barnaby C; Blazeby, Jane M

2017-04-01

Randomized controlled trials in surgery are notoriously difficult to design and conduct due to numerous methodological and cultural challenges. Over the last 5 years, several UK-based surgical trial-related initiatives have been funded to address these issues. These include the development of Surgical Trials Centers and Surgical Specialty Leads (individual surgeons responsible for championing randomized controlled trials in their specialist fields), both funded by the Royal College of Surgeons of England; networks of research-active surgeons in training; and investment in methodological research relating to surgical randomized controlled trials (to address issues such as recruitment, blinding, and the selection and standardization of interventions). This article discusses these initiatives more in detail and provides exemplar cases to illustrate how the methodological challenges have been tackled. The initiatives have surpassed expectations, resulting in a renaissance in surgical research throughout the United Kingdom, such that the number of patients entering surgical randomized controlled trials has doubled.

A randomized controlled trial of the effects of transcendental meditation on quality of life in older breast cancer patients.

PubMed

Nidich, Sanford I; Fields, Jeremy Z; Rainforth, Maxwell V; Pomerantz, Rhoda; Cella, David; Kristeller, Jean; Salerno, John W; Schneider, Robert H

2009-09-01

This single-blind, randomized controlled trial evaluated the impact of the Transcendental Meditation program plus standard care as compared with standard care alone on the quality of life (QOL) of older women (>or=55 years) with stage II to IV breast cancer. One hundred and thirty women (mean age = 63.8) were randomly assigned to either experimental (n = 64) or control (n = 66) groups. Functional Assessment of Cancer Therapy-Breast (FACT-B), Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being (FACIT-SP), and Short-Form (SF)-36 mental health and vitality scales were administered every 6 months over an average 18-month intervention period. Significant improvements were found in the Transcendental Meditation group compared with controls in overall QOL, measured by the FACT-B total score (P = .037), emotional well-being (P = .046), and social well-being (P = .003) subscales, and SF-36 mental health ( P = .017). It is recommended that this stress reduction program, with its ease of implementation and home practice, be adopted in public health programs.

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.

Cognitive Training and Transcranial Direct Current Stimulation for Mild Cognitive Impairment in Parkinson's Disease: A Randomized Controlled Trial

PubMed Central

Gasson, Natalie; Johnson, Andrew R.; Booth, Leon; Loftus, Andrea M.

2018-01-01

This study examined whether standard cognitive training, tailored cognitive training, transcranial direct current stimulation (tDCS), standard cognitive training + tDCS, or tailored cognitive training + tDCS improved cognitive function and functional outcomes in participants with PD and mild cognitive impairment (PD-MCI). Forty-two participants with PD-MCI were randomized to one of six groups: (1) standard cognitive training, (2) tailored cognitive training, (3) tDCS, (4) standard cognitive training + tDCS, (5) tailored cognitive training + tDCS, or (6) a control group. Interventions lasted 4 weeks, with cognitive and functional outcomes measured at baseline, post-intervention, and follow-up. The trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR: 12614001039673). While controlling for moderator variables, Generalized Linear Mixed Models (GLMMs) showed that when compared to the control group, the intervention groups demonstrated variable statistically significant improvements across executive function, attention/working memory, memory, language, activities of daily living (ADL), and quality of life (QOL; Hedge's g range = 0.01 to 1.75). More outcomes improved for the groups that received standard or tailored cognitive training combined with tDCS. Participants with PD-MCI receiving cognitive training (standard or tailored) or tDCS demonstrated significant improvements on cognitive and functional outcomes, and combining these interventions provided greater therapeutic effects. PMID:29780572

A Derivation of the Dick Effect from Control-Loop Models for Periodically Interrogated Passive Frequency Standards

NASA Technical Reports Server (NTRS)

Greenhall, Charles A.

1996-01-01

The phase of a frequency standard that uses periodic interrogation and control of a local oscillator (LO) is degraded by a long-term random-walk component induced by downconversion of LO noise into the loop passband. The Dick formula for the noise level of this degradation can be derived from explicit solotions of two LO control-loop models. A summary of the derivations is given here.

Universal screening and decolonization for control of MRSA in nursing homes: a cluster randomized controlled study.

PubMed

Bellini, Cristina; Petignat, Christiane; Masserey, Eric; Büla, Christophe; Burnand, Bernard; Rousson, Valentin; Blanc, Dominique S; Zanetti, Giorgio

2015-04-01

The risk of carrying methicillin-resistant Staphylococcus aureus (MRSA) is higher among nursing home (NH) residents than in the general population. However, control strategies are not clearly defined in this setting. In this study, we compared the impact of standard precautions either alone (control) or combined with screening of residents and decolonization of carriers (intervention) to control MRSA in NHs. Cluster randomized controlled trial. NHs of the state of Vaud, Switzerland. Of 157 total NHs in Vaud, 104 (67%) participated in the study. Standard precautions were enforced in all participating NHs, and residents underwent MRSA screening at baseline and 12 months thereafter. All carriers identified in intervention NHs, either at study entry or among newly admitted residents, underwent topical decolonization combined with environmental disinfection, except in cases of MRSA infection, MRSA bacteriuria, or deep skin ulcers. NHs were randomly allocated to a control group (51 NHs, 2,412 residents) or an intervention group (53 NHs, 2,338 residents). Characteristics of NHs and residents were similar in both groups. The mean screening rates were 86% (range, 27%-100%) in control NHs and 87% (20%-100%) in intervention NHs. Prevalence of MRSA carriage averaged 8.9% in both control NHs (range, 0%-43%) and intervention NHs (range, 0%-38%) at baseline, and this rate significantly declined to 6.6% in control NHs and to 5.8% in intervention NHs after 12 months. However, the decline did not differ between groups (P=.66). Universal screening followed by decolonization of carriers did not significantly reduce the prevalence of the MRSA carriage rate at 1 year compared with standard precautions.

EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial.

PubMed

Bardutzky, Jürgen; Witsch, Jens; Jüttler, Eric; Schwab, Stefan; Vajkoczy, Peter; Wolf, Stefan

2011-09-14

Aneurysmal subarachnoid hemorrhage (SAH) may be complicated by delayed cerebral ischemia, which is a major cause of unfavorable clinical outcome and death in SAH-patients. Delayed cerebral ischemia is presumably related to the development of vasospasm triggered by the presence of blood in the basal cisterns. To date, oral application of the calcium antagonist nimodipine is the only prophylactic treatment for vasospasm recognized under international guidelines.In retrospective trials lumbar drainage of cerebrospinal fluid has been shown to be a safe and feasible measure to remove the blood from the basal cisterns and decrease the incidence of delayed cerebral ischemia and vasospasm in the respective study populations. However, the efficacy of lumbar drainage has not been evaluated prospectively in a randomized controlled trial yet. This is a protocol for a 2-arm randomized controlled trial to compare an intervention group receiving early continuous lumbar CSF-drainage and standard neurointensive care to a control group receiving standard neurointensive care only. Adults suffering from a first aneurysmal subarachnoid hemorrhage whose aneurysm has been secured by means of coiling or clipping are eligible for trial participation. The effect of early CSF drainage (starting < 72 h after securing the aneurysm) will be measured in the following ways: the primary endpoint will be disability after 6 months, assessed by a blinded investigator during a personal visit or standardized telephone interview using the modified Rankin Scale. Secondary endpoints include mortality after 6 months, angiographic vasospasm, transcranial Doppler sonography (TCD) mean flow velocity in both middle cerebral arteries and rate of shunt insertion at 6 months after hospital discharge. Here, we present the study design of a multicenter prospective randomized controlled trial to investigate whether early application of a lumbar drainage improves clinical outcome after aneurysmal subarachnoid hemorrhage.

Robotic virtual reality simulation plus standard robotic orientation versus standard robotic orientation alone: a randomized controlled trial.

PubMed

Vaccaro, Christine M; Crisp, Catrina C; Fellner, Angela N; Jackson, Christopher; Kleeman, Steven D; Pavelka, James

2013-01-01

The objective of this study was to compare the effect of virtual reality simulation training plus robotic orientation versus robotic orientation alone on performance of surgical tasks using an inanimate model. Surgical resident physicians were enrolled in this assessor-blinded randomized controlled trial. Residents were randomized to receive either (1) robotic virtual reality simulation training plus standard robotic orientation or (2) standard robotic orientation alone. Performance of surgical tasks was assessed at baseline and after the intervention. Nine of 33 modules from the da Vinci Skills Simulator were chosen. Experts in robotic surgery evaluated each resident's videotaped performance of the inanimate model using the Global Rating Scale (GRS) and Objective Structured Assessment of Technical Skills-modified for robotic-assisted surgery (rOSATS). Nine resident physicians were enrolled in the simulation group and 9 in the control group. As a whole, participants improved their total time, time to incision, and suture time from baseline to repeat testing on the inanimate model (P = 0.001, 0.003, <0.001, respectively). Both groups improved their GRS and rOSATS scores significantly (both P < 0.001); however, the GRS overall pass rate was higher in the simulation group compared with the control group (89% vs 44%, P = 0.066). Standard robotic orientation and/or robotic virtual reality simulation improve surgical skills on an inanimate model, although this may be a function of the initial "practice" on the inanimate model and repeat testing of a known task. However, robotic virtual reality simulation training increases GRS pass rates consistent with improved robotic technical skills learned in a virtual reality environment.

Evaluation of random plasma glucose for assessment of glycaemic control in type 2 diabetes mellitus.

PubMed

Ain, Qurratul; Latif, Atif; Jaffar, Syed Raza; Ijaz, Aamir

2017-09-01

To evaluate the accuracy of random plasma glucose in outpatients with type 2 diabetes mellitus for assessing glycaemic control. This comparative, cross-sectional study was conducted at the chemical pathology department of PNS Shifa Hospital, Karachi, from August 2015 to March 2016, and comprised data of subjects with type 2 diabetes mellitus who reported for evaluation of glycaemic control in non-fasting state. All blood samples were analysed for random plasma glucose and glycated haemoglobin. Random plasma glucose was compared as an index test with glycated haemoglobin considering it as reference standard at a value of less than 7% for good glycaemic control. SPSS 20 was used for data analysis. Of the 222 subjects, 93(42%) had good glycaemic control. Random plasma glucose showed strong positive correlation with glycated haemoglobin (p=0.000).Area under curve for random plasma glucose as determined by plotting receiver operating characteristic curve against glycated haemoglobin value of 7% was 0.89 (95% confidence interval: 0.849-0.930). Random plasma glucose at cut-off value of 150 mg/dl was most efficient for ruling out poor glycaemic control among patients with type 2 diabetes mellitus with 90.7% sensitivity and69.9% specificity and Youden's index of 0.606. Random plasma glucose may be used to reflect glycaemic control in adults with type 2 diabetes mellitus in areas where glycated haemoglobin is not feasible.

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.

A pilot randomized, controlled trial of the effectiveness of a psychoeducational intervention on family caregivers of patients with advanced cancer.

PubMed

Leow, Mabel; Chan, Sally; Chan, Moon

2015-03-01

To evaluate the effectiveness of a psychoeducational intervention, the Caring for the Caregiver Programme (CCP).
 A pilot randomized, controlled trial, two-group pretest, and repeated post-tests.
 Four home hospice organizations and an outpatient clinic in Singapore.
 80 caregivers were randomized into experimental and standard care groups.
 Outcomes were measured at baseline, week 4, and week 8 after the intervention. The standard care group received routine home hospice care, and the intervention group received the CCP in addition to routine care.
 Quality of life (QOL), social support, stress and depression, self-efficacy in self-care, closeness with the patient, rewards, and knowledge.
 Compared to the standard care group, the intervention group reported significantly higher QOL, social support satisfaction and number of supported people, closeness with the patient, self-efficacy in self-care, rewards of caregiving, and knowledge, and lower stress and depression. 
 The CCP had positive effects on family caregivers of patients with advanced cancer. 
 A psychoeducational intervention potentially could help caregivers cope with the demands of caregiving. 


A randomized controlled trial of the effects of hypnosis with 3-D virtual reality animation on tiredness, mood, and salivary cortisol.

PubMed

Thompson, Trevor; Steffert, Tony; Steed, Anthony; Gruzelier, John

2011-01-01

Case studies suggest hypnosis with a virtual reality (VR) component may be an effective intervention; although few follow-up randomized, controlled trials have been performed comparing such interventions with standard hypnotic treatments. Thirty-five healthy participants were randomized to self-hypnosis with VR imagery, standard self-hypnosis, or relaxation interventions. Changes in sleep, cortisol levels, and mood were examined. Self-hypnosis involved 10- to 20-min. sessions visualizing a healthy immune scenario. Trait absorption was also recorded as a possible moderator. Moderated regression indicated that both hypnosis interventions produced significantly lower tiredness ratings than relaxation when trait absorption was high. When trait absorption was low, VR resulted in significantly higher engagement ratings, although this did not translate to demonstrable improvement in outcome. Results suggest that VR imagery may increase engagement relative to traditional methods, but further investigation into its potential to enhance therapeutic efficacy is required.

Effects of Mat Pilates on Physical Functional Performance of Older Adults: A Meta-analysis of Randomized Controlled Trials.

PubMed

Bueno de Souza, Roberta Oliveira; Marcon, Liliane de Faria; Arruda, Alex Sandro Faria de; Pontes Junior, Francisco Luciano; Melo, Ruth Caldeira de

2018-06-01

The present meta-analysis aimed to examine evidence from randomized controlled trials to determine the effects of mat Pilates on measures of physical functional performance in the older population. A search was conducted in the MEDLINE/PubMed, Scopus, Scielo, and PEDro databases between February and March 2017. Only randomized controlled trials that were written in English, included subjects aged 60 yrs who used mat Pilates exercises, included a comparison (control) group, and reported performance-based measures of physical function (balance, flexibility, muscle strength, and cardiorespiratory fitness) were included. The methodological quality of the studies was analyzed according to the PEDro scale and the best-evidence synthesis. The meta-analysis was conducted with the Review Manager 5.3 software. The search retrieved 518 articles, nine of which fulfilled the inclusion criteria. High methodological quality was found in five of these studies. Meta-analysis indicated a large effect of mat Pilates on dynamic balance (standardized mean difference = 1.10, 95% confidence interval = 0.29-1.90), muscle strength (standardized mean difference = 1.13, 95% confidence interval = 0.30-1.96), flexibility (standardized mean difference = 1.22, 95% confidence interval = 0.39-2.04), and cardiorespiratory fitness (standardized mean difference = 1.48, 95% confidence interval = 0.42-2.54) of elderly subjects. There is evidence that mat Pilates improves dynamic balance, lower limb strength, hip and lower back flexibility, and cardiovascular endurance in elderly individuals. Furthermore, high-quality studies are necessary to clarify the effects of mat Pilates on other physical functional measurements among older adults.

The effects of physical training without equipment on pain perception and balance in the elderly: A randomized controlled trial.

PubMed

Patti, Antonino; Bianco, Antonino; Karsten, Bettina; Montalto, Maria Alessandra; Battaglia, Giuseppe; Bellafiore, Marianna; Cassata, Daniela; Scoppa, Fabio; Paoli, Antonio; Iovane, Angelo; Messina, Giuseppe; Palma, Antonio

2017-01-01

Research supports a link between exercise and falls prevention in the older population. Our aims were to evaluate pain perception and balance skills in a group of elderly subjects and to examine the consequences of a standardized equipment-free exercise program intervention on these variables. The study utilized a randomized controlled trial method. 92 subjects were recruited from a rural Sicilian village (Resuttano, Sicily, Italy). Subjects were randomly split into two groups, an experimental group (EG; n = 49) and a control group (CG; n = 43). Qualified fitness instructors delivered the standardized physical exercise program for the EG whilst the CG did not receive this exercise intervention. The Berg Balance Scale and the Oswestry Disability Index were administered in both groups before (T0) and after the intervention (T1). At T1, the EG group significantly improvement in balance (p < 0.0001) and pain perception (p < 0.0001). No significant differences were found within the CG both in BBS and ODI, respectively. Our findings suggest that a 13-weeks standardized exercise equipment-free program is effective in improving balance and perception of pain in the elderly. This type of intervention can consequently provide a low cost strategy to counteract the rate of disability in elderly.

Enhanced Medical Rehabilitation increases therapy intensity and engagement and improves functional outcomes in post-acute rehabilitation of older adults: a randomized controlled trial

PubMed Central

Lenze, Eric J.; Host, Helen H.; Hildebrand, Mary W.; Morrow-Howell, Nancy; Carpenter, Brian; Freedland, Kenneth E.; Baum, Carolyn A.; Dixon, David; Doré, Peter; Wendleton, Leah; Binder, Ellen F.

2012-01-01

Objectives For millions of disabled older adults each year, post-acute care in skilled nursing facilities (SNFs) is a brief window of opportunity to regain enough function to return home and live independently. Too often this goal is not achieved, possibly due to therapy that is inadequately intense or engaging. This study tested Enhanced Medical Rehabilitation, an intervention designed to increase patient engagement in, and intensity of, daily physical and occupational therapy sessions in post-acute care rehabilitation. Design Randomized controlled trial of Enhanced Medical Rehabilitation versus standard-of-care rehabilitation. Setting Post-acute care unit of a skilled nursing facility in St Louis, MO. Participants 26 older adults admitted from a hospital for post-acute rehabilitation. Intervention Based on models of motivation and behavior change, Enhanced Medical Rehabilitation is a set of behavioral skills for physical and occupational therapists (PT/OT) that increase patient engagement and intensity, with the goal of improving functional outcome, through: (1) a patient-directed, interactive approach, (2) increased rehabilitation intensity, and (3) frequent feedback to patients on their effort and progress. Measurements Therapy intensity: assessment of patient active time in therapy sessions. Therapy engagement: Rehabilitation Participation Scale. Functional and performance outcomes: Barthel Index, gait speed, and six-minute walk. Results Participants randomized to Enhanced Medical Rehabilitation had higher intensity therapy and were more engaged in their rehabilitation sessions; they had more improvement in gait speed (improving from 0.08 to 0.38 meter/sec vs. 0.08 to 0.22 in standard of care,p=0.003) and six-minute walk (from 73 to 266 feet vs. 40 to 94 feet in standard of care, p=0.026), with a trend for better improvement of Barthel Index (+43 points vs. 26 points in standard of care, p=0.087), compared to participants randomized to standard-of-care rehabilitation. Conclusion Higher intensity and patient engagement in the post-acute rehabilitation setting is achievable, with resultant better functional outcomes for older adults. Findings should be confirmed in a larger randomized controlled trial. PMID:22863663

A randomized, controlled trial of interactive, multimedia software for patient colonoscopy education.

PubMed

Shaw, M J; Beebe, T J; Tomshine, P A; Adlis, S A; Cass, O W

2001-02-01

The purpose of our study was to assess the effectiveness of computer-assisted instruction (CAI) in patients having colonoscopies. We conducted a randomized, controlled trial in large, multispecialty clinic. Eighty-six patients were referred for colonoscopies. The interventions were standard education versus standard education plus CAI, and the outcome measures were anxiety, comprehension, and satisfaction. Computer-assisted instruction had no effect on patients' anxiety. The group receiving CAI demonstrated better overall comprehension (p < 0.001). However, Comprehension of certain aspects of serious complications and appropriate postsedation behavior were unaffected by educational method. Patients in the CAI group were more likely to indicate satisfaction with the amount of information provided when compared with the standard education counterparts (p = 0.001). Overall satisfaction was unaffected by educational method. Computer-assisted instruction for colonoscopy provided better comprehension and greater satisfaction with the adequacy of education than standard education. Computer-assisted instruction helps physicians meet their educational responsibilities with no decrement to the interpersonal aspects of the patient-physician relationship.

Evaluation of a cognitive behavioural self-help manual for reducing depression: a randomized controlled trial.

PubMed

Songprakun, W; McCann, T V

2012-09-01

The prevalence of depression is increasing in Thailand. We used a randomized controlled trial to examine the effectiveness of a self-help programme in reducing depression in people with depression in Chiang Mai Province in Thailand. Fifty-six individuals diagnosed with moderate depression participated. They were assigned randomly to an intervention (n= 27) or control (n= 29) group. The intervention group were given a self-help manual along with standard care and treatment, while the control group continued to receive standard care and treatment. Both groups were also given a short weekly telephone call. The findings showed statistically significant differences between the groups, and within the intervention group, in their depression levels. Between baseline and post-test, a sharp decrease in depression was evident in the intervention group, whereas the level of depression increased in the control group. Between post-test and follow-up, a decrease was apparent in depression in both groups. However, the intervention group showed a much lower level of depression than the control group. The results support the use of bibliotherapy as an adjunct to mental health nurses' and other professionals' work in caring for people with moderate depression in the community. http://www.ANZCTR.org.au/ACTRN12611000905965.aspx. © 2012 Blackwell Publishing.

Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi.

PubMed

Pitchford, Nicola J

2015-01-01

Evaluation of educational interventions is necessary prior to wide-scale rollout. Yet very few rigorous studies have been conducted on the effectiveness of tablet-based interventions, especially in the early years and in developing countries. This study reports a randomized control trial to evaluate the effectiveness of a tablet intervention for supporting the development of early mathematical skills in primary school children in Malawi. A total sample of 318 children, spanning Standards 1-3, attending a medium-sized urban primary school, were randomized to one of three groups: maths tablet intervention, non-maths tablet control, and standard face-to-face practice. Children were pre-tested using tablets at the start of the school year on two tests of mathematical knowledge and a range of basic skills related to scholastic progression. Class teachers then delivered the intervention over an 8-weeks period, for the equivalent of 30-min per day. Technical support was provided from the local Voluntary Service Overseas (VSO). Children were then post-tested on the same assessments as given at pre-test. A final sample of 283 children, from Standards 1-3, present at both pre- and post-test, was analyzed to investigate the effectiveness of the maths tablet intervention. Significant effects of the maths tablet intervention over and above standard face-to-face practice or using tablets without the maths software were found in Standards 2 and 3. In Standard 3 the greater learning gains shown by the maths tablet intervention group compared to both of the control groups on the tablet-based assessments transferred to paper and pencil format, illustrating generalization of knowledge gained. Thus, tablet technology can effectively support early years mathematical skills in developing countries if the software is carefully designed to engage the child in the learning process and the content is grounded in a solid well-constructed curriculum appropriate for the child's developmental stage.

Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi

PubMed Central

Pitchford, Nicola J.

2015-01-01

Evaluation of educational interventions is necessary prior to wide-scale rollout. Yet very few rigorous studies have been conducted on the effectiveness of tablet-based interventions, especially in the early years and in developing countries. This study reports a randomized control trial to evaluate the effectiveness of a tablet intervention for supporting the development of early mathematical skills in primary school children in Malawi. A total sample of 318 children, spanning Standards 1–3, attending a medium-sized urban primary school, were randomized to one of three groups: maths tablet intervention, non-maths tablet control, and standard face-to-face practice. Children were pre-tested using tablets at the start of the school year on two tests of mathematical knowledge and a range of basic skills related to scholastic progression. Class teachers then delivered the intervention over an 8-weeks period, for the equivalent of 30-min per day. Technical support was provided from the local Voluntary Service Overseas (VSO). Children were then post-tested on the same assessments as given at pre-test. A final sample of 283 children, from Standards 1–3, present at both pre- and post-test, was analyzed to investigate the effectiveness of the maths tablet intervention. Significant effects of the maths tablet intervention over and above standard face-to-face practice or using tablets without the maths software were found in Standards 2 and 3. In Standard 3 the greater learning gains shown by the maths tablet intervention group compared to both of the control groups on the tablet-based assessments transferred to paper and pencil format, illustrating generalization of knowledge gained. Thus, tablet technology can effectively support early years mathematical skills in developing countries if the software is carefully designed to engage the child in the learning process and the content is grounded in a solid well-constructed curriculum appropriate for the child’s developmental stage. PMID:25954236

The CHOLEGAS study: multicentric randomized, blinded, controlled trial of gastrectomy plus prophylactic cholecystectomy versus gastrectomy only, in adults submitted to gastric cancer surgery with curative intent.

PubMed

Farsi, Marco; Bernini, Marco; Bencini, Lapo; Miranda, Egidio; Manetti, Roberto; de Manzoni, Giovanni; Verlato, Giuseppe; Marrelli, Daniele; Pedrazzani, Corrado; Roviello, Francesco; Marchet, Alberto; Cristadoro, Luigi; Gerard, Leonardo; Moretti, Renato

2009-05-15

The incidence of gallstones and gallbladder sludge is known to be higher in patients after gastrectomy than in general population. This higher incidence is probably related to surgical dissection of the vagus nerve branches and the anatomical gastrointestinal reconstruction. Therefore, some surgeons perform routine concomitant cholecystectomy during standard surgery for gastric malignancies. However, not all the patients who are diagnosed to have cholelithiasis after gastric cancer surgery will develop symptoms or require additional surgical treatments and a standard laparoscopic cholecystectomy is feasible even in those patients who underwent previous gastric surgery. At the present, no randomized study has been published and the decision of gallbladder management is left to each surgeon preference. The study is a randomized controlled investigation. The study will be performed in the General and Oncologic Surgery, Department of Oncology-Azienda Ospedaliero-Universitaria Careggi-Florence-Italy, a large teaching institution, with the participation of all surgeons who accept to be involved in, together with other Italian Surgical Centers, on behalf of the GIRCG (Italian Research Group for Gastric Cancer).The patients will be randomized into two groups: in the first group the patient will be submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer (subtotal or total gastrectomy), while in the second group he/she will be submitted to standard gastric surgery only. ClinicalTrials.gov ID. NCT00757640.

Residual anastomoses in twin-twin transfusion syndrome after laser: the Solomon randomized trial.

PubMed

Slaghekke, Femke; Lewi, Liesbeth; Middeldorp, Johanna M; Weingertner, Anne Sophie; Klumper, Frans J; Dekoninck, Philip; Devlieger, Roland; Lanna, Mariano M; Deprest, Jan; Favre, Romain; Oepkes, Dick; Lopriore, Enrico

2014-09-01

Residual anastomoses after fetoscopic laser surgery for twin-to-twin transfusion syndrome (TTTS) may lead to severe postoperative complications, including recurrent TTTS and twin anemia-polycythemia sequence (TAPS). A novel technique (Solomon technique) using laser coagulation of the entire vascular equator was recently investigated in a randomized controlled trial (Solomon trial) and compared with the Standard selective laser technique. The aim of this secondary analysis was to evaluate the occurrence and characteristics of residual anastomoses in placentas included in the Solomon trial. International multicenter randomized controlled trial in TTTS, randomized 1:1 ratio to either the Solomon laser technique or Standard laser technique. At time of laser, surgeons recorded whether they considered the procedure to be complete. Placental dye injection was performed after birth in the participating centers to evaluate the presence of residual anastomoses. A total of 151 placentas were included in the study. The percentage of placentas with residual anastomoses in the Solomon group and Standard group was 19% (14/74) and 34% (26/77), respectively (P = .04). The percentage of placentas with residual anastomoses in the subgroup of cases where the procedure was recorded as complete was 8/65 (12%) and 22/69 (32%) in the Solomon group and Standard group, respectively (P < .01). The Solomon laser technique reduces the risk of residual anastomoses. However, careful follow-up remains essential also after the Solomon technique, as complete dichorionization is not always achieved. Copyright © 2014 Mosby, Inc. All rights reserved.

Trauma-informed Temporary Assistance for Needy Families (TANF): A Randomized Controlled Trial with a Two-Generation Impact.

PubMed

Booshehri, Layla G; Dugan, Jerome; Patel, Falguni; Bloom, Sandra; Chilton, Mariana

2018-01-01

Temporary Assistance for Needy Families (TANF) has limited success in building self-sufficiency, and rarely addresses exposure to trauma as a barrier to employment. The objective of the Building Wealth and Health Network randomized controlled trial was to test effectiveness of financial empowerment combined with trauma-informed peer support against standard TANF programming. Through the method of single-blind randomization we assigned 103 caregivers of children under age six into three groups: control (standard TANF programming), partial (28-weeks financial education), and full (same as partial with simultaneous 28-weeks of trauma-informed peer support). Participants completed baseline and follow-up surveys every 3 months over 15 months. Group response rates were equivalent throughout. With mixed effects analysis we compared post-program outcomes at months 9, 12, and 15 to baseline. We modeled the impact of amount of participation in group classes on participant outcomes. Despite high exposure to trauma and adversity results demonstrate that, compared to the other groups, caregivers in the full intervention reported improved self-efficacy and depressive symptoms, and reduced economic hardship. Unlike the intervention groups, the control group reported increased developmental risk among their children. Although the control group showed higher levels of employment, the full intervention group reported greater earnings. The partial intervention group showed little to no differences compared with the control group. We conclude that financial empowerment education with trauma-informed peer support is more effective than standard TANF programming at improving behavioral health, reducing hardship, and increasing income. Policymakers may consider adapting TANF to include trauma-informed programming.

Evaluation of a bibliotherapy manual for reducing psychological distress in people with depression: a randomized controlled trial.

PubMed

Songprakun, Wallapa; McCann, Terence V

2012-12-01

This article reports a study to evaluate the efficacy of a self-help manual in reducing psychological distress in individuals with moderate depression. The prevalence of depression in Thailand is increasing markedly (e.g. from 56-197 per 100,000 population between 1997-2007). We conducted a randomized controlled trial with 54 outpatients with depression in Chiang Mai Province in Thailand. Participants were assigned randomly to an intervention or control group. The intervention group participants were given a self-help manual in addition to standard care and treatment while the control group received standard care and treatment. Psychological distress was measured with the Kessler Psychological Distress Scale. Data were collected between October 2007-April 2008. The findings showed statistically significant differences between both groups in their levels of psychological distress (e.g. tiredness, hopelessness, restlessness). At post-test, the distress scores of the intervention group were lower than those in the control group. Between post-test and 1-month follow-up, distress scores continued to decrease steadily in the intervention group but only decreased slightly in the control group. The findings affirm the benefits of bibliotherapy or self-help therapy in book form in helping to reduce psychological distress in people with moderate depression. The approach is easy to use and can be incorporated as an adjunct to standard care and treatment. Bibliotherapy can be used by community mental health nurses and other clinicians to reduce psychological distress and promote recovery in people with moderate depression. © 2012 Blackwell Publishing Ltd.

Standardized versus Individualized Acupuncture for Chronic Low Back Pain: A Randomized Controlled Trial

PubMed Central

Pach, Daniel; Yang-Strobel, Xiaoli; Lüdtke, Rainer; Icke, Katja; Brinkhaus, Benno; Witt, Claudia M.

2013-01-01

We aimed to compare the effectiveness of standardized and individualized acupuncture treatment in patients with chronic low back pain. A single-center randomized controlled single-blind trial was performed in a general medical practice in Germany run by a Chinese-born medical doctor trained in western and Chinese medicine. One hundred and fifty outpatients with chronic low back pain were randomly allocated to two groups (78 standardized and 72 individualized acupuncture). Patients received either standardized acupuncture or individualized acupuncture. Treatment encompassed between 10 and 15 treatments based on individual symptoms with two treatments per week. The main outcome measure was the area under the curve (AUC) summarizing eight weeks of daily rated pain severity measured with a visual analogue scale (0 mm = no pain, 100 mm = worst imaginable pain). No significant differences between groups were observed for the AUC (individualized acupuncture mean: 1768.7 (95% CI, 1460.4; 2077.1); standardized acupuncture 1482.9 (1177.2; 1788.7); group difference, 285.8 (−33.9; 605.5) P = 0.080). In this single-center trial, individualized acupuncture was not superior to standardized acupuncture for patients suffering from chronic pain. As a next step, a multicenter noninferiority study should be performed to investigate whether standardised acupuncture treatment for chronic low back pain might be applicable in a broader usual care setting. This trial is registered with ClinicalTrials.gov NCT00758017. PMID:24288556

Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial.

PubMed

Bekelis, Kimon; Calnan, Daniel; Simmons, Nathan; MacKenzie, Todd A; Kakoulides, George

2017-06-01

To investigate the effect of exposure to a virtual reality (VR) environment preoperatively on patient-reported outcomes for surgical operations. There is a scarcity of well-developed quality improvement initiatives targeting patient satisfaction. We performed a randomized controlled trial of patients undergoing cranial and spinal operations in a tertiary referral center. Patients underwent a 1:1 randomization to an immersive preoperative VR experience or standard preoperative experience stratified on type of operation. The primary outcome measures were the Evaluation du Vecu de l'Anesthesie Generale (EVAN-G) score and the Amsterdam Preoperative Anxiety and Information (APAIS) score, as markers of the patient's experience during the surgical encounter. During the study period, a total of 127 patients (mean age 55.3 years, 41.9% females) underwent randomization. The average EVAN-G score was 84.3 (standard deviation, SD, 6.4) after VR, and 64.3 (SD, 11.7) after standard preoperative experience (difference, 20.0; 95% confidence interval, CI, 16.6-23.3). Exposure to an immersive VR experience also led to higher APAIS score (difference, 29.9; 95% CI, 24.5-35.2). In addition, VR led to lower preoperative VAS stress score (difference, -41.7; 95% CI, -33.1 to -50.2), and higher preoperative VAS preparedness (difference, 32.4; 95% CI, 24.9-39.8), and VAS satisfaction (difference, 33.2; 95% CI, 25.4-41.0) scores. No association was identified with VAS stress score (difference, -1.6; 95% CI, -13.4 to 10.2). In a randomized controlled trial, we demonstrated that patients exposed to preoperative VR had increased satisfaction during the surgical encounter. Harnessing the power of this technology, hospitals can create an immersive environment that minimizes stress, and enhances the perioperative experience.

Treatment of Chronic Plantar Fasciitis with Noninvasive Interactive Neurostimulation: A Prospective Randomized Controlled Study.

PubMed

Razzano, Cristina; Carbone, Stefano; Mangone, Massimiliano; Iannotta, M Raffaella; Battaglia, Alessandro; Santilli, Valter

The initial treatment of plantar fasciitis should be conservative, with most cases responding to standard physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), heel pads, and stretching. In cases of chronic refractory symptoms, more invasive treatment could be necessary. Noninvasive interactive neurostimulation (NIN) is a form of electric therapy that works by locating areas of lower skin impedance. The objective of the present prospective randomized controlled study was to evaluate whether the use of NIN for chronic plantar fasciitis could result in greater improvement in a foot functional score, lower levels of reported pain, reduced patient consumption of NSAIDs, and greater patient satisfaction compared with electric shockwave therapy in patients without a response to standard conservative treatment. The patients were randomized using random blocks to the NIN program (group 1) or electric shockwave therapy (group 2). The outcome measurements were the pain subscale of the validated Foot Function Index (PS-FFI), patient-reported subjective assessment of the level of pain using a standard visual analog scale, and daily intake of NSAID tablets (etoricoxib 60 mg). The study group was evaluated at baseline (time 0), week 4 (time 1), and week 12 (final follow-up point). Group 1 (55 patients) experienced significantly better results compared with group 2 (49 patients) in term of the PS-FFI score, visual analog scale score, and daily intake of etoricoxib 60 mg. NIN was an effective treatment of chronic resistant plantar fasciitis, with full patient satisfaction in >90% of cases. The present prospective randomized controlled study showed superior results for noninvasive neurostimulation compared with electric shockwave therapy, in terms of the functional score, pain improvement, and use of NSAIDs. Copyright © 2017 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

Randomized controlled comparative study on effect of training to improve lower limb motor paralysis in convalescent patients with post-stroke hemiplegia

PubMed Central

Kawakami, Kenji; Miyasaka, Hiroyuki; Nonoyama, Sayaka; Hayashi, Kazuya; Tonogai, Yusuke; Tanino, Genichi; Wada, Yosuke; Narukawa, Akihisa; Okuyama, Yuko; Tomita, Yutaka; Sonoda, Shigeru

2015-01-01

[Purpose] The motor paralysis-improving effect on the hemiplegic lower limb was compared among mirror therapy, integrated volitional-control electrical stimulation, therapeutic electrical stimulation, repetitive facilitative exercises, and the standard training method in post-stroke hemiplegia patients. [Subjects and Methods] Eighty one stroke patients admitted to a convalescent rehabilitation ward were randomly allocated to the above 5 treatment groups. Each patient performed functional training of the paralytic lower limb for 20 minutes a day for 4 weeks, and changes in the lower limb function were investigated using the Stroke Impairment Assessment Set. [Results] The hip and knee joint functions did not significantly improve in the standard training control group, but significant improvements were observed after 4 weeks in the other intervention groups. Significant improvement was noted in the ankle joint function in all groups. [Conclusion] Although the results were influenced by spontaneous recovery and the standard training in the control group, the hip and knee joints were more markedly improved by the interventions in the other 4 groups of patients with moderate paralysis, compared to the control group. PMID:26504331

Randomized, Controlled Trial of Behavioral Family Systems Therapy for Diabetes: Maintenance and Generalization of Effects on Parent-Adolescent Communication

ERIC Educational Resources Information Center

Wysocki, Tim; Harris, Michael A.; Buckloh, Lisa M.; Mertlich, Deborah; Lochrie, Amanda Sobel; Taylor, Alexandra; Sadler, Michelle; White, Neil H.

2008-01-01

We report a randomized trial of a revised Behavioral Family Systems Therapy for Diabetes (BFST-D) intervention. Families of 104 adolescents with diabetes were randomized to standard care (SC) or to 6 months of an educational support group (ES) or BFST-D. Family communication and problem-solving skills were assessed at 0, 6, 12, and 18 months by…

Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial.

PubMed

Ferrando, Carlos; Soro, Marina; Canet, Jaume; Unzueta, Ma Carmen; Suárez, Fernando; Librero, Julián; Peiró, Salvador; Llombart, Alicia; Delgado, Carlos; León, Irene; Rovira, Lucas; Ramasco, Fernando; Granell, Manuel; Aldecoa, César; Diaz, Oscar; Balust, Jaume; Garutti, Ignacio; de la Matta, Manuel; Pensado, Alberto; Gonzalez, Rafael; Durán, M Eugenia; Gallego, Lucia; Del Valle, Santiago García; Redondo, Francisco J; Diaz, Pedro; Pestaña, David; Rodríguez, Aurelio; Aguirre, Javier; García, Jose M; García, Javier; Espinosa, Elena; Charco, Pedro; Navarro, Jose; Rodríguez, Clara; Tusman, Gerardo; Belda, Francisco Javier

2015-04-27

Postoperative pulmonary and non-pulmonary complications are common problems that increase morbidity and mortality in surgical patients, even though the incidence has decreased with the increased use of protective lung ventilation strategies. Previous trials have focused on standard strategies in the intraoperative or postoperative period, but without personalizing these strategies to suit the needs of each individual patient and without considering both these periods as a global perioperative lung-protective approach. The trial presented here aims at comparing postoperative complications when using an individualized ventilatory management strategy in the intraoperative and immediate postoperative periods with those when using a standard protective ventilation strategy in patients scheduled for major abdominal surgery. This is a comparative, prospective, multicenter, randomized, and controlled, four-arm trial that will include 1012 patients with an intermediate or high risk for postoperative pulmonary complications. The patients will be divided into four groups: (1) individualized perioperative group: intra- and postoperative individualized strategy; (2) intraoperative individualized strategy + postoperative continuous positive airway pressure (CPAP); (3) intraoperative standard ventilation + postoperative CPAP; (4) intra- and postoperative standard strategy (conventional strategy). The primary outcome is a composite analysis of postoperative complications. The Individualized Perioperative Open-lung Ventilatory Strategy (iPROVE) is the first multicenter, randomized, and controlled trial to investigate whether an individualized perioperative approach prevents postoperative pulmonary complications. Registered on 5 June 2014 with identification no. NCT02158923 .

Metal-backed versus all-polyethylene tibial components in primary total knee arthroplasty

PubMed Central

2011-01-01

Background and purpose The choice of either all-polyethylene (AP) tibial components or metal-backed (MB) tibial components in total knee arthroplasty (TKA) remains controversial. We therefore performed a meta-analysis and systematic review of randomized controlled trials that have evaluated MB and AP tibial components in primary TKA. Methods The search strategy included a computerized literature search (Medline, EMBASE, Scopus, and the Cochrane Central Register of Controlled Trials) and a manual search of major orthopedic journals. A meta-analysis and systematic review of randomized or quasi-randomized trials that compared the performance of tibial components in primary TKA was performed using a fixed or random effects model. We assessed the methodological quality of studies using Detsky quality scale. Results 9 randomized controlled trials (RCTs) published between 2000 and 2009 met the inclusion quality standards for the systematic review. The mean standardized Detsky score was 14 (SD 3). We found that the frequency of radiolucent lines in the MB group was significantly higher than that in the AP group. There were no statistically significant differences between the MB and AP tibial components regarding component positioning, knee score, knee range of motion, quality of life, and postoperative complications. Interpretation Based on evidence obtained from this study, the AP tibial component was comparable with or better than the MB tibial component in TKA. However, high-quality RCTs are required to validate the results. PMID:21895503

Design of a randomized, controlled, comparative-effectiveness trial testing a Family Model of Diabetes Self-Management Education (DSME) vs. Standard DSME for Marshallese in the United States.

PubMed

Kim Yeary, Karen Hye-Cheon; Long, Christopher R; Bursac, Zoran; McElfish, Pearl Anna

2017-06-01

Type 2 diabetes (T2D) is a significant public health problem, with U.S. Pacific Islander communities-such as the Marshallese-bearing a disproportionate burden. Using a community-based participatory approach (CBPR) that engages the strong family-based social infrastructure characteristic of Marshallese communities is a promising way to manage T2D. Led by a collaborative community-academic partnership, the Family Model of Diabetes Self-Management Education (DSME) aimed to change diabetes management behaviors to improve glycemic control in Marshallese adults with T2D by engaging the entire family. To test the Family Model of DSME, a randomized, controlled, comparative effectiveness trial with 240 primary participants was implemented. Half of the primary participants were randomly assigned to the Standard DSME and half were randomly assigned to the Family Model DSME. Both arms received ten hours of content comprised of 6-8 sessions delivered over a 6-8 week period. The Family Model DSME was a cultural adaptation of DSME, whereby the intervention focused on engaging family support for the primary participant with T2D. The Standard DSME was delivered to the primary participant in a community-based group format. Primary participants and participating family members were assessed at baseline and immediate post-intervention, and will also be assessed at 6 and 12 months. The Family Model of DSME aimed to improve glycemic control in Marshallese with T2D. The utilization of a CBPR approach that involves the local stakeholders and the engagement of the family-based social infrastructure of Marshallese communities increase potential for the intervention's success and sustainability.

Reducing Decisional Conflict and Enhancing Satisfaction with Information among Women Considering Breast Reconstruction following Mastectomy: Results from the BRECONDA Randomized Controlled Trial.

PubMed

Sherman, Kerry A; Shaw, Laura-Kate E; Winch, Caleb J; Harcourt, Diana; Boyages, John; Cameron, Linda D; Brown, Paul; Lam, Thomas; Elder, Elisabeth; French, James; Spillane, Andrew

2016-10-01

Deciding whether or not to have breast reconstruction following breast cancer diagnosis is a complex decision process. This randomized controlled trial assessed the impact of an online decision aid [Breast RECONstruction Decision Aid (BRECONDA)] on breast reconstruction decision-making. Women (n = 222) diagnosed with breast cancer or ductal carcinoma in situ, and eligible for reconstruction following mastectomy, completed an online baseline questionnaire. They were then assigned randomly to receive either standard online information about breast reconstruction (control) or standard information plus access to BRECONDA (intervention). Participants then completed questionnaires at 1 and 6 months after randomization. The primary outcome was participants' decisional conflict 1 month after exposure to the intervention. Secondary outcomes included decisional conflict at 6 months, satisfaction with information at 1 and 6 months, and 6-month decisional regret. Linear mixed-model analyses revealed that 1-month decisional conflict was significantly lower in the intervention group (27.18) compared with the control group (35.5). This difference was also sustained at the 6-month follow-up. Intervention participants reported greater satisfaction with information at 1- and 6-month follow-up, and there was a nonsignificant trend for lower decisional regret in the intervention group at 6-month follow-up. Intervention participants' ratings for BRECONDA demonstrated high user acceptability and overall satisfaction. Women who accessed BRECONDA benefited by experiencing significantly less decisional conflict and being more satisfied with information regarding the reconstruction decisional process than women receiving standard care alone. These findings support the efficacy of BRECONDA in helping women to arrive at their breast reconstruction decision.

Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial.

PubMed

Arabi, Yaseen M; Alothman, Adel; Balkhy, Hanan H; Al-Dawood, Abdulaziz; AlJohani, Sameera; Al Harbi, Shmeylan; Kojan, Suleiman; Al Jeraisy, Majed; Deeb, Ahmad M; Assiri, Abdullah M; Al-Hameed, Fahad; AlSaedi, Asim; Mandourah, Yasser; Almekhlafi, Ghaleb A; Sherbeeni, Nisreen Murad; Elzein, Fatehi Elnour; Memon, Javed; Taha, Yusri; Almotairi, Abdullah; Maghrabi, Khalid A; Qushmaq, Ismael; Al Bshabshe, Ali; Kharaba, Ayman; Shalhoub, Sarah; Jose, Jesna; Fowler, Robert A; Hayden, Frederick G; Hussein, Mohamed A

2018-01-30

It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018. ClinicalTrials.gov, ID: NCT02845843 . Registered on 27 July 2016.

Working Memory Training in ADHD: Controlling for Engagement, Motivation, and Expectancy of Improvement (Pilot Study).

PubMed

Mawjee, Karizma; Woltering, Steven; Lai, Nathan; Gotlieb, Howell; Kronitz, Reena; Tannock, Rosemary

2017-09-01

The aim of this study was to evaluate whether a shortened-length session of CogMed Working Memory Training (CWMT) would be a suitable active control group and evaluate study protocol to aid in design refinements for a larger randomized controlled trial (RCT). Thirty-eight post-secondary students diagnosed with ADHD were randomized into 25 sessions of standard (45 min/session) or shortened (15 min/session) CWMT, or into a waitlist control group. There was no significant difference in completion rate or training index score between the standard- and shortened-length groups indicating that both groups showed improvement and put forth good effort during training. Preliminary findings suggest that shorter training sessions may induce similar levels of engagement, motivation, and expectancy of improvement in participants. We conclude that a larger scale RCT that utilizes shortened-length training as an active control group is warranted, but that a few modifications to the study protocol will be required.

Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

DTIC Science & Technology

2010-09-30

a novel hypocretiniorexin antagonist, almorexant (ALM), to a standard hypnotic , zolpidem (ZOL), and placebo (PBO) on neurocognitive performance at...Placebo-Controlled, Randomized, Parallel- Group Study Comparing the Effect of a Novel HypocretiniOrexin Antagonist (Almorexant) Versus a Standard Hypnotic ...Group Study Comparing the Effect of a Novel HypocretiniOrexin Antagonist (Almorexant) Versus a Standard Hypnotic (Zolpidem) and Placebo on

The importance of preservation of the ethical principle of equipoise in the design of clinical trials: relative impact of the methodological quality domains on the treatment effect in randomized controlled trials.

PubMed

Djulbegovic, Benjamin; Cantor, Alan; Clarke, Mike

2003-01-01

Previous research has identified methodological problems in the design and conduct of randomized trials that could, if left unaddressed, lead to biased results. In this report we discuss one such problem, inadequate control intervention, and argue that it can be by far the most important design characteristic of randomized trials in overestimating the effect of new treatments. Current guidelines for the design and reporting of randomized trials, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, do not address the choice of the comparator intervention. We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle."

Translating a Fall Prevention Intervention Into Practice: A Randomized Community Trial

PubMed Central

Peterson, Donna J.; Christiansen, Ann L.; Mahoney, Jane; Laud, Purushottam; Layde, Peter M.

2015-01-01

Objectives. We examined whether community translation of an effective evidence-based fall prevention program via standard monetary support can produce a community-wide reduction in fall injuries in older adults and evaluated whether an enhanced version with added technical support and capacity building amplified the fall reduction effect. Methods. We completed a randomized controlled community trial among adults aged 65 and older in (1) 10 control communities receiving no special resources or guidance on fall prevention, (2) 5 standard support communities receiving modest funding to implement Stepping On, and (3) 5 enhanced support communities receiving funding and technical support. The primary outcome was hospital inpatient and emergency department discharges for falls, examined with Poisson regression. Results. Compared with control communities, standard and enhanced support communities showed significantly higher community-wide reductions (9% and 8%, respectively) in fall injuries from baseline (2007–2008) to follow-up (2010–2011). No significant difference was found between enhanced and standard support communities. Conclusions. Population-based fall prevention interventions can be effective when implemented in community settings. More research is needed to identify the barriers and facilitators that influence the successful adoption and implementation of fall prevention interventions into broad community practice. PMID:25602891

Translating a Fall Prevention Intervention Into Practice: A Randomized Community Trial.

PubMed

Guse, Clare E; Peterson, Donna J; Christiansen, Ann L; Mahoney, Jane; Laud, Purushottam; Layde, Peter M

2015-07-01

We examined whether community translation of an effective evidence-based fall prevention program via standard monetary support can produce a community-wide reduction in fall injuries in older adults and evaluated whether an enhanced version with added technical support and capacity building amplified the fall reduction effect. We completed a randomized controlled community trial among adults aged 65 and older in (1) 10 control communities receiving no special resources or guidance on fall prevention, (2) 5 standard support communities receiving modest funding to implement Stepping On, and (3) 5 enhanced support communities receiving funding and technical support. The primary outcome was hospital inpatient and emergency department discharges for falls, examined with Poisson regression. Compared with control communities, standard and enhanced support communities showed significantly higher community-wide reductions (9% and 8%, respectively) in fall injuries from baseline (2007-2008) to follow-up (2010-2011). No significant difference was found between enhanced and standard support communities. Population-based fall prevention interventions can be effective when implemented in community settings. More research is needed to identify the barriers and facilitators that influence the successful adoption and implementation of fall prevention interventions into broad community practice.

Effects of mindfulness meditation on chronic pain: a randomized controlled trial.

PubMed

la Cour, Peter; Petersen, Marian

2015-04-01

This randomized controlled clinical trial investigated the effects of mindfulness meditation on chronic pain. A total of 109 patients with nonspecific chronic pain were randomized to either a standardized mindfulness meditation program (mindfulness-based stress reduction [MBSR]) or to a wait list control. Pain, physical function, mental function, pain acceptance, and health-related quality of life were measured. The SF36 vitality scale was chosen as the primary outcome measure; the primary end point was after completing the MBSR course. Within a 2.5-year period, 43 of the 109 randomized patients completed the mindfulness program, while 47 remained in the control group. Data were compared at three time points: at baseline, after completion of the course/waiting period, and at the 6-month follow-up. Significant effect (Cohen's d = 0.39) was found on the primary outcome measure, the SF36 vitality scale. On the secondary variables, significant medium to large size effects (Cohen's d = 0.37-0.71) were found for lower general anxiety and depression, better mental quality of life (psychological well-being), feeling in control of the pain, and higher pain acceptance. Small (nonsignificant) effect sizes were found for pain measures. There were no significant differences in the measures just after the intervention vs the 6-month follow-up. A standardized mindfulness program (MBSR) contributes positively to pain management and can exert clinically relevant effects on several important dimensions in patients with long-lasting chronic pain. © 2014 American Academy of Pain Medicine.

Randomized clinical trial studying effects of a personalized supervised lifestyle intervention program on cardiovascular status in physically inactive healthy volunteers

PubMed Central

Westergren, Helena U; Gan, Li-Ming; Månsson, Marianne; Svedlund, Sara

2018-01-01

Background The impact of personalized exercise training and a healthy dietary lifestyle in healthy volunteers on coronary flow reserve and cardiovascular function remains to be investigated in a controlled study setting. Purpose To examine the effects of a Mediterranean-inspired diet combined with regular physical exercise (standard) and a personalized supervised exercise program (DAPS) on coronary flow reserve and cardiovascular function. Results The number of males were 10 (59%) and 9 (47%) and mean age was 54 ± 12 and 55 ± 5 years in standard versus DAPS group, respectively. Primary outcomes were in addition to improved body composition and aerobic capacity, increased TDE-CFR (5.0%, CI:1.62,8.64, p = 0.005) and left ventricle ejection fraction (LVEF) during hyperemia (10.2%, CI:1.62,19.4, p = 0.022) in DAPS adjusted for the control period. Also, plasma fibrinogen decreased (−12.1%, CI:-22.0,–0.92, p = 0.035) in the DAPS group. Secondary outcomes, after adjusting DAPS intervention effects for the standard-training period, TDE-CFR and hyperemic LVEF remained significantly improved. Materials and Methods This randomized, controlled clinical trial (URL: http://www.clinicaltrials.gov NCT02713724) included 36 healthy volunteers who underwent exercise ECG before randomization to standard or DAPS groups. Standard-group was given gym-membership with limited instructions and general dietary advice. DAPS-group received personalized supervised exercise programs and more detailed dietary advice with regular contact with a personal trainer. Effects were evaluated after 3 months. All participants underwent coronary flow reserve by transthoracic ultrasound (TDE-CFR), blood marker analysis and examinations of vascular function. Standard-group was evaluated pre-control, post-control (=pre-intervention) and post-intervention. DAPS-group was examined at pre-intervention and post-intervention. Conclusions A personalized supervised training- and diet program improves cardiovascular status in healthy subjects with a physically inactive lifestyle and may be a promising approach for cardiovascular prevention in the general population. PMID:29507706

Comparative Evaluations of Randomly Selected Four Point-of-Care Glucometer Devices in Addis Ababa, Ethiopia.

PubMed

Wolde, Mistire; Tarekegn, Getahun; Kebede, Tedla

2018-05-01

Point-of-care glucometer (PoCG) devices play a significant role in self-monitoring of the blood sugar level, particularly in the follow-up of high blood sugar therapeutic response. The aim of this study was to evaluate blood glucose test results performed with four randomly selected glucometers on diabetes and control subjects versus standard wet chemistry (hexokinase) methods in Addis Ababa, Ethiopia. A prospective cross-sectional study was conducted on randomly selected 200 study participants (100 participants with diabetes and 100 healthy controls). Four randomly selected PoCG devices (CareSens N, DIAVUE Prudential, On Call Extra, i-QARE DS-W) were evaluated against hexokinase method and ISO 15197:2003 and ISO 15197:2013 standards. The minimum and maximum blood sugar values were recorded by CareSens N (21 mg/dl) and hexokinase method (498.8 mg/dl), respectively. The mean sugar values of all PoCG devices except On Call Extra showed significant differences compared with the reference hexokinase method. Meanwhile, all four PoCG devices had strong positive relationship (>80%) with the reference method (hexokinase). On the other hand, none of the four PoCG devices fulfilled the minimum accuracy measurement set by ISO 15197:2003 and ISO 15197:2013 standards. In addition, the linear regression analysis revealed that all four selected PoCG overestimated the glucose concentrations. The overall evaluation of the selected four PoCG measurements were poorly correlated with standard reference method. Therefore, before introducing PoCG devices to the market, there should be a standardized evaluation platform for validation. Further similar large-scale studies on other PoCG devices also need to be undertaken.

Behavior Intervention for Students with Externalizing Behavior Problems: Primary-Level Standard Protocol

ERIC Educational Resources Information Center

Benner, Gregory J.; Nelson, J. Ron; Sanders, Elizabeth A.; Ralston, Nicole C.

2012-01-01

This article examined the efficacy of a primary-level, standard-protocol behavior intervention for students with externalizing behavioral disorders. Elementary schools were randomly assigned to treatment (behavior intervention) or control (business as usual) conditions, and K-3 students were screened for externalizing behavior risk status. The…

25 CFR 543.7 - What are the minimum internal control standards for bingo?

Code of Federal Regulations, 2011 CFR

2011-04-01

... software upgrades, data storage media replacement, etc.). The information recorded must be used when...., draw objects and back-up draw objects); and (ii) Random number generator software. (Additional information technology security standards can be found in § 543.16 of this part.) (2) The game software...

25 CFR 543.7 - What are the minimum internal control standards for bingo?

Code of Federal Regulations, 2012 CFR

2012-04-01

... software upgrades, data storage media replacement, etc.). The information recorded must be used when...., draw objects and back-up draw objects); and (ii) Random number generator software. (Additional information technology security standards can be found in § 543.16 of this part.) (2) The game software...

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).

The Childhood Adenotonsillectomy Trial (CHAT): Rationale, Design, and Challenges of a Randomized Controlled Trial Evaluating a Standard Surgical Procedure in a Pediatric Population

PubMed Central

Redline, Susan; Amin, Raouf; Beebe, Dean; Chervin, Ronald D.; Garetz, Susan L.; Giordani, Bruno; Marcus, Carole L.; Moore, Renee H.; Rosen, Carol L.; Arens, Raanan; Gozal, David; Katz, Eliot S.; Mitchell, Ronald B.; Muzumdar, Hiren; Taylor, H.G.; Thomas, Nina; Ellenberg, Susan

2011-01-01

Each year, over 500,000 adenotonsillectomies (AT), mostly for the treatment of pediatric obstructive sleep apnea (OSA) are performed in the US in children under 15 years of age. No definitive study, however, has been yet conducted that has rigorously evaluated the effectiveness of AT for not only improving sleep disordered breathing, but also for improving clinically relevant outcomes, such as neurocognitive function, behavior, and quality of life. The Childhood Adenotonsillectomy Trial (CHAT) was designed to assess neuropsychological and health outcomes in children randomized to receive early AT (eAT) as compared to Watchful Waiting with Supportive Care (WWSC). Important secondary goals of the study are to evaluate outcomes in subgroups defined by obesity and race. This paper addresses key elements in the design and implementation of a controlled trial for a widely used “standard practice” surgical intervention in a pediatric population, that include establishment of standardized data collection procedures across sites for a wide variety of data types, establishment of equipoise, and approaches for minimizing unblinding of selected key personnel. The study framework that was established should provide a useful template for other pediatric controlled studies or other studies that evaluate surgical interventions. Citation: Redline S; Amin R; Beebe D; Chervin RD; Garetz SL; Giordani B; Marcus CL; Moore RH; Rosen CL; Arens R; Gozal D; Katz ES; Mitchell RB; Muzumdar H; Taylor HG; Thomas N; Ellenberg S. The Childhood Adenotonsillectomy Trial (CHAT): rationale, design, and challenges of a randomized controlled trial evaluating a standard surgical procedure in a pediatric population. SLEEP 2011;34(11):1509-1517. PMID:22043122

Effects of gut-directed hypnotherapy on IBS in different clinical settings-results from two randomized, controlled trials.

PubMed

Lindfors, Perjohan; Unge, Peter; Arvidsson, Patrik; Nyhlin, Henry; Björnsson, Einar; Abrahamsson, Hasse; Simrén, Magnus

2012-02-01

Gut-directed hypnotherapy has been found to be effective in irritable bowel syndrome (IBS). However, randomized, controlled studies are rare and few have been performed outside highly specialized research centers. The objective of this study was to study the effect of gut-directed hypnotherapy in IBS in different clinical settings outside the traditional research units. The study population included IBS patients refractory to standard management. In study 1, patients were randomized to receive gut-directed hypnotherapy (12 sessions, 1 h/week) in psychology private practices or supportive therapy, whereas patients were randomized to receive gut-directed hypnotherapy in a small county hospital or to serve as waiting list controls in study 2. Gastrointestinal symptom severity and quality of life were evaluated at baseline, at 3 months follow-up and after 1 year. We randomized 138 IBS patients refractory to standard management, 90 in study 1 and 48 in study 2. In both the studies, IBS-related symptoms were improved at 3 months in the gut-directed hypnotherapy groups (P<0.05), but not in the control groups (ns). In study 1, a significantly greater improvement of IBS-related symptom severity could be detected in the gut-directed hypnotherapy group than in the control group (P<0.05), and a trend in the same direction was seen in study 2 (P=0.17). The results seen at 3 months were sustained up to 1 year. Gut-directed hypnotherapy is an effective treatment alternative for patients with refractory IBS, but the effectiveness is lower when the therapy is given outside the highly specialized research centers.

Effect of aerobic exercise on peripheral nerve functions of population with diabetic peripheral neuropathy in type 2 diabetes: a single blind, parallel group randomized controlled trial.

PubMed

Dixit, Snehil; Maiya, Arun G; Shastry, B A

2014-01-01

To evaluate the effect of moderate intensity aerobic exercise (40%-60% of Heart Rate Reserve (HRR)) on diabetic peripheral neuropathy. A parallel-group, randomized controlled trial was carried out in a tertiary health care setting, India. The study comprised of experimental (moderate intensity aerobic exercise and standard care) and control groups (standard care). Population with type 2 diabetes with clinical neuropathy, defined as a minimum score of seven on the Michigan Diabetic Neuropathy Score (MDNS), was randomly assigned to experimental and control groups by computer generated random number tables. RANOVA was used for data analysis (p<0.05 was significant). A total of 87 patients with DPN were evaluated in the study. After randomization there were 47 patients in the control group and 40 patients in the experimental group. A comparison of two groups using RANOVA for anthropometric measures showed an insignificant change at eight weeks. For distal peroneal nerve's conduction velocity there was a significant difference in two groups at eight weeks (p<0.05), Degrees of freedom (Df)=1, 62, F=5.14, and p=0.03. Sural sensory nerve at eight weeks showed a significant difference in two groups for conduction velocity, Df =1, 60, F=10.16, and p=0.00. Significant differences in mean scores of MDNS were also observed in the two groups at eight weeks (p value significant<0.05). Moderate intensity aerobic exercises can play a valuable role to disrupt the normal progression of DPN in type 2 diabetes. Copyright © 2014 Elsevier Inc. All rights reserved.

Usual and Unusual Care: Existing Practice Control Groups In Randomized Controlled Trials of Behavioral Interventions

PubMed Central

Freedland, Kenneth E.; Mohr, David C.; Davidson, Karina W.; Schwartz, Joseph E.

2011-01-01

Objective To examine the use of existing practice control groups in randomized controlled trials of behavioral interventions, and the role of extrinsic healthcare services in the design and conduct of behavioral trials. Method Selective qualitative review. Results Extrinsic healthcare services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment as usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. Conclusion This review highlights the need for a scientific consensus statement on control groups in behavioral trials. PMID:21536837

Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions.

PubMed

Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E

2011-05-01

To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. Selective qualitative review. Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment-as-usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. This review highlights the need for a scientific consensus statement on control groups in behavioral trials.

Parental mental health moderates the efficacy of exercise training on health-related quality of life in adolescents with congenital heart disease.

PubMed

Dulfer, Karolijn; Duppen, Nienke; Van Dijk, Arie P J; Kuipers, Irene M; Van Domburg, Ron T; Verhulst, Frank C; Van der Ende, Jan; Helbing, Willem A; Utens, Elisabeth M W J

2015-01-01

To evaluate the moderating influence of parental variables on changes in health-related quality of life (HRQoL) in adolescents with Tetralogy of Fallot (ToF) or a Fontan circulation after participation in standardized exercise training. A multicenter randomized controlled trail in which 56 patients, aged 10-15, were randomly allocated (stratified by age, gender, and congenital heart disease) to a 12-week period with either: (a) 3 times per week standardized exercise training or (b) care-as-usual (randomization ratio 2:1). Adolescents and their parents filled in online questionnaires at baseline and at 12-week follow-up. In this randomized controlled trail, primary analyses involved influence of parental mental health and parental social support for exercise on changes in the TNO/AZL Child Quality of Life Questionnaire Child Form at follow-up. Secondary analyses concerned comparing levels of parental characteristics with normative data. Compared with controls, adolescents in the exercise group reported a decrease in social functioning when their parents had more anxiety/insomnia or severe depression themselves. Adolescents also reported a decrease in social functioning when their parents showed poorer overall mental health themselves. Parents reported comparable or even better mental health compared with normative data. The effect of a standardized exercise program on HRQoL changes in adolescents with ToF or a Fontan circulation is moderated by parental mental health, more specifically by parental anxiety/insomnia and severe depression. The trial registration number of this article is NTR2731 ( www.trialregister.nl ).

A 30-month worksite-based lifestyle program to promote cardiovascular health in middle-aged bank employees: Design of the TANSNIP-PESA randomized controlled trial.

PubMed

Coffeng, Jennifer K; van der Ploeg, Hidde P; Castellano, José M; Fernández-Alvira, Juan M; Ibáñez, Borja; García-Lunar, Inés; van der Beek, Allard J; Fernández-Ortiz, Antonio; Mocoroa, Agustín; García-Leal, Laura; Cárdenas, Evelyn; Rojas, Carolina; Martínez-Castro, María I; Santiago-Sacristán, Silvia; Fernández-Gallardo, Miriam; Mendiguren, José M; Bansilal, Sameer; van Mechelen, Willem; Fuster, Valentín

2017-02-01

Cardiovascular disease (CVD) is the leading cause of death worldwide. With atherosclerosis as the underlying cause for many CVD events, prevention or reduction of subclinical atherosclerotic plaque burden (SAPB) through a healthier lifestyle may have substantial public health benefits. The objective was to describe the protocol of a randomized controlled trial investigating the effectiveness of a 30-month worksite-based lifestyle program aimed to promote cardiovascular health in participants having a high or a low degree of SAPB compared with standard care. We will conduct a randomized controlled trial including middle-aged bank employees from the Progression of Early Subclinical Atherosclerosis cohort, stratified by SAPB (high SAPB n=260, low SAPB n=590). Within each stratum, participants will be randomized 1:1 to receive a lifestyle program or standard care. The program consists of 3 elements: (a) 12 personalized lifestyle counseling sessions using Motivational Interviewing over a 30-month period, (b) a wrist-worn physical activity tracker, and (c) a sit-stand workstation. Primary outcome measure is a composite score of blood pressure, physical activity, sedentary time, body weight, diet, and smoking (ie, adapted Fuster-BEWAT score) measured at baseline and at 1-, 2-, and 3-year follow-up. The study will provide insights into the effectiveness of a 30-month worksite-based lifestyle program to promote cardiovascular health compared with standard care in participants with a high or low degree of SAPB. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

META-ANALYSIS OF ACUTE EXERCISE EFFECTS ON STATE ANXIETY: AN UPDATE OF RANDOMIZED CONTROLLED TRIALS OVER THE PAST 25 YEARS.

PubMed

Ensari, Ipek; Greenlee, Tina A; Motl, Robert W; Petruzzello, Steven J

2015-08-01

One prominent and well-cited meta-analysis published nearly 25 years ago reported that an acute or single bout of exercise reduced state anxiety by approximately ¼ standard deviation. We conducted a meta-analysis of randomized controlled trials (RCTs) published after that meta-analysis for updating our understanding of the acute effects of exercise on state anxiety. We searched PubMed, EBSCOHost, Medline, PsycINFO, ERIC, and ScienceDirect for RCTs of acute exercise and state anxiety as an outcome. There were 36 RCTs that met inclusion criteria and yielded data for effect size (ES) generation (Cohen's d). An overall ES was calculated using a random effects model and expressed as Hedge's g. The weighted mean ES was small (Hedge's g = 0.16, standard error (SE) = 0.06), but statistically significant (P < 0.05), and indicated that a single bout of exercise resulted in an improvement in state anxiety compared with control. The overall ES was heterogeneous and post hoc, exploratory analyses using both random- and fixed-effects models identified several variables as moderators including sample age, sex and health status, baseline activity levels, exercise intensity, modality and control condition, randomization, overall study quality, and the anxiety measure (P < 0.05). The cumulative evidence from high quality studies indicates that acute bouts of exercise can yield a small reduction in state anxiety. The research is still plagued by floor effects associated with recruiting persons with normal or lower levels of state anxiety, and this should be overcome in subsequent trials. © 2015 Wiley Periodicals, Inc.

A Randomized Controlled Trial of Short and Standard-Length Consent Forms for a Genetic Cohort Study: Is Longer Better?

PubMed Central

Matsui, Kenji; Lie, Reidar K.; Turin, Tanvir C.; Kita, Yoshikuni

2012-01-01

Background Although the amount of detail in informed consent documents has increased over time and the documents have therefore become very long, there is little research on whether longer informed consent documents actually result in (1) better informed research subjects or (2) higher consent rates. We therefore conducted an add-on randomized controlled trial to the Takashima Study, a prospective Japanese population-based genetic cohort study, to test the hypothesis that a shorter informed consent form would satisfy both of the above goals. Methods Standard (10 459 words, 11 pages) and short (3602 words, 5 pages) consent forms in Japanese were developed and distributed using cluster-randomization to 293 potential cohort subjects living in 9 medico-social units and 288 subjects in 8 medico-social units, respectively. Results Few differences were found between the 2 groups with regard to outcome measures, including participants’ self-perceived understanding, recall of information, concerns, voluntariness, trust, satisfaction, sense of duty, and consent rates. Conclusions A short informed consent form was no less valid than a standard form with regard to fulfilling ethical requirements and securing the scientific validity of research. PMID:22447213

Randomized controlled trial of perioperative antimicrobial therapy based on the results of preoperative bile cultures in patients undergoing biliary reconstruction.

PubMed

Okamura, Kunishige; Tanaka, Kimitaka; Miura, Takumi; Nakanishi, Yoshitsugu; Noji, Takehiro; Nakamura, Toru; Tsuchikawa, Takahiro; Okamura, Keisuke; Shichinohe, Toshiaki; Hirano, Satoshi

2017-07-01

The high frequency of surgical site infections (SSIs) after hepato-pancreato-biliary (HPB) surgery is a problem that needs to be addressed. This prospective, randomized, controlled study examined whether perioperative prophylactic use of antibiotics based on preoperative bile culture results in HPB surgery could decrease SSI. Participants comprised 126 patients who underwent HPB (bile duct, gallbladder, ampullary, or pancreatic) cancer surgery with biliary reconstruction at Hokkaido University Hospital between August 2008 and March 2013 (UMIN Clinical Trial Registry #00001278). Before surgery, subjects were randomly allocated to a targeted group administered antibiotics based on bile culture results or a standard group administered cefmetazole. The primary endpoint was SSI rates within 30 days after surgery. Secondary endpoint was SSI rates for each operative procedure. Of the 126 patients, 124 were randomly allocated (targeted group, n = 62; standard group, n = 62). Frequency of SSI after surgery was significantly lower in the targeted group (27 patients, 43.5%) than in the standard group (44 patients, 71.0%; P = 0.002). Among patients who underwent pancreaticoduodenectomy and hepatectomy, SSI occurred significantly less frequently in the targeted group (P = 0.001 and P = 0.025, respectively). This study demonstrated that preoperative bile culture-targeted administration of prophylactic antibiotics decreased SSIs following HBP surgery with biliary reconstruction. © 2017 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

Ear Acupuncture for Post-Operative Pain Associated with Ambulatory Arthroscopic Knee Surgery: A Randomized Controlled Trial

DTIC Science & Technology

2014-01-14

E7(/(3+21(180%(5 ,QFOXGHDUHDFRGH 14 Jan 2014 Final Report Ear acupuncture for post-operative pain associated with ambulatory arthroscopic...DISTRIBUTION A. Approved for public release: distribution unlimited. The purpose of this study is to compare ear acupuncture plus standard therapy versus...3298 Ear Acupuncture for Post-operative Pa111 Assoc1ated With Ambulatory Arthroscopic Knee Surgery A Randomized Controlled Trial ’• V ’’ ’-’ I

Bibliotherapy for Children with Anxiety Disorders Using Written Materials for Parents: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Rapee, Ronald M.; Abbott, Maree J.; Lyneham, Heidi J.

2006-01-01

The current trial examined the value of modifying empirically validated treatment for childhood anxiety for application via written materials for parents of anxious children. Two hundred sixty-seven clinically anxious children ages 6-12 years and their parents were randomly allocated to standard group treatment, wait list, or a bibliotherapy…

Randomized Trial of a Calling-Infused Career Workshop Incorporating Counselor Self-Disclosure

ERIC Educational Resources Information Center

Dik, Bryan J.; Steger, Michael F.

2008-01-01

A randomized controlled trial was used to test (1) the efficacy of a two-session career development workshop for college student participants; (2) the effect of counselor self-disclosure on outcomes; and (3) the effect of infusing calling and vocation concepts on outcomes. Both standard (person-environment fit) and calling/vocation-infused…

Why Randomized Trials Are Challenging within Adventure Therapy Research: Lessons Learned in Norway

ERIC Educational Resources Information Center

Gabrielsen, Leiv Einar; Fernee, Carina Ribe; Aasen, Gunnar Oland; Eskedal, Leif Torvald

2016-01-01

There are few high-quality studies using randomized controlled trials (RCTs) in the adventure and wilderness therapy literature. Thus, a unison call is heard for more such studies to be carried out. This article presents a Norwegian wilderness therapy research project that planned to incorporate this "gold standard" that is regarded as…

The effects of the Bali Yoga Program (BYP-BC) on reducing psychological symptoms in breast cancer patients receiving chemotherapy: results of a randomized, partially blinded, controlled trial.

PubMed

Lanctôt, Dominique; Dupuis, Gilles; Marcaurell, Roger; Anestin, Annélie S; Bali, Madan

2016-12-01

Background Several cognitive behavioral interventions have been reported to reduce psychological symptoms in breast cancer (BC) patients. The goal of this study was to evaluate the effects of a yoga intervention in reducing depression and anxiety symptoms in BC patients. Methods This study was a randomized, partially blinded, controlled trial comparing a standardized yoga intervention to standard care. It was conducted at three medical centers in Montreal, Canada. Eligible patients were women diagnosed with stage I-III BC receiving chemotherapy. Participants were randomly assigned to receive yoga intervention immediately (experimental group, n=58) or after a waiting period (n=43 control group). The Bali Yoga Program for Breast Cancer Patients (BYP-BC) consisted of 23 gentle Hatha asanas (poses), 2 prayanamas (breathing techniques), shavasanas (relaxation corpse poses) and psychoeducational themes. Participants attended eight weekly sessions lasting 90 min each and received a DVD for home practice with 20- and 40-min sessions. Participants in the wait list control group received standard care during the 8-week waiting period. Results A total of 101 participants took part in the final intention-to-treat analyses. The repeated measures analyses demonstrated that depression symptoms increased in the control group (p=0.007), while no change was reported in the BYP-BC group (p=0.29). Also, depression symptoms decreased in the WL control group after receiving the BYP-BC intervention (p=0.03). Finally, there was no statistical significance in terms of anxiety symptoms (p=0.10). Conclusions Results support the BYP-BC intervention as a beneficial means of reducing and preventing the worsening of depression symptoms during chemotherapy treatment.

The effects of physical training without equipment on pain perception and balance in the elderly: A randomized controlled trial

PubMed Central

Patti, Antonino; Bianco, Antonino; Karsten, Bettina; Montalto, Maria Alessandra; Battaglia, Giuseppe; Bellafiore, Marianna; Cassata, Daniela; Scoppa, Fabio; Paoli, Antonio; Iovane, Angelo; Messina, Giuseppe; Palma, Antonio

2017-01-01

BACKGROUND: Research supports a link between exercise and falls prevention in the older population. OBJECTIVES: Our aims were to evaluate pain perception and balance skills in a group of elderly subjects and to examine the consequences of a standardized equipment-free exercise program intervention on these variables. The study utilized a randomized controlled trial method. METHODS: 92 subjects were recruited from a rural Sicilian village (Resuttano, Sicily, Italy). Subjects were randomly split into two groups, an experimental group (EG; n = 49) and a control group (CG; n = 43). Qualified fitness instructors delivered the standardized physical exercise program for the EG whilst the CG did not receive this exercise intervention. The Berg Balance Scale and the Oswestry Disability Index were administered in both groups before (T0) and after the intervention (T1). RESULTS: At T1, the EG group significantly improvement in balance (p < 0.0001) and pain perception (p < 0.0001). No significant differences were found within the CG both in BBS and ODI, respectively. CONCLUSIONS: Our findings suggest that a 13-weeks standardized exercise equipment-free program is effective in improving balance and perception of pain in the elderly. This type of intervention can consequently provide a low cost strategy to counteract the rate of disability in elderly. PMID:28506013

The Next Step Trial: impact of a worksite colorectal cancer screening promotion program.

PubMed

Tilley, B C; Vernon, S W; Myers, R; Glanz, K; Lu, M; Hirst, K; Kristal, A R

1999-03-01

The Next Step Trial was a randomized trial of worksite colorectal cancer screening promotion and nutrition interventions for automobile industry employees at increased risk of colorectal cancer. Interventions were tested at 28 worksites with 5,042 employees. This report describes results of the screening promotion intervention. Worksites randomized to the control group received a standard program including rectal examination, fecal occult blood testing, and flexible sigmoidoscopy. Intervention worksites received an enhanced program (i.e., standard program plus an educational booklet/telephone call). Compliance (i.e., completion of all recommended screening examinations) and coverage (i.e., completion of at least one screening examination), the primary and secondary outcomes, were measured over 2 years. In the 2 years prior to baseline, 61% of employees had been screened. After random assignment, baseline differences in several employee characteristics and worksite screening procedures were detected, including more past history of screening in control worksites. After adjusting for differences, we found modest, but higher, compliance and coverage in intervention compared with control worksites (odds ratio [95% confidence limits] = 1.46 [1.1-2.0] and 1.33 [1.1, 1.6], respectively). Adding a personally tailored behavioral intervention to a standard colorectal cancer screening program can promote continued employee participation in screening as measured by compliance. Further research is needed to assess intervention effects in other populations. Copyright 1999 American Health Foundation and Academic Press.

Is a videotape to change beliefs and behaviors superior to a standard videotape in acute low back pain? A randomized controlled trial.

PubMed

Newcomer, Karen L; Vickers Douglas, Kristin S; Shelerud, Randy A; Long, Kirsten Hall; Crawford, Brianna

2008-01-01

Cognitive behavioral therapy has been used successfully in acute low back pain (LBP) treatment, but the use of a cognitive behavioral videotape as an adjunct to treatment has not been studied. To determine outcomes for patients with acute LBP receiving a videotape designed to change beliefs and behaviors compared with a standard instructional videotape. Randomized controlled trial; multidisciplinary clinic in an academic setting. Consecutive subjects with less than 3 months of LBP. Of 224 eligible subjects, 138 participated and completed the initial questionnaires. Oswestry Disability Index, Pain and Impairment Relationship Scale, Fear-Avoidance Beliefs Questionnaire; medical costs related to LBP and total medical costs incurred by participants during 1 year of follow-up. Subjects were randomly assigned to receive a behavioral videotape or a control videotape. Other than the videotape, usual care was provided to each patient. No significant differences in any outcome measures or medical costs between the two groups at 12 months. However, baseline Vermont Disability Prediction Questionnaire was significantly lower in those who completed the entire study compared with those who did not complete the study. Compared with a standard instructional videotape, a behavioral videotape did not change beliefs, outcomes, or costs over 1 year. Cost-effective behavioral interventions with high patient retention rates are needed, especially for those at greatest risk of high utilization of resources.

Long-term outcomes and recurrence patterns of standard versus extended pancreatectomy for pancreatic head cancer: a multicenter prospective randomized controlled study.

PubMed

Jang, Jin-Young; Kang, Jae Seung; Han, Youngmin; Heo, Jin Seok; Choi, Seong Ho; Choi, Dong Wook; Park, Sang Jae; Han, Sung-Sik; Yoon, Dong Sup; Park, Joon Seong; Yu, Hee Chul; Kang, Koo Jeong; Kim, Sang Geol; Lee, Hongeun; Kwon, Wooil; Yoon, Yoo-Seok; Han, Ho-Seong; Kim, Sun-Whe

2017-07-01

Our previous randomized controlled trial revealed no difference in 2-year overall survival (OS) between extended and standard resection for pancreatic adenocarcinoma. The present study evaluated the 5-year OS and recurrence patterns according to the extent of pancreatectomy. Between 2006 and 2009, 169 consecutive patients were prospectively enrolled and randomized to standard (n = 83) or extended resection (n = 86) groups to compare 5-year OS rate, long-term recurrence patterns and factors associated with long-term survival. The surgical R0 rate was similar between the standard and extended groups (85.5 vs. 90.7%, P = 0.300). Five-year OS (18.4 vs. 14.4%, P = 0.388), 5-year disease-free survival (14.8 vs. 14.0%, P = 0.531), and overall recurrence rates (74.7 vs. 69.9%, P = 0.497) were not significantly different between the two groups, although the incidence of peritoneal seeding was higher in the extended group (25 vs. 8.1%, P = 0.014). Extended pancreatectomy does not have better short-term and long-term survival outcomes, and shows similar R0 rates and overall recurrence rates compared with standard pancreatectomy. Extended pancreatectomy does not have to be performed routinely for all cases of resectable pancreatic adenocarcinoma, especially considering its associated increased morbidity shown in our previous study. © 2017 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

25-Hydroxyvitamin-D3 serum modulation after use of sunbeds compliant with European Union standards: A randomized open observational controlled trial.

PubMed

Weber, Benedikt; Bachmann, Chantal C; Braun, Ralph; Abraham, Alison G; Serra, Andreas L; Hofbauer, Günther F L

2017-07-01

Regular use of sunbed exposure has been reported to increase 25-hydroxyvitamin-D3 [25(OH)D] serum levels. However, the influence of sunbeds compliant with the recent European Union standard EN-60335-2-27 on 25(OH)D serum levels is unknown. We investigated the impact of standard sunbed use compliant with the European Union standard on 25(OH)D serum modulation and well-being. In a randomized controlled study, 25(OH)D serum levels were measured at enrollment, after 1 week, and after completion of the 12-week period of sunbed use with twice weekly exposure and compared with the control group without any sunbed exposure. In the sunbed intervention group (N = 31), a 27% increase of mean 25(OH)D levels was noted 1 week after starting sunbed use (P < .01). However, after 12 weeks, mean 25(OH)D levels had declined and were no longer different from baseline (P = .06). After 12 weeks, 25(OH)D levels did not differ between the intervention and control group (P = .36). Also the 5-item World Health Organization Well-Being Index score did not differ between the sunbed and control groups (P = .19). For ethical reasons recruitment was limited to persons actively seeking sunbed exposure. Standard use of sunbeds compliant with the European Union standard induced a transient increase of 25(OH)D levels, whereas no change in well-being was observed. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Topical Allium ampeloprasum subsp Iranicum (Leek) extract cream in patients with symptomatic hemorrhoids: a pilot randomized and controlled clinical trial.

PubMed

Mosavat, Seyed Hamdollah; Ghahramani, Leila; Sobhani, Zahra; Haghighi, Ehsan Rahmanian; Heydari, Mojtaba

2015-04-01

Allium ampeloprasum subsp iranicum (Leek) has been traditionally used in antihemorrhoidal topical herbal formulations. This study aimed to evaluate its safety and efficacy in a pilot randomized controlled clinical trial. Twenty patients with symptomatic hemorrhoids were randomly allocated to receive the topical leek extract cream or standard antihemorrhoid cream for 3 weeks. The patients were evaluated before and after the intervention in terms of pain, defecation discomfort, bleeding severity, anal itching severity, and reported adverse events. A significant decrease was observed in the grade of bleeding severity and defecation discomfort in both the leek and antihemorrhoid cream groups after the intervention, while no significant change was observed in pain scores. There was no significant difference between the leek and antihemorrhoid cream groups with regard to mean changes in outcome measures. This pilot study showed that the topical use of leek cream can be as effective as a standard antihemorrhoid cream. © The Author(s) 2015.

A pilot randomized controlled trial of the Yoga of Awareness program in the management of fibromyalgia

PubMed Central

Carson, James W.; Carson, Kimberly M.; Jones, Kim D.; Bennett, Robert M.; Wright, Cheryl L.; Mist, Scott D.

2017-01-01

A mounting body of literature recommends that treatment for fibromyalgia (FM) encompass medications, exercise and improvement of coping skills. However, there is a significant gap in determining an effective counterpart to pharmacotherapy that incorporates both exercise and coping. The aim of this randomized controlled trial was to evaluate the effects of a comprehensive yoga intervention on FM symptoms and coping. A sample of 53 female FM patients were randomized to the 8-week Yoga of Awareness program (gentle poses, meditation, breathing exercises, yoga-based coping instructions, group discussions) or to wait-listed standard care. Data were analyzed by intention to treat. At post-treatment, women assigned to the yoga program showed significantly greater improvements on standardized measures of FM symptoms and functioning, including pain, fatigue, and mood, and in pain catastrophizing, acceptance, and other coping strategies. This pilot study provides promising support for the potential benefits of a yoga program for women with FM. PMID:20946990

EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background Aneurysmal subarachnoid hemorrhage (SAH) may be complicated by delayed cerebral ischemia, which is a major cause of unfavorable clinical outcome and death in SAH-patients. Delayed cerebral ischemia is presumably related to the development of vasospasm triggered by the presence of blood in the basal cisterns. To date, oral application of the calcium antagonist nimodipine is the only prophylactic treatment for vasospasm recognized under international guidelines. In retrospective trials lumbar drainage of cerebrospinal fluid has been shown to be a safe and feasible measure to remove the blood from the basal cisterns and decrease the incidence of delayed cerebral ischemia and vasospasm in the respective study populations. However, the efficacy of lumbar drainage has not been evaluated prospectively in a randomized controlled trial yet. Methods/Design This is a protocol for a 2-arm randomized controlled trial to compare an intervention group receiving early continuous lumbar CSF-drainage and standard neurointensive care to a control group receiving standard neurointensive care only. Adults suffering from a first aneurysmal subarachnoid hemorrhage whose aneurysm has been secured by means of coiling or clipping are eligible for trial participation. The effect of early CSF drainage (starting < 72 h after securing the aneurysm) will be measured in the following ways: the primary endpoint will be disability after 6 months, assessed by a blinded investigator during a personal visit or standardized telephone interview using the modified Rankin Scale. Secondary endpoints include mortality after 6 months, angiographic vasospasm, transcranial Doppler sonography (TCD) mean flow velocity in both middle cerebral arteries and rate of shunt insertion at 6 months after hospital discharge. Discussion Here, we present the study design of a multicenter prospective randomized controlled trial to investigate whether early application of a lumbar drainage improves clinical outcome after aneurysmal subarachnoid hemorrhage. Trial registration www.clinicaltrials.gov Identifier: NCT01258257 PMID:21917146

Cervical dystonia: effectiveness of a standardized physical therapy program; study design and protocol of a single blind randomized controlled trial

PubMed Central

2013-01-01

Background Cervical dystonia is characterized by involuntary muscle contractions of the neck and abnormal head positions that affect daily life activities and social life of patients. Patients are usually treated with botulinum toxin injections into affected neck muscles to relief pain and improve control of head postures. In addition, many patients are referred for physical therapy to improve their ability to perform activities of daily living. A recent review on allied health interventions in cervical dystonia showed a lack of randomized controlled intervention studies regarding the effectiveness of physical therapy interventions. Methods/design The (cost-) effectiveness of a standardized physical therapy program compared to regular physical therapy, both as add-on treatment to botulinum toxin injections will be determined in a multi-centre, single blinded randomized controlled trial with 100 cervical dystonia patients. Primary outcomes are disability in daily functioning assessed with the disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale. Secondary outcomes are pain, severity of dystonia, active range of motion of the head, quality of life, anxiety and depression. Data will be collected at baseline, after six months and one year by an independent blind assessor just prior to botulinum toxin injections. For the cost effectiveness, an additional economic evaluation will be performed with the costs per quality adjusted life-year as primary outcome parameter. Discussion Our study will provide new evidence regarding the (cost-) effectiveness of a standardized, tailored physical therapy program for patients with cervical dystonia. It is widely felt that allied health interventions, including physical therapy, may offer a valuable supplement to the current therapeutic options. A positive outcome will lead to a greater use of the standardized physical therapy program. For the Dutch situation a positive outcome implies that the standardized physical therapy program forms the basis for a national treatment guideline for cervical dystonia. Trial registration Number Dutch Trial registration (Nederlands Trial Register): NTR3437 PMID:23855591

Cervical dystonia: effectiveness of a standardized physical therapy program; study design and protocol of a single blind randomized controlled trial.

PubMed

van den Dool, Joost; Visser, Bart; Koelman, J Hans T M; Engelbert, Raoul H H; Tijssen, Marina A J

2013-07-15

Cervical dystonia is characterized by involuntary muscle contractions of the neck and abnormal head positions that affect daily life activities and social life of patients. Patients are usually treated with botulinum toxin injections into affected neck muscles to relief pain and improve control of head postures. In addition, many patients are referred for physical therapy to improve their ability to perform activities of daily living. A recent review on allied health interventions in cervical dystonia showed a lack of randomized controlled intervention studies regarding the effectiveness of physical therapy interventions. The (cost-) effectiveness of a standardized physical therapy program compared to regular physical therapy, both as add-on treatment to botulinum toxin injections will be determined in a multi-centre, single blinded randomized controlled trial with 100 cervical dystonia patients. Primary outcomes are disability in daily functioning assessed with the disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale. Secondary outcomes are pain, severity of dystonia, active range of motion of the head, quality of life, anxiety and depression. Data will be collected at baseline, after six months and one year by an independent blind assessor just prior to botulinum toxin injections. For the cost effectiveness, an additional economic evaluation will be performed with the costs per quality adjusted life-year as primary outcome parameter. Our study will provide new evidence regarding the (cost-) effectiveness of a standardized, tailored physical therapy program for patients with cervical dystonia. It is widely felt that allied health interventions, including physical therapy, may offer a valuable supplement to the current therapeutic options. A positive outcome will lead to a greater use of the standardized physical therapy program. For the Dutch situation a positive outcome implies that the standardized physical therapy program forms the basis for a national treatment guideline for cervical dystonia. Number Dutch Trial registration (Nederlands Trial Register): NTR3437.

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.

The prompted optional randomization trial: a new design for comparative effectiveness research.

PubMed

Flory, James; Karlawish, Jason

2012-12-01

Randomized controlled trials are the gold standard for medical evidence because randomization provides the best-known protection against confounding of results. Randomization has practical and ethical problems that limit the number of trials that can be conducted, however. A different method for collecting clinical data retains the statistically useful properties of randomization without incurring its practical and ethical challenges. A computerized prompt introduces a random element into clinical decision-making that can be instantly overridden if it conflicts with optimal patient care. This creates a weak form of randomization that still eliminates the effect of all confounders, can be carried out without disturbing routine clinical care, and arguably will not require research-grade informed consent.

The use of Animal-Assisted Therapy in adolescents with acute mental disorders: A randomized controlled study.

PubMed

Stefanini, M C; Martino, A; Allori, P; Galeotti, F; Tani, F

2015-02-01

The aim of this study was to compare the effects of Animal-Assisted Therapy (AAT) with a standard treatment protocol in children and adolescents admitted to the psychiatry hospital for acute mental disorders. We used a methodology involving high quality standards for AAT research. A pre-post experimental design with a randomized controlled trial (RCT) in 34 hospitalized patients (17 treatment, 17 control) was carried out. The study focused on improvement in clinical status including, global functioning measured by the Children Global Assessment Scale (C GAS), format of care and ordinary school attendance measured by a rating scale. Our results indicate a statistically significant improvement in global functioning, reduction in format of care and increased ordinary school attendance in the treatment group, but not in the control group. Our results verify that AAT can have significant positive effects on therapeutic progress and the recovery process. Copyright © 2015 Elsevier Ltd. All rights reserved.

A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'

PubMed Central

Sgandurra, Giuseppina; Lorentzen, Jakob; Inguaggiato, Emanuela; Bartalena, Laura; Beani, Elena; Cecchi, Francesca; Dario, Paolo; Giampietri, Matteo; Greisen, Gorm; Herskind, Anna; Nielsen, Jens Bo; Rossi, Giuseppe; Cioni, Giovanni

2017-01-01

CareToy system is an innovative tele-rehabilitative tool, useful in providing intensive, individualized, home-based, family-centred Early Intervention (EI) in infants. Our aim was to evaluate, through a Randomized Clinical Trial (RCT) study, the effects of CareToy intervention on early motor and visual development in preterm infants. 41 preterm infants (range age: 3.0–5.9 months of corrected age) were enrolled and randomized into two groups, CareToy and Standard Care. 19 infants randomized in CareToy group performed a 4-week CareToy program, while 22 allocated to control group completed 4 weeks of Standard Care. Infant Motor Profile (IMP) was primary outcome measure, Alberta Infant Motor Scale (AIMS) and Teller Acuity Cards were secondary ones. Assessments were carried out at baseline (T0) and at the end of CareToy training or Standard Care period (T1). T1 was the primary endpoint. After RCT phase, 17 infants from control group carried out a 4-week CareToy program, while 18 infants from the CareToy group continued with Standard Care. At the end of this phase, infants were re-assessed at T2. In RCT phase, delta IMP total score and variation and performance sub-domains were significantly higher (P<0.050) in CareToy group if compared to Standard Care group. Similar results were found for Teller Acuity Cards, while no differences between groups were found for AIMS. No differences were found in any outcome measure results (T2-T0), between infants who started CareToy training before or after one month of standard care. This RCT study confirms the results of a previous pilot study, indicating that CareToy system can provide effective home-based EI. Trial Registration: This trial has been registered at www.clinicaltrials.gov (Identifier NCT01990183). PMID:28328946

The effect of a supersaturated calcium phosphate mouth rinse on the development of oral mucositis in head and neck cancer patients treated with (chemo)radiation: a single-center, randomized, prospective study of a calcium phosphate mouth rinse + standard of care versus standard of care.

PubMed

Lambrecht, Maarten; Mercier, Carole; Geussens, Yasmyne; Nuyts, Sandra

2013-10-01

Mucosal damage is an important and debilitating side effect when treating head and neck cancer patients with (chemo-)radiation. The aim of this randomized clinical trial was to investigate whether the addition of a neutral, supersaturated, calcium phosphate (CP) mouth rinse benefits the severity and duration of acute mucositis in head and neck cancer patients treated with (chemo)radiation. A total of 60 patients with malignant neoplasms of the head and neck receiving (chemo)radiation were included in this study. Fifty-eight patients were randomized into two treatment arms: a control group receiving standard of care (n = 31) and a study group receiving standard of care + daily CP mouth rinses (n = 27) starting on the first day of (chemo-)radiation. Oral mucositis and dysphagia were assessed twice a week using the National Cancer Institute common toxicity criteria scale version 3, oral pain was scored with a visual analogue scale. No significant difference in grade III mucositis (59 vs. 71 %; p = 0.25) and dysphagia (33 vs. 42 %, p = 0.39) was observed between the study group compared to the control group. Also no significant difference in time until development of peak mucositis (28.6 vs. 28.7 days; p = 0.48), duration of peak mucositis (22.7 vs. 24.6 days; p = 0.31), recuperation of peak dysphagia (20.5 vs 24.2 days; p = 0.13) and occurrence of severe pain (56 vs. 52 %, p = 0.5). In this randomized study, the addition of CP mouth rinse to standard of care did not improve the frequency, duration or severity of the most common acute toxicities during and early after (chemo)radiation. There is currently no evidence supporting its standard use in daily practice.

The Quality of Reporting of Abstracts in Physical Therapy Literature is Suboptimal: Cross-Sectional, Bibliographic Analysis.

PubMed

Richter, Randy R; Sebelski, Chris A; Austin, Tricia M

2016-09-01

The quality of abstract reporting in physical therapy literature is unknown. The purpose of this study was to provide baseline data for judging the future impact of the 2010 Consolidated Standards of Reporting Trials statement specifically referencing the 2008 Consolidated Standards of Reporting Trials statement for reporting of abstracts of randomized controlled trials across and between a broad sample and a core sample of physical therapy literature. A cross-sectional, bibliographic analysis was conducted. Abstracts of randomized controlled trials from 2009 were retrieved from PubMed, PEDro, and CENTRAL. Eligibility was determined using PEDro criteria. For outcomes measures, items from the Consolidated Standards of Reporting Trials statement for abstract reporting were used for assessment. Raters were not blinded to citation details. Using a computer-generated set of random numbers, 150 abstracts from 112 journals comprised the broad sample. A total of 53 abstracts comprised the core sample. Fourteen of 20 Consolidated Standards of Reporting Trials items for both samples were reported in less than 50% of the abstracts. Significantly more abstracts in the core sample reported (% difference core - broad; 95% confidence interval) title (28.4%; 12.9%-41.2%), blinding (15.2%; 1.6%-29.8%), setting (47.6%; 32.4%-59.4%), and confidence intervals (13.1%; 5.0%-25.1%). These findings provide baseline data for determining if continuing efforts to improve abstract reporting are heeded.

Efficacy of combination herbal product (Curcuma longa and Eugenia jambolana) used for diabetes mellitus.

PubMed

Rao, Sadia Saleem; Najam, Rahila

2016-01-01

The purpose of this research was to evaluate the efficacy of a combination herbal product that is traditionally used for managing diabetes mellitus. Herbal drug contains Curcuma longa and Eugenia jambolanain the ratio of 1:1. It was orally administered at the dose of 1082 mg/70 kg twice a day for a period of 6 weeks to alloxan induced diabetic rats and compared with glibenclamide (standard). The effects of drug were observed at intervals, with respect to random and fasting glucose levels. HbA1C was also monitored after the drug treatment to monitor the overall diabetic effect. Results revealed that the combination of two herbs significantly reduced fasting and random glucose levels with HbA1C of less than 6% (p<0.001) in comparison to diabetic control. The control of fasting blood glucose levels by herbal combination is similar to the standard drug, glibenclamide (p<0.05). Random glucose levels by herbal combination is better than standard drug after one week and six weeks of treatment (p<0.01 and p<0.001 respectively) and similar after third week of treatment (p<0.05). Also, herbal drug combination showed HbA1C closer to the standard drug. It shows that this herbal combination can be of potential benefit in managing diabetes mellitus in future.

Standard dose versus low dose non-vitamin K antagonist oral anticoagulants in Asian patients with atrial fibrillation: A meta-analysis of contemporary randomized controlled trials.

PubMed

Wang, Kang-Ling; Giugliano, Robert P; Goto, Shinya; Chiu, Chun-Chih; Lin, Chun-Yi; Lai, En-Yu; Chiang, Chern-En

2016-12-01

Although randomized controlled trials (RCTs) indicated that standard dose non-vitamin K antagonist oral anticoagulants (NOACs) were more compelling, low dose NOACs are commonly used in clinical practice in Asia. The purpose of this study was to assess the relative therapeutic benefit and risk of standard dose vs low dose NOACs in Asian patients enrolled in contemporary RCTs. We performed a prespecified meta-analysis of 3155 Asian patients with NOACs in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) and ENGAGE AF-TIMI 48 (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) trials. Efficacy and safety with standard dose vs low dose NOACs were compared by risk ratios (RRs) and 95% confidence intervals (CIs) in a random-effects model. An evidence network incorporating additional Asian patients from ROCKET AF, J- ROCKET AF, and ARISTOTLE was constructed with the Bayesian method. Risks of stroke or systemic embolism and ischemic stroke were significantly reduced with standard dose vs low dose NOACs (RR 0.62, 95% CI 0.45-0.85; and RR 0.55, 95% CI 0.38-0.79, respectively). Rates of major, intracranial, and life-threatening bleeding with 2 dosing regimens were broadly similar (RR 1.31, 95% CI 0.74-2.33; RR 1.54, 95% CI 0.72-3.30; and RR 1.49, 95% CI 0.87-2.55, respectively). Absolute rates of all-cause mortality and the net clinical outcome with standard dose NOACs were lower but not statistically significant (absolute reduction 0.4% per year and 1.1% per year, respectively). Network meta-analyses demonstrated that standard dose NOACs had the most favorable risk-benefit profile among oral anticoagulants. In Asian patients, standard dose NOACs represent a more appealing therapeutic option than low dose NOACs, with a significant reduction in ischemic stroke without an excess of major bleeding. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Interventions for reducing fear of childbirth: A systematic review and meta-analysis of clinical trials.

PubMed

MoghaddamHosseini, Vahideh; Nazarzadeh, Milad; Jahanfar, Shayesteh

2017-11-07

Fear of childbirth is a problematic mental health issue during pregnancy. But, effective interventions to reduce this problem are not well understood. To examine effective interventions for reducing fear of childbirth. The Cochrane Central Register of Controlled Trials, PubMed, Embase and PsycINFO were searched since inception till September 2017 without any restriction. Randomised controlled trials and quasi-randomised controlled trials comparing interventions for treatment of fear of childbirth were included. The standardized mean differences were pooled using random and fixed effect models. The heterogeneity was determined using the Cochran's test and I 2 index and was further explored in meta-regression model and subgroup analyses. Ten studies inclusive of 3984 participants were included in the meta-analysis (2 quasi-randomized and 8 randomized clinical trials). Eight studies investigated education and two studies investigated hypnosis-based intervention. The pooled standardized mean differences of fear for the education intervention and hypnosis group in comparison with control group were -0.46 (95% CI -0.73 to -0.19) and -0.22 (95% CI -0.34 to -0.10), respectively. Both types of interventions were effective in reducing fear of childbirth; however our pooled results revealed that educational interventions may reduce fear with double the effect of hypnosis. Further large scale randomized clinical trials and individual patient data meta-analysis are warranted for assessing the association. Copyright © 2017 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

Resistance training for hot flushes in postmenopausal women: Randomized controlled trial protocol.

PubMed

Berin, Emilia; Hammar, Mats L; Lindblom, Hanna; Lindh-Åstrand, Lotta; Spetz Holm, Anna-Clara E

2016-03-01

Hot flushes and night sweats affect 75% of all women after menopause and is a common reason for decreased quality of life in mid-aged women. Hormone therapy is effective in ameliorating symptoms but cannot be used by all women due to contraindications and side effects. Engagement in regular exercise is associated with fewer hot flushes in observational studies, but aerobic exercise has not proven effective in randomized controlled trials. It remains to be determined whether resistance training is effective in reducing hot flushes and improves quality of life in symptomatic postmenopausal women. The aim of this study is to investigate the effect of standardized resistance training on hot flushes and other health parameters in postmenopausal women. This is an open, parallel-group, randomized controlled intervention study conducted in Linköping, Sweden. Sixty symptomatic and sedentary postmenopausal women with a mean of at least four moderate to severe hot flushes per day or 28 per week will be randomized to an exercise intervention or unchanged physical activity (control group). The intervention consists of 15 weeks of standardized resistance training performed three times a week under supervision of a physiotherapist. The primary outcome is hot flush frequency assessed by self-reported hot flush diaries, and the difference in change from baseline to week 15 will be compared between the intervention group and the control group. The intention is that this trial will contribute to the evidence base regarding effective treatment for hot flushes. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Efficacy and safety of Vernonia cinerea (L.) Less. for smoking cessation: A systematic review and meta-analysis of randomized controlled trials.

PubMed

Puttarak, Panupong; Pornpanyanukul, Patarachai; Meetam, Thunyaluk; Bunditanukul, Katha; Chaiyakunapruk, Nathorn

2018-04-01

Several randomized controlled trials have investigated Vernonia cinerea (L.) Less. for smoking cessation but there remains no critical summary of overall findings. This study uses systematic review and meta-analysis to summarize the efficacy and safety of V. cinerea. Nine databases were searched through November 2017. Randomized controlled trials that reported the smoking cessation effect of V. cinerea were included. Data were extracted by two independent researchers. Study quality was assessed using the Cochrane risk of bias and JADAD score. The estimates of pooled effects were calculated as relative risk (RR) with 95% CI using a random-effects model. Five trials with 347 smokers were included. V. cinerea treatment group was significantly associated with cessation rate higher than that in the control group with no evidence of heterogeneity for both continuous abstinence rate (CAR) at week 8 with risk ratio (RR): 1.69, 95% CI [1.00, 2.86]; week 12 RR: 2.18, 95% CI [1.17, 4.04]) and 7-day point prevalence abstinence rate (PAR) (week 8 RR: 1.51, 95% CI [1.01, 2.27]; week 12 RR: 1.93, 95% CI [1.24, 2.99]) at week 8 and 12, respectively. There was no significant difference of all adverse events between the treatment and the control groups. Our study demonstrates that V. cinerea has potential efficacy for smoking cessation. Further well-design RCTs of standardized V. cinerea compared with standard treatment should be conducted to strengthen this evidence. Copyright © 2018 Elsevier Ltd. All rights reserved.

Autologous platelet-rich gel for treatment of diabetic chronic refractory cutaneous ulcers: A prospective, randomized clinical trial.

PubMed

Li, Lan; Chen, Dawei; Wang, Chun; Yuan, Nanbing; Wang, Yan; He, Liping; Yang, Yanzhi; Chen, Lihong; Liu, Guanjian; Li, Xiujun; Ran, Xingwu

2015-01-01

The purpose of the study is to examine the safety and effectiveness of topical autologous platelet-rich gel (APG) application on facilitating the healing of diabetic chronic refractory cutaneous ulcers. The study was designed as a prospective, randomized controlled trial between January 1, 2007 and December 31, 2011. Eligible inpatients at the Diabetic Foot Care Center of West China Hospital, Sichuan University (China) were randomly prescribed with a 12-week standard treatment of ulcers (the control group) or standard treatment plus topical application APG (the APG group). The wound healing grades (primary endpoint), time to complete healing, and healing velocity within 12 weeks were monitored as short-term effectiveness measurements, while side effects were documented safety endpoints. The rates of survival and recurrence within the follow up were recorded as long-term effectiveness endpoints. Analysis on total diabetic ulcers (DUs) (n = 117) and subgroup analysis on diabetic foot ulcers (DFUs) (n = 103) were both conducted. Standard treatment plus APG treatment was statistically more effective than standard treatment (p < 0.05 in both total DUs and subgroup of DFUs). The subjects defined as healing grade 1 were 50/59 (84.8%) in total DUs and 41/48 (85.4%) in DFUs in the APG group compared with 40/58 (69.0%) and 37/55 (67.3%) in the control group from intent to treat population. The Kaplan-Meier time-to-healing were significantly different between the two groups (p < 0.05 in both total DUs and subgroup of DFUs). No side effects were identified after topical APG application. The long-term survival and recurrence rates were comparative between groups (p > 0.05). This study shows that topical APG application plus standard treatment is safe and quite effective on diabetic chronic refractory cutaneous ulcers, compared with standard treatment. © 2015 by the Wound Healing Society.

Small laser spot versus standard laser spot photodynamic therapy for idiopathic choroidal neovascularization: a randomized controlled study.

PubMed

Li, Xiao-xin; Tao, Yong

2012-12-01

Idiopathic choroidal neovascularization (ICNV) affects young patients and thus may have a significant impact on vision and life quality over a patient's lifespan. This study was designed to compare the visual outcome and retinal pigment epithelium (RPE) damage after photodynamic therapy (PDT) with small laser spot and PDT with standard laser spot for idiopathic choroidal neovascularization (ICNV). This was a randomized controlled study. Fifty-two patients with ICNV were enrolled and randomly divided into a study group (small laser spot PDT, n = 27) and a control group (standard laser spot PDT, n = 25). Best corrected visual acuity (BCVA), optic coherence tomography (OCT) and fluorescein angiography (FA) findings were the main measurements. The patients were followed up 1 week, 1, 3, 6, 9 months and 1 year after PDT. BCVA improvement was statistically significantly higher in the study group than the control group at 6-month ((25.53 ± 15.01) letters vs. (14.71 ± 11.66) letters, P = 0.025) and 9-month follow-ups ((27.53 ± 17.78) letters vs. (15.59 ± 12.21) letters, P = 0.039). At 3- and 6-month follow-ups, the quadrants of RPE damage between the two groups varied significantly (P < 0.001 and P = 0.023, respectively). In each follow-up, the number of cases with decreased or unchanged leakage of choroidal neovascularization by FA and reduced subretinal fluid by OCT did not vary significantly between the two groups. Ten cases (37.0%) in the study group and eight cases (32.0%) in the control group suffered from recurrent CNV (P = 0.703). Better visual improvements, less RPE damage, a similar recurrent rate of CNV and change of subretinal fluid were observed in the small laser spot PDT group than in the standard laser spot PDT group for ICNV.

In Vivo Arthroscopic Temperatures: A Comparison Between 2 Types of Radiofrequency Ablation Systems in Arthroscopic Anterior Cruciate Ligament Reconstruction-A Randomized Controlled Trial.

PubMed

Matthews, Brent; Wilkinson, Matthew; McEwen, Peter; Hazratwala, Kaushik; Doma, Kenji; Manoharan, Varaguna; Bahho, Zaid; McEwen, Shannon

2017-01-01

To compare a plasma ablation device with a standard ablation device in anterior cruciate ligament (ACL) reconstruction to determine which system is superior in terms of intra-articular heat generation and diathermy efficiency. This was a prospective, randomized controlled trial. The inclusion criteria were adult patients undergoing primary ACL reconstruction. Patients were randomized preoperatively to the standard ablation group or the plasma ablation group. A thermometer was inserted into the inferior suprapatellar pouch, and the temperature, time, and duration of radiofrequency ablation were measured continually. No significant differences were found between the standard ablation system and the plasma ablation system for maximum temperature (29.77°C and 29.34°C, respectively; P = .95), mean temperature (26.16°C and 26.99°C, respectively; P = .44), minimum temperature (22.66°C and 23.94°C, respectively; P = .54), and baseline temperature (26.80°C and 27.93°C, respectively; P = .35). Similarly, no significant differences were found for operative time (82.90 minutes and 80.50 minutes, respectively; P = .72) and mean diathermy activation times (2.6 minutes for both systems; P = .90). The between-system coefficient of variation for the measured parameters ranged from 0.12% to 3.69%. No intra-articular readings above the temperature likely to damage chondrocytes were recorded. The mean irrigation fluid temperature had a significant correlation with the maximum temperature reached during the procedure (Spearman rank correlation, r = 0.87; P < .01). No difference in temperature was observed between the standard ablation and plasma ablation probes during ACL reconstruction. Temperatures did not exceed critical temperatures associated with chondrocyte death. Level I, randomized controlled trial. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Prevention of hypothermia in patients undergoing orthotopic liver transplantation using the humigard® open surgery humidification system: a prospective randomized pilot and feasibility clinical trial.

PubMed

Weinberg, Laurence; Huang, Andrew; Alban, Daniel; Jones, Robert; Story, David; McNicol, Larry; Pearce, Brett

2017-01-23

Perioperative thermal disturbances during orthotopic liver transplantation (OLT) are common. We hypothesized that in patients undergoing OLT the use of a humidified high flow CO 2 warming system maintains higher intraoperative temperatures when compared to standardized multimodal strategies to maintain thermoregulatory homeostasis. We performed a randomized pilot study in adult patients undergoing primary OLT. Participants were randomized to receive either open wound humidification with a high flow CO 2 warming system in addition to standard care (Humidification group) or to standard care alone (Control group). The primary end point was nasopharyngeal core temperature measured 5 min immediately prior to reperfusion of the donor liver (Stage 3 - 5 min). Secondary endpoints included intraoperative PaCO 2 , minute ventilation and the use of vasoconstrictors. Eleven patients were randomized to each group. Both groups were similar for age, body mass index, MELD, SOFA and APACHE II scores, baseline temperature, and duration of surgery. Immediately prior to reperfusion (Stage 3 - 5 min) the mean (SD) core temperature was higher in the Humidification Group compared to the Control Group: 36.0 °C (0.13) vs. 35.4 °C (0.22), p = 0.028. Repeated measured ANOVA showed that core temperatures over time during the stages of the transplant were higher in the Humidification Group compared to the Control Group (p < 0.0001). There were no significant differences in the ETCO 2 , PaCO 2 , minute ventilation, or inotropic support. The humidified high flow CO 2 warming system was superior to standardized multimodal strategies in maintaining normothermia in patients undergoing OLT. Use of the device was feasible and did not interfere with any aspects of surgery. A larger study is needed to investigate if the improved thermoregulation observed is associated with improved patient outcomes. ACTRN12616001631493 . Retrospectively registered 25 November 2016.

Effect of therapeutic exercises on pregnancy-related low back pain and pelvic girdle pain: Secondary analysis of a randomized controlled trial.

PubMed

Sklempe Kokic, Iva; Ivanisevic, Marina; Uremovic, Melita; Kokic, Tomislav; Pisot, Rado; Simunic, Bostjan

2017-03-06

To investigate the effect of a supervised, structured exercise programme on the occurrence and severity of pregnancy-related lumbopelvic pain. Randomized controlled trial. A total of 45 pregnant women were randomly assigned to 2 groups: an experimental group (n = 20; mean age 32.8 (standard deviation (SD) 3.6) years) and a control group (n = 22; mean age 32.2 years (SD 4.9)). Exercise intervention for the experimental group consisted of aerobic and resistance exercises performed bi-weekly from the date of inclusion into the study until the end of pregnancy, together with at least 30 min of brisk daily walks. A numeric rating scale, Roland-Morris Disability Questionnaire (RMDQ), and Pelvic Girdle Questionnaire (PGQ) were used to measure outcomes. The control group received only standard antenatal care. There were significant differences between the 2 groups on the numeric rating scale, PGQ and RMDQ scores in the 36th week of pregnancy (p = 0.017; p = 0.005; p < 0.001, respectively) in favour of the experimental group. The exercise programme had a beneficial effect on the severity of lumbopelvic pain in pregnancy, reducing the intensity of pain and the level of disability experienced as a result.

Effects of a College Access Program for Youth Underrepresented in Higher Education: A Randomized Experiment

ERIC Educational Resources Information Center

Bergin, David A.; Cooks, Helen C.; Bergin, Christi C.

2007-01-01

This article describes EXCEL, a program that encourages youth underrepresented in higher education to enroll in higher education, specifically at the sponsoring university. Eighty-three eighth grade students with GPA of B and above and standardized test scores at grade level or above were randomly assigned to the program or to a control group. The…

Randomized Trial of Prize-Based Reinforcement Density for Simultaneous Abstinence from Cocaine and Heroin

ERIC Educational Resources Information Center

Ghitza, Udi E.; Epstein, David H.; Schmittner, John; Vahabzadeh, Massoud; Lin, Jia-Ling; Preston, Kenzie L.

2007-01-01

To examine the effect of reinforcer density in prize-based abstinence reinforcement, heroin/cocaine users (N = 116) in methadone maintenance (100 mg/day) were randomly assigned to a noncontingent control group (NonC) or to 1 of 3 groups that earned prize draws for abstinence: manual drawing with standard prize density (MS) or computerized drawing…

Preliminary Evaluation of a Tier 2 Mathematics Intervention for First-Grade Students: Using a Theory of Change to Guide Formative Evaluation Activities

ERIC Educational Resources Information Center

Clarke, Ben; Doabler, Christian T.; Strand Cary, Mari; Kosty, Derek; Baker, Scott; Fien, Hank; Smolkowski, Keith

2014-01-01

This pilot study examined the efficacy of a Tier 2 first-grade mathematics intervention program targeting whole-number understanding for students at risk in mathematics. The study used a randomized block design. Students (N = 89) were randomly assigned to treatment (Fusion) or control (standard district practice) conditions. Measures of…

The Maudsley Model of Family-Based Treatment for Anorexia Nervosa: A Qualitative Evaluation of Parent-to-Parent Consultation

ERIC Educational Resources Information Center

Rhodes, Paul; Brown, Jac; Madden, Sloane

2009-01-01

This article describes the qualitative analysis of a randomized control trial that explores the use of parent-to-parent consultations as an augmentation to the Maudsley model of family-based treatment for anorexia. Twenty families were randomized into two groups, 10 receiving standard treatment and 10 receiving an additional parent-to-parent…

Efficacy and safety of electroacupuncture with different acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial.

PubMed

Chen, Bo; Hu, Shu-xiang; Liu, Bao-hu; Zhao, Tian-yi; Li, Bo; Liu, Yan; Li, Ming-yue; Pan, Xing-fang; Guo, Yong-ming; Chen, Ze-lin; Guo, Yi

2015-05-12

Many patients experience nausea and vomiting during chemotherapy treatment. Evidence demonstrates that electroacupuncture is beneficial for controlling chemotherapy-induced nausea and vomiting (CINV). However, the acupoint or matching acupoint with the best efficacy for controlling CINV still remains unidentified. This study consists of a randomized controlled trial (RCT) with four parallel arms: a control group and three electroacupuncture groups (one with Neiguan (PC6), one with Zhongwan (CV12), and one with both PC6 and CV12). The control group received standard antiemetic only, while the other three groups received electroacupuncture stimulation with different acupoints besides the standard antiemetic. The intervention is done once daily from the first day (day 1) to the fourth day (day 4) during chemotherapy treatment. The primary outcome measures include frequency of nausea, vomiting and retching. The secondary outcome measures are the grade of constipation and diarrhea, electrogastrogram, assessment of quality of life, assessment of anxiety and depression, and other adverse effects during the chemotherapy. Assessments are scheduled from one day pre-chemotherapy (day 0) to the fifth day of chemotherapy (day 5). Follow-ups are done from day 6 to day 21. The aim of this study is to evaluate the efficacy and safety of electro-acupuncture with different acupoints in the management of CINV. The register number of randomized controlled trial is NCT02195908 . The date of registration was 21 July 2014.

Developing a Reporting Guideline for Social and Psychological Intervention Trials

PubMed Central

Mayo-Wilson, Evan; Hopewell, Sally; Macdonald, Geraldine; Moher, David; Grant, Sean

2013-01-01

Understanding randomized controlled trials of complex social and psychological interventions requires a detailed description of the interventions tested and the methods used to evaluate them. However, randomized controlled trial reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. We explain how reporting guidelines have improved the quality of reports in medicine, and describe the ongoing development of a new reporting guideline for randomized controlled trials: an extension of the Consolidated Standards of Reporting Trials for social and psychological interventions. We invite readers to participate in the project by visiting our Web site, to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/consort-study). PMID:23947317

Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

PubMed

Johansen, Mette Yun; MacDonald, Christopher Scott; Hansen, Katrine Bagge; Karstoft, Kristian; Christensen, Robin; Pedersen, Maria; Hansen, Louise Seier; Zacho, Morten; Wedell-Neergaard, Anne-Sophie; Nielsen, Signe Tellerup; Iepsen, Ulrik Wining; Langberg, Henning; Vaag, Allan Arthur; Pedersen, Bente Klarlund; Ried-Larsen, Mathias

2017-08-15

It is unclear whether a lifestyle intervention can maintain glycemic control in patients with type 2 diabetes. To test whether an intensive lifestyle intervention results in equivalent glycemic control compared with standard care and, secondarily, leads to a reduction in glucose-lowering medication in participants with type 2 diabetes. Randomized, assessor-blinded, single-center study within Region Zealand and the Capital Region of Denmark (April 2015-August 2016). Ninety-eight adult participants with non-insulin-dependent type 2 diabetes who were diagnosed for less than 10 years were included. Participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n = 64) or the standard care group (n = 34). All participants received standard care with individual counseling and standardized, blinded, target-driven medical therapy. Additionally, the lifestyle intervention included 5 to 6 weekly aerobic training sessions (duration 30-60 minutes), of which 2 to 3 sessions were combined with resistance training. The lifestyle participants received dietary plans aiming for a body mass index of 25 or less. Participants were followed up for 12 months. Primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 12-month follow-up, and equivalence was prespecified by a CI margin of ±0.4% based on the intention-to-treat population. Superiority analysis was performed on the secondary outcome reductions in glucose-lowering medication. Among 98 randomized participants (mean age, 54.6 years [SD, 8.9]; women, 47 [48%]; mean baseline HbA1c, 6.7%), 93 participants completed the trial. From baseline to 12-month follow-up, the mean HbA1c level changed from 6.65% to 6.34% in the lifestyle group and from 6.74% to 6.66% in the standard care group (mean between-group difference in change of -0.26% [95% CI, -0.52% to -0.01%]), not meeting the criteria for equivalence (P = .15). Reduction in glucose-lowering medications occurred in 47 participants (73.5%) in the lifestyle group and 9 participants (26.4%) in the standard care group (difference, 47.1 percentage points [95% CI, 28.6-65.3]). There were 32 adverse events (most commonly musculoskeletal pain or discomfort and mild hypoglycemia) in the lifestyle group and 5 in the standard care group. Among adults with type 2 diabetes diagnosed for less than 10 years, a lifestyle intervention compared with standard care resulted in a change in glycemic control that did not reach the criterion for equivalence, but was in a direction consistent with benefit. Further research is needed to assess superiority, as well as generalizability and durability of findings. clinicaltrials.gov Identifier: NCT02417012.

Science, Medicine, and Intercessory Prayer

PubMed Central

Sloan, Richard P.; Ramakrishnan, Rajasekhar

2012-01-01

Among the many recent attempts to demonstrate the medical benefits of religious activity, the methodologically strongest seem to be studies of the effects of distant intercessory prayer (IP). In these studies, patients are randomly assigned to receive standard care or standard care plus the prayers or “healing intentions” of distant intercessors. Most of the scientific community has dismissed such research, but cavalier rejection of studies of IP is unwise, because IP studies appear to conform to the standards of randomized controlled trials (RCTs) and, as such, would have a significant advantage over observational investigations of associations between religious variables and health outcomes. As we demonstrate, however, studies of IP fail to meet the standards of RCTs in several critical respects. They fail to adequately measure and control exposure to prayer from others, which is likely to exceed IP and to vary widely from subject to subject, and whose magnitude is unknown. This supplemental prayer so greatly attenuates the differences between the treatment and control groups that sample sizes are too large to justify studies of IP. Further, IP studies generally do not specify the outcome variables, raising problems of multiple comparisons and Type 1 errors. Finally, these studies claim findings incompatible with current views of the physical universe and consciousness. Unless these problems are solved, studies of IP should not be conducted. PMID:17146135

Effect of High Intensity Interval and Continuous Swimming Training on Body Mass Adiposity Level and Serum Parameters in High-Fat Diet Fed Rats.

PubMed

da Rocha, Guilherme L; Crisp, Alex H; de Oliveira, Maria R M; da Silva, Carlos A; Silva, Jadson O; Duarte, Ana C G O; Sene-Fiorese, Marcela; Verlengia, Rozangela

2016-01-01

This study aimed to investigate the effects of interval and continuous training on the body mass gain and adiposity levels of rats fed a high-fat diet. Forty-eight male Sprague-Dawley rats were randomly divided into two groups, standard diet and high-fat diet, and received their respective diets for a period of four weeks without exercise stimuli. After this period, the animals were randomly divided into six groups (n = 8): control standard diet (CS), control high-fat diet (CH), continuous training standard diet (CTS), continuous training high-fat diet (CTH), interval training standard diet (ITS), and interval training high-fat diet (ITH). The interval and continuous training consisted of a swimming exercise performed over eight weeks. CH rats had greater body mass gain, sum of adipose tissues mass, and lower serum high density lipoprotein values than CS. The trained groups showed lower values of feed intake, caloric intake, body mass gain, and adiposity levels compared with the CH group. No significant differences were observed between the trained groups (CTS versus ITS and CTH versus ITH) on body mass gains and adiposity levels. In conclusion, both training methodologies were shown to be effective in controlling body mass gain and adiposity levels in high-fat diet fed rats.

The comparison between limited open carpal tunnel release using direct vision and tunneling technique and standard open carpal tunnel release: a randomized controlled trial study.

PubMed

Suppaphol, Sorasak; Worathanarat, Patarawan; Kawinwongkovit, Viroj; Pittayawutwinit, Preecha

2012-04-01

To compare the operative outcome of carpal tunnel release between limited open carpal tunnel release using direct vision and tunneling technique (group A) with standard open carpal tunnel release (group B). Twenty-eight patients were enrolled in the present study. A single blind randomized control trial study was conducted to compare the postoperative results between group A and B. The study parameters were Levine's symptom severity and functional score, grip and pinch strength, and average two-point discrimination. The postoperative results between two groups were comparable with no statistical significance. Only grip strength at three months follow up was significantly greater in group A than in group B. The limited open carpal tunnel release in the present study is effective comparable to the standard open carpal tunnel release. The others advantage of this technique are better cosmesis and improvement in grip strength at the three months postoperative period.

A Randomized Controlled Trial of an Intensive Nutrition Intervention Versus Standard Nutrition Care to Avoid Excess Weight Gain After Kidney Transplantation: The INTENT Trial.

PubMed

Henggeler, Cordula K; Plank, Lindsay D; Ryan, Kristin J; Gilchrist, Emily L; Casas, Jessie M; Lloyd, Lyn E; Mash, Laura E; McLellan, Sandra L; Robb, Jennifer M; Collins, Michael G

2018-05-02

Excessive weight gain is common after kidney transplantation and increases cardiovascular risk. The aim of this randomized controlled trial was to determine whether an intensive nutrition and exercise intervention delivered alongside routine post-transplant care would reduce post-transplant weight gain. Single-blind, randomized controlled trial. Adult kidney transplant recipients at a regional transplant center were recruited during routine outpatient clinic visits in the first month after transplant. Patients with a body mass index >40 kg/m 2 or <18.5 kg/m 2 , severe malnutrition, or ongoing medical complications were excluded. Participants were randomized to intensive nutrition intervention (individualized nutrition and exercise counselling; 12 dietitian visits; 3 exercise physiologist visits over 12 months) or to standard nutrition care (guideline based; 4 dietitian visits). The primary outcome was weight at 6 months after transplant adjusted for baseline weight, obesity, and gender, analyzed using analysis of covariance. The secondary outcomes included body composition, biochemistry, quality of life, and physical function. Thirty-seven participants were randomized to the intensive intervention (n = 19) or to standard care (n = 18); one intensive group participant withdrew before baseline. Weight increased between baseline, 6 and 12 months (78.0 ± 13.7 [standard deviation], 79.6 ± 13.0 kg, 81.6 ± 12.9 kg; mean change 4.6% P < .001) but at 6 months did not differ significantly between the groups: 77.0 ± 12.4 kg (intensive); 82.2 ± 13.4 kg (standard); difference in adjusted means 0.4 kg (95% confidence interval: -2.2 to 3.0 kg); analysis of covariance P = .7. No between-group differences in secondary outcomes were observed. Across the whole cohort, total body protein and physical function (gait speed, sit to stand, grip strength, physical activity, and quality of life [all but 2 domains]) improved. However, adverse changes were seen for total body fat, HbA1c, and fasting glucose across the cohort. Kidney transplant recipients in the first year after transplant did not benefit from an intensive nutrition intervention compared with standard nutrition care, although weight gain was relatively modest in both groups. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Measuring the Effects of an Animal-Assisted Intervention for Pediatric Oncology Patients and Their Parents: A Multisite Randomized Controlled Trial [Formula: see text].

PubMed

McCullough, Amy; Ruehrdanz, Ashleigh; Jenkins, Molly A; Gilmer, Mary Jo; Olson, Janice; Pawar, Anjali; Holley, Leslie; Sierra-Rivera, Shirley; Linder, Deborah E; Pichette, Danielle; Grossman, Neil J; Hellman, Cynthia; Guérin, Noémi A; O'Haire, Marguerite E

2018-05-01

This multicenter, parallel-group, randomized trial examined the effects of an animal-assisted intervention on the stress, anxiety, and health-related quality of life for children diagnosed with cancer and their parents. Newly diagnosed patients, aged 3 to 17 years (n = 106), were randomized to receive either standard care plus regular visits from a therapy dog (intervention group), or standard care only (control group). Data were collected at set points over 4 months of the child's treatment. Measures included the State-Trait Anxiety Inventory™, Pediatric Quality of Life Inventory, Pediatric Inventory for Parents, and child blood pressure and heart rate. All instruments were completed by the child and/or his/her parent(s). Children in both groups experienced a significant reduction in state anxiety ( P < .001). Parents in the intervention group showed significantly decreased parenting stress ( P = .008), with no changes in stress among parents in the control group. However, no significant differences between groups over time on any measures were observed. Animal-assisted interventions may provide certain benefits for parents and families during the initial stages of pediatric cancer treatment.

Adjunctive Hyperbaric Oxygen Therapy for Healing of Chronic Diabetic Foot Ulcers: A Randomized Controlled Trial.

PubMed

Chen, Chen-Yu; Wu, Re-Wen; Hsu, Mei-Chi; Hsieh, Ching-Jung; Chou, Man-Chun

The purpose of this study was to compare the effect of standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care alone on wound healing, markers of inflammation, glycemic control, amputation rate, survival rate of tissue, and health-related quality of life in patients with diabetic foot ulcers (DFUs). Prospective, randomized, open-label, controlled study. The sample comprised 38 patients with nonhealing DFUs who were deemed poor candidates for vascular surgery. Subjects were randomly allocated to an experimental group (standard care plus HBOT, n = 20) or a control group (standard care alone, n = 18). The study setting was a medical center in Kaohsiung City, Taiwan. Hyperbaric oxygen therapy was administered in a hyperbaric chamber under 2.5 absolute atmospheric pressure for 120 minutes; subjects were treated 5 days a week for 4 consecutive weeks. Both groups received standard wound care including debridement of necrotic tissue, topical therapy for Wagner grade 2 DFUs, dietary control and pharmacotherapy to maintain optimal blood glucose levels. Wound physiological indices were measured and blood tests (eg, markers of inflammation) were undertaken. Health-related quality of life was measured using the Medical Outcomes Study 36-Item Short Form. Complete DFU closure was achieved in 5 patients (25%) in the HBOT group (n = 20) versus 1 participant (5.5%) in the routine care group (n = 18) (P = .001). The amputation rate was 5% for the HBOT group and 11% for the routine care group (χ = 15.204, P = .010). The HBOT group showed statistically significant improvements in inflammation index, blood flow, and health-related quality of life from pretreatment to 2 weeks after the last therapy ended (P < .05). Hemoglobin A1c was significantly lower in the HBOT group following treatment (P < .05) but not in the routine care group. Adjunctive HBOT improved wound healing in persons with DFU. Therapy also reduced the risk of amputation of the affected limb. We assert that at least 20 HBOT sessions are required to be effective.

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

Kegel, T.M.

Calibration laboratories are faced with the need to become accredited or registered to one or more quality standards. One requirement common to all of these standards is the need to have in place a measurement assurance program. What is a measurement assurance program? Brian Belanger, in Measurement Assurance Programs: Part 1, describes it as a {open_quotes}quality assurance program for a measurement process that quantifies the total uncertainty of the measurements (both random and systematic components of error) with respect to national or designated standards and demonstrates that the total uncertainty is sufficiently small to meet the user`s requirements.{close_quotes} Rolf Schumachermore » is more specific in Measurement Assurance in Your Own Laboratory. He states, {open_quotes}Measurement assurance is the application of broad quality control principles to measurements of calibrations.{close_quotes} Here, the focus is on one important part of any measurement assurance program: implementation of statistical process control (SPC). Paraphrasing Juran`s Quality Control Handbook, a process is in statistical control if the only observed variations are those that can be attributed to random causes. Conversely, a process that exhibits variations due to assignable causes is not in a state of statistical control. Finally, Carrol Croarkin states, {open_quotes}In the measurement assurance context the measurement algorithm including instrumentation, reference standards and operator interactions is the process that is to be controlled, and its direct product is the measurement per se. The measurements are assumed to be valid if the measurement algorithm is operating in a state of control.{close_quotes} Implicit in this statement is the important fact that an out-of-control process cannot produce valid measurements. 7 figs.« less

Electrical Stimulation for Pressure Injuries: A Health Technology Assessment.

PubMed

2017-01-01

Pressure injuries (bedsores) are common and reduce quality of life. They are also costly and difficult to treat. This health technology assessment evaluates the effectiveness, cost-effectiveness, budget impact, and lived experience of adding electrical stimulation to standard wound care for pressure injuries. We conducted a systematic search for studies published to December 7, 2016, limited to randomized and non-randomized controlled trials examining the effectiveness of electrical stimulation plus standard wound care versus standard wound care alone for patients with pressure injuries. We assessed the quality of evidence through Grading of Recommendations Assessment, Development, and Evaluation (GRADE). In addition, we conducted an economic literature review and a budget impact analysis to assess the cost-effectiveness and affordability of electrical stimulation for treatment of pressure ulcers in Ontario. Given uncertainties in clinical evidence and resource use, we did not conduct a primary economic evaluation. Finally, we conducted qualitative interviews with patients and caregivers about their experiences with pressure injuries, currently available treatments, and (if applicable) electrical stimulation. Nine randomized controlled trials and two non-randomized controlled trials were found from the systematic search. There was no significant difference in complete pressure injury healing between adjunct electrical stimulation and standard wound care. There was a significant difference in wound surface area reduction favouring electrical stimulation compared with standard wound care.The only study on cost-effectiveness of electrical stimulation was partially applicable to the patient population of interest. Therefore, the cost-effectiveness of electrical stimulation cannot be determined. We estimate that the cost of publicly funding electrical stimulation for pressure injuries would be $0.77 to $3.85 million yearly for the next 5 years.Patients and caregivers reported that pressure injuries were burdensome and reduced their quality of life. Patients and caregivers also noted that electrical stimulation seemed to reduce the time it took the wounds to heal. While electrical stimulation is safe to use (GRADE quality of evidence: high) there is uncertainty about whether it improves wound healing (GRADE quality of evidence: low). In Ontario, publicly funding electrical stimulation for pressure injuries could result in extra costs of $0.77 to $3.85 million yearly for the next 5 years.

Mud-Bath Therapy in Addition to Usual Care in Bilateral Knee Osteoarthritis: An Economic Evaluation Alongside a Randomized Controlled Trial.

PubMed

Ciani, Oriana; Pascarelli, Nicola Antonio; Giannitti, Chiara; Galeazzi, Mauro; Meregaglia, Michela; Fattore, Giovanni; Fioravanti, Antonella

2017-07-01

To perform a cost-effectiveness analysis of mud-bath therapy (MBT) in addition to usual treatment compared to usual treatment alone in patients with bilateral knee osteoarthritis (OA). An economic evaluation alongside a randomized controlled trial was conducted. Patients were randomly assigned to receive either a 2-week cycle of MBT in addition to their usual treatment or to continue routine care alone. The EuroQol 5-domain questionnaire was administered at baseline, 2 weeks, and at 3, 6, 9, and 12 months. Direct health care resource consumption data up until 12 months were derived from a daily diary given to patients and returned at prescheduled followup visits. A total of 103 patients were included (n = 53 for MBT patients; n = 50 for controls). Overall, patients in the MBT group accrued mean ± SD 0.835 ± 0.10 quality-adjusted life years (QALYs) compared to 0.753 ± 0.11 in the control group (P < 0.001). Average direct costs per patient (€303 versus €975; P < 0.001) were higher in the control group, primarily because of hospitalization for total knee replacement and use of intraarticular hyaluronic acid. Bootstrapping replications of costs and QALY sample distributions consistently indicated that the MBT therapy combined with standard therapy represents a dominant strategy as compared with standard therapy alone. The probability of MBT being cost-effective at standard cost-effectiveness thresholds (e.g., €20,000/QALY) is 100%. The results of this cost-effectiveness analysis support the use of MBT as midterm complementary therapy in the management of knee OA. © 2016, American College of Rheumatology.

Effects of physical activity on schoolchildren's academic performance: The Active Smarter Kids (ASK) cluster-randomized controlled trial.

PubMed

Resaland, Geir K; Aadland, Eivind; Moe, Vegard Fusche; Aadland, Katrine N; Skrede, Turid; Stavnsbo, Mette; Suominen, Laura; Steene-Johannessen, Jostein; Glosvik, Øyvind; Andersen, John R; Kvalheim, Olav M; Engelsrud, Gunn; Andersen, Lars B; Holme, Ingar M; Ommundsen, Yngvar; Kriemler, Susi; van Mechelen, Willem; McKay, Heather A; Ekelund, Ulf; Anderssen, Sigmund A

2016-10-01

To investigate the effect of a seven-month, school-based cluster-randomized controlled trial on academic performance in 10-year-old children. In total, 1129 fifth-grade children from 57 elementary schools in Sogn og Fjordane County, Norway, were cluster-randomized by school either to the intervention group or to the control group. The children in the 28 intervention schools participated in a physical activity intervention between November 2014 and June 2015 consisting of three components: 1) 90min/week of physically active educational lessons mainly carried out in the school playground; 2) 5min/day of physical activity breaks during classroom lessons; 3) 10min/day physical activity homework. Academic performance in numeracy, reading and English was measured using standardized Norwegian national tests. Physical activity was measured objectively by accelerometry. We found no effect of the intervention on academic performance in primary analyses (standardized difference 0.01-0.06, p>0.358). Subgroup analyses, however, revealed a favorable intervention effect for those who performed the poorest at baseline (lowest tertile) for numeracy (p=0.005 for the subgroup∗group interaction), compared to controls (standardized difference 0.62, 95% CI 0.19-1.07). This large, rigorously conducted cluster RCT in 10-year-old children supports the notion that there is still inadequate evidence to conclude that increased physical activity in school enhances academic achievement in all children. Still, combining physical activity and learning seems a viable model to stimulate learning in those academically weakest schoolchildren. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Immediate effect of a functional wrist orthosis for children with cerebral palsy or brain injury: A randomized controlled trial.

PubMed

Jackman, Michelle; Novak, Iona; Lannin, Natasha; Galea, Claire

2017-10-28

Two-group randomized controlled trial. Upper limb orthoses worn during functional tasks are commonly used in pediatric neurologic rehabilitation, despite a paucity of high-level evidence. The purpose of this study was to investigate if a customized functional wrist orthosis, when placed on the limb, leads to an immediate improvement in hand function for children with cerebral palsy or brain injury. A 2-group randomized controlled trial involving 30 children was conducted. Participants were randomized to either receive a customized functional wrist orthosis (experimental, n = 15) or not receive an orthosis (control, n = 15). The box and blocks test was administered at baseline and repeated 1 hour after experimental intervention, with the orthosis on if randomized to the orthotic group. After intervention, there were no significant differences on the box and blocks test between the orthotic group (mean, 10.13; standard deviation, 11.476) and the no orthotic group (mean, 14.07; standard deviation, 11.106; t[28], -0.954; P = .348; and 95% confidence interval, -12.380 to 4.513). In contrast to the findings of previous studies, our results suggest that a functional wrist orthosis, when supporting the joint in a 'typical' position, may not lead to an immediate improvement in hand function. Wearing a functional wrist orthosis did not lead to an immediate improvement in the ability of children with cerebral palsy or brain injury to grasp and release. Further research is needed combining upper limb orthoses with task-specific training and measuring outcomes over the medium to long term. Copyright © 2017 Hanley & Belfus. All rights reserved.

Helping Seniors Plan for Posthospital Discharge Needs Before a Hospitalization Occurs: Results from the Randomized Control Trial of PlanYourLifespan.org.

PubMed

Lindquist, Lee A; Ramirez-Zohfeld, Vanessa; Sunkara, Priya D; Forcucci, Chris; Campbell, Dianne S; Mitzen, Phyllis; Ciolino, Jody D; Kricke, Gayle; Seltzer, Anne; Ramirez, Ana V; Cameron, Kenzie A

2017-11-01

Investigate the effect of PlanYourLifespan.org (PYL) on knowledge of posthospital discharge options. Multisite randomized controlled trial. Nonhospitalized adults, aged =65 years, living in urban, suburban, and rural areas of Texas, Illinois, and Indiana. PYL is a national, publicly available tool that provides education on posthospital therapy choices and local home-based resources. Participants completed an in-person baseline survey, followed by exposure to intervention or attention control (AC) websites, then 1-month and 3-month telephone surveys. The primary knowledge outcome was measured with 6 items (possible 0-6 points) pertaining to hospital discharge needs. Among 385 participants randomized, mean age was 71.9 years (standard deviation 5.6) and 79.5% of participants were female. At 1 month, the intervention group had a 0.6 point change (standard deviation = 1.6) versus the AC group who had a -0.1 point change in knowledge score. Linear mixed modeling results suggest sex, health literacy level, level of education, income, and history of high blood pressure/kidney disease were significant predictors of knowledge over time. Controlling for these variables, treatment effect remained significant (P < 0.0001). Seniors who used PYL demonstrated an increased understanding of posthospitalization and home services compared to the control group. © 2017 Society of Hospital Medicine

Healthy Learning Mind - a school-based mindfulness and relaxation program: a study protocol for a cluster randomized controlled trial.

PubMed

Volanen, Salla-Maarit; Lassander, Maarit; Hankonen, Nelli; Santalahti, Päivi; Hintsanen, Mirka; Simonsen, Nina; Raevuori, Anu; Mullola, Sari; Vahlberg, Tero; But, Anna; Suominen, Sakari

2016-07-11

Mindfulness has shown positive effects on mental health, mental capacity and well-being among adult population. Among children and adolescents, previous research on the effectiveness of mindfulness interventions on health and well-being has shown promising results, but studies with methodologically sound designs have been called for. Few intervention studies in this population have compared the effectiveness of mindfulness programs to alternative intervention programs with adequate sample sizes. Our primary aim is to explore the effectiveness of a school-based mindfulness intervention program compared to a standard relaxation program among a non-clinical children and adolescent sample, and a non-treatment control group in school context. In this study, we systematically examine the effects of mindfulness intervention on mental well-being (primary outcomes being resilience; existence/absence of depressive symptoms; experienced psychological strengths and difficulties), cognitive functions, psychophysiological responses, academic achievements, and motivational determinants of practicing mindfulness. The design is a cluster randomized controlled trial with three arms (mindfulness intervention group, active control group, non-treatment group) and the sample includes 59 Finnish schools and approx. 3 000 students aged 12-15 years. Intervention consists of nine mindfulness based lessons, 45 mins per week, for 9 weeks, the dose being identical in active control group receiving standard relaxation program called Relax. The programs are delivered by 14 educated facilitators. Students, their teachers and parents will fill-in the research questionnaires before and after the intervention, and they will all be followed up 6 months after baseline. Additionally, students will be followed 12 months after baseline. For longer follow-up, consent to linking the data to the main health registers has been asked from students and their parents. The present study examines systematically the effectiveness of a school-based mindfulness program compared to a standard relaxation program, and a non-treatment control group. A strength of the current study lies in its methodologically rigorous, randomized controlled study design, which allows novel evidence on the effectiveness of mindfulness over and above a standard relaxation program. ISRCTN18642659 . Retrospectively registered 13 October 2015.

Therapeutic alliance in psychological therapy for people with recent onset psychosis who use cannabis.

PubMed

Berry, Katherine; Gregg, Lynsey; Lobban, Fiona; Barrowclough, Christine

2016-05-01

This paper examines the role of therapeutic alliance in predicting outcomes in a Randomized Controlled Trial of Motivational Interviewing and Cognitive Behavioral Therapy (MICBT) for problematic cannabis use in recent onset psychosis. All clients were participating in a three arm pragmatic rater-blind randomized controlled trial of brief MICBT plus standard care compared with longer term MICBT plus standard care and standard care alone. Participants completed measures to assess clinical symptoms, global functioning and substance misuse at baseline, 4.5months, 9months and 18months. Clients and therapists completed the Working Alliance Inventory approximately one month into therapy. Client alliance data was available for 35 participants randomized to therapy and therapist alliance data was available for 52 participants randomized to therapy. At baseline, poorer client-rated alliance was associated with more negative symptoms, poorer insight and greater cannabis use, whereas poorer therapist-rated alliance was only associated with amount of cannabis used per cannabis using day. Alliance ratings were also positively associated with amount of therapy: client-rated alliance was higher in the longer compared to the briefer therapy; therapist-rated alliance was associated with greater number of sessions attended (controlling for type of therapy) and therapy completion. In predicting outcome, client-rated alliance predicted total symptom scores and global functioning scores at follow-up. Neither client nor therapist alliance predicted changes in substance misuse at any time point. Findings demonstrate that individuals with psychosis and substance misuse who form better alliances with their therapists gain greater benefits from therapy, at least in terms of improvements in global functioning. Copyright © 2016 Elsevier Inc. All rights reserved.

Tight versus standard blood pressure control in patients with hypertension with and without cardiovascular disease.

PubMed

Reboldi, Gianpaolo; Angeli, Fabio; de Simone, Giovanni; Staessen, Jan A; Verdecchia, Paolo

2014-03-01

An excessive blood pressure (BP) reduction might be dangerous in high-risk patients with cardiovascular disease. In the Studio Italiano Sugli Effetti CARDIOvascolari del Controllo della Pressione Arteriosa SIStolica (Cardio-Sis), 1111 nondiabetic patients with systolic BP ≥150 mm Hg were randomly assigned to a systolic BP target <140 mm Hg (standard control) or <130 mm Hg (tight control). We stratified patients by absence (n=895) or presence (n=216) of established cardiovascular disease at entry. Antihypertensive treatment was open-label and tailored to each patient's needs. After 2-year follow-up, the primary end point of the study, electrocardiographic left ventricular hypertrophy, occurred less frequently in the tight than in the standard control group in the patients without (10.8% versus 15.2%) and with (14.1% versus 23.5%) established cardiovascular disease (P for interaction=0.82). The main secondary end point, a composite of cardiovascular events and all-cause death, occurred less frequently in the tight than in the standard control group both in patients without (1.47 versus 3.68 patient-years; P=0.016) and with (7.87 versus 11.22 patient-years; P=0.049) previous cardiovascular disease. In a multivariable Cox model, allocation to tight BP control reduced the risk of cardiovascular events to a similar extent in patients with or without overt cardiovascular disease at randomization (P for interaction=0.43). In conclusion, an intensive treatment aimed to lower systolic BP<130 mm Hg reduced left ventricular hypertrophy and improved clinical outcomes to a similar extent in patients with hypertension and without established cardiovascular disease.

Randomized control trial to evaluate the effects of acute testosterone administration in men on muscle mass, strength, and physical function following ACL reconstructive surgery: rationale, design, methods.

PubMed

Wu, Brian W; Berger, Max; Sum, Jonathan C; Hatch, George F; Schroeder, E Todd

2014-12-06

The anterior cruciate ligament (ACL) is one of four major ligaments in the knee that provide stability during physical activity. A tear in the ACL is characterized by joint instability that leads to decreased activity, knee dysfunction, reduced quality of life and a loss of muscle mass and strength. While rehabilitation is the standard-of-care for return to daily function, additional surgical reconstruction can provide individuals with an opportunity to return to sports and strenuous physical activity. Over 200,000 ACL reconstructions are performed in the United States each year, and rehabilitation following surgery is slow and expensive. One possible method to improve the recovery process is the use of intramuscular testosterone, which has been shown to increase muscle mass and strength independent of exercise. With short-term use of supraphysiologic doses of testosterone, we hope to reduce loss of muscle mass and strength and minimize loss of physical function following ACL reconstruction compared to standard-of-care alone. This study is a double-blinded randomized control trial. Men 18-50 years of age, scheduled for ACL reconstruction are randomized into two groups. Participants randomized to the testosterone group receive intramuscular testosterone administration once per week for 8 weeks starting 2 weeks prior to surgery. Participants randomized to the control group receive a saline placebo intramuscularly instead of testosterone. Lean mass, muscle strength and physical function are measured at 5 time points: 2 weeks pre-surgery, 1 day pre-surgery, and 6, 12, 24 weeks post-surgery. Both groups follow standard-of-care rehabilitation protocol. We believe that testosterone therapy will help reduce the loss of muscle mass and strength experienced after ACL injury and reconstruction. Hopefully this will provide a way to shorten the rehabilitation necessary following ACL reconstruction. If successful, testosterone therapy may also be used for other injuries involving trauma and muscle atrophy. NCT01595581, REGISTRATION: May 8, 2012.

The Trouble with the Gold Standard: School Libraries & Research

ERIC Educational Resources Information Center

Gordon, Carol

2007-01-01

Although science has provided empirical evidence for centuries, it's only as recently as the 1940s that a scientific method called randomized controlled trials (RCT) emerged as a technique to test the efficacy of drugs and medical procedures. Since RCT is unique in that it can claim causality, it's considered the "gold standard" of research…

The effect of mud therapy on pain relief in patients with knee osteoarthritis: a meta-analysis of randomized controlled trials.

PubMed

Liu, Hua; Zeng, Chao; Gao, Shu-guang; Yang, Tuo; Luo, Wei; Li, Yu-sheng; Xiong, Yi-lin; Sun, Jin-peng; Lei, Guang-hua

2013-10-01

A meta-analysis was conducted to examine the effect of mud therapy on pain relief in patients with knee osteoarthritis (OA). A detailed search of PubMed®/MEDLINE® was undertaken to identify randomized controlled trials and prospective comparative studies published before 9 March 2013 that compared mud therapy with control group treatments in patients with knee OA. A quantitative meta-analysis of seven studies (410 patients) was performed. There was a significant difference between the groups in the visual analogue scale pain score (standardized mean difference [SMD] -0.73) and Western Ontario and McMaster Universities Osteoarthritis Index pain score (SMD -0.30), with differences in favour of mud therapy. Mud therapy is a favourable option for pain relief in patients with knee OA. Additional high-quality randomized controlled trials need to be conducted to explore this issue further and to confirm this conclusion.

Blinded randomized controlled study of a web-based otoscopy simulator in undergraduate medical education.

PubMed

Stepniak, Camilla; Wickens, Brandon; Husein, Murad; Paradis, Josee; Ladak, Hanif M; Fung, Kevin; Agrawal, Sumit K

2017-06-01

OtoTrain is a Web-based otoscopy simulator that has previously been shown to have face and content validity. The objective of this study was to evaluate the effectiveness of this Web-based otoscopy simulator in teaching diagnostic otoscopy to novice learners STUDY DESIGN: Prospective, blinded randomized control trial. Second-year medical students were invited to participate in the study. A pretest consisted of a series of otoscopy videos followed by an open-answer format assessment pertaining to the characteristics and diagnosis of each video. Participants were then randomly divided into a control group and a simulator group. Following the pretest, both groups attended standard otology lectures, but the simulator group was additionally given unlimited access to OtoTrain for 1 week. A post-test was completed using a separate set of otoscopy videos. Tests were graded based on a comprehensive marking scheme. The pretest and post-test were anonymized, and the three evaluators were blinded to student allotment. A total of 41 medical students were enrolled in the study and randomized to the control group (n = 20) and the simulator group (n = 21). There was no significant difference between the two groups on their pretest scores. With the standard otology lectures, the control group had a 31% improvement in their post-test score (mean ± standard error of the mean, 30.4 ± 1.5) compared with their pretest score (23.3 ± 1.8) (P < .001). The simulator group had the addition of OtoTrain to the otology lectures, and their score improved by 71% on their post-test (37.8 ± 1.6) compared to their pretest (22.1 ± 1.9) (P < .001). Comparing the post-test results, the simulator group had a 24% higher score than the control group (P < .002). Inter-rater reliability between the blinded evaluators was excellent (r = 0.953, P < .001). The use of OtoTrain increased the diagnostic otoscopic performance in novice learners. OtoTrain may be an effective teaching adjunct for undergraduate medical students. 1b. Laryngoscope, 127:1306-1311, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

Patient-specific instrumentation in total knee arthroplasty: simpler, faster and more accurate than standard instrumentation-a randomized controlled trial.

PubMed

Vide, João; Freitas, Tânia Pinto; Ramos, Acácio; Cruz, Henrique; Sousa, João Paulo

2017-08-01

This randomized controlled trial was conducted to compare patient-specific instrumentation (PSI) to standard instrumentation regarding efficacy to achieve a good coronal alignment and differences in surgical time, blood loss and length of stay. Ninety-five of 100 randomized patients eligible for total knee arthroplasty were analysed. PSI with magnetic resonance and long-leg radiograph was performed in 47 patients, while 48 patients received standard instrumentation. Primary outcome measure was coronal alignment, evaluated with long-leg radiograph. Deviation >3° varus/valgus was considered an outlier. Surgical time was compared from skin to skin. Length of stay was a post hoc analysis. Blood loss was evaluated comparing the number of blood units spent, fall in haemoglobin and haematocrit levels. Standard instrumentation had a higher number of outliers in the coronal alignment with a relative risk of 3.015, compared to PSI. Surgical time was reduced by 18 min (24.8 %) with the PSI, as well as length of stay, with a half-day reduction. Number of blood units spent was significantly less in the PSI group. Relative risk of transfusion was 7.09 for patients in the standard instrumentation group. Difference in Hg and Htc levels were not significant. No patient had to abandon PSI. Minor changes to preoperative plan occurred in 14.9 % of the patient: cut review in 4.3 % and insert change in 10.6 %. Patient-specific instrumentation (PSI) is able to provide important advantages over standard instrumentation in total knee arthroplasty: it lowers the risk of outliers and transfusion, is a faster procedure and enables a shorter length of stay with a low rate of intraoperative adjustments. I.

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.

A randomized controlled trial of comprehensive early intervention care in patients with first-episode psychosis in Japan: 1.5-year outcomes from the J-CAP study.

PubMed

Nishida, Atsushi; Ando, Shuntaro; Yamasaki, Syudo; Koike, Shinsuke; Ichihashi, Kayo; Miyakoshi, Yuji; Maekawa, Sanae; Nakamura, Tomohisa; Natsubori, Tatsunobu; Ichikawa, Eriko; Ishigami, Hiroki; Sato, Kojiro; Matsunaga, Asami; Smith, Jo; French, Paul; Harima, Hirohiko; Kishi, Yoshiki; Fujita, Izumi; Kasai, Kiyoto; Okazaki, Yuji

2018-04-08

The first episode of psychosis represents a critical period wherein comprehensive early intervention in psychosis (EIP) may alter the course of illness. However, evidence from randomized controlled trials that have examined the impact of comprehensive EIP care on clinical and functional recovery assessed by independent blinded raters is limited. The objective of this study was to conduct a single-blinded multicenter trial comparing comprehensive EIP care and standard care in young patients with first-episode psychosis (FEP) in Japan (J-CAP Study). A total of 77 participants with FEP (aged 15-35 years) were randomized to receive standard care or specialized comprehensive EIP care and were followed up for 1.5 years (trial no.: UMIN000005092). Function (measured with the Global Assessment of Functioning) and clinical remission (defined by internationally standardized criteria proposed by the Remission in Schizophrenia Working Group) were evaluated by independent raters who were blinded to group assignment. Dropout rate and other secondary outcomes were also examined. The specialized EIP care group had a higher clinical remission rate (odds ratio, 6.3; 95% confidence interval, 1.0-37.9) and lower treatment dropout rate (odds ratio, 0.038; 95% confidence interval, 0.002-0.923) than the standard care group, even after adjusting for baseline characteristics. Functional improvement in the specialized EIP care group was slightly higher than that in the standard care group, but this difference was not statistically significant (p = 0.195). From the results, we conclude that comprehensive EIP care may provide advantages over standard care in patients with FEP. Copyright © 2018. Published by Elsevier Ltd.

Simulation improves procedural protocol adherence during central venous catheter placement: a randomized-controlled trial

PubMed Central

Peltan, Ithan D.; Shiga, Takashi; Gordon, James A.; Currier, Paul F.

2015-01-01

Background Simulation training may improve proficiency at and reduces complications from central venous catheter (CVC) placement, but the scope of simulation’s effect remains unclear. This randomized controlled trial evaluated the effects of a pragmatic CVC simulation program on procedural protocol adherence, technical skill, and patient outcomes. Methods Internal medicine interns were randomized to standard training for CVC insertion or standard training plus simulation-based mastery training. Standard training involved a lecture, a video-based online module, and instruction by the supervising physician during actual CVC insertions. Intervention-group subjects additionally underwent supervised training on a venous access simulator until they demonstrated procedural competence. Raters evaluated interns’ performance during internal jugular CVC placement on actual patients in the medical intensive care unit. Generalized estimating equations were used to account for outcome clustering within trainees. Results We observed 52 interns place 87 CVCs. Simulation-trained interns exhibited better adherence to prescribed procedural technique than interns who received only standard training (p=0.024). There were no significant differences detected in first-attempt or overall cannulation success rates, mean needle passes, global assessment scores or complication rates. Conclusions Simulation training added to standard training improved protocol adherence during CVC insertion by novice practitioners. This study may have been too small to detect meaningful differences in venous cannulation proficiency and other clinical outcomes, highlighting the difficulty of patient-centered simulation research in settings where poor outcomes are rare. For high-performing systems, where protocol deviations may provide an important proxy for rare procedural complications, simulation may improve CVC insertion quality and safety. PMID:26154250

Active involvement and intervention in patients exposed to whiplash trauma in automobile crashes reduces costs: a randomized, controlled clinical trial and health economic evaluation.

PubMed

Rosenfeld, Mark; Seferiadis, Aris; Gunnarsson, Ronny

2006-07-15

To examine and compare the costs and consequences in a partial economic evaluation of two competing interventions in patients exposed to whiplash trauma in automobile crashes. The interventions were an active involvement and intervention using early mobilization and a standard intervention of rest, recommended short-term immobilization in a cervical collar and a cautious, gradual self-exercise program according to a leaflet. The study was randomized and controlled. The aim of the study was to compare the costs of an active involvement and intervention versus a standard intervention and to relate them to the clinical benefits in patients exposed to whiplash trauma in automobile crashes to facilitate decision-making regarding intervention and resource allocation. There is very little known about the health economic aspects of various interventions in the target treatment group of patients. Based on a prospective, randomized, clinical trial, data on clinical effectiveness and resources used for the active involvement and intervention and standard intervention were collected for a comparative analysis of the costs related to physical therapy treatment and sick leave. A cost-consequence analysis consisting of a modified cost-effectiveness analysis was used. The costs were significantly lower after 6 and 36 months with an active involvement and intervention as compared with the standard intervention. The active involvement and intervention were significantly superior in reducing experienced pain and reducing sick leave. For patients exposed to whiplash trauma in a motor vehicle collision, an active involvement and intervention were both less costly and more effective than a standard intervention.

Impact of a Randomized Controlled Trial in Arsenic Risk Communication on Household Water-Source Choices in Bangladesh

PubMed Central

Tarozzi, Alessandro; Pfaff, Alexander; Balasubramanya, Soumya; Ahmed, Kazi Matin; van Geen, Alexander

2013-01-01

We conducted a randomized controlled trial in rural Bangladesh to examine how household drinking-water choices were affected by two different messages about risk from naturally occurring groundwater arsenic. Households in both randomized treatment arms were informed about the arsenic level in their well and whether that level was above or below the Bangladesh standard for arsenic. Households in one group of villages were encouraged to seek water from wells below the national standard. Households in the second group of villages received additional information explaining that lower-arsenic well water is always safer and these households were encouraged to seek water from wells with lower levels of arsenic, irrespective of the national standard. A simple model of household drinking-water choice indicates that the effect of the emphasis message is theoretically ambiguous. Empirically, we find that the richer message had a negative, but insignificant, effect on well-switching rates, but the estimates are sufficiently precise that we can rule out large positive effects. The main policy implication of this finding is that a one-time oral message conveying richer information on arsenic risks, while inexpensive and easily scalable, is unlikely to be successful in reducing exposure relative to the status-quo policy. PMID:23997355

Efficacy of standardized extract of Hibiscus sabdariffa L. (Malvaceae) in improving iron status of adults in malaria endemic area: A randomized controlled trial.

PubMed

Peter, Emanuel L; Rumisha, Susan F; Mashoto, Kijakazi O; Minzi, Omary Ms; Mfinanga, Sayoki

2017-09-14

Indigenous community of Mkuranga district have been using aqueous extract of H. sabdariffa L. for treating anemia. However, there have been neither safety nor efficacy studies to validate this medicinal product in anemia. The purpose of this study was to establish efficacy and safety of standardized aqueous extract of H. sabdariffa L. in anemic adults. This was a randomized controlled clinical trial in which 130 adults' men and women aged 18-50 years were involved after meeting the inclusion criteria. Initially, standardized aqueous extract of H. sabdariffa L. was prepared using optimized extraction parameters. Stratified randomization was used to randomize participants into four fixed dose groups. The first group received oral dose of 1000ml while the 2nd group was randomized to receive 1500ml orally. The last two groups were given a dose of 2000ml of extract and 200mg ferrous sulphate tablet respectively. Primary endpoint was the actual change of iron status indicators at the end of 30 days follow up period as compared to those recorded at baseline. Adverse effects were assessed at every 10th day scheduled visit. In all arms, HB and hematopoietic parameters were measured using HemoCue hemoglobinometer® (HemoCue, Ängelholm, Sweden) and hematology analyzer® respectively at the trial site. Follow up was done for 30 days. A total of 82 participants were included for analysis. A standardized aqueous extract of H. sabdariffa L. did not improve iron status in anemic adults in malaria endemic region (P>0.005). However, there was evidence to support the safety of the extract for human consumptions as herbal supplement. Iron and organic acids contents of H. sabdariffa L. extract showed the potential of improving hematopoietic parameters. Studies with bigger sample size are therefore needed to establish the efficacy of the extract when concurrently used with malaria chemoprophylaxis in malaria endemic areas. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Simulation-based Randomized Comparative Assessment of Out-of-Hospital Cardiac Arrest Resuscitation Bundle Completion by Emergency Medical Service Teams Using Standard Life Support or an Experimental Automation-assisted Approach.

PubMed

Choi, Bryan; Asselin, Nicholas; Pettit, Catherine C; Dannecker, Max; Machan, Jason T; Merck, Derek L; Merck, Lisa H; Suner, Selim; Williams, Kenneth A; Jay, Gregory D; Kobayashi, Leo

2016-12-01

Effective resuscitation of out-of-hospital cardiac arrest (OHCA) patients is challenging. Alternative resuscitative approaches using electromechanical adjuncts may improve provider performance. Investigators applied simulation to study the effect of an experimental automation-assisted, goal-directed OHCA management protocol on EMS providers' resuscitation performance relative to standard protocols and equipment. Two-provider (emergency medical technicians (EMT)-B and EMT-I/C/P) teams were randomized to control or experimental group. Each team engaged in 3 simulations: baseline simulation (standard roles); repeat simulation (standard roles); and abbreviated repeat simulation (reversed roles, i.e., basic life support provider performing ALS tasks). Control teams used standard OHCA protocols and equipment (with high-performance cardiopulmonary resuscitation training intervention); for second and third simulations, experimental teams performed chest compression, defibrillation, airway, pulmonary ventilation, vascular access, medication, and transport tasks with goal-directed protocol and resuscitation-automating devices. Videorecorders and simulator logs collected resuscitation data. Ten control and 10 experimental teams comprised 20 EMT-B's; 1 EMT-I, 8 EMT-C's, and 11 EMT-P's; study groups were not fully matched. Both groups suboptimally performed chest compressions and ventilations at baseline. For their second simulations, control teams performed similarly except for reduced on-scene time, and experimental teams improved their chest compressions (P=0.03), pulmonary ventilations (P<0.01), and medication administration (P=0.02); changes in their performance of chest compression, defibrillation, airway, and transport tasks did not attain significance against control teams' changes. Experimental teams maintained performance improvements during reversed-role simulations. Simulation-based investigation into OHCA resuscitation revealed considerable variability and improvable deficiencies in small EMS teams. Goal-directed, automation-assisted OHCA management augmented select resuscitation bundle element performance without comprehensive improvement.

Dose-dense weekly chemotherapy in advanced ovarian cancer: An updated meta-analysis of randomized controlled trials.

PubMed

Marchetti, C; De Felice, F; Di Pinto, A; D'Oria, O; Aleksa, N; Musella, A; Palaia, I; Muzii, L; Tombolini, V; Benedetti Panici, P

2018-05-01

The use of dose-dense weekly chemotherapy in the management of advanced ovarian cancer (OC) remains controversial. The aim of this meta-analysis was to evaluate the efficacy of dose-dense regimen to improve clinical outcomes in OC patients with the inclusion of new trials. For this updated meta-analysis, PubMed Medline and Scopus databases and meeting proceedings were searched for eligible studies with the limitation of randomized controlled trials, comparing dose-dense chemotherapy versus standard treatment. Trials were grouped in two types of dose-dense chemotherapy: weekly dose-dense (both paclitaxel and carboplatin weekly administration) and semi-weekly dose-dense (weekly paclitaxel and three weekly carboplatin administration). Data were extracted independently and were analyzed using RevMan statistical software version 5.3 (http://www.cochrane.org). Primary end-point was progression-free survival (PFS). Four randomized controlled trials comprising 3698 patients were identified as eligible. Dose-dense chemotherapy had not a significant benefit on PFS (HR 0.92, 95% CI 0.81-1.04, p = 0.20). When the analysis was restricted to both weekly and semi-weekly dose-dense data, a no significant interaction between dose-dense and standard regimen was confirmed (HR 1.01, 95% CI 0.93-1.10 and HR 0.82, 95% CI 0.63-1.08, respectively). In the absence of PFS superiority of dose-dense schedule, three weekly schedule should remain the standard of care for advanced OC. Copyright © 2018 Elsevier B.V. All rights reserved.

Dressing wear time after breast reconstruction: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background One of the major risk variables for surgical site infection is wound management. Understanding infection risk factors for breast operations is essential in order to develop infection-prevention strategies and improve surgical outcomes. The aim of this trial is to assess the influence of dressing wear time on surgical site infection rates and skin colonization. Patients’ perception at self-assessment will also be analyzed. Methods/Design This is a two-arm randomized controlled trial. Two hundred breast cancer patients undergoing immediate or delayed breast reconstruction will be prospectively enrolled. Patients will be randomly allocated to group I (dressing removed on postoperative day one) or group II (dressing removed on postoperative day six). Surgical site infections will be defined by standard criteria from the Centers for Disease Control and Prevention (CDC). Skin colonization will be assessed by culture of samples collected at predefined time points. Patients will score dressing wear time with regard to safety, comfort and convenience. Discussion The evidence to support dressing standards for breast surgery wounds is empiric and scarce. CDC recommends protecting, with a sterile dressing for 24 to 48 hours postoperatively, a primarily closed incision, but there is no recommendation to cover this kind of incision beyond 48 hours, or on the appropriate time to shower or bathe with an uncovered incision. The results of the ongoing trial may support standard recommendations regarding dressing wear time after breast reconstruction. Trial registration ClinicalTrials.gov identifier: http://NCT01148823. PMID:23432779

The Traditional Chinese Medicine and Relevant Treatment for the Efficacy and Safety of Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

PubMed Central

Shi, Zhao-feng; Song, Tie-bing; Xie, Juan; Yan, Yi-quan

2017-01-01

Background Atopic dermatitis (AD) has become a common skin disease that requires systematic and comprehensive treatment to achieve adequate clinical control. Traditional Chinese medicines and related treatments have shown clinical effects for AD in many studies. But the systematic reviews and meta-analyses for them are lacking. Objective The systematic review and meta-analysis based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement were conducted to evaluate the efficacy and safety of traditional Chinese medicines and related treatments for AD treatment. Methods Randomized controlled trials (RCTs) were searched based on standardized searching rules in eight medical databases from the inception up to December 2016 and a total of 24 articles with 1,618 patients were enrolled in this meta-analysis. Results The results revealed that traditional Chinese medicines and related treatments did not show statistical differences in clinical effectiveness, SCORAD amelioration, and SSRI amelioration for AD treatment compared with control group. However, EASI amelioration of traditional Chinese medicines and related treatments for AD was superior to control group. Conclusion We need to make conclusion cautiously for the efficacy and safety of traditional Chinese medicine and related treatment on AD therapy. More standard, multicenter, double-blind randomized controlled trials (RCTs) of traditional Chinese medicine and related treatment for AD were required to be conducted for more clinical evidences providing in the future. PMID:28713436

Use of a low-literacy written action plan to improve parent understanding of pediatric asthma management: A randomized controlled study.

PubMed

Yin, Hsiang Shonna; Gupta, Ruchi S; Mendelsohn, Alan L; Dreyer, Benard; van Schaick, Linda; Brown, Christina R; Encalada, Karen; Sanchez, Dayana C; Warren, Christopher M; Tomopoulos, Suzy

2017-11-01

The objective of the study was to determine whether parents who use a low-literacy, pictogram- and photograph-based written asthma action plan (WAAP) have a better understanding of child asthma management compared to parents using a standard plan. A randomized controlled study was carried out in 2 urban pediatric outpatient clinics. Inclusion criteria were English- and Spanish-speaking parents of 2- to 12-year-old asthmatic children. Parents were randomized to receive a low-literacy or standard asthma action plan (American Academy of Allergy, Asthma and Immunology) for a hypothetical patient on controller and rescue medications. A structured questionnaire was used to assess whether there was an error in knowledge of (1) medications to give everyday and when sick, (2) need for spacer use, and (3) appropriate emergency response to give albuterol and seek medical help. Multiple logistic regression analyses were performed, adjusting for parent age, health literacy (Newest Vital Sign); child asthma severity, medications; and site. 217 parents were randomized (109 intervention and 108 control). Parents who received the low-literacy plan were (1) less likely to make an error in knowledge of medications to take everyday and when sick compared to parents who received the standard plan (63.0 vs. 77.3%, p = 0.03; adjusted odds ratio [AOR] = 0.5[95% confidence interval: 0.2-0.9]) and (2) less likely to make an error regarding spacer use (14.0 vs. 51.1%, p < 0.001; AOR = 0.1 [0.06-0.3]). No difference in error in appropriate emergency response was seen (43.1 vs. 48.1%, p = 0.5). Use of a low-literacy WAAP was associated with better parent understanding of asthma management. Further study is needed to assess whether the use of this action plan improves child asthma outcomes.

Study protocol: an early intervention program to improve motor outcome in preterm infants: a randomized controlled trial and a qualitative study of physiotherapy performance and parental experiences

PubMed Central

2012-01-01

Abstract Background Knowledge about early physiotherapy to preterm infants is sparse, given the risk of delayed motor development and cerebral palsy. Methods/Design A pragmatic randomized controlled study has been designed to assess the effect of a preventative physiotherapy program carried out in the neonatal intensive care unit. Moreover, a qualitative study is carried out to assess the physiotherapy performance and parents' experiences with the intervention. The aim of the physiotherapy program is to improve motor development i.e. postural control and selective movements in these infants. 150 infants will be included and randomized to either intervention or standard follow-up. The infants in the intervention group will be given specific stimulation to facilitate movements based on the individual infant's development, behavior and needs. The physiotherapist teaches the parents how to do the intervention and the parents receive a booklet with photos and descriptions of the intervention. Intervention is carried out twice a day for three weeks (week 34, 35, 36 postmenstrual age). Standardized tests are carried out at baseline, term age and at three, six, 12 and 24 months corrected age. In addition eight triads (infant, parent and physiotherapist) are observed and videotaped in four clinical encounters each to assess the process of physiotherapy performance. The parents are also interviewed on their experiences with the intervention and how it influences on the parent-child relationship. Eight parents from the follow up group are interviewed about their experience. The interviews are performed according to the same schedule as the standardized measurements. Primary outcome is at two years corrected age. Discussion The paper presents the protocol for a randomized controlled trial designed to study the effect of physiotherapy to preterm infants at neonatal intensive care units. It also studies physiotherapy performance and the parent's experiences with the intervention. Trial registration ClinicalTrials.gov NCT01089296 PMID:22336194

Efficacy and safety of everolimus with reduced tacrolimus in living-donor liver transplant recipients: 12-month results of a randomized multicenter study.

PubMed

Jeng, Long-Bin; Lee, Sung Gyu; Soin, Arvinder Singh; Lee, Wei-Chen; Suh, Kyung-Suk; Joo, Dong Jin; Uemoto, Shinji; Joh, Jaewon; Yoshizumi, Tomoharu; Yang, Horng-Ren; Song, Gi-Won; Lopez, Patricia; Kochuparampil, Jossy; Sips, Carole; Kaneko, Shuhei; Levy, Gary

2018-06-01

In a multicenter, open-label, study, 284 living-donor liver transplant patients were randomized at 30 ± 5 days posttransplant to start everolimus+reduced tacrolimus (EVR+rTAC) or continue standard tacrolimus (TAC Control). EVR+rTAC was non-inferior to TAC Control for the primary efficacy endpoint of treated BPAR, graft loss or death at 12 months posttransplant: difference -0.7% (90% CI -5.2%, 3.7%); P < .001 for non-inferiority. Treated BPAR occurred in 2.2% and 3.6% of patients, respectively. The key secondary endpoint, change in estimated glomerular filtration rate (eGFR) from randomization to month 12, achieved non-inferiority (P < .001 for non-inferiority), but not superiority and was similar between groups overall (mean -8.0 vs. -12.1 mL/min/1.73 m 2 , P = .108), and in patients continuing randomized treatment (-8.0 vs. -13.3 mL/min/1.73 m 2 , P = .046). In the EVR+rTAC and TAC control groups, study drug was discontinued in 15.5% and 17.6% of patients, adverse events with suspected relation to study drug occurred in 57.0% and 40.4%, and proteinuria ≥1 g/24 h in 9.3% and 0%, respectively. Everolimus did not negatively affect liver regeneration. At 12 months, hepatocellular recurrence was only seen in the standard TAC-treated patients (5/62; 8.1%). In conclusion, early introduction of EVR+rTAC was non-inferior to standard tacrolimus in terms of efficacy and renal function at 12 months, with hepatocellular carcinoma recurrence only in TAC Control patients. ClinicalTrials.gov Identifier: NCT01888432. © 2017 The American Society of Transplantation and the American Society of Transplant Surgeons.

Efficacy of autologous platelet-rich plasma use for orthopaedic indications: a meta-analysis.

PubMed

Sheth, Ujash; Simunovic, Nicole; Klein, Guy; Fu, Freddie; Einhorn, Thomas A; Schemitsch, Emil; Ayeni, Olufemi R; Bhandari, Mohit

2012-02-15

The recent emergence of autologous blood concentrates, such as platelet-rich plasma, as a treatment option for patients with orthopaedic injuries has led to an extensive debate about their clinical benefit. We conducted a systematic review and meta-analysis to determine the efficacy of autologous blood concentrates in decreasing pain and improving healing and function in patients with orthopaedic bone and soft-tissue injuries. We searched MEDLINE and Embase for randomized controlled trials or prospective cohort studies that compared autologous blood concentrates with a control therapy in patients with an orthopaedic injury. We identified additional studies by searching through the bibliographies of eligible studies as well as the archives of orthopaedic conferences and meetings. Twenty-three randomized trials and ten prospective cohort studies were identified. There was a lack of consistency in outcome measures across all studies. In six randomized controlled trials (n = 358) and three prospective cohort studies (n = 88), the authors reported visual analog scale (VAS) scores when comparing platelet-rich plasma with a control therapy across injuries to the acromion, rotator cuff, lateral humeral epicondyle, anterior cruciate ligament, patella, tibia, and spine. The use of platelet-rich plasma provided no significant benefit up to (and including) twenty-four months across the randomized trials (standardized mean difference, -0.34; 95% confidence interval [CI], -0.75 to 0.06) or the prospective cohort studies (standardized mean difference, -0.20; 95% CI, -0.64 to 0.23). Both point estimates suggested a small trend favoring platelet-rich plasma, but the associated wide confidence intervals were consistent with nonsignificant effects. The current literature is complicated by a lack of standardization of study protocols, platelet-separation techniques, and outcome measures. As a result, there is uncertainty about the evidence to support the increasing clinical use of platelet-rich plasma and autologous blood concentrates as a treatment modality for orthopaedic bone and soft-tissue injuries.

Cost-effectiveness of an experimental caries-control regimen in a 3.4-yr randomized clinical trial among 11-12-yr-old Finnish schoolchildren.

PubMed

Hietasalo, Pauliina; Seppä, Liisa; Lahti, Satu; Niinimaa, Ahti; Kallio, Jouko; Aronen, Pasi; Sintonen, Harri; Hausen, Hannu

2009-12-01

The aim of this study was to assess the cost-effectiveness of an experimental caries-control regimen in a randomized clinical trial (RCT) conducted in Pori, Finland, in 2001-2005. Children (n = 497) who were 11-12 yr of age and had at least one active initial caries lesion at baseline were studied. The children in the experimental group (n = 250) were offered an individually designed patient-centered regimen for caries control. The children in the control group (n = 247) received standard dental care. Furthermore, the whole population was exposed to continuous community-level oral health promotion. Individual costs of treatment procedures and outcomes (DMFS increment score) for the follow-up period of 3.4 yr were calculated for each child in both groups. The incremental cost-effectiveness ratio was euro 34.07 per averted DMF surface. The experimental regimen was more effective, and also more costly. However, the total costs decreased year after year, and for the last 2 yr the experimental regimen was less expensive than the standard dental care. The experimental regimen would probably have been more cost-effective than standard dental care if the follow-up period had been longer, the regimen less comprehensive, and/or if dental nurses had conducted the preventive procedures.

Effects of standard training in the use of closed-circuit televisions in visually impaired adults: design of a training protocol and a randomized controlled trial.

PubMed

Burggraaff, Marloes C; van Nispen, Ruth M A; Melis-Dankers, Bart J M; van Rens, Ger H M B

2010-03-10

Reading problems are frequently reported by visually impaired persons. A closed-circuit television (CCTV) can be helpful to maintain reading ability, however, it is difficult to learn how to use this device. In the Netherlands, an evidence-based rehabilitation program in the use of CCTVs was lacking. Therefore, a standard training protocol needed to be developed and tested in a randomized controlled trial (RCT) to provide an evidence-based training program in the use of this device. To develop a standard training program, information was collected by studying literature, observing training in the use of CCTVs, discussing the content of the training program with professionals and organizing focus and discussion groups. The effectiveness of the program was evaluated in an RCT, to obtain an evidence-based training program. Dutch patients (n = 122) were randomized into a treatment group: normal instructions from the supplier combined with training in the use of CCTVs, or into a control group: instructions from the supplier only. The effect of the training program was evaluated in terms of: change in reading ability (reading speed and reading comprehension), patients' skills to operate the CCTV, perceived (vision-related) quality of life and tasks performed in daily living. The development of the CCTV training protocol and the design of the RCT in the present study may serve as an example to obtain an evidence-based training program. The training program was adjusted to the needs and learning abilities of individual patients, however, for scientific reasons it might have been preferable to standardize the protocol further, in order to gain more comparable results. http://www.trialregister.nl, identifier: NTR1031.

Effects of standard training in the use of closed-circuit televisions in visually impaired adults: design of a training protocol and a randomized controlled trial

PubMed Central

2010-01-01

Background Reading problems are frequently reported by visually impaired persons. A closed-circuit television (CCTV) can be helpful to maintain reading ability, however, it is difficult to learn how to use this device. In the Netherlands, an evidence-based rehabilitation program in the use of CCTVs was lacking. Therefore, a standard training protocol needed to be developed and tested in a randomized controlled trial (RCT) to provide an evidence-based training program in the use of this device. Methods/Design To develop a standard training program, information was collected by studying literature, observing training in the use of CCTVs, discussing the content of the training program with professionals and organizing focus and discussion groups. The effectiveness of the program was evaluated in an RCT, to obtain an evidence-based training program. Dutch patients (n = 122) were randomized into a treatment group: normal instructions from the supplier combined with training in the use of CCTVs, or into a control group: instructions from the supplier only. The effect of the training program was evaluated in terms of: change in reading ability (reading speed and reading comprehension), patients' skills to operate the CCTV, perceived (vision-related) quality of life and tasks performed in daily living. Discussion The development of the CCTV training protocol and the design of the RCT in the present study may serve as an example to obtain an evidence-based training program. The training program was adjusted to the needs and learning abilities of individual patients, however, for scientific reasons it might have been preferable to standardize the protocol further, in order to gain more comparable results. Trial registration http://www.trialregister.nl, identifier: NTR1031 PMID:20219120

Including the Copenhagen Adduction Exercise in the FIFA 11+ Provides Missing Eccentric Hip Adduction Strength Effect in Male Soccer Players: A Randomized Controlled Trial.

PubMed

Harøy, Joar; Thorborg, Kristian; Serner, Andreas; Bjørkheim, André; Rolstad, Linn E; Hölmich, Per; Bahr, Roald; Andersen, Thor Einar

2017-11-01

The FIFA 11+ was developed as a complete warm-up program to prevent injuries in soccer players. Although reduced hip adduction strength is associated with groin injuries, none of the exercises included in the FIFA 11+ seem to specifically target hip adduction strength. To investigate the effect on eccentric hip adduction strength of the FIFA 11+ warm-up program with or without the Copenhagen adduction exercise. Randomized controlled trial; Level of evidence, 1. We recruited 45 eligible players from 2 U19 elite male soccer teams. Players were randomized into 2 groups; 1 group carried out the standard FIFA 11+ program, while the other carried out the FIFA 11+ but replaced the Nordic hamstring exercise with the Copenhagen adduction exercise. Both groups performed the intervention 3 times weekly for 8 weeks. Players completed eccentric strength and sprint testing before and after the intervention. Per-protocol analyses were performed, and 12 players were excluded due to low compliance (<67% of sessions completed). The main outcome was eccentric hip adduction strength (N·m/kg). Between-group analyses revealed a significantly greater increase in eccentric hip adduction strength of 0.29 Nm/kg (8.9%; P = .01) in favor of the group performing the Copenhagen adduction exercise, whereas no within-group change was noted in the group that used the standard FIFA 11+ program (-0.02 N·m/kg [-0.7%]; P = .69). Including the Copenhagen adduction exercise in the FIFA 11+ program increases eccentric hip adduction strength, while the standard FIFA 11+ program does not. Registration: Registration: ISRCTN13731446 (International Standard Randomised Controlled Trial Number registry).

Citywide cluster randomized trial to restore blighted vacant land and its effects on violence, crime, and fear

Treesearch

Charles C. Branas; Eugenia South; Michelle C. Kondo; Bernadette C. Hohl; Philippe Bourgois; Douglas J. Wiebe; John M. MacDonald

2018-01-01

Vacant and blighted urban land is a widespread and potentially risky environmental condition encountered by millions of people on a daily basis. About 15% of the land in US cities is deemed vacant or abandoned, an area roughly the size of Switzerland. In a citywide cluster randomized controlled trial, we investigated the effects of standardized, reproducible...

Effects of a Randomized Couple-Based Intervention on Quality of Life of Breast Cancer Patients and Their Partners

ERIC Educational Resources Information Center

Kayser, Karen; Feldman, Barry N.; Borstelmann, Nancy A.; Daniels, Ann A.

2010-01-01

The purpose of this study was to determine the effectiveness of a couple-based intervention on the quality of life (QOL) of early-stage breast cancer patients and their partners. A randomized controlled design was used to assign couples to either the hospital standard social work services (SSWS) or a couple-based intervention, the Partners in…

WWC Review of the Report "Accommodations for English Language Learner Students: The Effect of Linguistic Modification of Math Test Item Sets"

ERIC Educational Resources Information Center

What Works Clearinghouse, 2012

2012-01-01

The research described in this report is a randomized controlled trial in which seventh- and eighth-grade students were randomly assigned to complete a set of 25 math questions delivered with either standard language or language that had undergone "linguistic modification" by the research team. The purpose of the study was to assess the…

Randomized outcome trial of nutrient-enriched formula and neurodevelopment outcome in preterm infants.

PubMed

Giannì, Maria Lorella; Roggero, Paola; Amato, Orsola; Picciolini, Odoardo; Piemontese, Pasqua; Liotto, Nadia; Taroni, Francesca; Mosca, Fabio

2014-03-19

Preterm infants are at risk for adverse neurodevelopment. Furthermore, nutrition may play a key role in supporting neurodevelopment. The aim of this study was to evaluate whether a nutrient-enriched formula fed to preterm infants after hospital discharge could improve their neurodevelopment at 24 months (term-corrected age). We conducted an observer-blinded, single-center, randomized controlled trial in infants admitted to the Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Italy between 2009 and 2011. Inclusion criteria were gestational age < 32 weeks and/or birth weight < 1500 g, and being fed human milk for < 20% of the total milk intake. Exclusion criteria were congenital malformations or conditions that could interfere with growth or body composition. Included infants were randomized to receive a standard full-term formula or a nutrient-enriched formula up until 6 months of corrected age, using two computer-generated randomization lists; one appropriate for gestational age (AGA) and one for small for gestational age (SGA) infants. We assessed neurodevelopment at 24 months of corrected age using the Griffiths Mental Development Scale and related subscales (locomotor, personal-social, hearing and speech, hand and eye coordination, and performance). Of the 207 randomized infants, 181 completed the study. 52 AGA and 35 SGA infants were fed a nutrient-enriched formula, whereas 56 AGA and 38 SGA infants were fed a standard full-term formula. The general quotient at 24 months of corrected age was not significantly different between infants randomized to receive a nutrient-enriched formula compared with a standard term formula up until 6 months of corrected age (AGA infants: 93.8 ± 12.6 vs. 92.4 ± 10.4, respectively; SGA infants: 96.1 ± 9.9 vs. 98.2 ± 9, respectively). The scores of related subscales were also similar among groups. This study found that feeding preterm infants a nutrient-enriched formula after discharge does not affect neurodevelopment at 24 months of corrected age, in either AGA or SGA infants, free from major comorbidities. Current Controlled Trials (http://www.controlled-trials.com/ISRCTN30189842) London, UK.

Impact of a social franchising program on uptake of oral rehydration solution plus zinc for childhood diarrhea in myanmar: a community-level randomized controlled trial.

PubMed

Aung, Tin; Montagu, Dominic; Su Su Khin, Hnin; Win, Zaw; San, Ang Kyaw; McFarland, Willi

2014-06-01

Diarrhea's impact on childhood morbidity can be reduced by administering oral rehydration solution (ORS) with zinc; challenges to wider use are changing health-seeking behavior and ensuring access. We conducted a randomized controlled trial to increase ORS plus zinc uptake in rural Myanmar. Village tracts, matched in 52 pairs, were randomized to standard ORS access vs. a social franchising program training community educators and supplying ORS plus zinc. Intervention and control communities were comparable on demographics, prevalence of diarrhea and previous use of ORS. One year after randomization, ORS plus zinc use was 13.7% in the most recent case of diarrhea in intervention households compared with 1.8% in control households (p < 0.001) (N = 3605). A significant increase in ORS plus zinc use was noted in the intervention (p = 0.044) but not in the control (p = 0.315) group. Social franchising increased optimal treatment of childhood diarrhea in rural Myanmar. Scale-up stands to reduce morbidity among children in similar settings. Current Controlled Trials ISRCTN73606238. © The Author [2014]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Effects of Pilates-Based Core Stability Training in Ambulant People With Multiple Sclerosis: Multicenter, Assessor-Blinded, Randomized Controlled Trial.

PubMed

Fox, Esther E; Hough, Alan D; Creanor, Siobhan; Gear, Margaret; Freeman, Jennifer A

2016-08-01

Pilates exercise is often undertaken by people with multiple sclerosis (MS) who have balance and mobility difficulties. The primary aim of the study was to compare the effects of 12 weeks of Pilates exercises with relaxation on balance and mobility. Secondary aims were: (1) to compare standardized exercises with relaxation and (2) to compare Pilates exercises with standardized exercises. A multicenter, assessor-blinded, randomized controlled trial was conducted. Participants with Expanded Disability Status Scale scores of 4.0 to 6.5 were randomly allocated to groups receiving 12 weeks of Pilates exercises, standardized exercises, or relaxation. Assessments were undertaken at baseline and weeks 12 and 16 (primary outcome measure: 10-Meter Timed Walk Test [10MTW]). One hundred participants (mean age=54 years, 74% female) were randomized to study groups. Six participants relapsed (withdrew from the study), leaving 94 participants for intention-to-treat analysis. There was no significant difference in mean 10MTW measurements between the Pilates and relaxation groups. At 12 weeks, there was a mean reduction of 4.2 seconds for the standardized exercise group compared with the relaxation group (95% confidence interval [relaxation group minus standardized exercise group measurements]=0.0, 8.4) and a mean reduction of 3.7 seconds for the Pilates group compared with the standardized exercise group (95% confidence interval [Pilates group minus standardized exercise group measurements]=-0.4 to 7.8). At 16 weeks, mean 10MTW times for the standardized exercise group remained quicker than those for the Pilates and relaxation groups, although the differences were nonsignificant. There were no significant differences between the Pilates and relaxation groups for any secondary outcome measure. In this study, therapists were limited to a standardized basket of exercises that may have affected the study outcomes. Furthermore, choosing measures such as posturography to assess balance, accelerometry to assess walking, or a specific trunk assessment scale might have been more responsive in detecting changes in outcome. Participants did not improve significantly, either in the short term or at the 4-week follow-up, on the 10MTW after 12 weeks of Pilates exercises compared with 12 weeks of relaxation. © 2016 American Physical Therapy Association.

[The OPTIMISE study (Optimal Type 2 Diabetes Management Including Benchmarking and Standard Treatment]. Results for Luxembourg].

PubMed

Michel, G

2012-01-01

The OPTIMISE study (NCT00681850) has been run in six European countries, including Luxembourg, to prospectively assess the effect of benchmarking on the quality of primary care in patients with type 2 diabetes, using major modifiable vascular risk factors as critical quality indicators. Primary care centers treating type 2 diabetic patients were randomized to give standard care (control group) or standard care with feedback benchmarked against other centers in each country (benchmarking group). Primary endpoint was percentage of patients in the benchmarking group achieving pre-set targets of the critical quality indicators: glycated hemoglobin (HbAlc), systolic blood pressure (SBP) and low-density lipoprotein (LDL) cholesterol after 12 months follow-up. In Luxembourg, in the benchmarking group, more patients achieved target for SBP (40.2% vs. 20%) and for LDL-cholesterol (50.4% vs. 44.2%). 12.9% of patients in the benchmarking group met all three targets compared with patients in the control group (8.3%). In this randomized, controlled study, benchmarking was shown to be an effective tool for improving critical quality indicator targets, which are the principal modifiable vascular risk factors in diabetes type 2.

Improving Herpes Zoster Vaccination Rates Through Use of a Clinical Pharmacist and a Personal Health Record

PubMed Central

Otsuka, Shelley H.; Tayal, Neeraj H.; Porter, Kyle; Embi, Peter J.; Beatty, Stuart J.

2014-01-01

BACKGROUND Preventative health services, including herpes zoster vaccination rates, remain low despite known benefits. A new care model to improve preventative health services is warranted. The objective of this study is to investigate whether the functions of an electronic medical record, in combination with a pharmacist as part of the care team, can improve the herpes zoster vaccination rate. METHODS This study was a 6-month, randomized controlled trial at a General Internal Medicine clinic at The Ohio State University. The 2589 patients aged 60 years and older without documented herpes zoster vaccination in the electronic medical record were stratified on the basis of activated personal health record status, an online tool used to share health information between patient and provider. Of the 674 personal health record users, 250 were randomized to receive information regarding the herpes zoster vaccination via an electronic message and 424 were randomized to standard of care. Likewise, of the 1915 nonpersonal health record users, 250 were randomized to receive the same information via the US Postal Service and 1665 were randomized to standard of care. After pharmacist chart review, eligible patients were mailed a herpes zoster vaccine prescription. Herpes zoster vaccination rates were compared by chi-square tests. RESULTS Intervention recipients had significantly higher vaccination rates than controls in both personal health record (relative risk, 2.7; P = .0007) and nonpersonal health record (relative risk, 2.9; P = .0001) patient populations. CONCLUSIONS Communication outside of face-to-face office visits, by both personal health record electronic message and information by mail, can improve preventative health intervention rates compared with standard care. PMID:23830534

The Efficacy of a Viscoelastic Foam Overlay on Prevention of Pressure Injury in Acutely Ill Patients: A Prospective Randomized Controlled Trial.

PubMed

Park, Kyung Hee; Park, Joohee

The purpose of this study was to compare a viscoelastic foam overlay (VEFO) to a standard hospital mattress for pressure injury (PI) prevention. We also compared interface pressures (IPs) of the VEFO to our facility's standard hospital mattress. Prospective, randomized controlled trial. Data analysis was based on 110 participants (55 in each group) who were 19 years or older, had a Braden Scale for Pressure Sore Risk score of 16 or less, and were cared for on a neurology, oncology, or pulmonology inpatient care unit. The research setting was the Samsung Medical Center in Seoul, South Korea. Participants were divided into 2 groups: the experimental group were based on a VEFO on top of the standard hospital mattress used in our facility. Participants in the control group were placed on a standard hospital mattress with/without air overlay. All patients were given standard nursing care for prevention of PI. Skin assessments were completed daily over a period of 2 weeks. In addition, we compared IPs of the standard hospital mattress and the VEFO in participants randomly allocated to the intervention group. Interface pressure was measured over the sacral/coccygeal area with subjects in the supine position. Pressures were measured immediately before and immediately following placement of the VEFO and just before data collection began. Data were collected between October 2013 and November 2014. Pressure injury incidence was compared between groups using the χ test, and IPs were compared using the paired t test. Pressure injury development was determined using the staging system described in guidelines from the National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, and Pan Pacific Pressure Injury Alliance in 2014. Interface pressure was measured using a device manufactured for this purpose. The incidence of PI development was significantly lower in subjects assigned to the experimental group as compared to those in the control group (3.6%-27.3% over the 2-week data collection period; P = .001). The maximum IP was significantly lower on the VEFO with standard hospital mattress than on the standard hospital mattress (paired t = 8.87, P < .001). Patients managed with a VEFO had a significantly lower incidence of PI than those managed with a standard hospital mattress. Additional research is needed to further characterize the efficacy of the VEFO, its effect on PI healing, and its effect of PI prevention in high-risk populations such as critically ill patients.

Randomized trials published in some Chinese journals: how many are randomized?

PubMed

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-07-02

The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9-7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18-2.13, and relative risk 14.42, 95% confidence interval 9.40-22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83-14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0-81.0). Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing to a lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed.

Randomized trials published in some Chinese journals: how many are randomized?

PubMed Central

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-01-01

Background The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. Methods The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9–7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18–2.13, and relative risk 14.42, 95% confidence interval 9.40–22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83–14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0–81.0). Conclusion Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing toa lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed. PMID:19573242

Study protocol: to investigate effects of highly specialized rehabilitation for patients with multiple sclerosis. A randomized controlled trial of a personalized, multidisciplinary intervention

PubMed Central

2012-01-01

Background Multiple sclerosis (MS) is a complex, chronic and progressive disease and rehabilitation services can provide important support to patients. Few MS rehabilitation programs have been shown to provide health improvements to patients in a cost-effective manner. The objective of this study is to assess the effects in terms of changes measured by a variety of standardized quality of life, mastery, coping, compliance and individual goal-related endpoints. This combination provides the basis for analyzing the complexity of MS and outcomes of a personalized rehabilitation. Methods/Design Patients with MS referred to hospital rehabilitation services will be randomized to either early admission (within two months) or usual admission (after an average waiting time of eight months). They will complete a battery of standardized health outcome instruments prior to randomization, and again six and twelve months after randomization, and a battery of goal-related outcome measures at admission and discharge, and again one, six and twelve months after randomization. Discussion The results of the study are expected to contribute to further development of MS rehabilitation services and to discussions about the design and content of such services. The results will also provide additional information to health authorities responsible for providing and financing rehabilitation services. Trial registration Current Controlled Trials (ISRCTN05245917) PMID:22954027

A single blind randomized control trial on support groups for Chinese persons with mild dementia.

PubMed

Young, Daniel K W; Kwok, Timothy C Y; Ng, Petrus Y N

2014-01-01

Persons with mild dementia experience multiple losses and manifest depressive symptoms. This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia. Participants were randomly assigned to either a ten-session support group or a control group. Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants. Upon completion of the study, 20 treatment group participants and 16 control group participants completed all assessments. At baseline, the treatment and control groups did not show any significant difference on all demographic variables, as well as on all baseline measures; over one-half (59%) of all the participants reported having depression, as assessed by a Chinese Geriatric Depression Scale score ≥8. After completing the support group, the depressive mood of the treatment group participants reduced from 8.83 (standard deviation =2.48) to 7.35 (standard deviation =2.18), which was significant (Wilcoxon signed-rank test; P=0.017, P<0.05), while the control group's participants did not show any significant change. This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society. In particular, this present study shows that a support group can reduce depressive symptoms for participants.

Systematic review: proton pump inhibitors (PPIs) for the healing of reflux oesophagitis - a comparison of esomeprazole with other PPIs.

PubMed

Edwards, S J; Lind, T; Lundell, L

2006-09-01

No randomized controlled trial has compared all the licensed standard dose proton pump inhibitors in the healing of reflux oesophagitis. To compare the effectiveness of esomeprazole with licensed standard dose proton pump inhibitors for healing of reflux oesophagitis (i.e. lansoprazole 30 mg, omeprazole 20 mg, pantoprazole 40 mg and rabeprazole 20 mg). Systematic review of CENTRAL, BIOSIS, EMBASE and MEDLINE for randomized controlled trials in patients with reflux oesophagitis. Searching was completed in February 2005. Data on endoscopic healing rates at 4 and 8 weeks were extracted and re-analysed if not analysed by intention-to-treat. Meta-analysis was conducted using a fixed effects model. Of 133 papers identified in the literature search, six were of sufficient quality to be included in the analysis. No studies were identified comparing rabeprazole with esomeprazole. A meta-analysis of healing rates of esomeprazole 40 mg compared with standard dose proton pump inhibitors gave the following results: at 4 weeks [relative risk (RR) 0.92; 95% CI: 0.90, 0.94; P < 0.00001], and 8 weeks (RR 0.95; 95% CI: 0.94, 0.97; P < 0.00001). Publication bias did not have a significant impact on the results. The results were robust to changes in the inclusion/exclusion criteria and using a random effects model. Esomeprazole consistently demonstrates higher healing rates when compared with standard dose proton pump inhibitors.

Reduction of exit-site infections of tunnelled intravascular catheters among neutropenic patients by sustained-release chlorhexidine dressings: results from a prospective randomized controlled trial.

PubMed

Chambers, S T; Sanders, J; Patton, W N; Ganly, P; Birch, M; Crump, J A; Spearing, R L

2005-09-01

Exit-site and tunnel infections of tunnelled central intravascular catheters are a frequent source of morbidity among neutropenic patients and may necessitate catheter removal. They require antimicrobial therapy that increases healthcare costs and is associated with adverse drug reactions. A prospective randomized clinical trial was conducted among adult patients undergoing chemotherapy in a haematology unit. Tunnelled intravascular catheters were randomized to receive the control of a standard dressing regimen as recommended by the British Committee for Standards in Haematology, or to receive the intervention of a sustained-release chlorhexidine dressing. Follow-up data were available in 112 of 114 tunnelled intravascular catheters which were randomized. Exit-site or combined exit-site/tunnel infections occurred in 23 (43%) of 54 catheters in the control group, and five (9%) of 58 catheters in the intervention group [odds ratio (OR) for intervention group compared with control group =0.13, 95% confidence intervals (CI) 0.04-0.37, P<0.001]. More tunnelled intravascular catheters were prematurely removed from the control group than the intervention group for documented infections [20/54 (37%) vs 6/58 (10%), OR=0.20, 95%CI 0.53-0.07]. However, there was no difference in the numbers of tunnelled intravascular catheters removed for all proven and suspected intravascular catheter-related infections [21/54 (39%) vs 19/58 (33%)], or in the time to removal of catheters for any reason other than death or end of treatment for underlying disease. Thus chlorhexidine dressings reduced the incidence of exit-site/tunnel infections of indwelling tunnelled intravascular catheters without prolonging catheter survival in neutropenic patients, and could be considered as part of the routine management of indwelling tunnelled intravascular catheters among neutropenic patients.

Five Year Follow-Up of a Randomized Controlled Trial on Warming and Humidification of Insufflation Gas in Laparoscopic Colonic Surgery—Impact on Small Bowel Obstruction and Oncologic Outcomes

PubMed Central

Sammour, Tarik; Hill, Andrew G.

2015-01-01

Warming and humidification of insufflation gas has been shown to reduce adhesion formation and tumor implantation in the laboratory setting, but clinical evidence is lacking. We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced adhesion formation, and improve oncologic outcomes in laparoscopic colonic surgery. This was a 5-year follow-up of a multicenter, double-blinded, randomized, controlled trial investigating warming and humidification of insufflation gas. The study group received warmed (37°C), humidified (98%) insufflation carbon dioxide, and the control group received standard gas (19°C, 0%). All other aspects of patient care were standardized. Admissions for small bowel obstruction were recorded, as well as whether management was operative or nonoperative. Local and systemic cancer recurrence, 5-year overall survival, and cancer specific survival rates were also recorded. Eighty two patients were randomized, with 41 in each arm. Groups were well matched at baseline. There was no difference between the study and control groups in the rate of clinical small bowel obstruction (5.7% versus 0%, P 0.226); local recurrence (6.5% versus 6.1%, P 1.000); overall survival (85.7% versus 82.1%, P 0.759); or cancer-specific survival (90.3% versus 87.9%, P 1.000). Warming and humidification of insufflation CO2 in laparoscopic colonic surgery does not appear to confer a clinically significant long term benefit in terms of adhesion reduction or oncological outcomes, although a much larger randomized controlled trial (RCT) would be required to confirm this. ClinicalTrials.gov Trial identifier: NCT00642005; US National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894, USA. PMID:25875541

Five year follow-up of a randomized controlled trial on warming and humidification of insufflation gas in laparoscopic colonic surgery--impact on small bowel obstruction and oncologic outcomes.

PubMed

Sammour, Tarik; Hill, Andrew G

2015-04-01

Warming and humidification of insufflation gas has been shown to reduce adhesion formation and tumor implantation in the laboratory setting, but clinical evidence is lacking. We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced adhesion formation, and improve oncologic outcomes in laparoscopic colonic surgery. This was a 5-year follow-up of a multicenter, double-blinded, randomized, controlled trial investigating warming and humidification of insufflation gas. The study group received warmed (37°C), humidified (98%) insufflation carbon dioxide, and the control group received standard gas (19°C, 0%). All other aspects of patient care were standardized. Admissions for small bowel obstruction were recorded, as well as whether management was operative or nonoperative. Local and systemic cancer recurrence, 5-year overall survival, and cancer specific survival rates were also recorded. Eighty two patients were randomized, with 41 in each arm. Groups were well matched at baseline. There was no difference between the study and control groups in the rate of clinical small bowel obstruction (5.7% versus 0%, P 0.226); local recurrence (6.5% versus 6.1%, P 1.000); overall survival (85.7% versus 82.1%, P 0.759); or cancer-specific survival (90.3% versus 87.9%, P 1.000). Warming and humidification of insufflation CO2 in laparoscopic colonic surgery does not appear to confer a clinically significant long term benefit in terms of adhesion reduction or oncological outcomes, although a much larger randomized controlled trial (RCT) would be required to confirm this. ClinicalTrials.gov Trial identifier: NCT00642005; US National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894, USA.

Three-level sampler having automated thresholds

NASA Technical Reports Server (NTRS)

Jurgens, R. F.

1976-01-01

A three-level sampler is described that has its thresholds controlled automatically so as to track changes in the statistics of the random process being sampled. In particular, the mean value is removed and the ratio of the standard deviation of the random process to the threshold is maintained constant. The system is configured in such a manner that slow drifts in the level comparators and digital-to-analog converters are also removed. The ratio of the standard deviation to threshold level may be chosen within the constraints of the ratios of two integers N and M. These may be chosen to minimize the quantizing noise of the sampled process.

Comparison of group-based outpatient physiotherapy with usual care after total knee replacement: a feasibility study for a randomized controlled trial.

PubMed

Artz, Neil; Dixon, Samantha; Wylde, Vikki; Marques, Elsa; Beswick, Andrew D; Lenguerrand, Erik; Blom, Ashley W; Gooberman-Hill, Rachael

2017-04-01

To evaluate the feasibility of conducting a randomized controlled trial comparing group-based outpatient physiotherapy with usual care in patients following total knee replacement. A feasibility study for a randomized controlled trial. One secondary-care hospital orthopaedic centre, Bristol, UK. A total of 46 participants undergoing primary total knee replacement. The intervention group were offered six group-based exercise sessions after surgery. The usual care group received standard postoperative care. Participants were not blinded to group allocation. Feasibility was assessed by recruitment, reasons for non-participation, attendance, and completion rates of study questionnaires that included the Lower Extremity Functional Scale and Knee Injury and Osteoarthritis Outcome Score. Recruitment rate was 37%. Five patients withdrew or were no longer eligible to participate. Intervention attendance was high (73%) and 84% of group participants reported they were 'very satisfied' with the exercises. Return of study questionnaires at six months was lower in the usual care (75%) than in the intervention group (100%). Mean (standard deviation) Lower Extremity Functional Scale scores at six months were 45.0 (20.8) in the usual care and 57.8 (15.2) in the intervention groups. Recruitment and retention of participants in this feasibility study was good. Group-based physiotherapy was acceptable to participants. Questionnaire return rates were lower in the usual care group, but might be enhanced by telephone follow-up. The Lower Extremity Functional Scale had high responsiveness and completion rates. Using this outcome measure, 256 participants would be required in a full-scale randomized controlled trial.

Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial.

PubMed

North, Richard B; Kidd, David H; Farrokhi, Farrokh; Piantadosi, Steven A

2005-01-01

Persistent or recurrent radicular pain after lumbosacral spine surgery is often associated with nerve root compression and is treated by repeated operation or, as a last resort, by spinal cord stimulation (SCS). We conducted a prospective, randomized, controlled trial to test our hypothesis that SCS is more likely than reoperation to result in a successful outcome by standard measures of pain relief and treatment outcome, including subsequent use of health care resources. For an average of 3 years postoperatively, disinterested third-party interviewers followed 50 patients selected for reoperation by standard criteria and randomized to SCS or reoperation. If the results of the randomized treatment were unsatisfactory, patients could cross over to the alternative. Success was based on self-reported pain relief and patient satisfaction. Crossover to the alternative procedure was an outcome measure. Use of analgesics, activities of daily living, and work status were self-reported. Among 45 patients (90%) available for follow-up, SCS was more successful than reoperation (9 of 19 patients versus 3 of 26 patients, P <0.01). Patients initially randomized to SCS were significantly less likely to cross over than were those randomized to reoperation (5 of 24 patients versus 14 of 26 patients, P=0.02). Patients randomized to reoperation required increased opiate analgesics significantly more often than those randomized to SCS (P <0.025). Other measures of activities of daily living and work status did not differ significantly. SCS is more effective than reoperation as a treatment for persistent radicular pain after lumbosacral spine surgery, and in the great majority of patients, it obviates the need for reoperation.

[Try to achieve quickly the blood pressure target in newly diagnosed hypertensive patients is safe and effective].

PubMed

Kichou, B; Henine, N; Kichou, L; Boubchir, M A; Ait Said, M A; Zatout, M; Hammouche, A; Mazeghrane, A; Madiou, A; Benbouabdellah, M

2018-06-01

To compare a so-called an "accelerated" antihypertensive strategy to a "standard" strategy, in terms of blood pressure control rates and adverse events. Prospective open-label randomized controlled trial, which included consecutive hypertensive patients, newly diagnosed, 40 to 70 years old, with no prior antihypertensive treatment. Hypertension was diagnosed if office blood pressure was≥140/90mmHg, confirmed by an increase of Home or a daytime ambulatory blood pressure. The patients were randomly assigned according to 1:1 ratio to an "accelerated" strategy or to a "standard" strategy. The primary end-point was the rate of blood pressure control at 12weeks. The secondary end-point was the rate of adverse events (a safety end-point). We recruited 268 patients (132 in the "accelerated" strategy group), with a mean age of 55 years and 62% of men. The mean office blood pressure at baseline was 168/95mmHg. The clinical characteristics were on average similar between the 2 treatment groups. At 12 weeks, the rates of blood pressure control were 63.6% in the "accelerated" strategy and 38.2% in the "standard" strategy (P<0.001). There was no significantly difference between the rates of adverse events in the 2 strategies (6.06% versus 5.14%; P=0.8). The "accelerated" antihypertensive strategy was more effective than a standard one, in terms of blood pressure control, without an increase in adverse events rate. This could translate into a future cardiovascular events reduction. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Continuous Practice-Based Research on the Use of Standardized Patients: Experience from Shanghai Medical College of Fudan University

ERIC Educational Resources Information Center

Zeng, Yong; Wu, Yan; Lai, Yanni; Lu, Yingqing; Zou, Hejian; Feng, Xueshan

2014-01-01

In the past ten years, the objective structured clinical examination (OSCE) project team of the Shanghai Medical College of Fudan University has continuously conducted further study on the development and maintenance of standardized patients and their application in teaching. The team carried out a series of randomized controlled studies on the…

Randomized Trial of Intensive Housing Placement and Community Transition Services for Episodic and Recidivist Homeless Families

PubMed Central

Mitchell, Kristen; Pareti, Lauren; DeGenova, Joe; Heller, Anne; Hannigan, Anthony; Gholston, Jennifer

2013-01-01

Objectives. We compared Home to Stay, a pilot of intensive housing placement and community transition services for episodic and recidivist homeless families, with a standard services approach. Methods. Using intention-to-treat analyses, we conducted a modified randomized trial of 138 Home to Stay client families and a control group of 192 client families receiving standard shelter services. Results. Home to Stay clients exited shelter more quickly than clients in the control group (Cox regression, P < .001), more commonly exited shelter with housing subsidies (75% vs 56%), stayed out of shelter longer (Cox regression, P = .011), and spent fewer total days in shelter (376 days vs 449 days). Home to Stay performed best with clients who entered shelter within 180 days of the pilot’s start date and had less impact on clients entering shelter before that time. Conclusions. Relative to standard services, Home to Stay services can accelerate exit from shelter and reduce return to shelter and total sheltered days for episodic and recidivist homeless families. Standard shelter services may be able to narrow this performance gap by incentivizing work with all episodic and recidivist homeless families. PMID:24148053

Evidence that self-incentives increase fruit consumption: a randomized exploratory trial among high-risk romanian adolescents.

PubMed

Armitage, Christopher J

2014-04-01

High mortality rates associated with cancer and cardiovascular disease in Romania have been partly attributed to low fruit consumption. The aim of the present research was to test whether self-incentives delivered via implementation intentions could increase fruit consumption among 238 high-risk Romanian adolescents. Participants were randomly allocated to either: (1) a control condition (asked to plan to increase their fruit intake but given no further instruction), (2) a standard implementation intention condition (asked to form an implementation intention using standard open-ended instructions), or (3) a self-incentivizing implementation intention condition (asked to reward themselves at the end of the week if they had successfully consumed an extra portion of fruit each day). There were significant increases in fruit consumption in the self-incentivizing implementation intention condition, but not in the control condition or-contrary to predictions-in the standard implementation intention condition. The findings support the use of implementation intentions to deliver self-incentives and increase fruit consumption, and suggest that providing children with a structured prompt might enhance the effectiveness of implementation intention-based interventions compared with standard implementation intention instructions.

Rationale and design of the HepZero study: a prospective, multicenter, international, open, randomized, controlled clinical study with parallel groups comparing heparin-free dialysis with heparin-coated dialysis membrane (Evodial) versus standard care: study protocol for a randomized controlled trial.

PubMed

Rossignol, Patrick; Dorval, Marc; Fay, Renaud; Ros, Joan Fort; Loughraieb, Nathalie; Moureau, Frédérique; Laville, Maurice

2013-06-01

Anticoagulation for chronic dialysis patients with contraindications to heparin administration is challenging. Current guidelines state that in patients with increased bleeding risks, strategies that can induce systemic anticoagulation should be avoided. Heparin-free dialysis using intermittent saline flushes is widely adopted as the method of choice for patients at risk of bleeding, although on-line blood predilution may also be used. A new dialyzer, Evodial (Gambro, Lund, Sweden), is grafted with unfractionated heparin during the manufacturing process and may allow safe and efficient heparin-free hemodialysis sessions. In the present trial, Evodial was compared to standard care with either saline flushes or blood predilution. The HepZero study is the first international (seven countries), multicenter (10 centers), randomized, controlled, open-label, non-inferiority (and if applicable subsequently, superiority) trial with two parallel groups, comprising 252 end-stage renal disease patients treated by maintenance hemodialysis for at least 3 months and requiring heparin-free dialysis treatments. Patients will be treated during a maximum of three heparin-free dialysis treatments with either saline flushes or blood predilution (control group), or Evodial. The first heparin-free dialysis treatment will be considered successful when there is: no complete occlusion of air traps or dialyzer rendering dialysis impossible; no additional saline flushes to prevent clotting; no change of dialyzer or blood lines because of clotting; and no premature termination (early rinse-back) because of clotting.The primary objectives of the study are to determine the effectiveness of the Evodial dialyzer, compared with standard care in terms of successful treatments during the first heparin-free dialysis. If the non-inferiority of Evodial is demonstrated then the superiority of Evodial over standard care will be tested. The HepZero study results may have major clinical implications for patient care. ClinicalTrials.gov NCT01318486.

Multiple effects of probiotics on different types of diabetes: a systematic review and meta-analysis of randomized, placebo-controlled trials.

PubMed

Wang, Xia; Juan, Qi-Fang; He, Yu-Wei; Zhuang, Li; Fang, Yuan-Yuan; Wang, Yong-Hong

2017-05-24

A systematic review and meta-analysis was designed to evaluate the effect of probiotics on diabetes and its associated risk factors. We systematically searched the Cochrane Library, PubMed, EMBASE and Web of Science to June 2016. We also hand-searched the citation lists of included studies and previously identified systematic reviews to identify further relevant trials. Our primary outcome variables included glucose, glycated hemoglobin (HbA1c) and insulin. The pooled standardized mean difference was used to compare the effect between the probiotics and controlled groups, and the pooled standardized mean difference effect size with a 95% confidence interval (CI) was estimated using a random-effect model. Heterogeneity was assessed with Cochran's Q and Higgins I2 tests. Two reviewers assessed trial quality and extracted data independently. The analysis and bias for each included study was performed and assessed using Review Manager 5.2. Eighteen randomized, placebo-controlled studies (n=1056 participants, 527 consuming probiotics, 529 not consuming probiotics) were included for analysis. Comparing the probiotics groups with the control groups, there were statistically significant pooled standardized mean differences on the reduction of glucose (-0.61, 95% CI -0.98, -0.24; p=0.001), insulin (-0.49, 95% CI -0.93, -0.04; p=0.03) and HbA1c (-0.39, 95% CI -0.60, -0.19%; p=0.0001). Subgroup analysis also indicated statistical significance on the reduction of low-density lipoprotein cholesterol (LDL-C) in non-type 2 diabetes (non-T2DM) mellitus patients with diabetes, for the pooled standardized mean difference was -0.29 (95% CI -0.54, -0.04; p=0.02). Probiotics may have beneficial effects on the reduction of glucose, insulin and HbA1c for diabetes, especially for T2DM mellitus patients.

The Girlfriends Project: Evaluating a Promising Community-Based Intervention from a Bottom-Up Perspective

ERIC Educational Resources Information Center

Hawk, Mary

2015-01-01

Randomized controlled trials are the gold standard in research but may not fully explain or predict outcome variations in community-based interventions. Demonstrating efficacy of externally driven programs in well-controlled environments may not translate to community-based implementation where resources and priorities vary. A bottom-up evaluation…

Intensified treatment with high dose Rifampicin and Levofloxacin compared to standard treatment for adult patients with Tuberculous Meningitis (TBM-IT): protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background Tuberculous meningitis is the most severe form of tuberculosis. Mortality for untreated tuberculous meningitis is 100%. Despite the introduction of antibiotic treatment for tuberculosis the mortality rate for tuberculous meningitis remains high; approximately 25% for HIV-negative and 67% for HIV positive patients with most deaths occurring within one month of starting therapy. The high mortality rate in tuberculous meningitis reflects the severity of the condition but also the poor antibacterial activity of current treatment regimes and relatively poor penetration of these drugs into the central nervous system. Improving the antitubercular activity in the central nervous system of current therapy may help improve outcomes. Increasing the dose of rifampicin, a key drug with known poor cerebrospinal fluid penetration may lead to higher drug levels at the site of infection and may improve survival. Of the second generation fluoroquinolones, levofloxacin may have the optimal pharmacological features including cerebrospinal fluid penetration, with a ratio of Area Under the Curve (AUC) in cerebrospinal fluid to AUC in plasma of >75% and strong bactericidal activity against Mycobacterium tuberculosis. We propose a randomized controlled trial to assess the efficacy of an intensified anti-tubercular treatment regimen in tuberculous meningitis patients, comparing current standard tuberculous meningitis treatment regimens with standard treatment intensified with high-dose rifampicin and additional levofloxacin. Methods/Design A randomized, double blind, placebo-controlled trial with two parallel arms, comparing standard Vietnamese national guideline treatment for tuberculous meningitis with standard treatment plus an increased dose of rifampicin (to 15 mg/kg/day total) and additional levofloxacin. The study will include 750 patients (375 per treatment group) including a minimum of 350 HIV-positive patients. The calculation assumes an overall mortality of 40% vs. 30% in the two arms, respectively (corresponding to a target hazard ratio of 0.7), a power of 80% and a two-sided significance level of 5%. Randomization ratio is 1:1. The primary endpoint is overall survival, i.e. time from randomization to death during a follow-up period of 9 months. Secondary endpoints are: neurological disability at 9 months, time to new neurological event or death, time to new or recurrent AIDS-defining illness or death (in HIV-positive patients only), severe adverse events, and rate of treatment interruption for adverse events. Discussion Currently very few options are available for the treatment of TBM and the mortality rate remains unacceptably high with severe disabilities seen in many of the survivors. This trial is based on the hypothesis that current anti-mycobacterial treatment schedules for TBM are not potent enough and that outcomes will be improved by increasing the CSF penetrating power of this regimen by optimising dosage and using additional drugs with better CSF penetration. Trial registration International Standard Randomised Controlled Trial Number ISRCTN61649292 PMID:21288325

Intensified treatment with high dose rifampicin and levofloxacin compared to standard treatment for adult patients with tuberculous meningitis (TBM-IT): protocol for a randomized controlled trial.

PubMed

Heemskerk, Dorothee; Day, Jeremy; Chau, Tran Thi Hong; Dung, Nguyen Huy; Yen, Nguyen Thi Bich; Bang, Nguyen Duc; Merson, Laura; Olliaro, Piero; Pouplin, Thomas; Caws, Maxine; Wolbers, Marcel; Farrar, Jeremy

2011-02-02

Tuberculous meningitis is the most severe form of tuberculosis. Mortality for untreated tuberculous meningitis is 100%. Despite the introduction of antibiotic treatment for tuberculosis the mortality rate for tuberculous meningitis remains high; approximately 25% for HIV-negative and 67% for HIV positive patients with most deaths occurring within one month of starting therapy. The high mortality rate in tuberculous meningitis reflects the severity of the condition but also the poor antibacterial activity of current treatment regimes and relatively poor penetration of these drugs into the central nervous system. Improving the antitubercular activity in the central nervous system of current therapy may help improve outcomes. Increasing the dose of rifampicin, a key drug with known poor cerebrospinal fluid penetration may lead to higher drug levels at the site of infection and may improve survival. Of the second generation fluoroquinolones, levofloxacin may have the optimal pharmacological features including cerebrospinal fluid penetration, with a ratio of Area Under the Curve (AUC) in cerebrospinal fluid to AUC in plasma of >75% and strong bactericidal activity against Mycobacterium tuberculosis. We propose a randomized controlled trial to assess the efficacy of an intensified anti-tubercular treatment regimen in tuberculous meningitis patients, comparing current standard tuberculous meningitis treatment regimens with standard treatment intensified with high-dose rifampicin and additional levofloxacin. A randomized, double blind, placebo-controlled trial with two parallel arms, comparing standard Vietnamese national guideline treatment for tuberculous meningitis with standard treatment plus an increased dose of rifampicin (to 15 mg/kg/day total) and additional levofloxacin. The study will include 750 patients (375 per treatment group) including a minimum of 350 HIV-positive patients. The calculation assumes an overall mortality of 40% vs. 30% in the two arms, respectively (corresponding to a target hazard ratio of 0.7), a power of 80% and a two-sided significance level of 5%. Randomization ratio is 1:1. The primary endpoint is overall survival, i.e. time from randomization to death during a follow-up period of 9 months. Secondary endpoints are: neurological disability at 9 months, time to new neurological event or death, time to new or recurrent AIDS-defining illness or death (in HIV-positive patients only), severe adverse events, and rate of treatment interruption for adverse events. Currently very few options are available for the treatment of TBM and the mortality rate remains unacceptably high with severe disabilities seen in many of the survivors. This trial is based on the hypothesis that current anti-mycobacterial treatment schedules for TBM are not potent enough and that outcomes will be improved by increasing the CSF penetrating power of this regimen by optimising dosage and using additional drugs with better CSF penetration. International Standard Randomised Controlled Trial Number ISRCTN61649292.

Medical yoga for patients with stress-related symptoms and diagnoses in primary health care: a randomized controlled trial.

PubMed

Köhn, Monica; Persson Lundholm, Ulla; Bryngelsson, Ing-Liss; Anderzén-Carlsson, Agneta; Westerdahl, Elisabeth

2013-01-01

An increasing number of patients are suffering from stress-related symptoms and diagnoses. The purpose of this study was to evaluate the medical yoga treatment in patients with stress-related symptoms and diagnoses in primary health care. A randomized controlled study was performed at a primary health care centre in Sweden from March to June, 2011. Patients were randomly allocated to a control group receiving standard care or a yoga group treated with medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. A total of 37 men and women, mean age of 53 ± 12 years were included. General stress level (measured using Perceived Stress Scale (PSS)), burnout (Shirom-Melamed Burnout Questionnaire (SMBQ)), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), insomnia severity (Insomnia Severity Index (ISI)), pain (visual analogue scale (VAS)), and overall health status (Euro Quality of Life VAS (EQ-VAS)) were measured before and after 12 weeks. Patients assigned to the Yoga group showed significantly greater improvements on measures of general stress level (P < 0.000), anxiety (P < 0.019), and overall health status (P < 0.018) compared to controls. Treatment with medical yoga is effective in reducing levels of stress and anxiety in patients with stress-related symptoms in primary health care.

Medical Yoga for Patients with Stress-Related Symptoms and Diagnoses in Primary Health Care: A Randomized Controlled Trial

PubMed Central

Köhn, Monica; Persson Lundholm, Ulla; Bryngelsson, Ing-Liss; Anderzén-Carlsson, Agneta; Westerdahl, Elisabeth

2013-01-01

An increasing number of patients are suffering from stress-related symptoms and diagnoses. The purpose of this study was to evaluate the medical yoga treatment in patients with stress-related symptoms and diagnoses in primary health care. A randomized controlled study was performed at a primary health care centre in Sweden from March to June, 2011. Patients were randomly allocated to a control group receiving standard care or a yoga group treated with medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. A total of 37 men and women, mean age of 53 ± 12 years were included. General stress level (measured using Perceived Stress Scale (PSS)), burnout (Shirom-Melamed Burnout Questionnaire (SMBQ)), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), insomnia severity (Insomnia Severity Index (ISI)), pain (visual analogue scale (VAS)), and overall health status (Euro Quality of Life VAS (EQ-VAS)) were measured before and after 12 weeks. Patients assigned to the Yoga group showed significantly greater improvements on measures of general stress level (P < 0.000), anxiety (P < 0.019), and overall health status (P < 0.018) compared to controls. Treatment with medical yoga is effective in reducing levels of stress and anxiety in patients with stress-related symptoms in primary health care. PMID:23533465

The Effects of Self-Book© Art Therapy on Cancer-Related Distress in Female Cancer Patients during Active Treatment: A Randomized Controlled Trial.

PubMed

Radl, Donna; Vita, Maureen; Gerber, Nancy; Gracely, Edward J; Bradt, Joke

2018-05-10

National attention on patients' cancer-related emotional distress produced a need for evidence-based, psychosocial interventions in oncology care. The purpose of this study was to evaluate the efficacy of Self-Book© art therapy for emotional distress and psychological well-being of female oncology patients during active oncology treatment. Sixty consenting women with cancer were randomly assigned to either a six-session Self-Book© art therapy program or standard care. A repeated measures randomized controlled trial design was employed. Data were collected using the Distress Thermometer (DT), Perceived Emotional Distress Inventory (PEDI), Patient-Reported Outcomes Measurement Information System (PROMIS) Brief Psychological Well-being test, and the Functional Assessment of Chronic Illness Therapy - Spiritual Well-being (FACIT-Sp). Measurements were obtained at baseline, week 3, week 6, and 1-to-2 months post-intervention. Forty participants were included in the final analysis. No significant differences between groups were found for the primary outcome measures: emotional distress and psychological well-being. Greater improvements in Self-Book© art therapy participants' spiritual well-being were found compared to the standard care control participants (p = 0.02). Although no statistically significant differences were present between the groups for the primary outcomes, several positive trends were noted. Thirty percent of Self-Book© art therapy participants reported post-intervention emotional distress scores that were below the abnormal range for emotional distress, compared with only 5% of standard care control participants, suggesting that Self-Book© art therapy may have clinical value. Further studies are recommended to better understand the therapeutic mechanisms of Self-Book© art therapy for enhancing psychological well-being. This article is protected by copyright. All rights reserved.

Extracorporeal shock wave therapy as an adjunct wound treatment: a systematic review of the literature.

PubMed

Dymarek, Robert; Halski, Tomasz; Ptaszkowski, Kuba; Slupska, Lucyna; Rosinczuk, Joanna; Taradaj, Jakub

2014-07-01

Standard care procedures for complex wounds are sometimes supported and reinforced by physical treatment modalities such as extracorporeal shock wave therapy (ESWT). To evaluate available evidence of ESWT effectiveness in humans, a systematic review of the literature was conducted using MEDLINE, PubMed, Scopus, EBSCOhost, and PEDro databases. Of the 393 articles found, 13 met the publication date (year 2000-2013), study type (clinical study), language (English only), and abstract availability (yes) criteria. The 13 studies (n = 919 patients with wounds of varying etiologies) included seven randomized controlled trials that were evaluated using Cochrane Collaboration Group standards. Only studies with randomization, well prepared inclusion/exclusion criteria protocol, written in English, and full version available were analyzed. An additional six publications reporting results of other clinical studies including a total of 523patients were identified and summarized. ESWT was most commonly applied once or twice a week using used low or medium energy, focused or defocused generator heads (energy range 0.03 to 0.25 mJ/mm2; usually 0.1 mJ/mm2), and electrohydraulic or electromagnetic sources. Few safety concerns were reported, and in the controlled clinical studies statistically significant differences in rates of wound closure were reported compared to a variety of standard topical treatment modalities, sham ESWT treatment, and hyperbaric oxygen therapy. Based on this analysis, ESWT can be characterized as noninvasive, mostly painless, and safe. Controlled, randomized, multicenter, blind clinical trials still are required to evaluate the efficacy and cost-effectiveness of ESWT compared to sham control, other adjunctive treatments, and commonly used moisture-retentive dressings. In the future, ESWT may play an important role in wound care once evidence-based practice guidelines are developed.

Effect of High Intensity Interval and Continuous Swimming Training on Body Mass Adiposity Level and Serum Parameters in High-Fat Diet Fed Rats

PubMed Central

da Rocha, Guilherme L.; Crisp, Alex H.; de Oliveira, Maria R. M.; da Silva, Carlos A.; Silva, Jadson O.; Duarte, Ana C. G. O.; Sene-Fiorese, Marcela; Verlengia, Rozangela

2016-01-01

This study aimed to investigate the effects of interval and continuous training on the body mass gain and adiposity levels of rats fed a high-fat diet. Forty-eight male Sprague-Dawley rats were randomly divided into two groups, standard diet and high-fat diet, and received their respective diets for a period of four weeks without exercise stimuli. After this period, the animals were randomly divided into six groups (n = 8): control standard diet (CS), control high-fat diet (CH), continuous training standard diet (CTS), continuous training high-fat diet (CTH), interval training standard diet (ITS), and interval training high-fat diet (ITH). The interval and continuous training consisted of a swimming exercise performed over eight weeks. CH rats had greater body mass gain, sum of adipose tissues mass, and lower serum high density lipoprotein values than CS. The trained groups showed lower values of feed intake, caloric intake, body mass gain, and adiposity levels compared with the CH group. No significant differences were observed between the trained groups (CTS versus ITS and CTH versus ITH) on body mass gains and adiposity levels. In conclusion, both training methodologies were shown to be effective in controlling body mass gain and adiposity levels in high-fat diet fed rats. PMID:26904718

A randomized controlled trial comparing 2 interventions for visual field loss with standard occupational therapy during inpatient stroke rehabilitation.

PubMed

Mödden, Claudia; Behrens, Marion; Damke, Iris; Eilers, Norbert; Kastrup, Andreas; Hildebrandt, Helmut

2012-06-01

Compensatory and restorative treatments have been developed to improve visual field defects after stroke. However, no controlled trials have compared these interventions with standard occupational therapy (OT). A total of 45 stroke participants with visual field defect admitted for inpatient rehabilitation were randomized to restorative computerized training (RT) using computer-based stimulation of border areas of their visual field defects or to a computer-based compensatory therapy (CT) teaching a visual search strategy. OT, in which different compensation strategies were used to train for activities of daily living, served as standard treatment for the active control group. Each treatment group received 15 single sessions of 30 minutes distributed over 3 weeks. The primary outcome measures were visual field expansion for RT, visual search performance for CT, and reading performance for both treatments. Visual conjunction search, alertness, and the Barthel Index were secondary outcomes. Compared with OT, CT resulted in a better visual search performance, and RT did not result in a larger expansion of the visual field. Intragroup pre-post comparisons demonstrated that CT improved all defined outcome parameters and RT several, whereas OT only improved one. CT improved functional deficits after visual field loss compared with standard OT and may be the intervention of choice during inpatient rehabilitation. A larger trial that includes lesion location in the analysis is recommended.

Toward a Better Understanding of the Relationship between Belief in the Paranormal and Statistical Bias: The Potential Role of Schizotypy

PubMed Central

Dagnall, Neil; Denovan, Andrew; Drinkwater, Kenneth; Parker, Andrew; Clough, Peter

2016-01-01

The present paper examined relationships between schizotypy (measured by the Oxford-Liverpool Inventory of Feelings and Experience; O-LIFE scale brief), belief in the paranormal (assessed via the Revised Paranormal Belief Scale; RPBS) and proneness to statistical bias (i.e., perception of randomness and susceptibility to conjunction fallacy). Participants were 254 volunteers recruited via convenience sampling. Probabilistic reasoning problems appeared framed within both standard and paranormal contexts. Analysis revealed positive correlations between the Unusual Experience (UnExp) subscale of O-LIFE and paranormal belief measures [RPBS full scale, traditional paranormal beliefs (TPB) and new age philosophy]. Performance on standard problems correlated negatively with UnExp and belief in the paranormal (particularly the TPB dimension of the RPBS). Consideration of specific problem types revealed that perception of randomness associated more strongly with belief in the paranormal than conjunction; both problem types related similarly to UnExp. Structural equation modeling specified that belief in the paranormal mediated the indirect relationship between UnExp and statistical bias. For problems presented in a paranormal context a framing effect occurred. Whilst UnExp correlated positively with conjunction proneness (controlling for perception of randomness), there was no association between UnExp and perception of randomness (controlling for conjunction). PMID:27471481

Toward a Better Understanding of the Relationship between Belief in the Paranormal and Statistical Bias: The Potential Role of Schizotypy.

PubMed

Dagnall, Neil; Denovan, Andrew; Drinkwater, Kenneth; Parker, Andrew; Clough, Peter

2016-01-01

The present paper examined relationships between schizotypy (measured by the Oxford-Liverpool Inventory of Feelings and Experience; O-LIFE scale brief), belief in the paranormal (assessed via the Revised Paranormal Belief Scale; RPBS) and proneness to statistical bias (i.e., perception of randomness and susceptibility to conjunction fallacy). Participants were 254 volunteers recruited via convenience sampling. Probabilistic reasoning problems appeared framed within both standard and paranormal contexts. Analysis revealed positive correlations between the Unusual Experience (UnExp) subscale of O-LIFE and paranormal belief measures [RPBS full scale, traditional paranormal beliefs (TPB) and new age philosophy]. Performance on standard problems correlated negatively with UnExp and belief in the paranormal (particularly the TPB dimension of the RPBS). Consideration of specific problem types revealed that perception of randomness associated more strongly with belief in the paranormal than conjunction; both problem types related similarly to UnExp. Structural equation modeling specified that belief in the paranormal mediated the indirect relationship between UnExp and statistical bias. For problems presented in a paranormal context a framing effect occurred. Whilst UnExp correlated positively with conjunction proneness (controlling for perception of randomness), there was no association between UnExp and perception of randomness (controlling for conjunction).

The Impact of Preoperative Enteral Nutrition Enriched with Eicosapentaenoic Acid on Postoperative Hypercytokinemia after Pancreatoduodenectomy: The Results of a Double-Blinded Randomized Controlled Trial.

PubMed

Ashida, Ryo; Okamura, Yukiyasu; Wakabayashi-Nakao, Kanako; Mizuno, Takashi; Aoki, Shuichi; Uesaka, Katsuhiko

2018-06-08

To investigate whether preoperative enteral diets -enriched in eicosapentaenoic acid (EPA) supplements could reduce the incidence of hypercytokinemia after pancreatoduodenectomy (PD) in a double-blinded randomized -controlled trial. Patients with resectable periampullary cancer were randomized into either the control group or the treatment group. Patients in the treatment group received oral supplementation (600 kcal/day) containing EPA for 7 days before surgery. Patients in the control group received isocaloric isonitrogenous standard nutrition (600 kcal/day) without EPA for 7 days before surgery. The primary endpoint was postoperative serum concentrations of interleukin-6 (IL-6). The secondary endpoints were the postoperative nutritional status and the incidence of postoperative infectious complications. Twenty-four patients were enrolled in the present study. After exclusion, 20 patients (control group, n = 9; treatment group, n = 11) were analyzed. There were no significant differences in the curves for the serum concentration of IL-6 (p = 0.68) or the incidence of infectious complications between the 2 groups (control group: 78%, treatment group: 55%, p = 0.37). The results of a double-blinded randomized controlled trial indicated that preoperative immunonutrition had no marked impact on the rates of postoperative hypercytokinemia or infectious complications after PD. © 2018 S. Karger AG, Basel.

The feasibility of progressive resistance training in women with polycystic ovary syndrome: a pilot randomized controlled trial.

PubMed

Vizza, Lisa; Smith, Caroline A; Swaraj, Soji; Agho, Kingsley; Cheema, Birinder S

2016-01-01

To evaluate the feasibility of executing a randomized controlled trial of progressive resistance training (PRT) in women with polycystic ovary syndrome (PCOS). Women with PCOS were randomized to an experimental (PRT) group or a no-exercise (usual care) control group. The PRT group was prescribed two supervised and two unsupervised (home-based) training sessions per week for 12 weeks. Feasibility outcomes included recruitment and attrition, adherence, adverse events, and completion of assessments. Secondary outcomes, collected pre and post intervention, included a range of pertinent physiological, functional and psychological measures. Fifteen participants were randomised into the PRT group (n = 8) or control group (n = 7); five women (n = 2 in PRT group and n = 3 in control group) withdrew from the study. The most successful recruitment sources were Facebook (40 %) and online advertisement (27 %), while least successful methods were referrals by clinicians, colleagues and flyers. In the PRT group, attendance to supervised sessions was higher (95 %; standard deviation ±6 %) compared to unsupervised sessions (51 %; standard deviation ±28 %). No adverse events were attributed to PRT. Change in menstrual cycle status was not significantly different between groups over time (p = 0.503). However, the PRT group significantly increased body weight (p = 0.01), BMI (p = 0.04), lean mass (p = 0.01), fat-free mass (p = 0.005) and lower body strength (p = 0.03), while reducing waist circumference (p = 0.03) and HbA1c (p = 0.033) versus the control group. The PRT group also significantly improved across several domains of disease-specific and general health-related quality of life, depression, anxiety and exercise self-efficacy. A randomized controlled trial of PRT in PCOS would be feasible, and this mode of exercise may elicit a therapeutic effect on clinically important outcomes in this cohort. The success of a large-scale trial required to confirm these findings would be contingent on addressing the feasibility hurdles identified in this study with respect to recruitment, attrition, compliance, and collection of standardized clinical data. Australia New Zealand Clinical Trials Registry; ACTRN12614000517673 Registered 15 May 2014.

Efficacy of Standardized Extract of Bacopa monnieri (Bacognize®) on Cognitive Functions of Medical Students: A Six-Week, Randomized Placebo-Controlled Trial

PubMed Central

Abichandani, L. G.; Thawani, Vijay; Gharpure, K. J.; Naidu, M. U. R.; Venkat Ramana, G.

2016-01-01

Rationale. Bacopa monnieri, popularly known as Brahmi, has been traditionally used in Ayurveda since ages for its memory enhancing properties. However, data on placebo-controlled trial of Bacopa monnieri on intellectual sample is scarce. Hence this study was planned to evaluate the effect of Bacopa monnieri on memory of medical students for six weeks. Objective. To evaluate the efficacy of Bacopa monnieri on memory of medical students with six weeks' administration. Method and Material. This was a randomized double blind placebo-controlled noncrossover, parallel trial. Sixty medical students of either gender from second year of medical school, third term, regular batch, were enrolled from Government Medical College, Nagpur, India. Baseline biochemical and memory tests were done. The participants were randomly divided in two groups to receive either 150 mg of standardized extract of Bacopa monnieri (Bacognize) or matching placebo twice daily for six weeks. All baseline investigations were repeated at the end of the trial. Students were followed up for 15 days after the intervention. Results. Statistically significant improvement was seen in the tests relating to the cognitive functions with use of Bacopa monnieri. Blood biochemistry also showed a significant increase in serum calcium levels (still within normal range). PMID:27803728

Local anaesthetic infiltration for the rubber band ligation of early symptomatic haemorrhoids: a systematic review and meta-analysis.

PubMed

Sajid, M S; Bhatti, M I; Caswell, J; Sains, P; Baig, M K

2015-03-01

The objective of this article is to systematically analyse the randomized, controlled trials evaluating the effectiveness of local anaesthetic infiltration prior to the rubber band ligation of early symptomatic haemorrhoids. Published randomized, controlled trials comparing the use of local anaesthetic (LA) versus no-local anaesthetic (NLA) for the rubber band ligation of early symptomatic haemorrhoids were analysed using RevMan®, and the combined outcomes were expressed as odds ratios (OR) and standardized mean difference (SMD). Four randomized, controlled trials evaluating 387 patients were retrieved from the standard electronic databases. The risk of treatment failure (OR 0.44; 95% CI 0.07, 2.79; z = 0.87; p = 0.39) and post-procedure complications (OR 0.48; 95% CI 0.08, 2.76; z = 0.83; p = 0.41) was similar between two techniques. However, the post-procedure pain score (SMD -5.19; 95% CI -9.08, -1.30; z = 2.62; p < 0.009) was significantly lower in the group of patients undergoing rubber band ligation of haemorrhoids under local anaesthetic injection. The use of LA appears to have clinically measurable advantages over NLA in the rubber band ligation of early symptomatic haemorrhoids to lessen post-procedure pain.

[Report quality of randomized controlled trials of moxibustion for knee osteoarthritis based on CONSORT and STRICTOM].

PubMed

Xiong, Jun; Zhu, Daocheng; Chen, Rixin; Ye, Wenguo

2015-08-01

The report quality of randomized controlled trials (RCTs) of moxibustion for knee osteoarthritis (KOA) in China was evaluated by Consolidated Standards for Reporting of Trials (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Moxibustion (STRICTOM). Computer and manual retrieval was used. Four databases of China National Knowledge Infrastructure (CNKD, China Biomedicine (CBM), VIP and WNFANG were searched in combination with manual retrieval for relevant journals to screen the literature that: met the inclusive criteria, and CONSORT and STRICTOM were used to assess the report quality. A total of 52 RCTs were included. It was found that unclear description of random methods, low use of blind methods, no allocation concealment, no sample size calculation, no intention-to-treat analysis,inadequate report of moxibustion details and no mention of practitioners background existed in the majority of the RCTs. Although the quality of RCTs of moxibustion for KOA was generally low, reducing the reliability and homogeneous comparability of the reports ,the quality of heat-sensitive moxibustion RCTs was high. It was believed that in order to improve the reliability and quality of RCTs of moxibustion, CONSORT and STRICTOM should be introduced into the RCT design of moxibustion and be strictly performed.

Challenging the One-Dose-Fits-All Model for Insulin in the Acute Treatment of Pediatric Diabetic Ketoacidosis. A Critical Appraisal of "Low-Dose Versus Standard-Dose Insulin in Pediatric Diabetic Ketoacidosis: A Randomized Clinical Trial" by Nallasamy et al (JAMA Pediatrics 2014; 168:999-1005).

PubMed

Orwoll, Benjamin Edward

2016-10-01

To review the findings and discuss the implications of the use of low-dose insulin infusions in pediatric diabetic ketoacidosis compared with standard-dose insulin. A search of the electronic PubMed database was used to perform the clinical query as well as to search for additional relevant literature. The article by Nallasamy K et al "Low-Dose vs Standard-Dose Insulin in Pediatric Diabetic Ketoacidosis: A Randomized Clinical Trial. JAMA Pediatrics 2014; 17:e477-e480" was selected for critical appraisal and literature review. The authors performed a randomized controlled trial among 50 consecutive patients of 0-12 years old presenting to the emergency department in diabetic ketoacidosis. They found that low-dose (0.05 U/kg/hr) insulin infusion was noninferior to standard-dose (0.1 U/kg/hr) insulin in terms of resolution of hyperglycemia and acidosis with a trend toward lower rates of therapy-related complications in the low-dose group. Low-dose insulin infusion is noninferior to standard-dose insulin in the treatment of younger pediatric patients with diabetic ketoacidosis and may lead to fewer therapy-related complications.

Individualizing duration of antibiotic therapy in community-acquired pneumonia.

PubMed

Aliberti, Stefano; Ramirez, Julio; Giuliani, Fabio; Wiemken, Timothy; Sotgiu, Giovanni; Tedeschi, Sara; Carugati, Manuela; Valenti, Vincenzo; Marchioni, Marco; Camera, Marco; Piro, Roberto; Del Forno, Manuela; Milani, Giuseppe; Faverio, Paola; Richeldi, Luca; Deotto, Martina; Villani, Massimiliano; Voza, Antonio; Tobaldini, Eleonora; Bernardi, Mauro; Bellone, Andrea; Bassetti, Matteo; Blasi, Francesco

2017-08-01

International experts suggest tailoring antibiotic duration in community-acquired pneumonia (CAP) according to patients' characteristics. We aimed to assess the effectiveness of an individualized approach to antibiotic duration based on time in which CAP patients reach clinical stability during hospitalization. In a multicenter, non-inferiority, randomized, controlled trial hospitalized adult patients with CAP reaching clinical stability within 5 days after hospitalization were randomized to a standard vs. individualized antibiotic duration. In the Individualized group, antibiotics were discontinued 48 h after the patient reached clinical stability, with at least five days of total antibiotic treatment. Early failure within 30 days was the primary composite outcome. 135 patients were randomized to the Standard group and 125 to the Individualized group. The trial was interrupted by the safety committee because of an apparent inferiority of the Individualized group over the Standard treatment: 14 (11.2%) patients in the Individualized group experienced early failure vs. 10 (7.4%) patients in the Standard group, p = 0.200, at the intention-to-treat analysis. 30-day mortality rate was four-time higher in the Individualized group than the Standard group. Shortening antibiotic duration according to patients' characteristics still remains an open question. Copyright © 2017 Elsevier Ltd. All rights reserved.

Investigation of standard care versus sham Reiki placebo versus actual Reiki therapy to enhance comfort and well-being in a chemotherapy infusion center.

PubMed

Catlin, Anita; Taylor-Ford, Rebecca L

2011-05-01

To determine whether provision of Reiki therapy during outpatient chemotherapy is associated with increased comfort and well-being. Double-blind, randomized clinical controlled trial. Outpatient chemotherapy center. 189 participants were randomized to actual Reiki, sham Reiki placebo, or standard care. Patients receiving chemotherapy were randomly placed into one of three groups. Patients received either standard care, a placebo, or an actual Reiki therapy treatment. A demographic tool and pre- and post-tests were given before and after chemotherapy infusion. Reiki therapy, sham Reiki placebo therapy, standard care, and self-reported levels of comfort and well-being pre- and postintervention. Although Reiki therapy was statistically significant in raising the comfort and well-being of patients post-therapy, the sham Reiki placebo also was statistically significant. Patients in the standard care group did not experience changes in comfort and well-being during their infusion session. The findings indicate that the presence of an RN providing one-on-one support during chemotherapy was influential in raising comfort and well-being levels, with or without an attempted healing energy field. An attempt by clinic nurses to provide more designated one-to-one presence and support for patients while receiving their chemotherapy infusions could increase patient comfort and well-being.

Traffic signal inventory project

DOT National Transportation Integrated Search

2001-06-01

The purpose of this study was to determine the level of compliance with the "Manual on Uniform Traffic Control Devices" (MUTCD) and other industry standards of traffic signals on the Iowa state highway system. Signals were randomly selected in cities...

Effect of metronidazole versus standard care on length of stay of patients admitted with severe infectious mononucleosis: a randomized controlled trial.

PubMed

Lennon, P; O'Neill, J P; Fenton, J E

2014-07-01

Metronidazole may be of use in the treatment of infectious mononucleosis (IM). Our aim is to show that metronidazole shortens hospital stay for patients with severe IM. A single-centre randomized controlled trial was undertaken in patients admitted with severe IM, who were with a similar group treated by the standard care. Patients were blinded to which treatment arm they were in. Forty-two of these patients were enrolled in the trial. The primary endpoint was the difference in length of stay. This was significantly less in the metronidazole group (3.67 days v 4.67) (p 0.032). This study demonstrates that metronidazole has a role to play in severe infectious mononucleosis. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

Comparison of the Anti-Adhesion Activity of Three Different Cranberry Extracts on Uropathogenic P-fimbriated Escherichia coli: a Randomized, Double-blind, Placebo Controlled, Ex Vivo, Acute Study.

PubMed

Howell, Amy; Souza, Dan; Roller, Marc; Fromentin, Emilie

2015-07-01

Research suggests that cranberry (Vaccinium macrocarpon) helps maintain urinary tract health. Bacterial adhesion to the uroepithelium is the initial step in the progression to development of a urinary tract infection. The bacterial anti-adhesion activity of cranberry proanthocyanidins (PACs) has been demonstrated in vitro. Three different cranberry extracts were developed containing a standardized level of 36 mg of PACs. This randomized, double-blind, placebo controlled, ex vivo, acute study was designed to compare the anti-adhesion activity exhibited by human urine following consumption of three different cranberry extracts on uropathogenic P-fimbriated Escherichia coli in healthy men and women. All three cranberry extracts significantly increased anti-adhesion activity in urine. from 6 to 12 hours after intake of a single dose standardized to deliver 36 mg of PACs (as measured by the BL-DMAC method), versus placebo.

The outcome of tactile touch on stress parameters in intensive care: a randomized controlled trial.

PubMed

Henricson, Maria; Ersson, Anders; Määttä, Sylvia; Segesten, Kerstin; Berglund, Anna-Lena

2008-11-01

The study aimed to investigate the effects of a five-day tactile touch intervention in order to find new and unconventional measures to moderate the detrimental influence of patients' stressors during intensive care. The hypothesis was that tactile touch would decrease stress indicators such as anxiety, glucose metabolism, blood pressure, heart rate and requirements of sedative drugs and noradrenalin. A randomized controlled trial was undertaken with 44 patients, which were assigned either to tactile touch or standard treatment (a rest hour). Observations of the stress indicators were made before, during and after the intervention or standard treatment. The study showed that tactile touch led to significantly lower levels of anxiety. The circulatory parameters suggested increased circulatory stability indicated by a reduction in noradrenalin requirement. The results need to be further validated through studies with larger sample sizes.

Personalized versus standardized dosing strategies for the treatment of childhood amblyopia: study protocol for a randomized controlled trial.

PubMed

Moseley, Merrick J; Wallace, Michael P; Stephens, David A; Fielder, Alistair R; Smith, Laura C; Stewart, Catherine E

2015-04-25

Amblyopia is the commonest visual disorder of childhood in Western societies, affecting, predominantly, spatial visual function. Treatment typically requires a period of refractive correction ('optical treatment') followed by occlusion: covering the nonamblyopic eye with a fabric patch for varying daily durations. Recent studies have provided insight into the optimal amount of patching ('dose'), leading to the adoption of standardized dosing strategies, which, though an advance on previous ad-hoc regimens, take little account of individual patient characteristics. This trial compares the effectiveness of a standardized dosing strategy (that is, a fixed daily occlusion dose based on disease severity) with a personalized dosing strategy (derived from known treatment dose-response functions), in which an initially prescribed occlusion dose is modulated, in a systematic manner, dependent on treatment compliance. A total of 120 children aged between 3 and 8 years of age diagnosed with amblyopia in association with either anisometropia or strabismus, or both, will be randomized to receive either a standardized or a personalized occlusion dose regimen. To avoid confounding by the known benefits of refractive correction, participants will not be randomized until they have completed an optical treatment phase. The primary study objective is to determine whether, at trial endpoint, participants receiving a personalized dosing strategy require fewer hours of occlusion than those in receipt of a standardized dosing strategy. Secondary objectives are to quantify the relationship between observed changes in visual acuity (logMAR, logarithm of the Minimum Angle of Resolution) with age, amblyopia type, and severity of amblyopic visual acuity deficit. This is the first randomized controlled trial of occlusion therapy for amblyopia to compare a treatment arm representative of current best practice with an arm representative of an entirely novel treatment regimen based on statistical modelling of previous trial outcome data. Should the personalized dosing strategy demonstrate superiority over the standardized dosing strategy, then its adoption into routine practice could bring practical benefits in reducing the duration of treatment needed to achieve an optimal outcome. ISRCTN ISRCTN12292232.

Case-based Learning Outperformed Simulation Exercises in Disaster Preparedness Education Among Nursing Trainees in India: A Randomized Controlled Trial.

PubMed

Aluisio, Adam R; Daniel, Pia; Grock, Andrew; Freedman, Joseph; Singh, Ajai; Papanagnou, Dimitrios; Arquilla, Bonnie

2016-10-01

In resource-constrained environments, appropriately employing triage in disaster situations is crucial. Although both case-based learning (CBL) and simulation exercises (SEs) commonly are utilized in teaching disaster preparedness to adult learners, there is no substantial evidence supporting one as a more efficacious methodology. This randomized controlled trial (RCT) evaluated the effectiveness of CBL versus SEs in addition to standard didactic instruction in knowledge attainment pertaining to disaster triage preparedness. This RCT was performed during a one-day disaster preparedness course in Lucknow, India during October 2014. Following provision of informed consent, nursing trainees were randomized to knowledge assessment after didactic teaching (control group); didactic plus CBL (Intervention Group 1); or didactic plus SE (Intervention Group 2). The educational curriculum used the topical focus of triage processes during disaster situations. Cases for the educational intervention sessions were scripted, identical between modalities, and employed structured debriefing. Trained live actors were used for SEs. After primary assessment, the groups underwent crossover to take part in the alternative educational modality and were re-assessed. Two standardized multiple-choice question batteries, encompassing key core content, were used for assessments. A sample size of 48 participants was calculated to detect a ≥20% change in mean knowledge score (α=0.05; power=80%). Robustness of randomization was evaluated using X 2, anova, and t-tests. Mean knowledge attainment scores were compared using one- and two-sample t-tests for intergroup and intragroup analyses, respectively. Among 60 enrolled participants, 88.3% completed follow-up. No significant differences in participant characteristics existed between randomization arms. Mean baseline knowledge score in the control group was 43.8% (standard deviation=11.0%). Case-based learning training resulted in a significant increase in relative knowledge scores at 20.8% (P=0.003) and 10.3% (P=.033) in intergroup and intragroup analyses, respectively. As compared to control, SEs did not significantly alter knowledge attainment scores with an average score increase of 6.6% (P=.396). In crossover intra-arm analysis, SEs were found to result in a 26.0% decrement in mean assessment score (P < .001). Among nursing trainees assessed in this RCT, the CBL modality was superior to SEs in short-term disaster preparedness educational translation. Simulation exercises resulted in no detectable improvement in knowledge attainment in this population, suggesting that CBL may be utilized preferentially for adult learners in similar disaster training settings. Aluisio AR , Daniel P , Grock A , Freedman J , Singh A , Papanagnou D , Arquilla B . Case-based learning outperformed simulation exercises in disaster preparedness education among nursing trainees in India: a randomized controlled trial. Prehosp Disaster Med. 2016;31(5):516-523.

A two-way enriched clinical trial design: combining advantages of placebo lead-in and randomized withdrawal.

PubMed

Ivanova, Anastasia; Tamura, Roy N

2015-12-01

A new clinical trial design, designated the two-way enriched design (TED), is introduced, which augments the standard randomized placebo-controlled trial with second-stage enrichment designs in placebo non-responders and drug responders. The trial is run in two stages. In the first stage, patients are randomized between drug and placebo. In the second stage, placebo non-responders are re-randomized between drug and placebo and drug responders are re-randomized between drug and placebo. All first-stage data, and second-stage data from first-stage placebo non-responders and first-stage drug responders, are utilized in the efficacy analysis. The authors developed one, two and three degrees of freedom score tests for treatment effect in the TED and give formulae for asymptotic power and for sample size computations. The authors compute the optimal allocation ratio between drug and placebo in the first stage for the TED and compare the operating characteristics of the design to the standard parallel clinical trial, placebo lead-in and randomized withdrawal designs. Two motivating examples from different disease areas are presented to illustrate the possible design considerations. © The Author(s) 2011.

The clinical effectiveness of concise cognitive behavioral therapy with or without pharmacotherapy for depressive and anxiety disorders; a pragmatic randomized controlled equivalence trial in clinical practice.

PubMed

Meuldijk, D; Carlier, I V E; van Vliet, I M; van Veen, T; Wolterbeek, R; van Hemert, A M; Zitman, F G

2016-03-01

Depressive and anxiety disorders contribute to a high disease burden. This paper investigates whether concise formats of cognitive behavioral- and/or pharmacotherapy are equivalent with longer standard care in the treatment of depressive and/or anxiety disorders in secondary mental health care. A pragmatic randomized controlled equivalence trial was conducted at five Dutch outpatient Mental Healthcare Centers (MHCs) of the Regional Mental Health Provider (RMHP) 'Rivierduinen'. Patients (aged 18-65 years) with a mild to moderate anxiety and/or depressive disorder, were randomly allocated to concise or standard care. Data were collected at baseline, 3, 6 and 12 months by Routine Outcome Monitoring (ROM). Primary outcomes were the Brief Symptom Inventory (BSI) and the Web Screening Questionnaire (WSQ). We used Generalized Estimating Equations (GEE) to assess outcomes. Between March 2010 and December 2012, 182 patients, were enrolled (n=89 standard care; n=93 concise care). Both intention-to-treat and per-protocol analyses demonstrated equivalence of concise care and standard care at all time points. Severity of illness reduced, and both treatments improved patient's general health status and subdomains of quality of life. Moreover, in concise care, the beneficial effects started earlier. Concise care has the potential to be a feasible and promising alternative to longer standard secondary mental health care in the treatment of outpatients with a mild to moderate depressive and/or anxiety disorder. For future research, we recommend adhering more strictly to the concise treatment protocols to further explore the beneficial effects of the concise treatment. The study is registered in the Netherlands Trial Register, number NTR2590. Clinicaltrials.gov identifier: NCT01643642. Copyright © 2015 Elsevier Inc. All rights reserved.

Randomized, single-blind, controlled trial of a specialist behavior therapy team for challenging behavior in adults with intellectual disabilities.

PubMed

Hassiotis, Angela; Robotham, Dan; Canagasabey, Anton; Romeo, Renee; Langridge, Diane; Blizard, Robert; Murad, Shahed; King, Michael

2009-11-01

Community-based specialist behavior therapy teams may be helpful in managing challenging behavior, but evidence of their effectiveness is limited. This study was designed to examine the effectiveness and costs associated with treatment by a specialist behavior therapy team. This was a parallel-group, randomized, single-blind controlled trial carried out in an intellectual disabilities service in England. Participants were 63 male and female service users with mild to severe intellectual disability who presented with challenging behavior. The interventions were standard treatment plus applied behavioral analysis (N=32) and standard treatment only (N=31). The primary outcome measure was challenging behavior, as measured by total and subscale scores on the Aberrant Behavior Checklist 3 and 6 months after randomization. Secondary outcome measures were psychiatric comorbidity assessed at 3 and 6 months using the Psychiatric Assessment Schedule for Adults With a Developmental Disability Checklist (PAS-ADD) and total costs recorded at 6 months. Multilevel modeling was used to compare square root transformations of Aberrant Behavior Checklist scores. Significant differences were found in the transformed total scores on the Aberrant Behavior Checklist (difference=-0.89, 95% CI=-1.74 to -0.04) and transformed lethargy and hyperactivity subscale scores (common intervention effect=-0.56, 95% CI=-0.97 to -0.15). Standard care participants fared worse on the PAS-ADD comorbid organic disorder subscale. There was a clear trend for lower overall costs of the intervention. Use of a specialist behavior therapy team in addition to standard treatment appears to be more effective in improving challenging behavior and may have financial advantages over standard treatment.

Preliminary efficacy and safety of an oromucosal standardized cannabis extract in chemotherapy-induced nausea and vomiting.

PubMed

Duran, Marta; Pérez, Eulàlia; Abanades, Sergio; Vidal, Xavier; Saura, Cristina; Majem, Margarita; Arriola, Edurne; Rabanal, Manel; Pastor, Antoni; Farré, Magí; Rams, Neus; Laporte, Joan-Ramon; Capellà, Dolors

2010-11-01

Despite progress in anti-emetic treatment, many patients still suffer from chemotherapy-induced nausea and vomiting (CINV). This is a pilot, randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate the tolerability, preliminary efficacy, and pharmacokinetics of an acute dose titration of a whole-plant cannabis-based medicine (CBM) containing delta-9-tetrahydrocannabinol and cannabidiol, taken in conjunction with standard therapies in the control of CINV. Patients suffering from CINV despite prophylaxis with standard anti-emetic treatment were randomized to CBM or placebo, during the 120 h post-chemotherapy period, added to standard anti-emetic treatment. Tolerability was measured as the number of withdrawals from the study during the titration period because of adverse events (AEs). The endpoint for the preliminary efficacy analysis was the proportion of patients showing complete or partial response. Seven patients were randomized to CBM and nine to placebo. Only one patient in the CBM arm was withdrawn due to AEs. A higher proportion of patients in the CBM group experienced a complete response during the overall observation period [5/7 (71.4%) with CMB vs. 2/9 (22.2%) with placebo, the difference being 49.2% (95% CI 1%, 75%)], due to the delayed period. The incidence of AEs was higher in the CBM group (86% vs. 67%). No serious AEs were reported. The mean daily dose was 4.8 sprays in both groups. Compared with placebo, CBM added to standard antiemetic therapy was well tolerated and provided better protection against delayed CINV. These results should be confirmed in a phase III clinical trial. © 2010 Department of Health, Generalitat of Catalonia. British Journal of Clinical Pharmacology © 2010 The British Pharmacological Society.

Biodegradable implants versus standard metal fixation for displaced radial head fractures. A prospective, randomized, multicenter study.

PubMed

Helling, Hanns-Joachim; Prokop, Axel; Schmid, Hans Ulrich; Nagel, Michael; Lilienthal, Jürgen; Rehm, Klaus Emil

2006-01-01

This multicenter, prospective, randomized study compares the use of biodegradable polylactide pins with standard metal mini-fragment implants for the treatment of displaced radial head fractures. It compares complication rates and clinical outcomes of both treatment methods. At 2 years, 135 (82%) of 164 patients were available for evaluation. Equivalence of treatment method was defined as a difference of 10% or less in the number of complication-free patients. Functional status was assessed by using the Broberg and Morrey Elbow Score and compared by an unpaired t test. Good or excellent clinical results were achieved by 92% (56/61) of the control patients and 96% (71/74) of the polylactide patients. The incidence of complication-free patients was 3.7% less in the polylactide group than in the control group. The 1-sided 95% confidence interval for the treatment difference between the 2 groups was more than -6.1%. Biodegradable polylactide pins have at least comparable outcomes as standard metal implants for the internal fixation of reconstructable displaced radial head fractures.

The effect of static scanning and mobility training on mobility in people with hemianopia after stroke: A randomized controlled trial comparing standardized versus non-standardized treatment protocols

PubMed Central

2011-01-01

Background Visual loss following stroke impacts significantly on activities of daily living and is an independent risk factor for becoming dependent. Routinely, allied health clinicians provide training for visual field loss, mainly with eye movement based therapy. The effectiveness of the compensatory approach to rehabilitation remains inconclusive largely due to difficulty in validating functional outcome with the varied type and dosage of therapy received by an individual patient. This study aims to determine which treatment is more effective, a standardized approach or individualized therapy in patients with homonymous hemianopia post stroke. Methods/Design This study is a double-blind randomized controlled, multicenter trial. A standardised scanning rehabilitation program (Neuro Vision Technology (NVT) program) of 7 weeks at 3 times per week, is compared to individualized therapy recommended by clinicians. Discussion The results of the trial will provide information that could potentially inform the allocation of resources in visual rehabilitation post stroke. Trial Registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000494033 PMID:21767413

An Investigation of the Hypoalgesic Effects of TENS Delivered by a Glove Electrode

PubMed Central

Cowan, Stephen; McKenna, Joanne; McCrum-Gardner, Evie; Johnson, Mark I.; Sluka, Kathleen A.; Walsh, Deirdre M.

2009-01-01

This randomized, placebo-controlled, blinded study investigated the hypoalgesic effects of high-frequency transcutaneous electrical nerve stimulation (TENS) delivered via a glove electrode compared with standard self-adhesive electrodes. Fifty-six TENS-naïve, healthy individuals (18 to 50 years old; 28 men, 28 women) were randomly allocated to 1 of 4 groups (n = 14 per group): glove electrode; placebo TENS using a glove electrode; standard electrode; and no treatment control. Active TENS (continuous stimulus, 100 Hz, strong but comfortable intensity) was applied to the dominant forearm/hand for 30 minutes. Placebo TENS was applied using a burst stimulus, 100-Hz frequency, 5-second cycle time for 42 seconds, after which the current amplitude was automatically reset to 0 mA. Pressure pain thresholds (PPTs) were recorded from 3 points on the dominant and nondominant upper limbs before and after TENS. Statistical analyses of dominant PPT data using between-within groups ANOVA showed significant differences between groups at all 3 recording points (P = .01). Post hoc Scheffe tests indicated no significant difference between the standard electrode and glove electrode groups. There was a significant hypoalgesic effect in the standard electrode group compared with the control group and between the glove electrode group and both the control and placebo TENS groups. There was no significant interactive effect between time and group at any of the recording points (P > .05). Perspective This study presents a comparison of the hypoalgesic effects of 2 different types of TENS electrode, a novel glove electrode and standard self-adhesive rectangular electrodes. The glove electrode provides a larger contact area with the skin, thereby stimulating a greater number of nerve fibers. The results show that both electrodes have similar hypoalgesic effects and therefore give the clinician another choice in electrode. PMID:19398378

Does padded headgear prevent head injury in rugby union football?

PubMed

McIntosh, Andrew S; McCrory, Paul; Finch, Caroline F; Best, John P; Chalmers, David J; Wolfe, Rory

2009-02-01

Concussion is a serious problem in many contact sports, including rugby union football. The study's primary aim was to measure the efficacy of padded headgear in reducing the rates of head injury or concussion. A cluster randomized controlled trial with three arms was conducted with rugby union football teams as the unit of randomization. Teams consisted of males participating in under 13-, 15-, 18-, and 20-yr age group competitions. The interventions were "standard" and "modified" padded headgear. Headgear wearing and injury were measured for each study team at each game over two seasons. Eighty-two teams participated in year 1 and 87 in year 2. A total of 1493 participants (10,040 player hours) were in the control group, 1128 participants (8170 player hours) were assigned to the standard headgear group, and 1474 participants (10,650 player hours) were assigned to the modified headgear group. The compliance rates were low in all groups, but 46% of participants wore standard headgear. An intention-to-treat analysis showed no differences in the rates of head injury or concussion between controls and headgear arms. Incidence rate ratios for standard headgear wearers referenced to controls were 0.95 and 1.02 for game and missed game injuries. Analyses of injury rates based on observed wearing patterns also showed no significant differences. Incidence rate ratios for standard headgear wearers referenced to nonwearers were 1.11 and 1.10 for game and missed game injuries. Padded headgear does not reduce the rate of head injury or concussion. The low compliance rates are a limitation. Although individuals may choose to wear padded headgear, the routine or mandatory use of protective headgear cannot be recommended.

Taichi exercise for self-rated sleep quality in older people: a systematic review and meta-analysis.

PubMed

Du, Shizheng; Dong, Jianshu; Zhang, Heng; Jin, Shengji; Xu, Guihua; Liu, Zengxia; Chen, Lixia; Yin, Haiyan; Sun, Zhiling

2015-01-01

Self-reported sleep disorders are common in older adults, resulting in serious consequences. Non-pharmacological measures are important complementary interventions, among which Taichi exercise is a popular alternative. Some experiments have been performed; however, the effect of Taichi exercise in improving sleep quality in older people has yet to be validated by systematic review. Using systematic review and meta-analysis, this study aimed to examine the efficacy of Taichi exercise in promoting self-reported sleep quality in older adults. Systematic review and meta-analysis of randomized controlled studies. 4 English databases: Pubmed, Cochrane Library, Web of Science and CINAHL, and 4 Chinese databases: CBMdisc, CNKI, VIP, and Wanfang database were searched through December 2013. Two reviewers independently selected eligible trials, conducted critical appraisal of the methodological quality by using the quality appraisal criteria for randomized controlled studies recommended by Cochrane Handbook. A standardized data form was used to extract information. Meta-analysis was performed. Five randomized controlled studies met inclusion criteria. All suffered from some methodological flaws. The results of this study showed that Taichi has large beneficial effect on sleep quality in older people, as indicated by decreases in the global Pittsburgh Sleep Quality Index score [standardized mean difference=-0.87, 95% confidence intervals (95% confidence interval) (-1.25, -0.49)], as well as its sub-domains of subjective sleep quality [standardized mean difference=-0.83, 95% confidence interval (-1.08, -0.57)], sleep latency [standardized mean difference=-0.75, 95% confidence interval (-1.42, -0.07)], sleep duration [standardized mean difference=-0.55, 95% confidence interval (-0.90, -0.21)], habitual sleep efficiency [standardized mean difference=-0.49, 95% confidence interval (-0.74, -0.23)], sleep disturbance [standardized mean difference=-0.44, 95% confidence interval (-0.69, -0.19)], and daytime dysfunction [standardized mean difference=-0.34, 95% confidence interval (-0.59, -0.09)]. Daytime sleepiness improvement was also observed. Weak evidence shows that Taichi exercise has a beneficial effect in improving self-rated sleep quality for older adults, suggesting that Taichi could be an effective alternative and complementary approach to existing therapies for older people with sleep problems. More rigorous experimental studies are required. Copyright © 2014 Elsevier Ltd. All rights reserved.

Observational studies are complementary to randomized controlled trials.

PubMed

Grootendorst, Diana C; Jager, Kitty J; Zoccali, Carmine; Dekker, Friedo W

2010-01-01

Randomized controlled trials (RCTs) are considered the gold standard study design to investigate the effect of health interventions, including treatment. However, in some situations, it may be unnecessary, inappropriate, impossible, or inadequate to perform an RCT. In these special situations, well-designed observational studies, including cohort and case-control studies, may provide an alternative to doing nothing in order to obtain estimates of treatment effect. It should be noted that such studies should be performed with caution and correctly. The aims of this review are (1) to explain why RCTs are considered the optimal study design to evaluate treatment effects, (2) to describe the situations in which an RCT is not possible and observational studies are an adequate alternative, and (3) to explain when randomization is not needed and can be approximated in observational studies. Examples from the nephrology literature are used for illustration. Copyright 2009 S. Karger AG, Basel.

Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

PubMed

Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

2016-07-06

Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation.

Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics

PubMed Central

2016-01-01

Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers’ scientific epistemology of “falsificationism.” Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

The Effects of Personalized Practice Software on Learning Math Standards in the Third through Fifth Grades

ERIC Educational Resources Information Center

Gomez, Angela Nicole

2012-01-01

The purpose of this study was to investigate the effectiveness of "MathFacts in a Flash" software in helping students learn math standards. In each of their classes, the third-, fourth-, and fifth-grade students in a small private Roman Catholic school from the Pacific Northwest were randomly assigned either to a control group that used…

Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight

USDA-ARS?s Scientific Manuscript database

Our objective was to evaluate whether premature infants who received an exclusive human milk (HM)-based diet and a HM-derived cream supplement (cream) would have weight gain (g/kg/d) at least as good as infants receiving a standard feeding regimen (control). In a prospective noninferiority, randomiz...

Positive psychotherapy for smoking cessation enhanced with text messaging: Protocol for a randomized controlled trial.

PubMed

Kahler, Christopher W; Surace, Anthony; Rebecca, E F; Gordon, B A; Cioe, Patricia A; Spillane, Nichea S; Parks, Acacia; Bock, Beth C; Brown, Richard A

2018-06-21

Despite reductions in cigarette smoking in the U.S., improvements in the efficacy of smoking cessation treatments are needed, as rates of sustained abstinence remain disappointingly low. Both low positive affect and high negative affect contribute to smoking relapse and constitute viable targets for smoking cessation interventions. Although some clinical trials have evaluated interventions to address depression as a smoking relapse risk factor, very few have focused on positive affect. Recently, we developed and conducted a preliminary clinical trial of a smoking cessation treatment that targets positive affect and cognitions by incorporating interventions rooted in positive psychology. The current randomized controlled trial will expand upon this preliminary trial to test whether this positive psychology-informed approach results in higher smoking cessation rates compared to a time-matched standard smoking cessation treatment control. Three hundred and forty adult daily smokers will be randomly assigned to either positive psychotherapy for smoking cessation or standard behavioral smoking cessation counseling. Participants will meet weekly with a study counselor for 6 weeks and will receive transdermal nicotine patch and text messaging smoking cessation support. Additionally, text messaging in the positive psychotherapy condition will encourage engagement in positive psychology-specific strategies for boosting mood and staying smoke free. Smoking cessation outcomes will be measured at 12, 26, and 52 weeks following target quit date. Results from this study will provide evidence on whether incorporating positive psychology interventions into smoking cessation treatment can improve smoking cessation outcomes relative to standard behavioral counseling with nicotine patch and text messaging. Copyright © 2018. Published by Elsevier Inc.

Modified Reporting of Positive Urine Cultures to Reduce Inappropriate Treatment of Asymptomatic Bacteriuria Among Nonpregnant, Noncatheterized Inpatients: A Randomized Controlled Trial.

PubMed

Daley, Peter; Garcia, David; Inayatullah, Raheel; Penney, Carla; Boyd, Sarah

2018-05-28

DESIGNWe conducted a randomized, parallel, unblinded, superiority trial of a laboratory reporting intervention designed to reduce antibiotic treatment of asymptomatic bacteriuria (ASB).METHODSResults of positive urine cultures from 110 consecutive inpatients at 2 urban acute-care hospitals were randomized to standard report (control) or modified report (intervention). The standard report included bacterial count, bacterial identification, and antibiotic susceptibility information including drug dosage and cost. The modified report stated: "This POSITIVE urine culture may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call the microbiology laboratory … for identification and susceptibility results." We used the following exclusion criteria: age <18 years, pregnancy, presence of an indwelling urinary catheter, samples from patients already on antibiotics, neutropenia, or admission to an intensive care unit. The primary efficacy outcome was the proportion of appropriate antibiotic therapy prescribed.RESULTSAccording to our intention-to-treat (ITT) analysis, the proportion of appropriate treatment (urinary tract infection treated plus ASB not treated) was higher in the modified arm than in the standard arm: 44 of 55 (80.0%) versus 29 of 55 (52.7%), respectively (absolute difference, -27.3%; RR, 0.42; P = .002; number needed to report for benefit, 3.7).CONCLUSIONSModified reporting resulted in a significant reduction in inappropriate antibiotic treatment without an increase in adverse events. Safety should be further assessed in a large effectiveness trial before implementationTRIAL REGISTRATION. clinicaltrials.gov#NCT02797613Infect Control Hosp Epidemiol 2018;1-6.

In vitro development of donated frozen-thawed human embryos in a prototype static microfluidic device: a randomized controlled trial.

PubMed

Kieslinger, Dorit C; Hao, Zhenxia; Vergouw, Carlijn G; Kostelijk, Elisabeth H; Lambalk, Cornelis B; Le Gac, Séverine

2015-03-01

To compare the development of human embryos in microfluidic devices with culture in standard microdrop dishes, both under static conditions. Prospective randomized controlled trial. In vitro fertilization laboratory. One hundred eighteen donated frozen-thawed human day-4 embryos. Random allocation of embryos that fulfilled the inclusion criteria to single-embryo culture in a microfluidics device (n = 58) or standard microdrop dish (n = 60). Blastocyst formation rate and quality after 24, 28, 48, and 72 hours of culture. The percentage of frozen-thawed day-4 embryos that developed to the blastocyst stage did not differ significantly in the standard microdrop dishes and microfluidic devices after 28 hours of culture (53.3% vs. 58.6%) or at any of the other time points. The proportion of embryos that would have been suitable for embryo transfer was comparable after 28 hours of culture in the control dishes and microfluidic devices (90.0% vs. 93.1%). Furthermore, blastocyst quality was similar in the two study groups. This study shows that a microfluidic device can successfully support human blastocyst development in vitro under static culture conditions. Future studies need to clarify whether earlier stage embryos will benefit from the culture in microfluidic devices more than the tested day-4 embryos because many important steps in the development of human embryos already take place before day 4. Further improvements of the microfluidic device will include parallel culture of single embryos, application of medium refreshment, and built-in sensors. NTR3867. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Protocol: the effect of 12 weeks of Tai Chi practice on anxiety in healthy but stressed people compared to exercise and wait-list comparison groups: a randomized controlled trial.

PubMed

Zheng, Shuai; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

2014-06-01

Stress is a major problem in today's fast-paced society and can lead to serious psychosomatic complications. The ancient Chinese mind-body exercise of Tai Chi may provide an alternative and self-sustaining option to pharmaceutical medication for stressed individuals to improve their coping mechanisms. The protocol of this study is designed to evaluate whether Tai Chi practice is equivalent to standard exercise and whether the Tai Chi group is superior to a wait-list control group in improving stress coping levels. This study is a 6-week, three-arm, parallel, randomized, clinical trial designed to evaluate Tai Chi practice against standard exercise and a Tai Chi group against a nonactive control group over a period of 6 weeks with a 6-week follow-up. A total of 72 healthy adult participants (aged 18-60 years) who are either Tai Chi naïve or have not practiced Tai Chi in the past 12 months will be randomized into a Tai Chi group (n = 24), an exercise group (n = 24) or a wait-list group (n = 24). The primary outcome measure will be the State Trait Anxiety Inventory with secondary outcome measures being the Perceived Stress Scale 14, heart rate variability, blood pressure, Short Form 36 and a visual analog scale. The protocol is reported using the appropriate Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) items. Copyright © 2014. Published by Elsevier B.V.

Differences in energy expenditure during high-speed versus standard-speed yoga: A randomized sequence crossover trial.

PubMed

Potiaumpai, Melanie; Martins, Maria Carolina Massoni; Rodriguez, Roberto; Mooney, Kiersten; Signorile, Joseph F

2016-12-01

To compare energy expenditure and volume of oxygen consumption and carbon dioxide production during a high-speed yoga and a standard-speed yoga program. Randomized repeated measures controlled trial. A laboratory of neuromuscular research and active aging. Sun-Salutation B was performed, for eight minutes, at a high speed versus and a standard-speed separately while oxygen consumption was recorded. Caloric expenditure was calculated using volume of oxygen consumption and carbon dioxide production. Difference in energy expenditure (kcal) of HSY and SSY. Significant differences were observed in energy expenditure between yoga speeds with high-speed yoga producing significantly higher energy expenditure than standard-speed yoga (MD=18.55, SE=1.86, p<0.01). Significant differences were also seen between high-speed and standard-speed yoga for volume of oxygen consumed and carbon dioxide produced. High-speed yoga results in a significantly greater caloric expenditure than standard-speed yoga. High-speed yoga may be an effective alternative program for those targeting cardiometabolic markers. Copyright © 2016 Elsevier Ltd. All rights reserved.

Low-Sodium Versus Standard-Sodium Peritoneal Dialysis Solution in Hypertensive Patients: A Randomized Controlled Trial.

PubMed

Rutkowski, Bolesław; Tam, Paul; van der Sande, Frank M; Vychytil, Andreas; Schwenger, Vedat; Himmele, Rainer; Gauly, Adelheid

2016-05-01

Peritoneal dialysis (PD) solutions with reduced sodium content may have advantages for hypertensive patients; however, they have lower osmolarity and solvent drag, so the achieved Kt/Vurea may be lower. Furthermore, the increased transperitoneal membrane sodium gradient can influence sodium balance with consequences for blood pressure (BP) control. Prospective, randomized, double-blind clinical trial to prove the noninferiority of total weekly Kt/Vurea with low-sodium versus standard-sodium PD solution, with the lower confidence limit above the clinically accepted difference of -0.5. Hypertensive patients (≥ 1 antihypertensive drug, including diuretics, or office systolic BP ≥ 130 mmHg) on continuous ambulatory PD therapy from 17 sites. 108 patients were randomly assigned (1:1) to 6-month treatments with either low-sodium (125 mmol/L of sodium; 1.5%, 2.3%, or 4.25% glucose; osmolarity, 338-491 mOsm/L) or standard-sodium (134 mmol/L of sodium; 1.5%, 2.3%, or 4.25% glucose; osmolarity, 356-509 mOsm/L) PD solution. Primary end point: weekly total Kt/Vurea; secondary outcomes: BP control, safety, and tolerability. Total Kt/Vurea was determined from 24-hour dialysate and urine collection; BP, by office measurement. Total Kt/Vurea after 12 weeks was 2.53 ± 0.89 in the low-sodium group (n = 40) and 2.97 ± 1.58 in the control group (n = 42). The noninferiority of total Kt/Vurea could not be confirmed. There was no difference for peritoneal Kt/Vurea (1.70 ± 0.38 with low sodium, 1.77 ± 0.44 with standard sodium), but there was a difference in renal Kt/Vurea (0.83 ± 0.80 with low sodium, 1.20 ± 1.54 with standard sodium). Mean daily sodium removal with dialysate at week 12 was 1.188 g higher in the low-sodium group (P < 0.001). BP changed marginally with standard-sodium solution, but decreased with low-sodium PD solution, resulting in less antihypertensive medication. Broader variability of study population than anticipated, particularly regarding residual kidney function. The noninferiority of the low-sodium PD solution for total Kt/Vurea could not be proved; however, it showed beneficial clinical effects on sodium removal and BP. Copyright © 2016 Fresenius Medical Care. Published by Elsevier Inc. All rights reserved.

Registration status and methodological reporting of randomized controlled trials in obesity research: A review.

PubMed

Byrne, Jillian L S; Yee, Tamara; O'Connor, Kathleen; Dyson, Michele P; Ball, Geoff D C

2017-04-01

To assess registration and reporting details of randomized controlled trials (RCTs) published from 2011 to 2016 across four obesity journals. All issues from four leading obesity journals were searched systematically for RCTs from January 2011 to June 2016. Data on registration status were extracted from manuscripts, online trial registries, and a trial database; corresponding authors were contacted for registration details, when necessary. The methodological reporting of RCTs was assessed on specific criteria from the Consolidated Standards of Reporting Trials. A total of 223 RCTs were reviewed. Three-quarters (n = 170) were registered publicly; 94 (55.3%) reported registration details in the manuscript, and 82 (48.2%) were registered prospectively. Newer RCTs were more likely to be registered prospectively than older RCTs (2014-2016: 57.3% vs. 2011-2013: 39.2%; c 2  = 5.5, P = 0.02). Assessment on the Consolidated Standards of Reporting Trials demonstrated that less than half of all studies reported data collection dates (n = 108; 48.4%) or included "randomized trial" in the title (n = 89; 39.9%). The methodological reporting of RCTs published in obesity journals is suboptimal, despite current guidelines and policies. To complement existing standards, editorial boards should incorporate mandatory fields within the online manuscript submission process to enhance the quality, transparency, and comprehensiveness of reporting RCTs in obesity journals. © 2017 The Obesity Society.

Systematic review: standard- and double-dose proton pump inhibitors for the healing of severe erosive oesophagitis -- a mixed treatment comparison of randomized controlled trials.

PubMed

Edwards, S J; Lind, T; Lundell, L; DAS, R

2009-09-15

No randomized controlled trial (RCT) has compared all European-licensed standard- and double-dose PPIs for the healing of severe erosive oesophagitis. To compare the effectiveness of licensed doses of PPIs for healing severe erosive oesophagitis (i.e. esomeprazole 40 mg, lansoprazole 30 mg, omeprazole 20 mg and 40 mg, pantoprazole 40 mg and rabeprazole 20 mg). Systematic review of CENTRAL, EMBASE and MEDLINE for RCTs in patients with erosive oesophagitis (completed October 2008). Endoscopically verified healing rates at 4 and 8 weeks were extracted and re-calculated if not analysed by intention-to-treat. A mixed treatment comparison was used to combine direct treatment comparisons with indirect trial evidence while maintaining randomization. Odds ratios (OR) are reported compared to omeprazole 20 mg. A total of 3021 papers were identified in the literature search; 12 were of sufficient quality to be included in the analysis. Insufficient data were available to included rabeprazole. Esomeprazole 40 mg was found to provide significantly higher healing rates at 4 weeks [OR 1.84, 95% Credible Interval (95% CrI): 1.50 to 2.22] and 8 weeks (OR 1.91, 95% CrI: 1.13 to 2.88). No other PPI investigated had significantly higher healing rates than omeprazole 20 mg. Esomeprazole 40 mg consistently demonstrates higher healing rates compared with licensed standard- and double-dose PPIs.

When Wait Lists Are Not Feasible, Nothing Is a Thing That Does Not Need to Be Done

ERIC Educational Resources Information Center

Devilly, Grant J.; McFarlane, Alexander C.

2009-01-01

Clinical psychology practices initially grew through the use of case studies, uncontrolled trials, and eventually through randomized controlled trials (RCTs). The use of a wait-list control group is standard practice in such trials of treatment regimens for psychopathological conditions. However, as knowledge advances regarding the successful…

Electrical Stimulation for Pressure Injuries: A Health Technology Assessment

PubMed Central

Lambrinos, Anna; Falk, Lindsey; Ali, Arshia; Holubowich, Corinne; Walter, Melissa

2017-01-01

Background Pressure injuries (bedsores) are common and reduce quality of life. They are also costly and difficult to treat. This health technology assessment evaluates the effectiveness, cost-effectiveness, budget impact, and lived experience of adding electrical stimulation to standard wound care for pressure injuries. Methods We conducted a systematic search for studies published to December 7, 2016, limited to randomized and non–randomized controlled trials examining the effectiveness of electrical stimulation plus standard wound care versus standard wound care alone for patients with pressure injuries. We assessed the quality of evidence through Grading of Recommendations Assessment, Development, and Evaluation (GRADE). In addition, we conducted an economic literature review and a budget impact analysis to assess the cost-effectiveness and affordability of electrical stimulation for treatment of pressure ulcers in Ontario. Given uncertainties in clinical evidence and resource use, we did not conduct a primary economic evaluation. Finally, we conducted qualitative interviews with patients and caregivers about their experiences with pressure injuries, currently available treatments, and (if applicable) electrical stimulation. Results Nine randomized controlled trials and two non–randomized controlled trials were found from the systematic search. There was no significant difference in complete pressure injury healing between adjunct electrical stimulation and standard wound care. There was a significant difference in wound surface area reduction favouring electrical stimulation compared with standard wound care. The only study on cost-effectiveness of electrical stimulation was partially applicable to the patient population of interest. Therefore, the cost-effectiveness of electrical stimulation cannot be determined. We estimate that the cost of publicly funding electrical stimulation for pressure injuries would be $0.77 to $3.85 million yearly for the next 5 years. Patients and caregivers reported that pressure injuries were burdensome and reduced their quality of life. Patients and caregivers also noted that electrical stimulation seemed to reduce the time it took the wounds to heal. Conclusions While electrical stimulation is safe to use (GRADE quality of evidence: high) there is uncertainty about whether it improves wound healing (GRADE quality of evidence: low). In Ontario, publicly funding electrical stimulation for pressure injuries could result in extra costs of $0.77 to $3.85 million yearly for the next 5 years. PMID:29201261

Adaptive Randomization of Veliparib-Carboplatin Treatment in Breast Cancer.

PubMed

Rugo, Hope S; Olopade, Olufunmilayo I; DeMichele, Angela; Yau, Christina; van 't Veer, Laura J; Buxton, Meredith B; Hogarth, Michael; Hylton, Nola M; Paoloni, Melissa; Perlmutter, Jane; Symmans, W Fraser; Yee, Douglas; Chien, A Jo; Wallace, Anne M; Kaplan, Henry G; Boughey, Judy C; Haddad, Tufia C; Albain, Kathy S; Liu, Minetta C; Isaacs, Claudine; Khan, Qamar J; Lang, Julie E; Viscusi, Rebecca K; Pusztai, Lajos; Moulder, Stacy L; Chui, Stephen Y; Kemmer, Kathleen A; Elias, Anthony D; Edmiston, Kirsten K; Euhus, David M; Haley, Barbara B; Nanda, Rita; Northfelt, Donald W; Tripathy, Debasish; Wood, William C; Ewing, Cheryl; Schwab, Richard; Lyandres, Julia; Davis, Sarah E; Hirst, Gillian L; Sanil, Ashish; Berry, Donald A; Esserman, Laura J

2016-07-07

The genetic and clinical heterogeneity of breast cancer makes the identification of effective therapies challenging. We designed I-SPY 2, a phase 2, multicenter, adaptively randomized trial to screen multiple experimental regimens in combination with standard neoadjuvant chemotherapy for breast cancer. The goal is to match experimental regimens with responding cancer subtypes. We report results for veliparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, combined with carboplatin. In this ongoing trial, women are eligible for participation if they have stage II or III breast cancer with a tumor 2.5 cm or larger in diameter; cancers are categorized into eight biomarker subtypes on the basis of status with regard to human epidermal growth factor receptor 2 (HER2), hormone receptors, and a 70-gene assay. Patients undergo adaptive randomization within each biomarker subtype to receive regimens that have better performance than the standard therapy. Regimens are evaluated within 10 biomarker signatures (i.e., prospectively defined combinations of biomarker subtypes). Veliparib-carboplatin plus standard therapy was considered for HER2-negative tumors and was therefore evaluated in 3 signatures. The primary end point is pathological complete response. Tumor volume changes measured by magnetic resonance imaging during treatment are used to predict whether a patient will have a pathological complete response. Regimens move on from phase 2 if and when they have a high Bayesian predictive probability of success in a subsequent phase 3 neoadjuvant trial within the biomarker signature in which they performed well. With regard to triple-negative breast cancer, veliparib-carboplatin had an 88% predicted probability of success in a phase 3 trial. A total of 72 patients were randomly assigned to receive veliparib-carboplatin, and 44 patients were concurrently assigned to receive control therapy; at the completion of chemotherapy, the estimated rates of pathological complete response in the triple-negative population were 51% (95% Bayesian probability interval [PI], 36 to 66%) in the veliparib-carboplatin group versus 26% (95% PI, 9 to 43%) in the control group. The toxicity of veliparib-carboplatin was greater than that of the control. The process used in our trial showed that veliparib-carboplatin added to standard therapy resulted in higher rates of pathological complete response than standard therapy alone specifically in triple-negative breast cancer. (Funded by the QuantumLeap Healthcare Collaborative and others; I-SPY 2 TRIAL ClinicalTrials.gov number, NCT01042379.).

Safety and Tolerance Evaluation of Milk Fat Globule Membrane-Enriched Infant Formulas: A Randomized Controlled Multicenter Non-Inferiority Trial in Healthy Term Infants

PubMed Central

Billeaud, Claude; Puccio, Giuseppe; Saliba, Elie; Guillois, Bernard; Vaysse, Carole; Pecquet, Sophie; Steenhout, Philippe

2014-01-01

OBJECTIVE This multicenter non-inferiority study evaluated the safety of infant formulas enriched with bovine milk fat globule membrane (MFGM) fractions. METHODS Healthy, full-term infants (n = 119) age ≤14 days were randomized to standard infant formula (control), standard formula enriched with a lipid-rich MFGM fraction (MFGM-L), or standard formula enriched with a protein-rich MFGM fraction (MFGM-P). Primary outcome was mean weight gain per day from enrollment to age 4 months (non-inferiority margin: −3.0 g/day). Secondary (length, head circumference, tolerability, morbidity, adverse events) and exploratory (phospholipids, metabolic markers, immune markers) outcomes were also evaluated. RESULTS Weight gain was non-inferior in the MFGM-L and MFGM-P groups compared with the control group. Among secondary and exploratory outcomes, few between-group differences were observed. Formula tolerance rates were high (>94%) in all groups. Adverse event and morbidity rates were similar across groups except for a higher rate of eczema in the MFGM-P group (13.9% vs control [3.5%], MFGM-L [1.4%]). CONCLUSION Both MFGM-enriched formulas met the primary safety endpoint of non-inferiority in weight gain and were generally well tolerated, although a higher rate of eczema was observed in the MFGM-P group. PMID:25452707

The Effectiveness of Educational Interventions to Enhance the Adoption of Fee-Based Arsenic Testing in Bangladesh: A Cluster Randomized Controlled Trial

PubMed Central

George, Christine Marie; Inauen, Jennifer; Rahman, Sheikh Masudur; Zheng, Yan

2013-01-01

Arsenic (As) testing could help 22 million people, using drinking water sources that exceed the Bangladesh As standard, to identify safe sources. A cluster randomized controlled trial was conducted to evaluate the effectiveness of household education and local media in the increasing demand for fee-based As testing. Randomly selected households (N = 452) were divided into three interventions implemented by community workers: 1) fee-based As testing with household education (HE); 2) fee-based As testing with household education and a local media campaign (HELM); and 3) fee-based As testing alone (Control). The fee for the As test was US$ 0.28, higher than the cost of the test (US$ 0.16). Of households with untested wells, 93% in both intervention groups HE and HELM purchased an As test, whereas only 53% in the control group. In conclusion, fee-based As testing with household education is effective in the increasing demand for As testing in rural Bangladesh. PMID:23716409

The effectiveness of educational interventions to enhance the adoption of fee-based arsenic testing in Bangladesh: a cluster randomized controlled trial.

PubMed

George, Christine Marie; Inauen, Jennifer; Rahman, Sheikh Masudur; Zheng, Yan

2013-07-01

Arsenic (As) testing could help 22 million people, using drinking water sources that exceed the Bangladesh As standard, to identify safe sources. A cluster randomized controlled trial was conducted to evaluate the effectiveness of household education and local media in the increasing demand for fee-based As testing. Randomly selected households (N = 452) were divided into three interventions implemented by community workers: 1) fee-based As testing with household education (HE); 2) fee-based As testing with household education and a local media campaign (HELM); and 3) fee-based As testing alone (Control). The fee for the As test was US$ 0.28, higher than the cost of the test (US$ 0.16). Of households with untested wells, 93% in both intervention groups HE and HELM purchased an As test, whereas only 53% in the control group. In conclusion, fee-based As testing with household education is effective in the increasing demand for As testing in rural Bangladesh.

Efficacy and safety of acupuncture for chronic dizziness: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Dizziness is one of the most challenging symptoms in medicine. No medication for dizziness in current use has well-established curative or prophylactic value or is suitable for long-term palliative use. Unconventional remedies, such as acupuncture, should be considered and scientifically evaluated. However, there has been relatively little evidence in randomized controlled clinical trials on acupuncture to treat chronic dizziness. The aim of our study is to evaluate the efficacy and safety of acupuncture in patients with dizziness. Methods/Design This trial is a randomized, single-blind, controlled study. A total of 80 participants will be randomly assigned to two treatment groups receiving acupuncture and sham acupuncture treatment, respectively, for 4 weeks. The primary outcome measures are the Dizziness Handicap Inventory (DHI) and the Vertigo Symptom Scale (VSS). Treatment will be conducted over a period of 4 weeks, at a frequency of two sessions per week. The assessment is at baseline (before treatment initiation), 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session. Discussion The results from this study will provide clinical evidence on the efficacy and safety of acupuncture in patients with chronic dizziness. Trial registration International Standard Randomized Controlled Trial Number Register: ISRCTN52695239 PMID:24330810

Discontinuation, Efficacy, and Safety of Cholinesterase Inhibitors for Alzheimer’s Disease: a Meta-Analysis and Meta-Regression of 43 Randomized Clinical Trials Enrolling 16 106 Patients

PubMed Central

Blanco-Silvente, Lídia; Saez, Marc; Barceló, Maria Antònia; Garre-Olmo, Josep; Vilalta-Franch, Joan; Capellà, Dolors

2017-01-01

Abstract Background: We investigated the effect of cholinesterase inhibitors on all-cause discontinuation, efficacy and safety, and the effects of study design-, intervention-, and patient-related covariates on the risk-benefit of cholinesterase inhibitors for Alzheimer’s disease. Methods: A systematic review and meta-analysis of randomized placebo-controlled clinical trials comparing cholinesterase inhibitors and placebo was performed. The effect of covariates on study outcomes was analysed by means of meta-regression using a Bayesian framework. Results: Forty-three randomized placebo-controlled clinical trials involving 16106 patients were included. All-cause discontinuation was higher with cholinesterase inhibitors (OR = 1.66), as was discontinuation due to adverse events (OR=1.75). Cholinesterase inhibitors improved cognitive function (standardized mean difference = 0.38), global symptomatology (standardized mean difference=0.28) and functional capacity (standardized mean difference=0.16) but not neuropsychiatric symptoms. Rivastigmine was associated with a poorer outcome on all-cause discontinuation (Diff OR = 1.66) and donepezil with a higher efficacy on global change (Diff standardized mean difference = 0.41). The proportion of patients with serious adverse events decreased with age (Diff OR = -0.09). Mortality was lower with cholinesterase inhibitors than with placebo (OR = 0.65). Conclusion: While cholinesterase inhibitors show a poor risk-benefit relationship as indicated by mild symptom improvement and a higher than placebo all-cause discontinuation, a reduction of mortality was suggested. Intervention- and patient-related factors modify the effect of cholinesterase inhibitors in patients with Alzheimer’s disease. PMID:28201726

Discontinuation, Efficacy, and Safety of Cholinesterase Inhibitors for Alzheimer's Disease: a Meta-Analysis and Meta-Regression of 43 Randomized Clinical Trials Enrolling 16 106 Patients.

PubMed

Blanco-Silvente, Lídia; Castells, Xavier; Saez, Marc; Barceló, Maria Antònia; Garre-Olmo, Josep; Vilalta-Franch, Joan; Capellà, Dolors

2017-07-01

We investigated the effect of cholinesterase inhibitors on all-cause discontinuation, efficacy and safety, and the effects of study design-, intervention-, and patient-related covariates on the risk-benefit of cholinesterase inhibitors for Alzheimer's disease. A systematic review and meta-analysis of randomized placebo-controlled clinical trials comparing cholinesterase inhibitors and placebo was performed. The effect of covariates on study outcomes was analysed by means of meta-regression using a Bayesian framework. Forty-three randomized placebo-controlled clinical trials involving 16106 patients were included. All-cause discontinuation was higher with cholinesterase inhibitors (OR = 1.66), as was discontinuation due to adverse events (OR=1.75). Cholinesterase inhibitors improved cognitive function (standardized mean difference = 0.38), global symptomatology (standardized mean difference=0.28) and functional capacity (standardized mean difference=0.16) but not neuropsychiatric symptoms. Rivastigmine was associated with a poorer outcome on all-cause discontinuation (Diff OR = 1.66) and donepezil with a higher efficacy on global change (Diff standardized mean difference = 0.41). The proportion of patients with serious adverse events decreased with age (Diff OR = -0.09). Mortality was lower with cholinesterase inhibitors than with placebo (OR = 0.65). While cholinesterase inhibitors show a poor risk-benefit relationship as indicated by mild symptom improvement and a higher than placebo all-cause discontinuation, a reduction of mortality was suggested. Intervention- and patient-related factors modify the effect of cholinesterase inhibitors in patients with Alzheimer's disease. © The Author 2017. Published by Oxford University Press on behalf of CINP.

A randomized controlled trial investigating the effects of craniosacral therapy on pain and heart rate variability in fibromyalgia patients.

PubMed

Castro-Sánchez, Adelaida María; Matarán-Peñarrocha, Guillermo A; Sánchez-Labraca, Nuria; Quesada-Rubio, José Manuel; Granero-Molina, José; Moreno-Lorenzo, Carmen

2011-01-01

Fibromyalgia is a prevalent musculoskeletal disorder associated with widespread mechanical tenderness, fatigue, non-refreshing sleep, depressed mood and pervasive dysfunction of the autonomic nervous system: tachycardia, postural intolerance, Raynaud's phenomenon and diarrhoea. To determine the effects of craniosacral therapy on sensitive tender points and heart rate variability in patients with fibromyalgia. A randomized controlled trial. Ninety-two patients with fibromyalgia were randomly assigned to an intervention group or placebo group. Patients received treatments for 20 weeks. The intervention group underwent a craniosacral therapy protocol and the placebo group received sham treatment with disconnected magnetotherapy equipment. Pain intensity levels were determined by evaluating tender points, and heart rate variability was recorded by 24-hour Holter monitoring. After 20 weeks of treatment, the intervention group showed significant reduction in pain at 13 of the 18 tender points (P < 0.05). Significant differences in temporal standard deviation of RR segments, root mean square deviation of temporal standard deviation of RR segments and clinical global impression of improvement versus baseline values were observed in the intervention group but not in the placebo group. At two months and one year post therapy, the intervention group showed significant differences versus baseline in tender points at left occiput, left-side lower cervical, left epicondyle and left greater trochanter and significant differences in temporal standard deviation of RR segments, root mean square deviation of temporal standard deviation of RR segments and clinical global impression of improvement. Craniosacral therapy improved medium-term pain symptoms in patients with fibromyalgia.

Seated T'ai Chi in Older Taiwanese People Using Wheelchairs: A Randomized Controlled Trial Investigating Mood States and Self-Efficacy.

PubMed

Hsu, Chen-Yuan; Moyle, Wendy; Cooke, Marie; Jones, Cindy

2016-12-01

There is growing interest in t'ai chi, but little research has addressed whether t'ai chi is effective in older people using wheelchairs for mobilization. The aim of this study was to compare the effects of seated t'ai chi exercise and usual standard activities on mood states and self-efficacy in older people living in a long-term care facility and using wheelchairs for mobilization. Randomized controlled trial (trial registration no. ACTRN12613000029796). One long-term-care facility in Taiwan. Sixty participants were randomly assigned by a computer-generated random sequence to a t'ai chi group (n = 30) or a usual exercise and entertainment activities group (n = 30). Seated t'ai chi exercise for 40 minutes three times a week for 26 weeks was provided. Mood states (Profile of Mood States Short Form [POMS-SF]) and self-efficacy (Self-Efficacy for Exercise [SEE]). At week 26, participants in the t'ai chi group reported significantly lower mood states on the fatigue-inertia dimension of the POMS-SF (mean score ± standard deviation, 3.56 ± 3.71) than did the control group (mean score, 7.16 ± 6.36) (F [1, 58] = 7.15; p < 0.05). The t'ai chi group recorded significantly higher SEE levels (mean, 35.66 ± 36.83) than did those in the control group (mean, 15.30 ± 26.43) (F [1, 58] = 6.05; p < 0.05). The findings highlight the importance of t'ai chi for a reduction in the fatigue-inertia mood state and an increase in self-efficacy for older people using wheelchairs.

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

Project LifeSkills - a randomized controlled efficacy trial of a culturally tailored, empowerment-based, and group-delivered HIV prevention intervention for young transgender women: study protocol.

PubMed

Kuhns, Lisa M; Mimiaga, Matthew J; Reisner, Sari L; Biello, Katie; Garofalo, Robert

2017-09-16

Transgender women in the U.S. have an alarmingly high incidence rate of HIV infection; condomless anal and vaginal sex is the primary risk behavior driving transmission. Young transgender women are the subpopulation at the highest risk for HIV. Despite this, there are no published randomized controlled efficacy trials testing interventions to reduce sexual risk for HIV among this group. This paper describes the design of a group-based intervention trial to reduce sexual risk for HIV acquisition and transmission in young transgender women. This study, funded by the National Institutes of Health, is a randomized controlled trial of a culturally-specific, empowerment-based, and group-delivered six-session HIV prevention intervention, Project LifeSkills, among sexually active young transgender women, ages 16-29 years in Boston and Chicago. Participants are randomized (2:2:1) to either the LifeSkills intervention, standard of care only, or a diet and nutrition time- and attention-matched control. At enrollment, all participants receive standardized HIV pre- and post-test counseling and screening for HIV and urogenital gonorrhea and chlamydia infections. The primary outcome is difference in the rate of change in the number of self-reported condomless anal or vaginal sex acts during the prior 4-months, assessed at baseline, 4-, 8-, and 12-month follow-up visits. Behavioral interventions to reduce sexual risk for HIV acquisition and transmission are sorely needed for young transgender women. This study will provide evidence to determine feasibility and efficacy in one of the first rigorously designed trials for this population. ClinicalTrials.gov number, NCT01575938 , registered March 29, 2012.

Coordinate based random effect size meta-analysis of neuroimaging studies.

PubMed

Tench, C R; Tanasescu, Radu; Constantinescu, C S; Auer, D P; Cottam, W J

2017-06-01

Low power in neuroimaging studies can make them difficult to interpret, and Coordinate based meta-analysis (CBMA) may go some way to mitigating this issue. CBMA has been used in many analyses to detect where published functional MRI or voxel-based morphometry studies testing similar hypotheses report significant summary results (coordinates) consistently. Only the reported coordinates and possibly t statistics are analysed, and statistical significance of clusters is determined by coordinate density. Here a method of performing coordinate based random effect size meta-analysis and meta-regression is introduced. The algorithm (ClusterZ) analyses both coordinates and reported t statistic or Z score, standardised by the number of subjects. Statistical significance is determined not by coordinate density, but by a random effects meta-analyses of reported effects performed cluster-wise using standard statistical methods and taking account of censoring inherent in the published summary results. Type 1 error control is achieved using the false cluster discovery rate (FCDR), which is based on the false discovery rate. This controls both the family wise error rate under the null hypothesis that coordinates are randomly drawn from a standard stereotaxic space, and the proportion of significant clusters that are expected under the null. Such control is necessary to avoid propagating and even amplifying the very issues motivating the meta-analysis in the first place. ClusterZ is demonstrated on both numerically simulated data and on real data from reports of grey matter loss in multiple sclerosis (MS) and syndromes suggestive of MS, and of painful stimulus in healthy controls. The software implementation is available to download and use freely. Copyright © 2017 Elsevier Inc. All rights reserved.

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.

A Multicenter, Rater-Blinded, Randomized Controlled Study of Auditory Processing-Focused Cognitive Remediation Combined With Open-Label Lurasidone in Patients With Schizophrenia and Schizoaffective Disorder.

PubMed

Kantrowitz, Joshua T; Sharif, Zafar; Medalia, Alice; Keefe, Richard S E; Harvey, Philip; Bruder, Gerard; Barch, Deanna M; Choo, Tse; Lee, Seonjoo; Lieberman, Jeffrey A

2016-06-01

Small-scale studies of auditory processing cognitive remediation programs have demonstrated efficacy in schizophrenia. We describe a multicenter, rater-blinded, randomized, controlled study of auditory-focused cognitive remediation, conducted from June 24, 2010, to June 14, 2013, and approved by the local institutional review board at all sites. Prior to randomization, participants with schizophrenia (DSM-IV-TR) were stabilized on a standardized antipsychotic regimen (lurasidone [40-160 mg/d]), followed by randomization to adjunctive cognitive remediation: auditory focused (Brain Fitness) versus control (nonspecific video games), administered 1-2 times weekly for 30 sessions. Coprimary outcome measures included MATRICS Consensus Cognitive Battery (MCCB) and the University of California, San Diego, Performance-Based Skills Assessment-Brief scale. 120 participants were randomized and completed at least 1 auditory-focused cognitive remediation (n = 56) or video game control session (n = 64). 74 participants completed ≥ 25 sessions and postrandomization assessments. At study completion, the change from prestabilization was statistically significant for MCCB composite score (d = 0.42, P < .0001) across groups. Participants randomized to auditory-focused cognitive remediation had a trend-level higher mean MCCB composite score compared to participants randomized to control cognitive remediation (P = .08). After controlling for scores at the time of randomization, there were no significant between-treatment group differences at study completion. Auditory processing cognitive remediation combined with lurasidone did not lead to differential improvement over nonspecific video games. Across-group improvement from prestabilization baseline to study completion was observed, but since all participants were receiving lurasidone open label, it is difficult to interpret the source of these effects. Future studies comparing both pharmacologic and behavioral cognitive enhancers should consider a 2 × 2 design, using a control for both the medication and the cognitive remediation. ClinicalTrials.gov identifier: NCT01173874. © Copyright 2016 Physicians Postgraduate Press, Inc.

A randomized trial of goal directed vs. standard fluid therapy in cytoreductive surgery with hyperthermic intraperitoneal chemotherapy.

PubMed

Colantonio, Luca; Claroni, Claudia; Fabrizi, Luana; Marcelli, Maria Elena; Sofra, Maria; Giannarelli, Diana; Garofalo, Alfredo; Forastiere, Ester

2015-04-01

The use of adequate fluid therapy during cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) remains controversial. The aim of the study was to assess whether the use of fluid therapy protocol combined with goal-directed therapy (GDT) is associated with a significant change in morbidity, length of hospital stay, and mortality compared to standard fluid therapy. Patients American Society of Anesthesiologists (ASA) II-III undergoing CRS and HIPEC were randomized into two groups. The GDT group (N = 38) received fluid therapy according to a protocol guided by monitored hemodynamic parameters. The control group (N = 42) received standard fluid therapy. We evaluated incidence of major complications, total length of hospital stay, total amount of fluids administered, and mortality rate. The incidence of major abdominal complications was 10.5% in GDT group and 38.1% in the control group (P = 0.005). The median duration of hospitalization was 19 days in GDT group and 29 days in the control group (P < 0.0001). The mortality rate was zero in GDT group vs. 9.5% in the control group (P = 0.12). GDT group received a significantly (P < 0.0001) lower amount of fluid (5812 ± 1244 ml) than the control group (8269 ± 1452 ml), with a significantly (P < 0.0001) lower volume of crystalloids (3884 ± 1003 vs. 68,528 ± 1413 ml). In CRS and HIPEC, the use of a GDT improves outcome in terms of incidence of major abdominal and systemic postoperative complications and length of hospital stay, compared to standard fluid therapy protocol.

The CASCADE trial: effectiveness of ceramic versus PEEK cages for anterior cervical discectomy with interbody fusion; protocol of a blinded randomized controlled trial.

PubMed

Arts, Mark P; Wolfs, Jasper F C; Corbin, Terry P

2013-08-16

Anterior cervical discectomy with interbody fusion cages is considered the standard surgical procedure in patients with cervical disc herniation. However, PEEK or metal cages have some undesirable imaging characteristics, leading to a search for alternative materials not creating artifacts on images; silicon nitride ceramic. Whether patients treated with silicon nitride ceramic cages have similar functional outcome as patients treated with PEEK cages is not known. We present the design of the CASCADE trial on effectiveness of ceramic cages versus PEEK cages in patients with cervical disc herniation and/or osteophytes. Patients (age 18-75 years) with monoradicular symptoms in one or both arms lasting more than 8 weeks, due to disc herniation and/or osteophytes, are eligible for the trial. The study is designed as a randomized controlled equivalence trial in which patients are blinded to the type of cage for 1 year. The total follow-up period is 2 years. The primary outcome measure is improvement in the Neck and Disability Index (NDI). Secondary outcomes measures include improvement in arm pain and neck pain (VAS), SF-36 and patients' perceived recovery. The final elements of comparison are perioperative statistics including operating time, blood loss, length of hospital stay, and adverse events. Lateral plane films at each follow-up visit and CT scan (at 6 months) will be used to judge fusion and the incidence of subsidence. Based on a power of 90% and assuming 8% loss to follow-up, 100 patients will be randomized into the 2 groups. The first analysis will be conducted when all patients have 1 year of follow-up, and the groups will be followed for 1 additional year to judge stability of outcomes. While the new ceramic cage has received the CE Mark based on standard compliance and animal studies, a randomized comparative study with the golden standard product will provide more conclusive information for clinicians. Implementation of any new device should only be done after completion of randomized controlled effectiveness trials.

Cartilage Restoration of the Knee: A Systematic Review and Meta-analysis of Level 1 Studies.

PubMed

Mundi, Raman; Bedi, Asheesh; Chow, Linda; Crouch, Sarah; Simunovic, Nicole; Sibilsky Enselman, Elizabeth; Ayeni, Olufemi R

2016-07-01

Focal cartilage defects of the knee are a substantial cause of pain and disability in active patients. There has been an emergence of randomized controlled trials evaluating surgical techniques to manage such injuries, including marrow stimulation (MS), autologous chondrocyte implantation (ACI), and osteochondral autograft transfer (OAT). A meta-analysis was conducted to determine if any single technique provides superior clinical results at intermediate follow-up. Systematic review and meta-analysis of randomized controlled trials. The MEDLINE, EMBASE, and Cochrane Library databases were systematically searched and supplemented with manual searches of PubMed and reference lists. Eligible studies consisted exclusively of randomized controlled trials comparing MS, ACI, or OAT techniques in patients with focal cartilage defects of the knee. The primary outcome of interest was function (Lysholm score, International Knee Documentation Committee score, Knee Osteoarthritis Outcome Score) and pain at 24 months postoperatively. A meta-analysis using standardized mean differences was performed to provide a pooled estimate of effect comparing treatments. A total of 12 eligible randomized trials with a cumulative sample size of 765 patients (62% males) and a mean (±SD) lesion size of 3.9 ± 1.3 cm(2) were included in this review. There were 5 trials comparing ACI with MS, 3 comparing ACI with OAT, and 3 evaluating different generations of ACI. In a pooled analysis comparing ACI with MS, there was no difference in outcomes at 24-month follow-up for function (standardized mean difference, 0.47 [95% CI, -0.19 to 1.13]; P = .16) or pain (standardized mean difference, -0.13 [95% CI, -0.39 to 0.13]; P = .33). The comparisons of ACI to OAT or between different generations of ACI were not amenable to pooled analysis. Overall, 5 of the 6 trials concluded that there was no significant difference in functional outcomes between ACI and OAT or between generations of ACI. There is no significant difference between MS, ACI, and OAT in improving function and pain at intermediate-term follow-up. Further randomized trials with long-term outcomes are warranted. © 2015 The Author(s).

Effectiveness of disease-management programs for improving diabetes care: a meta-analysis.

PubMed

Pimouguet, Clément; Le Goff, Mélanie; Thiébaut, Rodolphe; Dartigues, Jean François; Helmer, Catherine

2011-02-08

We conducted a meta-analysis of randomized controlled trials to assess the effectiveness of disease-management programs for improving glycemic control in adults with diabetes mellitus and to study which components of programs are associated with their effectiveness. We searched several databases for studies published up to December 2009. We included randomized controlled trials involving adults with type 1 or 2 diabetes that evaluated the effect of disease-management programs on glycated hemoglobin (hemoglobin A₁(C)) concentrations. We performed a meta-regression analysis to determine the effective components of the programs. We included 41 randomized controlled trials in our review. Across these trials, disease-management programs resulted in a significant reduction in hemoglobin A₁(C) levels (pooled standardized mean difference between intervention and control groups -0.38 [95% confidence interval -0.47 to -0.29], which corresponds to an absolute mean difference of 0.51%). The finding was robust in the sensitivity analyses based on quality assessment. Programs in which the disease manager was able to start or modify treatment with or without prior approval from the primary care physician resulted in a greater improvement in hemoglobin A₁(C) levels (standardized mean difference -0.60 v. -0.28 in trials with no approval to do so; p < 0.001). Programs with a moderate or high frequency of contact reported a significant reduction in hemoglobin A₁(C) levels compared with usual care; nevertheless, only programs with a high frequency of contact led to a significantly greater reduction compared with low-frequency contact programs (standardized mean difference -0.56 v. -0.30, p = 0.03). Disease-management programs had a clinically moderate but significant impact on hemoglobin A₁(C) levels among adults with diabetes. Effective components of programs were a high frequency of patient contact and the ability for disease managers to adjust treatment with or without prior physician approval.

Effectiveness of disease-management programs for improving diabetes care: a meta-analysis

PubMed Central

Pimouguet, Clément; Le Goff, Mélanie; Thiébaut, Rodolphe; Dartigues, Jean François; Helmer, Catherine

2011-01-01

Background We conducted a meta-analysis of randomized controlled trials to assess the effectiveness of disease-management programs for improving glycemic control in adults with diabetes mellitus and to study which components of programs are associated with their effectiveness. Methods We searched several databases for studies published up to December 2009. We included randomized controlled trials involving adults with type 1 or 2 diabetes that evaluated the effect of disease-management programs on glycated hemoglobin (hemoglobin A1C) concentrations. We performed a meta-regression analysis to determine the effective components of the programs. Results We included 41 randomized controlled trials in our review. Across these trials, disease-management programs resulted in a significant reduction in hemoglobin A1C levels (pooled standardized mean difference between intervention and control groups −0.38 [95% confidence interval −0.47 to −0.29], which corresponds to an absolute mean difference of 0.51%). The finding was robust in the sensitivity analyses based on quality assessment. Programs in which the disease manager was able to start or modify treatment with or without prior approval from the primary care physician resulted in a greater improvement in hemoglobin A1C levels (standardized mean difference −0.60 v. −0.28 in trials with no approval to do so; p < 0.001). Programs with a moderate or high frequency of contact reported a significant reduction in hemoglobin A1C levels compared with usual care; nevertheless, only programs with a high frequency of contact led to a significantly greater reduction compared with low-frequency contact programs (standardized mean difference −0.56 v. −0.30, p = 0.03). Interpretation Disease-management programs had a clinically moderate but significant impact on hemoglobin A1C levels among adults with diabetes. Effective components of programs were a high frequency of patient contact and the ability for disease managers to adjust treatment with or without prior physician approval. PMID:21149524

A controlled trial of an expert system and self-help manual intervention based on the stages of change versus standard self-help materials in smoking cessation.

PubMed

Aveyard, Paul; Griffin, Carl; Lawrence, Terry; Cheng, K K

2003-03-01

To examine the population impact and effectiveness of the Pro-Change smoking cessation course based on the Transtheoretical Model (TTM) compared to standard self-help smoking cessation literature. Randomized controlled trial. Sixty-five West Midlands general practices. Randomly sampled patients recorded as smokers by their general practitioners received an invitation letter and 2471 current smokers agreed. Responders were randomized to one of four interventions. The control group received standard self-help literature. In the Manual intervention group, participants received the Pro-Change system, a self-help workbook and three questionnaires at 3-monthly intervals, which generated individually tailored feedback. In the Phone intervention group, participants received the Manual intervention plus three telephone calls. In the Nurse intervention group, participants received the Manual intervention plus three visits to the practice nurse. Biochemically confirmed point prevalence of being quit and 6-month sustained abstinence, 12 months after study commencement. A total of 9.1% of registered current smokers participated, of whom 83.0% were not ready to quit. Less than half of participants returned questionnaires to generate second and third individualized feedback. Telephone calls reached 75% of those scheduled, but few participants visited the nurse. There were small differences between the three Pro-Change arms. The odds ratio (95% confidence intervals) for all Pro-Change arms combined versus the control arm were 1.50 (0.85-2.67) and 1.53 (0.76-3.10), for point prevalence and 6-month abstinence, respectively. This constitutes 2.1% of the TTM group versus 1.4% of the control group achieving confirmed 6-month sustained abstinence. There was no statistically significant benefit of the intervention apparent in this trial and the high relapse of quitters means that any population impact is small.

A standardized crisis management model for self-harming and suicidal individuals with three or more diagnostic criteria of borderline personality disorder: The Brief Admission Skåne randomized controlled trial protocol (BASRCT).

PubMed

Liljedahl, Sophie I; Helleman, Marjolein; Daukantaité, Daiva; Westrin, Åsa; Westling, Sofie

2017-06-15

Brief Admission is a crisis and risk management strategy in which self-harming and suicidal individuals with three or more diagnostic criteria of borderline personality disorder self-admit to hospital at times of increasing risk when other efforts to stay safe are failing. Standardized in the current randomized controlled trial, the intensity of Brief Admission Skåne is implemented in durations of three days, with a maximum frequency of three times a month. Brief Admission is integrated into existing treatment plans in advance of crises to prevent reliance on general psychiatric admissions for risk management, as these may be lengthy, unstructured, and of uncertain therapeutic value. The overall objective of the Brief Admission Skåne randomized controlled trial is to determine if Brief Admission can replace general psychiatric admission for self-harming and suicidal individuals with complex mental illness at times of escalating risk. Other objectives of the study are to evaluate whether Brief Admission increases daily functioning and enhances coping, reduces psychiatric symptoms including frequency and severity of self-harm and suicidal behaviours. A final objective is to determine if Brief Admission is an effective crisis management model for this population. Participants are randomized at an individual level to either Brief Admission Skåne plus Treatment as Usual or Treatment As Usual. Based on a priori power analyses, N = 124 participants will be recruited to the study. Data collection is in progress, and will continue until June 2018. All participant data are single-blinded and will be handled with intention-to-treat analysis. Based on the combined clinical experience of our international research group, the Brief Admission Skåne randomized controlled trial upon which the current protocol is based represents the first initiative to standardize, implement and evaluate Brief Admission amongst self-harming and suicidal individuals, including those with borderline traits. Objectively measuring protocol fidelity and developing English-language Brief Admission study protocols and training materials are implementation and dissemination targets developed in order to facilitate adherent international export of Brief Admission Skåne. NCT02985047 . Registered November 25, 2016. Retrospectively registered.

CPAP Treatment Supported by Telemedicine Does Not Improve Blood Pressure in High Cardiovascular Risk OSA Patients: A Randomized, Controlled Trial

PubMed Central

Mendelson, Monique; Vivodtzev, Isabelle; Tamisier, Renaud; Laplaud, David; Dias-Domingos, Sonia; Baguet, Jean-Philippe; Moreau, Laurent; Koltes, Christian; Chavez, Léonidas; De Lamberterie, Gilles; Herengt, Frédéric; Levy, Patrick; Flore, Patrice; Pépin, Jean-Louis

2014-01-01

Study Objectives: Obstructive sleep apnea (OSA) has been associated with hypertension, which is one of the intermediary mechanisms leading to increased cardiovascular morbidity. This study aimed at evaluating the effects of a combination of continuous positive airway pressure (CPAP) and telemedicine support on blood pressure (BP) reduction in high cardiovascular risk OSA patients. Design: A multi-center randomized controlled trial that compared standard CPAP care and CPAP care and a telemedicine intervention. Setting: Sleep clinics in France. Patients or Participants: 107 adult (18-65 years old) OSA patients (AHI > 15 events/h) with a high cardiovascular risk (cardiovascular SCORE > 5% or secondary prevention). Interventions: Patients were randomized to either standard care CPAP (n = 53) or CPAP and telemedicine (n = 54). Patients assigned to telemedicine were equipped with a smartphone for uploading BP measurements, CPAP adherence, sleepiness, and quality of life data; in return, they received pictograms containing health-related messages. Measurements: The main outcome was home self-measured BP and secondary outcomes were cardiovascular risk evolution, objective physical activity, CPAP adherence, sleepiness and quality of life. Results: Self-measured BP did not improve in either group (telemedicine or standard care). Patients in primary prevention showed greater BP reduction with CPAP treatment than those in secondary prevention. Conclusions: CPAP treatment supported by telemedicine alone did not improve blood pressure and cardiovascular risk in high cardiovascular risk OSA patients. This study emphasizes the need for diet and physical activity training programs in addition to CPAP when aiming at decreasing cardiometabolic risk factors in these patients. Clinical Trials Registration: ClinicalTrials.gov identifier: NCT01226641. Citation: Mendelson M, Vivodtzev I, Tamisier R, Laplaud D, Dias-Domingos S, Baguet JP, Moreau L, Koltes C, Chavez L, De Lamberterie G, Herengt F, Levy P, Flore P, Pépin JL. CPAP treatment supported by telemedicine does not improve blood pressure in high cardiovascular risk OSA patients: a randomized, controlled trial. SLEEP 2014;37(11):1863-1870. PMID:25364081

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.

Microcontroller for automation application

NASA Technical Reports Server (NTRS)

Cooper, H. W.

1975-01-01

The description of a microcontroller currently being developed for automation application was given. It is basically an 8-bit microcomputer with a 40K byte random access memory/read only memory, and can control a maximum of 12 devices through standard 15-line interface ports.

Methodological reporting quality of randomized controlled trials: A survey of seven core journals of orthopaedics from Mainland China over 5 years following the CONSORT statement.

PubMed

Zhang, J; Chen, X; Zhu, Q; Cui, J; Cao, L; Su, J

2016-11-01

In recent years, the number of randomized controlled trials (RCTs) in the field of orthopaedics is increasing in Mainland China. However, randomized controlled trials (RCTs) are inclined to bias if they lack methodological quality. Therefore, we performed a survey of RCT to assess: (1) What about the quality of RCTs in the field of orthopedics in Mainland China? (2) Whether there is difference between the core journals of the Chinese department of orthopedics and Orthopaedics Traumatology Surgery & Research (OTSR). This research aimed to evaluate the methodological reporting quality according to the CONSORT statement of randomized controlled trials (RCTs) in seven key orthopaedic journals published in Mainland China over 5 years from 2010 to 2014. All of the articles were hand researched on Chongqing VIP database between 2010 and 2014. Studies were considered eligible if the words "random", "randomly", "randomization", "randomized" were employed to describe the allocation way. Trials including animals, cadavers, trials published as abstracts and case report, trials dealing with subgroups analysis, or trials without the outcomes were excluded. In addition, eight articles selected from Orthopaedics Traumatology Surgery & Research (OTSR) between 2010 and 2014 were included in this study for comparison. The identified RCTs are analyzed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT), including the sample size calculation, allocation sequence generation, allocation concealment, blinding and handling of dropouts. A total of 222 RCTs were identified in seven core orthopaedic journals. No trials reported adequate sample size calculation, 74 (33.4%) reported adequate allocation generation, 8 (3.7%) trials reported adequate allocation concealment, 18 (8.1%) trials reported adequate blinding and 16 (7.2%) trials reported handling of dropouts. In OTSR, 1 (12.5%) trial reported adequate sample size calculation, 4 (50.0%) reported adequate allocation generation, 1 (12.5%) trials reported adequate allocation concealment, 2 (25.0%) trials reported adequate blinding and 5 (62.5%) trials reported handling of dropouts. There were statistical differences as for sample size calculation and handling of dropouts between papers from Mainland China and OTSR (P<0.05). The findings of this study show that the methodological reporting quality of RCTs in seven core orthopaedic journals from the Mainland China is far from satisfaction and it needs to further improve to keep up with the standards of the CONSORT statement. Level III case control. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

A randomized controlled trial to evaluate the relative efficacy of enhanced versus standard voluntary counseling and testing on promoting condom use among men who have sex with men in China.

PubMed

Hao, Chun; Huan, Xiping; Yan, Hongjing; Yang, Haitao; Guan, Wenhui; Xu, Xiaoqin; Zhang, Min; Wang, Na; Tang, Weiming; Gu, Jing; Lau, Joseph T F

2012-07-01

The randomized controlled trial investigated the relative efficacy of an enhanced (EVCT) versus standard (SVCT) voluntary counseling and testing in reducing unprotected anal intercourse (UAI) among men who have sex with men (MSM) in China. 295 participants who recruited by respondent driven sampling methods were randomly allocated to the two arms. In addition to the SVCT, the EVCT group watched a theory-based video narrated by a HIV positive MSM, received enhanced counseling and a reminder gift. As compared to the SVCT group, the EVCT group reported lower prevalence of UAI with any male sex partners (48.4% versus 66.7%, RR = 0.7, ARR = -18.3%, p = 0.010) and with regular male sex partners (52.2% versus 68.9%, RR = 0.8, ARR = -16.7%, p = 0.043) at Month 6, whilst baseline between-group differences were statistically non-significant. Between-group differences in HIV/syphilis incidence were statistically non-significant. Translational research should be conducted to integrate non-intensive enhancements such as the EVCT into regular testing services.

Smoking relapse-prevention intervention for cancer patients: Study design and baseline data from the surviving SmokeFree randomized controlled trial.

PubMed

Díaz, Diana B; Brandon, Thomas H; Sutton, Steven K; Meltzer, Lauren R; Hoehn, Hannah J; Meade, Cathy D; Jacobsen, Paul B; McCaffrey, Judith C; Haura, Eric B; Lin, Hui-Yi; Simmons, Vani N

2016-09-01

Continued smoking after a cancer diagnosis contributes to several negative health outcomes. Although many cancer patients attempt to quit smoking, high smoking relapse rates have been observed. This highlights the need for a targeted, evidence-based smoking-relapse prevention intervention. The design, method, and baseline characteristics of a randomized controlled trial assessing the efficacy of a self-help smoking-relapse prevention intervention are presented. Cancer patients who had recently quit smoking were randomized to one of two conditions. The Usual Care (UC) group received the institution's standard of care. The smoking relapse-prevention intervention (SRP) group received standard of care, plus 8 relapse-prevention booklets mailed over a 3month period, and a targeted educational DVD developed specifically for cancer patients. Four hundred and fourteen participants were enrolled and completed a baseline survey. Primary outcomes will be self-reported smoking status at 6 and 12-months after baseline. Biochemical verification of smoking status was completed for a subsample. If found to be efficacious, this low-cost intervention could be easily disseminated with significant potential for reducing the risk of negative cancer outcomes associated with continued smoking. Copyright © 2016 Elsevier Inc. All rights reserved.

[Physical therapy intervention during hospitalization in patients with acute exacerbation of chronic obstructive pulmonary disease and pneumonia: A randomized clinical trial].

PubMed

Martín-Salvador, Adelina; Colodro-Amores, Gloria; Torres-Sánchez, Irene; Moreno-Ramírez, M Paz; Cabrera-Martos, Irene; Valenza, Marie Carmen

2016-04-01

Respiratory infections involve not only hospitalization due to pneumonia, but also acute exacerbations of COPD (AECOPD). The objective of the present study was to evaluate the effectiveness of a physical therapy intervention during hospitalization in patients admitted due to community-acquired pneumonia (CAP) and AECOPD. Randomized clinical trial, 44 patients were randomized into 2 groups: a control group which received standard medical therapy (oxygen therapy and pharmacotherapy) and an experimental group that received standard treatment and a physical therapy intervention (breathing exercises, electrostimulation, exercises with elastic bands and relaxation). Between-groups analysis showed that after the intervention (experimental vs. control) significant differences were found in perceived dyspnoea (P=.041), and right and left quadriceps muscle strength (P=.008 and P=.010, respectively). In addition, the subscale of "domestic activities" of the functional ability related to respiratory symptoms questionnaire showed significant differences (P=.036). A physical therapy intervention during hospitalization in patients with AECOPD and CAP can generate skeletal muscle level gains that exceed the deterioration caused by immobilization during hospitalization. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

Does wearing unstable shoes reduce low back pain and disability in nurses? A randomized controlled pilot study.

PubMed

Vieira, Edgar R; Brunt, Denis

2016-02-01

To evaluate if wearing unstable shoes reduces low back pain and disability in nurses. A randomized controlled trial. Hospitals and homecare. A total of 20 matched female registered nurses with low back pain. The mean (standard deviation) age was 31 years (5) for the control and 34 years (6) for the intervention group; height was 161 cm (5) and 165 cm (7), respectively. The intervention group received unstable shoes at Week 2 to wear for at least 36 h/week for a month. The Oswestry Low Back Pain Disability Questionnaire and a visual analogue pain scale. The mean (standard deviation) pain level was 6 (1) at baseline vs. 6 (2) at Week 6 for the control group, and 5 (1) vs. 1 (1) for the intervention group. The mean (standard deviation) disability level was 31% (9) at baseline vs. 28% (7) at Week 6 for the control, and 27% (12) vs. 13% (5) for the intervention group. There were no significant changes over time on pain or disability levels for the control group. The intervention group reported lower levels of pain on Weeks 4 (mean difference ⩾-1.4, p ⩽ 0.009) and 6 (mean difference ⩾-3.1, p < 0.001). Disability levels were also lower on Weeks 4 (mean difference = -4.5%, p NS) and 6 (mean difference = -14.1%, p = 0.020). Wearing unstable shoes reduced low back pain and disability in nurses and might be helpful as part of the back pain rehabilitation process. © The Author(s) 2015.

Improved quality monitoring of multi-center acupuncture clinical trials in China

PubMed Central

2009-01-01

Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). Methods A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture. PMID:20035630

Perioperative strategy in colonic surgery; LAparoscopy and/or FAst track multimodal management versus standard care (LAFA trial)

PubMed Central

Wind, Jan; Hofland, Jan; Preckel, Benedikt; Hollmann, Markus W; Bossuyt, Patrick MM; Gouma, Dirk J; van Berge Henegouwen, Mark I; Fuhring, Jan Willem; Dejong, Cornelis HC; van Dam, Ronald M; Cuesta, Miguel A; Noordhuis, Astrid; de Jong, Dick; van Zalingen, Edith; Engel, Alexander F; Goei, T Hauwy; de Stoppelaar, I Erica; van Tets, Willem F; van Wagensveld, Bart A; Swart, Annemiek; van den Elsen, Maarten JLJ; Gerhards, Michael F; de Wit, Laurens Th; Siepel, Muriel AM; van Geloven, Anna AW; Juttmann, Jan-Willem; Clevers, Wilfred; Bemelman, Willem A

2006-01-01

Background Recent developments in large bowel surgery are the introduction of laparoscopic surgery and the implementation of multimodal fast track recovery programs. Both focus on a faster recovery and shorter hospital stay. The randomized controlled multicenter LAFA-trial (LAparoscopy and/or FAst track multimodal management versus standard care) was conceived to determine whether laparoscopic surgery, fast track perioperative care or a combination of both is to be preferred over open surgery with standard care in patients having segmental colectomy for malignant disease. Methods/design The LAFA-trial is a double blinded, multicenter trial with a 2 × 2 balanced factorial design. Patients eligible for segmental colectomy for malignant colorectal disease i.e. right and left colectomy and anterior resection will be randomized to either open or laparoscopic colectomy, and to either standard care or the fast track program. This factorial design produces four treatment groups; open colectomy with standard care (a), open colectomy with fast track program (b), laparoscopic colectomy with standard care (c), and laparoscopic surgery with fast track program (d). Primary outcome parameter is postoperative hospital length of stay including readmission within 30 days. Secondary outcome parameters are quality of life two and four weeks after surgery, overall hospital costs, morbidity, patient satisfaction and readmission rate. Based on a mean postoperative hospital stay of 9 +/- 2.5 days a group size of 400 patients (100 each arm) can reliably detect a minimum difference of 1 day between the four arms (alfa = 0.95, beta = 0.8). With 100 patients in each arm a difference of 10% in subscales of the Short Form 36 (SF-36) questionnaire and social functioning can be detected. Discussion The LAFA-trial is a randomized controlled multicenter trial that will provide evidence on the merits of fast track perioperative care and laparoscopic colorectal surgery in patients having segmental colectomy for malignant disease. PMID:17134506

One-stop-shop with confocal microscopy imaging vs. standard care for surgical treatment of basal cell carcinoma: an open-label, noninferiority, randomized controlled multicentre trial.

PubMed

Kadouch, D J; Elshot, Y S; Zupan-Kajcovski, B; van Haersma de With, A S E; van der Wal, A C; Leeflang, M; Jóźwiak, K; Wolkerstorfer, A; Bekkenk, M W; Spuls, P I; de Rie, M A

2017-09-01

Routine punch biopsies are considered to be standard care for diagnosing and subtyping basal cell carcinoma (BCC) when clinically suspected. We assessed the efficacy of a one-stop-shop concept using in vivo reflectance confocal microscopy (RCM) imaging as a diagnostic tool vs. standard care for surgical treatment in patients with clinically suspected BCC. In this open-label, parallel-group, noninferiority, randomized controlled multicentre trial we enrolled patients with clinically suspected BCC at two tertiary referral centres in Amsterdam, the Netherlands. Patients were randomly assigned to the RCM one-stop-shop (diagnosing and subtyping using RCM followed by direct surgical excision) or standard care (planned excision based on the histological diagnosis and subtype of a punch biopsy). The primary outcome was the proportion of patients with tumour-free margins after surgical excision of BCC. Of the 95 patients included, 73 (77%) had a BCC histologically confirmed using a surgical excision specimen. All patients (40 of 40, 100%) in the one-stop-shop group had tumour-free margins. In the standard-care group tumour-free margins were found in all but two patients (31 of 33, 94%). The difference in the proportion of patients with tumour-free margins after BCC excision between the one-stop-shop group and the standard-care group was -0·06 (90% confidence interval -0·17-0·01), establishing noninferiority. The proposed new treatment strategy seems suitable in facilitating early diagnosis and direct treatment for patients with BCC, depending on factors such as availability of RCM, size and site of the lesion, patient preference and whether direct surgical excision is feasible. © 2017 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

The Clinical Effects of Aromatherapy Massage on Reducing Pain for the Cancer Patients: Meta-Analysis of Randomized Controlled Trials.

PubMed

Chen, Ting-Hao; Tung, Tao-Hsin; Chen, Pei-Shih; Wang, Shu-Hui; Chao, Chuang-Min; Hsiung, Nan-Hsing; Chi, Ching-Chi

2016-01-01

Purpose. Aromatherapy massage is an alternative treatment in reducing the pain of the cancer patients. This study was to investigate whether aromatherapy massage could improve the pain of the cancer patients. Methods. We searched PubMed and Cochrane Library for relevant randomized controlled trials without language limitations between 1 January 1990 and 31 July 2015 with a priori defined inclusion and exclusion criteria. The search terms included aromatherapy, essential oil, pain, ache, cancer, tumor, and carcinoma. There were 7 studies which met the selection criteria and 3 studies were eventually included among 63 eligible publications. Results. This meta-analysis included three randomized controlled trials with a total of 278 participants (135 participants in the massage with essential oil group and 143 participants in the control (usual care) group). Compared with the control group, the massage with essential oil group had nonsignificant effect on reducing the pain (standardized mean difference = 0.01; 95% CI [-0.23,0.24]). Conclusion. Aromatherapy massage does not appear to reduce pain of the cancer patients. Further rigorous studies should be conducted with more objective measures.

Effect of Sleep Hygiene Education on Sleep Quality in Hemodialysis Patients

PubMed Central

Soleimani, Farzaneh; Hasanpour-Dehkordi, Ali

2016-01-01

Introduction Sleep is referred a regular, recurring and easily revocable state of organism which is characterized by relative immobility and significant increase in response threshold to environmental stimuli. Sleep disorders are common among haemodialysis patients. Aim The aim of this study was to investigate the effect of sleep hygiene education on sleep quality in haemodialysis patients. Materials and Methods This study is a randomized controlled clinical trial. The participants of this study were 60 haemodialysis patients admitted to the Dialysis Center of Shahid Ayatollah Madani Hospital of Khoy, affiliated with the Urmia University of Medical Sciences. Sampling was done randomly and the partcipants were randomly divided into intervention group (30 patients) and control group (30 patients). Sleep quality of participants was measured before and after the intervention by Pittsburgh Sleep Quality Index (PSQI). Training process for sleep hygiene behaviours was presented to the participants face-to-face. The data were analysed using SPSS 16. Results A significant difference in the mean (standard deviation) score for PSQI (p<0.001) was observed before and after intervention in the intervention group, while in the control group, the difference was not significant (p=0.704), In addition, a significant difference was observed in the mean (standard deviation) score for PSQI between the two, intervention and control groups after the educational intervention (p=0.034). Conclusion Sleep hygiene education, alongside other appro-aches, is a low-cost, accessible and practical method which can be implemented within a short period of time. PMID:28208884

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.

A 6-month randomized controlled trial to test the efficacy of a lifestyle intervention for weight gain management in schizophrenia

PubMed Central

2013-01-01

Background Patients with schizophrenia have lower longevity than the general population as a consequence of a combination of risk factors connected to the disease, lifestyle and the use of medications, which are related to weight gain. Methods A multicentric, randomized, controlled-trial was conducted to test the efficacy of a 12-week group Lifestyle Wellness Program (LWP). The program consists of a one-hour weekly session to discuss topics like dietary choices, lifestyle, physical activity and self-esteem with patients and their relatives. Patients were randomized into two groups: standard care (SC) and standard care plus intervention (LWP). Primary outcome was defined as the weight and body mass index (BMI). Results 160 patients participated in the study (81 in the intervention group and 79 in the SC group). On an intent to treat analysis, after three months the patients in the intervention group presented a decrease of 0.48 kg (CI 95% -0.65 to 1.13) while the standard care group showed an increase of 0.48 kg (CI 95% 0.13 to 0.83; p=0.055). At six-month follow-up, there was a significant weight decrease of −1.15 kg, (CI 95% -2.11 to 0.19) in the intervention group compared to a weight increase in the standard care group (+0.5 kg, CI 95% -0.42–1.42, p=0.017). Conclusion In conclusion, this was a multicentric randomized clinical trial with a lifestyle intervention for individuals with schizophrenia, where the intervention group maintained weight and presented a tendency to decrease weight after 6 months. It is reasonable to suppose that lifestyle interventions may be important long-term strategies to avoid the tendency of these individuals to increase weight. Clinicaltrials.gov identifier NCT01368406 PMID:23418863

Randomized controlled multicentre study comparing biological mesh closure of the pelvic floor with primary perineal wound closure after extralevator abdominoperineal resection for rectal cancer (BIOPEX-study)

PubMed Central

2014-01-01

Background Primary perineal wound closure after conventional abdominoperineal resection (cAPR) for rectal cancer has been the standard of care for many years. Since the introduction of neo-adjuvant radiotherapy and the extralevator APR (eAPR), oncological outcome has been improved, but at the cost of increased rates of perineal wound healing problems and perineal hernia. This has progressively increased the use of biological meshes, although not supported by sufficient evidence. The aim of this study is to determine the effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo)radiotherapy compared to primary perineal wound closure. Methods/Design In this multicentre randomized controlled trial, patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo)radiotherapy will be considered eligible. Exclusion criteria are prior radiotherapy, sacral resection above S4/S5, allergy to pig products or polysorbate, collagen disorders, and severe systemic diseases affecting wound healing, except for diabetes. After informed consent, 104 patients will be randomized between standard care using primary wound closure of the perineum and the experimental arm consisting of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm. Patients will be followed for one year after the intervention and outcome assessors and patients will be blinded for the study treatment. The primary endpoint is the percentage of uncomplicated perineal wound healing, defined as a Southampton wound score of less than II on day 30. Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs. Discussion The BIOPEX-study is the first randomized controlled multicentre study to determine the additive value of using a biological mesh for perineal wound closure after eAPR with neo-adjuvant radiotherapy compared to primary perineal wound closure with regard to perineal wound healing and the occurrence of perineal hernia. Trail registration number NCT01927497 (Clinicaltrial.gov). PMID:25163547

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).

Perioperative supplemental oxygen therapy and surgical site infection: a meta-analysis of randomized controlled trials.

PubMed

Qadan, Motaz; Akça, Ozan; Mahid, Suhal S; Hornung, Carlton A; Polk, Hiram C

2009-04-01

To conduct a meta-analysis of randomized controlled trials in which high inspired oxygen concentrations were compared with standard concentrations to assess the effect on the development of surgical site infections (SSIs). A systematic literature search was conducted using the MEDLINE, EMBASE, and Cochrane databases and included a manual search of references of original articles, poster presentations, and abstracts from major meetings ("gray" literature). Twenty-one of 2167 articles met the inclusion criteria. Of these, 5 randomized controlled trials (3001 patients) assessed the effect of perioperative supplemental oxygen use on the SSI rate. Studies used a treatment-inspired oxygen concentration of 80%. Maximum follow-up was 30 days. Data were abstracted by 3 independent reviewers using a standardized data collection form. Relative risks were reported using a fixed-effects model. Results were subjected to publication bias testing and sensitivity analyses. Infection rates were 12.0% in the control group and 9.0% in the hyperoxic group, with relative risk reduction of 25.3% (95% confidence interval [CI], 8.1%-40.1%) and absolute risk reduction of 3.0% (1.1%-5.3%). The overall risk ratio was 0.742 (95% CI, 0.599-0.919; P = .006). The benefit from increasing oxygen concentration was greater in colorectal-specific procedures, with a risk ratio of 0.556 (95% CI, 0.383-0.808; P = .002). Perioperative supplemental oxygen therapy exerts a significant beneficial effect in the prevention of SSIs. We recommend its use along with maintenance of normothermia, meticulous glycemic control, and preservation of intravascular volume perioperatively in the prevention of SSIs.

Influence of an apical negative pressure irrigation system on bacterial elimination during endodontic therapy: a prospective randomized clinical study.

PubMed

Pawar, Rekha; Alqaied, Abdullah; Safavi, Kamran; Boyko, Jennifer; Kaufman, Blythe

2012-09-01

Recent in vitro studies that use an apical negative pressure irrigation system, EndoVac, have demonstrated promising results in the production of debris-free root canals, while also preventing potential extrusion of irrigants into the periapical region. We conducted a randomized, controlled, prospective clinical study to determine whether the use of EndoVac irrigation (EndoVac group) was more efficient compared with standard needle irrigation (control group) in obtaining canals from which microbes could not be cultivated. Routine endodontic therapy was performed in 48 patients with necrotic, single-rooted, single-canal teeth. The patients were randomly assigned to either the EndoVac group (n = 25) or control group (n = 23). Irrigation with either method was carried out with 0.5% sodium hypochlorite. After surface disinfection, before instrumentation and on completion of chemomechanical preparation, intracanal microbial samples were obtained and cultured under anaerobic conditions. The frequency of microbial cultivability by using either irrigation system was analyzed. The frequency of obtaining culture-negative root canals was 90.9% and 82.6% for the control group and EndoVac group, respectively. There was no significant difference in the antimicrobial efficacy of either control group or EndoVac group (Fisher exact test, P = .665). Furthermore, no significant association between study variables and the irrigation systems' antimicrobial efficacy was found (P > .05). The results of this prospective in vivo study demonstrate that the antimicrobial efficacy of EndoVac irrigation is comparable to that of standard irrigation. Copyright © 2012 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

The influence of parenteral glutamine supplementation on glucose homeostasis in critically ill polytrauma patients--A randomized-controlled clinical study.

PubMed

Grintescu, Ioana Marina; Luca Vasiliu, Irina; Cucereanu Badica, Ioana; Mirea, Liliana; Pavelescu, Daniela; Balanescu, Andreea; Grintescu, Ioana Cristina

2015-06-01

Rapid onset of resistance to insulin is a prominent component of stress metabolism in multiple trauma patients. Recent studies have clarified the role of amino acids (especially glutamine) in glucose transportation and the benefits of parenteral alanyl-glutamine supplementation (0.3-0.6 g/kg/day) in glucose homeostasis. The aims of this study are to evaluate the incidence of hyperglycemic episodes and the need for exogenous insulin to maintain stable glucose levels in critically ill polytrauma patients supplemented with parenteral glutamine dipeptide (Dipeptiven(®)) versus standard nutritional support. This was an open-label randomized-controlled trial of 82 polytrauma patients aged 20-60 years old, randomly assigned into two equal groups independent of sex, age and Injury Severity Score. We excluded patients with diabetes mellitus, or renal or hepatic failure. One group received parenteral Dipeptiven(®) supplementation of 0.5 g/kg/day and the other received standard isocaloric isoproteinic nutritional support. We found that 63% of patients in the glutamine-supplemented group had no hyperglycemic episodes; only 37% required exogenous insulin (mean daily requirement of 44 units/day). In the control group, 51% of patients required insulin (mean daily requirement 63 unit/day; p = 0.0407). The effect of glutamine supplementation on glucose homeostasis is associated with a lower incidence of hyperglycemia among critically ill polytrauma patients, and leads to a lower mean daily dose of insulin. Controlled-trials.com Identifier: ISRCTN71592366 (http://www.controlled-trials.com/ISRCTN71592366/ISRCTN71592366). Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Influence of adjunctive classical homeopathy on global health status and subjective wellbeing in cancer patients - A pragmatic randomized controlled trial.

PubMed

Frass, Michael; Friehs, Helmut; Thallinger, Christiane; Sohal, Narinderjit Kaur; Marosi, Christine; Muchitsch, Ilse; Gaertner, Katharina; Gleiss, Andreas; Schuster, Ernst; Oberbaum, Menachem

2015-06-01

The use of complementary and alternative medicine has increased over the past decade. The aim of this study was to evaluate whether homeopathy influenced global health status and subjective wellbeing when used as an adjunct to conventional cancer therapy. In this pragmatic randomized controlled trial, 410 patients, who were treated by standard anti-neoplastic therapy, were randomized to receive or not receive classical homeopathic adjunctive therapy in addition to standard therapy. The study took place at the Medical University Vienna, Department of Medicine I, Clinical Division of Oncology. The main outcome measures were global health status and subjective wellbeing as assessed by the patients. At each of three visits (one baseline, two follow-up visits), patients filled in two different questionnaires. 373 patients yielded at least one of three measurements. The improvement of global health status between visits 1 and 3 was significantly stronger in the homeopathy group by 7.7 (95% CI 2.3-13.0, p=0.005) when compared with the control group. A significant group difference was also observed with respect to subjective wellbeing by 14.7 (95% CI 8.5-21.0, p<0.001) in favor of the homeopathic as compared with the control group. Control patients showed a significant improvement only in subjective wellbeing between their first and third visits. Results suggest that the global health status and subjective wellbeing of cancer patients improve significantly when adjunct classical homeopathic treatment is administered in addition to conventional therapy. Copyright © 2015 Elsevier Ltd. All rights reserved.

Efficacy of a New Medical Information system, Ubiquitous Healthcare Service with Voice Inception Technique in Elderly Diabetic Patients.

PubMed

Kim, Kyoung Min; Park, Kyeong Seon; Lee, Hyun Ju; Lee, Yun Hee; Bae, Ji Seon; Lee, Young Joon; Choi, Sung Hee; Jang, Hak Chul; Lim, Soo

2015-12-11

We have demonstrated previously that an individualized health management system using advanced medical information technology, named ubiquitous (u)-healthcare, was helpful in achieving better glycemic control than routine care. Recently, we generated a new u-healthcare system using a voice inception technique for elderly diabetic patients to communicate information about their glucose control, physical activity, and diet more easily. In a randomized clinical trial, 70 diabetic patients aged 60-85 years were assigned randomly to a standard care group or u-healthcare group for 6 months. The primary end points were the changes in glycated hemoglobin (HbA1c) and glucose fluctuation assessed by the mean amplitude glycemic excursion (MAGE). Changes in body weight, lifestyle, and knowledge about diabetes were also investigated. After 6 months, the HbA1c levels decreased significantly in the u-healthcare group (from 8.6 ± 1.0% to 7.5 ± 0.6%) compared with the standard care group (from 8.7 ± 0.9% to 8.2 ± 1.1%, P < 0.01). The MAGE decreased more in the u-healthcare group than in the standard care group. Systolic blood pressure and body weight decreased and liver functions improved in the u-healthcare group, but not in the standard care group. The u-healthcare system with voice inception technique was effective in achieving glycemic control without hypoglycemia in elderly diabetic patients (Clinicaltrials.gov: NCT01891474).

[Methodological quality evaluation of randomized controlled trials for traditional Chinese medicines for treatment of sub-health].

PubMed

Zhao, Jun; Liao, Xing; Zhao, Hui; Li, Zhi-Geng; Wang, Nan-Yue; Wang, Li-Min

2016-11-01

To evaluate the methodological quality of the randomized controlled trials(RCTs) for traditional Chinese medicines for treatment of sub-health, in order to provide a scientific basis for the improvement of clinical trials and systematic review. Such databases as CNKI, CBM, VIP, Wanfang, EMbase, Medline, Clinical Trials, Web of Science and Cochrane Library were searched for RCTS for traditional Chinese medicines for treatment of sub-health between the time of establishment and February 29, 2016. Cochrane Handbook 5.1 was used to screen literatures and extract data, and CONSORT statement and CONSORT for traditional Chinese medicine statement were adopted as the basis for quality evaluation. Among the 72 RCTs included in this study, 67 (93.05%) trials described the inter-group baseline data comparability, 39(54.17%) trials described the unified diagnostic criteria, 28(38.89%) trials described the unified standards of efficacy, 4 (5.55%) trials mentioned the multi-center study, 19(26.38%) trials disclosed the random distribution method, 6(8.33%) trials used the random distribution concealment, 15(20.83%) trials adopted the method of blindness, 3(4.17%) study reported the sample size estimation in details, 5 (6.94%) trials showed a sample size of more than two hundred, 19(26.38%) trials reported the number of withdrawal, defluxion cases and those lost to follow-up, but only 2 trials adopted the ITT analysis,10(13.89%) trials reported the follow-up results, none of the trial reported the test registration and the test protocol, 48(66.7%) trials reported all of the indicators of expected outcomes, 26(36.11%) trials reported the adverse reactions and adverse events, and 4(5.56%) trials reported patient compliance. The overall quality of these randomized controlled trials for traditional Chinese medicines for treatment of sub-health is low, with methodological defects in different degrees. Therefore, it is still necessary to emphasize the correct application of principles such as blindness, randomization and control in RCTs, while requiring reporting in accordance with international standards. Copyright© by the Chinese Pharmaceutical Association.

Interferential and horizontal therapies in chronic low back pain due to multiple vertebral fractures: a randomized, double blind, clinical study.

PubMed

Zambito, A; Bianchini, D; Gatti, D; Rossini, M; Adami, S; Viapiana, O

2007-11-01

Chronic low back pain due to multiple vertebral fractures is of difficult management. Electrical nerve stimulation is frequently used, but its efficacy has never been properly evaluated. In a randomized placebo-controlled clinical trial, we have shown that both interferential currents and horizontal therapy are more effective than placebo for functional. Multiple vertebral fractures almost invariably ensue in chronic low back pain that remains of difficult management. Electrical nerve stimulation is frequently used but its efficacy has never been properly evaluated. One hundred and fifteen women with chronic back pain due to previous multiple vertebral osteoporotic fractures (CBPMF) were randomly assigned to either interferential currents (IFT), horizontal therapy (HT) or sham HT administered for 30 minutes daily for 5 days per week for two weeks together with a standard exercise program. Efficacy assessment was obtained at baseline and at week 2, 6 and 14 and included a functional questionnaire (Backill), the standard visual analog scale (VAS) and the mean analgesic consumption. At week 2 a significant and similar improvement in both the VAS and Backill score was observed in the three groups. The two scores continued to improve in the two active groups with changes significantly (p < 0.001) greater than those observed in control patients at week 6 and 14. The use of analgesic medications improved only in the HT group. This randomized double-blind controlled study provides the first evidence that IFT and HT therapy are significantly effective in alleviating both pain and disability in patients with CBPMF.

The Impact of the 6:3 Polyunsaturated Fatty Acid Ratio on Intermediate Markers of Breast Cancer

DTIC Science & Technology

2007-05-01

Sereika SM. Effects of a vegetarian diet and treatment preference on biological and dietary \\,ariables in overweight and obese adults: a randomized trial...combination witl standard diet or lacto-ovo- vegetarian diet on weight loss: a randomized controlled trial.(Under review at Intemational Joumal of...In press at American Joumal of Clinical Nutrition) Burke LE, Styn MA, Warziski M, Music E, Hudson AG, Sereika SM. The effects of diet preference in

Multipoint Pacing versus conventional ICD in Patients with a Narrow QRS complex (MPP Narrow QRS trial): study protocol for a pilot randomized controlled trial.

PubMed

Gasparini, Maurizio; Galimberti, Paola; Bragato, Renato; Ghio, Stefano; Raineri, Claudia; Landolina, Maurizio; Chieffo, Enrico; Lunati, Maurizio; Mulargia, Ederina; Proclemer, Alessandro; Facchin, Domenico; Rordorf, Roberto; Vicentini, Alessandro; Marcantoni, Lina; Zanon, Francesco; Klersy, Catherine

2016-12-03

Despite an intensive search for predictors of the response to cardiac resynchronization therapy (CRT), the QRS duration remains the simplest and most robust predictor of a positive response. QRS duration of ≥ 130 ms is considered to be a prerequisite for CRT; however, some studies have shown that CRT may also be effective in heart failure (HF) patients with a narrow QRS (<130 ms). Since CRT can now be performed by pacing the left ventricle from multiple vectors via a single quadripolar lead, it is possible that multipoint pacing (MPP) might be effective in HF patients with a narrow QRS. This article reports the design of the MPP Narrow QRS trial, a prospective, randomized, multicenter, controlled feasibility study to investigate the efficacy of MPP using two LV pacing vectors in patients with a narrow QRS complex (100-130 ms). Fifty patients with a standard ICD indication will be enrolled and randomized (1:1) to either an MPP group or a Standard ICD group. All patients will undergo a low-dose dobutamine stress echo test and only those with contractile reserve will be included in the study and randomized. The primary endpoint will be the percentage of patients in each group that have reverse remodeling at 12 months, defined as a reduction in left ventricular end-systolic volume (LVESV) of >15% from the baseline. This feasibility study will determine whether MPP improves reverse remodeling, as compared with standard ICD, in HF patients who have a narrow QRS complex (100-130 ms). ClinicalTrials.gov, NCT02402816 . Registered on 25 March 2015.

Speech Recognition as a Transcription Aid: A Randomized Comparison With Standard Transcription

PubMed Central

Mohr, David N.; Turner, David W.; Pond, Gregory R.; Kamath, Joseph S.; De Vos, Cathy B.; Carpenter, Paul C.

2003-01-01

Objective. Speech recognition promises to reduce information entry costs for clinical information systems. It is most likely to be accepted across an organization if physicians can dictate without concerning themselves with real-time recognition and editing; assistants can then edit and process the computer-generated document. Our objective was to evaluate the use of speech-recognition technology in a randomized controlled trial using our institutional infrastructure. Design. Clinical note dictations from physicians in two specialty divisions were randomized to either a standard transcription process or a speech-recognition process. Secretaries and transcriptionists also were assigned randomly to each of these processes. Measurements. The duration of each dictation was measured. The amount of time spent processing a dictation to yield a finished document also was measured. Secretarial and transcriptionist productivity, defined as hours of secretary work per minute of dictation processed, was determined for speech recognition and standard transcription. Results. Secretaries in the endocrinology division were 87.3% (confidence interval, 83.3%, 92.3%) as productive with the speech-recognition technology as implemented in this study as they were using standard transcription. Psychiatry transcriptionists and secretaries were similarly less productive. Author, secretary, and type of clinical note were significant (p < 0.05) predictors of productivity. Conclusion. When implemented in an organization with an existing document-processing infrastructure (which included training and interfaces of the speech-recognition editor with the existing document entry application), speech recognition did not improve the productivity of secretaries or transcriptionists. PMID:12509359

Effects of neurofeedback on the short-term memory and continuous attention of patients with moderate traumatic brain injury: A preliminary randomized controlled clinical trial.

PubMed

Rostami, Reza; Salamati, Payman; Yarandi, Kourosh Karimi; Khoshnevisan, Alireza; Saadat, Soheil; Kamali, Zeynab Sadat; Ghiasi, Somaie; Zaryabi, Atefeh; Ghazi Mir Saeid, Seyed Shahab; Arjipour, Mehdi; Rezaee-Zavareh, Mohammad Saeid; Rahimi-Movaghar, Vafa

2017-10-01

There are some studies which showed neurofeedback therapy (NFT) can be effective in clients with traumatic brain injury (TBI) history. However, randomized controlled clinical trials are still needed for evaluation of this treatment as a standard option. This preliminary study was aimed to evaluate the effect of NFT on continuous attention (CA) and short-term memory (STM) of clients with moderate TBI using a randomized controlled clinical trial (RCT). In this preliminary RCT, seventeen eligible patients with moderate TBI were randomly allocated in two intervention and control groups. All the patients were evaluated for CA and STM using the visual continuous attention test and Wechsler memory scale-4th edition (WMS-IV) test, respectively, both at the time of inclusion to the project and four weeks later. The intervention group participated in 20 sessions of NFT through the first four weeks. Conversely, the control group participated in the same NF sessions from the fifth week to eighth week of the project. Eight subjects in the intervention group and five subjects in the control group completed the study. The mean and standard deviation of participants' age were (26.75 ± 15.16) years and (27.60 ± 8.17) years in experiment and control groups, respectively. All of the subjects were male. No significant improvement was observed in any variables of the visual continuous attention test and WMS-IV test between two groups (p ≥ 0.05). Based on our literature review, it seems that our study is the only study performed on the effect of NFT on TBI patients with control group. NFT has no effect on CA and STM in patients with moderate TBI. More RCTs with large sample sizes, more sessions of treatment, longer time of follow-up and different protocols are recommended. Copyright © 2017 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Production and hosting by Elsevier B.V. All rights reserved.

Improving practice in community-based settings: a randomized trial of supervision - study protocol.

PubMed

Dorsey, Shannon; Pullmann, Michael D; Deblinger, Esther; Berliner, Lucy; Kerns, Suzanne E; Thompson, Kelly; Unützer, Jürgen; Weisz, John R; Garland, Ann F

2013-08-10

Evidence-based treatments for child mental health problems are not consistently available in public mental health settings. Expanding availability requires workforce training. However, research has demonstrated that training alone is not sufficient for changing provider behavior, suggesting that ongoing intervention-specific supervision or consultation is required. Supervision is notably under-investigated, particularly as provided in public mental health. The degree to which supervision in this setting includes 'gold standard' supervision elements from efficacy trials (e.g., session review, model fidelity, outcome monitoring, skill-building) is unknown. The current federally-funded investigation leverages the Washington State Trauma-focused Cognitive Behavioral Therapy Initiative to describe usual supervision practices and test the impact of systematic implementation of gold standard supervision strategies on treatment fidelity and clinical outcomes. The study has two phases. We will conduct an initial descriptive study (Phase I) of supervision practices within public mental health in Washington State followed by a randomized controlled trial of gold standard supervision strategies (Phase II), with randomization at the clinician level (i.e., supervisors provide both conditions). Study participants will be 35 supervisors and 130 clinicians in community mental health centers. We will enroll one child per clinician in Phase I (N = 130) and three children per clinician in Phase II (N = 390). We use a multi-level mixed within- and between-subjects longitudinal design. Audio recordings of supervision and therapy sessions will be collected and coded throughout both phases. Child outcome data will be collected at the beginning of treatment and at three and six months into treatment. This study will provide insight into how supervisors can optimally support clinicians delivering evidence-based treatments. Phase I will provide descriptive information, currently unavailable in the literature, about commonly used supervision strategies in community mental health. The Phase II randomized controlled trial of gold standard supervision strategies is, to our knowledge, the first experimental study of gold standard supervision strategies in community mental health and will yield needed information about how to leverage supervision to improve clinician fidelity and client outcomes. ClinicalTrials.gov NCT01800266.

Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation.

PubMed

Pokhis, Karina; Bitterlich, Norman; Cornelli, Umberto; Cassano, Giuseppina

2015-01-01

The purpose of this clinical study was to ascertain whether low molecular weight chitosan polyglucosamine is able to produce significantly better weight loss than placebo. 115 participants were included in the study. We used a two-center randomized, double blind, placebo-controlled design. The participants followed a standard treatment (ST), which included the combination of a low-calorie diet achieved through creating a daily calorie deficit (500 cal) and an increased daily physical activity (7 MET-h/week). They were randomized to receive standard treatment plus placebo (ST + PL) or standard treatment plus polyglucosamine (ST + PG), respectively. Participants were instructed to take 2 × 2 tablets before the two meals containing the highest fat content for at least 24 weeks. Body weight, BMI, waist circumference and the time needed for a 5 % body weight reduction (5R) were taken as main variables. The average weight loss over a period of 25 weeks in the ITT population was 5.8 ± 4.09 kg in the ST + PG group versus 4.0 ± 2.94 kg in the ST + PL (pU = 0.023; pt = 0.010). After 25 weeks, 34 participants achieved 5R in the ST + PG group (64.1 %) compared to only 23 participants in the ST + PL group (42.6 %) (ITT) (p Fisher = 0.033). Weight loss through hypo-caloric diets have been found to be effective. The additional effect of PG in combination with standard treatment is able to produce significantly better weight loss than placebo. Participants treated with ST + PG showed a significant amount of weight loss, an additional 1.8 kg, compared to controls treated with ST + PL. Trial Registration at ClinicalTrials.gov: NCT02410785 Registered 07 April 2015.

Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital.

PubMed

Knudson, Rachel A; Dunlavy, Paul W; Franko, Jan; Raman, Shankar R; Kraemer, Soren R

2016-09-01

Prior industry conducted studies have shown that long acting liposomal bupivacaine injection improves pain control postoperatively. To evaluate whether liposomal bupivacaine reduced the use of postoperative opioid (http://links.lww.com/DCR/A253) pain medication as compared to standard bupivacaine following colorectal surgery. A double blinded, prospective, randomized controlled trial comparing liposomal bupivacaine versus standard bupivacaine in patients undergoing elective colon resection. Community hospital with general surgery residency program with all cases performed by colorectal surgeons. Fifty-seven patients were randomized and reported as intention-to-treat analysis with 6 protocol violations. Sensitivity analysis excluding these 6 patients demonstrated no change in study results or conclusion. Mean age was 67 ± 2 years and 56% were male. There were 36 patients who underwent minimally invasive surgery, and 21 patients had an open colon resection. Experimental arm received liposomal bupivacaine while control arm received standard bupivacaine. Primary outcome measure was intravenous hydromorphone equivalent used via PCA during first 48 hours after operation. There was no significant difference between the two groups in the amount of opioid used orally or intravenously in the postoperative period. The primary outcome measure was PCA hydromorphone consumption during first two postoperative days after operation (hydromorphone equivalent use in standard bupivacaine group 11.3 ± 8.9 mg versus 13.3 ± 11.9 mg in liposomal bupivacaine group, p = 0.58 Mann-Whitney test). Small pragmatic trials typically remain underpowered for secondary analyses. A larger study could help to further delineate other outcomes that are impacted by postoperative pain. Liposomal bupivacaine did not change the amount of opioid used postoperatively. Based on our study, liposomal bupivacaine does not provide any added benefit over conventional bupivacaine after colon resection. (ClinicalTrials.gov: NCT02052557).

Randomized Controlled Trials in Music Therapy: Guidelines for Design and Implementation.

PubMed

Bradt, Joke

2012-01-01

Evidence from randomized controlled trials (RCTs) plays a powerful role in today's healthcare industry. At the same time, it is important that multiple types of evidence contribute to music therapy's knowledge base and that the dialogue of clinical effectiveness in music therapy is not dominated by the biomedical hierarchical model of evidence-based practice. Whether or not one agrees with the hierarchical model of evidence in the current healthcare climate, RCTs can contribute important knowledge to our field. Therefore, it is important that music therapists are prepared to design trials that meet current methodological standards and, equally important, are able to respond appropriately to those design aspects that may not be feasible in music therapy research. To provide practical guidelines to music therapy researchers for the design and implementation of RCTs as well as to enable music therapists to be well-informed consumers of RCT evidence. This article reviews key design aspects of RCTs and discusses how to best implement these standards in music therapy trials. A systematic presentation of basic randomization methods, allocation concealment strategies, issues related to blinding in music therapy trials and strategies for implementation, the use of treatment manuals, types of control groups, outcome selection, and sample size computation is provided. Despite the challenges of meeting all key design demands typical of an RCT, it is possible to design rigorous music therapy RCTs that accurately estimate music therapy treatment benefits.

Minimal intervention dentistry for early childhood caries and child dental anxiety: a randomized controlled trial.

PubMed

Arrow, P; Klobas, E

2017-06-01

To compare changes in child dental anxiety after treatment for early childhood caries (ECC) using two treatment approaches. Children with ECC were randomized to test (atraumatic restorative treatment (ART)-based approach) or control (standard care approach) groups. Children aged 3 years or older completed a dental anxiety scale at baseline and follow up. Changes in child dental anxiety from baseline to follow up were tested using the chi-squared statistic, Wilcoxon rank sum test, McNemar's test and multinomial logistic regression. Two hundred and fifty-four children were randomized (N = 127 test, N = 127 control). At baseline, 193 children completed the dental anxiety scale, 211 at follow up and 170 completed the scale on both occasions. Children who were anxious at baseline (11%) were no longer anxious at follow up, and 11% non-anxious children became anxious. Multinomial logistic regression found each increment in the number of visits increased the odds of worsening dental anxiety (odds ratio (OR), 2.2; P < 0.05), whereas each increment in the number of treatments lowered the odds of worsening anxiety (OR, 0.50; P = 0.05). The ART-based approach to managing ECC resulted in similar levels of dental anxiety to the standard treatment approach and provides a valuable alternative approach to the management of ECC in a primary dental care setting. © 2016 Australian Dental Association.

Randomized trials published in Chinese or Western journals: comparative empirical analysis.

PubMed

Purgato, Marianna; Cipriani, Andrea; Barbui, Corrado

2012-06-01

A major concern to the inclusion in systematic reviews of studies originating in China and published in Chinese journals refers to the quality of study reporting. In this systematic survey of randomized trials, we compared the characteristics of studies published in Chinese journals with those of studies published in Western journals. We included 69 studies comparing citalopram with other antidepressant drugs in the treatment of major depression. Of these, 37 (54%) were published in Chinese journals. The standard of reporting was generally poor in both Western and Chinese studies. In some Chinese studies, the generation of the randomization sequence raised concern about their experimental nature, and in almost all included studies, the concealment of allocation was not properly described. Blinding was seldom adopted in Chinese studies, and the risk of sponsorship bias was uncertain because Chinese studies did not report any financial support. In most Western studies, outcome data were selectively and incompletely reported. Pooling together all trials revealed that citalopram was similarly effective in comparison with all other antidepressant drugs both in Western studies (standardized mean difference, -0.04; 95% confidence interval, -0.15 to 0.06) and in Chinese studies (standardized mean difference, -0.08, 95% confidence interval, -0.18 to 0.02). Randomized controlled trials published in Chinese journals represent most of the studies included in this review. This suggests that omitting to search biomedical databases originating from China would systematically exclude a relevant proportion of randomized trials published in Chinese journals, with a risk of random error or bias. The increasing inclusion of Chinese studies in systematic reviews reinforces the need to check the quality of randomized trials that are meta-analyzed.

Importance of Standardized DXA Protocol for Assessing Physique Changes in Athletes.

PubMed

Nana, Alisa; Slater, Gary J; Hopkins, Will G; Halson, Shona L; Martin, David T; West, Nicholas P; Burke, Louise M

2016-06-01

The implications of undertaking DXA scans using best practice protocols (subjects fasted and rested) or a less precise but more practical protocol in assessing chronic changes in body composition following training and a specialized recovery technique were investigated. Twenty-one male cyclists completed an overload training program, in which they were randomized to four sessions per week of either cold water immersion therapy or control groups. Whole-body DXA scans were undertaken with best practice protocol (Best) or random activity protocol (Random) at baseline, after 3 weeks of overload training, and after a 2-week taper. Magnitudes of changes in total, lean and fat mass from baseline-overload, overload-taper and baseline-taper were assessed by standardization (Δmean/SD). The standard deviations of change scores for total and fat-free soft tissue mass (FFST) from Random scans (2-3%) were approximately double those observed in the Best (1-2%), owing to extra random errors associated with Random scans at baseline. There was little difference in change scores for fat mass. The effect of cold water immersion therapy on baseline-taper changes in FFST was possibly harmful (-0.7%; 90% confidence limits ±1.2%) with Best scans but unclear with Random scans (0.9%; ±2.0%). Both protocols gave similar possibly harmful effects of cold water immersion therapy on changes in fat mass (6.9%; ±13.5% and 5.5%; ±14.3%, respectively). An interesting effect of cold water immersion therapy on training-induced changes in body composition might have been missed with a less precise scanning protocol. DXA scans should be undertaken with Best.

Adaptive random walks on the class of Web graphs

NASA Astrophysics Data System (ADS)

Tadić, B.

2001-09-01

We study random walk with adaptive move strategies on a class of directed graphs with variable wiring diagram. The graphs are grown from the evolution rules compatible with the dynamics of the world-wide Web [B. Tadić, Physica A 293, 273 (2001)], and are characterized by a pair of power-law distributions of out- and in-degree for each value of the parameter β, which measures the degree of rewiring in the graph. The walker adapts its move strategy according to locally available information both on out-degree of the visited node and in-degree of target node. A standard random walk, on the other hand, uses the out-degree only. We compute the distribution of connected subgraphs visited by an ensemble of walkers, the average access time and survival probability of the walks. We discuss these properties of the walk dynamics relative to the changes in the global graph structure when the control parameter β is varied. For β≥ 3, corresponding to the world-wide Web, the access time of the walk to a given level of hierarchy on the graph is much shorter compared to the standard random walk on the same graph. By reducing the amount of rewiring towards rigidity limit β↦βc≲ 0.1, corresponding to the range of naturally occurring biochemical networks, the survival probability of adaptive and standard random walk become increasingly similar. The adaptive random walk can be used as an efficient message-passing algorithm on this class of graphs for large degree of rewiring.

Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage: a prospective, randomized, controlled trial (LUMAS).

PubMed

Al-Tamimi, Yahia Z; Bhargava, Deepti; Feltbower, Richard G; Hall, Gregory; Goddard, Anthony J P; Quinn, Audrey C; Ross, Stuart A

2012-03-01

A single-center prospective randomized controlled trial has been conducted to determine if lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage reduces the prevalence of delayed ischemic neurological deficit and improves clinical outcome. Patients with World Federation of Neurological Surgeons Grade 1 to 3 aneurysmal subarachnoid hemorrhage and modified Fisher Grades 2, 3, 4, and 3+4 were randomized to either the study group of standard therapy plus insertion of a lumbar drain or the control group of standard therapy alone. The primary outcome measure was the prevalence of delayed ischemic neurological deficit. Two hundred ten patients with aneurysmal subarachnoid hemorrhage (166 female, 44 male; median age, 54 years; interquartile range, 45-62 years) were recruited into the control (n=105) and study (n=105) groups of the trial. World Federation of Neurological Surgeons grade was: 1 (n=139), 2 (n=60), and 3 (n=11); Fisher grade was: 2 (n=87), 3 (n=85), and 4 (n=38). The prevalence of delayed ischemic neurological deficit was 35.2% and 21.0% in the control and study groups, respectively (P=0.021). The prevalence of a modified Rankin Scale score of 4, 5, or 6 at Day 10 and 6 months, respectively, was 62.5% and 18.6% in the control group and 44.8% and 19.8% in the study group (P=0.009 and 0.83, respectively). Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage has been shown to reduce the prevalence of delayed ischemic neurological deficit and improve early clinical outcome but failed to improve outcome at 6 months after aneurysmal subarachnoid hemorrhage. URL: www.clinicaltrials.gov. Unique identifier: NCT00842049.

Computer Decision Support Software Safely Improves Glycemic Control in the Burn Intensive Care Unit: A Randomized Controlled Clinical Study

DTIC Science & Technology

2011-01-01

Program Jointly Managed by the USA MRMC, NIH, NASA, and the Juvenile Diabetes Research Foundation and Combat Casualty Care Division, United States Army...were performed in the CP group (p = 0.0003), and nursing staff compliance with CP recommendations was greater (p < 0.0001). Conclusions—Glycemic...enhanced consistency in practice, providing standardization among nursing staff. Keywords Glycemic control; hypoglycemia; computer decision support

Dimensions of dependence and their influence on the outcome of cognitive behaviour therapy for health anxiety: randomized controlled trial.

PubMed

Tyrer, Peter; Wang, Duolao; Tyrer, Helen; Crawford, Mike; Cooper, Sylvia

2016-05-01

The personality trait of dependence is common in health-seeking behaviour. We therefore examined its impact in a large randomized controlled trial of psychological treatment for health anxiety. To test whether dependent personality traits were positive or negative in determining the outcome of an adapted form of cognitive behaviour therapy for health anxiety (CBT-HA) over the course of 5 years and whether dependent personality dysfunction could be viewed dimensionally in a similar way to the new ICD-11 diagnostic system for general personality disorder. Dependent personality dysfunction was assessed using a self-rated questionnaire, the Dependent Personality Questionnaire, at baseline in a randomized controlled trial of 444 patients from medical clinics with pathological health anxiety treated with a modified form of CBT-HA or standard treatment in the medical clinics, with assessment on five occasions over 5 years. Dependent personality dysfunction was assessed using four severity groups. Patients with mild and moderate dependent personality disorder treated with CBT-HA showed the greatest reduction in health anxiety compared with standard care, and those with no dependent dysfunction showed the least benefit. Patients with higher dependent traits received significantly more treatment sessions (8.6) than those with low trait levels (5.4) (p < 0.01). The results suggest that patients treated with cognitive behaviour therapy for health anxiety respond better if they have moderate dependent personality. The reasons for this may be related to better adherence to psychological treatment and greater negative effects of frequent reassurance and excessive consultation in those treated in standard care. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Cognitive-behavioral treatment with behavioral activation for smokers with depressive symptomatology: study protocol of a randomized controlled trial.

PubMed

Becoña, Elisardo; Martínez-Vispo, Carmela; Senra, Carmen; López-Durán, Ana; Rodríguez-Cano, Rubén; Fernández Del Río, Elena

2017-04-08

Smoking is an important risk factor for mental health-related problems. Numerous studies have supported a bi-directional association between cigarette smoking and depression. Despite the advances in understanding the comorbidity between both problems, the most effective psychological treatment that simultaneously targets smoking and depressive symptomatology remains unclear. The objective of this study is to assess the effectiveness of a cognitive-behavioral intervention for smoking cessation with components of behavioral activation for managing depressed mood. A single blind, three-arm, superiority randomized controlled trial is proposed. Participants will be smokers over 18 years old, who smoke at least 8 cigarettes per day. Participants will be randomized to one of three conditions, using a 2:2:1 allocation ratio: 1) standard cognitive-behavioral smoking cessation treatment; 2) standard cognitive-behavioral smoking cessation treatment plus behavioral activation; or 3) a three-month delayed treatment control group. The primary outcome measures will be biochemically verified point-prevalence abstinence (carbon monoxide in expired air) and significant change from baseline in depressive symptoms to the end of treatment, and at the 3-, 6-, and 12-month follow-up. This study aims to assess the efficacy of a cognitive-behavioral intervention with behavioral activation components for smoking cessation and depressive symptoms, compared to a standard cognitive-behavioral intervention to quit smoking. As the relation between depressive symptoms, even at subclinical levels, and quitting smoking difficulties is well known, we expect that such intervention will allow obtaining higher abstinence rates, lower relapse rates, and mood improvement. ClinicalTrials.gov : NCT02844595 . Retrospectively registered 19th July, 2016. The study started in January 2016, and the recruitment is ongoing.

Comparison of the Effect of Sensory-Level and Conventional Motor-Level Neuromuscular Electrical Stimulations on Quadriceps Strength After Total Knee Arthroplasty: A Prospective Randomized Single-Blind Trial.

PubMed

Yoshida, Yosuke; Ikuno, Koki; Shomoto, Koji

2017-12-01

To compare sensory-level neuromuscular electrical stimulation (NMES) and conventional motor-level NMES in patients after total knee arthroplasty. Prospective randomized single-blind trial. Hospital total arthroplasty center: inpatients. Patients with osteoarthritis (N=66; mean age, 73.5±6.3y; 85% women) were randomized to receive either sensory-level NMES applied to the quadriceps (the sensory-level NMES group), motor-level NMES (the motor-level NMES group), or no stimulation (the control group) in addition to a standard rehabilitation program. Each type of NMES was applied in 45-minute sessions, 5d/wk, for 2 weeks. Data for the quadriceps maximum voluntary isometric contraction, the leg skeletal muscle mass determined using multiple-frequency bioelectrical impedance analysis, the timed Up and Go test, the 2-minute walk test, the visual analog scale, and the range of motion of the knee were measured preoperatively and at 2 and 4 weeks after total knee arthroplasty. The motor-level NMES (P=.001) and sensory-level NMES (P=.028) groups achieved better maximum voluntary isometric contraction results than did the control group. The motor-level NMES (P=.003) and sensory-level NMES (P=.046) groups achieved better 2-minute walk test results than did the control group. Some patients in the motor-level NMES group dropped out of the experiment because of discomfort. Motor-level NMES significantly improved muscle strength and functional performance more than did the standard program alone. Motor-level NMES was uncomfortable for some patients. Sensory-level NMES was comfortable and improved muscle strength and functional performance more than did the standard program alone. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Effectiveness of Disease-Specific Cognitive Behavioral Therapy on Anxiety, Depression, and Quality of Life in Youth With Inflammatory Bowel Disease: A Randomized Controlled Trial.

PubMed

Stapersma, Luuk; van den Brink, Gertrude; van der Ende, Jan; Szigethy, Eva M; Beukers, Ruud; Korpershoek, Thea A; Theuns-Valks, Sabine D M; Hillegers, Manon H J; Escher, Johanna C; Utens, Elisabeth M W J

2018-05-29

To evaluate the effectiveness of a disease-specific cognitive behavioral therapy (CBT) protocol on anxiety and depressive symptoms and health-related quality of life (HRQOL) in adolescents and young adults with inflammatory bowel disease (IBD). A parallel group randomized controlled trial was conducted in 6 centers of (pediatric) gastroenterology. Included were 70 patients and young adults (10-25 years) with IBD and subclinical anxiety and/or depressive symptoms. Patients were randomized into 2 groups, stratified by center: (a) standard medical care (care-as-usual [CAU]) plus disease-specific manualized CBT (Primary and Secondary Control Enhancement Training for Physical Illness; PASCET-PI), with 10 weekly sessions, 3 parent sessions, and 3 booster sessions (n = 37), or (b) CAU only (n = 33). Primary analysis concerned the reliable change in anxiety and depressive symptoms after 3 months (immediate posttreatment assessment). Exploratory analyses concerned (1) the course of anxiety and depressive symptoms and HRQOL in subgroups based on age, and (2) the influence of age, gender, and disease type on the effect of the PASCET-PI. Overall, all participants improved significantly in their anxiety and depressive symptoms and HRQOL, regardless of group, age, gender, and disease type. Primary chi-square tests and exploratory linear mixed models showed no difference in outcomes between the PASCET-PI (n = 35) and the CAU group (n = 33). In youth with IBD and subclinical anxiety and/or depressive symptoms, preliminary results of immediate post-treatment assessment indicated that a disease-specific CBT added to standard medical care did not perform better than standard medical care in improving psychological symptoms or HRQOL. ClinicalTrials.gov: NCT02265588.

Use of a reduced-carbohydrate, modified-fat enteral formula for improving metabolic control and clinical outcomes in long-term care residents with type 2 diabetes: results of a pilot trial.

PubMed

Craig, L D; Nicholson, S; SilVerstone, F A; Kennedy, R D

1998-06-01

Physiologic responses of 30 enterally-fed long-term care residents with type 2 diabetes receiving total nutrition support via either a disease-specific (reduced-carbohydrate, modified-fat) formula or a standard high-carbohydrate formula for 3 mo were compared. Objectives of the study included evaluating metabolic response (glycemic control and lipids) and clinical outcomes. Thirty-four subjects requiring total enteral nutrition support by tube were enrolled in this prospectively randomized, double-blind, controlled, parallel group 3-mo pilot trial. Thirty were evaluable in that they completed 4 wk. Twenty-seven completed all 12 wk. The groups were well-matched for physiologic and demographic parameters at baseline. Fasting serum glucose and capillary (fingerstick) glucose values demonstrated better control in the disease-specific formula-fed group. Serum lipid profiles of this group were similar to or better than those of the standard formula-fed group. The amount of insulin administered to insulin-using subjects in the disease-specific formula-fed group was consistently less than before initiation of the formula, whereas the amount administered was consistently higher in the group fed the standard formula. Overall, subjects randomized to the disease-specific formula experienced better numerical biochemical control and better clinical outcomes when expressed on a numerical and percentage basis. These included surrogate markers of diabetes control such as serum glucose and glycohemoglobin, as well as clinical outcomes such as incidence of infections and pressure ulcers. These findings confirm that the disease-specific formula provides better glycemic control, poses no risk to lipoprotein metabolism, and provides for better clinical outcomes.

The Consolidated Standards of Reporting Trials (CONSORT) Statement applied to allergen-specific immunotherapy with inhalant allergens: a Global Allergy and Asthma European Network (GA(2)LEN) article.

PubMed

Bousquet, Philippe J; Calderón, Moisés A; Demoly, Pascal; Larenas, Désirée; Passalacqua, Giovanni; Bachert, Claus; Brozek, Jan; Canonica, G Walter; Casale, Thomas; Fonseca, Joao; Dahl, Ronald; Durham, Stephen R; Merk, Hans; Worm, Margitta; Wahn, Ulrich; Zuberbier, Torsten; Schünemann, Holger J; Bousquet, Jean

2011-01-01

Randomized trials provide evidence to inform treatment decisions. The Consolidated Standards of Reporting Trials (CONSORT) Statement is a set of recommendations for the reporting of trials. We sought to assess the quality of reporting allergen-specific immunotherapy trials according to CONSORT criteria. The reporting of the procedure, randomization, dropouts, strict conduct of intention-to-treat (ITT) analysis, and sample size calculation according to CONSORT were assessed in the 46 subcutaneous and 48 sublingual immunotherapy (SLIT) blind, placebo-controlled randomized trials published between 1996 and 2009 in English. One subcutaneous immunotherapy (2.2%) and 3 SLIT (6.6%) trials met CONSORT Statement criteria. These were used for the registration of sublingual tablets to the European Medicines Agency. In subcutaneous immunotherapy, 16 (35%) studies reported a CONSORT flow chart, and 12 (26%) provided a description of dropouts. Adequate randomization was reported in 9 (35%) studies, and incomplete randomization was reported in 15 (33%). Power analysis was reported in 15 (33%) studies. In SLIT, 20 (42%) studies reported a CONSORT flow chart, and 16 (32%) a description of dropouts. ITT analysis was carried out in 1 (2.2%) SLIT study, and a modified ITT analysis was used in 1 (2.2%) subcutaneous immunotherapy study and 2 (4.4%) SLIT studies. Adequate randomization was reported in 6 (12%) studies, and incomplete randomization was reported in 16 (32%). Power analysis was reported in 15 (27%) studies. As in other areas of medicine, the quality of reporting of most immunotherapy trials is low, and only 4.2% of SLIT randomized controlled trials met all of the criteria of the CONSORT Statement. Use of the CONSORT criteria should be encouraged. Copyright © 2010 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

Randomized controlled clinical trial evaluating multiplex polymerase chain reaction for pathogen identification and therapy adaptation in critical care patients with pulmonary or abdominal sepsis.

PubMed

Tafelski, Sascha; Nachtigall, Irit; Adam, Thomas; Bereswill, Stefan; Faust, Jana; Tamarkin, Andrey; Trefzer, Tanja; Deja, Maria; Idelevich, Evgeny A; Wernecke, Klaus-Dieter; Becker, Karsten; Spies, Claudia

2015-06-01

To determine whether a multiplex polymerase chain reaction (PCR)-based test could reduce the time required for initial pathogen identification in patients in an intensive care unit (ICU) setting. This double-blind, parallel-group randomized controlled trial** enrolled adults with suspected pulmonary or abdominal sepsis caused by an unknown pathogen. Both the intervention and control groups underwent the standard blood culture (BC) testing, but additional pathogen identification, based on the results of a LightCycler® SeptiFast PCR test, were provided in the intervention group. The study enrolled 37 patients in the control group and 41 in the intervention group. Baseline clinical and demographic characteristics were similar in both groups. The PCR-based test identified a pathogen in 10 out of 41 (24.4%) patients in the intervention group, with a mean duration from sampling to providing the information to the ICU of 15.9 h. In the control group, BC results were available after a significantly longer period (38.1 h). The LightCycler® SeptiFast PCR test demonstrated a significant reduction in the time required for initial pathogen identification, compared with standard BC. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Different effect of psyllium and guar dietary supplementation on blood pressure control in hypertensive overweight patients: a six-month, randomized clinical trial.

PubMed

Cicero, Arrigo F G; Derosa, Giuseppe; Manca, Marco; Bove, Marilisa; Borghi, Claudio; Gaddi, Antonio V

2007-08-01

In the setting of a six-month, open-label clinical trial, 141 consecutively enrolled, hypertensive, overweight patients were randomized to the oral ingestion of psyllium powder or guar gum 3.5 gr t.i.d., to be taken 20 min before the main two meals, or to standard diet. Both fibers improved significantly BMI, FPG, FPI, HOMA Index, HbA1c, LDL-C, and ApoB. Psyllium supplementation only exerted a significant improvement in plasma TG concentration, in SBP and DBP. In our study, six-month supplementation with psyllium fiber, but not with guar fiber nor standard diet, appears to significantly reduce both SBP and DBP in hypertensive overweight subjects.

Effects of tai chi qigong on psychosocial well-being among hidden elderly, using elderly neighborhood volunteer approach: a pilot randomized controlled trial.

PubMed

Chan, Aileen Wk; Yu, Doris Sf; Choi, K C

2017-01-01

To test the feasibility and preliminary effectiveness of a tai chi qigong program with the assistance of elderly neighborhood volunteers in strengthening social networks and enhancing the psychosocial well-being of hidden elderly. "Hidden elderly" is a term used to describe older adults who are socially isolated and refuse social participation. This pilot randomized controlled trial recruited 48 older adults aged 60 or above who did not engage in any social activity. They were randomized into tai chi qigong (n=24) and standard care control (n=24) groups. The former group underwent a three-month program of two 60-minute sessions each week, with the socially active volunteers paired up with them during practice. Standard care included regular home visits by social workers. Primary outcomes were assessed by means of the Lubben social network and De Jong Gieveld loneliness scales, and by a revised social support questionnaire. Secondary outcomes were covered by a mental health inventory and the Rosenberg self-esteem scale, and quality of life by using the 12-Item Short Form Health Survey. Data was collected at baseline, and at three and six months thereafter. The generalized estimating equations model revealed general improvement in outcomes among participants on the tai chi qigong program. In particular, participants reported a significantly greater improvement on the loneliness scale ( B =-1.32, 95% confidence interval [CI] -2.54 to -0.11, P =0.033) and the satisfaction component of the social support questionnaire ( B =3.43, 95% CI 0.10-6.76, P =0.044) than the control group. The pilot study confirmed that tai chi qigong with elderly neighborhood volunteers is a safe and feasible social intervention for hidden elderly. Its potential benefits in improving social and psychological health suggest the need for a full-scale randomized controlled trial to reveal its empirical effects.

A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices.

PubMed

Lüthje, Lars; Vollmann, Dirk; Seegers, Joachim; Sohns, Christian; Hasenfuß, Gerd; Zabel, Markus

2015-08-01

Only limited comparative data exist on the benefits of fluid monitoring (FM) combined with remote monitoring (RM) regarding morbidity and mortality of heart failure (HF) patients. This prospective single-centre randomized pilot study aimed to estimate the influence of RM in combination with FM on HF hospitalizations as well as ventricular tachyarrhythmias and mortality. Patients with standard indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy and defibrillator were implanted with devices capable of RM and FM, and were followed for 15 months. Subjects were randomly allocated to RM including OptiVol and predefined management of alerts (remote group), or standard in-office visits every 3 months (control group). A total of 176 patients (77% male; 66 ± 12 years; left ventricular ejection fraction (LVEF) 32 ± 11%; ischemic cardiomyopathy 50%; CRT device 50%; primary prevention 85%) were analysed. Cox proportional hazard analysis on the time to first HF-related hospitalization showed a hazard ratio of 1.23 [0.62-2.44] (P = 0.551) favouring the control group. In the remote group, 13 patients (15%) experienced ICD shocks vs. 10 patients (11%) in the control group (P = 0.512). The average time to first ICD shock was 212 ± 173 days in the remote arm and 212 ± 143 days in the control arm (P = 0.994). The Kaplan-Meier estimate of mortality after 1 year was 8.6% (eight deaths) in the remote group vs. 4.6% in the control group (six deaths; P = 0.502). In a single-centre randomized pilot study of RM in combination with FM, no significant influence on HF-related hospitalizations, ICD shocks, or mortality was found. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Effects of Adding an Internet-Based Pain Coping Skills Training Protocol to a Standardized Education and Exercise Program for People With Persistent Hip Pain (HOPE Trial): Randomized Controlled Trial Protocol

PubMed Central

Rini, Christine; Keefe, Francis; French, Simon; Nelligan, Rachel; Kasza, Jessica; Forbes, Andrew; Dobson, Fiona; Haxby Abbott, J.; Dalwood, Andrew; Vicenzino, Bill; Harris, Anthony; Hinman, Rana S.

2015-01-01

Background Persistent hip pain in older people is usually due to hip osteoarthritis (OA), a major cause of pain, disability, and psychological dysfunction. Objective The purpose of this study is to evaluate whether adding an Internet-based pain coping skills training (PCST) protocol to a standardized intervention of education followed by physical therapist–instructed home exercise leads to greater reductions in pain and improvements in function. Design An assessor-, therapist-, and participant-blinded randomized controlled trial will be conducted. Setting The study will be conducted in a community setting. Participants The participants will be 142 people over 50 years of age with self-reported hip pain consistent with hip OA. Intervention Participants will be randomly allocated to: (1) a control group receiving a 24-week standardized intervention comprising an 8-week Internet-based education package followed by 5 individual physical therapy exercise sessions plus home exercises (3 times weekly) or (2) a PCST group receiving an 8-week Internet-based PCST protocol in addition to the control intervention. Measurements Outcomes will be measured at baseline and 8, 24, and 52 weeks, with the primary time point at 24 weeks. Primary outcomes are hip pain on walking and self-reported physical function. Secondary outcomes include health-related quality-of-life, participant-perceived treatment response, self-efficacy for pain management and function, pain coping attempts, pain catastrophizing, and physical activity. Measurements of adherence, adverse events, use of health services, and process measures will be collected at 24 and 52 weeks. Cost-effectiveness will be assessed at 52 weeks. Limitations A self-reported diagnosis of persistent hip pain will be used. Conclusions The findings will help determine whether adding an Internet-based PCST protocol to standardized education and physical therapist–instructed home exercise is more effective than education and exercise alone for persistent hip pain. This study has the potential to guide clinical practice toward innovative modes of psychosocial health care provision. PMID:26023213

Effects of Adding an Internet-Based Pain Coping Skills Training Protocol to a Standardized Education and Exercise Program for People With Persistent Hip Pain (HOPE Trial): Randomized Controlled Trial Protocol.

PubMed

Bennell, Kim L; Rini, Christine; Keefe, Francis; French, Simon; Nelligan, Rachel; Kasza, Jessica; Forbes, Andrew; Dobson, Fiona; Abbott, J Haxby; Dalwood, Andrew; Vicenzino, Bill; Harris, Anthony; Hinman, Rana S

2015-10-01

Persistent hip pain in older people is usually due to hip osteoarthritis (OA), a major cause of pain, disability, and psychological dysfunction. The purpose of this study is to evaluate whether adding an Internet-based pain coping skills training (PCST) protocol to a standardized intervention of education followed by physical therapist-instructed home exercise leads to greater reductions in pain and improvements in function. An assessor-, therapist-, and participant-blinded randomized controlled trial will be conducted. The study will be conducted in a community setting. The participants will be 142 people over 50 years of age with self-reported hip pain consistent with hip OA. Participants will be randomly allocated to: (1) a control group receiving a 24-week standardized intervention comprising an 8-week Internet-based education package followed by 5 individual physical therapy exercise sessions plus home exercises (3 times weekly) or (2) a PCST group receiving an 8-week Internet-based PCST protocol in addition to the control intervention. Outcomes will be measured at baseline and 8, 24, and 52 weeks, with the primary time point at 24 weeks. Primary outcomes are hip pain on walking and self-reported physical function. Secondary outcomes include health-related quality-of-life, participant-perceived treatment response, self-efficacy for pain management and function, pain coping attempts, pain catastrophizing, and physical activity. Measurements of adherence, adverse events, use of health services, and process measures will be collected at 24 and 52 weeks. Cost-effectiveness will be assessed at 52 weeks. A self-reported diagnosis of persistent hip pain will be used. The findings will help determine whether adding an Internet-based PCST protocol to standardized education and physical therapist-instructed home exercise is more effective than education and exercise alone for persistent hip pain. This study has the potential to guide clinical practice toward innovative modes of psychosocial health care provision. © 2015 American Physical Therapy Association.

Randomized Controlled Trial Evaluating a Standardized Strategy for Uveitis Etiologic Diagnosis (ULISSE).

PubMed

de Parisot, Audrey; Kodjikian, Laurent; Errera, Marie-Hélène; Sedira, Neila; Heron, Emmanuel; Pérard, Laurent; Cornut, Pierre-Loïc; Schneider, Christelle; Rivière, Sophie; Ollé, Priscille; Pugnet, Grégory; Cathébras, Pascal; Manoli, Pierre; Bodaghi, Bahram; Saadoun, David; Baillif, Stéphanie; Tieulie, Nathalie; Andre, Marc; Chiambaretta, Frédéric; Bonin, Nicolas; Bielefeld, Philip; Bron, Alain; Mouriaux, Frédéric; Bienvenu, Boris; Vicente, Stéphanie; Bin, Sylvie; Broussolle, Christiane; Decullier, Evelyne; Sève, Pascal

2017-06-01

To prospectively assess the efficiency of a standardized diagnostic approach, compared to an open strategy, for the etiologic diagnosis of uveitis. Noninferiority, prospective, multicenter, clustered randomized controlled trial. Consecutive patients with uveitis, who visited 1 of the participating departments of ophthalmology, were included. In the standardized group, all patients had a minimal evaluation regardless of the type of uveitis (complete blood count, erythrocyte sedimentation rate, C-reactive protein, tuberculin skin test, syphilis serology, and chest radiograph) followed by more complex investigations according to ophthalmologic findings. In the open group, the ophthalmologist could order any type of investigation. Main outcome was the percentage of etiologic diagnoses at 6 months. Nine hundred and three patients with uveitis were included from January 2010 to May 2013 and the per-protocol population comprised 676 patients (open 373; standardized 303). Mean age at diagnosis was 46 years. Anatomic distribution of uveitis was as follows: anterior (60.8% and 72.3%, P = .0017), intermediate (11.7% and 12.3%, P = .8028), posterior (17.8% and 8.2%, P = .0004), and panuveitis (15.3% and 15.2%, P = .9596). An etiologic diagnosis was established in 54.4% of cases in the open group and 49.5% in the standardized group (P = .2029). The difference between both strategies (standardized minus open) was -4.9% (95% CI [-12.5%; 2.6%]). There were more investigations in the open group than in the standardized group (5371 vs 3759, P < .0001). The standardized strategy appears to be an efficient diagnostic approach for the etiologic diagnosis of uveitis, although its noninferiority cannot be proved. Copyright © 2017 Elsevier Inc. All rights reserved.

Reporting Quality Assessment of Randomized Controlled Trials Published in Nephrology Urology Monthly Journal.

PubMed

Mehrazmay, Alireza; Karambakhsh, Alireza; Salesi, Mahmood

2015-07-01

Randomized controlled trials (RCTs) are important tools for evidence-based health care decisions. It is, therefore, important that they be conducted and reported with the highest possible standards. The aim of this study was to evaluate the reporting quality of the RCTs published in nephrology urology monthly journal and to examine whether there was a change over time in the reporting quality. The quality of each report was assessed using the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement checklist and a 5-point quality assessment instrument, i.e. the Jadad scale. Eighteen (14 Iranian and 4 non-Iranian) RCTs were published from 2012 to 2014 on topics including renal stone (16.6%), hemodialysis and transplantation (38.8%), and prostate conditions (11.1%). Interventions comprised surgery, drugs, and teaching method in 7 (38 %), 10 (55%), and 1 (5%) of them, respectively. According to the CONSORT checklist, the weakest reported items were registration number, identification as a randomized trial in the title, and settings and locations where the data were collected. The mean Jadad score of the reports was 2.72 ± 1.36 (54% of their maximum possible total score). According to the Jadad and CONSORT scales, there was an increase in the quality of reporting from 2012 to 2014. This assessment shows low reporting quality scores in reports. Training courses for researchers, using standard reporting tools (e.g. CONSORT 2010 Statement checklist), and consultation with methodologists can improve the quality of published RCTs.

Two new mini-slings compared with transobturator tension-free vaginal tape for treatment of stress urinary incontinence: A 1-year follow-up randomized controlled trial.

PubMed

Gaber, Mohamed E; Borg, Tamer; Samour, Hazem; Nawara, Mai; Reda, Ahmed

2016-12-01

The aim of this study was to compare the outcome of two single-incision mini-slings (the Contasure-Needleless [C-NDL] and the endopelvic free anchorage) with the standard midurethral transobturator tension-free vaginal tape (TVT-O) procedure. A double blind randomized controlled study was conducted at Ain Shams University Maternity Hospital from August 2014 until July 2015. A total of 209 patients were randomized into three groups. The first group underwent the TVT-O procedure, the second group underwent the endopelvic free anchorage procedure and the third group underwent the C-NDL procedure. Patients were followed up for 12 months in terms of subjective cure, objective cure, and complications rate. After 12 months of follow-up, there were no differences among the three groups in terms of objective cure rate, subjective cure rate, patient satisfaction, or incidence of complications (de novo urge, hemorrhage, infection, and mesh erosion). The C-NDL was associated with a shorter operative time (P < 0.001) and less blood loss (P = 0.021) than the standard TVT-O. The new single-incision mini-slings showed similar efficacy and patient acceptance to that of the standard TVT-O for up to 12 months postoperatively with no difference in the complications rate. The C-NDL is associated with shorter operative time and less blood loss. © 2016 Japan Society of Obstetrics and Gynecology.

Standard versus prosocial online support groups for distressed breast cancer survivors: a randomized controlled trial.

PubMed

Lepore, Stephen J; Buzaglo, Joanne S; Lieberman, Morton A; Golant, Mitch; Davey, Adam

2011-08-25

The Internet can increase access to psychosocial care for breast cancer survivors through online support groups. This study will test a novel prosocial online group that emphasizes both opportunities for getting and giving help. Based on the helper therapy principle, it is hypothesized that the addition of structured helping opportunities and coaching on how to help others online will increase the psychological benefits of a standard online group. A two-armed randomized controlled trial with pretest and posttest. Non-metastatic breast cancer survivors with elevated psychological distress will be randomized to either a standard facilitated online group or to a prosocial facilitated online group, which combines online exchanges of support with structured helping opportunities (blogging, breast cancer outreach) and coaching on how best to give support to others. Validated and reliable measures will be administered to women approximately one month before and after the interventions. Self-esteem, positive affect, and sense of belonging will be tested as potential mediators of the primary outcomes of depressive/anxious symptoms and sense of purpose in life. This study will test an innovative approach to maximizing the psychological benefits of cancer online support groups. The theory-based prosocial online support group intervention model is sustainable, because it can be implemented by private non-profit or other organizations, such as cancer centers, which mostly offer face-to-face support groups with limited patient reach. ClinicalTrials.gov: NCT01396174.

Design of the multicenter standardized supervised exercise training intervention for the claudication: exercise vs endoluminal revascularization (CLEVER) study.

PubMed

Bronas, Ulf G; Hirsch, Alan T; Murphy, Timothy; Badenhop, Dalynn; Collins, Tracie C; Ehrman, Jonathan K; Ershow, Abby G; Lewis, Beth; Treat-Jacobson, Diane J; Walsh, M Eileen; Oldenburg, Niki; Regensteiner, Judith G

2009-11-01

The CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study is the first randomized, controlled, clinical, multicenter trial that is evaluating a supervised exercise program compared with revascularization procedures to treat claudication. In this report, the methods and dissemination techniques of the supervised exercise training intervention are described. A total of 217 participants are being recruited and randomized to one of three arms: (1) optimal medical care; (2) aortoiliac revascularization with stent; or (3) supervised exercise training. Of the enrolled patients, 84 will receive supervised exercise therapy. Supervised exercise will be administered according to a protocol designed by a central CLEVER exercise training committee based on validated methods previously used in single center randomized control trials. The protocol will be implemented at each site by an exercise committee member using training methods developed and standardized by the exercise training committee. The exercise training committee reviews progress and compliance with the protocol of each participant weekly. In conclusion, a multicenter approach to disseminate the supervised exercise training technique and to evaluate its efficacy, safety and cost-effectiveness for patients with claudication due to peripheral arterial disease (PAD) is being evaluated for the first time in CLEVER. The CLEVER study will further establish the role of supervised exercise training in the treatment of claudication resulting from PAD and provide standardized methods for use of supervised exercise training in future PAD clinical trials as well as in clinical practice.

Lidcombe Program Webcam Treatment for Early Stuttering: A Randomized Controlled Trial.

PubMed

Bridgman, Kate; Onslow, Mark; O'Brian, Susan; Jones, Mark; Block, Susan

2016-10-01

Webcam treatment is potentially useful for health care in cases of early stuttering in which clients are isolated from specialized treatment services for geographic and other reasons. The purpose of the present trial was to compare outcomes of clinic and webcam deliveries of the Lidcombe Program treatment (Packman et al., 2015) for early stuttering. The design was a parallel, open plan, noninferiority randomized controlled trial of the standard Lidcombe Program treatment and the experimental webcam Lidcombe Program treatment. Participants were 49 children aged 3 years 0 months to 5 years 11 months at the start of treatment. Primary outcomes were the percentage of syllables stuttered at 9 months postrandomization and the number of consultations to complete Stage 1 of the Lidcombe Program. There was insufficient evidence of a posttreatment difference of the percentage of syllables stuttered between the standard and webcam Lidcombe Program treatments. There was insufficient evidence of a difference between the groups for typical stuttering severity measured by parents or the reported clinical relationship with the treating speech-language pathologist. This trial confirmed the viability of the webcam Lidcombe Program intervention. It appears to be as efficacious and economically viable as the standard, clinic Lidcombe Program treatment.

Texting atopic dermatitis patients to optimize learning and eczema area and severity index scores: A pilot randomized control trial.

PubMed

Singer, Hannah M; Levin, Laura E; Morel, Kimberly D; Garzon, Maria C; Stockwell, Melissa S; Lauren, Christine T

2018-05-02

Atopic dermatitis is a common, chronic, debilitating disease. Poor adherence to treatment is the most important preventable contributor to adverse outcomes. Thus, improving adherence can improve patient outcomes. Text message reminders with embedded condition-specific information have been shown to improve pediatric immunization adherence but have not been assessed in atopic dermatitis. The objective was to assess the effect of daily text messages on Eczema Area Severity Index scores and caregiver knowledge of atopic dermatitis. In this pilot randomized controlled trial, caregivers of children with atopic dermatitis enrolled during their initial appointment with a pediatric dermatologist and randomized 1:1 to standard care or daily text messages with patient education material and treatment reminders. Participants completed a multiple-choice atopic dermatitis knowledge quiz at initial and follow-up visits, and Eczema Area Severity Index scores were assessed. Forty-two patients enrolled, and 30 completed the study: 16 standard care group, 14 text message group. There was no significant difference in Eczema Area Severity Index score between the standard care and text message groups at follow-up, with mean decreases in Eczema Area Severity Index score of 53% and 58%, respectively. Mean score on follow-up atopic dermatitis knowledge quiz was significantly higher in the text message group (84% correct) than in the standard care group (75% correct) (P = .04). This pilot study did not demonstrate a difference in Eczema Area Severity Index scores with text message reminders. The significantly higher follow-up atopic dermatitis quiz score in the text message group indicates that participants read and retained information from text messages. Limitations include small sample size and short duration of follow-up. © 2018 Wiley Periodicals, Inc.

Paraspinous Lidocaine Injection for Chronic Nonspecific Low Back Pain: A Randomized Controlled Clinical Trial.

PubMed

Imamura, Marta; Imamura, Satiko Tomikawa; Targino, Rosa Alves; Morales-Quezada, León; Onoda Tomikawa, Luis C; Onoda Tomikawa, Luis G; Alfieri, Fabio M; Filippo, Thais R; da Rocha, Ivan D; Neto, Raul Bolliger; Fregni, Felipe; Battistella, Linamara Rizzo

2016-05-01

In this large, sham-controlled, randomized trial, we examined the efficacy of the combination of standard treatment and paraspinous lidocaine injection compared with standard therapy alone in subjects with chronic low back pain. There is little research-based evidence for the routine clinical use of paraspinous lidocaine injection for low back pain. A total of 378 subjects with nonspecific chronic low back pain were randomized to 3 groups: paraspinous lidocaine injection, analgesics, and exercises (group 1, LID-INJ); sham paraspinous lidocaine injection, analgesics, and exercises (group 2, SH-INJ); and analgesics and exercises (group 3, STD-TTR). A blinded rater assessed the study outcomes at 3 time points: baseline, after treatment, and after 3 months of follow-up. There were increased frequency of pain responses and better low back functional scores in the LID-INJ group compared with the SH-INJ and STD-TTR groups. These effects remained at the 3-month follow-up but differed between all 3 groups. There were significant changes in pain threshold immediately after treatment, supporting the effects of this intervention in reducing central sensitization. Paraspinous lidocaine injection therapy is not associated with a higher risk of adverse effects compared with conventional treatment and sham injection. Its effects on hyperalgesia might correlate with changes in central sensitization. NCT02387567. There are few data to support paraspinous lidocaine injection use in patients with nonspecific chronic low back pain. Our results show that this therapy when combined with standard therapy significantly increases the number of responders versus standard treatment alone. Its effects on hyperalgesia might correlate with a change in central sensitization. Copyright © 2016. Published by Elsevier Inc.

An Open-Label, Analgesic Efficacy and Safety of Pituitary Radiosurgery for Patients With Opioid-Refractory Pain: Study Protocol for a Randomized Controlled Trial.

PubMed

Borius, Pierre-Yves; Garnier, Stéphanie Ranque; Baumstarck, Karine; Castinetti, Frédéric; Donnet, Anne; Guedj, Eric; Cornu, Philippe; Blond, Serge; Salas, Sébastien; Régis, Jean

2017-08-02

Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life. Copyright © 2017 by the Congress of Neurological Surgeons

Effectiveness of adjunct psychotherapy for cancer treatment: a review.

PubMed

Chen, YokeYong; Ahmad, Mahadir

2018-05-16

Psychotherapies were offered to alleviate psychological and physical symptoms; however, most psychological interventions were only delivered after cancer treatment. Newly diagnosed cancer patients experienced psychological distress while waiting for treatments. This review paper focused on randomized control trial studies, aimed to investigate the effectiveness of psychological intervention among newly diagnosed cancer patients. Eight randomized control trial papers were found in recent 10 years period through electronic database. A moderate to large effect size was detected on the outcomes, ranging from 0.43 to 0.89. This indicated that psychological-based prehabilitation with standard care yielded better outcomes than standard care alone. Psychological-based prehabilitation provides evidence in its effectiveness to reduce psychological distress, functional impairment, recurrence of cancer, numbers of immune reactivity and sleeping quality; however, inconsistent with longer survival result among cancer patients. In conclusion, psychological-based prehabilitation before cancer treatment is necessary for better treatment outcome, and future research is needed to investigate more directly the outcome.

Subthreshold diode laser micropulse photocoagulation for the treatment of diabetic macular edema.

PubMed

Sivaprasad, Sobha; Dorin, Giorgio

2012-03-01

Diabetic macular edema (DME) is a sight-threatening complication of diabetic retinopathy, the leading cause of visual loss in the working-age population in the industrialized and emerging world. The standard of care for DME is focal/grid laser photocoagulation, which is proven effective in reducing the risk of vision loss, but inherently destructive and associated with tissue damage and collateral effects. Subthreshold diode laser micropulse photocoagulation is a nondestructive tissue-sparing laser procedure, which, in randomized controlled trials for the treatment of DME, has been found equally effective as conventional photocoagulation. Functional and anatomical outcomes from four independent randomized controlled trials provide level one evidence that vision stabilization/improvement and edema resolution/reduction can be elicited with less or no retinal damage, and with fewer or no complications. This review describes the principles of subthreshold diode laser micropulse photocoagulation, its treatment modalities and clinical outcomes in the context of standard laser treatments and of emerging nonlaser therapies for DME.

The Healing Effect of Low-Temperature Atmospheric-Pressure Plasma in Pressure Ulcer: A Randomized Controlled Trial.

PubMed

Chuangsuwanich, Apirag; Assadamongkol, Tananchai; Boonyawan, Dheerawan

2016-12-01

Pressure ulcers are difficult to treat. Recent reports of low-temperature atmospheric-pressure plasma (LTAPP) indicated its safe and effectiveness in chronic wound care management. It has been shown both in vitro and vivo studies that LTAPP not only helps facilitate wound healing but also has antimicrobial efficacy due to its composition of ion and electron, free radicals, and ultraviolet ray. We studied the beneficial effect of LTAPP specifically on pressure ulcers. In a prospective randomized study, 50 patients with pressure ulcers were divided into 2 groups: Control group received standard wound care and the study group was treated with LTAPP once every week for 8 consecutive weeks in addition to standard wound care. We found that the group treated with LTAPP had significantly better PUSH (Pressure Ulcer Scale for Healing) scores and exudate amount after 1 week of treatment. There was also a reduction in bacterial load after 1 treatment regardless of the species of bacteria identified.

Attention bias modification augments cognitive-behavioral group therapy for social anxiety disorder: a randomized controlled trial.

PubMed

Lazarov, Amit; Marom, Sofi; Yahalom, Naomi; Pine, Daniel S; Hermesh, Haggai; Bar-Haim, Yair

2017-12-20

Cognitive-behavioral group therapy (CBGT) is a first-line treatment for social anxiety disorder (SAD). However, since many patients remain symptomatic post-treatment, there is a need for augmenting procedures. This randomized controlled trial (RCT) examined the potential augmentation effect of attention bias modification (ABM) for CBGT. Fifty patients with SAD from three therapy groups were randomized to receive an 18-week standard CBGT with either ABM designed to shift attention away from threat (CBGT + ABM), or a placebo protocol not designed to modify threat-related attention (CBGT + placebo). Therapy groups took place in a large mental health center. Clinician and self-report measures of social anxiety and depression were acquired pre-treatment, post-treatment, and at 3-month follow-up. Attention bias was assessed at pre- and post-treatment. Patients randomized to the CBGT + ABM group, relative to those randomized to the CBGT + placebo group, showed greater reductions in clinician-rated SAD symptoms post-treatment, with effects maintained at 3-month follow-up. Group differences were not evident for self-report or attention-bias measures, with similar reductions in both groups. Finally, reduction in attention bias did not mediate the association between group and reduction in Liebowitz Social Anxiety Scale Structured Interview (LSAS) scores. This is the first RCT to examine the possible augmenting effect of ABM added to group-based cognitive-behavioral therapy for adult SAD. Training patients' attention away from threat might augment the treatment response to standard CBGT in SAD, a possibility that could be further evaluated in large-scale RCTs.

Evaluation of a reduced nicotine product standard: moderating effects of and impact on cannabis use*

PubMed Central

Pacek, Lauren R.; Vandrey, Ryan; Dermody, Sarah S.; Denlinger, Rachel L.; Lemieux, Andrine; Tidey, Jennifer W.; McClernon, F. Joseph; Bangdiwala, Ananta S.; Drobes, David J.; al'Absi, Mustafa; Strasser, Andrew A.; Koopmeiners, Joseph S.; Hatsukami, Dorothy K.; Donny, Eric C.

2016-01-01

Introduction The Family Smoking Prevention and Tobacco Control Act authorized the FDA to reduce the nicotine content in cigarettes. Research is needed to guide proposed regulations, including evaluation of consequences to public health. This study evaluated how a reduced nicotine product standard might be moderated by and impact cannabis use. Methods Secondary analysis of a controlled clinical trial examining the effects of nicotine content in cigarettes in adult daily smokers. Linear regression assessed whether baseline cannabis use moderated behavioral, subjective, or physiological effects of smoking very low nicotine content (VLNC) versus normal nicotine content (NNC) cigarettes. Repeated measures analysis of associations between nicotine condition and prevalence and frequency of cannabis use was completed using generalized estimating equations (GEE). Results Among cannabis users and non-users, smokers randomized to VLNC cigarettes reported lower nicotine dependence, cigarettes per day, biomarkers of nicotine exposure, and craving compared to smokers randomized to NNC cigarettes. Non-cannabis using smokers randomized to VLNC cigarettes also reported lower smoking dependence motives and had lower tobacco-specific nitrosamine exposure and total puff volume versus smokers randomized to NNC cigarettes. For cannabis users, smokers randomized to VLNC cigarettes reported decreased positive affect. Cannabis use did not moderate most effects of VLNC cigarettes. VLNC cigarette use did not impact the prevalence or frequency of cannabis use. Discussion Findings provide evidence that nicotine reduction in cigarettes could have beneficial effects on cigarette smoking regardless of cannabis use. Results suggest that transitioning to VLNC cigarettes is unlikely to alter current rates of cannabis use. PMID:27590743

Evaluation of a reduced nicotine product standard: Moderating effects of and impact on cannabis use.

PubMed

Pacek, Lauren R; Vandrey, Ryan; Dermody, Sarah S; Denlinger-Apte, Rachel L; Lemieux, Andrine; Tidey, Jennifer W; McClernon, F Joseph; Bangdiwala, Ananta S; Drobes, David J; al'Absi, Mustafa; Strasser, Andrew A; Koopmeiners, Joseph S; Hatsukami, Dorothy K; Donny, Eric C

2016-10-01

The Family Smoking Prevention and Tobacco Control Act authorized the FDA to reduce the nicotine content in cigarettes. Research is needed to guide proposed regulations, including evaluation of consequences to public health. This study evaluated how a reduced nicotine product standard might be moderated by and impact cannabis use. Secondary analysis of a controlled clinical trial examining the effects of nicotine content in cigarettes in adult daily smokers. Linear regression assessed whether baseline cannabis use moderated behavioral, subjective, or physiological effects of smoking very low nicotine content (VLNC) versus normal nicotine content (NNC) cigarettes. Repeated measures analysis of associations between nicotine condition and prevalence and frequency of cannabis use was completed using generalized estimating equations (GEE). Cannabis use did not moderate most of the following effects of VLNC cigarettes: Among cannabis users and non-users, smokers randomized to VLNC cigarettes reported lower nicotine dependence, cigarettes per day, biomarkers of nicotine exposure, and craving compared to smokers randomized to NNC cigarettes. Non-cannabis using smokers randomized to VLNC cigarettes also reported lower smoking dependence motives and had lower tobacco-specific nitrosamine exposure and total puff volume versus smokers randomized to NNC cigarettes. For cannabis users, smokers randomized to VLNC cigarettes reported decreased positive affect. VLNC cigarette use did not impact the prevalence or frequency of cannabis use. Findings provide evidence that nicotine reduction in cigarettes could have beneficial effects on cigarette smoking regardless of cannabis use. Results suggest that transitioning to VLNC cigarettes is unlikely to alter current rates of cannabis use. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Uncrackable code for nuclear weapons

ScienceCinema

Hart, Mark

2018-05-11

Mark Hart, a scientist and engineer in Lawrence Livermore National Laboratory's (LLNL) Defense Technologies Division, has developed a new approach for ensuring nuclear weapons and their components can't fall prey to unauthorized use. The beauty of his approach: Let the weapon protect itself. "Using the random process of nuclear radioactive decay is the gold standard of random number generators," said Mark Hart. "You’d have a better chance of winning both Mega Millions and Powerball on the same day than getting control of IUC-protected components."

Uncrackable code for nuclear weapons

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

Hart, Mark

Mark Hart, a scientist and engineer in Lawrence Livermore National Laboratory's (LLNL) Defense Technologies Division, has developed a new approach for ensuring nuclear weapons and their components can't fall prey to unauthorized use. The beauty of his approach: Let the weapon protect itself. "Using the random process of nuclear radioactive decay is the gold standard of random number generators," said Mark Hart. "You’d have a better chance of winning both Mega Millions and Powerball on the same day than getting control of IUC-protected components."

The Effect of Upper Limb Massage on Infants' Venipuncture Pain.

PubMed

Chik, Yuen-Man; Ip, Wan-Yim; Choi, Kai-Chow

2017-02-01

The purpose of the study was to investigate the effect of upper limb massage on relieving pain among infants undergoing venipuncture in Hong Kong. This study was a crossover, double-blind, randomized controlled trial. Eighty infants at the neonatal intensive care unit were randomly assigned to 2 groups in different order to receive interventions. The massage first group (N = 40) received 2-minute massage before venipuncture on the first occasion then received usual care (control) on the second occasion, and vice versa in the massage second group (N = 40). The infants' behavior and physiological responses were recorded on two occasions: (1) right after the intervention and (2) during the first 30 seconds of venipuncture procedure. The mean pain scores (Premature Infant Pain Profile) were significantly lower in infants who received massage (massage first: 6.0 [standard deviation = 3.3]; massage second: 7.30 [standard deviation = 4.4]) versus control (massage first: 12.0 [standard deviation = 4.3]; massage second: 12.7 [standard deviation = 3.1]). The crude and adjusted generalized estimating equations model showed that the infants had significantly lower pain score when receiving massage as compared to receiving the control treatment, and there were no significant time and carryover effects: -6.03 (95% confidence interval: -7.67 to -4.38), p < .001 and -5.96 (95% confidence interval: -7.56 to -4.36), p < .001, respectively. Upper limb massage may be effective in decreasing infants' venipuncture pain perception. Copyright © 2016 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Premedication with N-acetylcysteine and simethicone improves mucosal visualization during gastroscopy: a randomized, controlled, endoscopist-blinded study.

PubMed

Neale, James R; James, Shirley; Callaghan, James; Patel, Praful

2013-07-01

Diagnostic gastroscopy provides a unique opportunity to diagnose early oesophagogastric neoplasia; however, intraluminal mucus and bile can obscure mucosal visualization. The aim of this study was to determine whether the use of a premedication solution containing the mucolytic agent N-acetylcysteine and the surfactant simethicone improves mucosal visualization within a UK diagnostic gastroscopy service. A total of 75 consecutive patients were recruited from a single (S.J.) endoscopist's diagnostic gastroscopy list. They were randomized into three treatment groups: (a) standard control=clear fluids only for 6 h, nil by mouth for 2 h; (b) water control=standard control+100 ml sterile water (given 20 min before gastroscopy); and (c) solution=standard control+100 ml investigated solution (20 min before gastroscopy). The endoscopist was blinded to patient preparation. Inadequate mucosal visualization was defined as fluid/mucus during gastroscopy that could not be suctioned and required flushing with water. The volume of flush, the site at which it was used and the total procedure times were recorded. All three groups showed no statistical difference for age, sex ratio, procedure priority or indication. The mean volume of flush required to obtain clear mucosa was significantly less in the solution group compared with the other groups. The mean overall procedure time was also less in the solution group compared with the other groups. Premedication with N-acetylcysteine and simethicone markedly improves mucosal visibility during gastroscopy. It also reduces the time taken for the procedure. This low-cost and well-tolerated intervention may improve detection of early neoplasia.

Randomized Trial of Reduced-Nicotine Standards for Cigarettes.

PubMed

Donny, Eric C; Denlinger, Rachel L; Tidey, Jennifer W; Koopmeiners, Joseph S; Benowitz, Neal L; Vandrey, Ryan G; al'Absi, Mustafa; Carmella, Steven G; Cinciripini, Paul M; Dermody, Sarah S; Drobes, David J; Hecht, Stephen S; Jensen, Joni; Lane, Tonya; Le, Chap T; McClernon, F Joseph; Montoya, Ivan D; Murphy, Sharon E; Robinson, Jason D; Stitzer, Maxine L; Strasser, Andrew A; Tindle, Hilary; Hatsukami, Dorothy K

2015-10-01

The Food and Drug Administration can set standards that reduce the nicotine content of cigarettes. We conducted a double-blind, parallel, randomized clinical trial between June 2013 and July 2014 at 10 sites. Eligibility criteria included an age of 18 years or older, smoking of five or more cigarettes per day, and no current interest in quitting smoking. Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes, provided free. The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco (typical of commercial brands) to 0.4 mg per gram. The primary outcome was the number of cigarettes smoked per day during week 6. A total of 840 participants underwent randomization, and 780 completed the 6-week study. During week 6, the average number of cigarettes smoked per day was lower for participants randomly assigned to cigarettes containing 2.4, 1.3, or 0.4 mg of nicotine per gram of tobacco (16.5, 16.3, and 14.9 cigarettes, respectively) than for participants randomly assigned to their usual brand or to cigarettes containing 15.8 mg per gram (22.2 and 21.3 cigarettes, respectively; P<0.001). Participants assigned to cigarettes with 5.2 mg per gram smoked an average of 20.8 cigarettes per day, which did not differ significantly from the average number among those who smoked control cigarettes. Cigarettes with lower nicotine content, as compared with control cigarettes, reduced exposure to and dependence on nicotine, as well as craving during abstinence from smoking, without significantly increasing the expired carbon monoxide level or total puff volume, suggesting minimal compensation. Adverse events were generally mild and similar among groups. In this 6-week study, reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked. (Funded by the National Institute on Drug Abuse and the Food and Drug Administration Center for Tobacco Products; ClinicalTrials.gov number, NCT01681875.).

Permission Form Synopses to Improve Parents' Understanding of Research: A Randomized Trial

PubMed Central

D'Angio, Carl T.; Wang, Hongyue; Hunn, Julianne E.; Pryhuber, Gloria S.; Chess, Patricia R.; Lakshminrusimha, Satyan

2017-01-01

Objective We hypothesized that, among parents of potential neonatal research subjects, an accompanying cover sheet added to the permission form (intervention) would increase understanding of the research, when compared to a standard form (control). Study Design This pilot study enrolled parents approached for one of two index studies: one randomized trial and one observational study. A one-page cover sheet described critical study information. Families were randomized 1:1 to receive the cover sheet or not. Objective and subjective understanding and satisfaction were measured. Result Thirty-two parents completed all measures (17 control, 15 intervention). There were no differences in comprehension score (16.8 ± 5.7 v. 16.3 ± 3.5), subjective understanding (median 6.0 v. 6.5), or overall satisfaction with consent (median 7.0 v. 6.5) between control and intervention groups (all p>0.50). Conclusion A simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited. PMID:28358380

Active music therapy approach in amyotrophic lateral sclerosis: a randomized-controlled trial.

PubMed

Raglio, Alfredo; Giovanazzi, Elena; Pain, Debora; Baiardi, Paola; Imbriani, Chiara; Imbriani, Marcello; Mora, Gabriele

2016-12-01

This randomized controlled study assessed the efficacy of active music therapy (AMT) on anxiety, depression, and quality of life in amyotrophic lateral sclerosis (ALS). Communication and relationship during AMT treatment were also evaluated. Thirty patients were assigned randomly to experimental [AMT plus standard of care (SC)] or control (SC) groups. AMT consisted of 12 sessions (three times a week), whereas the SC treatment was based on physical and speech rehabilitation sessions, occupational therapy, and psychological support. ALS Functional Rating Scale-Revised, Hospital Anxiety and Depression Scale, McGill Quality of Life Questionnaire, and Music Therapy Rating Scale were administered to assess functional, psychological, and music therapy outcomes. The AMT group improved significantly in McGill Quality of Life Questionnaire global scores (P=0.035) and showed a positive trend in nonverbal and sonorous-music relationship during the treatment. Further studies involving larger samples in a longer AMT intervention are needed to confirm the effectiveness of this approach in ALS.

A randomized controlled trial of a brief versus standard group parenting program for toddler aggression.

PubMed

Tully, Lucy A; Hunt, Caroline

2017-05-01

Physical aggression (PA) in the toddler years is common and developmentally normal, however, longitudinal research shows that frequent PA is highly stable and associated with long-term negative outcomes. Significant research has demonstrated the efficacy of parenting interventions for reducing externalizing behavior in children yet their typical length may overburden families, leading to low participation rates and high attrition rates. To increase the reach of parenting interventions and impact on the prevalence of externalizing behavior problems, brief interventions are needed. This RCT compared a standard (8 session) group Triple P to a brief (3 session) discussion group and a waitlist control for reducing toddler PA, dysfunctional parenting and related aspects of parent functioning. Sixty-nine self-referred families of toddlers with PA were randomized to the respective conditions. At post-assessment, families in the standard intervention had significantly lower levels of observed child aversive behavior, mother reports of PA and dysfunctional parenting, and higher levels of mother- and partner-rated behavioral self-efficacy than the waitlist control. Families in the standard intervention also had significantly lower levels mother-rated dysfunctional parenting than the brief intervention, and the brief intervention had significantly lower levels of mother-rated dysfunctional parenting than waitlist. There were no significant group differences at post-assessment for measures of parental negative affect or satisfaction with the partner relationship. By 6 month follow-up, families in the brief and standard intervention did not differ significantly on any measure. The implications of the findings to delivery of brief parenting interventions are discussed. Aggr. Behav. 43:291-303, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Inflammatory Bowel Disease Telemedicine Clinical Trial: Impact of Educational Text Messages on Disease-Specific Knowledge Over 1 Year.

PubMed

Abutaleb, Ameer; Buchwald, Andrea; Chudy-Onwugaje, Kenechukwu; Langenberg, Patricia; Regueiro, Miguel; Schwartz, David A; Tracy, J Kathleen; Ghazi, Leyla; Patil, Seema A; Quezada, Sandra M; Russman, Katharine M; Quinn, Charlene C; Jambaulikar, Guruprasad; Beaulieu, Dawn B; Horst, Sara; Cross, Raymond K

2018-05-18

Effective treatments are available for patients with inflammatory bowel disease (IBD); however, suboptimal outcomes occur and are often linked to patients' limited disease knowledge. The aim of this analysis was to determine if delivery of educational messages through a telemedicine system improves IBD knowledge. TELEmedicine for Patients with IBD (TELE-IBD) was a randomized controlled trial with visits at baseline, 6 months, and 12 months; patient knowledge was a secondary aim of the study. Patients were randomized to receive TELE-IBD every other week (EOW), weekly (TELE-IBD W), or standard of care. Knowledge was assessed at each visit with the Crohn's and Colitis Knowledge (CCKNOW) survey. The primary outcome was change in CCKNOW score over 1 year compared between the TELE-IBD and control groups. This analysis included 219 participants. Participants in the TELE-IBD arms had a greater improvement in CCKNOW score compared with standard care (TELE-IBD EOW +2.4 vs standard care +1.8, P = 0.03; TELE-IBD W +2.0 vs standard care +1.8, P = 0.35). Participants with lower baseline CCKNOW scores had a greater change in their score over time (P < 0.01). However, after adjusting for race, site, and baseline knowledge, there was no difference in CCKNOW score change between the control and telemedicine arms. Telemedicine improves IBD-specific knowledge through text messaging, although the improvement is not additive with greater frequency of text messages. However, after adjustment for confounding variables, telemedicine is not superior to education given through standard visits at referral centers. Further research is needed to determine if revised systems with different modes of delivery and/or frequency of messages improve disease knowledge.

A fixed inhaled nitrous oxide/oxygen mixture as an analgesic for adult cancer patients with breakthrough pain: study protocol for a randomized controlled trial.

PubMed

Liu, Qiang; Wang, Yu; Luo, Xiang-Jiang; Wang, Ning-Ju; Chen, Ping; Jin, Xin; Mu, Guo-Xia; Chai, Xiao-Min; Zhang, Yue-Juan; Li, Yu-Xiang; Yu, Jian-Qiang

2017-01-11

The management of breakthrough pain in cancer patients is always a challenge for medical professions. Occurring in 80% of cancer patients with advanced disease, breakthrough pain significantly decreases both patient's and caregiver's quality of life. The aim of this study is to assess the analgesic efficacy of a fixed inhaled nitrous oxide/oxygen mixture for adult cancer patients with breakthrough pain. This is a randomized, placebo-controlled, double-blind study; it will be conducted in the General Hospital of Ningxia Medical University. The target study subjects are at least 18 years old, and are hospitalized cancer patients who are receiving routine opioids to control cancer-related pain but still experience breakthrough pain. A total of 240 patients will be recruited and randomly allocated between three treatment groups (A, B, C) and a control group (group D) in a ratio of 3:1. All treatment groups (A, B, C) will receive standard pain treatment (oral immediate-release morphine) plus a pre-prepared nitrous oxide/oxygen mixture, and the control group (D) will receive the standard pain treatment plus oxygen. Patients, doctors, nurses, and data collectors are all blind to the experiment. Assessments will be taken before treatment (T0), at 5 min (T1) and 15 min (T2) during treatment, and at 5 min after treatment (T3). The primary endpoint measures will be the percentage of patients whose pain is relieved at T1, T2, and T3. Secondary outcome measures will include the safety of treatment, adverse events, and satisfaction from both health professionals and patients. This study aims to provide an effective and practical intervention for a fast breakthrough pain relief and to improve cancer patients' quality of life significantly. The Evidence-Based Medicine Working Group claim that a randomized, double-blind, placebo-controlled experimental intervention is the most appropriate design to demonstrate its efficacy, so this study could give a new approach to controlling breakthrough pain episodes. ChiCTR-INC-16008075 . Registered on 8 March 2016.

Effect of novel patient interaction on students’ performance of pregnancy options counseling

PubMed Central

Shaddeau, Angela; Nimz, Abigail; Sheeder, Jeanelle; Tocce, Kristina

2015-01-01

Background Although options counseling is a fundamental skill for medical providers, previous research has identified gaps in medical school reproductive health education. Purpose To determine if a 1-h novel patient interaction (NPI) improves student performance when caring for a standardized patient with an unintended pregnancy. Methods From September 2012 to June 2013 we randomized third-year medical students at the University of Colorado School of Medicine to the standard curriculum plus an NPI, or the standard curriculum only. The NPI consisted of a 1-h small-group session with a patient who discussed her experiences with options counseling and her decision to terminate her pregnancy. Students completed an Objective Structured Clinical Examination (OSCE) at the rotation's end, which included options counseling. The primary outcome was the proportion of participants achieving ‘excellence’ on the OSCE checklist. ‘Excellence’ was defined as a score ≥90%. Examinations were flagged as ‘unsatisfactory encounters’ if core competencies were not addressed. OSCE standardized patients and evaluators were blinded to group assignment. Results In total, 135 students were eligible and randomized: 75 to NPI; 60 to control. During the OSCE, few students achieved ‘excellence’ (24% NPI vs. 28% control, p=0.57). There were no differences between scores for components of options counseling. More students in the control group ‘appeared somewhat uncomfortable’ delivering the pregnancy test results (5% NPI vs. 18% control, p=0.006). More than half (54%) of the intervention group and 67% of controls had ‘unsatisfactory encounters’ (p=0.16), almost exclusively due to omission of adoption. Most students addressed abortion (96% NPI vs. 92% control, p=0.29). Conclusions A 1-h NPI does not improve medical students’ performance of pregnancy options counseling and the option of adoption is routinely omitted. Adoption is clearly an area that needs greater attention when designing comprehensive reproductive health curriculum for medical students. PMID:26654215

Effect of novel patient interaction on students' performance of pregnancy options counseling.

PubMed

Shaddeau, Angela; Nimz, Abigail; Sheeder, Jeanelle; Tocce, Kristina

2015-01-01

Although options counseling is a fundamental skill for medical providers, previous research has identified gaps in medical school reproductive health education. To determine if a 1-h novel patient interaction (NPI) improves student performance when caring for a standardized patient with an unintended pregnancy. From September 2012 to June 2013 we randomized third-year medical students at the University of Colorado School of Medicine to the standard curriculum plus an NPI, or the standard curriculum only. The NPI consisted of a 1-h small-group session with a patient who discussed her experiences with options counseling and her decision to terminate her pregnancy. Students completed an Objective Structured Clinical Examination (OSCE) at the rotation's end, which included options counseling. The primary outcome was the proportion of participants achieving 'excellence' on the OSCE checklist. 'Excellence' was defined as a score ≥90%. Examinations were flagged as 'unsatisfactory encounters' if core competencies were not addressed. OSCE standardized patients and evaluators were blinded to group assignment. In total, 135 students were eligible and randomized: 75 to NPI; 60 to control. During the OSCE, few students achieved 'excellence' (24% NPI vs. 28% control, p=0.57).There were no differences between scores for components of options counseling. More students in the control group 'appeared somewhat uncomfortable' delivering the pregnancy test results (5% NPI vs. 18% control, p=0.006). More than half (54%) of the intervention group and 67% of controls had 'unsatisfactory encounters' (p=0.16), almost exclusively due to omission of adoption. Most students addressed abortion (96% NPI vs. 92% control, p=0.29). A 1-h NPI does not improve medical students' performance of pregnancy options counseling and the option of adoption is routinely omitted. Adoption is clearly an area that needs greater attention when designing comprehensive reproductive health curriculum for medical students.

Plasma fat-soluble vitamin and carotenoid concentrations after plant sterol and plant stanol consumption: a meta-analysis of randomized controlled trials.

PubMed

Baumgartner, Sabine; Ras, Rouyanne T; Trautwein, Elke A; Mensink, Ronald P; Plat, Jogchum

2017-04-01

Plant sterols and stanols interfere with intestinal cholesterol absorption, and it has been questioned whether absorption and plasma concentrations of fat-soluble vitamins and carotenoids are also affected. We conducted a meta-analysis to assess the effects of plant sterol and stanol consumption on plasma fat-soluble vitamin and carotenoid concentrations. Forty-one randomized controlled trials involving 3306 subjects were included. Weighted absolute and relative changes of non-standardized and total cholesterol (TC)-standardized values (expressed as summary estimates and 95 % CIs) were calculated for three fat-soluble vitamins (α- and γ-tocopherol, retinol and vitamin D) and six carotenoids (β-carotene, α-carotene, lycopene, lutein, zeaxanthin and β-cryptoxanthin) using a random effects model. Heterogeneity was assessed using predefined subject and treatment characteristics. Average plant sterol or stanol intake was 2.5 g/d. Relative non-standardized and TC-standardized concentrations of β-carotene decreased by, respectively, -16.3 % (95 % CI -18.3; -14.3) and -10.1 % (-12.3; -8.0), α-carotene by -14.4 % (-17.5; 11.3) and -7.8 % (-11.3; -4.3), and lycopene by -12.3 % (-14.6; -10.1) and -6.3 % (-8.6; -4.0). Lutein concentrations decreased by -7.4 % (-10.1; -4.8), while TC-standardized concentrations were not changed. For zeaxanthin, these values were -12.9 % (-18.9; -6.8) and -7.7 % (-13.8; -1.7) and for β-cryptoxanthin -10.6 % (-14.3; -6.9) and -4.8 % (-8.7; -0.9). Non-standardized α-tocopherol concentrations decreased by -7.1 % (-8.0; -6.2) and γ-tocopherol by -6.9 % (-9.8; -3.9), while TC-standardized tocopherol concentrations were not changed. Non-standardized retinol and vitamin D concentrations were not affected. Results were not affected by baseline concentrations, dose, duration and type of plant sterols/stanols, except for significant effects of duration (≤4 vs. >4 weeks) on TC-standardized lutein concentrations (1.0 vs. -5.6 %) and type of plant sterol/stanol on TC-standardized β-carotene concentrations (-8.9 vs. -14.2 %). Plant sterol and stanol intake lowers TC-standardized hydrocarbon carotenoid concentrations, differently affects TC-standardized oxygenated carotenoid concentrations, but does not affect TC-standardized tocopherol concentrations or absolute retinol and vitamin D concentrations. Observed concentrations remained within normal ranges.

Prediction models for clustered data: comparison of a random intercept and standard regression model

PubMed Central

2013-01-01

Background When study data are clustered, standard regression analysis is considered inappropriate and analytical techniques for clustered data need to be used. For prediction research in which the interest of predictor effects is on the patient level, random effect regression models are probably preferred over standard regression analysis. It is well known that the random effect parameter estimates and the standard logistic regression parameter estimates are different. Here, we compared random effect and standard logistic regression models for their ability to provide accurate predictions. Methods Using an empirical study on 1642 surgical patients at risk of postoperative nausea and vomiting, who were treated by one of 19 anesthesiologists (clusters), we developed prognostic models either with standard or random intercept logistic regression. External validity of these models was assessed in new patients from other anesthesiologists. We supported our results with simulation studies using intra-class correlation coefficients (ICC) of 5%, 15%, or 30%. Standard performance measures and measures adapted for the clustered data structure were estimated. Results The model developed with random effect analysis showed better discrimination than the standard approach, if the cluster effects were used for risk prediction (standard c-index of 0.69 versus 0.66). In the external validation set, both models showed similar discrimination (standard c-index 0.68 versus 0.67). The simulation study confirmed these results. For datasets with a high ICC (≥15%), model calibration was only adequate in external subjects, if the used performance measure assumed the same data structure as the model development method: standard calibration measures showed good calibration for the standard developed model, calibration measures adapting the clustered data structure showed good calibration for the prediction model with random intercept. Conclusion The models with random intercept discriminate better than the standard model only if the cluster effect is used for predictions. The prediction model with random intercept had good calibration within clusters. PMID:23414436

Prediction models for clustered data: comparison of a random intercept and standard regression model.

PubMed

Bouwmeester, Walter; Twisk, Jos W R; Kappen, Teus H; van Klei, Wilton A; Moons, Karel G M; Vergouwe, Yvonne

2013-02-15

When study data are clustered, standard regression analysis is considered inappropriate and analytical techniques for clustered data need to be used. For prediction research in which the interest of predictor effects is on the patient level, random effect regression models are probably preferred over standard regression analysis. It is well known that the random effect parameter estimates and the standard logistic regression parameter estimates are different. Here, we compared random effect and standard logistic regression models for their ability to provide accurate predictions. Using an empirical study on 1642 surgical patients at risk of postoperative nausea and vomiting, who were treated by one of 19 anesthesiologists (clusters), we developed prognostic models either with standard or random intercept logistic regression. External validity of these models was assessed in new patients from other anesthesiologists. We supported our results with simulation studies using intra-class correlation coefficients (ICC) of 5%, 15%, or 30%. Standard performance measures and measures adapted for the clustered data structure were estimated. The model developed with random effect analysis showed better discrimination than the standard approach, if the cluster effects were used for risk prediction (standard c-index of 0.69 versus 0.66). In the external validation set, both models showed similar discrimination (standard c-index 0.68 versus 0.67). The simulation study confirmed these results. For datasets with a high ICC (≥15%), model calibration was only adequate in external subjects, if the used performance measure assumed the same data structure as the model development method: standard calibration measures showed good calibration for the standard developed model, calibration measures adapting the clustered data structure showed good calibration for the prediction model with random intercept. The models with random intercept discriminate better than the standard model only if the cluster effect is used for predictions. The prediction model with random intercept had good calibration within clusters.

Quality of surgical randomized controlled trials for acute cholecystitis: assessment based on CONSORT and additional check items.

PubMed

Shikata, Satoru; Nakayama, Takeo; Yamagishi, Hisakazu

2008-01-01

In this study, we conducted a limited survey of reports of surgical randomized controlled trials, using the consolidated standards of reporting trials (CONSORT) statement and additional check items to clarify problems in the evaluation of surgical reports. A total of 13 randomized trials were selected from two latest review articles on biliary surgery. Each randomized trial was evaluated according to 28 quality measures that comprised items from the CONSORT statement plus additional items. Analysis focused on relationships between the quality of each study and the estimated effect gap ("pooled estimate in meta-analysis" -- "estimated effect of each study"). No definite relationships were found between individual study quality and the estimated effect gap. The following items could have been described but were not provided in almost all the surgical RCT reports: "clearly defined outcomes"; "details of randomization"; "participant flow charts"; "intention-to-treat analysis"; "ancillary analyses"; and "financial conflicts of interest". The item, "participation of a trial methodologist in the study" was not found in any of the reports. Although the quality of reporting trials is not always related to a biased estimation of treatment effect, the items used for quality measures must be described to enable readers to evaluate the quality and applicability of the reporting. Further development of an assessment tool is needed for items specific to surgical randomized controlled trials.

CR-Calculus and adaptive array theory applied to MIMO random vibration control tests

NASA Astrophysics Data System (ADS)

Musella, U.; Manzato, S.; Peeters, B.; Guillaume, P.

2016-09-01

Performing Multiple-Input Multiple-Output (MIMO) tests to reproduce the vibration environment in a user-defined number of control points of a unit under test is necessary in applications where a realistic environment replication has to be achieved. MIMO tests require vibration control strategies to calculate the required drive signal vector that gives an acceptable replication of the target. This target is a (complex) vector with magnitude and phase information at the control points for MIMO Sine Control tests while in MIMO Random Control tests, in the most general case, the target is a complete spectral density matrix. The idea behind this work is to tailor a MIMO random vibration control approach that can be generalized to other MIMO tests, e.g. MIMO Sine and MIMO Time Waveform Replication. In this work the approach is to use gradient-based procedures over the complex space, applying the so called CR-Calculus and the adaptive array theory. With this approach it is possible to better control the process performances allowing the step-by-step Jacobian Matrix update. The theoretical bases behind the work are followed by an application of the developed method to a two-exciter two-axis system and by performance comparisons with standard methods.

Efficacy and Safety of Individualized Coaching After Stroke: the LAST Study (Life After Stroke): A Pragmatic Randomized Controlled Trial.

PubMed

Askim, Torunn; Langhammer, Birgitta; Ihle-Hansen, Hege; Gunnes, Mari; Lydersen, Stian; Indredavik, Bent

2018-02-01

The evidence for interventions to prevent functional decline in the long term after stroke is lacking. The aim of this trial was to evaluate the efficacy and safety of an 18-month follow-up program of individualized regular coaching on physical activity and exercise. This was a multicentre, pragmatic, single-blinded, randomized controlled trial. Adults (age ≥18 years) with first-ever or recurrent stroke, community dwelling, with modified Rankin Scale <5, and no serious comorbidities were included 10 to 16 weeks poststroke. The intervention group received individualized regular coaching on physical activity and exercise every month for 18 consecutive months. The control group received standard care. Primary outcome was the Motor Assessment Scale at end of intervention (18-month follow-up). Secondary measures were Barthel index, modified Rankin Scale, item 14 from Berg Balance Scale, Timed Up and Go test, gait speed, 6-minute walk test, and Stroke Impact Scale. Other outcomes were adverse events and compliance to the intervention assessed by training diaries and the International Physical Activity Questionnaire. Three hundred and eighty consenting participants were randomly assigned to individualized coaching (n=186) or standard care (n=194). The mean estimated difference on Motor Assessment Scale in favor of control group was -0.70 points (95% confidence interval, -2.80, 1.39), P =0.512. There were no differences between the groups on Barthel index, modified Rankin Scale, or Berg Balance Scale. The frequency of adverse events was low in both groups. Results from International Physical Activity Questionnaire and training diaries showed increased activity levels but low intensity of the exercise in the intervention group. The regular individualized coaching did not improve maintenance of motor function or the secondary outcomes compared with standard care. The intervention should be regarded as safe. Despite the neutral results, the health costs related to the intervention should be investigated. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01467206. © 2017 American Heart Association, Inc.

Randomized Trial of Pentoxifylline and Vitamin E vs Standard Follow-up After Breast Irradiation to Prevent Breast Fibrosis, Evaluated by Tissue Compliance Meter

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

Jacobson, Geraldine, E-mail: geraldine-jacobson@uiowa.edu; Bhatia, Sudershan; Smith, Brian J.

Purpose: To conduct a randomized clinical trial to determine whether the combination of pentoxifylline (PTX) and vitamin E given for 6 months after breast/chest wall irradiation effectively prevents radiation-induced fibrosis (RIF). Methods and Materials: Fifty-three breast cancer patients with localized disease were enrolled and randomized to treatment with oral PTX 400 mg 3 times daily and oral vitamin E 400 IU daily for 6 months after radiation (n=26), or standard follow up (n=27). Tissue compliance meter (TCM) measurements were obtained at 18 months to compare tissue compliance in the irradiated and untreated breast/chest wall in treated subjects and controls. Measurementsmore » were obtained at 2 mirror image sites on each breast/chest wall, and the average difference in tissue compliance was scored. Differences in TCM measurements were compared using a t test. Subjects were followed a minimum of 2 years for local recurrence, disease-free survival, and overall survival. Results: The mean difference in TCM measurements in the 2 groups was 0.88 mm, median of 1.00 mm (treated) and 2.10 mm, median of 2.4 mm (untreated). The difference between the 2 groups was significant (P=.0478). Overall survival (100% treated, 90.6% controls at 5 years) and disease-free survival (96.2% treated, 86.8% controls at 5 years) were not significantly different in the 2 groups. Conclusions: This study of postirradiation breast cancer patients treated with PTX/vitamin E or standard follow-up indicated a significant difference in radiation-induced fibrosis as measured by TCM. There was no observed impact on local control or survival within the first 2 years of follow-up. The treatment was safe and well tolerated. Pentoxifylline/vitamin E may be clinically useful in preventing fibrosis after radiation in high-risk patients.« less

A randomized controlled trial to evaluate the effects of high Protein Complete (lActo) VEgetaRian (PACER) diet in non-diabetic obese Asian Indians in North India.

PubMed

Bhardwaj, Swati; Misra, Anoop; Gulati, Seema; Anoop, Shajith; Kamal, Vineet Kumar; Pandey, Ravindra Mohan

2017-12-01

In view of the increasing prevalence of obesity in largely vegetarian Asian Indians, it is important to research a high protein, low carbohydrate vegetarian diet. The present study was designed to evaluate the effects of a "High P rotein C omplete (lacto) V E geta R ian Diet (Acronym; 'PACER diet'), on weight, body composition and metabolic profiles in non-diabetic obese Asian Indians living in north India. In this 8-week randomized control trial, 102 vegetarian subjects with body mass index (BMI) >25 kg/m 2 were randomized to either a test diet (PACER diet; high protein, high fat and moderately low carbohydrate, lacto-vegetarian diet) or control diet (standard vegetarian diet formulated as the dietary guidelines for Asian Indians) after 4 weeks of diet and exercise run-in period. A standard exercise protocol was followed for both groups. Body weight, BMI, waist circumference (WC), blood pressure, fasting plasma glucose (FPG), fasting serum insulin and lipid profile were assessed before and after the intervention. There was significant weight loss along with improvements in cardio-metabolic risk factors among both the groups post intervention. Percent reductions in the intervention group for weight (6.1± 2.9; p < 0.001), WC (3.9 ± 1.7; p < 0.001), FPG (5.9 ± 3.2; p < 0.001), total cholesterol (10.2 ± 6.3: p < 0.001), serum triacylglycerol (13.6 ± 10.6; p < 0.001) and low-density lipoprotein cholesterol (11.9 ± 7.1; p < 0.001]) were significantly greater than the control diet group. In summary, intervention with a PACER diet (high protein, high fat and moderately low carbohydrate, lacto-vegetarian diet) showed significant improvement in weight loss, body composition and cardio-metabolic profile as compared to a standard vegetarian diet among obese Asian Indians in north India.

Home exercise programmes supported by video and automated reminders compared with standard paper-based home exercise programmes in patients with stroke: a randomized controlled trial.

PubMed

Emmerson, Kellie B; Harding, Katherine E; Taylor, Nicholas F

2017-08-01

To determine whether patients with stroke receiving rehabilitation for upper limb deficits using smart technology (video and reminder functions) demonstrate greater adherence to prescribed home exercise programmes and better functional outcomes when compared with traditional paper-based exercise prescription. Randomized controlled trial comparing upper limb home exercise programmes supported by video and automated reminders on smart technology, with standard paper-based home exercise programmes. A community rehabilitation programme within a large metropolitan health service. Patients with stroke with upper limb deficits, referred for outpatient rehabilitation. Participants were randomly assigned to the control (paper-based home exercise programme) or intervention group (home exercise programme filmed on an electronic tablet, with an automated reminder). Both groups completed their prescribed home exercise programme for four weeks. The primary outcome was adherence using a self-reported log book. Secondary outcomes were change in upper limb function and patient satisfaction. A total of 62 participants were allocated to the intervention ( n = 30) and control groups ( n = 32). There were no differences between the groups for measures of adherence (mean difference 2%, 95% CI -12 to 17) or change in the Wolf Motor Function Test log transformed time (mean difference 0.02 seconds, 95% CI -0.1 to 0.1). There were no between-group differences in how participants found instructions ( p = 0.452), whether they remembered to do their exercises ( p = 0.485), or whether they enjoyed doing their exercises ( p = 0.864). The use of smart technology was not superior to standard paper-based home exercise programmes for patients recovering from stroke. This trial design was registered prospectively with the Australian and New Zealand Clinical Trials Register, ID: ACTRN 12613000786796. http://www.anzctr.org.au/trialSearch.aspx.

Probiotics in Helicobacter pylori eradication therapy: A systematic review and meta-analysis

PubMed Central

Zhang, Min-Min; Qian, Wei; Qin, Ying-Yi; He, Jia; Zhou, Yu-Hao

2015-01-01

AIM: To summarize the evidence from randomized controlled trials (RCTs) regarding the effect of probiotics by using a meta-analytic approach. METHODS: In July 2013, we searched PubMed, EMBASE, Ovid, the Cochrane Library, and three Chinese databases (Chinese Biomedical Literature Database, Chinese Medical Current Content, and Chinese Scientific Journals database) to identify relevant RCTs. We included RCTs investigating the effect of a combination of probiotics and standard therapy (probiotics group) with standard therapy alone (control group). Risk ratios (RRs) were used to measure the effect of probiotics plus standard therapy on Helicobacter pylori (H. pylori) eradication rates, adverse events, and patient compliance using a random-effect model. RESULTS: We included data on 6997 participants from 45 RCTs, the overall eradication rates of the probiotic group and the control group were 82.31% and 72.08%, respectively. We noted that the use of probiotics plus standard therapy was associated with an increased eradication rate by per-protocol set analysis (RR = 1.11; 95%CI: 1.08-1.15; P < 0.001) or intention-to-treat analysis (RR = 1.13; 95%CI: 1.10-1.16; P < 0.001). Furthermore, the incidence of adverse events was 21.44% in the probiotics group and 36.27% in the control group, and it was found that the probiotics plus standard therapy significantly reduced the risk of adverse events (RR = 0.59; 95%CI: 0.48-0.71; P < 0.001), which demonstrated a favorable effect of probiotics in reducing adverse events associated with H. pylori eradication therapy. The specific reduction in adverse events ranged from 30% to 59%, and this reduction was statistically significant. Finally, probiotics plus standard therapy had little or no effect on patient compliance (RR = 0.98; 95%CI: 0.68-1.39; P = 0.889). CONCLUSION: The use of probiotics plus standard therapy was associated with an increase in the H. pylori eradication rate, and a reduction in adverse events resulting from treatment in the general population. However, this therapy did not improve patient compliance. PMID:25892886

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

The statistical pitfalls of the partially randomized preference design in non-blinded trials of psychological interventions.

PubMed

Gemmell, Isla; Dunn, Graham

2011-03-01

In a partially randomized preference trial (PRPT) patients with no treatment preference are allocated to groups at random, but those who express a preference receive the treatment of their choice. It has been suggested that the design can improve the external and internal validity of trials. We used computer simulation to illustrate the impact that an unmeasured confounder could have on the results and conclusions drawn from a PRPT. We generated 4000 observations ("patients") that reflected the distribution of the Beck Depression Index (DBI) in trials of depression. Half were randomly assigned to a randomized controlled trial (RCT) design and half were assigned to a PRPT design. In the RCT, "patients" were evenly split between treatment and control groups; whereas in the preference arm, to reflect patient choice, 87.5% of patients were allocated to the experimental treatment and 12.5% to the control. Unadjusted analyses of the PRPT data consistently overestimated the treatment effect and its standard error. This lead to Type I errors when the true treatment effect was small and Type II errors when the confounder effect was large. The PRPT design is not recommended as a method of establishing an unbiased estimate of treatment effect due to the potential influence of unmeasured confounders. Copyright © 2011 John Wiley & Sons, Ltd.

Effects of Music Therapy on Drug Therapy of Adult Psychiatric Outpatients: A Pilot Randomized Controlled Study

PubMed Central

Degli Stefani, Mario; Biasutti, Michele

2016-01-01

Objective: Framed in the patients’ engagement perspective, the current study aims to determine the effects of group music therapy in addition to drug care in comparison with drug care in addition to other non-expressive group activities in the treatment of psychiatric outpatients. Method: Participants (n = 27) with ICD-10 diagnoses of F20 (schizophrenia), F25 (schizoaffective disorders), F31 (bipolar affective disorder), F32 (depressive episode), and F60 (specific personality disorders) were randomized to receive group music therapy plus standard care (48 weekly sessions of 2 h) or standard care only. The clinical measures included dosages of neuroleptics, benzodiazepines, mood stabilizers, and antidepressants. Results: The participants who received group music therapy demonstrated greater improvement in drug dosage with respect to neuroleptics than those who did not receive group music therapy. Antidepressants had an increment for both groups that was significant only for the control group. Benzodiazepines and mood stabilizers did not show any significant change in either group. Conclusion: Group music therapy combined with standard drug care was effective for controlling neuroleptic drug dosages in adult psychiatric outpatients who received group music therapy. We discussed the likely applications of group music therapy in psychiatry and the possible contribution of music therapy in improving the psychopathological condition of adult outpatients. In addition, the implications for the patient-centered perspective were also discussed. PMID:27774073

Effective Recruitment of Schools for Randomized Clinical Trials: Role of School Nurses.

PubMed

Petosa, R L; Smith, L

2017-01-01

In school settings, nurses lead efforts to improve the student health and well-being to support academic success. Nurses are guided by evidenced-based practice and data to inform care decisions. The randomized controlled trial (RCT) is considered the gold standard of scientific rigor for clinical trials. RCTs are critical to the development of evidence-based health promotion programs in schools. The purpose of this article is to present practical solutions to implementing principles of randomization to RCT trials conducted in school settings. Randomization is a powerful sampling method used to build internal and external validity. The school's daily organization and educational mission provide several barriers to randomization. Based on the authors' experience in conducting school-based RCTs, they offer a host of practical solutions to working with schools to successfully implement randomization procedures. Nurses play a critical role in implementing RCTs in schools to promote rigorous science in support of evidence-based practice.

Association of Intensive Blood Pressure Control and Kidney Disease Progression in Nondiabetic Patients With Chronic Kidney Disease: A Systematic Review and Meta-analysis.

PubMed

Tsai, Wan-Chuan; Wu, Hon-Yen; Peng, Yu-Sen; Yang, Ju-Yeh; Chen, Hung-Yuan; Chiu, Yen-Ling; Hsu, Shih-Ping; Ko, Mei-Ju; Pai, Mei-Fen; Tu, Yu-Kang; Hung, Kuan-Yu; Chien, Kuo-Liong

2017-06-01

The optimal blood pressure (BP) target remains debated in nondiabetic patients with chronic kidney disease (CKD). To compare intensive BP control (<130/80 mm Hg) with standard BP control (<140/90 mm Hg) on major renal outcomes in patients with CKD without diabetes. Searches of PubMed, MEDLINE, Embase, and Cochrane Library for publications up to March 24, 2016. Randomized clinical trials that compared an intensive vs a standard BP target in nondiabetic adults with CKD, reporting changes in glomerular filtration rate (GFR), doubling of serum creatinine level, 50% reduction in GFR, end-stage renal disease (ESRD), or all-cause mortality. Random-effects meta-analyses for pooling effect measures. Meta-regression and subgroup analyses for exploring heterogeneity. Differences in annual rate of change in GFR were expressed as mean differences with 95% CIs. Differences in doubling of serum creatinine or 50% reduction in GFR, ESRD, composite renal outcome, and all-cause mortality were expressed as risk ratios (RRs) with 95% CIs. We identified 9 trials with 8127 patients and a median follow-up of 3.3 years. Compared with standard BP control, intensive BP control did not show a significant difference on the annual rate of change in GFR (mean difference, 0.07; 95% CI, -0.16 to 0.29 mL/min/1.73 m2/y), doubling of serum creatinine level or 50% reduction in GFR (RR, 0.99; 95% CI, 0.76-1.29), ESRD (RR, 0.96; 95% CI, 0.78-1.18), composite renal outcome (RR, 0.99; 95% CI, 0.81-1.21), or all-cause mortality (RR, 0.95; 95% CI, 0.66-1.37). Nonblacks and patients with higher levels of proteinuria showed a trend of lower risk of kidney disease progression with intensive BP control. Targeting BP below the current standard did not provide additional benefit for renal outcomes compared with standard treatment during a follow-up of 3.3 years in patients with CKD without diabetes. However, nonblack patients or those with higher levels of proteinuria might benefit from the intensive BP-lowering treatments.

Direct Field Acoustic Testing

NASA Technical Reports Server (NTRS)

Larkin, Paul; Goldstein, Bob

2008-01-01

This paper presents an update to the methods and procedures used in Direct Field Acoustic Testing (DFAT). The paper will discuss some of the recent techniques and developments that are currently being used and the future publication of a reference standard. Acoustic testing using commercial sound system components is becoming a popular and cost effective way of generating a required acoustic test environment both in and out of a reverberant chamber. This paper will present the DFAT test method, the usual setup and procedure and the development and use of a closed-loop, narrow-band control system. Narrow-band control of the acoustic PSD allows all standard techniques and procedures currently used in random control to be applied to acoustics and some examples are given. The paper will conclude with a summary of the development of a standard practice guideline that is hoped to be available in the first quarter of next year.

Trial Registration: Understanding and Preventing Reporting Bias in Social Work Research

ERIC Educational Resources Information Center

Harrison, Bronwyn A.; Mayo-Wilson, Evan

2014-01-01

Randomized controlled trials are considered the gold standard for evaluating social work interventions. However, published reports can systematically overestimate intervention effects when researchers selectively report large and significant findings. Publication bias and other types of reporting biases can be minimized through prospective trial…

A double-blind, randomized controlled trial to compare the effect of biannual peripheral magnetic resonance imaging, radiography and standard of care disease progression monitoring on pharmacotherapeutic escalation in rheumatoid and undifferentiated inflammatory arthritis: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Permanent joint damage is a major consequence of rheumatoid arthritis (RA), the most common and destructive form of inflammatory arthritis. In aggressive disease, joint damage can occur within 6 months from symptom onset. Early, intensive treatment with conventional and biologic disease-modifying anti-rheumatic drugs (DMARDs) can delay the onset and progression of joint damage. The primary objective of the study is to investigate the value of magnetic resonance imaging (MRI) or radiography (X-ray) over standard of care as tools to guide DMARD treatment decision-making by rheumatologists for the care of RA. Methods A double-blind, randomized controlled trial has been designed. Rheumatoid and undifferentiated inflammatory arthritis patients will undergo an MRI and X-ray assessment every 6 months. Baseline adaptive randomization will be used to allocate participants to MRI, X-ray, or sham-intervention groups on a background of standard of care. Prognostic markers, treating physician, and baseline DMARD therapy will be used as intervention allocation parameters. The outcome measures in rheumatology RA MRI score and the van der Heijde-modified Sharp score will be used to evaluate the MRI and X-ray images, respectively. Radiologists will score anonymized images for all patients regardless of intervention allocation. Disease progression will be determined based on the study-specific, inter-rater smallest detectable difference. Allocation-dependent, intervention-concealed reports of positive or negative disease progression will be reported to the treating rheumatologist. Negative reports will be delivered for the sham-intervention group. Study-based radiology clinical reports will be provided to the treating rheumatologists for extra-study X-ray requisitions to limit patient radiation exposure as part of diagnostic imaging standard of care. DMARD treatment dose escalation and therapy changes will be measured to evaluate the primary objective. A sample size of 186 (62 per group) patients will be required to determine a 36% difference in pharmacological treatment escalation between the three groups with intermediate dispersion of data with 90% power at a 5% level of significance. Discussion This study will determine if monitoring RA and undifferentiated inflammatory arthritis patients using MRI and X-ray every 6 months over 2 years provides incremental evidence over standard of care to influence pharmacotherapeutic decision-making and ultimately hinder disease progression. Trial registration This trial has been registered at ClinicalTrials.gov: NCT00808496 (registered on 12 December 2008). PMID:24997587

Child oral health-related quality of life and early childhood caries: a non-inferiority randomized control trial.

PubMed

Arrow, P; Klobas, E

2016-06-01

The aim of this study was to compare changes in child oral health-related quality of life (COHRQoL) after treatment for early childhood caries (ECC) using two alternative treatment approaches. A randomized control trial with random allocation of parent/child dyads with ECC to test (minimum intervention) or control (standard care). Participating parents completed the Early Childhood Oral Health Impact Scale (ECOHIS) at baseline and follow-up. Changes in ECOHIS scores and extent of COHRQoL impacts between and within groups were tested using the chi-squared statistic for groups, Wilcoxon's rank-sum test, and matched-pairs signed-rank test. Two hundred and fifty-four children were randomized (test = 127; control = 127). At baseline, mean ECOHIS score 11.1, sd 8.2; mean age = 3.8 years, sd 0.90; mean dmft = 4.9, sd 4.0; and 59% male. After a mean interval of 11.4 months, 210 children were followed-up and returned a completed questionnaire (test = 111; control = 99). There was no significant difference in COHRQoL changes between test and control. For all the children combined, there were significantly fewer impacts at follow-up in the child and family domains and the total ECOHIS, Wilcoxon signed-rank test, p < 0.05. COHRQoL improved with primary dental care for ECC, and there was no statistically significant difference between test and control in the extent of the improvement. © 2016 Australian Dental Association.

[Development of a multimedia learning DM diet education program using standardized patients and analysis of its effects on clinical competency and learning satisfaction for nursing students].

PubMed

Hyun, Kyung Sun; Kang, Hyun Sook; Kim, Won Ock; Park, Sunhee; Lee, Jia; Sok, Sohyune

2009-04-01

The purpose of this study was to develop a multimedia learning program for patients with diabetes mellitus (DM) diet education using standardized patients and to examine the effects of the program on educational skills, communication skills, DM diet knowledge and learning satisfaction. The study employed a randomized control posttest non-synchronized design. The participants were 108 third year nursing students (52 experimental group, 56 control group) at K university in Seoul, Korea. The experimental group had regular lectures and the multimedia learning program for DM diet education using standardized patients while the control group had regular lectures only. The DM educational skills were measured by trained research assistants. The students who received the multimedia learning program scored higher for DM diet educational skills, communication skills and DM diet knowledge compared to the control group. Learning satisfaction of the experimental group was higher than the control group, but statistically insignificant. Clinical competency was improved for students receiving the multimedia learning program for DM diet education using standardized patients, but there was no statistically significant effect on learning satisfaction. In the nursing education system there is a need to develop and apply more multimedia materials for education and to use standardized patients effectively.

Massage therapy and exercise therapy in patients with multiple sclerosis: a randomized controlled pilot study.

PubMed

Negahban, Hossein; Rezaie, Solmaz; Goharpey, Shahin

2013-12-01

The primary aim was to investigate the comparative effects of massage therapy and exercise therapy on patients with multiple sclerosis. The secondary aim was to investigate whether combination of both massage and exercise has an additive effect. Randomized controlled pilot trial with repeated measurements and blinded assessments. Local Multiple Sclerosis Society. A total of 48 patients with multiple sclerosis were randomly assigned to four equal subgroups labelled as massage therapy, exercise therapy, combined massage-exercise therapy and control group. The treatment group received 15 sessions of supervised intervention for five weeks. The massage therapy group received a standard Swedish massage. The exercise therapy group was given a combined set of strength, stretch, endurance and balance exercises. Patients in the massage-exercise therapy received a combined set of massage and exercise treatments. Patients in the control group were asked to continue their standard medical care. Pain, fatigue, spasticity, balance, gait and quality of life were assessed before and after intervention. Massage therapy resulted in significantly larger improvement in pain reduction (mean change 2.75 points, P = 0.001), dynamic balance (mean change, 3.69 seconds, P = 0.009) and walking speed (mean change, 7.84 seconds, P = 0.007) than exercise therapy. Patients involved in the combined massage-exercise therapy showed significantly larger improvement in pain reduction than those in the exercise therapy (mean change, 1.67 points, P = 0.001). Massage therapy could be more effective than exercise therapy. Moreover, the combination of massage and exercise therapy may be a little more effective than exercise therapy alone.

Training pharmacy workers in recognition, management, and prevention of STDs: district-randomized controlled trial.

PubMed Central

Garcia, Patricia; Hughes, James; Carcamo, Cesar; Holmes, King K.

2003-01-01

OBJECTIVES: To determine the effectiveness of an intervention for pharmacy workers in improving their recognition and management of sexually transmitted disease (STD) syndromes. METHODS: We randomly selected 14 districts (total population nearly 4 million) from the 24 districts of low socioeconomic status in Lima, Peru. We randomly assigned paired districts to receive training and support for management and prevention of STDs or a control intervention about management of diarrhoea. The STD intervention included interactive luncheon seminars on recognition and management of four STD syndromes (urethral discharge, vaginal discharge, genital ulcers, and pelvic inflammatory disease) and STD/HIV prevention counselling; monthly pharmacy visits by "prevention salespersons" who distributed materials that included "STD/HIV prevention packets" containing information, condoms, and cards given to patients for referral of their sex partners; and workshops for physicians on managing patients with STD syndromes referred from pharmacies. Standardized simulated patients visited pharmacies in intervention and control districts at one, three, and six months after training to assess outcomes. FINDINGS: Standardized simulated patients reported significantly better recognition and management (appropriate antimicrobial regimens provided for discharge syndromes and referral to specially trained physicians for genital ulcers or pelvic inflammatory disease) by pharmacy workers of all four STD syndromes. They also reported significantly more frequent recommendations for use of condoms and treatment of partners at pharmacies in intervention districts than in control districts (by "intention-to-train" analyses, P<0.05 for 47/48 primary outcome comparisons). CONCLUSION: Training was feasible and effectively improved pharmacy workers' practices. PMID:14758407

Virtual reality exercise improves mobility after stroke: an inpatient randomized controlled trial.

PubMed

McEwen, Daniel; Taillon-Hobson, Anne; Bilodeau, Martin; Sveistrup, Heidi; Finestone, Hillel

2014-06-01

Exercise using virtual reality (VR) has improved balance in adults with traumatic brain injury and community-dwelling older adults. Rigorous randomized studies regarding its efficacy, safety, and applicability with individuals after stroke are lacking. The purpose of this study was to determine whether an adjunct VR therapy improves balance, mobility, and gait in stroke rehabilitation inpatients. A blinded randomized controlled trial studying 59 stroke survivors on an inpatient stroke rehabilitation unit was performed. The treatment group (n=30) received standard stroke rehabilitation therapy plus a program of VR exercises that challenged balance (eg, soccer goaltending, snowboarding) performed while standing. The control group (n=29) received standard stroke rehabilitation therapy plus exposure to identical VR environments but whose games did not challenge balance (performed in sitting). VR training consisted of 10 to 12 thirty-minute daily sessions for a 3-week period. Objective outcome measures of balance and mobility were assessed before, immediately after, and 1 month after training. Confidence intervals and effect sizes favored the treatment group on the Timed Up and Go and the Two-Minute Walk Test, with both groups meeting minimal clinical important differences after training. More individuals in the treatment group than in the control group showed reduced impairment in the lower extremity as measured by the Chedoke McMaster Leg domain (P=0.04) immediately after training. This VR exercise intervention for inpatient stroke rehabilitation improved mobility-related outcomes. Future studies could include nonambulatory participants as well as the implementation strategies for the clinical use of VR. http://www.ANZCTR.org.au/. Unique identifier: ACTRN12613000710729. © 2014 American Heart Association, Inc.

Chronic graft-versus-host disease: long-term results from a randomized trial on graft-versus-host disease prophylaxis with or without anti-T-cell globulin ATG-Fresenius.

PubMed

Socié, Gérard; Schmoor, Claudia; Bethge, Wolfgang A; Ottinger, Hellmut D; Stelljes, Matthias; Zander, Axel R; Volin, Liisa; Ruutu, Tapani; Heim, Dominik A; Schwerdtfeger, Rainer; Kolbe, Karin; Mayer, Jiri; Maertens, Johan A; Linkesch, Werner; Holler, Ernst; Koza, Vladimir; Bornhäuser, Martin; Einsele, Hermann; Kolb, Hans-Jochem; Bertz, Hartmut; Egger, Matthias; Grishina, Olga; Finke, Jürgen

2011-06-09

Previous randomized graft-versus-host disease (GVHD)-prophylaxis trials have failed to demonstrate reduced incidence and severity of chronic GVHD (cGVHD). Here we reanalyzed and updated a randomized phase 3 trial comparing standard GVHD prophylaxis with or without pretransplantation ATG-Fresenius (ATG-F) in 201 adult patients receiving myeloablative conditioning before transplantation from unrelated donors. The cumulative incidence of extensive cGVHD after 3 years was 12.2% in the ATG-F group versus 45.0% in the control group (P < .0001). The 3-year cumulative incidence of relapse and of nonrelapse mortality was 32.6% and 19.4% in the ATG-F group and 28.2% and 33.5% in the control group (hazard ratio [HR] = 1.21, P = .47, and HR = 0.68, P = .18), respectively. This nonsignificant reduction in nonrelapse mortality without increased relapse risk led to an overall survival rate after 3 years of 55.2% in the ATG-F group and 43.3% in the control group (HR = 0.84, P = .39, nonsignificant). The HR for receiving immunosuppressive therapy (IST) was 0.31 after ATG-F (P < .0001), and the 3-year probability of survival free of IST was 52.9% and 16.9% in the ATG-F versus control, respectively. The addition of ATG-F to standard cyclosporine, methotrexate GVHD prophylaxis lowers the incidence and severity of cGVHD, and the risk of receiving IST without raising the relapse rate. ATG-F prophylaxis reduces cGVHD morbidity.

A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder.

PubMed

McGovern, Mark P; Lambert-Harris, Chantal; Xie, Haiyi; Meier, Andrea; McLeman, Bethany; Saunders, Elizabeth

2015-07-01

Post-traumatic stress disorder (PTSD) is common among people with substance use disorders, and the comorbidity is associated with negative outcomes. We report on a randomized controlled trial comparing the effect of integrated cognitive-behavioral therapy (ICBT) plus standard care, individual addiction counseling plus standard care and standard care alone on substance use and PTSD symptoms. Three-group, multi-site randomized controlled trial. Seven addiction treatment programs in Vermont and New Hampshire, USA. Recruitment took place between December 2010 and January 2013. In this single-blind study, 221 participants were randomized to one of three conditions: ICBT plus standard care (SC) (n = 73), individual addiction counseling (IAC) plus SC (n = 75) or SC only (n = 73). One hundred and seventy-two patients were assessed at 6-month follow-up (58 ICBT; 61 IAC; 53 SC). Intervention and comparators: ICBT is a manual-guided therapy focused on PTSD and substance use symptom reduction with three main components: patient education, mindful relaxation and flexible thinking. IAC is a manual-guided therapy focused exclusively on substance use and recovery with modules organized in a stage-based approach: treatment initiation, early abstinence, maintaining abstinence and recovery. SC are intensive out-patient program services that include 9-12 hours of face-to-face contact per week over 2-4 days of group and individual therapies plus medication management. Primary outcomes were PTSD severity and substance use severity at 6 months. Secondary outcomes were therapy retention. PTSD symptoms reduced in all conditions with no difference between them. In analyses of covariance, ICBT produced more favorable outcomes on toxicology than IAC or SC [comparison with IAC, parameter estimate: 1.10; confidence interval (CI) = 0.17-2.04; comparison with SC, parameter estimate: 1.13; CI = 0.18-2.08] and had a greater reduction in reported drug use than SC (parameter estimate: -9.92; CI = -18.14 to -1.70). ICBT patients had better therapy continuation versus IAC (P<0.001). There were no unexpected or study-related adverse events. Integrated cognitive behavioral therapy may improve drug-related outcomes in post-traumatic stress disorder sufferers with substance use disorder more than drug-focused counseling, but probably not by reducing post-traumatic stress disorder symptoms to a greater extent. © 2015 Society for the Study of Addiction.

A Randomized Control Study on Psycho-Education Group on Improving Health-Related Quality of Life of Chinese Persons with Major Neurocognitive Disorder.

PubMed

Young, Kim-Wan

2016-01-01

People with a major neurocognitive disorder (PwND) are found to have a lower health related quality of life (HRQoL) than those without neurocognitive disorder. This research study aims to evaluate the effectiveness of a psycho-education group in improving the HRQoL of Chinese PwND. By adopting randomized control trial (RCT), Chinese PwND were randomly assigned to either a 10-session psycho-education group or the control group. Family caregivers of treatment group were encouraged to take part in two sessions focusing on the caring and communication skills. Control group and their family caregivers received standardized educational materials on basic information on neurocognitive disorder for them to read at home. Standardized assessment was conducted both with PwND and their caregivers independently to give the self-rated and caregiver-rated HRQoL of PwND in the pre- and post- treatment periods by a research assistant who was blind to the group assignment of the participants. Moreover, qualitative interviews were also conducted for ten participants and five family caregivers of the treatment group to identify those group elements relating to its effectiveness. 2 × 2 repeated measures ANCOVA demonstrated that the treatment group (n = 32) was significantly more effective than the control group (n = 32) in improving the caregiver-rated HRQoL (F[1, 61] = 4.35, p = .04 < .05) with a moderate effect size, but not self-rated HRQoL, Qualitative analysis suggested several group elements relating to its effectiveness. This present RCT shows that the psycho-education group significantly improves caregiver-rated HRQoL of PwND, supporting the feasibility and effectiveness of the psycho-education group.

A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial.

PubMed

Chacko, Sara A; Yeh, Gloria Y; Davis, Roger B; Wee, Christina C

2016-10-01

This study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery. Randomized, controlled pilot trial. Beth Israel Deaconess Medical Center, Boston, MA, USA. Bariatric patients 1-5 years post-surgery (n=18) were randomized to receive a 10-week MBI or a standard intervention. Primary outcomes were feasibility and acceptability of the MBI. Secondary outcomes included changes in weight, eating behaviors, psychosocial outcomes, and metabolic and inflammatory biomarkers. Qualitative exit interviews were conducted post-intervention. Major themes were coded and extracted. Attendance was excellent (6 of 9 patients attended ≥7 of 10 classes). Patients reported high satisfaction and overall benefit of the MBI. The intervention was effective in reducing emotional eating at 6 months (-4.9±13.7 in mindfulness vs. 6.2±28.4 in standard, p for between-group difference=0.03) but not weight. We also observed a significant increase in HbA1C (0.34±0.38 vs. -0.06±0.31, p=0.03). Objective measures suggested trends of an increase in perceived stress and symptoms of depression, although patients reported reduced stress reactivity, improved eating behaviors, and a desire for continued mindfulness-based support in qualitative interviews. This novel mindfulness-based approach is highly acceptable to bariatric patients post-surgery and may be effective for reducing emotional eating, although it did not improve weight or glycemic control in the short term. Longer-term studies of mindfulness-based approaches may be warranted in this population. ClinicalTrials.gov identifier NCT02603601. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effects of inspiratory muscle training on pulmonary function, respiratory muscle strength and functional capacity in patients with atrial fibrillation: a randomized controlled trial.

PubMed

Zeren, Melih; Demir, Rengin; Yigit, Zerrin; Gurses, Hulya N

2016-12-01

To investigate the effects of inspiratory muscle training on pulmonary function, respiratory muscle strength and functional capacity in patients with atrial fibrillation. Prospective randomized controlled single-blind study. Cardiology department of a university hospital. A total of 38 patients with permanent atrial fibrillation were randomly allocated to either a treatment group (n = 19; age 66.2 years (8.8)) or a control group (n = 19; age 67.1 years (6.4)). The training group received inspiratory muscle training at 30% of maximal inspiratory pressure for 15 minutes twice a day, 7 days a week, for 12 weeks alongside the standard medical treatment. The control group received standard medical treatment only. Spirometry, maximal inspiratory and expiratory pressures and 6-minute walking distance was measured at the beginning and end of the study. There was a significant increase in maximal inspiratory pressure (27.94 cmH 2 O (8.90)), maximal expiratory pressure (24.53 cmH 2 O (10.34)), forced vital capacity (10.29% (8.18) predicted), forced expiratory volume in one second (13.88% (13.42) predicted), forced expiratory flow 25%-75% (14.82% (12.44) predicted), peak expiratory flow (19.82% (15.62) predicted) and 6-minute walking distance (55.53 m (14.13)) in the training group (p < 0.01). No significant changes occurred in the control group (p > 0.05). Inspiratory muscle training can improve pulmonary function, respiratory muscle strength and functional capacity in patients with atrial fibrillation. © The Author(s) 2016.

Interferential and horizontal therapies in chronic low back pain: a randomized, double blind, clinical study.

PubMed

Zambito, A; Bianchini, D; Gatti, D; Viapiana, O; Rossini, M; Adami, S

2006-01-01

Chronic Low Back Pain (CLBP) is one of the most frequent medical problems. Electrical nerve stimulation is frequently used but its efficacy remains controversial. Twenty-six men and 94 women with CLBP associated with either degenerative disk disease or previous multiple vertebral osteoporotic fractures were randomly assigned to either interferential currents (IFT), horizontal therapy (HT) or sham HT administered for 10, 40 and 40 minutes, respectively, daily for 5 days per week for two weeks together with a standard flexion-extension stretching exercise program, Blind efficacy assessment were obtained at baseline and at week 2, 6 and 14 and included a functional questionnaire (Backill), the standard visual analog scale (VAS) and the mean analgesic consumption. At week 2 a significant and similar improvement in both the VAS and Backill score was observed in all three groups. The Backill score continued to improve only in the two active groups with changes significantly greater than those observed in control patients at week 14. The pain VAS score returned to baseline values at week 6 and 14 in the control group while in the IFT and HT groups it continued to improve (p< 0.01 vs controls). The use of analgesic medications significantly improved at week 14 versus pretreatment assessment and over control patients only in the HT group. This randomized double-blind controlled study provides the first evidence that IFT and HT therapy are significantly effective in alleviating both pain and disability in patients with CLBP. The placebo effect is remarkable at the beginning of the treatment but it tends to vanish within a couple of weeks.

The Efficacy of Eye Movement Desensitization and Reprocessing in Children and Adults Who Have Experienced Complex Childhood Trauma: A Systematic Review of Randomized Controlled Trials.

PubMed

Chen, Runsen; Gillespie, Amy; Zhao, Yanhui; Xi, Yingjun; Ren, Yanping; McLean, Loyola

2018-01-01

Background: Survivors of complex childhood trauma (CT) such as sexual abuse show poorer outcomes compared to single event trauma survivors. A growing number of studies investigate Eye Movement Desensitization and Reprocessing (EMDR) treatment for posttraumatic stress disorder (PTSD), but no systematic reviews have focused on EMDR treatment for CT as an intervention for both adults and children. This study therefore systematically reviewed all randomized controlled trials (RCTs) evaluating the effect of EMDR on PTSD symptoms in adults and children exposed to CT. Methods: Databases including PubMed, Web of Science, and PsycINFO were searched in October 2017. Randomized controlled trials which recruited adult and children with experience of CT, which compared EMDR to alternative treatments or control conditions, and which measured PTSD symptoms were included. Study methodology quality was evaluated with Platinum Standard scale. Results: Six eligible RCTs of 251 participants were included in this systematic review. The results indicated that EMDR was associated with reductions in PTSD symptoms, depression and/or anxiety both post-treatment and at follow-up compared with all other alternative therapies (cognitive behavior therapy, individual/group therapy and fluoxetine) and control treatment (pill placebo, active listening, EMDR delayed treatment, and treatment as usual). However, studies suffered from significant heterogeneity in study populations, length of EMDR treatment, length of follow-up, comparison groups, and outcome measures. One study had a high risk of bias. Discussion: This systematic review suggests that there is growing evidence to support the clinical efficacy of EMDR in treating CT in both children and adults. However, conclusions are limited by the small number of heterogenous trials. Further RCTs with standardized methodologies, as well as studies addressing real world challenges in treating CT are required.

The Efficacy of Eye Movement Desensitization and Reprocessing in Children and Adults Who Have Experienced Complex Childhood Trauma: A Systematic Review of Randomized Controlled Trials

PubMed Central

Chen, Runsen; Gillespie, Amy; Zhao, Yanhui; Xi, Yingjun; Ren, Yanping; McLean, Loyola

2018-01-01

Background: Survivors of complex childhood trauma (CT) such as sexual abuse show poorer outcomes compared to single event trauma survivors. A growing number of studies investigate Eye Movement Desensitization and Reprocessing (EMDR) treatment for posttraumatic stress disorder (PTSD), but no systematic reviews have focused on EMDR treatment for CT as an intervention for both adults and children. This study therefore systematically reviewed all randomized controlled trials (RCTs) evaluating the effect of EMDR on PTSD symptoms in adults and children exposed to CT. Methods: Databases including PubMed, Web of Science, and PsycINFO were searched in October 2017. Randomized controlled trials which recruited adult and children with experience of CT, which compared EMDR to alternative treatments or control conditions, and which measured PTSD symptoms were included. Study methodology quality was evaluated with Platinum Standard scale. Results: Six eligible RCTs of 251 participants were included in this systematic review. The results indicated that EMDR was associated with reductions in PTSD symptoms, depression and/or anxiety both post-treatment and at follow-up compared with all other alternative therapies (cognitive behavior therapy, individual/group therapy and fluoxetine) and control treatment (pill placebo, active listening, EMDR delayed treatment, and treatment as usual). However, studies suffered from significant heterogeneity in study populations, length of EMDR treatment, length of follow-up, comparison groups, and outcome measures. One study had a high risk of bias. Discussion: This systematic review suggests that there is growing evidence to support the clinical efficacy of EMDR in treating CT in both children and adults. However, conclusions are limited by the small number of heterogenous trials. Further RCTs with standardized methodologies, as well as studies addressing real world challenges in treating CT are required. PMID:29695993

Can smartphone mental health interventions reduce symptoms of anxiety? A meta-analysis of randomized controlled trials.

PubMed

Firth, Joseph; Torous, John; Nicholas, Jennifer; Carney, Rebekah; Rosenbaum, Simon; Sarris, Jerome

2017-08-15

Various psychological interventions are effective for reducing symptoms of anxiety when used alone, or as an adjunct to anti-anxiety medications. Recent studies have further indicated that smartphone-supported psychological interventions may also reduce anxiety, although the role of mobile devices in the treatment and management of anxiety disorders has yet to be established. We conducted a systematic review and meta-analysis of all randomized clinical trials (RCTs) reporting the effects of psychological interventions delivered via smartphone on symptoms of anxiety (sub-clinical or diagnosed anxiety disorders). A systematic search of major electronic databases conducted in November 2016 identified 9 eligible RCTs, with 1837 participants. Random-effects meta-analyses were used to calculate the standardized mean difference (as Hedges' g) between smartphone interventions and control conditions. Significantly greater reductions in total anxiety scores were observed from smartphone interventions than control conditions (g=0.325, 95% C.I.=0.17-0.48, p<0.01), with no evidence of publication bias. Effect sizes from smartphone interventions were significantly greater when compared to waitlist/inactive controls (g=0.45, 95% C.I.=0.30-0.61, p<0.01) than active control conditions (g=0.19, 95% C.I.=0.07-0.31, p=0.003). The extent to which smartphone interventions can match (or exceed) the efficacy of recognised treatments for anxiety has yet to established. This meta-analysis shows that psychological interventions delivered via smartphone devices can reduce anxiety. Future research should aim to develop pragmatic methods for implementing smartphone-based support for people with anxiety, while also comparing the efficacy of these interventions to standard face-to-face psychological care. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Prevention of Recurrent Foot Ulcers With Plantar Pressure–Based In-Shoe Orthoses: The CareFUL Prevention Multicenter Randomized Controlled Trial

PubMed Central

Ulbrecht, Jan S.; Hurley, Timothy; Mauger, David T.

2014-01-01

OBJECTIVE To assess the efficacy of in-shoe orthoses that were designed based on shape and barefoot plantar pressure in reducing the incidence of submetatarsal head plantar ulcers in people with diabetes, peripheral neuropathy, and a history of similar prior ulceration. RESEARCH DESIGN AND METHODS Single-blinded multicenter randomized controlled trial with subjects randomized to wear shape- and pressure-based orthoses (experimental, n = 66) or standard-of-care A5513 orthoses (control, n = 64). Patients were followed for 15 months, until a study end point (forefoot plantar ulcer or nonulcerative plantar forefoot lesion) or to study termination. Proportional hazards regression was used for analysis. RESULTS There was a trend in the composite primary end point (both ulcers and nonulcerative lesions) across the full follow-up period (P = 0.13) in favor of the experimental orthoses. This trend was due to a marked difference in ulcer occurrence (P = 0.007) but no difference in the rate of nonulcerative lesions (P = 0.76). At 180 days, the ulcer prevention effect of the experimental orthoses was already significant (P = 0.003) when compared with control, and the benefit of the experimental orthoses with respect to the composite end point was also significant (P = 0.042). The hazard ratio was 3.4 (95% CI 1.3–8.7) for the occurrence of a submetatarsal head plantar ulcer in the control compared with experimental arm over the duration of the study. CONCLUSIONS We conclude that shape- and barefoot plantar pressure–based orthoses were more effective in reducing submetatarsal head plantar ulcer recurrence than current standard-of-care orthoses, but they did not significantly reduce nonulcerative lesions. PMID:24760263

Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial.

PubMed

Ulbrecht, Jan S; Hurley, Timothy; Mauger, David T; Cavanagh, Peter R

2014-07-01

To assess the efficacy of in-shoe orthoses that were designed based on shape and barefoot plantar pressure in reducing the incidence of submetatarsal head plantar ulcers in people with diabetes, peripheral neuropathy, and a history of similar prior ulceration. Single-blinded multicenter randomized controlled trial with subjects randomized to wear shape- and pressure-based orthoses (experimental, n = 66) or standard-of-care A5513 orthoses (control, n = 64). Patients were followed for 15 months, until a study end point (forefoot plantar ulcer or nonulcerative plantar forefoot lesion) or to study termination. Proportional hazards regression was used for analysis. There was a trend in the composite primary end point (both ulcers and nonulcerative lesions) across the full follow-up period (P = 0.13) in favor of the experimental orthoses. This trend was due to a marked difference in ulcer occurrence (P = 0.007) but no difference in the rate of nonulcerative lesions (P = 0.76). At 180 days, the ulcer prevention effect of the experimental orthoses was already significant (P = 0.003) when compared with control, and the benefit of the experimental orthoses with respect to the composite end point was also significant (P = 0.042). The hazard ratio was 3.4 (95% CI 1.3-8.7) for the occurrence of a submetatarsal head plantar ulcer in the control compared with experimental arm over the duration of the study. We conclude that shape- and barefoot plantar pressure-based orthoses were more effective in reducing submetatarsal head plantar ulcer recurrence than current standard-of-care orthoses, but they did not significantly reduce nonulcerative lesions. © 2014 by the American Diabetes Association.

A randomized controlled trial to evaluate utilization of physical activity recommendations among patients of cardiovascular healthcare centres in Eastern Slovakia: study design and rationale of the AWATAR study.

PubMed

Zelko, Aurel; Bukova, Alena; Kolarcik, Peter; Bakalar, Peter; Majercak, Ivan; Potocnikova, Jana; Reijneveld, Sijmen A; van Dijk, Jitse P

2018-04-04

Guidelines on modifiable risk factors regarding cardiological patients are poorly implemented in clinical practice perhaps due to low health literacy. Several digital tools for improving lifestyle and behavioural intervention were developed. Our primary aim is to evaluate the effectiveness of a digital exercise prescription tool on the adherence to physical activity recommendations among patients with cardiovascular diseases. A randomized controlled trial will be realized in cooperation with Cardiovascular Health Centres in Eastern Slovakia. Patients recruited through their cardiologists, will be randomised at 1:1 ratio to the three-months' experimental condition or control condition. The experimental group will receive standard lifestyle consultation leading to individually optimized prescription of physical activity. The control group will receive standard, usual-cardio-care lifestyle counselling, also in the domain of physical activity. The digital system will be used for optimized exercise prescription. The primary outcome is a change in the patient's adherence to exercise recommendations. Data will be collected in both groups prior to consultation and after 3 months. This study protocol presents background and design of a randomized control trial to investigate the effectiveness of a digital system-provide exercise prescription tool on the adherence to physical activity recommendations. An optimized exercise prescription that better reflects patient's diagnosis, comorbidities and medication can have a significant impact on secondary prevention of cardiovascular disease. This trial can provide important evidence about the effectiveness of digital exercise guidance in everyday practice of cardiovascular healthcare. The study was registered on 1st November, 2017 and is available online at ClinicalTrials.gov (ID: NCT03329053 ).

Effect of probiotics on the incidence of ventilator-associated pneumonia in critically ill patients: a randomized controlled multicenter trial.

PubMed

Zeng, Juan; Wang, Chun-Ting; Zhang, Fu-Shen; Qi, Feng; Wang, Shi-Fu; Ma, Shuang; Wu, Tie-Jun; Tian, Hui; Tian, Zhao-Tao; Zhang, Shu-Liu; Qu, Yan; Liu, Lu-Yi; Li, Yuan-Zhong; Cui, Song; Zhao, He-Ling; Du, Quan-Sheng; Ma, Zhuang; Li, Chun-Hua; Li, Yun; Si, Min; Chu, Yu-Feng; Meng, Mei; Ren, Hong-Sheng; Zhang, Ji-Cheng; Jiang, Jin-Jiao; Ding, Min; Wang, Yu-Ping

2016-06-01

To evaluate the potential preventive effect of probiotics on ventilator-associated pneumonia (VAP). This was an open-label, randomized, controlled multicenter trial involving 235 critically ill adult patients who were expected to receive mechanical ventilation for ≥48 h. The patients were randomized to receive (1) a probiotics capsule containing live Bacillus subtilis and Enterococcus faecalis (Medilac-S) 0.5 g three times daily through a nasogastric feeding tube plus standard preventive strategies or (2) standard preventive strategies alone, for a maximum of 14 days. The development of VAP was evaluated daily, and throat swabs and gastric aspirate were cultured at baseline and once or twice weekly thereafter. The incidence of microbiologically confirmed VAP in the probiotics group was significantly lower than that in the control patients (36.4 vs. 50.4 %, respectively; P = 0.031). The mean time to develop VAP was significantly longer in the probiotics group than in the control group (10.4 vs. 7.5 days, respectively; P = 0.022). The proportion of patients with acquisition of gastric colonization of potentially pathogenic microorganisms (PPMOs) was lower in the probiotics group (24 %) than the control group (44 %) (P = 0.004). However, the proportion of patients with eradication PPMO colonization on both sites of the oropharynx and stomach were not significantly different between the two groups. The administration of probiotics did not result in any improvement in the incidence of clinically suspected VAP, antimicrobial consumption, duration of mechanical ventilation, mortality and length of hospital stay. Therapy with the probiotic bacteria B. Subtilis and E. faecalis are an effective and safe means for preventing VAP and the acquisition of PPMO colonization in the stomach.

Benchmarking is associated with improved quality of care in type 2 diabetes: the OPTIMISE randomized, controlled trial.

PubMed

Hermans, Michel P; Elisaf, Moses; Michel, Georges; Muls, Erik; Nobels, Frank; Vandenberghe, Hans; Brotons, Carlos

2013-11-01

To assess prospectively the effect of benchmarking on quality of primary care for patients with type 2 diabetes by using three major modifiable cardiovascular risk factors as critical quality indicators. Primary care physicians treating patients with type 2 diabetes in six European countries were randomized to give standard care (control group) or standard care with feedback benchmarked against other centers in each country (benchmarking group). In both groups, laboratory tests were performed every 4 months. The primary end point was the percentage of patients achieving preset targets of the critical quality indicators HbA1c, LDL cholesterol, and systolic blood pressure (SBP) after 12 months of follow-up. Of 4,027 patients enrolled, 3,996 patients were evaluable and 3,487 completed 12 months of follow-up. Primary end point of HbA1c target was achieved in the benchmarking group by 58.9 vs. 62.1% in the control group (P = 0.398) after 12 months; 40.0 vs. 30.1% patients met the SBP target (P < 0.001); 54.3 vs. 49.7% met the LDL cholesterol target (P = 0.006). Percentages of patients meeting all three targets increased during the study in both groups, with a statistically significant increase observed in the benchmarking group. The percentage of patients achieving all three targets at month 12 was significantly larger in the benchmarking group than in the control group (12.5 vs. 8.1%; P < 0.001). In this prospective, randomized, controlled study, benchmarking was shown to be an effective tool for increasing achievement of critical quality indicators and potentially reducing patient cardiovascular residual risk profile.

Effects of Exercise on Mild-to-Moderate Depressive Symptoms in the Postpartum Period: A Meta-analysis.

PubMed

McCurdy, Ashley P; Boulé, Normand G; Sivak, Allison; Davenport, Margie H

2017-06-01

To examine the influence of exercise on depressive symptoms and the prevalence of depression in the postpartum period. A structured search of MEDLINE, EMBASE, CINAHL, Sport Discus, Ovid's All EBM Reviews, and ClinicalTrials.gov databases was performed with dates from the beginning of the databases until June 16, 2016. The search combined keywords and MeSH-like terms including, but not limited to, "exercise," "postpartum," "depression," and "randomized controlled trial." Randomized controlled trials comparing postpartum exercise (structured, planned, repetitive physical activity) with the standard care for which outcomes assessing depressive symptoms or depressive episodes (as defined by trial authors) were assessed. Trials were identified as prevention trials (women from the general postpartum population) or treatment trials (women were classified as having depression by the trial authors). Effect sizes with 95% confidence intervals (CIs) were calculated using Hedges' g method and standardized mean differences in postintervention depression outcomes were pooled using a random-effects model. Across all 16 trials (1,327 women), the pooled standardized mean difference was -0.34 (95% CI -0.50 to -0.19, I=37%), suggesting a small effect of exercise among all postpartum women on depressive symptoms. Among the 10 treatment trials, a moderate effect size of exercise on depressive symptoms was found (standardized mean difference-0.48, 95% CI -0.73 to -0.22, I=42%). In six prevention trials, a small effect (standardized mean difference-0.22, 95% CI -0.36 to -0.08, I=2%) was found. In women with depression preintervention, exercise increased the odds of resolving depression postintervention by 54% (odds ratio 0.46, Mantel-Haenszel method, 95% CI 0.25-0.84, I=0%). The trials included in this meta-analysis were small and some had methodologic limitations. Light-to-moderate intensity aerobic exercise improves mild-to-moderate depressive symptoms and increases the likelihood that mild-to-moderate depression will resolve.

Intravenous immunoglobulin treatment of the complex regional pain syndrome: a randomized trial.

PubMed

Goebel, Andreas; Baranowski, Andrew; Maurer, Konrad; Ghiai, Artemis; McCabe, Candy; Ambler, Gareth

2010-02-02

Treatment of long-standing complex regional pain syndrome (CRPS) is empirical and often of limited efficacy. Preliminary data suggest that the immune system is involved in sustaining this condition and that treatment with low-dose intravenous immunoglobulin (IVIG) may substantially reduce pain in some patients. To evaluate the efficacy of IVIG in patients with longstanding CRPS under randomized, controlled conditions. A randomized, double-blind, placebo-controlled crossover trial. (National Research Registry number: N0263177713; International Standard Randomised Controlled Trial Number Registry: 63918259) University College London Hospitals Pain Management Centre. Persons who had pain intensity greater than 4 on an 11-point (0 to 10) numerical rating scale and had CRPS for 6 to 30 months that was refractory to standard treatment. IVIG, 0.5 g/kg, and normal saline in separate treatments, divided by a washout period of at least 28 days. The primary outcome was pain intensity 6 to 19 days after the initial treatment and the crossover treatment. 13 eligible participants were randomly assigned between November 2005 and May 2008; 12 completed the trial. The average pain intensity was 1.55 units lower after IVIG treatment than after saline (95% CI, 1.29 to 1.82; P < 0.001). In 3 patients, pain intensity after IVIG was less than after saline by 50% or more. No serious adverse reactions were reported. The trial was small, and recruitment bias and chance variation could have influenced results and their interpretation. IVIG, 0.5 g/kg, can reduce pain in refractory CRPS. Studies are required to determine the best immunoglobulin dose, the duration of effect, and when repeated treatments are needed. Association of Anaesthetists of Great Britain and Ireland, University College London Hospitals Charity, and CSL-Behring.

Effect of Probiotics on Glucose and Lipid Metabolism in Type 2 Diabetes Mellitus: A Meta-Analysis of 12 Randomized Controlled Trials.

PubMed

Yao, Kecheng; Zeng, Linghai; He, Qian; Wang, Wei; Lei, Jiao; Zou, Xiulan

2017-06-22

BACKGROUND It has been unclear whether supplemental probiotics therapy improves clinical outcomes in type 2 diabetic patients. This meta-analysis aimed to summarize the effect of probiotics on glucose and lipid metabolism and C-reactive protein (CRP) from 12 randomized controlled trials (RCTs). MATERIAL AND METHODS An up-to-date search was performed for all relevant RCTs up to April 2016 from PubMed, Embase, and Cochrane Library. Standardized mean difference (SMD) and weighted mean difference (WMD) were calculated for a fixed-effect and random-effect meta-analysis to assess the impact of supplemental probiotics on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR), lipid profile, and CRP level. RESULTS A total of 12 studies (684 patients) were entered into the final analysis. The effect of probiotics was significant on reducing HbA1c level (standardized mean difference [SMD], -0.38; confidence interval [CI], -0.62 to -0.14, P=0.002; I²=0%, P=0.72 for heterogeneity), fasting insulin level (SMD, -0.38; CI -0.59 to -0.18, P=0.0003; I²=0%, P=0.81 for heterogeneity), and HOMA-IR (SMD, -0.99; CI -1.52 to -0.47, P=0.0002; I²=86%, P<0.00001 for heterogeneity). Pooled results on effects of probiotics on FPG, CRP, or lipid profile were either non-significant or highly heterogeneous. CONCLUSIONS This meta-analysis demonstrated that probiotics supplementation was associated with significant improvement in HbA1c and fasting insulin in type 2 diabetes patients. More randomized placebo-controlled trials with large sample sizes are warranted to confirm our conclusions.

Effect of Probiotics on Glucose and Lipid Metabolism in Type 2 Diabetes Mellitus: A Meta-Analysis of 12 Randomized Controlled Trials

PubMed Central

Yao, Kecheng; Zeng, Linghai; He, Qian; Wang, Wei; Lei, Jiao; Zou, Xiulan

2017-01-01

Background It has been unclear whether supplemental probiotics therapy improves clinical outcomes in type 2 diabetic patients. This meta-analysis aimed to summarize the effect of probiotics on glucose and lipid metabolism and C-reactive protein (CRP) from 12 randomized controlled trials (RCTs). Material/Methods An up-to-date search was performed for all relevant RCTs up to April 2016 from PubMed, Embase, and Cochrane Library. Standardized mean difference (SMD) and weighted mean difference (WMD) were calculated for a fixed-effect and random-effect meta-analysis to assess the impact of supplemental probiotics on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR), lipid profile, and CRP level. Results A total of 12 studies (684 patients) were entered into the final analysis. The effect of probiotics was significant on reducing HbA1c level (standardized mean difference [SMD], −0.38; confidence interval [CI], −0.62 to −0.14, P=0.002; I2=0%, P=0.72 for heterogeneity), fasting insulin level (SMD, −0.38; CI −0.59 to −0.18, P=0.0003; I2=0%, P=0.81 for heterogeneity), and HOMA-IR (SMD, −0.99; CI −1.52 to −0.47, P=0.0002; I2=86%, P<0.00001 for heterogeneity). Pooled results on effects of probiotics on FPG, CRP, or lipid profile were either non-significant or highly heterogeneous. Conclusions This meta-analysis demonstrated that probiotics supplementation was associated with significant improvement in HbA1c and fasting insulin in type 2 diabetes patients. More randomized placebo-controlled trials with large sample sizes are warranted to confirm our conclusions. PMID:28638006

Randomized controlled trials in children's heart surgery in the 21st century: a systematic review.

PubMed

Drury, Nigel E; Patel, Akshay J; Oswald, Nicola K; Chong, Cher-Rin; Stickley, John; Barron, David J; Jones, Timothy J

2018-04-01

Randomized controlled trials are the gold standard for evaluating health care interventions, yet are uncommon in children's heart surgery. We conducted a systematic review of clinical trials in paediatric cardiac surgery to evaluate the scope and quality of the current international literature. We searched MEDLINE, CENTRAL and LILACS, and manually screened retrieved references and systematic reviews to identify all randomized controlled trials reporting the effect of any intervention on the conduct or outcomes of heart surgery in children published in any language since January 2000; secondary publications and those reporting inseparable adult data were excluded. Two reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases. We identified 333 trials from 34 countries randomizing 23 902 children. Most were early phase (313, 94.0%), recruiting few patients (median 45, interquartile range 28-82), and only 11 (3.3%) directly evaluated a surgical intervention. One hundred and nine (32.7%) trials calculated a sample size, 52 (15.6%) reported a CONSORT diagram, 51 (15.3%) were publicly registered and 25 (7.5%) had a Data Monitoring Committee. The overall risk of bias was low in 22 (6.6%), high in 69 (20.7%) and unclear in 242 (72.7%). The recent literature in children's heart surgery contains few late-phase clinical trials. Most trials did not conform to the accepted standards of reporting, and the overall risk of bias was low in few studies. There is a need for high-quality, multicentre clinical trials to provide a robust evidence base for contemporary paediatric cardiac surgical practice.

Randomized controlled trials in children’s heart surgery in the 21st century: a systematic review

PubMed Central

Drury, Nigel E; Patel, Akshay J; Oswald, Nicola K; Chong, Cher-Rin; Stickley, John; Barron, David J; Jones, Timothy J

2018-01-01

Abstract OBJECTIVES Randomized controlled trials are the gold standard for evaluating health care interventions, yet are uncommon in children’s heart surgery. We conducted a systematic review of clinical trials in paediatric cardiac surgery to evaluate the scope and quality of the current international literature. METHODS We searched MEDLINE, CENTRAL and LILACS, and manually screened retrieved references and systematic reviews to identify all randomized controlled trials reporting the effect of any intervention on the conduct or outcomes of heart surgery in children published in any language since January 2000; secondary publications and those reporting inseparable adult data were excluded. Two reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases. RESULTS We identified 333 trials from 34 countries randomizing 23 902 children. Most were early phase (313, 94.0%), recruiting few patients (median 45, interquartile range 28–82), and only 11 (3.3%) directly evaluated a surgical intervention. One hundred and nine (32.7%) trials calculated a sample size, 52 (15.6%) reported a CONSORT diagram, 51 (15.3%) were publicly registered and 25 (7.5%) had a Data Monitoring Committee. The overall risk of bias was low in 22 (6.6%), high in 69 (20.7%) and unclear in 242 (72.7%). CONCLUSIONS The recent literature in children’s heart surgery contains few late-phase clinical trials. Most trials did not conform to the accepted standards of reporting, and the overall risk of bias was low in few studies. There is a need for high-quality, multicentre clinical trials to provide a robust evidence base for contemporary paediatric cardiac surgical practice. PMID:29186478

Results of the HepZero study comparing heparin-grafted membrane and standard care show that heparin-grafted dialyzer is safe and easy to use for heparin-free dialysis.

PubMed

Laville, Maurice; Dorval, Marc; Fort Ros, Joan; Fay, Renaud; Cridlig, Joëlle; Nortier, Joëlle L; Juillard, Laurent; Dębska-Ślizień, Alicja; Fernández Lorente, Loreto; Thibaudin, Damien; Franssen, Casper; Schulz, Michael; Moureau, Frédérique; Loughraieb, Nathalie; Rossignol, Patrick

2014-12-01

Heparin is used to prevent clotting during hemodialysis, but heparin-free hemodialysis is sometimes needed to decrease the risk of bleeding. The HepZero study is a randomized, multicenter international controlled open-label trial comparing no-heparin hemodialysis strategies designed to assess non-inferiority of a heparin grafted dialyzer (NCT01318486). A total of 251 maintenance hemodialysis patients at increased risk of hemorrhage were randomly allocated for up to three heparin-free hemodialysis sessions using a heparin-grafted dialyzer or the center standard-of-care consisting of regular saline flushes or pre-dilution. The first heparin-free hemodialysis session was considered successful when there was neither complete occlusion of air traps or dialyzer, nor additional saline flushes, changes of dialyzer or bloodlines, or premature termination. The current standard-of-care resulted in high failure rates (50%). The success rate in the heparin-grafted membrane arm was significantly higher than in the control group (68.5% versus 50.4%), which was consistent for both standard-of-care modalities. The absolute difference between the heparin-grafted membrane and the controls was 18.2%, with a lower bound of the 90% confidence interval equal to plus 7.9%. The hypothesis of the non-inferiority at the minus 15% level was accepted, although superiority at the plus 15% level was not reached. Thus, use of a heparin-grafted membrane is a safe, helpful, and easy-to-use method for heparin-free hemodialysis in patients at increased risk of hemorrhage.

Standard versus Rotation Technique for Insertion of Supraglottic Airway Devices: Systematic Review and Meta-Analysis

PubMed Central

Park, Jin Ha; Lee, Jong Seok; Nam, Sang Beom; Ju, Jin Wu

2016-01-01

Purpose Supraglottic airway devices have been widely utilized as an alternative to tracheal intubation in various clinical situations. The rotation technique has been proposed to improve the insertion success rate of supraglottic airways. However, the clinical efficacy of this technique remains uncertain as previous results have been inconsistent, depending on the variable evaluated. Materials and Methods We systematically searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials in April 2015 for randomized controlled trials that compared the rotation and standard techniques for inserting supraglottic airways. Results Thirteen randomized controlled trials (1505 patients, 753 with the rotation technique) were included. The success rate at the first attempt was significantly higher with the rotation technique than with the standard technique [relative risk (RR): 1.13; 95% confidence interval (CI): 1.05 to 1.23; p=0.002]. The rotation technique provided significantly higher overall success rates (RR: 1.06; 95% CI: 1.04 to 1.09; p<0.001). Device insertion was completed faster with the rotation technique (mean difference: -4.6 seconds; 95% CI: -7.37 to -1.74; p=0.002). The incidence of blood staining on the removed device (RR: 0.36; 95% CI: 0.27 to 0.47; p<0.001) was significantly lower with the rotation technique. Conclusion The rotation technique provided higher first-attempt and overall success rates, faster insertion, and a lower incidence of blood on the removed device, reflecting less mucosal trauma. Thus, it may be considered as an alternative to the standard technique when predicting or encountering difficulty in inserting supraglottic airways. PMID:27189296

A systematic review of Investigator Global Assessment (IGA) in atopic dermatitis (AD) trials: Many options, no standards.

PubMed

Futamura, Masaki; Leshem, Yael A; Thomas, Kim S; Nankervis, Helen; Williams, Hywel C; Simpson, Eric L

2016-02-01

Investigators often use global assessments to provide a snapshot of overall disease severity in dermatologic clinical trials. Although easy to perform, the frequency of use and standardization of global assessments in studies of atopic dermatitis (AD) is unclear. We sought to assess the frequency, definitions, and methods of analysis of Investigator Global Assessment in randomized controlled trials of AD. We conducted a systematic review using all published randomized controlled trials of AD treatments in the Global Resource of Eczema Trials database (2000-2014). We determined the frequency of global scales application and defining features. Among 317 trials identified, 101 trials (32%) used an investigator-performed global assessment as an outcome measure. There was large variability in global assessments between studies in nomenclature, scale size, definitions, outcome description, and analysis. Both static and dynamic scales were identified that ranged from 4- to 7-point scales. North American studies used global assessments more commonly than studies from other countries. The search was restricted to the Global Resource of Eczema Trials database. Global assessments are used frequently in studies of AD, but their complete lack of standardized definitions and implementation preclude any meaningful comparisons between studies, which in turn impedes data synthesis to inform clinical decision-making. Standardization is urgently required. Copyright © 2015. Published by Elsevier Inc.

Topical oxygen therapy results in complete wound healing in diabetic foot ulcers.

PubMed

Yu, Janelle; Lu, Suzanne; McLaren, Ann-Marie; Perry, Julie A; Cross, Karen M

2016-11-01

Diabetic foot ulcers (DFUs) are a significant problem in an aging population. Fifteen percent of diabetics develop a DFU over their lifetime, which can lead to potential amputation. The 5-year survival rate after amputation is 31%, which is greater than the lifetime risk of mortality from cancer. Topical oxygen is a promising technique for the adjunctive therapy of chronic wounds including DFUs, but few controlled studies exist to support its clinical adoption. The aim of this study was to compare a portable topical oxygen delivery system in patients with nonhealing DFUs to standard best practice. Twenty patients were randomized into a topical oxygen group (n = 10), and a nonplacebo control group with regular dressings and standard care (n = 10), and attended the diabetic foot clinic once weekly for 8 weeks. Ulcer surface area over time was analyzed using standardized digital imaging software. DFUs were present without healing for a mean duration of 76 weeks prior to the study. They found a significant difference in healing rate between patients receiving topical oxygen and those receiving standard care. Topical oxygen, therefore, represents a potentially exciting new technology to shorten healing time in patients with nonhealing DFUs. More prospective randomized and powered studies are needed to determine the benefits of topical oxygen, but our current results are very promising. © 2016 by the Wound Healing Society.

The Oregon health insurance experiment: when limited policy resources provide research opportunities.

PubMed

Allen, Heidi; Baicker, Katherine; Taubman, Sarah; Wright, Bill; Finkelstein, Amy

2013-12-01

In 2008 Oregon allocated access to its Medicaid expansion program, Oregon Health Plan Standard, by drawing names from a waiting list by lottery. The lottery was chosen by policy makers and stakeholders as the preferred way to allocate limited resources. At the same time, it also gave rise to the Oregon Health Insurance Experiment: an unprecedented opportunity to do a randomized evaluation - the gold standard in medical and scientific research - of the impact of expanding Medicaid. In this article we provide historical context for Oregon's decision to conduct a lottery, discuss the importance of randomized controlled designs for policy evaluation, and describe some of the practical challenges in successfully capitalizing on the research opportunity presented by the Oregon lottery through public-academic partnerships. Since policy makers will always face tough choices about how to distribute scarce resources, we urge thoughtful consideration of the opportunities to incorporate randomization that can substantially improve the evidence available to inform policy decisions without compromising policy goals.

Music therapy for mood disturbance during hospitalization for autologous stem cell transplantation: a randomized controlled trial.

PubMed

Cassileth, Barrie R; Vickers, Andrew J; Magill, Lucanne A

2003-12-15

High-dose therapy with autologous stem cell transplantation (HDT/ASCT) is a commonly used treatment for hematologic malignancies. The procedure causes significant psychological distress and no interventions have been demonstrated to improve mood in these patients. Music therapy has been shown to improve anxiety in a variety of acute medical settings. In the current study, the authors determined the effects of music therapy compared with standard care on mood during inpatient stays for HDT/ASCT. Patients with hematologic malignancy admitted for HDT/ASCT at two sites (Memorial Sloan-Kettering Cancer Center and Ireland Cancer Center in Cleveland, Ohio) were randomized to receive music therapy given by trained music therapists or standard care. Outcome was assessed at baseline and every 3 days after randomization using the Profile of Mood States. Of 69 patients registered in the study, follow-up data were available for 62 (90%). During their inpatient stay, patients in the music therapy group scored 28% lower on the combined Anxiety/Depression scale (P = 0.065) and 37% lower (P = 0.01) on the total mood disturbance score compared with controls. Music therapy is a noninvasive and inexpensive intervention that appears to reduce mood disturbance in patients undergoing HDT/ASCT. Copyright 2003 American Cancer Society.

Improving informed consent to chemotherapy: a randomized controlled trial of written information versus an interactive multimedia CD-ROM.

PubMed

Olver, Ian N; Whitford, Hayley S; Denson, Linley A; Peterson, Melissa J; Olver, Scott I

2009-02-01

This randomized controlled trial aimed to determine whether an interactive CD-ROM improved cancer patients' recall of chemotherapy treatment information over standard written information, and whether demographic, cognitive, and psychological factors better predicted recall than this format of delivery. One-hundred-and-one new patients about to commence chemotherapy were randomized to receive written information or a CD-ROM containing treatment information before giving informed consent. Patients' recall, concentration, short-term memory, reading comprehension, anxiety, depression, and coping styles were assessed with standardized measures pre-treatment. Seventy-seven patients completed tests for recall of treatment information before their second chemotherapy session. Intention-to-treat analyses indicated no significant differences between the written information and CD-ROM groups across recall questions about number of drugs received (p=.43), treatment length (p=.23), and treatment goal (p=.69). Binary logistic regressions indicated that for groups combined different variables predicted each of the recall questions. An interactive CD-ROM did not improve cancer patients' recall of treatment information enough to warrant changes in consent procedures. Different variables predicted recall of different treatment aspects highlighting the complex nature of attempting to improve patient recall. Attending to the effect of depression on patient knowledge and understanding appears paramount.

Comparison of Address-based Sampling and Random-digit Dialing Methods for Recruiting Young Men as Controls in a Case-Control Study of Testicular Cancer Susceptibility

PubMed Central

Clagett, Bartholt; Nathanson, Katherine L.; Ciosek, Stephanie L.; McDermoth, Monique; Vaughn, David J.; Mitra, Nandita; Weiss, Andrew; Martonik, Rachel; Kanetsky, Peter A.

2013-01-01

Random-digit dialing (RDD) using landline telephone numbers is the historical gold standard for control recruitment in population-based epidemiologic research. However, increasing cell-phone usage and diminishing response rates suggest that the effectiveness of RDD in recruiting a random sample of the general population, particularly for younger target populations, is decreasing. In this study, we compared landline RDD with alternative methods of control recruitment, including RDD using cell-phone numbers and address-based sampling (ABS), to recruit primarily white men aged 18–55 years into a study of testicular cancer susceptibility conducted in the Philadelphia, Pennsylvania, metropolitan area between 2009 and 2012. With few exceptions, eligible and enrolled controls recruited by means of RDD and ABS were similar with regard to characteristics for which data were collected on the screening survey. While we find ABS to be a comparably effective method of recruiting young males compared with landline RDD, we acknowledge the potential impact that selection bias may have had on our results because of poor overall response rates, which ranged from 11.4% for landline RDD to 1.7% for ABS. PMID:24008901

The Clinical Effects of Aromatherapy Massage on Reducing Pain for the Cancer Patients: Meta-Analysis of Randomized Controlled Trials

PubMed Central

Chen, Ting-Hao; Tung, Tao-Hsin; Chen, Pei-Shih; Wang, Shu-Hui; Chao, Chuang-Min; Hsiung, Nan-Hsing; Chi, Ching-Chi

2016-01-01

Purpose. Aromatherapy massage is an alternative treatment in reducing the pain of the cancer patients. This study was to investigate whether aromatherapy massage could improve the pain of the cancer patients. Methods. We searched PubMed and Cochrane Library for relevant randomized controlled trials without language limitations between 1 January 1990 and 31 July 2015 with a priori defined inclusion and exclusion criteria. The search terms included aromatherapy, essential oil, pain, ache, cancer, tumor, and carcinoma. There were 7 studies which met the selection criteria and 3 studies were eventually included among 63 eligible publications. Results. This meta-analysis included three randomized controlled trials with a total of 278 participants (135 participants in the massage with essential oil group and 143 participants in the control (usual care) group). Compared with the control group, the massage with essential oil group had nonsignificant effect on reducing the pain (standardized mean difference = 0.01; 95% CI [−0.23,0.24]). Conclusion. Aromatherapy massage does not appear to reduce pain of the cancer patients. Further rigorous studies should be conducted with more objective measures. PMID:26884799

Knee osteoarthritis and role for surgical intervention: lessons learned from randomized clinical trials and population-based cohorts.

PubMed

Buchbinder, Rachelle; Richards, Bethan; Harris, Ian

2014-03-01

Over the last decade, there has been increased recognition of the importance of high-quality randomized controlled trials in determining the role of surgery for knee osteoarthritis. This review highlights key findings from the best available studies, and considers whether or not this knowledge has resulted in better evidence-based care. Use of arthroscopy to treat knee osteoarthritis has not declined despite strong evidence-based recommendations that do not sanction its use. A large randomized controlled trial has demonstrated that arthroscopic partial meniscectomy followed by a standardized physical therapy program results in similar improvements in pain and function at 6 and 12 months in comparison to physical therapy alone in patients with knee osteoarthritis and a symptomatic meniscal tear, confirming the findings of two previous trials. Two recent randomized controlled trials have demonstrated that decision aids help people to reach better-informed decisions about total knee arthroplasty. A majority of studies have indicated that for people with obesity the positive results of total knee arthroplasty may be compromised by postoperative complications, particularly infection. More efforts are needed to overcome significant evidence-practice gaps in the surgical management of knee osteoarthritis, particularly arthroscopy. Decision aids are a promising tool.

Registry-based randomized controlled trials merged the strength of randomized controlled trails and observational studies and give rise to more pragmatic trials.

PubMed

Mathes, Tim; Buehn, Stefanie; Prengel, Peggy; Pieper, Dawid

2018-01-01

The objective of this study was to analyze the features of registry-based randomized trials (rRCTs). We systematically searched PubMed for rRCTs. Study selection was performed independently by two reviewers. We extracted all data in standardized tables and prepared descriptive summary statistics. The search resulted in 1,202 hits. We included 71 rRCTs. Most rRCTs were from Denmark and Sweden. Chronic conditions were considered in 82.2%. A preventive intervention was examined in 45.1%. The median of included patients was 2,000 (range: 69-246,079). Definition of the study population was mostly broad. Study procedures were regularly little standardized. The number of included and analyzed patients was the same in 82.1%. In half of the rRCTs, more than one registry was utilized. Various linkage techniques were used. In median, two outcomes were collected from the registry/ies. The median follow-up of the rRCTs was 5.3 years (range: 6 weeks to 27 years). Information on quality of registry data was reported in 11.3%. rRCTs can provide valid (randomization, low lost-to-follow-up rates, generalizable) patient important long-term comparative-effectiveness data for relative little effort. Researchers planning an RCT should always check whether existing registries can be used for data collection. Reporting on data quality must be improved for use in evidence synthesis. Copyright © 2017 Elsevier Inc. All rights reserved.

Multimedia support for improving preoperative patient education: a randomized controlled trial using the example of radical prostatectomy.

PubMed

Huber, Johannes; Ihrig, Andreas; Yass, Mohammed; Bruckner, Tom; Peters, Tim; Huber, Christian G; Konyango, Beryl; Lozankovski, Novica; Stredele, Regina J F; Moll, Peter; Schneider, Meike; Pahernik, Sascha; Hohenfellner, Markus

2013-01-01

Growing evidence supports the use of multimedia presentations for informing patients. Therefore, we supported preoperative education by adding a multimedia tool and examined the effects in a randomized controlled trial. We randomized German-speaking patients scheduled for radical prostatectomy at our center to receive either a multimedia-supported (MME) or a standard education (SE). Outcomes were measured in a structured interview. Primary outcome was patient satisfaction. In addition, we applied validated instruments to determine anxiety and measures of decision-making. Results were given by mean and standard deviation. For comparison of groups we used t test and chi-square test. For an explorative analysis we applied multivariate logistic regression. We randomized 203 patients to receive MME (n=102) or SE (n=101). Complete satisfaction with preoperative education was more frequent in the MME group (69 vs 52%, p=.016) and patients after MME reported more questions (5.7 vs 4.2, p=.018). There was no difference concerning the duration of talks and the number of recalled risks. However, perceived knowledge was higher after MME (1.3 vs 1.6, p=.037). Anxiety and measures of decision-making were comparable. Patients judged the multimedia tool very positive, and 74% of the MME group thought that their preoperative education had been superior to SE. Multimedia support should be considered worthwhile for improving the informed consent process before surgery (www.germanctr.de; DRKS00000096).

A clinical carepath for obese pregnant women: A pragmatic pilot cluster randomized controlled trial.

PubMed

McDonald, Sarah D; Viaje, Kristen A; Rooney, Rebecca A; Jarde, Alexander; Giglia, Lucia; Maxwell, Cynthia V; Small, David; Kelly, Tracy Pearce; Midwifery, B H Sc; Sabatino, Lisa; Thabane, Lehana

2018-05-17

Obese women are at increased risks for complications during pregnancy, birth and in their infants. Although guidelines have been established for the clinical care of obese pregnant women, management is sometimes suboptimal. Our goal was to determine the feasibility of implementing and testing a clinical carepath for obese pregnant women compared to standard care, in a pilot cluster randomized controlled trial (RCT). A pragmatic pilot cluster RCT was conducted, randomly allocating eight clinics to the carepath or standard care for obese pregnant women. Women were eligible if they had a prepregnancy body mass index of ≥ 30 kg/m 2 and a viable singleton < 21 weeks. The primary outcomes were the feasibility of conducting a full-scale cluster RCT (defined as > 80%: randomization of clinics, use in eligible women, and completeness of follow-up) and of the intervention (defined as > 80%: compliance with each step in the carepath, and recommendation of the carepath by clinicians to a colleague). All eight approached clinics agreed to participate and were randomized. Half of the intervention clinics used the carepath, resulting in < 80% uptake of eligible women. High follow-up (99.5%) was achieved, in 188 of 189 women. The carepath was feasible for numerous guideline-directed recommendations for screening, but less so for counselling topics. When the carepath was used in the majority of women, all clinicians, most of whom were midwives, reported they would recommend it to a colleague. The intervention group had significantly higher overall adherence to the guideline recommendations compared to control (relative risk 1.71, 95% confidence interval 1.57-1.87). In this pragmatic pilot cluster RCT, a guideline-directed clinical carepath improved some aspects of care of obese pregnant women and was recommended by clinicians, particularly midwives. A cluster RCT may not be feasible in a mix of obstetric and midwifery clinics, but may be feasible in midwifery clinics. This pragmatic pilot cluster RCT was registered on clinicaltrials.gov (identifier: NCT02534051 ).

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.

The role of randomized cluster crossover trials for comparative effectiveness testing in anesthesia: design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial.

PubMed

Spence, Jessica; Belley-Côté, Emilie; Lee, Shun Fu; Bangdiwala, Shrikant; Whitlock, Richard; LeManach, Yannick; Syed, Summer; Lamy, Andre; Jacobsohn, Eric; MacIsaac, Sarah; Devereaux, P J; Connolly, Stuart

2018-07-01

Increasingly, clinicians and researchers recognize that studies of interventions need to evaluate not only their therapeutic efficacy (i.e., the effect on an outcome in ideal, controlled settings) but also their real-world effectiveness in broad, unselected patient groups. Effectiveness trials inform clinical practice by comparing variations in therapeutic approaches that fall within the standard of care. In this article, we discuss the need for studies of comparative effectiveness in anesthesia and the limitations of individual patient randomized-controlled trials in determining comparative effectiveness. We introduce the concept of randomized cluster crossover trials as a means of answering questions of comparative effectiveness in anesthesia, using the design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial (Clinicaltrials.gov identifier NCT03053869).

Proton Pump Inhibitors Decrease Phlebotomy Need in HFE Hemochromatosis: Double-Blind Randomized Placebo-Controlled Trial.

PubMed

Vanclooster, Annick; van Deursen, Cees; Jaspers, Reggy; Cassiman, David; Koek, Ger

2017-09-01

Phlebotomy constitutes the established treatment for HFE-related hemochromatosis. Retrospective studies have suggested proton pump inhibitors (PPIs) reduce the need for phlebotomy in this population. We conducted a randomized controlled trial to prove this. Thirty p.C282Y homozygous patients were randomly allocated to PPI (pantoprazole 40 mg/day) or placebo for 12 months. Phlebotomies were performed when serum ferritin was > 100 μg/L. Phlebotomy need turned out to be significantly lower in patients taking PPI (P = .0052). PPI treatment significantly reduces the need for phlebotomies in p.C282Y homozygous patients. In view of the known long-term safety profile of PPI, they can be a valuable addition to standard therapy. Clinicaltrials.gov: NCT01524757. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Is there a role for e-cigarettes in smoking cessation?

PubMed

Leduc, Charlotte; Quoix, Elisabeth

2016-04-01

The use of e-cigarettes has dramatically increased over the past few years and their role in smoking cessation remains controversial. Several clinical studies have evaluated their efficacy in smoking cessation but most of them are prospective cohort studies. Only two randomized, controlled trials have compared e-cigarettes versus placebo or patches. A meta-analysis of these two randomized, controlled trials has been performed. Nicotine-containing e-cigarettes appear to help smokers unable to stop smoking altogether to reduce their cigarette consumption when compared with placebo. However, these results are rated 'low' by GRADE standards. Many cohort studies have been conducted, with contradictory results. For some, e-cigarettes could increase the risk of nonsmokers developing nicotine dependence and of current smokers maintaining their dependence. The debate remains open and more randomized trials are needed with long-term data about the efficacy and safety of e-cigarettes. © The Author(s), 2015.

Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder

PubMed Central

Schneider, Kristin L.; Pagoto, Sherry L.; Handschin, Barbara; Panza, Emily; Bakke, Susan; Liu, Qin; Blendea, Mihaela; Ockene, Ira S.; Ma, Yunsheng

2011-01-01

Background The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. Methods/Design Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. Discussion A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. Trial registration NCT01024790 PMID:21765864

Heart rate variability biofeedback in patients with alcohol dependence: a randomized controlled study

PubMed Central

Penzlin, Ana Isabel; Siepmann, Timo; Illigens, Ben Min-Woo; Weidner, Kerstin; Siepmann, Martin

2015-01-01

Background and objective In patients with alcohol dependence, ethyl-toxic damage of vasomotor and cardiac autonomic nerve fibers leads to autonomic imbalance with neurovascular and cardiac dysfunction, the latter resulting in reduced heart rate variability (HRV). Autonomic imbalance is linked to increased craving and cardiovascular mortality. In this study, we sought to assess the effects of HRV biofeedback training on HRV, vasomotor function, craving, and anxiety. Methods We conducted a randomized controlled study in 48 patients (14 females, ages 25–59 years) undergoing inpatient rehabilitation treatment. In the treatment group, patients (n=24) attended six sessions of HRV biofeedback over 2 weeks in addition to standard rehabilitative care, whereas, in the control group, subjects received standard care only. Psychometric testing for craving (Obsessive Compulsive Drinking Scale), anxiety (Symptom Checklist-90-Revised), HRV assessment using coefficient of variation of R-R intervals (CVNN) analysis, and vasomotor function assessment using laser Doppler flowmetry were performed at baseline, immediately after completion of treatment or control period, and 3 and 6 weeks afterward (follow-ups 1 and 2). Results Psychometric testing showed decreased craving in the biofeedback group immediately postintervention (OCDS scores: 8.6±7.9 post-biofeedback versus 13.7±11.0 baseline [mean ± standard deviation], P<0.05), whereas craving was unchanged at this time point in the control group. Anxiety was reduced at follow-ups 1 and 2 post-biofeedback, but was unchanged in the control group (P<0.05). Following biofeedback, CVNN tended to be increased (10.3%±2.8% post-biofeedback, 10.1%±3.5% follow-up 1, 10.1%±2.9% follow-up 2 versus 9.7%±3.6% baseline; P=not significant). There was no such trend in the control group. Vasomotor function assessed using the mean duration to 50% vasoconstriction of cutaneous vessels after deep inspiration was improved following biofeedback immediately postintervention and was unchanged in the control group (P<0.05). Conclusion Our data indicate that HRV biofeedback might be useful to decrease anxiety, increase HRV, and improve vasomotor function in patients with alcohol dependence when complementing standard rehabilitative inpatient care. PMID:26557753

Mindfulness Therapy for Maladaptive Interpersonal Dependency: A Preliminary Randomized Controlled Trial.

PubMed

McClintock, Andrew S; Anderson, Timothy; Cranston, Saryn

2015-11-01

Existing treatments for maladaptive interpersonal dependency and dependent personality disorder do not meet basic scientific standards for effectiveness. The present investigation tested the efficacy of a mindfulness-based approach: mindfulness therapy for maladaptive interpersonal dependency (MT-MID). Forty-eight participants who reported consistently high levels of maladaptive dependency (i.e., scored higher than 1 standard deviation above the mean on the Interpersonal Dependency Inventory at two separate assessments) were randomized to either 5 sessions of MT-MID or a minimal contact control. Five self-reported outcomes (mindfulness, maladaptive interpersonal dependency, helplessness, fears of negative evaluation, and excessive reassurance seeking) were assessed at pretreatment, posttreatment, and a 4-week follow-up. Intent-to-treat analyses indicated that MT-MID yielded greater improvements than the control on all 5 outcomes at posttreatment (median d=1.61) and follow-up (median d=1.51). Participants assigned to MT-MID were more likely than control participants to meet criteria for clinically significant change at posttreatment (56.5% vs. 0%) and follow-up (42.9% vs. 0%). There was also evidence that increases in mindfulness mediated the dependency-related improvements. These results provide preliminary support for the efficacy of a mindfulness-based approach for treating the symptoms of maladaptive dependency. Copyright © 2015. Published by Elsevier Ltd.

Triadic Gaze Intervention for Young Children with Physical Disabilities

PubMed Central

Olswang, Lesley B.; Dowden, Patricia; Feuerstein, Julie; Greenslade, Kathryn; Pinder, Gay Lloyd; Fleming, Kandace

2018-01-01

Purpose This randomized controlled study investigated whether a supplemental treatment designed to teach triadic gaze (TG) as a signal of coordinated joint attention (CJA) would yield a significantly greater increase in TG in the experimental versus control group. Method Eighteen 10- to 24-month-old children with severe motor impairments were randomly assigned to an experimental (n=9) or control group (n=9). For approximately 29 sessions over 17 weeks, experimental participants received TG treatment twice weekly with a speech-language pathologist (SLP) in addition to standard practice. Controls received only standard practice from birth-to-three therapists. Coders masked to group assignment coded TG productions with an unfamiliar SLP at baseline, every three weeks during the experimental phase, and at the final measurement session. Results TG increased across groups from baseline to final measurement, with the experimental group showing slightly greater change. Performance trends were examined using experimental phase moving averages. Comparisons revealed significant differences between groups at two time points (at 12 weeks, r= .30, a medium effect and at the end of the phase r=.50, large effect). Conclusion Results suggest the promise of a short-term, focused treatment to teach TG as a behavioral manifestation of CJA to children with severe physical disabilities. PMID:24686825

Endothelial Dysfunction in Resuscitated Cardiac Arrest (ENDO-RCA): safety and efficacy of low-dose prostacyclin administration and blood pressure target in addition to standard therapy, as compared to standard therapy alone, in post-cardiac arrest syndrome patients: study protocol for a randomized controlled trial.

PubMed

Meyer, Anna Sina P; Ostrowski, Sisse R; Kjaergaard, Jesper; Johansson, Pär I; Hassager, Christian

2016-08-02

Morbidity and mortality following initial survival of cardiac arrest remain high despite great efforts to improve resuscitation techniques and post-resuscitation care, in part due to the ischemia-reperfusion injury secondary to the restoration of the blood circulation. Patients resuscitated from cardiac arrest display evidence of endothelial injury and coagulopathy (hypocoagulability, hyperfibrinolysis), which in associated with poor outcome. Recent randomized controlled trials have revealed that treatment with infusion of prostacyclin reduces endothelial damage after major surgery and AMI. Thus, a study is pertinent to investigate if prostacyclin infusion as a therapeutic intervention reduces endothelial damage without compromising, or even improving, the hemostatic competence in resuscitated cardiac arrest patients. Post-cardiac arrest patients frequently have a need for vasopressor therapy (catecholamines) to achieve the guideline-supported blood pressure goals. To evaluate a possible catecholamine interaction with the primary endpoints of this study, included patients will be randomized into two different blood pressure goals within guideline-recommended targets. A randomized, placebo-controlled, double-blind investigator-initiated pilot trial in 40 out-of-hospital-cardiac-arrest (OHCA) patients will be conducted. Patients will be randomly assigned to either the active treatment group (48 hours of active study drug (iloprost, 1 ng/kg/min) or to the control group [placebo (saline) infusion]. Target mean blood pressure levels will be allocated 1:1 to 65 mmHg or approximately 75 mmHg, which gives four different permutations, namely: (i) iloprost/65 mHg, (ii) iloprost/75 mmHg, (iii) placebo/65 mmHg, and (iv) placebo/75 mmHg. All randomized patients will be treated in accordance with state-of-the art therapy including targeted temperature management. The primary endpoint of this study is change in biomarkers indicative of endothelial activation and damage, [soluble thrombomodulin (sTM), sE-selectin, syndecan-1, soluble vascular endothelial growth factor (sVEGF), nucleosomes] and sympathoadrenal over activation (epinephrine/norepinephrine) from baseline to 48 hours post-randomization. The secondary endpoints of this trial will include: (1) the hemostatic profile [change in functional hemostatic blood test (thrombelastography (TEG) and whole blood platelet aggregometry (multiplate)) blood cell and endothelial cell-derived microparticles]; (2) feasibility of blood pressure target intervention (target 90 %); (3) interaction of primary endpoints and blood pressure target; (4) levels of neuron-specific enolase at 48 hours post-inclusion according to blood pressure targets. The ENDO-RCA study is a pilot study trial that investigates safety and efficacy of low-dose infusion of prostacyclin administration as compared to standard therapy in post-cardiac arrest syndrome patients. Trial registration at ClinicalTrials.gov (identifier NCT02685618 ) on 18 February 2016.

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.

Predictors of outcome from computer-based treatment for substance use disorders: Results from a randomized clinical trial.

PubMed

Kim, Sunny Jung; Marsch, Lisa A; Guarino, Honoria; Acosta, Michelle C; Aponte-Melendez, Yesenia

2015-12-01

Although empirical evidence for the effectiveness of technology-mediated interventions for substance use disorders is rapidly growing, the role of baseline characteristics of patients in predicting treatment outcomes of a technology-based therapy is largely unknown. Participants were randomly assigned to either standard methadone maintenance treatment or reduced standard treatment combined with the computer-based therapeutic education system (TES). An array of demographic and behavioral characteristics of participants (N=160) was measured at baseline. Opioid abstinence and treatment retention were measured weekly for a 52-week intervention period. Generalized linear model and Cox-regression were used to estimate the predictive roles of baseline characteristics in predicting treatment outcomes. We found significant predictors of opioid abstinence and treatment retention within and across conditions. Among 21 baseline characteristics of participants, employment status, anxiety, and ambivalent attitudes toward substance use predicted better opioid abstinence in the reduced-standard-plus-TES condition compared to standard treatment. Participants who had used cocaine/crack in the past 30 days at baseline showed lower dropout rates in standard treatment, whereas those who had not used exhibited lower dropout rates in the reduced-standard-plus-TES condition. This study is the first randomized controlled trial, evaluating over a 12-month period, how various aspects of participant characteristics impact outcomes for treatments that do or do not include technology-based therapy. Compared to standard alone treatment, including TES as part of the care was preferable for patients who were employed, highly anxious, and ambivalent about substance use and did not produce worse outcomes for any subgroups of participants. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

School Programs Targeting Stress Management in Children and Adolescents: A Meta-Analysis

ERIC Educational Resources Information Center

Kraag, Gerda; Zeegers, Maurice P.; Kok, Gerjo; Hosman, Clemens; Abu-Saad, Huda Huijer

2006-01-01

Introduction: This meta-analysis evaluates the effect of school programs targeting stress management or coping skills in school children. Methods: Articles were selected through a systematic literature search. Only randomized controlled trials or quasi-experimental studies were included. The standardized mean differences (SMDs) between baseline…

Poor Implementation of Learner-Centered Practices: A Cautionary Tale

ERIC Educational Resources Information Center

Ikemoto, Gina Schuyler; Steele, Jennifer L.; Pane, John F.

2016-01-01

Many school systems are adopting new curricula in response to more rigorous standards that require higher-order thinking skills. This chapter presents implementation findings from a randomized, controlled trial of the Cognitive Tutor Geometry curriculum. We found a significant negative effect on student achievement despite the curriculum's focus…

Examining the Efficacy of a Tier 2 Kindergarten Mathematics Intervention

ERIC Educational Resources Information Center

Clarke, Ben; Doabler, Christian T.; Smolkowski, Keith; Baker, Scott K.; Fien, Hank; Cary, Mari Strand

2016-01-01

This study examined the efficacy of a Tier 2 kindergarten mathematics intervention program, ROOTS, focused on developing whole number understanding for students at risk in mathematics. A total of 29 classrooms were randomly assigned to treatment (ROOTS) or control (standard district practices) conditions. Measures of mathematics achievement were…

What Is the Minimum Information Needed to Estimate Average Treatment Effects in Education RCTs?

ERIC Educational Resources Information Center

Schochet, Peter Z.

2014-01-01

Randomized controlled trials (RCTs) are considered the "gold standard" for evaluating an intervention's effectiveness. Recently, the federal government has placed increased emphasis on the use of opportunistic experiments. A key criterion for conducting opportunistic experiments, however, is that there is relatively easy access to data…

Problem-Solving Therapy for Depression in Adults: A Systematic Review

ERIC Educational Resources Information Center

Gellis, Zvi D.; Kenaley, Bonnie

2008-01-01

Objectives: This article presents a systematic review of the evidence on problem-solving therapy (PST) for depressive disorders in noninstitutionalized adults. Method: Intervention studies using randomized controlled designs are included and methodological quality is assessed using a standard set of criteria from the Cochrane Collaborative Review…

Accelerating Recovery from Poverty: Prevention Effects for Recently Separated Mothers

ERIC Educational Resources Information Center

Forgatch, Marion S.; DeGarmo, David S.

2007-01-01

This study evaluated benefits of a preventive intervention to the living standards of recently separated mothers. In the Oregon Divorce Study's randomized experimental design, data were collected 5 times over 30 months and evaluated with Hierarchical Linear Growth Models. Relative to their no-intervention control counterparts, experimental mothers…

Are There Benefits from Teaching Yoga at Schools? A Systematic Review of Randomized Control Trials of Yoga-Based Interventions

PubMed Central

Ferreira-Vorkapic, C.; Feitoza, J. M.; Marchioro, M.; Simões, J.; Telles, S.

2015-01-01

Introduction. Yoga is a holistic system of varied mind-body practices that can be used to improve mental and physical health and it has been utilized in a variety of contexts and situations. Educators and schools are looking to include yoga as a cost-effective, evidence-based component of urgently needed wellness programs for their students. Objectives. The primary goal of this study was to systematically examine the available literature for yoga interventions exclusively in school settings, exploring the evidence of yoga-based interventions on academic, cognitive, and psychosocial benefits. Methods. An extensive search was conducted for studies published between 1980 and October 31, 2014 (PubMed, PsycInfo, Embase, ISI, and the Cochrane Library). Effect size analysis, through standardized mean difference and Hedges'g, allowed for the comparison between experimental conditions. Results and Conclusions. Nine randomized control trials met criteria for inclusion in this review. Effect size was found for mood indicators, tension and anxiety in the POMS scale, self-esteem, and memory when the yoga groups were compared to control. Future research requires greater standardization and suitability of yoga interventions for children. PMID:26491461

The effect of topical application of pure honey on radiation-induced mucositis: a randomized clinical trial.

PubMed

Motallebnejad, M; Akram, S; Moghadamnia, A; Moulana, Z; Omidi, S

2008-03-01

Radiation-induced mucositis is an early effect of head and neck radiotherapy. Mucositis can cause ulcers, and patients may experience pain and dysphasia which need treatment. The aim of this study is to evaluate the effect of pure natural honey on radiation induced mucositis. In this randomized single blind (examiner blind) clinical trial 40 patients with head and neck cancer requiring radiation to the oropharyngeal mucosa were randomly assigned to two groups. Twenty patients assigned to the study group received honey, while both the study and control groups received standard head and neck radiation therapy based on a standard protocol. In the study group patients were instructed to take 20 ml of honey 15 minutes before radiation therapy, then again at intervals of 15 minutes and six hours after radiation. In the control group patients were instructed to rinse with 20 ml of saline before and after radiation. Patients were evaluated weekly for progression of mucositis using the Oral Mucositis Assessing Scale (OMAS). Data were analyzed using the independent t-test, Mann-Whitney, and Friedman tests. A significant reduction in mucositis among honey-received patients compared with controls (p=0.000) occurred. Within the limits of this study the results showed the application of natural honey is effective in managing radiation induced mucositis. Natural honey is a product with rich nutritional qualities that could be a pleasant, simple, and economic modality for the management of radiation mucositis.

Wanted: A Positive Control for Anomalous Subdiffusion

PubMed Central

Saxton, Michael J.

2012-01-01

Anomalous subdiffusion in cells and model systems is an active area of research. The main questions are whether diffusion is anomalous or normal, and if it is anomalous, its mechanism. The subject is controversial, especially the hypothesis that crowding causes anomalous subdiffusion. Anomalous subdiffusion measurements would be strengthened by an experimental standard, particularly one able to cross-calibrate the different types of measurements. Criteria for a calibration standard are proposed. First, diffusion must be anomalous over the length and timescales of the different measurements. The length-scale is fundamental; the time scale can be adjusted through the viscosity of the medium. Second, the standard must be theoretically well understood, with a known anomalous subdiffusion exponent, ideally readily tunable. Third, the standard must be simple, reproducible, and independently characterizable (by, for example, electron microscopy for nanostructures). Candidate experimental standards are evaluated, including obstructed lipid bilayers; aqueous systems obstructed by nanopillars; a continuum percolation system in which a prescribed fraction of randomly chosen obstacles in a regular array is ablated; single-file diffusion in pores; transient anomalous subdiffusion due to binding of particles in arrays such as transcription factors in randomized DNA arrays; and computer-generated physical trajectories. PMID:23260043

On-line preparatory information for children and their families undergoing dental extractions under general anesthesia: A phase III randomized controlled trial.

PubMed

Huntington, Corinne; Liossi, Christina; Donaldson, Ana Nora; Newton, Jonathan Timothy; Reynolds, Patricia A; Alharatani, Reham; Hosey, Marie Therese

2018-02-01

Family-centered interactive on-line games are increasingly popular in healthcare, but their effectiveness for preoperative preparation needs further research. www.scottga.org is the new on-line version of a proven nonweb-based game for children and parents/caregivers. The aim of this study was to evaluate if www.scottga.org improved children's anxiety and families' satisfaction compared with controls. In this phase III double-blind randomized controlled trial, children/parents/caregivers received (i) www.scottga.org, (ii) standard care, or (iii) a placebo hand-washing game. The intervention and placebo games were available online for home usage and provided again on the ward before surgery. All children were accompanied by parent/caregivers at induction and observed and scored using validated measures. Stratified randomization and generalized linear models were used. An intention-to-treat approach was adopted. Overall, 52/176 children had baseline "psychological disturbance." Children's anxiety increased preinduction, but there were no differences between groups (Facial Image Scale: video-standard OR = 1.08, P = .82, 95% CI [0.56, 2.1]; video-placebo OR = 0.9, P = .77 95% CI [0.46, 1.8]). There were no differences in induction behavior (visual analog scale: video mean = 3.5; standard care mean = 3.5; placebo mean = 3.7: video-standard OR = 2.0, P = .42, 95% CI [-0.6, 1.3]; video-placebo OR = 1.53, P = .65, 95% CI [-0.8, 1.1]) or induction anxiety (modified Yale Preoperative Anxiety Scale: video-standard OR 1.02, P = .97, 95% CI [0.61, 2.6]; video-placebo OR 1.38, P = .49, 95% CI [0.87, 3.81]). Families favored the intervention regarding the "child handling the visit better" (Treatment Evaluation Inventory: video-standard OR = 12; 95% CI 4.7-32; P < .001; video-placebo OR = 8.2; 95% CI 3-22; P < .001) and "improving the child's ability to cope" (Treatment Evaluation Inventory: video-standard OR = 21; 95% CI 8-56; P < .001 and video-placebo OR = 13; 95% CI 5-34; P < .001). Families believed that a video-game preparation helped their child's perioperative anxiety, but there were no objective measures of behavioral improvement associated with this intervention. © 2017 The Authors. Pediatric Anesthesia Published by John Wiley & Sons Ltd.

Effects of programmed exercise on depressive symptoms in midlife and older women: A meta-analysis of randomized controlled trials.

PubMed

Pérez-López, Faustino R; Martínez-Domínguez, Samuel J; Lajusticia, Héctor; Chedraui, Peter

2017-12-01

To perform a systematic review and meta-analysis to clarify the effect of programmed exercise on depressive symptoms (DSs) in midlife and older women. We carried out a structured search of PubMed-Medline, Web of Science, Scopus, Embase, Cochrane Library and Scielo, from database inception through June 29, 2017, without language restriction. The search included the following terms: "depression", "depressive symptoms", "exercise", "physical activity", "menopause", and "randomized controlled trial" (RCTs) in midlife and older women. The US, UK and Australian Clinical Trials databases were also searched. We assessed randomized controlled trials (RCTs) that compared the effect of exercise for at least 6 weeks versus no intervention on DSs as the outcome (as defined by trial authors). Exercise was classified according to duration as "mid-term exercise intervention" (MTEI; lasting for 12 weeks to 4 months), and "long-term exercise intervention" (LTEI; lasting for 6-12 months). Mean changes (±standard deviations) in DSs, as assessed with different questionnaires, were extracted to calculate Hedges' g and then used as the effect size for meta-analysis. Standardized mean differences (SMDs) of DSs after intervention were pooled using a random-effects model. Eleven publications were included for analysis related to 1943 midlife and older women (age range 44-55 years minimum to 65.5±4.0 maximum), none of whom was using a hormone therapy. Seven MTEIs were associated with a significant reduction in DSs (SMD=-0.44; 95% CI -0.69, -0.18; p=0.0008) compared with controls. The reduction in DSs was also significant in six LTEIs (SMD=- 0.29; 95% CI -0.49; -0.09; p=0.005). Heterogeneity of effects among studies was moderate to high. Less perceived stress and insomnia (after exercise) were also found as secondary outcomes. Exercise of low to moderate intensity reduces depressive symptoms in midlife and older women. Copyright © 2017. Published by Elsevier B.V.

The Effectiveness and Cost-Effectiveness of Web-Based and Home-Based Postnatal Psychoeducational Interventions for First-Time Mothers: Randomized Controlled Trial Protocol

PubMed Central

Chong, Yap-Seng; Jiao, Nana; Luo, Nan

2018-01-01

Background In addition to recuperating from the physical and emotional demands of childbirth, first-time mothers are met with demands of adapting to their social roles while picking up new skills to take care of their newborn. Mothers may not feel adequately prepared for parenthood if they are situated in an unsupported environment. Postnatal psychoeducational interventions have been shown to be useful and can offer a cost-effective solution for improving maternal outcomes. Objective The objective of this study was to examine the effectiveness and cost-effectiveness of Web-based and home-based postnatal psychoeducational programs for first-time mothers on maternal outcomes. Methods A randomized controlled three-group pre- and posttests experimental design is proposed. This study plans to recruit 204 first-time mothers on their day of discharge from a public tertiary hospital in Singapore. Eligible first-time mothers will be randomly allocated to either a Web-based psychoeducation group, a home-based psychoeducation group, or a control group receiving standard care. The outcomes include maternal parental self-efficacy, social support, psychological well-being (anxiety and postnatal depression), and cost evaluation. Data will be collected at baseline, 1 month, 3 months, and 6 months post-delivery. Results The recruitment (n=204) commenced in October 2016 and was completed in February 2017, with 68 mothers in each group. The 6-month follow-up data collection was completed in August 2017. Conclusions This study may identify an effective and cost-effective Web-based postnatal psychoeducational program to improve first-time mothers’ health outcomes. The provision of a widely-accessed Web-based postnatal psychoeducational program will eventually lead to more positive postnatal experiences for first-time mothers and positively influence their future birth plans. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 45202278; http://www.isrctn.com/ISRCTN45202278 (Archived by WebCite at http://www.webcitation.org/6whx0pQ2F). PMID:29386175

Day care PNL using 'Santosh-PGI hemostatic seal' versus standard PNL: A randomized controlled study.

PubMed

Kumar, Santosh; Singh, Shivanshu; Singh, Prashant; Singh, Shrawan Kumar

2016-01-01

To compare the outcomes of tubeless day care PNL using hemostatic seal in the access tract versus standard PNL. It was a prospective randomized controlled study. Cases were randomized to either the day care group with hemostatic seal (DCS) or the control group where patients were admitted and a nephrostomy tube was placed at the conclusion of surgery. A total of 180 cases were screened and out of these, 113 were included in the final analysis. The stone clearance rates were comparable in both the groups. The mean drop in hemoglobin was significantly lower in DCS group than the control group (1.05 ±0.68 vs. 1.30 ±0.58 gm/dl, p = 0.038).Mean postoperative pain score, analgesic requirement (paracetamol) and duration of hospital stay were also significantly lower in the DCS group (3.79 ±1.23 vs. 6.12 ±0.96, 1.48 ±0.50 vs. 4.09 ±1.11 grams and 0.48 ±0.26 vs. 4.74 ±1.53 days respectively; p <0.05). The incidence of urine leakage through the access tract site was significantly lower in the DCS subgroup when compared to the controls (3.6% vs. 21.1%, p <0.05). Cases in the DCS group resumed their normal activities in a significantly shorter time (8.05 ±3.05 vs.18.42 ±4.42 days; p <0.05). Higher proportion of cases in the DCS group got re-admitted, although it was not a statistically significant number (7.1% vs. 1.8%; p = 0.21). Tubeless day care PNL with composite hemostatic tract seal is considered safe. It resulted in a significant reduction of blood loss and analgesic requirement with significantly reduced hospital stay, nephrostomy tube site morbidity and time required to resume normal activity when compared to the standard PNL. However, patients must be compliant with the given instructions and should have access to a health care facility, as few of them may need re-admission.

Day care PNL using ‘Santosh-PGI hemostatic seal’ versus standard PNL: A randomized controlled study

PubMed Central

Singh, Shivanshu; Singh, Prashant; Singh, Shrawan Kumar

2016-01-01

Introduction To compare the outcomes of tubeless day care PNL using hemostatic seal in the access tract versus standard PNL. Material and methods It was a prospective randomized controlled study. Cases were randomized to either the day care group with hemostatic seal (DCS) or the control group where patients were admitted and a nephrostomy tube was placed at the conclusion of surgery. Results A total of 180 cases were screened and out of these, 113 were included in the final analysis. The stone clearance rates were comparable in both the groups. The mean drop in hemoglobin was significantly lower in DCS group than the control group (1.05 ±0.68 vs. 1.30 ±0.58 gm/dl, p = 0.038).Mean postoperative pain score, analgesic requirement (paracetamol) and duration of hospital stay were also significantly lower in the DCS group (3.79 ±1.23 vs. 6.12 ±0.96, 1.48 ±0.50 vs. 4.09 ±1.11 grams and 0.48 ±0.26 vs. 4.74 ±1.53 days respectively; p <0.05). The incidence of urine leakage through the access tract site was significantly lower in the DCS subgroup when compared to the controls (3.6% vs. 21.1%, p <0.05). Cases in the DCS group resumed their normal activities in a significantly shorter time (8.05 ±3.05 vs.18.42 ±4.42 days; p <0.05). Higher proportion of cases in the DCS group got re-admitted, although it was not a statistically significant number (7.1% vs. 1.8%; p = 0.21). Conclusions Tubeless day care PNL with composite hemostatic tract seal is considered safe. It resulted in a significant reduction of blood loss and analgesic requirement with significantly reduced hospital stay, nephrostomy tube site morbidity and time required to resume normal activity when compared to the standard PNL. However, patients must be compliant with the given instructions and should have access to a health care facility, as few of them may need re-admission. PMID:27551557

A multifaceted feedback strategy alone does not improve the adherence to organizational guideline-based standards: a cluster randomized trial in intensive care.

PubMed

de Vos, Maartje L G; van der Veer, Sabine N; Wouterse, Bram; Graafmans, Wilco C; Peek, Niels; de Keizer, Nicolette F; Jager, Kitty J; Westert, Gert P; van der Voort, Peter H J

2015-07-08

Organizational data such as bed occupancy rate and nurse-to-patient ratio are related to clinical outcomes and to the efficient use of intensive care unit (ICU) resources. Standards for these performance indicators are provided in guidelines. We studied the effects of a multifaceted feedback strategy to improve the adherence to these standards. In a cluster randomized controlled study design the intervention ICUs received extensive monthly feedback reports, they received outreach visits and initiated a quality improvement team. The control ICUs received limited quarterly feedback reports only. We collected primary data prospectively within the setting of a Dutch national ICU registry over a 14-month study period. The target indicators were bed occupancy rate (aiming at 80 % or below) and nurse-to-patient ratio (aiming at 0.5 or higher). Data were collected per 8-h nursing shift. Logistic regression analysis was performed. For both study end points, the odds ratios (OR) for improvements at follow-up versus at baseline were calculated separately for control and intervention ICUs. We analyzed data on 67,237 nursing shifts. The bed occupancy rate did not improve in the intervention group compared to baseline (adjusted OR 0.88; 95 % confidence interval (CI), 0.62-1.27) or compared to control group (OR 0.67; 95 % CI 0.39-1.15). The nurse-to-patient ratio did not improve (OR 0.72; 95 % CI 0.41-1.26 compared to baseline and OR 0.65; 95 % CI 0.35-1.19 compared to control group). A multifaceted feedback intervention did not improve the adherence to guideline-based standards on the organizational issues bed occupancy rate and nurse-to-patient ratio in the ICU. The reasons may be a limited confidence in data quality, the lack of practical tools for improvement, and the relatively short follow-up. ISRCTN50542146.

How random is a random vector?

NASA Astrophysics Data System (ADS)

Eliazar, Iddo

2015-12-01

Over 80 years ago Samuel Wilks proposed that the "generalized variance" of a random vector is the determinant of its covariance matrix. To date, the notion and use of the generalized variance is confined only to very specific niches in statistics. In this paper we establish that the "Wilks standard deviation" -the square root of the generalized variance-is indeed the standard deviation of a random vector. We further establish that the "uncorrelation index" -a derivative of the Wilks standard deviation-is a measure of the overall correlation between the components of a random vector. Both the Wilks standard deviation and the uncorrelation index are, respectively, special cases of two general notions that we introduce: "randomness measures" and "independence indices" of random vectors. In turn, these general notions give rise to "randomness diagrams"-tangible planar visualizations that answer the question: How random is a random vector? The notion of "independence indices" yields a novel measure of correlation for Lévy laws. In general, the concepts and results presented in this paper are applicable to any field of science and engineering with random-vectors empirical data.

Efficacy and Safety of Oral and Transdermal Opioid Analgesics for Musculoskeletal Pain in Older Adults: A Systematic Review of Randomized, Placebo-Controlled Trials.

PubMed

Megale, Rodrigo Z; Deveza, Leticia A; Blyth, Fiona M; Naganathan, Vasi; Ferreira, Paulo H; McLachlan, Andrew J; Ferreira, Manuela L

2018-05-01

This systematic review with meta-analysis was performed to evaluate the efficacy and safety of using opioid analgesics in older adults with musculoskeletal pain. We searched Cochrane Library, MEDLINE, EMBASE, Web of Science, AMED, CINAHL, and LILACS for randomized controlled trials with mean population age of 60 years or older, comparing the efficacy and safety of opioid analgesics with placebo for musculoskeletal pain conditions. Reviewers extracted data, assessed risk of bias, and evaluated the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach. Random effects models were used to calculate standardized mean differences (when different scales were used across trials), mean differences and odds ratios with respective 95% confidence intervals (CIs). Meta-regressions were carried out to assess the influence of opioid analgesic daily dose and treatment duration on our main outcomes. We included 23 randomized placebo-controlled trials in the meta-analysis. Opioid analgesics had a small effect on decreasing pain intensity (standardized mean difference = -.27; 95% CI = -.33 to -.20) and improving function (standardized mean difference = -.27, 95% CI = -.36 to -.18), which was not associated with daily dose or treatment duration. The odds of adverse events were 3 times higher (odds ratio = 2.94; 95% CI = 2.33-3.72) and the odds of treatment discontinuation due to adverse events 4 times higher (odds ratio = 4.04; 95% CI = 3.10-5.25) in patients treated with opioid analgesics. The results show that in older adults suffering from musculoskeletal pain, using opioid analgesics had only a small effect on pain and function at the cost of a higher odds of adverse events and treatment discontinuation. For this specific population, the opioid-related risks may outweigh the benefits. The systematic review shows that, in older adults suffering from musculoskeletal conditions, opioid analgesics have only a small effect on pain and disability. Conversely, this population is at higher risk of adverse events. The results may reflect age-related physiological changes in pain processing, pharmacokinetics, and pharmacodynamics. Copyright © 2017 The American Pain Society. Published by Elsevier Inc. All rights reserved.

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.

Failing to Prepare Is Preparing to Fail: A Single-Blinded, Randomized Controlled Trial to Determine the Impact of a Preoperative Instructional Video on the Ability of Residents to Perform Laparoscopic Right Colectomy.

PubMed

Crawshaw, Benjamin P; Steele, Scott R; Lee, Edward C; Delaney, Conor P; Mustain, W Conan; Russ, Andrew J; Shanmugan, Skandan; Champagne, Bradley J

2016-01-01

Laparoscopic colorectal resection is an index case for advanced skills training, yet many residents struggle to reach proficiency by graduation. Current methods to reduce the learning curve for residents remain expensive, time consuming, and poorly validated. The purpose of this study was to assess the impact of the addition of a preprocedural instructional video to improve the ability of a general surgery resident to perform laparoscopic right colectomy when compared with standard preparation. This was a single-blinded, randomized control study. Four university-affiliated teaching hospitals were included in the study. General surgery residents in postgraduation years 2 through 5 participated. Residents were randomly assigned to preparation with a narrated instructional video versus standard preparation. Resident performance, scored by a previously validated global assessment scale, was measured. Fifty-four residents were included. Half (n = 27) were randomly assigned to view the training video and half (n = 27) to standard preparation. There were no differences between groups in terms of training level or previous operative experience or in patient demographics (all p > 0.05). Groups were similar in the percentage of the case completed by residents (p = 0.39) and operative time (p = 0.74). Residents in the video group scored significantly higher in total score (mean: 46.8 vs 42.3; p = 0.002), as well as subsections directly measuring laparoscopic skill (vascular control mean: 11.3 vs 9.7, p < 0.001; mobilization mean: 7.6 vs. 7.0, p = 0.03) and overall performance score (mean: 4.0 vs 3.1; p < 0.001). Statistical significance persisted across training levels. There is potential for Hawthorne effect, and the study is underpowered at the individual postgraduate year level. The simple addition of a brief, narrated preprocedural video to general surgery resident case preparation significantly increased trainee ability to successfully perform a laparoscopic right colectomy. In an era of shortened hours and less exposure to cases, incorporating a brief but effective instructional video before surgery may improve the learning curve of trainees and ultimately improve safety.

Implementation and evaluation of an integrated computerized asthma management system in a pediatric emergency department: a randomized clinical trial.

PubMed

Dexheimer, Judith W; Abramo, Thomas J; Arnold, Donald H; Johnson, Kevin; Shyr, Yu; Ye, Fei; Fan, Kang-Hsien; Patel, Neal; Aronsky, Dominik

2014-11-01

The use of evidence-based guidelines can improve the care for asthma patients. We implemented a computerized asthma management system in a pediatric emergency department (ED) to integrate national guidelines. Our objective was to determine whether patient eligibility identification by a probabilistic disease detection system (Bayesian network) combined with an asthma management system embedded in the workflow decreases time to disposition decision. We performed a prospective, randomized controlled trial in an urban, tertiary care pediatric ED. All patients 2-18 years of age presenting to the ED between October 2010 and February 2011 were screened for inclusion by the disease detection system. Patients identified to have an asthma exacerbation were randomized to intervention or control. For intervention patients, asthma management was computer-driven and workflow-integrated including computer-based asthma scoring in triage, and time-driven display of asthma-related reminders for re-scoring on the electronic patient status board combined with guideline-compliant order sets. Control patients received standard asthma management. The primary outcome measure was the time from triage to disposition decision. The Bayesian network identified 1339 patients with asthma exacerbations, of which 788 had an asthma diagnosis determined by an ED physician-established reference standard (positive predictive value 69.9%). The median time to disposition decision did not differ among the intervention (228 min; IQR=(141, 326)) and control group (223 min; IQR=(129, 316)); (p=0.362). The hospital admission rate was unchanged between intervention (25%) and control groups (26%); (p=0.867). ED length of stay did not differ among intervention (262 min; IQR=(165, 410)) and control group (247 min; IQR=(163, 379)); (p=0.818). The control and intervention groups were similar in regards to time to disposition; the computerized management system did not add additional wait time. The time to disposition decision did not change; however the management system integrated several different information systems to support clinicians' communication. Copyright © 2014. Published by Elsevier Ireland Ltd.

Effect of a decision aid with patient narratives in reducing decisional conflict in choice for surgery among early-stage breast cancer patients: A three-arm randomized controlled trial.

PubMed

Osaka, Wakako; Nakayama, Kazuhiro

2017-03-01

We aimed to evaluate the effect of a decision aid (DA) with patient narratives on decisional conflict in surgery choice for Japanese women with early-stage breast cancer. Two hundred ten women with early-stage breast cancer were randomly assigned to an intervention or control group. Groups 1 and 2 received standard information and a DA, with or without patient narratives, and Group 3 received standard information (control) before surgery choice. At baseline, post-intervention (Time 2), and 1 month after surgery (Time 3), we evaluated decisional conflict as the primary outcome using a decisional conflict scale (DCS). Sidak corrections for multiple comparisons in analysis of covariate were used to compare Time 2 and Time 3 DCS mean scores between each pair of groups. At Time 3, decisional conflict was significantly reduced for Group 1 vs control (P=0.021, Cohen's d =0.26) and Group 2 vs control (P=0.008, Cohen's d=0.40). The DAs with and without patient narratives are equivalently effective at reducing postoperative decisional conflict in Japanese women with early-stage breast cancer. The DAs with and without patient narratives can be used in clinical practice for women with early-stage breast cancer. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

CPAP treatment supported by telemedicine does not improve blood pressure in high cardiovascular risk OSA patients: a randomized, controlled trial.

PubMed

Mendelson, Monique; Vivodtzev, Isabelle; Tamisier, Renaud; Laplaud, David; Dias-Domingos, Sonia; Baguet, Jean-Philippe; Moreau, Laurent; Koltes, Christian; Chavez, Léonidas; De Lamberterie, Gilles; Herengt, Frédéric; Levy, Patrick; Flore, Patrice; Pépin, Jean-Louis

2014-11-01

Obstructive sleep apnea (OSA) has been associated with hypertension, which is one of the intermediary mechanisms leading to increased cardiovascular morbidity. This study aimed at evaluating the effects of a combination of continuous positive airway pressure (CPAP) and telemedicine support on blood pressure (BP) reduction in high cardiovascular risk OSA patients. A multi-center randomized controlled trial that compared standard CPAP care and CPAP care and a telemedicine intervention. Sleep clinics in France. 107 adult (18-65 years old) OSA patients (AHI > 15 events/h) with a high cardiovascular risk (cardiovascular SCORE > 5% or secondary prevention). Patients were randomized to either standard care CPAP (n = 53) or CPAP and telemedicine (n = 54). Patients assigned to telemedicine were equipped with a smartphone for uploading BP measurements, CPAP adherence, sleepiness, and quality of life data; in return, they received pictograms containing health-related messages. The main outcome was home self-measured BP and secondary outcomes were cardiovascular risk evolution, objective physical activity, CPAP adherence, sleepiness and quality of life. Self-measured BP did not improve in either group (telemedicine or standard care). Patients in primary prevention showed greater BP reduction with CPAP treatment than those in secondary prevention. CPAP treatment supported by telemedicine alone did not improve blood pressure and cardiovascular risk in high cardiovascular risk OSA patients. This study emphasizes the need for diet and physical activity training programs in addition to CPAP when aiming at decreasing cardiometabolic risk factors in these patients. ClinicalTrials.gov identifier: NCT01226641.

[Methodological quality and reporting quality evaluation of randomized controlled trials published in China Journal of Chinese Materia Medica].

PubMed

Yu, Dan-Dan; Xie, Yan-Ming; Liao, Xing; Zhi, Ying-Jie; Jiang, Jun-Jie; Chen, Wei

2018-02-01

To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials （1.09%） reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials. At the same time, in order to improve the reporting quality of randomized controlled trials, CONSORT standards should be adopted in the preparation of research reports and submissions. Copyright© by the Chinese Pharmaceutical Association.

Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial.

PubMed

Saper, Robert B; Sherman, Karen J; Delitto, Anthony; Herman, Patricia M; Stevans, Joel; Paris, Ruth; Keosaian, Julia E; Cerrada, Christian J; Lemaster, Chelsey M; Faulkner, Carol; Breuer, Maya; Weinberg, Janice

2014-02-26

Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting ≥ 12 weeks and a self-reported average pain intensity of ≥ 4 on a 0-10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data. This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927.

Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. Methods/Design This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18–64 years old with non-specific low back pain lasting ≥12 weeks and a self-reported average pain intensity of ≥4 on a 0–10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data. Trial registration This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927. PMID:24568299

Effect of high-dose vs standard-dose multivitamin supplementation at the initiation of HAART on HIV disease progression and mortality in Tanzania: a randomized controlled trial.

PubMed

Isanaka, Sheila; Mugusi, Ferdinand; Hawkins, Claudia; Spiegelman, Donna; Okuma, James; Aboud, Said; Guerino, Chalamilla; Fawzi, Wafaie W

2012-10-17

Large randomized trials have previously shown that high-dose micronutrient supplementation can increase CD4 counts and reduce human immunodeficiency virus (HIV) disease progression and mortality among individuals not receiving highly active antiretroviral therapy (HAART); however, the safety and efficacy of such supplementation has not been established in the context of HAART. To test the hypothesis that high-dose multivitamin supplementation vs standard-dose multivitamin supplementation decreases the risk of HIV disease progression or death and improves immunological, virological, and nutritional parameters in patients with HIV initiating HAART. A randomized, double-blind, controlled trial of high-dose vs standard-dose multivitamin supplementation for 24 months in 3418 patients with HIV initiating HAART between November 2006 and November 2008 in 7 clinics in Dar es Salaam, Tanzania. INTERVENTION The provision of daily oral supplements of vitamin B complex, vitamin C, and vitamin E at high levels or standard levels of the recommended dietary allowance. The composite of HIV disease progression or death from any cause. The study was stopped early in March 2009 because of evidence of increased levels of alanine transaminase (ALT) in patients receiving the high-dose multivitamin supplement. At the time of stopping, 3418 patients were enrolled (median follow-up, 15 months), and there were 2374 HIV disease progression events and 453 observed deaths (2460 total combined events). Compared with standard-dose multivitamin supplementation, high-dose supplementation did not reduce the risk of HIV disease progression or death. The absolute risk of HIV progression or death was 72% in the high-dose group vs 72% in the standard-dose group (risk ratio [RR], 1.00; 95% CI, 0.96-1.04). High-dose supplementation had no effect on CD4 count, plasma viral load, body mass index, or hemoglobin level concentration, but increased the risk of ALT elevations (1239 events per 1215 person-years vs 879 events per 1236 person-years; RR, 1.44; 95% CI, 1.11-1.87) vs standard-dose supplementation. CONCLUSION In adults receiving HAART, use of high-dose multivitamin supplements compared with standard-dose multivitamin supplements did not result in a decrease in HIV disease progression or death but may have resulted in an increase in ALT levels. Clinicaltrials.gov Identifier: NCT00383669.

Fear of childbirth in expectant fathers, subsequent childbirth experience and impact of antenatal education: subanalysis of results from a randomized controlled trial.

PubMed

Bergström, Malin; Rudman, Ann; Waldenström, Ulla; Kieler, Helle

2013-08-01

To explore if antenatal fear of childbirth in men affects their experience of the birth event and if this experience is associated with type of childbirth preparation. Data from a randomized controlled multicenter trial on antenatal education. 15 antenatal clinics in Sweden between January 2006 and May 2007. 762 men, of whom 83 (10.9%) suffered from fear of childbirth. Of these 83 men, 39 were randomized to psychoprophylaxis childbirth preparation where men were trained to coach their partners during labor and 44 to standard care antenatal preparation for childbirth and parenthood without such training. Experience of childbirth was compared between men with and without fear of childbirth regardless of randomization, and between fearful men in the randomized groups. Analyses by logistic regression adjusted for sociodemographic variables. Self-reported data on experience of childbirth including an adapted version of the Wijma Delivery Experience Questionnaire (W-DEQ B). Men with antenatal fear of childbirth more often experienced childbirth as frightening than men without fear: adjusted odds ratio 4.68, 95% confidence interval 2.67-8.20. Men with antenatal fear in the psychoprophylaxis group rated childbirth as frightening less often than those in standard care: adjusted odds ratio 0.30, 95% confidence interval 0.10-0.95. Men who suffer from antenatal fear of childbirth are at higher risk of experiencing childbirth as frightening. Childbirth preparation including training as a coach may help fearful men to a more positive childbirth experience. Additional studies are needed to support this conclusion. © 2013 Nordic Federation of Societies of Obstetrics and Gynecology.

Lactobacillus GG (LGG) and smectite versus LGG alone for acute gastroenteritis: a double-blind, randomized controlled trial.

PubMed

Pieścik-Lech, Małgorzata; Urbańska, Magdalena; Szajewska, Hania

2013-02-01

Diarrhea treatment with either Lactobacillus GG (LGG) or smectite as an adjuvant to standard rehydration therapy has proven efficacy. In countries where both LGG and smectite are available, concomitant use is frequently practiced. We investigated whether LGG plus smectite is superior to LGG alone in the management of children with acute gastroenteritis (AGE). A double-blind, placebo-controlled, randomized trial was performed. Children aged 4 to 60 months with AGE received LGG 6 × 10(9) colony forming units/day plus randomly either smectite (3 g) or placebo as an adjuvant to the standard rehydration therapy. Of the 88 children randomized, 81 (92 %) were available for intention-to-treat analysis. The duration of diarrhea in the LGG/smectite group (n = 44) compared with the LGG/placebo group (n = 37) was similar (P = 0.43). There were no significant differences between the study groups for the secondary outcomes, with three exceptions. On day 4, in the LGG/placebo group compared to the LGG/smectite group, there was significantly reduced stool frequency (P = 0.03). While there was a significant (P = 0.05) difference in stool consistency on the Bristol Stool Form Scale on day 4, it was not of clinical relevance. Finally, in the LGG/smectite group compared to the LGG/placebo group, there was a significantly shorter duration of intravenous therapy after randomization (P = 0.02). No adverse events were observed in the study groups. LGG plus smectite and LGG alone are equally effective for treating young children with AGE. Combined use of the two interventions is not justified.

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.

Oral language skills intervention in pre-school-a cautionary tale.

PubMed

Haley, Allyson; Hulme, Charles; Bowyer-Crane, Claudine; Snowling, Margaret J; Fricke, Silke

2017-01-01

While practitioners are increasingly asked to be mindful of the evidence base of intervention programmes, evidence from rigorous trials for the effectiveness of interventions that promote oral language abilities in the early years is sparse. To evaluate the effectiveness of a language intervention programme for children identified as having poor oral language skills in preschool classes. A randomized controlled trial was carried out in 13 UK nursery schools. In each nursery, eight children (N = 104, mean age = 3 years 11 months) with the poorest performance on standardized language measures were selected to take part. All but one child were randomly allocated to either an intervention (N = 52) or a waiting control group (N = 51). The intervention group received a 15-week oral language programme in addition to their standard nursery curriculum. The programme was delivered by trained teaching assistants and aimed to foster vocabulary knowledge, narrative and listening skills. Initial results revealed significant differences between the intervention and control group on measures of taught vocabulary. No group differences were found on any standardized language measure; however, there were gains of moderate effect size in listening comprehension. The study suggests that an intervention, of moderate duration and intensity, for small groups of preschool children successfully builds vocabulary knowledge, but does not generalize to non-taught areas of language. The findings strike a note of caution about implementing language interventions of moderate duration in preschool settings. The findings also highlight the importance of including a control group in intervention studies. © 2016 Royal College of Speech and Language Therapists.

Experimental protocol of a randomized controlled clinical trial investigating the effects of personalized exercise rehabilitation on kidney transplant recipients' outcomes.

PubMed

Kastelz, Alexandra; Tzvetanov, Ivo G; Fernhall, Bo; Shetty, Aneesha; Gallon, Lorenzo; West-Thielke, Patricia; Hachaj, Greg; Grazman, Mark; Benedetti, Enrico

2015-11-01

This randomized controlled trial (RCT) will investigate the effects of a personalized exercise rehabilitation regimen on return to work and find work rate, vascular health, functional capacity, quality of life, kidney function, and body composition in kidney transplant (KT) recipients. This RCT will recruit 120 men and/or women who have had a KT to participate in a 12 month exercise intervention or control (standard clinical care only) group. The 12 month exercise intervention will consist of one-on-one, progressive exercise rehabilitation sessions twice a week, for 60 min each session. The control group will continue standard clinical care as recommended by their post-transplant medical team without any intervention. The primary outcomes will be assessments of vascular structure and function, walking and strength measures to assess functional capacity, blood markers to assess kidney function, questionnaires to assess quality of life, DXA body scan to assess body composition, and a 1-week free living physical activity assessment. Additionally, employment status will be assessed. These assessments will be performed at baseline, 6 months, and 12 months. This investigation will increase the understanding of the role exercise rehabilitation has on managing the physiological and psychological health of the individual as well as on the individual's personal economic impact (via employment status). This study design has the potential to assist in constructing an effective exercise rehabilitation program that can be incorporated into part of standard post-transplant care. Copyright © 2015 Elsevier Inc. All rights reserved.

The Effects of a Mobile Phone Application on Quality of Life in Patients With Type 1 Diabetes Mellitus: A Randomized Controlled Trial.

PubMed

Drion, Iefke; Pameijer, Loes R; van Dijk, Peter R; Groenier, Klaas H; Kleefstra, Nanne; Bilo, Henk J G

2015-05-11

The combination of an increasing prevalence of diabetes mellitus and more people having access to smartphones creates opportunities for patient care. This study aims to investigate whether the use of the Diabetes Under Control (DBEES) mobile phone application, a digital diabetes diary, results in a change in quality of life for patients with type 1 diabetes mellitus (T1DM) compared with the standard paper diary. In this randomized controlled open-label trial, 63 patients with T1DM having access to a smartphone were assigned to the intervention group using the DBEES application (n = 31) or the control group using the standard paper diary (n = 32). Primary outcome was the change in quality of life, as measured by the RAND-36 questionnaire, between both groups. Secondary outcomes included diabetes-related distress (PAID), HbA1c, frequency of self-monitoring blood glucose, and the usability of the diabetes application (SUS). Patients had a median age (IQR) of 33 (21) years, diabetes duration of 17 (16) years, and an HbA1c of 62 ± 16 mmol/mol. No significant differences in the QOL, using the RAND-36, within and between both groups were observed after 3 months. Glycemic control, diabetes-related emotional distress, and frequency of self-monitoring of blood glucose remained within and between groups. Users reviewed the usability of DBEES with a 72 ± 20, on a range of 0-100. The use of the DBEES application in the management of patients with T1DM for 3 months yields no alterations in quality of life compared to the standard paper diary. © 2015 Diabetes Technology Society.

Effects of yoga in patients with paroxysmal atrial fibrillation - a randomized controlled study.

PubMed

Wahlstrom, Maria; Rydell Karlsson, Monica; Medin, Jörgen; Frykman, Viveka

2017-01-01

Patients with atrial fibrillation often have an impaired quality of life (QoL). Practising yoga may decrease stress and have positive effects on mental and physical health. The aim of this study was to investigate whether yoga can improve QoL and decrease blood pressure and heart rate in patients with paroxysmal atrial fibrillation (PAF). In this pilot study, 80 patients diagnosed with PAF were randomized to standard treatment (control group, n=40) or standard treatment in combination with yoga (yoga group, n=40) during a 12-week period. QoL, blood pressure and heart rate were evaluated at baseline and at the end of the study (12 (+2) weeks). EuroQoL-5D (EQ-5D) Visual Analogue Scale (VAS) and the two dimensions in Short-Form Health Survey (SF-36) were used to evaluate QoL. At baseline there was a significant difference in QoL between the groups in EQ-5D VAS- scale ( p=0.02) and SF-36 mental health score ( p<0.001) in which the control group had higher scores. At the end of the study, the yoga group averaged higher SF-36 mental health scores. There was a significant difference between the two groups ( p=0.016), but no differences in EQ-5D VAS- scale and physiological health score was seen between the two groups. At the end of the study, the yoga group had significantly lower heart rate ( p=0.024) and systolic ( p=0.033) and diastolic blood pressure ( p<0.001) compared to the control group. Yoga with light movements and deep breathing may lead to improved QoL, lower blood pressure and lower heart rate in patients with PAF compared to a control group. Yoga could be a complementary treatment method to standard therapy.

A randomized controlled trial to assess the effect of a medication plan containing drug administration recommendations on patients' drug knowledge after 2 months.

PubMed

Send, A F J; Peters-Klimm, F; Bruckner, T; Haefeli, W E; Seidling, H M

2017-02-01

Patients' drug administration errors are often promoted by poor drug knowledge resulting from inadequate oral or written information. It has previously been shown that a medication plan enhanced with graphical and textual information on drug handling (enhanced medication plan) proved to immediately increase patients' drug knowledge. This study aimed to evaluate the effect of the enhanced medication plan on drug knowledge in outpatients after 2 months (intervention group) compared to patients with a simple medication plan with standard information (control group). We recruited patients using ≥5 drugs in four family practices in Germany. After inclusion, patients' knowledge on handling of their drugs was assessed using three questions from a standardized catalog. Thereafter, patients were randomized to the intervention or control group. After 2 months, drug knowledge was reassessed with three different questions from the same standardized catalog. Of 120 enrolled patients, 75% of participants in the control group (42/60 patients) and 78% of participants in the intervention group (46/60; P = 0·71) completed the study. Baseline drug knowledge was similar in both groups (43·7% vs. 40·6% correct answers). After 2 months, patients' drug knowledge showed an absolute increase of 23·2% in the intervention group (P < 0·01) and was unchanged in the control group (46·0%; P = 0·70). The enhanced medication plan outperformed the effect of a simple medication plan and persistently increased the fraction of correct answers of polypharmacy patients. This demonstrates that the enhanced medication plan may be a useful tool in promoting drug knowledge. © 2016 John Wiley & Sons Ltd.

Eight Weeks of Cosmos caudatus (Ulam Raja) Supplementation Improves Glycemic Status in Patients with Type 2 Diabetes: A Randomized Controlled Trial.

PubMed

Cheng, Shi-Hui; Ismail, Amin; Anthony, Joseph; Ng, Ooi Chuan; Hamid, Azizah Abdul; Barakatun-Nisak, Mohd Yusof

2015-01-01

Objectives. Optimizing glycemic control is crucial to prevent type 2 diabetes related complications. Cosmos caudatus is reported to have promising effect in improving plasma blood glucose in an animal model. However, its impact on human remains ambiguous. This study was carried out to evaluate the effectiveness of C. caudatus on glycemic status in patients with type 2 diabetes. Materials and Methods. In this randomized controlled trial with two-arm parallel-group design, a total of 101 subjects with type 2 diabetes were randomly allocated to diabetic-ulam or diabetic controls for eight weeks. Subjects in diabetic-ulam group consumed 15 g of C. caudatus daily for eight weeks while diabetic controls abstained from taking C. caudatus. Both groups received the standard lifestyle advice. Results. After 8 weeks of supplementation, C. caudatus significantly reduced serum insulin (-1.16 versus +3.91), reduced HOMA-IR (-1.09 versus +1.34), and increased QUICKI (+0.05 versus -0.03) in diabetic-ulam group compared with the diabetic controls. HbA1C level was improved although it is not statistically significant (-0.76% versus -0.37%). C. caudatus was safe to consume. Conclusions. C. caudatus supplementation significantly improves insulin resistance and insulin sensitivity in patients with type 2 diabetes.

Activity groups for people with schizophrenia: a randomized controlled trial.

PubMed

Dean, Madeleine; Weston, Adam R W; Osborn, David P; Willis, Suzie; Patterson, Sue; Killaspy, Helen; Leurent, Baptiste; Crawford, Mike J

2014-08-01

UK guidelines recommend that patients with schizophrenia are offered access to social activities, however, the impact of such interventions have not been examined in a large randomized trial. To investigate the effect of an activity group intervention on mental health and global functioning 12 months after randomization compared to standard care alone. Secondary analysis of data from the MATISSE study. Primary outcomes were global functioning, assessed using the Global Assessment of Functioning (GAF), and mental health symptoms measured using the Positive and Negative Syndrome Scale (PANSS). About 140 participants were randomized to activity groups and 137 to standard care alone. Follow-up data were collected from 242 (87%) participants. Mental health improved significantly among those offered activity groups (change in PANSS score = -6.0, 95% CI -2.3 to -9.8) but global functioning did not (change in GAF score = 0.8, 95% CI -1.7 to 3.3). No significant differences were found between treatment arms. Offering activity groups to patients with schizophrenia was not associated with any additional clinical benefits. There was poor uptake and attendance at activity groups. Interventions that aim to improve negative symptoms may be useful in enabling engagement in psychosocial interventions.

The effects of Snoezelen (multi-sensory behavior therapy) and psychiatric care on agitation, apathy, and activities of daily living in dementia patients on a short term geriatric psychiatric inpatient unit.

PubMed

Staal, Jason A; Sacks, Amanda; Matheis, Robert; Collier, Lesley; Calia, Tina; Hanif, Henry; Kofman, Eugene S

2007-01-01

A randomized, controlled, single-blinded, between group study of 24 participants with moderate to severe dementia was conducted on a geriatric psychiatric unit. All participants received pharmacological therapy, occupational therapy, structured hospital environment, and were randomized to receive multi sensory behavior therapy (MSBT) or a structured activity session. Greater independence in activities of daily living (ADLs) was observed for the group treated with MSBT and standard psychiatric inpatient care on the Katz Index of Activities of Daily Living (KI-ADL; P = 0.05) than standard psychiatric inpatient care alone. The combination treatment of MSBT and standard psychiatric care also reduced agitation and apathy greater than standard psychiatric inpatient care alone as measured with the Pittsburgh Agitation Scale and the Scale for the Assessment of Negative Symptoms in Alzheimer's Disease (P = 0.05). Multiple regression analysis predicted that within the multi-sensory group, activities of daily living (KI-ADL) increased as apathy and agitation reduced (R2 = 0.42; p = 0.03). These data suggest that utilizing MSBT with standard psychiatric inpatient care may reduce apathy and agitation and additionally improve activities of daily living in hospitalized people with moderate to severe dementia more than standard care alone.

Improving practice in community-based settings: a randomized trial of supervision – study protocol

PubMed Central

2013-01-01

Background Evidence-based treatments for child mental health problems are not consistently available in public mental health settings. Expanding availability requires workforce training. However, research has demonstrated that training alone is not sufficient for changing provider behavior, suggesting that ongoing intervention-specific supervision or consultation is required. Supervision is notably under-investigated, particularly as provided in public mental health. The degree to which supervision in this setting includes ‘gold standard’ supervision elements from efficacy trials (e.g., session review, model fidelity, outcome monitoring, skill-building) is unknown. The current federally-funded investigation leverages the Washington State Trauma-focused Cognitive Behavioral Therapy Initiative to describe usual supervision practices and test the impact of systematic implementation of gold standard supervision strategies on treatment fidelity and clinical outcomes. Methods/Design The study has two phases. We will conduct an initial descriptive study (Phase I) of supervision practices within public mental health in Washington State followed by a randomized controlled trial of gold standard supervision strategies (Phase II), with randomization at the clinician level (i.e., supervisors provide both conditions). Study participants will be 35 supervisors and 130 clinicians in community mental health centers. We will enroll one child per clinician in Phase I (N = 130) and three children per clinician in Phase II (N = 390). We use a multi-level mixed within- and between-subjects longitudinal design. Audio recordings of supervision and therapy sessions will be collected and coded throughout both phases. Child outcome data will be collected at the beginning of treatment and at three and six months into treatment. Discussion This study will provide insight into how supervisors can optimally support clinicians delivering evidence-based treatments. Phase I will provide descriptive information, currently unavailable in the literature, about commonly used supervision strategies in community mental health. The Phase II randomized controlled trial of gold standard supervision strategies is, to our knowledge, the first experimental study of gold standard supervision strategies in community mental health and will yield needed information about how to leverage supervision to improve clinician fidelity and client outcomes. Trial registration ClinicalTrials.gov NCT01800266 PMID:23937766

Glucose control and vascular complications in veterans with type 2 diabetes.

PubMed

Duckworth, William; Abraira, Carlos; Moritz, Thomas; Reda, Domenic; Emanuele, Nicholas; Reaven, Peter D; Zieve, Franklin J; Marks, Jennifer; Davis, Stephen N; Hayward, Rodney; Warren, Stuart R; Goldman, Steven; McCarren, Madeline; Vitek, Mary Ellen; Henderson, William G; Huang, Grant D

2009-01-08

The effects of intensive glucose control on cardiovascular events in patients with long-standing type 2 diabetes mellitus remain uncertain. We randomly assigned 1791 military veterans (mean age, 60.4 years) who had a suboptimal response to therapy for type 2 diabetes to receive either intensive or standard glucose control. Other cardiovascular risk factors were treated uniformly. The mean number of years since the diagnosis of diabetes was 11.5, and 40% of the patients had already had a cardiovascular event. The goal in the intensive-therapy group was an absolute reduction of 1.5 percentage points in the glycated hemoglobin level, as compared with the standard-therapy group. The primary outcome was the time from randomization to the first occurrence of a major cardiovascular event, a composite of myocardial infarction, stroke, death from cardiovascular causes, congestive heart failure, surgery for vascular disease, inoperable coronary disease, and amputation for ischemic gangrene. The median follow-up was 5.6 years. Median glycated hemoglobin levels were 8.4% in the standard-therapy group and 6.9% in the intensive-therapy group. The primary outcome occurred in 264 patients in the standard-therapy group and 235 patients in the intensive-therapy group (hazard ratio in the intensive-therapy group, 0.88; 95% confidence interval [CI], 0.74 to 1.05; P=0.14). There was no significant difference between the two groups in any component of the primary outcome or in the rate of death from any cause (hazard ratio, 1.07; 95% CI, 0.81 to 1.42; P=0.62). No differences between the two groups were observed for microvascular complications. The rates of adverse events, predominantly hypoglycemia, were 17.6% in the standard-therapy group and 24.1% in the intensive-therapy group. Intensive glucose control in patients with poorly controlled type 2 diabetes had no significant effect on the rates of major cardiovascular events, death, or microvascular complications with the exception of progression of albuminuria (P = 0.01) [added]. (ClinicalTrials.gov number, NCT00032487.) 2009 Massachusetts Medical Society

Probability-based constrained MPC for structured uncertain systems with state and random input delays

NASA Astrophysics Data System (ADS)

Lu, Jianbo; Li, Dewei; Xi, Yugeng

2013-07-01

This article is concerned with probability-based constrained model predictive control (MPC) for systems with both structured uncertainties and time delays, where a random input delay and multiple fixed state delays are included. The process of input delay is governed by a discrete-time finite-state Markov chain. By invoking an appropriate augmented state, the system is transformed into a standard structured uncertain time-delay Markov jump linear system (MJLS). For the resulting system, a multi-step feedback control law is utilised to minimise an upper bound on the expected value of performance objective. The proposed design has been proved to stabilise the closed-loop system in the mean square sense and to guarantee constraints on control inputs and system states. Finally, a numerical example is given to illustrate the proposed results.

[Effects of organic selenium supplement on glutathione peroxidase activities: a meta-analysis of randomized controlled trials].

PubMed

Jiang, Xia; Dong, Jiayi; Wang, Bo; Yin, Xuebin; Qin, Liqiang

2012-01-01

To study the effects of organic selenium supplementation on glutathione peroxidase (GPx) activities. Randomized controlled trials (RCT) published from January 1988 to December 2010 on the relationship between organic selenium supplementation and GPx activities were collected. Meta-analysis was applied to estimate the combined standardized mean difference (SMD) and 95% confidence interval (95% CI). A total of 10 RCTs were included. The number of studies observing GPx activities in plasma, erythrocyte and platelet was 8, 5 and 5, respectively. Compared with the controls, the combined SMD (95% CI) of GPx activities in plasma, erythrocyte and platelet of subjects supplemented with organic selenium was 0.46 (0.09 - 0.83), 0.36 (0.02 - 0.69) and 0.56 (-0.02 - 1.15). Supplementation with organic selenium increases GPx activities in healthy adults.

Increasing physical activity in patients with mental illness--A randomized controlled trial.

PubMed

Göhner, Wiebke; Dietsche, Christine; Fuchs, Reinhard

2015-11-01

The objective of the study was to evaluate whether a motivational-volitional intervention program offered in addition to an existing sport program during stationary treatment is capable of establishing a post-stationary increase in physical activity in persons with mental illness. N=112 in-patients were initially randomly assigned to the control group (CG; standard rehabilitation) or intervention group (IG; standard rehabilitation plus intervention). Assessments were conducted at four measurement points. At 6 months follow up, the level of exercise in the IG was 95 min/week higher than in the CG (p=.02). The participants of the IG were able to increase their level of goal intention until 6 months follow up (t2: p=.03; t4: p=.005); levels of self-efficacy of the IG increased during intervention (t2: p=.001). Changes in volitional aspects were significant over time (t1-t3), but not specifically for the IG. The intervention was effective at increasing the level of physical activity in patients with mental illness who were initially minimally active. Our results suggest that it could be of great use to place the emphasis of a physical activity-enhancing intervention on its motivational effect since volitional aspects are already taken into sufficient account in standard rehabilitation. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

The effects of embodied rhythm and robotic interventions on the spontaneous and responsive verbal communication skills of children with Autism Spectrum Disorder (ASD): A further outcome of a pilot randomized controlled trial

PubMed Central

Srinivasan, Sudha M.; Eigsti, Inge-Marie; Gifford, Timothy; Bhat, Anjana N.

2016-01-01

The current manuscript is the second in a mini-series of manuscripts reporting the effects of alternative, movement-based, rhythm and robotic interventions on the social communication skills of 36 school-age children with ASD. This pilot randomized controlled trial compared the effects of 8-weeks of rhythm and robotic interventions to those of a standard-of-care, comparison intervention. The first manuscript reported intervention effects on the spontaneous and responsive social attention skills of children. In this manuscript, we report intervention effects on the spontaneous and responsive verbal communication skills of children. Communication skills were assessed within a standardized test of responsive communication during the pretest and posttest as well as using training-specific measures of social verbalization during early, mid, and late training sessions. The rhythm and comparison groups improved on the standardized test in the posttest compared to the pretest. The rhythm and robot groups increased levels of social verbalization across training sessions. Movement-based and stationary contexts afforded different types and amounts of communication in children with ASD. Overall, movement-based interventions are a promising tool to enhance verbal and non-verbal communication skills in children with ASD. PMID:27668011

The effects of embodied rhythm and robotic interventions on the spontaneous and responsive verbal communication skills of children with Autism Spectrum Disorder (ASD): A further outcome of a pilot randomized controlled trial.

PubMed

Srinivasan, Sudha M; Eigsti, Inge-Marie; Gifford, Timothy; Bhat, Anjana N

2016-07-01

The current manuscript is the second in a mini-series of manuscripts reporting the effects of alternative, movement-based, rhythm and robotic interventions on the social communication skills of 36 school-age children with ASD. This pilot randomized controlled trial compared the effects of 8-weeks of rhythm and robotic interventions to those of a standard-of-care, comparison intervention. The first manuscript reported intervention effects on the spontaneous and responsive social attention skills of children. In this manuscript, we report intervention effects on the spontaneous and responsive verbal communication skills of children. Communication skills were assessed within a standardized test of responsive communication during the pretest and posttest as well as using training-specific measures of social verbalization during early, mid, and late training sessions. The rhythm and comparison groups improved on the standardized test in the posttest compared to the pretest. The rhythm and robot groups increased levels of social verbalization across training sessions. Movement-based and stationary contexts afforded different types and amounts of communication in children with ASD. Overall, movement-based interventions are a promising tool to enhance verbal and non-verbal communication skills in children with ASD.

Minimum intervention dentistry approach to managing early childhood caries: a randomized control trial.

PubMed

Arrow, Peter; Klobas, Elizabeth

2015-12-01

A pragmatic randomized control trial was undertaken to compare the minimum intervention dentistry (MID) approach, based on the atraumatic restorative treatment procedures (MID-ART: Test), against the standard care approach (Control) to treat early childhood caries in a primary care setting. Consenting parent/child dyads were allocated to the Test or Control group using stratified block randomization. Inclusion and exclusion criteria were applied. Participants were examined at baseline and at follow-up by two calibrated examiners blind to group allocation status (κ = 0.77), and parents completed a questionnaire at baseline and follow-up. Dental therapists trained in MID-ART provided treatment to the Test group and dentists treated the Control group using standard approaches. The primary outcome of interest was the number of children who were referred for specialist pediatric care. Secondary outcomes were the number of teeth treated, changes in child oral health-related quality of life and dental anxiety and parental perceptions of care received. Data were analyzed on an intention to treat basis; risk ratio for referral for specialist care, test of proportions, Wilcoxon rank test and logistic regression were used. Three hundred and seventy parents/carers were initially screened; 273 children were examined at baseline and 254 were randomized (Test = 127; Control = 127): mean age = 3.8 years, SD 0.90; 59% male, mean dmft = 4.9, SD 4.0. There was no statistically significant difference in age, sex, baseline caries experience or child oral health-related quality of life between the Test and Control group. At follow-up (mean interval 11.4 months, SD 3.1 months), 220 children were examined: Test = 115, Control = 105. Case-notes review of 231 children showed Test = 6 (5%) and Control = 53 (49%) were referred for specialist care, P < 0.0001. More teeth were filled in the Test group (mean = 2.93, SD 2.48) than in the Control group (mean = 1.54, SD 2.20), Wilcoxon's test, P < 0.0001. Logistic regression, after controlling for age and baseline caries experience, showed a higher risk of referral by allocation to control group, OR 32.6, 95% CI 10.8-98.4, P < 0.0001. The MID-ART approach reduced significantly the likelihood of referral for specialist care, and more children and teeth were provided with treatment. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The effects of reducing worry in patients with persecutory delusions: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Our approach to advancing the treatment of psychosis is to focus on key single symptoms and develop interventions that target the mechanisms that maintain them. In our theoretical research we have found worry to be an important factor in the development and maintenance of persecutory delusions. Worry brings implausible ideas to mind, keeps them there, and makes the experience distressing. Therefore the aim of the trial is to test the clinical efficacy of a cognitive-behavioral intervention for worry for patients with persecutory delusions and determine how the worry treatment might reduce delusions. Methods/Design An explanatory randomized controlled trial - called the Worry Intervention Trial (WIT) - with 150 patients with persecutory delusions will be carried out. Patients will be randomized to the worry intervention in addition to standard care or to standard care. Randomization will be carried out independently, assessments carried out single-blind, and therapy competence and adherence monitored. The study population will be individuals with persecutory delusions and worry in the context of a schizophrenia spectrum diagnosis. They will not have responded adequately to previous treatment. The intervention is a six-session cognitive-behavioral treatment provided over eight weeks. The control condition will be treatment as usual, which is typically antipsychotic medication and regular appointments. The principal hypotheses are that a worry intervention will reduce levels of worry and that it will also reduce the persecutory delusions. Assessments will be carried out at 0 weeks (baseline), 8 weeks (post treatment) and 24 weeks (follow-up). The statistical analysis strategy will follow the intention-to-treat principle and involve the use of linear mixed models to evaluate and estimate the relevant between- and within-subjects effects (allowing for the possibility of missing data). Both traditional regression and newer instrumental variables analyses will examine mediation. The trial is funded by the UK Medical Research Council (MRC)/NHS National Institute of Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) Programme. Discussion This will be the first large randomized controlled trial specifically focused upon persecutory delusions. The project will produce a brief, easily administered intervention that can be readily used in mental health services. Trial registration Current Controlled Trials ISRCTN23197625 PMID:23171601

Random errors in interferometry with the least-squares method

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

Wang Qi

2011-01-20

This investigation analyzes random errors in interferometric surface profilers using the least-squares method when random noises are present. Two types of random noise are considered here: intensity noise and position noise. Two formulas have been derived for estimating the standard deviations of the surface height measurements: one is for estimating the standard deviation when only intensity noise is present, and the other is for estimating the standard deviation when only position noise is present. Measurements on simulated noisy interferometric data have been performed, and standard deviations of the simulated measurements have been compared with those theoretically derived. The relationships havemore » also been discussed between random error and the wavelength of the light source and between random error and the amplitude of the interference fringe.« less

Randomized, controlled trial of standard, large-capacity versus jumbo biopsy forceps for polypectomy of small, sessile, colorectal polyps.

PubMed

Draganov, Peter V; Chang, Myron N; Alkhasawneh, Ahmad; Dixon, Lisa R; Lieb, John; Moshiree, Baharak; Polyak, Steven; Sultan, Shahnaz; Collins, Dennis; Suman, Amitabh; Valentine, John F; Wagh, Mihir S; Habashi, Samir L; Forsmark, Chris E

2012-01-01

Polypectomy with cold biopsy forceps is a frequently used technique for removal of small, sessile, colorectal polyps. Jumbo forceps may lead to more effective polypectomy because of the larger size of the forceps cup. To evaluate the efficiency of cold jumbo biopsy forceps compared with standard forceps for polypectomy of small, sessile, colorectal polyps. Randomized, controlled trial. Outpatient endoscopy center. This study involved 140 patients found to have at least one eligible polyp defined as a sessile polyp measuring ≤6 mm. Polypectomy with cold biopsy forceps. Complete visual polyp eradication with one forceps bite. In 140 patients, a total of 305 eligible polyps were detected (151 removed with jumbo forceps and 154 with standard forceps). Complete visual eradication of the polyp with one forceps bite was achieved in 78.8% of the jumbo forceps group and 50.7% of the standard forceps group (P < .0001). Biopsies from the polypectomy sites of adenomatous polyps thought to be visually completely eradicated with one bite showed a trend toward a higher complete histologic eradication rate with the jumbo forceps (82.4%) compared with the standard forceps (77.4%), but the difference did not reach statistical significance (P = .62). The withdrawal time for visual inspection of the colon and time to perform polypectomies were significantly shorter in the jumbo forceps group (mean 21.43 vs 18.23 minutes; P = .02). Lack of blinding to the type of forceps used. The jumbo biopsy forceps is superior to the standard forceps in removing small, sessile polyps. ( NCT00855790.). Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Integrating Technology into Standard Weight Loss Treatment: A Randomized Controlled Trial

PubMed Central

Spring, Bonnie; Duncan, Jennifer M.; Janke, E. Amy; Kozak, Andrea T.; McFadden, H. Gene; DeMott, Andrew; Pictor, Alex; Epstein, Leonard H.; Siddique, Juned; Pellegrini, Christine A.; Buscemi, Joanna; Hedeker, Donald

2013-01-01

Background A challenge in the delivery of intensive obesity treatment is making care scalable. Little is known about whether the outcome of clinician-directed weight loss treatment can be improved by adding mobile technology. Methods We conducted a 2-arm, 12-month study (between October, 2007 and September, 2010). Seventy adults (body mass index [BMI] >25 and ≤ 40 kg/m2) were randomly assigned to either standard of care group treatment alone (Standard) or Standard + connective mobile technology system (+Mobile). Participants attended biweekly weight loss groups held by the VA outpatient clinic. The +Mobile group was provided personal digital assistants (PDAs) to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months. Weight was measured at baseline, 3, 6, 9, and 12 months follow-up. Results Sixty-nine adults received intervention (mean age 57.7 years, 85.5% male). A longitudinal intent-to-treat analysis indicated that the +Mobile group lost on average 8.6 more pounds (representing 3.1% more weight loss relative to the control) than the Standard group at each post-baseline time point, 95% CI [4.9, 12.2]. As compared to the Standard group, the +Mobile group had significantly greater odds of having lost 5% or more of their baseline weight at each post-baseline time point [OR= 6.5; 95% CI = 2.3, 18.6]. Conclusions The addition of a PDA and telephone coaching can enhance short-term weight loss in combination with an existing system of care. Mobile connective technology holds promise as a scalable delivery mechanism to augment the impact of clinician-delivered weight loss treatment. PMID:23229890

A prospective double-blinded randomized controlled trial comparing systemic stress response in Laparoascopic cholecystectomy between low-pressure and standard-pressure pneumoperitoneum.

PubMed

Shoar, Saeed; Naderan, Mohammad; Ebrahimpour, Hossein; Soroush, Ahmadreza; Nasiri, Shirzad; Movafegh, Ali; Khorgami, Zhamak

2016-04-01

Laparoscopic cholecystectomy (LC) has become the gold-standard treatment for gallstone diseases. However, despite huge reduction in operative injury, systemic stress response remains high. This randomized controlled trial (RCT) aimed to compare systemic stress response between 2 different techniques of CO2 pneumoperitoneum. Trough a prospective, double-blinded RCT, serum levels of cortisol, adrenaline, glucose, and C-reactive protein (CRP) were compared between the two groups consisted of 50 patients undergoing LC under low-pressure and standard-pressure CO2 pneimoperitoneum. A total of fifty patients undergoing LC were equally assigned to 2 groups of twenty five patients. Average age was 48 ± 13.8 years (range, 19-74 years). Operative time was similar between standard-pressure group (47.8 ± 16.8 min) and low-pressure group (53.6 ± 25.1). Moreover, intra-operative IV volume administration and urine output did not differ significantly between the 2 groups (p > 0.05). Although the average heart rate and mean arterial pressure were slightly higher in a standard-pressure group compared with a low-pressure group, serial measurements of these parameters were statistically similar between the 2 groups. Serial changes of serum levels of cortisol, glucose, adrenaline, and CRP were compared between surgery day, postoperative 6-h and 1st postoperative day, which did not differ significantly between the standard-pressure and the low-pressure groups (p > 0.05). Our study did not reveal any alteration in systemic stress response with reduction in intra-abdominal pressure of pneumoperitoneum in LC. RCT REGISTRATION: irct.ir ID: IRCT201110072982N5. Copyright © 2016 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

Open transinguinal preperitoneal mesh repair of inguinal hernia: a targeted systematic review and meta-analysis of published randomized controlled trials

PubMed Central

Sajid, Muhammad S.; Craciunas, L.; Singh, K.K.; Sains, P.; Baig, M.K.

2013-01-01

Objective: The objective of this article is to systematically analyse the randomized, controlled trials comparing transinguinal preperitoneal (TIPP) and Lichtenstein repair (LR) for inguinal hernia. Methods: Randomized, controlled trials comparing TIPP vs LR were analysed systematically using RevMan® and combined outcomes were expressed as risk ratio (RR) and standardized mean difference. Results: Twelve randomized trials evaluating 1437 patients were retrieved from the electronic databases. There were 714 patients in the TIPP repair group and 723 patients in the LR group. There was significant heterogeneity among trials (P < 0.0001). Therefore, in the random effects model, TIPP repair was associated with a reduced risk of developing chronic groin pain (RR, 0.48; 95% CI, 0.26, 0.89; z = 2.33; P < 0.02) without influencing the incidence of inguinal hernia recurrence (RR, 0.18; 95% CI, 0.36, 1.83; z = 0.51; P = 0.61). Risk of developing postoperative complications and moderate-to-severe postoperative pain was similar following TIPP repair and LR. In addition, duration of operation was statistically similar in both groups. Conclusion: TIPP repair for inguinal hernia is associated with lower risk of developing chronic groin pain. It is comparable with LR in terms of risk of hernia recurrence, postoperative complications, duration of operation and intensity of postoperative pain. PMID:24759818

Effect of lifestyle improvement program on the biomarkers of adiposity, inflammation and gut hormones in overweight/obese Asian Indians with prediabetes.

PubMed

Gokulakrishnan, Kuppan; Ranjani, Harish; Weber, Mary Beth; Pandey, Gautam Kumar; Anjana, Ranjit Mohan; Balasubramanyam, Muthuswamy; Prabhakaran, Dorairaj; Tandon, Nikhil; Narayan, K M; Mohan, Viswanathan

2017-09-01

While lifestyle modification is known to offer several metabolic benefits, there is paucity of comprehensive data on changes in biomarkers of adiposity, inflammation as well as gut hormones. We investigated these biomarkers in overweight/obese individuals with prediabetes randomized to either 4 months of a lifestyle improvement program or standard care and followed them up for a year. Participants [standard care and intervention arm (n = 75 each)] were randomly selected from the Diabetes Community Lifestyle Improvement Program trial. Glycemic and lipid control and anthropometric measurements were assessed by standard protocols. Adipokines, inflammatory markers and gut hormones were measured using multiplex and standard ELISA kits. Along with modest benefits in primary outcomes (glycemic and lipid control and weight reduction), participants in the intervention group showed significant reductions (p < 0.001) in plasma levels of leptin (17.6%), TNF-α (35%), IL-6 (33.3%), MCP-1 (22.3%) and PYY (28.3%) and increased levels of adiponectin (33.1%) and ghrelin (23.6%) at the end of 4 months of lifestyle intervention. The changes were independent of weight and persisted even at 1 year of follow-up. In contrast, participants from the standard care arm did not show any statistically significant improvements on the above parameters. Participants who underwent an intensive lifestyle improvement program showed metabolic benefits as well as favorable beneficial changes in systemic levels of adipokines, cytokines and gut hormones, not only during the intervention period, but also during 12-month follow-up period.

The effectiveness of virtual reality interventions in improving balance in adults with impaired balance compared with standard or no treatment: a systematic review and meta-analysis.

PubMed

Booth, Vicky; Masud, Tahir; Connell, Louise; Bath-Hextall, Fiona

2014-05-01

To evaluate whether virtual reality interventions, including interactive gaming systems, are effective at improving balance in adults with impaired balance. Systematic review and meta-analysis of randomized control trials. Studies were identified from electronic databases (CENTRAL, MEDLINE, EMBASE, AMED, CINAHL, PyschINFO, PyschBITE, OTseeker, Ei Compendex, and Inspec) searched to November 2011, and repeated in November 2012. Two reviewers selected studies meeting inclusion criteria and quality of included studies assessed using a Joanna Briggs Institute appraisal tool. Data was pooled and a meta-analysis completed. The systematic review was reported following guidance of the PRISMA statement. A total of 251 articles were screened. Eight randomized control trials were included. These studies presented the results of 239 participants, with various aetiologies, and used a variety of virtual reality systems. The number of falls was documented in only one included study. Meta-analysis was completed on data from the Berg Balance Scale, walking speed, 30 second sit-to-stand test, and Timed Up and Go Test, and favoured standard therapy when compared with standard plus virtual reality interventions. There was a notable inconsistency in the outcome measures, experimental, and control interventions used within the included studies. The pooled results of the studies showed no significant difference. Therefore this review cannot support nor refute the use of virtual reality interventions, rather than conventional physiotherapy, to improve balance in adults with impaired balance.

A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol

PubMed Central

2011-01-01

Background Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we will compare a standardized Iyengar yoga program for young people with rheumatoid arthritis to a standard care wait-list control condition. Methods/Design Seventy rheumatoid arthritis patients aged 16-35 years will be randomized into either the 6-week Iyengar yoga program (12 - 1.5 hour sessions twice weekly) or the 6-week wait-list control condition. A 20% attrition rate is anticipated. The wait-list group will receive the yoga program following completion of the first arm of the study. We will collect data quantitatively, using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. Assessments include standardized measures of general and arthritis-specific function, pain, mood, and health-related quality of life, as well as qualitative interviews, blood pressure/resting heart rate measurements, a medical exam and the assessment of pro-inflammatory cytokines. Data will be collected three times: before treatment, post-treatment, and two months following the treatment. Discussion Results from this study will provide critical data on non-pharmacologic methods for enhancing function in rheumatoid arthritis patients. In particular, results will shed light on the feasibility and potential efficacy of a novel intervention for rheumatoid arthritis symptoms, paving the way for a larger clinical trial. Trial Registration ClinicalTrials.gov NCT01096823 PMID:21255431

BounceBack capsules for reduction of DOMS after eccentric exercise: a randomized, double-blind, placebo-controlled, crossover pilot study.

PubMed

Udani, Jay K; Singh, Betsy B; Singh, Vijay J; Sandoval, Elizabeth

2009-06-05

Delayed onset muscle soreness (DOMS) is muscle pain and discomfort experienced approximately one to three days after exercise. DOMS is thought to be a result of microscopic muscle fiber tears that occur more commonly after eccentric exercise rather than concentric exercise. This study sought to test the efficacy of a proprietary dietary supplement, BounceBack, to alleviate the severity of DOMS after standardized eccentric exercise. The study was a randomized, double-blind, placebo-controlled, crossover study. Ten healthy community-dwelling untrained subjects, ranging in age from 18-45 years, were enrolled. Mean differences within and between groups were assessed inferentially at each data collection time-point using t-tests for all outcome measures. In this controlled pilot study, intake of BounceBack capsules for 30 days resulted in a significant reduction in standardized measures of pain and tenderness post-eccentric exercise compared to the placebo group. There were trends towards reductions in plasma indicators of inflammation (high sensitivity C-reactive protein) and muscle damage (creatine phosphokinase and myoglobin). BounceBack capsules were able to significantly reduce standardized measures of pain and tenderness at several post-eccentric exercise time points in comparison to placebo. The differences in the serological markers of DOMS, while not statistically significant, appear to support the clinical findings. The product appears to have a good safety profile and further study with a larger sample size is warranted based on the current results.

BounceBack™ capsules for reduction of DOMS after eccentric exercise: a randomized, double-blind, placebo-controlled, crossover pilot study

PubMed Central

Udani, Jay K; Singh, Betsy B; Singh, Vijay J; Sandoval, Elizabeth

2009-01-01

Background Delayed onset muscle soreness (DOMS) is muscle pain and discomfort experienced approximately one to three days after exercise. DOMS is thought to be a result of microscopic muscle fiber tears that occur more commonly after eccentric exercise rather than concentric exercise. This study sought to test the efficacy of a proprietary dietary supplement, BounceBack™, to alleviate the severity of DOMS after standardized eccentric exercise. Methods The study was a randomized, double-blind, placebo-controlled, crossover study. Ten healthy community-dwelling untrained subjects, ranging in age from 18–45 years, were enrolled. Mean differences within and between groups were assessed inferentially at each data collection time-point using t-tests for all outcome measures. Results In this controlled pilot study, intake of BounceBack™ capsules for 30 days resulted in a significant reduction in standardized measures of pain and tenderness post-eccentric exercise compared to the placebo group. There were trends towards reductions in plasma indicators of inflammation (high sensitivity C-reactive protein) and muscle damage (creatine phosphokinase and myoglobin). Conclusion BounceBack™ capsules were able to significantly reduce standardized measures of pain and tenderness at several post-eccentric exercise time points in comparison to placebo. The differences in the serological markers of DOMS, while not statistically significant, appear to support the clinical findings. The product appears to have a good safety profile and further study with a larger sample size is warranted based on the current results. PMID:19500355

Impact of Tight Glycemic Control on Neurodevelopmental Outcomes at 1 Year of Age for Children with Congenital Heart Disease: A Randomized Controlled Trial.

PubMed

Sadhwani, Anjali; Asaro, Lisa A; Goldberg, Caren; Ware, Janice; Butcher, Jennifer; Gaies, Michael; Smith, Cynthia; Alexander, Jamin L; Wypij, David; Agus, Michael S D

2016-07-01

To assess the association of postoperative tight glycemic control and hypoglycemia in children undergoing cardiac surgery with neurodevelopmental outcomes at 1 year of age. A 2-center, prospective, randomized trial of postoperative tight glycemic control vs standard care was conducted in 980 children undergoing cardiac surgery. Neurodevelopmental outcomes were assessed at nine to 18 months using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), the Adaptive Behavior Assessment System, Second Edition, the Ages and Stages Questionnaire, Third Edition, and the Brief Infant Toddler Social-Emotional Assessment. Neurodevelopmental follow-up was performed on 237 patients with a mean age of 13 months. No significant treatment group differences were found in the Bayley-III and Adaptive Behavior Assessment System, Second Edition composite scores or percentage at risk based on the Ages and Stages Questionnaire, Third Edition and the Brief Infant Toddler Social-Emotional Assessment. Patients who experienced moderate to severe hypoglycemia (n = 8) had lower Bayley-III composite scores compared with patients with no to mild hypoglycemia, even after controlling for factors known to be associated with poorer neurodevelopmental outcomes. For infants undergoing cardiac surgery, tight glycemic control did not impact neurodevelopmental outcomes compared with standard care. These data suggest a possible association between moderate to severe hypoglycemia and poorer neurodevelopmental outcomes at 1 year of age. ClinicalTrials.gov: NCT00443599. Copyright © 2016 Elsevier Inc. All rights reserved.

Impact of Tight Glycemic Control on Neurodevelopmental Outcomes at 1 Year of Age for Children with Congenital Heart Disease: A Randomized Controlled Trial

PubMed Central

Sadhwani, Anjali; Asaro, Lisa A.; Goldberg, Caren; Ware, Janice; Butcher, Jennifer; Gaies, Michael; Smith, Cynthia; Alexander, Jamin L.; Wypij, David; Agus, Michael S. D.

2016-01-01

Objective To assess the association of postoperative tight glycemic control and hypoglycemia in children undergoing cardiac surgery with neurodevelopmental outcomes at 1 year of age. Study design A 2-center, prospective, randomized trial of postoperative tight glycemic control vs standard care was conducted in 980 children undergoing cardiac surgery. Neurodevelopmental outcomes were assessed at nine to 18 months using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), the Adaptive Behavior Assessment System, Second Edition, the Ages and Stages Questionnaire, Third Edition, and the Brief Infant Toddler Social-Emotional Assessment. Results Neurodevelopmental follow-up was performed on 237 patients with a mean age of 13 months. No significant treatment group differences were found in the Bayley-III and Adaptive Behavior Assessment System, Second Edition composite scores or percentage at risk based on the Ages and Stages Questionnaire, Third Edition and the Brief Infant Toddler Social-Emotional Assessment. Patients who experienced moderate to severe hypoglycemia (n = 8) had lower Bayley-III composite scores compared with patients with no to mild hypoglycemia, even after controlling for factors known to be associated with poorer neurodevelopmental outcomes. Conclusion For infants undergoing cardiac surgery, tight glycemic control did not impact neurodevelopmental outcomes compared with standard care. These data suggest a possible association between moderate to severe hypoglycemia and poorer neurodevelopmental outcomes at 1 year of age. PMID:27112038

Cluster Randomized Test-Negative Design (CR-TND) Trials: A Novel and Efficient Method to Assess the Efficacy of Community Level Dengue Interventions.

PubMed

Anders, Katherine L; Cutcher, Zoe; Kleinschmidt, Immo; Donnelly, Christl A; Ferguson, Neil M; Indriani, Citra; O'Neill, Scott L; Jewell, Nicholas P; Simmons, Cameron P

2018-05-07

Cluster randomized trials are the gold standard for assessing efficacy of community-level interventions, such as vector control strategies against dengue. We describe a novel cluster randomized trial methodology with a test-negative design, which offers advantages over traditional approaches. It utilizes outcome-based sampling of patients presenting with a syndrome consistent with the disease of interest, who are subsequently classified as test-positive cases or test-negative controls on the basis of diagnostic testing. We use simulations of a cluster trial to demonstrate validity of efficacy estimates under the test-negative approach. This demonstrates that, provided study arms are balanced for both test-negative and test-positive illness at baseline and that other test-negative design assumptions are met, the efficacy estimates closely match true efficacy. We also briefly discuss analytical considerations for an odds ratio-based effect estimate arising from clustered data, and outline potential approaches to analysis. We conclude that application of the test-negative design to certain cluster randomized trials could increase their efficiency and ease of implementation.

Randomised controlled trial of whether erotic material is required for semen collection: impact of informed consent on outcome.

PubMed

Handelsman, D J; Sivananathan, T; Andres, L; Bathur, F; Jayadev, V; Conway, A J

2013-11-01

Semen is collected to evaluate male fertility or cryostore sperm preferentially in laboratories but such collection facilities have no standard fit-out. It is widely believed but untested whether providing erotic material (EM) is required to collect semen by masturbation in the unfamiliar environment. To test this assumption, 1520 men (1046 undergoing fertility evaluation, 474 sperm cryostorage, providing 1932 semen collection episodes) consecutively attending the semen laboratory of a major metropolitan teaching hospital for semen analysis were eligible for randomization to be provided or not with printed erotic material EM (X-rated, soft-core magazines) during semen collection. Randomization was performed by providing magazines in the collection rooms (as a variation on non-standard fit-out) on alternate weeks using a schedule concealed from participants. In the pilot study, men were randomized without seeking consent. In the second part of the study, which continued on from the first without interruption, an approved informed consent procedure was added. The primary outcome, the time to collect semen defined as the time from receiving to returning the sample receptacle, was significantly longer (by ~6%, 14.9 ± 0.3 [mean ± standard error of mean] vs. 14.0 ± 0.2 minutes, p = 0.02) among men provided with EM than those randomized to not being provided. There was no significant increase in the failure to collect semen samples (2.6% overall) nor any difference in age, semen volume or sperm concentration, output or motility according to whether EM was provided or not. The significantly longer time to collect was evident in the pilot study and the study overall, but not in the main study where the informed consent procedure was used. This study provides evidence that refutes the assumption that EM needs to be provided for semen collection in a laboratory. It also provides an example of a usually unobservable participation bias influencing study outcome of a randomized controlled trials. © 2013 American Society of Andrology and European Academy of Andrology.

Three controlled trials of interventions to increase recruitment to a randomized controlled trial of mobile phone based smoking cessation support.

PubMed

Free, Caroline; Hoile, Elizabeth; Robertson, Steven; Knight, Rosemary

2010-06-01

Recruitment is a major challenge for trials but there is little evidence regarding interventions to increase trial recruitment. We report three controlled trials of interventions to increase recruitment to the Txt2stop trial. To evaluate: Trial 1. The impact on registrations of a text message regarding an online registration facility; Trial 2. The impact on randomizations of sending pound5 with a covering letter to those eligible to join the trial; Trial 3. The impact on randomizations of text messages containing quotes from existing participants. Single blind controlled trials with allocation concealment. Trial 1: A text message regarding our new online registration facility; Trial 2: A letter with pound5 enclosed; Trial 3: A series of four text messages containing quotes from participants. The control group in each trial received standard Txt2stop procedures. Trial 1: 3.6% (17/470) of the intervention group and 1.1% (5/467) of the control group registered for the trial, risk difference 2.5% (95% CI 0.6-4.5). 0% (0/ 470) of the intervention group and 0.2% (1/467) of the control group registered successfully online, risk difference -0.2 (95% CI -0.6-0.2); Trial 2: 4.5% (11/246) of the intervention group and 0.4% (1/245) of the control group were randomized into the Txt2stop trial, risk difference 4.0% (95% CI 1.4-6.7); Trial 3: 3.5% (14/405) of the intervention group and 0% (0/406) of the control group were randomized into the Txt2stop trial, risk difference 3.5 (95% CI 1.7-5.2). There were no baseline data available for trial 1. Allocation of participant IDs in trials 2 and 3 were systematic. Sending a text message about an online registration facility increased registrations to Txt2stop, but did not increase online registrations. Sending a pound5 reimbursement for participants' time and sending text messages containing quotes from existing participants increased randomizations into the Txt2stop trial. Clinical Trials 2010; 7: 265-273. http://ctj.sagepub.com.