Low Social Support Level Is Associated with Non-Adherence to Diet at 1 Year in the Family Intervention Trial for Heart Health (FIT Heart)

ERIC Educational Resources Information Center

Aggarwal, Brooke; Liao, Ming; Allegrante, John P.; Mosca, Lori

2010-01-01

Objective: Evaluate the relationship between low social support (SS) and adherence to diet in a cardiovascular disease (CVD) lifestyle intervention trial. Design: Prospective substudy. Setting and Participants: Blood relatives/cohabitants of hospitalized cardiac patients in a randomized controlled trial (n = 458; 66% female, 35% nonwhite, mean age…

Remission in Depressed Geriatric Primary Care Patients: A Report From the PROSPECT Study

PubMed Central

Alexopoulos, George S.; Katz, Ira R.; Bruce, Martha L.; Heo, Moonseong; Have, Thomas Ten; Raue, Patrick; Bogner, Hillary R.; Schulberg, Herbert C.; Mulsant, Benoit H.; Reynolds, Charles F.

2009-01-01

Objective This study compared time to first remission for elderly depressed patients in primary care for practices that implemented a care management model versus those providing usual care. In addition, it sought to identify risk factors for nonremission that could guide treatment planning and referral to care managers or specialists. Method Prevention of Suicide in Primary Care Elderly: Collaborative Trial (PROSPECT) data were analyzed. Participants were older patients (≥60 years) selected following screening of 9,072 randomly identified primary care patients. The present analysis examined patients with major depression and a 24-item Hamilton Depression Rating Scale score of 18 or greater who were followed for at least 4 months (N=215). Primary care practices were randomly assigned to offer the PROSPECT intervention or usual care. The intervention consisted of services of trained care managers, who offered algorithm-based recommendations to physicians and helped patients with treatment adherence over 18 months. Results First remission occurred earlier and was more common among patients receiving the intervention than among those receiving usual care. For all patients, limitations in physical and emotional functions predicted poor remission rate. Patients experiencing hopelessness were more likely to achieve remission if treated in intervention practices. Similarly, the intervention was more effective in patients with low baseline anxiety. Conclusions Longitudinal assessment of depression, hopelessness, anxiety, and physical and emotional functional limitations in depressed older primary care patients is critical. Patients with prominent symptoms or impairment in these areas may be candidates for care management or mental health care, since they are at risk for remaining depressed and disabled. PMID:15800144

Evidence-Based Management of Pain After Excisional Haemorrhoidectomy Surgery: A PROSPECT Review Update.

PubMed

Sammour, Tarik; Barazanchi, Ahmed W H; Hill, Andrew G

2017-02-01

The aim of this systematic review was to update previous PROSPECT ( http://www.postoppain.org ) review recommendations for the management of pain after excisional haemorrhoidectomy. Randomized studies and reviews published in the English language from July 2006 (end date of last review) to March 2016, assessing analgesic, anaesthetic, and operative interventions pertaining to excisional haemorrhoidectomy in adults, and reporting pain scores, were retrieved from the EMBASE and MEDLINE databases. An additional 464 studies were identified of which 74 met the inclusion criteria. There were 48 randomized controlled trials and 26 reviews. Quantitative analyses were not performed, as there were limited numbers of trials with a sufficiently homogeneous design. Pudendal nerve block, with or without general anaesthesia, is recommended for all patients undergoing haemorrhoidal surgery. Either closed haemorrhoidectomy, or open haemorrhoidectomy with electrocoagulation of the pedicle is recommended as the primary procedure. Combinations of analgesics (paracetamol, non-steroidal anti-inflammatory drugs, and opioids), topical lignocaine and glyceryl trinitrate, laxatives, and oral metronidazole are recommended post-operatively. The recommendations are largely based on single intervention, not multimodal intervention, studies.

Impact of providing psychiatry specialty pharmacist intervention on reducing drug-related problems among children with autism spectrum disorder related to disruptive behavioural symptoms: A prospective randomized open-label study.

PubMed

Wongpakaran, R; Suansanae, T; Tan-Khum, T; Kraivichian, C; Ongarjsakulman, R; Suthisisang, C

2017-06-01

Psychopharmacologic therapy has so far focused on ameliorating disruptive behaviours to improve patient's function and quality of life. Due to the complicated neurobiological aetiology of autism spectrum disorder (ASD), a traditional pharmacist intervention may be insufficient to initiate the optimal care for this vulnerable population. We evaluate the impact of providing specialty psychiatry (PS) pharmacist intervention in identifying and resolving drug-related problems (DRPs) among children with ASD associated with disruptive behaviours. An eight-week-long, prospective, randomized open-label study was conducted. Children between 2.5 and 12 years of age with ASD and showing disruptive behaviours were included. They were randomly assigned to an intervention or a control group. Patients in the intervention group received pharmacist interventions delivered by a PS pharmacist, while those in control group were cared by a hospital pharmacist. The primary outcome was the number of patients who resolved of at least one DRP by the end of the study. The secondary outcome was to compare the mean Aberrant Behavior Checklist-Irritability (ABC-I) scores between the two groups. Twenty-five patients were randomly assigned to either an intervention or control group. At week 8, the total number of patients who resolved of at least one DRP was 13 (52%) in the intervention group and 4 (16%) in the control group, respectively (P=.016). Improper drug selection, medication non-adherence and subtherapeutic dosage were the most common DRPs. Mean ABC-I scores improved in the intervention group more than in the control group (9.8±5.6 vs 17.7±7.9; P<.001). To the best of our knowledge, this is the first study which demonstrated that PS pharmacist intervention is an effective strategy to resolve DRPs in patient with ASD. The reduction in common DRPs mostly resulted from the PS pharmacist interventions, including selection of antipsychotic agent, adjustment of dosage based on ABC-I scores and provision of individualized drug counselling. Reducing DRPs led to the improvement of any disruptive behaviour. In addition, multidisciplinary team should develop drug therapy protocols to promote the role of pharmacists in this setting. © 2017 John Wiley & Sons Ltd.

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.

Effects of Aromatherapy Massage on Pregnant Women's Stress and Immune Function: A Longitudinal, Prospective, Randomized Controlled Trial.

PubMed

Chen, Pao-Ju; Chou, Cheng-Chen; Yang, Luke; Tsai, Yu-Lun; Chang, Yue-Cune; Liaw, Jen-Jiuan

2017-10-01

This study's aims are to examine the effects of aromatherapy massage on women's stress and immune function during pregnancy. This longitudinal, prospective, randomized controlled trial recruited 52 healthy pregnant women from a prenatal clinic in Taipei using convenience sampling. The participants were randomly assigned to the intervention (n = 24) or control (n = 28) group using Clinstat block randomization. The intervention group received 70 min of aromatherapy massage with 2% lavender essential oil every other week (10 times in total) for 20 weeks; the control group received only routine prenatal care. In both groups, participants' salivary cortisol and immunoglobulin A (IgA) levels were collected before and after the intervention group received aromatherapy massage (every month from 16 to 36 weeks gestation) and were analyzed using enzyme-linked immunosorbent assay. The pregnant women in the intervention group had lower salivary cortisol (p < 0.001) and higher IgA (p < 0.001) levels immediately after aromatherapy massage than those in the control group, which did not receive massage treatment. Comparing the long-term effects of aromatherapy massage on salivary IgA levels between groups at different times, the study found that the pretest salivary IgA levels at 32 (p = 0.002) and 36 (p < 0.001) weeks gestational age (GA) were significantly higher than the pretest IgA at 16 weeks GA (baseline). This study presented evidence that aromatherapy massage could significantly decrease stress and enhance immune function in pregnant women. The findings can guide clinicians or midwives in providing aromatherapy massage to women throughout the pregnancy.

Randomized, Prospective Study of the Impact of a Sleep Health Program on Firefighter Injury and Disability.

PubMed

Sullivan, Jason P; O'Brien, Conor S; Barger, Laura K; Rajaratnam, Shantha M W; Czeisler, Charles A; Lockley, Steven W

2017-01-01

Firefighters' schedules include extended shifts and long work weeks which cause sleep deficiency and circadian rhythm disruption. Many firefighters also suffer from undiagnosed sleep disorders, exacerbating fatigue. We tested the hypothesis that a workplace-based Sleep Health Program (SHP) incorporating sleep health education and sleep disorders screening would improve firefighter health and safety compared to standard practice. Prospective station-level randomized, field-based intervention. US fire department. 1189 firefighters. Sleep health education, questionnaire-based sleep disorders screening, and sleep clinic referrals for respondents who screened positive for a sleep disorder. Firefighters were randomized by station. Using departmental records, in an intention-to-treat analysis, firefighters assigned to intervention stations which participated in education sessions and had the opportunity to complete sleep disorders screening reported 46% fewer disability days than those assigned to control stations (1.4 ± 5.9 vs. 2.6 ± 8.5 days/firefighter, respectively; p = .003). There were no significant differences in departmental injury or motor vehicle crash rates between the groups. In post hoc analysis accounting for intervention exposure, firefighters who attended education sessions were 24% less likely to file at least one injury report during the study than those who did not attend, regardless of randomization (OR [95% CI] 0.76 [0.60, 0.98]; χ2 = 4.56; p = .033). There were no significant changes pre- versus post-study in self-reported sleep or sleepiness in those who participated in the intervention. A firefighter workplace-based SHP providing sleep health education and sleep disorders screening opportunity can reduce injuries and work loss due to disability in firefighters. © Sleep Research Society 2016. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

Improving language comprehension in preschool children with language difficulties: a cluster randomized trial.

PubMed

Hagen, Åste M; Melby-Lervåg, Monica; Lervåg, Arne

2017-10-01

Children with language comprehension difficulties are at risk of educational and social problems, which in turn impede employment prospects in adulthood. However, few randomized trials have examined how such problems can be ameliorated during the preschool years. We conducted a cluster randomized trial in 148 preschool classrooms. Our intervention targeted language comprehension skills and lasted 1 year and 1 month, with five blocks of 6 weeks and intervention three times per week (about 75 min per week). Effects were assessed on a range of measures of language performance. Immediately after the intervention, there were moderate effects on both near, intermediate and distal measures of language performance. At delayed follow-up (7 months after the intervention), these reliable effects remained for the distal measures. It is possible to intervene in classroom settings to improve the language comprehension skills of children with language difficulties. However, it appears that such interventions need to be intensive and prolonged. © 2017 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.

Psychophysiological effects of a web-based stress management system: a prospective, randomized controlled intervention study of IT and media workers [ISRCTN54254861].

PubMed

Hasson, Dan; Anderberg, Ulla Maria; Theorell, Töres; Arnetz, Bengt B

2005-07-25

The aim of the present study was to assess possible effects on mental and physical well-being and stress-related biological markers of a web-based health promotion tool. A randomized, prospectively controlled study was conducted with before and after measurements, involving 303 employees (187 men and 116 women, age 23-64) from four information technology and two media companies. Half of the participants were offered web-based health promotion and stress management training (intervention) lasting for six months. All other participants constituted the reference group. Different biological markers were measured to detect possible physiological changes. After six months the intervention group had improved statistically significantly compared to the reference group on ratings of ability to manage stress, sleep quality, mental energy, concentration ability and social support. The anabolic hormone dehydroepiandosterone sulphate (DHEA-S) decreased significantly in the reference group as compared to unchanged levels in the intervention group. Neuropeptide Y (NPY) increased significantly in the intervention group compared to the reference group. Chromogranin A (CgA) decreased significantly in the intervention group as compared to the reference group. Tumour necrosis factor alpha (TNFalpha) decreased significantly in the reference group compared to the intervention group. Logistic regression analysis revealed that group (intervention vs. reference) remained a significant factor in five out of nine predictive models. The results indicate that an automatic web-based system might have short-term beneficial physiological and psychological effects and thus might be an opportunity in counteracting some clinically relevant and common stress and health issues of today.

Cost-effectiveness analysis of motivational interviewing with feedback to reduce drinking among a sample of college students.

PubMed

Cowell, Alexander J; Brown, Janice M; Mills, Michael J; Bender, Randall H; Wedehase, Brendan J

2012-03-01

This study evaluated the costs and cost-effectiveness of combining motivational interviewing with feedback to address heavy drinking among university freshmen. Microcosting methods were used in a prospective cost and cost-effectiveness study of a randomized trial of assessment only (AO), motivational interviewing (MI), feedback only (FB), and motivational interviewing with feedback (MIFB) at a large public university in the southeastern United States. Students were recruited and screened into the study during freshman classes based on recent heavy drinking. A total of 727 students (60% female) were randomized, and 656 had sufficient data at 3-months' follow-up to be included in the cost-effectiveness analysis. Effectiveness outcomes were changes in average drinks per drinking occasion and number of heavy drinking occasions. Mean intervention costs per student were $16.51 for MI, $17.33 for FB, and $36.03 for MIFB. Cost-effectiveness analysis showed two cost-effective interventions for both outcomes: AO ($0 per student) and MIFB ($36 per student). This is the first prospective cost-effectiveness study to our knowledge to examine MI for heavy drinking among students in a university setting. Despite being the most expensive intervention, MIFB was the most effective intervention and may be a cost-effective intervention, depending on a university's willingness to pay for changes in the considered outcomes.

Cost-Effectiveness Analysis of Motivational Interviewing With Feedback to Reduce Drinking Among a Sample of College Students

PubMed Central

Cowell, Alexander J.; Brown, Janice M.; Mills, Michael J.; Bender, Randall H.; Wedehase, Brendan J.

2012-01-01

Objective: This study evaluated the costs and cost-effectiveness of combining motivational interviewing with feedback to address heavy drinking among university freshmen. Method: Microcosting methods were used in a prospective cost and cost-effectiveness study of a randomized trial of assessment only (AO), motivational interviewing (MI), feedback only (FB), and motivational interviewing with feedback (MIFB) at a large public university in the southeastern United States. Students were recruited and screened into the study during freshman classes based on recent heavy drinking. A total of 727 students (60% female) were randomized, and 656 had sufficient data at 3-months’ follow-up to be included in the cost-effectiveness analysis. Effectiveness outcomes were changes in average drinks per drinking occasion and number of heavy drinking occasions. Results: Mean intervention costs per student were $16.51 for MI, $17.33 for FB, and $36.03 for MIFB. Cost-effectiveness analysis showed two cost-effective interventions for both outcomes: AO ($0 per student) and MIFB ($36 per student). Conclusions: This is the first prospective cost-effectiveness study to our knowledge to examine MI for heavy drinking among students in a university setting. Despite being the most expensive intervention, MIFB was the most effective intervention and may be a cost-effective intervention, depending on a university’s willingness to pay for changes in the considered outcomes. PMID:22333330

Prospective Dutch colorectal cancer cohort: an infrastructure for long-term observational, prognostic, predictive and (randomized) intervention research.

PubMed

Burbach, J P M; Kurk, S A; Coebergh van den Braak, R R J; Dik, V K; May, A M; Meijer, G A; Punt, C J A; Vink, G R; Los, M; Hoogerbrugge, N; Huijgens, P C; Ijzermans, J N M; Kuipers, E J; de Noo, M E; Pennings, J P; van der Velden, A M T; Verhoef, C; Siersema, P D; van Oijen, M G H; Verkooijen, H M; Koopman, M

2016-11-01

Systematic evaluation and validation of new prognostic and predictive markers, technologies and interventions for colorectal cancer (CRC) is crucial for optimizing patients' outcomes. With only 5-15% of patients participating in clinical trials, generalizability of results is poor. Moreover, current trials often lack the capacity for post-hoc subgroup analyses. For this purpose, a large observational cohort study, serving as a multiple trial and biobanking facility, was set up by the Dutch Colorectal Cancer Group (DCCG). The Prospective Dutch ColoRectal Cancer cohort is a prospective multidisciplinary nationwide observational cohort study in the Netherlands (yearly CRC incidence of 15 500). All CRC patients (stage I-IV) are eligible for inclusion, and longitudinal clinical data are registered. Patients give separate consent for the collection of blood and tumor tissue, filling out questionnaires, and broad randomization for studies according to the innovative cohort multiple randomized controlled trial design (cmRCT), serving as an alternative study design for the classic RCT. Objectives of the study include: 1) systematically collected long-term clinical data, patient-reported outcomes and biomaterials from daily CRC practice; and 2) to facilitate future basic, translational and clinical research including interventional and cost-effectiveness studies for both national and international research groups with short inclusion periods, even for studies with stringent inclusion criteria. Seven months after initiation 650 patients have been enrolled, eight centers participate, 15 centers await IRB approval and nine embedded cohort- or cmRCT-designed studies are currently recruiting patients. This cohort provides a unique multidisciplinary data, biobank, and patient-reported outcomes collection initiative, serving as an infrastructure for various kinds of research aiming to improve treatment outcomes in CRC patients. This comprehensive design may serve as an example for other tumor types.

Apathy in nursing home residents with dementia: results from a cluster-randomized controlled trial.

PubMed

Treusch, Y; Majic, T; Page, J; Gutzmann, H; Heinz, A; Rapp, M A

2015-02-01

Here we evaluate an interdisciplinary occupational and sport therapy intervention for dementia patients suffering from apathy. A prospective, controlled, rater-blinded, clinical trial with two follow-ups was conducted as part of a larger cluster-randomized trial in 18 nursing homes in Berlin. n=117 dementia patients with apathy, defined as a score of 40 or more on the apathy evaluation scale (AES) or presence of apathy on the Neuropsychiatric Inventory (NPI), were randomly assigned to intervention or control group. The intervention included 10 months of brief activities, provided once a week. The primary outcome measure was the total score on the AES scale measured directly after the intervention period and again after 12 months. We found significant group differences with respect to apathy during the 10 month intervention period (F2,82=7.79, P<0.01), which reflected an increase in apathy in the control group, but not in the intervention group. Within one year after the intervention was ceased, the treatment group worsened and no longer differed significantly from the control group (P=0.55). Our intervention was effective for the therapy of apathy in dementia, when applied, but not one year after cessation of therapy. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

A Prospective, Randomized Trial in the Emergency Department of Suggestive Audio-Therapy under Deep Sedation for Smoking Cessation.

PubMed

Rodriguez, Robert M; Taylor, Opal; Shah, Sushma; Urstein, Susan

2007-08-01

In a sample of patients undergoing procedural deep sedation in the emergency department (ED), we conducted a prospective, randomized, single-blinded trial of audio-therapy for smoking cessation. We asked subjects about their smoking, including desire to quit (0-10 numerical scale) and number of cigarettes smoked per day. Subjects were randomized to either a control tape (music alone) or a tape with repeated smoking-cessation messages over music. Tapes were started with first doses of sedation and stopped with patient arousal. Telephone follow-up occurred between two weeks and three months to assess the number of cigarettes smoked per day. Study endpoints were self-reported complete cessation and decrease of half or more in total cigarettes smoked per day. One hundred eleven patients were enrolled in the study, 54 to intervention and 57 to control. Mean desire to quit was 7.15 +/- 2.6 and mean cigarettes per day was 17.5 +/- 12.1. We successfully contacted 69 (62%) patients. Twenty-seven percent of intervention and 26% of control patients quit (mean difference = 1%; 95% CI: -22.0% to 18.8%). Thirty-seven percent of intervention and 51% of control patients decreased smoking by half or more (mean difference = 14.6%; 95% CI: -8.7% to 35.6%). Suggestive audio-therapy delivered during deep sedation in the ED did not significantly decrease self-reported smoking behavior.

Reduction of Methicillin-Resistant Staphylococcus aureus (MRSA) Infection in Long Term Care is Possible While Maintaining Patient Socialization: A Prospective Randomized Clinical Trial

PubMed Central

Peterson, Lance R.; Boehm, Susan; Beaumont, Jennifer L.; Patel, Parul A.; Schora, Donna M.; Peterson, Kari E.; Burdsall, Deborah; Hines, Carolyn; Fausone, Maureen; Robicsek, Ari; Smith, Becky A.

2016-01-01

Background Antibiotic resistance is a challenge in Long Term Care Facilities (LTCFs). The objective was to demonstrate that a novel, minimally invasive program not interfering with activities of daily living (ADL) or socialization could lower methicillin-resistant Staphylococcus aureus (MRSA) disease. Methods This was a prospective, cluster-randomized, non-blinded trial initiated at three LTCFs. During Year 1 units were stratified by type of care and randomized to intervention or control. In Year 2 all units were converted to intervention consisting of universal decolonization using intranasal mupirocin and a chlorhexidine bath performed twice (two decolonization/bathing cycles one month apart) at the start of the intervention period. Subsequently, after initial decolonization, all admissions were screened on site using real-time PCR and those MRSA positive were decolonized, but not isolated. Units received annual instruction on hand hygiene. Enhanced bleach wipe cleaning of flat surfaces was done every four months. Results 16,773 tests were performed. The MRSA infection rate decreased 65% between the baseline (44 infections during 365,809 patient-days) and Year 2 (12 during 287,847 patient-days; p<0.001); significant reduction was observed at each of the LTCFs (p<0.03). Discussion and Conclusion On-site MRSA surveillance with targeted decolonization resulted in a significant decrease in clinical MRSA infection among LTCF residents. PMID:27492790

The role of physical activity in producing and maintaining weight loss

PubMed Central

Catenacci, Victoria A; Wyatt, Holly R

2015-01-01

Summary The majority of randomized, controlled trials (RCTs) show only modest weight loss with exercise intervention alone, and slight increases in weight loss when exercise intervention is added to dietary restriction. In most RCTs, the energy deficit produced by the prescribed exercise is far smaller than that usually produced by dietary restriction. In prospective studies that prescribed high levels of exercise, enrolled individuals achieved substantially greater weight loss—comparable to that obtained after similar energy deficits were produced by caloric restriction. High levels of exercise might, however, be difficult for overweight or obese adults to achieve and sustain. RCTs examining exercise and its effect on weight-loss maintenance demonstrated mixed results; however, weight maintenance interventions were usually of limited duration and long-term adherence to exercise was problematic. Epidemiologic, cross-sectional, and prospective correlation studies suggest an essential role for physical activity in weight-loss maintenance, and post hoc analysis of prospective trials shows a clear dose–response relationship between physical activity and weight maintenance. This article reviews the role of physical activity in producing and maintaining weight loss. We focus on prospective, RCTs lasting at least 4 months; however, other prospective trials, meta-analyses and large systematic reviews are included. Limitations in the current body of literature are discussed. PMID:17581621

The role of physical activity in producing and maintaining weight loss.

PubMed

Catenacci, Victoria A; Wyatt, Holly R

2007-07-01

The majority of randomized, controlled trials (RCTs) show only modest weight loss with exercise intervention alone, and slight increases in weight loss when exercise intervention is added to dietary restriction. In most RCTs, the energy deficit produced by the prescribed exercise is far smaller than that usually produced by dietary restriction. In prospective studies that prescribed high levels of exercise, enrolled individuals achieved substantially greater weight loss-comparable to that obtained after similar energy deficits were produced by caloric restriction. High levels of exercise might, however, be difficult for overweight or obese adults to achieve and sustain. RCTs examining exercise and its effect on weight-loss maintenance demonstrated mixed results; however, weight maintenance interventions were usually of limited duration and long-term adherence to exercise was problematic. Epidemiologic, cross-sectional, and prospective correlation studies suggest an essential role for physical activity in weight-loss maintenance, and post hoc analysis of prospective trials shows a clear dose-response relationship between physical activity and weight maintenance. This article reviews the role of physical activity in producing and maintaining weight loss. We focus on prospective, RCTs lasting at least 4 months; however, other prospective trials, meta-analyses and large systematic reviews are included. Limitations in the current body of literature are discussed.

Use of a portable voice organizer to remember therapy goals in traumatic brain injury rehabilitation: a within-subjects trial.

PubMed

Hart, Tessa; Hawkey, Karen; Whyte, John

2002-12-01

To test the efficacy of a portable voice organizer in helping people with traumatic brain injury (TBI) to recall therapy goals and plans discussed with their clinical case managers. Prospective within-subjects trial, in which individualized therapy goals were randomly assigned to intervention or no intervention. Comprehensive postacute TBI rehabilitation program. Ten people with moderate to severe TBI enrolled from 3 months to 18 years after injury. Memory for therapy goals. Clinicians generated statements describing six current therapy goals, half of which were randomly assigned to be recorded on a voice organizer during the next case management session. Participants selected three times per day to listen to the recorded goals, prompted by an alarm. One-week recall was tested using both free- and cued-recall formats. Recorded goals were recalled better than unrecorded goals and appeared to be associated with better awareness or follow-through with therapy objectives. Portable electronic devices have the potential to assist with treatment areas beyond tasks involving prospective memory.

The effects of assertiveness training in patients with schizophrenia: a randomized, single-blind, controlled study.

PubMed

Lee, Tso-Ying; Chang, Shih-Chin; Chu, Hsin; Yang, Chyn-Yng; Ou, Keng-Liang; Chung, Min-Huey; Chou, Kuei-Ru

2013-11-01

In this study, we investigated the effects of group assertiveness training on assertiveness, social anxiety and satisfaction with interpersonal communication among patients with chronic schizophrenia. Only limited studies highlighted the effectiveness of group assertiveness training among inpatients with schizophrenia. Given the lack of group assertiveness training among patients with schizophrenia, further development of programmes focusing on facilitating assertiveness, self-confidence and social skills among inpatients with chronic schizophrenia is needed. This study used a prospective, randomized, single-blinded, parallel-group design. This study employed a prospective, randomized, parallel-group design. Seventy-four patients were randomly assigned to experimental group receiving 12 sessions of assertiveness training, or a supportive control group. Data collection took place for the period of June 2009-July 2010. Among patients with chronic schizophrenia, assertiveness, levels of social anxiety and satisfaction with interpersonal communication significantly improved immediately after the intervention and at the 3-month follow-up in the intervention group. The results of a generalized estimating equation (GEE) indicated that: (1) assertiveness significantly improved from pre- to postintervention and was maintained until the follow-up; (2) anxiety regarding social interactions significantly decreased after assertiveness training; and (3) satisfaction with interpersonal communication slightly improved after the 12-session intervention and at the 3-month follow-up. Assertivenss training is a non-invasive and inexpensive therapy that appears to improve assertiveness, social anxiety and interpersonal communication among inpatients with chronic schizophrenia. These findings may provide a reference guide to clinical nurses for developing assertiveness-training protocols. © 2013 Blackwell Publishing Ltd.

Porcine small intestine submucosal grafts improve remucosalization and progenitor cell recruitment to sites of upper airway tissue remodeling.

PubMed

Nayak, Jayakar V; Rathor, Aakanksha; Grayson, Jessica W; Bravo, Dawn T; Velasquez, Nathalia; Noel, Julia; Beswick, Daniel M; Riley, Kristen O; Patel, Zara M; Cho, Do-Yeon; Dodd, Robert L; Thamboo, Andrew; Choby, Garret W; Walgama, Evan; Harsh, Griffith R; Hwang, Peter H; Clemons, Lisa; Lowman, Deborah; Richman, Joshua S; Woodworth, Bradford A

2018-06-01

To better understand upper airway tissue regeneration, the exposed cartilage and bone at donor sites of tissue flaps may serve as in vivo "Petri dishes" for active wound healing. The pedicled nasoseptal flap (NSF) for skull-base reconstruction creates an exposed donor site within the nasal airway. The objective of this study is to evaluate whether grafting the donor site with a sinonasal repair cover graft is effective in promoting wound healing. In this multicenter, prospective trial, subjects were randomized to intervention (graft) or control (no graft) intraoperatively after NSF elevation. Individuals were evaluated at 2, 6, and 12 weeks postintervention with endoscopic recordings. Videos were graded (Likert scale) by 3 otolaryngologists blinded to intervention on remucosalization, crusting, and edema. Scores were analyzed for interrater reliability and cohorts compared. Biopsy and immunohistochemistry at the leading edge of wound healing was performed in select cases. Twenty-one patients were randomized to intervention and 26 to control. Subjects receiving the graft had significantly greater overall remucosalization (p = 0.01) than controls over 12 weeks. Although crusting was less in the small intestine submucosa (SIS) group, this was not statistically significant (p = 0.08). There was no overall effect on nasal edema (p = 0.2). Immunohistochemistry demonstrated abundant upper airway basal cell progenitors in 2 intervention samples, suggesting that covering grafts may facilitate tissue proliferation via progenitor cell expansion. This prospective, randomized, controlled trial indicates that a porcine SIS graft placed on exposed cartilage and bone within the upper airway confers improved remucosalization compared to current practice standards. © 2018 ARS-AAOA, LLC.

Influence of Ventilation Strategies and Anesthetic Techniques on Regional Cerebral Oximetry in the Beach Chair Position: A Prospective Interventional Study with a Randomized Comparison of Two Anesthetics.

PubMed

Picton, Paul; Dering, Andrew; Alexander, Amir; Neff, Mary; Miller, Bruce S; Shanks, Amy; Housey, Michelle; Mashour, George A

2015-10-01

Beach chair positioning during general anesthesia is associated with cerebral oxygen desaturation. Changes in cerebral oxygenation resulting from the interaction of inspired oxygen fraction (FIO2), end-tidal carbon dioxide (PETCO2), and anesthetic choice have not been fully evaluated in anesthetized patients in the beach chair position. This is a prospective interventional within-group study of patients undergoing shoulder surgery in the beach chair position that incorporated a randomized comparison between two anesthetics. Fifty-six patients were randomized to receive desflurane or total intravenous anesthesia with propofol. Following induction of anesthesia and positioning, FIO2 and minute ventilation were sequentially adjusted for all patients. Regional cerebral oxygenation (rSO2) was the primary outcome and was recorded at each of five set points. While maintaining FIO2 at 0.3 and PETCO2 at 30 mmHg, there was a decrease in rSO2 from 68% (SD, 12) to 61% (SD, 12) (P < 0.001) following beach chair positioning. The combined interventions of increasing FIO2 to 1.0 and increasing PETCO2 to 45 mmHg resulted in a 14% point improvement in rSO2 to 75% (SD, 12) (P <0.001) for patients anesthetized in the beach chair position. There was no significant interaction effect of the anesthetic at the study intervention points. Increasing FIO2 and PETCO2 resulted in a significant increase in rSO2 that overcomes desaturation in patients anesthetized in the beach chair position and that appears independent of anesthetic choice.

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.

Incorporating spirituality in psychosocial group intervention for women undergoing in vitro fertilization: a prospective randomized controlled study.

PubMed

Chan, Celia H Y; Chan, Cecilia L W; Ng, Ernest H Y; Ho, P C; Chan, Timothy H Y; Lee, G L; Hui, W H C

2012-12-01

This study examined the efficacy of a group intervention, the Integrative Body-Mind-Spirit (I-BMS) intervention, which aims at improving the psychosocial and spiritual well-being of Chinese women undergoing their first IVF treatment cycle. The I-BMS intervention facilitates the search of meaning of life in the context of family and childbearing, as well as the letting go of high IVF expectations. A randomized controlled study of 339 women undergoing first IVF treatment cycle in a local Hong Kong hospital was conducted (intervention: n= 172; no-intervention control: n= 167). Assessments of anxiety, perceived importance of childbearing, and spiritual well-being were made at randomization (T(0) ), on the day starting ovarian stimulations (T(1)), and on the day undertaking embryo transfer (T(2)). Comparing T(0) and T(2), interaction analyses showed women who had received the intervention reported lower levels of physical distress, anxiety, and disorientation. They reported being more tranquil and satisfied with their marriage, and saw childbearing as less important compared to women in the control group. These findings suggest that I-BMS intervention was successful at improving the psychosocial and spiritual well-being of women undergoing their first IVF treatment cycle. This study highlights the importance of providing integrative fertility treatment that incorporates psychosocial and spiritual dimensions. ©2011 The British Psychological Society.

Alcohol-based instant hand sanitizer use in military settings: a prospective cohort study of Army basic trainees.

PubMed

Mott, Peter J; Sisk, Brian W; Arbogast, James W; Ferrazzano-Yaussy, Cristina; Bondi, Cara A M; Sheehan, James J

2007-11-01

We investigated the impact of a customized alcohol-based instant hand sanitizer hand-hygiene regimen in an Army basic training setting. The entire population at the U.S. Army Field Artillery Training Center, Fort Sill, Oklahoma, participated in the 13-week prospective cohort study between January 18, 2005 and April 18, 2005. Two training battalions were randomly assigned to the control group, one to the primary intervention group (customized Purell Instant Hand Sanitizer regimen, education, reinforcement) and one to the secondary intervention group (customized Purell Instant Hand Sanitizer regimen). When compared to the control group, intervention groups experienced 40% less respiratory illness (p < 0.001), 48% less gastrointestinal illness (p < 0.02), 44% less lost training time (p < 0.001), and 31% fewer health care encounters (p < 0.001). These findings suggest that this intervention is capable of significantly reducing illness in this setting and has the potential to help reduce absenteeism in the military workforce as a whole.

Prospective Study on the Effectiveness of Complementary Food Supplements on Improving Status of Elder Infants and Young Children in the Areas Affected by Wenchuan Earthquake

PubMed Central

Dong, Caixia; Ge, Pengfei; Ren, Xiaolan; Wang, Jie; Fan, Haoqiang; Yan, Xiang; Yin, Shi-an

2013-01-01

Objective To prospectively evaluate the efficiency of daily providing complementary food supplements decreasing malnutrition and anemia prevalence in elder infants and young children living in areas affected by Wenchuan Earthquake. Design Using promotional probability sampling method, 250 to 300 children from six-randomized townships (30 to 50 children in each township) in Kang County affected by the Earthquake were randomly chosen for follow up to evaluate intervention effectiveness using anthropometric measurement and hemoglobin level at six, twelve and eighteen months after start of intervention. Setting and Subjects All children from 6 to 18 months of age in Kang County (in North Western China) were daily provided with complementary food supplements containing multiple vitamins and minerals for up to 24 months of age. The intervention period lasted for one and half year. Results At beginning of intervention, malnutrition prevalence, including underweight, stunting and wasting were respectively 4.5%, 8.9% and 3.5%; anemia prevalence was 74.3%. After one and half year intervention, the growth and anemia status were significantly improved; the percentages of wasting, stunting underweight prevalence were decreased from 3.5%, 8.9% and 4.5% to 1.7%, 5.0% and 3.3% respectively, and the anemia rates were significantly decreased. Conclusions Our results indicated that an intervention using complementary food supplements could improve nutritional status and elevate hemoglobin level in elder infants and young children, which would significantly decrease the prevalence of malnutrition and anemia. PMID:24039797

Effects of Zataria Multi-Flora, Shirazi thyme, on the Severity of Premenstrual Syndrome

PubMed Central

Sodouri, Marzieh; Masoudi Alavi, Negin; Fathizadeh, Nahid; Taghizadeh, Mohsen; Azarbad, Zohreh; Memarzadeh, Mohammadreza

2013-01-01

Background: Premenstrual Syndrome (PMS) is a common problem in women. Zataria multiflora Boiss is a valuable plant. This herbal plant has been used in different conditions. Objectives: The study was performed to investigate the effects of Zataria multiflora Boiss to control PMS symptoms. Materials and Methods: This study was a double-blinded, prospective randomized trial. The study population was the college students living in the dormitories of Isfahan University. Eighty-eight eligible students were randomly divided to intervention and control groups. Students completed the prospective record of the impact and severity of menstrual symptoms (PRISM) calendar including 30 PMS symptoms for four menstrual cycles (two cycles before, and two after the intervention). The intervention group received pearls containing 20 mg of Zataria multi-flora essence (four pearls each day) for two menstrual cycles, seven days before menstruation. The mean difference of PMS severity score between groups was analyzed with Mann-Whitney U test. The difference in frequency score of symptoms was analyzed using repeated-measure analysis of variance. Results: Thirty-eight students in intervention and 37 students in placebo group completed the study. The groups had no significant difference regarding the severity of PMS. Both groups showed a significant improvement in PMS severity score after the intervention. The repeated-measure analysis of variance showed that the frequency of symptoms decreased significantly in the cycles, but it was not different in intervention and placebo groups. Conclusions: Our findings did not support the use of Zataria multiflora Boiss in premenstrual syndrome. PMID:25414880

Effectiveness of preventive home visits in reducing the risk of falls in old age: a randomized controlled trial

PubMed Central

Luck, Tobias; Motzek, Tom; Luppa, Melanie; Matschinger, Herbert; Fleischer, Steffen; Sesselmann, Yves; Roling, Gudrun; Beutner, Katrin; König, Hans-Helmut; Behrens, Johann; Riedel-Heller, Steffi G

2013-01-01

Background Falls in older people are a major public health issue, but the underlying causes are complex. We sought to evaluate the effectiveness of preventive home visits as a multifactorial, individualized strategy to reduce falls in community-dwelling older people. Methods Data were derived from a prospective randomized controlled trial with follow-up examination after 18 months. Two hundred and thirty participants (≥80 years of age) with functional impairment were randomized to intervention and control groups. The intervention group received up to three preventive home visits including risk assessment, home counseling intervention, and a booster session. The control group received no preventive home visits. Structured interviews at baseline and follow-up provided information concerning falls in both study groups. Random-effects Poisson regression evaluated the effect of preventive home visits on the number of falls controlling for covariates. Results Random-effects Poisson regression showed a significant increase in the number of falls between baseline and follow-up in the control group (incidence rate ratio 1.96) and a significant decrease in the intervention group (incidence rate ratio 0.63) controlling for age, sex, family status, level of care, and impairment in activities of daily living. Conclusion Our results indicate that a preventive home visiting program can be effective in reducing falls in community-dwelling older people. PMID:23788832

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.

Comparison of pregnancy rates between patients with and without local endometrial scratching before intrauterine insemination.

PubMed

Senocak, G C; Yapca, O E; Borekci, B

2017-11-01

To determine the implantation success of local endometrial injury in patients undergoing intrauterine insemination following ovulation induction with gonadotropins as an infertility treatment. In this prospective randomized controlled trial, ovulation induction was performed with gonadotropins in 80 patients following intrauterine insemination. In 40 patients, local endometrial injury (scratch) was performed in the midluteal phase of the cycle preceding ovarian stimulation with a Novak curette to the posterior side of the endometrial cavity. Fifteen pregnancies (37.5%) and 11 clinical pregnancies (27.5%) occurred in the intervention group, whereas eight pregnancies (20%) and five clinical pregnancies (12.5%) occurred in the control group. Although the pregnancy rates and clinical pregnancy rates were increased in the intervention group, no statistically significant difference was found between the intervention and control groups (pregnancy rates: P=0.084; clinical pregnancy rates: P=0.094). Performing local endometrial injury (scratch) in the cycle preceding ovulation induction in patients with a diagnosis of infertility and indication for intrauterine insemination increased the pregnancy and clinical pregnancy rates. This increase was not, however, statistically significant. More randomized, controlled, prospective studies with larger patient numbers are required before the use of iatrogenic induction of local endometrial injury can be recommended in routine clinical practice. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Early Adult Outcomes of Adolescents Who Deliberately Poisoned Themselves

ERIC Educational Resources Information Center

Harrington, Richard; Pickles, Andrew; Aglan, Azza; Harrington, Val; Burroughs, Heather; Kerfoot, Michael

2006-01-01

Objective: To describe the early adult psychopathological and social outcomes of adolescents who deliberately poisoned themselves. Method: Prospective cohort study with a 6-year follow-up of 132 of 158 (84%) adolescents who, between ages 11 and 16 years, had taken part in a randomized trial of a brief family intervention after deliberate…

Impact of lifestyle intervention on dry eye disease in office workers: a randomized controlled trial.

PubMed

Kawashima, Motoko; Sano, Kokoro; Takechi, Sayuri; Tsubota, Kazuo

2018-04-04

To evaluate the effects of a 2-month lifestyle intervention for dry eye disease in office workers. Prospective interventional study (randomized controlled study). Forty-one middle-aged Japanese office workers (men, 22; women, 19; 39.2 ± 8.0 years) with definite and probable dry eye disease were enrolled and randomized to an intervention group (n = 22) and a control group (n = 19). The intervention aimed at modifying diet, increasing physical activity, and encouraging positive thinking. The primary outcome was change in dry eye disease diagnoses. Secondary outcome was change in disease parameters, including dry eye symptoms, as assessed using the Dry Eye-Related Quality of Life Score, corneal and conjunctival staining scores, tear break-up time, and Schirmer test results. A total of 36 participants (intervention group, 17; control group, 19) completed the study. The number of definite dry eye disease diagnoses decreased from four to none (p =.05), and the dry eye symptom score showed a significant decrease in the intervention group (p =.03). In contrast, the corneal and conjunctival staining scores, tear break-up time, and Schirmer test results did not differ significantly between groups. The 2-month lifestyle intervention employed in this study improved dry eye disease status among office workers, with a considerable decrease in subjective symptoms. Lifestyle intervention may be a promising management option for dry eye disease, although further investigation of long-term effects are required.

Adolescent pregnancy prevention: An abstinence-centered randomized controlled intervention in a Chilean public high school.

PubMed

Cabezón, Carlos; Vigil, Pilar; Rojas, Iván; Leiva, M Eugenia; Riquelme, Rosa; Aranda, Waldo; García, Carlos

2005-01-01

To evaluate the efficacy of an abstinence-centered sex education program in adolescent pregnancy prevention, the TeenSTAR Program was applied in a high school in Santiago, Chile. A total of 1259 girls from a Santiago high school were divided into three cohorts depending on the year they started high school: the 1996 cohort of 425 students, which received no intervention; the 1997 cohort, in which 210 students received an intervention and 213 (control group) did not; and the 1998 cohort, in which 328 students received an intervention and 83 (control group) did not. Students were randomly assigned to control and intervention groups in these cohorts, before starting with the program. We conducted a prospective, randomized study using the application of the TeenSTAR sex education program during the first year of high school to the intervention groups in the 1997 and 1998 cohorts. All cohorts were followed up for 4 years; pregnancy rates were recorded and subsequently contrasted in the intervention and control groups. Pregnancy rates were measured and Risk Ratio with 95% confidence interval were calculated for intervention and control groups in each cohort. Pregnancy rates for the intervention and control groups in the 1997 cohort were 3.3% and 18.9%, respectively (RR: 0.176, CI: 0.076-0.408). Pregnancy rates for the intervention and control groups in the 1998 cohort were 4.4% and 22.6%, respectively (RR 0.195, CI: 0.099-0.384). The abstinence-centered TeenSTAR sex education intervention was effective in the prevention of unintended adolescent pregnancy.

The prospective impact of food pricing on improving dietary consumption: A systematic review and meta-analysis.

PubMed

Afshin, Ashkan; Peñalvo, José L; Del Gobbo, Liana; Silva, Jose; Michaelson, Melody; O'Flaherty, Martin; Capewell, Simon; Spiegelman, Donna; Danaei, Goodarz; Mozaffarian, Dariush

2017-01-01

While food pricing is a promising strategy to improve diet, the prospective impact of food pricing on diet has not been systematically quantified. To quantify the prospective effect of changes in food prices on dietary consumption. We systematically searched online databases for interventional or prospective observational studies of price change and diet; we also searched for studies evaluating adiposity as a secondary outcome. Studies were excluded if price data were collected before 1990. Data were extracted independently and in duplicate. Findings were pooled using DerSimonian-Laird's random effects model. Pre-specified sources of heterogeneity were analyzed using meta-regression; and potential for publication bias, by funnel plots, Begg's and Egger's tests. From 3,163 identified abstracts, 23 interventional studies and 7 prospective cohorts with 37 intervention arms met inclusion criteria. In pooled analyses, a 10% decrease in price (i.e., subsidy) increased consumption of healthful foods by 12% (95%CI = 10-15%; N = 22 studies/intervention arms) whereas a 10% increase price (i.e. tax) decreased consumption of unhealthful foods by 6% (95%CI = 4-8%; N = 15). By food group, subsidies increased intake of fruits and vegetables by 14% (95%CI = 11-17%; N = 9); and other healthful foods, by 16% (95%CI = 10-23%; N = 10); without significant effects on more healthful beverages (-3%; 95%CI = -16-11%; N = 3). Each 10% price increase reduced sugar-sweetened beverage intake by 7% (95%CI = 3-10%; N = 5); fast foods, by 3% (95%CI = 1-5%; N = 3); and other unhealthful foods, by 9% (95%CI = 6-12%; N = 3). Changes in price of fruits and vegetables reduced body mass index (-0.04 kg/m2 per 10% price decrease, 95%CI = -0.08-0 kg/m2; N = 4); price changes for sugar-sweetened beverages or fast foods did not significantly alter body mass index, based on 4 studies. Meta-regression identified direction of price change (tax vs. subsidy), number of intervention components, intervention duration, and study quality score as significant sources of heterogeneity (P-heterogeneity<0.05 each). Evidence for publication bias was not observed. These prospective results, largely from interventional studies, support efficacy of subsidies to increase consumption of healthful foods; and taxation to reduce intake of unhealthful beverages and foods. Use of subsidies and combined multicomponent interventions appear most effective.

A Theoretically Based Behavioral Nutrition Intervention for Community Elders at High Risk: The B-NICE Randomized Controlled Clinical Trial

PubMed Central

LOCHER, JULIE L.; BALES, CONNIE W.; ELLIS, AMY C.; LAWRENCE, JEANNINE C.; NEWTON, LAURA; RITCHIE, CHRISTINE S.; ROTH, DAVID L.; BUYS, DAVID L.; VICKERS, KRISTIN S.

2012-01-01

We conducted a study designed to evaluate the efficacy and feasibility of a multilevel self-management intervention to improve nutritional intake in a group of older adults receiving Medicare home health services who were at especially high risk for experiencing undernutrition. The Behavioral Nutrition Intervention for Community Elders (B-NICE) trial used a prospective randomized controlled design to determine whether individually tailored counseling focused on social and behavioral aspects of eating resulted in increased caloric intake and improved nutrition-related health outcomes in a high-risk population of older adults. The study was guided by the theoretical approaches of the Ecological Model and Social Cognitive Theory. The development and implementation of the B-NICE protocol, including the theoretical framework, methodology, specific elements of the behavioral intervention, and assurances of the treatment fidelity, as well as the health policy implications of the trial results, are presented in this article. PMID:22098180

Maximizing shoulder function after accessory nerve injury and neck dissection surgery: A multicenter randomized controlled trial.

PubMed

McGarvey, Aoife C; Hoffman, Gary R; Osmotherly, Peter G; Chiarelli, Pauline E

2015-07-01

Shoulder pain and dysfunction after neck dissection may result from injury to the accessory nerve. The effect of early physical therapy in the form of intensive scapular strengthening exercises is unknown. A total of 59 neck dissection participants were prospectively recruited for this study. Participants were randomly assigned to either the intervention group (n = 32), consisting of progressive scapular strengthening exercises for 12 weeks, or the control group (n = 29). Blinded assessment occurred at baseline, and at 3, 6, and 12 months. Three-month data were collected on 52 participants/53 shoulders. Per-protocol analysis demonstrated that the intervention group had statistically significantly higher active shoulder abduction at 3 months compared to the control group (+26.6°; 95% confidence interval [CI] 7.28-45.95; p = .007). The intervention is a favorable treatment for maximizing shoulder abduction in the short term. The effect of the intervention compared to usual care is uncertain in the longer term. © 2014 Wiley Periodicals, Inc.

Effect of a multifaceted educational intervention for anti-infectious measures on sepsis mortality: a cluster randomized trial.

PubMed

Bloos, Frank; Rüddel, Hendrik; Thomas-Rüddel, Daniel; Schwarzkopf, Daniel; Pausch, Christine; Harbarth, Stephan; Schreiber, Torsten; Gründling, Matthias; Marshall, John; Simon, Philipp; Levy, Mitchell M; Weiss, Manfred; Weyland, Andreas; Gerlach, Herwig; Schürholz, Tobias; Engel, Christoph; Matthäus-Krämer, Claudia; Scheer, Christian; Bach, Friedhelm; Riessen, Reimer; Poidinger, Bernhard; Dey, Karin; Weiler, Norbert; Meier-Hellmann, Andreas; Häberle, Helene H; Wöbker, Gabriele; Kaisers, Udo X; Reinhart, Konrad

2017-11-01

Guidelines recommend administering antibiotics within 1 h of sepsis recognition but this recommendation remains untested by randomized trials. This trial was set up to investigate whether survival is improved by reducing the time before initiation of antimicrobial therapy by means of a multifaceted intervention in compliance with guideline recommendations. The MEDUSA study, a prospective multicenter cluster-randomized trial, was conducted from July 2011 to July 2013 in 40 German hospitals. Hospitals were randomly allocated to receive conventional continuous medical education (CME) measures (control group) or multifaceted interventions including local quality improvement teams, educational outreach, audit, feedback, and reminders. We included 4183 patients with severe sepsis or septic shock in an intention-to-treat analysis comparing the multifaceted intervention (n = 2596) with conventional CME (n = 1587). The primary outcome was 28-day mortality. The 28-day mortality was 35.1% (883 of 2596 patients) in the intervention group and 26.7% (403 of 1587 patients; p = 0.01) in the control group. The intervention was not a risk factor for mortality, since this difference was present from the beginning of the study and remained unaffected by the intervention. Median time to antimicrobial therapy was 1.5 h (interquartile range 0.1-4.9 h) in the intervention group and 2.0 h (0.4-5.9 h; p = 0.41) in the control group. The risk of death increased by 2% per hour delay of antimicrobial therapy and 1% per hour delay of source control, independent of group assignment. Delay in antimicrobial therapy and source control was associated with increased mortality but the multifaceted approach was unable to change time to antimicrobial therapy in this setting and did not affect survival.

Locomotor disability: meaning, causes and effects of interventions.

PubMed

Ebrahim, Shah; Adamson, Joy; Ayis, Salma; Beswick, Andrew; Gooberman-Hill, Rachael

2008-10-01

This paper provides a synopsis of a long-term programme of MRC-funded work on locomotor disability in older people. Specifically it describes the meaning and experience of disability, examines the risk factors for disability and systematically reviews the evidence from randomized trials of complex interventions for disability. We undertook a national prospective study of a representative sample of 999 people aged 65 years or more plus in-depth interviews with a small subsample and a selected sample obtained from hospital sources. Secondary analysis of several large prospective studies was carried out and a systematic review and meta-analysis of published randomized controlled trials of the effects of complex interventions for disability. Very few participants subscribed to the constructs of longstanding illness, disability or infirmity that surveys often use. A wide range of social and psychological factors, independently of chronic diseases, were strongly associated with disability. People with greater functional reserve capacity and those with greater self-efficacy were generally less likely to suffer from catastrophic decline in ability and had better quality of life in the face of disability. In reviewing 89 trials (over 97,000 participants) of complex interventions for disability, evidence of benefits was found although no relationship with intensity of intervention was apparent. Our findings on the meaning and experience of disability suggest the need for modifications to routinely used survey questions and for different ways of understanding the need for and receipt of care among older people with disabilities. The diverse risk factors for disability suggest that novel approaches across social, psychological as well as more traditional rehabilitation and behavioural risk factor modification would be worth exploring. Complex interventions appeared to help older people to live independently and limit functional decline irrespective of age and health status.

Cerebral Oximetry Monitoring to Maintain Normal Cerebral Oxygen Saturation during High-risk Cardiac Surgery: A Randomized Controlled Feasibility Trial.

PubMed

Deschamps, Alain; Hall, Richard; Grocott, Hilary; Mazer, C David; Choi, Peter T; Turgeon, Alexis F; de Medicis, Etienne; Bussières, Jean S; Hudson, Christopher; Syed, Summer; Seal, Doug; Herd, Stuart; Lambert, Jean; Denault, André; Deschamps, Alain; Mutch, Alan; Turgeon, Alexis; Denault, Andre; Todd, Andrea; Jerath, Angela; Fayad, Ashraf; Finnegan, Barry; Kent, Blaine; Kennedy, Brent; Cuthbertson, Brian H; Kavanagh, Brian; Warriner, Brian; MacAdams, Charles; Lehmann, Christian; Fudorow, Christine; Hudson, Christopher; McCartney, Colin; McIsaac, Dan; Dubois, Daniel; Campbell, David; Mazer, David; Neilpovitz, David; Rosen, David; Cheng, Davy; Drapeau, Dennis; Dillane, Derek; Tran, Diem; Mckeen, Dolores; Wijeysundera, Duminda; Jacobsohn, Eric; Couture, Etienne; de Medicis, Etienne; Alam, Fahad; Abdallah, Faraj; Ralley, Fiona E; Chung, Frances; Lellouche, Francois; Dobson, Gary; Germain, Genevieve; Djaiani, George; Gilron, Ian; Hare, Gregory; Bryson, Gregory; Clarke, Hance; McDonald, Heather; Roman-Smith, Helen; Grocott, Hilary; Yang, Homer; Douketis, James; Paul, James; Beaubien, Jean; Bussières, Jean; Pridham, Jeremy; Armstrong, J N; Parlow, Joel; Murkin, John; Gamble, Jonathan; Duttchen, Kaylene; Karkouti, Keyvan; Turner, Kim; Baghirzada, Leyla; Szabo, Linda; Lalu, Manoj; Wasowicz, Marcin; Bautista, Michael; Jacka, Michael; Murphy, Michael; Schmidt, Michael; Verret, Michaël; Perrault, Michel-Antoine; Beaudet, Nicolas; Buckley, Norman; Choi, Peter; MacDougall, Peter; Jones, Philip; Drolet, Pierre; Beaulieu, Pierre; Taneja, Ravi; Martin, Rene; Hall, Richard; George, Ronald; Chun, Rosa; McMullen, Sarah; Beattie, Scott; Sampson, Sonia; Choi, Stephen; Kowalski, Stephen; McCluskey, Stuart; Syed, Summer; Boet, Sylvain; Ramsay, Tim; Saha, Tarit; Mutter, Thomas; Chowdhury, Tumul; Uppal, Vishal; Mckay, William

2016-04-01

Cerebral oxygen desaturation during cardiac surgery has been associated with adverse perioperative outcomes. Before a large multicenter randomized controlled trial (RCT) on the impact of preventing desaturations on perioperative outcomes, the authors undertook a randomized prospective, parallel-arm, multicenter feasibility RCT to determine whether an intervention algorithm could prevent desaturations. Eight Canadian sites randomized 201 patients between April 2012 and October 2013. The primary outcome was the success rate of reversing cerebral desaturations below 10% relative to baseline in the intervention group. Anesthesiologists were blinded to the cerebral saturation values in the control group. Intensive care unit personnel were blinded to cerebral saturation values for both groups. Secondary outcomes included the area under the curve of cerebral desaturation load, enrolment rates, and a 30-day follow-up for adverse events. Cerebral desaturations occurred in 71 (70%) of the 102 intervention group patients and 56 (57%) of the 99 control group patients (P = 0.04). Reversal was successful in 69 (97%) of the intervention group patients. The mean cerebral desaturation load (SD) in the operating room was smaller for intervention group patients compared with control group patients (104 [217] %.min vs. 398 [869] %.min, mean difference, -294; 95% CI, -562 to -26; P = 0.03). This was also true in the intensive care unit (P = 0.02). There were no differences in adverse events between the groups. Study sites were successful in reversal of desaturation, patient recruitment, randomization, and follow-up in cardiac surgery, supporting the feasibility of conducting a large multicenter RCT.

Physical therapy after prophylactic mastectomy with breast reconstruction: a prospective randomized study.

PubMed

Unukovych, Dmytro; Johansson, Hemming; Johansson, Elizabeth; Arver, Brita; Liljegren, Annelie; Brandberg, Yvonne

2014-08-01

The rate of prophylactic mastectomies (PM) is increasing. Patients generally report high levels of health related quality of life and satisfaction after the procedure, whereas body image perception and sexuality may be negatively affected. The aim of the study was to evaluate the interest in physical therapy as a means of improving body image and sexuality in women after PM. Patients undergoing PM at Karolinska University Hospital between 2006 and 2010 were eligible. The following patient-reported outcome measures were used at study baseline and 2 years postoperatively: the body image scale (BIS), the sexual activity questionnaire (SAQ), the short-form health survey (SF-36), the hospital anxiety and depression scale (HAD), and a study specific "pain/motion/sensation scale". Out of 125 patients invited to participate in this prospective randomized study, 43 (34%) consented and were randomized into the intervention (n = 24, 56%) or control (n = 19, 44%) groups. There were no statistically significant between-group differences found with respect to BIS, SAQ, SF-36, HAD, and "pain/motion/sensation". Two years postoperatively, more than half of the patients in both groups reported problems like feeling less attractive, less sexually attractive, their body feeling less whole, and being dissatisfied with their body. A majority marked a decreased sensation in breast area. The interest in a physiotherapy intervention was limited among women who had undergone PM. The intervention did not show any substantial effects. A large proportion of patients reported specific body image related and pain/motion/sensation problems postoperatively. Copyright © 2014 Elsevier Ltd. All rights reserved.

Role of patient information handouts following operative treatment of ankle fractures: a prospective randomized study.

PubMed

Mayich, D Joshua; Tieszer, Christina; Lawendy, Abdel; McCormick, William; Sanders, David

2013-01-01

Widespread evidence exists for directed patient information interventions (eg, pamphlets) in the setting of several orthopaedic conditions and interventions. Up until now, no study had assessed the role of these interventions in the management of patients following ankle fractures. Between 2005 and 2007, 40 patients who suffered an operative ankle fracture were randomized to either a standard treatment group for an ankle fracture or an enhanced information group who received an American Academy of Orthopaedic Surgeons ankle fracture information pamphlet that explained postoperative routine at our institution and a physiotherapy handout depicting a standard protocol. Study participants were followed for 3 months clinically and radiographically. At the 6-week and 3-month intervals, study participants completed the Olerud-Molander Questionnaire and 2 questions regarding their level of satisfaction. The primary outcome measure was the Likert-scale-based survey question determining the level of satisfaction with the treating staff. Participants in the enhanced information group were more satisfied with treatment at 3 months (9.2 vs 6.3; P < .001). There were significant improvements in work/activity ability at 6 weeks (P = .01), but this advantage disappeared at 3 months (P = .24). No differences in postoperative complication rates were noted. Information enhancement in the form of pamphlets can be helpful in providing patients with accessible information in the postoperative period. While they do not seem to have a sustained impact on postoperative outcomes, handouts may enhance the interaction between staff and patient at postoperative visits, improving patient satisfaction. Level I, appropriately powered randomized prospective cohort study.

Monetary and Nonmonetary Student Incentives for Tutoring Services: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Springer, Matthew G.; Rosenquist, Brooks A.; Swain, Walker A.

2015-01-01

In recent years, the largely punitive accountability measures imposed by the 2001 No Child Left Behind Act have given way to an emphasis on financial incentives. Although most policy interventions have focused primarily on linking teacher compensation to student test scores, several recent studies have examined the prospects for the use of…

Evaluating the Dissemination of "Body & Soul," an Evidence-based Fruit and Vegetable Intake Intervention: Challenges for Dissemination and Implementation Research

ERIC Educational Resources Information Center

Allicock, Marlyn; Campbell, Marci K.; Valle, Carmina G.; Carr, Carol; Resnicow, Ken; Gizlice, Ziya

2012-01-01

Objective: To evaluate whether the evidence-based "Body & Soul" program, when disseminated and implemented without researcher or agency involvement and support, would achieve results similar to those of earlier efficacy and effectiveness trials. Design: Prospective group randomized trial. Setting: Churches with predominantly African American…

Long-Term Outcomes of the ATHENA (Athletes Targeting Healthy Exercise & Nutrition Alternatives) Program for Female High School Athletes

ERIC Educational Resources Information Center

Elliot, Diane L.; Goldberg, Linn; Moe, Esther L.; DeFrancesco, Carol A.; Durham, Melissa B.; McGinnis, Wendy; Lockwood, Chondra

2008-01-01

Adolescence and emerging adulthood are critical windows for establishing life-long behaviors. We assessed long-term outcomes of a prospective randomized harm reduction/health promotion program for female high school athletes. The intervention's immediate beneficial effects on diet pill use and unhealthy eating behaviors have been reported;…

Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) for veterans with traumatic brain injury: pilot randomized controlled trial.

PubMed

Twamley, Elizabeth W; Jak, Amy J; Delis, Dean C; Bondi, Mark W; Lohr, James B

2014-01-01

Traumatic brain injury (TBI) can result in cognitive impairments and persistent postconcussive symptoms that limit functional recovery, including return to work. We evaluated a 12 wk compensatory cognitive training intervention (Cognitive Symptom Management and Rehabilitation Therapy [CogSMART]) in the context of supported employment for Veterans with mild to moderate TBI. Participants were randomly assigned to receive 12 wk of supported employment plus CogSMART or enhanced supported employment that controlled for therapist attention (control). CogSMART sessions were delivered by the employment specialist and included psychoeducation regarding TBI; strategies to improve sleep, fatigue, headaches, and tension; and compensatory cognitive strategies in the domains of prospective memory, attention, learning and memory, and executive functioning. Compared with controls, those assigned to supported employment plus CogSMART demonstrated significant reductions in postconcussive symptoms (Cohen d = 0.97) and improvements in prospective memory functioning (Cohen d = 0.72). Effect sizes favoring CogSMART for posttraumatic stress disorder symptom severity, depressive symptom severity, and attainment of competitive work within 14 wk were in the small to medium range (Cohen d = 0.35-0.49). Those who received CogSMART rated the intervention highly. Results suggest that adding CogSMART to supported employment may improve postconcussive symptoms and prospective memory. These effects, as well as smaller effects on psychiatric symptoms and ability to return to work, warrant replication in a larger trial.

Effect of music intervention on burn patients' pain and anxiety during dressing changes.

PubMed

Hsu, Kuo-Cheng; Chen, Li Fen; Hsiep, Pi Hsia

2016-12-01

For burn patients, the daily dressing process causes pain and anxiety. Although drugs can relieve them, the degree of pain during dressing changes is often moderate to severe. Therefore, relevant supporting interventions, like music as an ideal intervention, could alleviate the patient's pain. This study investigated the impact of music intervention at dressing change time on burn patients' pain and anxiety. This was a prospective, randomized clinical trial; patients were randomly assigned into control (standard intervention) and experimental groups (crystal music intervention) for five consecutive days (35 patients in each group). Patients' pain and anxiety measurements were collected before, during, and after dressing changes and morphine usage was recorded. The study period was October 2014 to September 2015. There was no difference in morphine dosage for both groups. By the fourth day of music intervention, burn patients' pain before, during, and after dressing changes had significantly decreased; anxiety on the fourth day during and after dressing changes had also significantly decreased. Nurses may use ordered prescription analgesics, but if non-pharmacological interventions are increased, such as providing timely music intervention and creating a friendly, comfortable hospital environment, patients' pain and anxiety will reduce. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

Use of prophylactic Saccharomyces boulardii to prevent Clostridium difficile infection in hospitalized patients: a controlled prospective intervention study.

PubMed

Carstensen, Jeppe West; Chehri, Mahtab; Schønning, Kristian; Rasmussen, Steen Christian; Anhøj, Jacob; Godtfredsen, Nina Skavlan; Andersen, Christian Østergaard; Petersen, Andreas Munk

2018-05-03

Clostridium difficile infection (CDI) is a common complication to antibiotic use. Saccharomyces boulardii has shown effect as a prophylactic agent. We aimed to evaluate the efficacy of S. boulardii in preventing CDI in unselected hospitalized patients treated with antibiotics. We conducted a 1 year controlled prospective intervention study aiming to prescribe Sacchaflor (S. boulardii 5 × 10 9 , Pharmaforce ApS) twice daily to hospitalized patients treated with antibiotics. Comparable departments from three other hospitals in our region were included as controls. All occurrences of CDI in patients receiving antibiotics were reported and compared to a baseline period defined as 2 years prior to intervention. Results were analyzed using run chart tests for non-random variation in CDI rates. In addition, odds ratios for CDI were calculated. S. boulardii compliance reached 44% at the intervention hospital, and 1389 patients were treated with Sacchaflor. Monthly CDI rates dropped from a median of 3.6% in the baseline period to 1.5% in the intervention period. S. boulardii treatment was associated with a reduced risk of CDI at the intervention hospital: OR = 0.06 (95% CI 0.02-0.16). At two control hospitals, CDI rates did not change. At one control hospital, the median CDI rate dropped from 3.5 to 2.4%, possibly reflecting the effects of simultaneous multifaceted intervention against CDI at that hospital. The results from this controlled prospective interventional study indicate that S. boulardii is effective for the prevention of CDI in an unselected cohort of mainly elderly patients from departments of internal medicine.

A Prospective Randomized Controlled Trial to Study the Impact of a Nutrition-Sensitive Intervention on Adult Women With Cancer Cachexia Undergoing Palliative Care in India.

PubMed

Kapoor, Neha; Naufahu, Jane; Tewfik, Sundus; Bhatnagar, Sushma; Garg, Rakesh; Tewfik, Ihab

2017-03-01

Advanced cancer patients with disease progression develop cachexia. Nevertheless, cancer patients at nutritional risk have shown improved body weight and quality of life with oral nutritional supplements. This was a randomized controlled trial in adult female cancer patients (n = 63) attending palliative clinics, with symptoms of cachexia. Eligible patients were randomly distributed into control (n = 33) and intervention (n = 30) groups. Both groups were provided with nutritional and physical activity counseling, but the intervention group received an additional 100 g of Improved Atta (IAtta) for 6 months daily consumption. This study was designed to assess the efficacy of IAtta (with counseling) in enhancing the health status of cachexic patients. Anthropometric measurements, dietary intake, physical activity level and quality of life parameters were assessed at baseline, after 3 months, and at the end of 6 months. Patients in the control group (n = 15) had significantly decreased body weight ( P = .003), mid-upper-arm circumference ( P = .002), and body fat ( P = .002) by the end of intervention. A trend of body weight gain in the intervention group (n = 17; P = .08) and significant increase of body fat ( P = .002) was observed; moreover, patients reported a significant improvement in fatigue ( P = .002) and appetite scores ( P = .006) under quality-of-life domains at the end of intervention. Embedding a nutrition-sensitive intervention ( IAtta ) within Indian palliative care therapy may improve quality of life and stabilize body weight in cancer cachexia patients.

Mechanical Thrombectomy-Ready Comprehensive Stroke Center Requirements and Endovascular Stroke Systems of Care: Recommendations from the Endovascular Stroke Standards Committee of the Society of Vascular and Interventional Neurology (SVIN)

PubMed Central

English, Joey D.; Yavagal, Dileep R.; Gupta, Rishi; Janardhan, Vallabh; Zaidat, Osama O.; Xavier, Andrew R.; Nogueira, Raul G.; Kirmani, Jawad F.; Jovin, Tudor G.

2016-01-01

Five landmark multicenter, prospective, randomized, open-label, blinded end point clinical trials have recently demonstrated significant clinical benefit of endovascular therapy with mechanical thrombectomy in acute ischemic stroke (AIS) patients presenting with proximal intracranial large vessel occlusions. The Society of Vascular and Interventional Neurology (SVIN) appointed an expert writing committee to summarize this new evidence and make recommendations on how these data should guide emergency endovascular therapy for AIS patients. PMID:27051410

A prospective randomized trial examining health care utilization in individuals using multiple smartphone-enabled biosensors.

PubMed

Bloss, Cinnamon S; Wineinger, Nathan E; Peters, Melissa; Boeldt, Debra L; Ariniello, Lauren; Kim, Ju Young; Sheard, Judith; Komatireddy, Ravi; Barrett, Paddy; Topol, Eric J

2016-01-01

Background. Mobile health and digital medicine technologies are becoming increasingly used by individuals with common, chronic diseases to monitor their health. Numerous devices, sensors, and apps are available to patients and consumers-some of which have been shown to lead to improved health management and health outcomes. However, no randomized controlled trials have been conducted which examine health care costs, and most have failed to provide study participants with a truly comprehensive monitoring system. Methods. We conducted a prospective randomized controlled trial of adults who had submitted a 2012 health insurance claim associated with hypertension, diabetes, and/or cardiac arrhythmia. The intervention involved receipt of one or more mobile devices that corresponded to their condition(s) (hypertension: Withings Blood Pressure Monitor; diabetes: Sanofi iBGStar Blood Glucose Meter; arrhythmia: AliveCor Mobile ECG) and an iPhone with linked tracking applications for a period of 6 months; the control group received a standard disease management program. Moreover, intervention study participants received access to an online health management system which provided participants detailed device tracking information over the course of the study. This was a monitoring system designed by leveraging collaborations with device manufacturers, a connected health leader, health care provider, and employee wellness program-making it both unique and inclusive. We hypothesized that health resource utilization with respect to health insurance claims may be influenced by the monitoring intervention. We also examined health-self management. Results & Conclusions. There was little evidence of differences in health care costs or utilization as a result of the intervention. Furthermore, we found evidence that the control and intervention groups were equivalent with respect to most health care utilization outcomes. This result suggests there are not large short-term increases or decreases in health care costs or utilization associated with monitoring chronic health conditions using mobile health or digital medicine technologies. Among secondary outcomes there was some evidence of improvement in health self-management which was characterized by a decrease in the propensity to view health status as due to chance factors in the intervention group.

A prospective randomized trial examining health care utilization in individuals using multiple smartphone-enabled biosensors

PubMed Central

Peters, Melissa; Boeldt, Debra L.; Ariniello, Lauren; Kim, Ju Young; Sheard, Judith; Komatireddy, Ravi; Barrett, Paddy

2016-01-01

Background. Mobile health and digital medicine technologies are becoming increasingly used by individuals with common, chronic diseases to monitor their health. Numerous devices, sensors, and apps are available to patients and consumers–some of which have been shown to lead to improved health management and health outcomes. However, no randomized controlled trials have been conducted which examine health care costs, and most have failed to provide study participants with a truly comprehensive monitoring system. Methods. We conducted a prospective randomized controlled trial of adults who had submitted a 2012 health insurance claim associated with hypertension, diabetes, and/or cardiac arrhythmia. The intervention involved receipt of one or more mobile devices that corresponded to their condition(s) (hypertension: Withings Blood Pressure Monitor; diabetes: Sanofi iBGStar Blood Glucose Meter; arrhythmia: AliveCor Mobile ECG) and an iPhone with linked tracking applications for a period of 6 months; the control group received a standard disease management program. Moreover, intervention study participants received access to an online health management system which provided participants detailed device tracking information over the course of the study. This was a monitoring system designed by leveraging collaborations with device manufacturers, a connected health leader, health care provider, and employee wellness program–making it both unique and inclusive. We hypothesized that health resource utilization with respect to health insurance claims may be influenced by the monitoring intervention. We also examined health-self management. Results & Conclusions. There was little evidence of differences in health care costs or utilization as a result of the intervention. Furthermore, we found evidence that the control and intervention groups were equivalent with respect to most health care utilization outcomes. This result suggests there are not large short-term increases or decreases in health care costs or utilization associated with monitoring chronic health conditions using mobile health or digital medicine technologies. Among secondary outcomes there was some evidence of improvement in health self-management which was characterized by a decrease in the propensity to view health status as due to chance factors in the intervention group. PMID:26788432

Subsequent surgery rates after cervical total disc replacement using a Mobi-C Cervical Disc Prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial with 5-year follow-up.

PubMed

Jackson, Robert J; Davis, Reginald J; Hoffman, Gregory A; Bae, Hyun W; Hisey, Michael S; Kim, Kee D; Gaede, Steven E; Nunley, Pierce Dalton

2016-05-01

OBJECTIVE Cervical total disc replacement (TDR) has been shown in a number of prospective clinical studies to be a viable treatment alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic degenerative disc disease. In addition to preserving motion, evidence suggests that cervical TDR may result in a lower incidence of subsequent surgical intervention than treatment with fusion. The goal of this study was to evaluate subsequent surgery rates up to 5 years in patients treated with TDR or ACDF at 1 or 2 contiguous levels between C-3 and C-7. METHODS This was a prospective, multicenter, randomized, unblinded clinical trial. Patients with symptomatic degenerative disc disease were enrolled to receive 1- or 2-level treatment with either TDR as the investigational device or ACDF as the control treatment. There were 260 patients in the 1-level study (179 TDR and 81 ACDF patients) and 339 patients in the 2-level study (234 TDR and 105 ACDF patients). RESULTS At 5 years, the occurrence of subsequent surgical intervention was significantly higher among ACDF patients for 1-level (TDR, 4.5% [8/179]; ACDF, 17.3% [14/81]; p = 0.0012) and 2-level (TDR, 7.3% [17/234]; ACDF, 21.0% [22/105], p = 0.0007) treatment. The TDR group demonstrated significantly fewer index- and adjacent-level subsequent surgeries in both the 1- and 2-level cohorts. CONCLUSIONS Five-year results showed treatment with cervical TDR to result in a significantly lower rate of subsequent surgical intervention than treatment with ACDF for both 1 and 2 levels of treatment. Clinical trial registration no.: NCT00389597 ( clinicaltrials.gov ).

A Prospective Randomized Trial of Postural Changes vs Passive Supine Lying during the Second Stage of Labor under Epidural Analgesia

PubMed Central

Simarro, María; Espinosa, José Angel; Salinas, Cecilia; Ojea, Ricardo; Salvadores, Paloma; Walker, Carolina; Schneider, José

2017-01-01

There exist very few studies comparing different postures or postural changes during labor in parturients with epidural analgesia. Aim: To disclose whether the intervention of a multidisciplinary nursing team including a physiotherapist during the second stage of labor improves the obstetric outcome in parturients with epidural analgesia. Design: Prospective randomized trial. Setting: University-affiliated hospital. Population: Women undergoing labor with epidural analgesia after a normal gestation. Methods: 150 women were randomized either to actively perform predefined postural changes during the passive phase of the second stage of labor under the guidance of the attending physiotherapist (study group), or to carry out the whole second stage of labor lying in the traditional supine position (control group). Results: There were significantly more eutocic deliveries (p = 0.005) and, conversely, significantly less instrumental deliveries (p < 0.05) and cesarean sections (p < 0.05) in the study group. The total duration of the second stage of labor was significantly shorter (p < 0.01) in the study group. This was at the expense of the passive phase of the second stage of labor (p < 0.01). Significantly less episiotomies were performed in the study group (31.2% vs 17.8%, p < 0.05). Conclusion: The intervention of a physiotherapist during the second stage of labor significantly improved the obstetric outcome. PMID:29099021

Preoperative nutritional support in cancer patients with no clinical signs of malnutrition--prospective randomized controlled trial.

PubMed

Kabata, Paweł; Jastrzębski, Tomasz; Kąkol, Michał; Król, Karolina; Bobowicz, Maciej; Kosowska, Anna; Jaśkiewicz, Janusz

2015-02-01

Preoperative nutrition is beneficial for malnourished cancer patients. Yet, there is little evidence whether or not it should be given to nonmalnourished patients. The aim of this study was to assess the need to introduce preoperative nutritional support in patients without malnutrition at qualification for surgery. This was a prospective, two-arm, randomized, controlled, open-label study. Patients in interventional group received nutritional supplementation for 14 days before surgery, while control group kept on to their everyday diet. Each patient's nutritional status was assessed twice--at qualification (weight loss in 6 months, laboratory parameters: albumin, total protein, transferrin, and total lymphocyte count) and 1 day before surgery (change in body weight and laboratory parameters). After surgery, all patients were followed up for 30 days for postoperative complications. Fifty-four patients in interventional and 48 in control group were analyzed. In postoperative period, patients in control group suffered from significantly higher (p < 0.001) number of serious complications compared with patients receiving nutritional supplementation. Moreover, levels of all laboratory parameters declined significantly (p < 0.001) in these patients, while in interventional arm were stable (albumin and total protein) or raised (transferrin and total lymphocyte count). Preoperative nutritional support should be introduced for nonmalnourished patients as it helps to maintain proper nutritional status and reduce number and severity of postoperative complications compared with patients without such support.

PHARMacy-based interdisciplinary program for patients with Chronic Heart Failure (PHARM-CHF): rationale and design of a randomized controlled trial, and results of the pilot study.

PubMed

Laufs, Ulrich; Griese-Mammen, Nina; Krueger, Katrin; Wachter, Angelika; Anker, Stefan D; Koehler, Friedrich; Rettig-Ewen, Volker; Botermann, Lea; Strauch, Dorothea; Trenk, Dietmar; Böhm, Michael; Schulz, Martin

2018-05-30

We report the rationale and design of a community PHARMacy-based prospective randomized controlled interdisciplinary study for ambulatory patients with Chronic Heart Failure (PHARM-CHF) and results of its pilot study. The pilot study randomized 50 patients to a pharmacy-based intervention or usual care for 12 months. It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence. The main study will randomize patients ≥60 years on stable pharmacotherapy including at least one diuretic and a history of heart failure hospitalization within 12 months. The intervention group will receive a medication review at baseline followed by regular dose dispensing of the medication, counselling regarding medication use and symptoms of heart failure. The control patients are unknown to the pharmacy and receive usual care. The primary efficacy endpoint is medication adherence, pre-specified as a significant difference of the proportion of days covered between the intervention and control group within 365 days following randomization using pharmacy claims data for three CHF medications (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists). The primary composite safety endpoint is days lost due to blindly adjudicated unplanned cardiovascular hospitalizations or death. Overall, 248 patients shall be randomized. The minimum follow-up is 12 months with an expected mean of 24 months. Based on the feasibility demonstrated in the pilot study, the randomized PHARM-CHF trial will test whether an interdisciplinary pharmacy-based intervention can safely improve medication adherence and will estimate the potential impact on clinical endpoints. ClinicalTrials.gov Identifier: NCT01692119. © 2018 The Authors. European Journal of Heart Failure © 2018 European Society of Cardiology.

Restoring Body Image After Cancer (ReBIC): Results of a Randomized Controlled Trial.

PubMed

Esplen, Mary Jane; Wong, Jiahui; Warner, Ellen; Toner, Brenda

2018-03-10

Purpose This study aimed to test a group psychosocial intervention focused on improving disturbances of body image (BI), sexual functioning, and quality of life in breast cancer (BC) survivors. Methods A prospective, randomized controlled trial was conducted to assess the efficacy of an 8-week group intervention in women after BC treatment. The manual-based intervention combined two powerful ingredients: expressive guided-imagery exercises integrated within a model of group-therapy principles. The intervention facilitates exploration of identity, the development of new self-schemas, and personal growth. In addition, the intervention included an educational component on the social and cultural factors affecting women's self-esteem and BI. The control condition included standard care plus educational reading materials. One hundred ninety-four BC survivors who had expressed concerns about negative BI and/or difficulties with sexual functioning participated in the study; 131 were randomly assigned to the intervention, and 63 were assigned to the control condition. Participants were followed for 1 year. Results Women in the intervention group reported significantly less concern/distress about body appearance ( P < .01), decreased body stigma ( P < .01), and lower level of BC-related concerns ( P < .01), compared with women in the control group. BC-related quality of life was also better in the intervention group compared with the control group at the 1-year follow-up ( P < .01). There was no statistically significant group difference in sexual functioning. Conclusion Restoring Body Image After Cancer (ReBIC), a group intervention using guided imagery within a group-therapy approach, is an effective method for addressing BI-related concerns and quality of life post-BC. The manual-based intervention can be easily adapted to both cancer centers and primary care settings.

Cost-Effectiveness of Wisconsin TEAM Model for Improving Adherence and Hypertension Control in Black Patients

PubMed Central

Shireman, Theresa I.; Svarstad, Bonnie L.

2016-01-01

Objective To assess the cost-effectiveness of the 6-month Team Education and Adherence Monitoring (TEAM) intervention for black patients with hypertension in community pharmacies using prospectively collected cost data. Design Cost-effectiveness analysis of a cluster-randomized trial. Setting 28 chain pharmacies in five Wisconsin cities from December 2006 to February 2009. Participants 576 black patients with uncontrolled hypertension Intervention Pharmacists and pharmacy technicians using novel tools for improving adherence and feedback to patients and physicians as compared to information only control group. Main outcome measure(s) Incremental cost analysis of variable costs from the pharmacy perspective captured prospectively at the participant level. Outcomes (effect measures) were 6-month refill adherence, changes in SBP and DBP, and proportion of patients achieving BP control. Results Mean cost of intervention personnel time and tools was $104.8± 45.2. Incremental variable costs per mmHg decrease in SBP and DBP were $22.2 ± 16.3 and $66.0 ± 228.4, respectively. The cost of helping one more person achieve the BP goal (< 140/90) was $665.2 ± 265.2; the cost of helping one more person achieve good refill adherence was $463.3 ± 110.7. Prescription drug costs were higher for the TEAM group ($392.8, SD = 396.3 versus $307.0, SD = 295.2, p = 0.02). The start-up cost for pharmacy furniture, equipment, and privacy screen was $168 per pharmacy. Conclusions Our randomized, practice based intervention demonstrated that community pharmacists can implement a cost-effective intervention to improve hypertension control in blacks. This approach imposes a nominal expense at the pharmacy level, can be integrated into the ongoing pharmacist-patient relationship, and can enhance clinical and behavioral outcomes. PMID:27184784

Improving the quality of hospital care for children by supportive supervision: a cluster randomized trial, Kyrgyzstan

PubMed Central

Shukurova, Venera; Davletbaeva, Marina; Monolbaev, Kubanychbek; Kulichenko, Tatiana; Akoev, Yuri; Bakradze, Maya; Margieva, Tea; Mityushino, Ilya; Namazova-Baranova, Leyla; Boronbayeva, Elnura; Kuttumuratova, Aigul; Weber, Martin Willy; Tamburlini, Giorgio

2017-01-01

Abstract Objective To determine whether periodic supportive supervision after a training course improved the quality of paediatric hospital care in Kyrgyzstan, where inappropriate care was common but in-hospital postnatal mortality was low. Methods In a cluster, randomized, parallel-group trial, 10 public hospitals were allocated to a 4-day World Health Organization (WHO) course on hospital care for children followed by periodic supportive supervision by paediatricians for 1 year, while 10 hospitals had no intervention. We assessed prospectively 10 key indicators of inappropriate paediatric case management, as indicated by WHO guidelines. The primary indicator was the combination of the three indicators: unnecessary hospitalization, increased iatrogenic risk and unnecessary painful procedures. An independent team evaluated the overall quality of care. Findings We prospectively reviewed the medical records of 4626 hospitalized children aged 2 to 60 months. In the intervention hospitals, the mean proportion of the primary indicator decreased from 46.9% (95% confidence interval, CI: 24.2 to 68.9) at baseline to 6.8% (95% CI: 1.1 to 12.1) at 1 year, but was unchanged in the control group (45.5%, 95% CI: 25.2 to 67.9, to 64.7%, 95% CI: 43.3 to 86.1). At 1 year, the risk ratio for the primary indicator in the intervention versus the control group was 0.09 (95% CI: 0.06 to 0.13). The proportions of the other nine indicators also decreased in the intervention group (P < 0.0001 for all). Overall quality of care improved significantly in intervention hospitals. Conclusion Periodic supportive supervision for 1 year after a training course improved both adherence to WHO guidelines on hospital care for children and the overall quality of paediatric care. PMID:28603306

The prospective impact of food pricing on improving dietary consumption: A systematic review and meta-analysis

PubMed Central

Afshin, Ashkan; Peñalvo, José L.; Del Gobbo, Liana; Silva, Jose; Michaelson, Melody; O'Flaherty, Martin; Capewell, Simon; Spiegelman, Donna; Danaei, Goodarz; Mozaffarian, Dariush

2017-01-01

Background While food pricing is a promising strategy to improve diet, the prospective impact of food pricing on diet has not been systematically quantified. Objective To quantify the prospective effect of changes in food prices on dietary consumption. Design We systematically searched online databases for interventional or prospective observational studies of price change and diet; we also searched for studies evaluating adiposity as a secondary outcome. Studies were excluded if price data were collected before 1990. Data were extracted independently and in duplicate. Findings were pooled using DerSimonian-Laird's random effects model. Pre-specified sources of heterogeneity were analyzed using meta-regression; and potential for publication bias, by funnel plots, Begg's and Egger's tests. Results From 3,163 identified abstracts, 23 interventional studies and 7 prospective cohorts with 37 intervention arms met inclusion criteria. In pooled analyses, a 10% decrease in price (i.e., subsidy) increased consumption of healthful foods by 12% (95%CI = 10–15%; N = 22 studies/intervention arms) whereas a 10% increase price (i.e. tax) decreased consumption of unhealthful foods by 6% (95%CI = 4–8%; N = 15). By food group, subsidies increased intake of fruits and vegetables by 14% (95%CI = 11–17%; N = 9); and other healthful foods, by 16% (95%CI = 10–23%; N = 10); without significant effects on more healthful beverages (-3%; 95%CI = -16-11%; N = 3). Each 10% price increase reduced sugar-sweetened beverage intake by 7% (95%CI = 3–10%; N = 5); fast foods, by 3% (95%CI = 1–5%; N = 3); and other unhealthful foods, by 9% (95%CI = 6–12%; N = 3). Changes in price of fruits and vegetables reduced body mass index (-0.04 kg/m2 per 10% price decrease, 95%CI = -0.08–0 kg/m2; N = 4); price changes for sugar-sweetened beverages or fast foods did not significantly alter body mass index, based on 4 studies. Meta-regression identified direction of price change (tax vs. subsidy), number of intervention components, intervention duration, and study quality score as significant sources of heterogeneity (P-heterogeneity<0.05 each). Evidence for publication bias was not observed. Conclusions These prospective results, largely from interventional studies, support efficacy of subsidies to increase consumption of healthful foods; and taxation to reduce intake of unhealthful beverages and foods. Use of subsidies and combined multicomponent interventions appear most effective. PMID:28249003

Beneficial Effect of Educational and Nutritional Intervention on the Nutritional Status and Compliance of Gastric Cancer Patients Undergoing Chemotherapy: A Randomized Trial.

PubMed

Xie, Feng-Lan; Wang, Yong-Qian; Peng, Li-Fen; Lin, Fang-Yu; He, Yu-Long; Jiang, Zhuo-Qin

2017-07-01

Surgery combined with chemotherapy is the standard treatment for gastric cancer (GC); however, chemotherapy-relative adverse effects are common and result in malnutrition and a poor prognosis. In addition, compliance to postoperative chemotherapy remains a problem. This study aimed to prospectively investigate the effect of educational and nutritional interventions on the nutritional status and compliance of GC patients undergoing postoperative chemotherapy. A total of 144 GC patients were randomized into an intervention group that received intensive individualized nutritional and educational interventions during the entire course of chemotherapy and control group that received basic nutrition care and health education during hospitalization. The nutritional status and compliance between the two groups were compared. The interventions significantly improved calorie and iron intake within 24 h after the first chemotherapy session, and improved patients' weight, hemoglobin, total serum protein, and albumin levels during the entire course of chemotherapy. The compliance rate with chemotherapy was significantly higher in the intervention group than in the control group (73.61% vs. 55.56%, P = 0.024). A combination of nutritional and educational interventions provided beneficial effect on the nutrition status and compliance of gastric patients undergoing postoperative chemotherapy, which is worthy of clinical application.

The impact of group music therapy on depression and cognition in elderly persons with dementia: a randomized controlled study.

PubMed

Chu, Hsin; Yang, Chyn-Yng; Lin, Yu; Ou, Keng-Liang; Lee, Tso-Ying; O'Brien, Anthony Paul; Chou, Kuei-Ru

2014-04-01

The aims of this study were to determine the effectiveness of group music therapy for improving depression and delaying the deterioration of cognitive functions in elderly persons with dementia. The study had a prospective, parallel-group design with permuted-block randomization. Older persons with dementia (N = 104) were randomly assigned to the experimental or control group. The experimental group received 12 sessions of group music therapy (two 30-min sessions per week for 6 weeks), and the control group received usual care. Data were collected 4 times: (1) 1 week before the intervention, (2) the 6th session of the intervention, (3) the 12th session of the intervention, and (4) 1 month after the final session. Group music therapy reduced depression in persons with dementia. Improvements in depression occurred immediately after music therapy and were apparent throughout the course of therapy. The cortisol level did not significantly decrease after the group music therapy. Cognitive function significantly improved slightly at the 6th session, the 12th session, and 1 month after the sessions ended; in particular, short-term recall function improved. The group music therapy intervention had the greatest impact in subjects with mild and moderate dementia. The group music intervention is a noninvasive and inexpensive therapy that appeared to reduce elders' depression. It also delayed the deterioration of cognitive functions, particularly short-term recall function. Group music therapy may be an appropriate intervention among elderly persons with mild and moderate dementia.

Prevention of EP Migratory Contamination in a Cluster Randomized Trial to Increase tPA Use in Stroke (The INSTINCT Trial)

PubMed Central

Weston, Victoria C.; Meurer, William J.; Frederiksen, Shirley M.; Fox, Allison K.; Scott, Phillip A.

2016-01-01

Objectives Cluster randomized trials (CRTs) are increasingly utilized to evaluate quality improvement interventions aimed at healthcare providers. In trials testing emergency department interventions, migration of emergency physicians (EPs) between hospitals is an important concern, as contamination may affect both internal and external validity. We hypothesized that geographically isolating emergency departments would prevent migratory contamination in a CRT designed to increase ED delivery of tPA in stroke (The INSTINCT Trial). Methods INSTINCT was a prospective, cluster randomized, controlled trial. 24 Michigan community hospitals were randomly selected in matched pairs for study. Contamination was defined at the cluster level, with substantial contamination defined a priori as >10% of EPs affected. Non-adherence, total crossover (contamination + non-adherence), migration distance and characteristics were determined. Results 307 emergency physicians were identified at all sites. Overall, 7 (2.3%) changed study sites. 1 moved between control sites, leaving 6 (2.0%) total crossovers. Of these, 2 (0.7%) moved from intervention to control (contamination) and 4 (1.3%) moved from control to intervention (non-adherence). Contamination was observed in 2 of 12 control sites, with 17% and 9% contamination of the total site EP workforce at follow-up, respectively. Average migration distance was 42 miles for all EPs moving in the study and 35 miles for EPs moving from intervention to control sites. Conclusion The mobile nature of emergency physicians should be considered in the design of quality improvement CRTs. Increased reporting of contamination in CRTs is encouraged to clarify thresholds and facilitate CRT design. PMID:25440230

Effects of prenatal yoga on women's stress and immune function across pregnancy: A randomized controlled trial.

PubMed

Chen, Pao-Ju; Yang, Luke; Chou, Cheng-Chen; Li, Chia-Chi; Chang, Yu-Cune; Liaw, Jen-Jiuan

2017-04-01

The effects of prenatal yoga on biological indicators have not been widely studied. Thus, we compared changes in stress and immunity salivary biomarkers from 16 to 36 weeks' gestation between women receiving prenatal yoga and those receiving routine prenatal care. For this longitudinal, prospective, randomized controlled trial, we recruited 94 healthy pregnant women at 16 weeks' gestation through convenience sampling from a prenatal clinic in Taipei. Participants were randomly assigned to intervention (n=48) or control (n=46) groups using Clinstat block randomization. The 20-week intervention comprised two weekly 70-min yoga sessions led by a midwife certified as a yoga instructor; the control group received only routine prenatal care. In both groups, participants' salivary cortisol and immunoglobulin A levels were collected before and after yoga every 4 weeks from 16 to 36 weeks' gestation. The intervention group had lower salivary cortisol (p<0.001) and higher immunoglobulin A (p<0.001) levels immediately after yoga than the control group. Specifically, the intervention group had significantly higher long-term salivary immunoglobulin A levels than the control group (p=0.018), and infants born to women in the intervention group weighed more than those born to the control group (p<0.001). Prenatal yoga significantly reduced pregnant women's stress and enhanced their immune function. Clinicians should learn the mechanisms of yoga and its effects on pregnant women. Our findings can guide clinicians to help pregnant women alleviate their stress and enhance their immune function. Copyright © 2017. Published by Elsevier Ltd.

Venous thromboembolism prophylaxis in gynecologic surgery: a systematic review.

PubMed

Rahn, David D; Mamik, Mamta M; Sanses, Tatiana V D; Matteson, Kristen A; Aschkenazi, Sarit O; Washington, Blair B; Steinberg, Adam C; Harvie, Heidi S; Lukban, James C; Uhlig, Katrin; Balk, Ethan M; Sung, Vivian W

2011-11-01

To comprehensively review and critically assess the available gynecologic surgery venous thromboembolism prophylaxis literature and provide clinical practice guidelines. MEDLINE and Cochrane databases from inception to July 2010. We included randomized controlled trials in gynecologic surgery populations. Interventions and comparators included graduated compression stockings, intermittent pneumatic compression, unfractionated heparin, and low molecular weight heparin; placebo and routine postoperative care were allowed as comparators. One thousand two hundred sixty-six articles were screened, and 14 randomized controlled trials (five benign gynecologic, nine gynecologic oncology) met eligibility criteria. In addition, nine prospective or retrospective studies with at least 150 women were identified and provided data on venous thromboembolism risk stratification, gynecologic laparoscopy, and urogynecologic populations. Two reviewers independently screened articles with discrepancies adjudicated by a third. Eligible randomized controlled trials were extracted for these characteristics: study, participant, surgery, intervention, comparator, and outcomes data, including venous thromboembolism incidence and bleeding complications. Studies were individually and collectively assessed for methodologic quality and strength of evidence. Overall incidence of clinical venous thromboembolism was 0-2% in the benign gynecologic population. With use of intermittent pneumatic compression for benign major procedures, venous thromboembolism incidence was less than 1%. No venous thromboembolisms were identified in prospective studies of benign laparoscopic procedures. Overall quality of evidence in the benign gynecologic literature was poor. Gynecologic-oncology randomized controlled trials reported venous thromboembolism incidence (including "silent" venous thromboembolisms) of 0-14.8% with prophylaxis and up to 34.6% without prophylaxis. Fair quality of evidence supports that unfractionated heparin and intermittent pneumatic compression are both superior to placebo or no intervention but insufficient to determine whether heparins are superior to intermittent pneumatic compression for venous thromboembolism prevention. Combining two of three risks (aged 60 years or older, cancer, or personal venous thromboembolism history) substantially elevated the risk of venous thromboembolism. Intermittent pneumatic compression provides sufficient prophylaxis for the majority of gynecology patients undergoing benign surgery. Additional risk factors warrant the use of combined mechanical and pharmacologic prophylaxis.

Using tailored interventions to enhance smoking cessation among African-Americans at a community health center.

PubMed

Lipkus, I M; Lyna, P R; Rimer, B K

1999-03-01

This prospective randomized study examined the impact of three tailored intervention approaches to increase quitting rates among African-American smokers who were clients of a community health center that serves primarily low-income and indigent persons. Smokers were randomized to one of three groups: (1) health care provider prompting intervention alone, (2) health care provider prompting intervention with tailored print communications, and (3) health care provider prompting intervention with tailored print communications and tailored telephone counseling. Among the 160 smokers who completed the study, 35 (21.8%) had quit smoking at follow-up. Smokers who received the provider prompting intervention with tailored print materials were more likely to report having quit than smokers who received the provider intervention alone (32.7% vs. 13.2%, p < 0.05). Smokers who received all three intervention components were not more likely to report having quit at follow-up than those who only received the provider intervention (19.2% vs. 13.2%). Smokers who at baseline were less educated, smoked less than half a pack of cigarettes per day, had a stronger desire to quit, felt more efficacious, and had thought about quitting were more likely to report having quit at follow-up. These results provide support for continued refinement of tailored communications to aid smoking cessation among African-American smokers.

Calorie Restriction in Overweight SeniorS: Response of Older Adults to a Dieting Study: The CROSSROADS Randomized Controlled Clinical Trial

PubMed Central

Haas, Marilyn C.; Bodner, Eric V.; Brown, Cynthia J.; Bryan, David; Buys, David R.; Keita, Akilah Dulin; Flagg, Lee Anne; Goss, Amy; Gower, Barbara; Hovater, Martha; Hunter, Gary; Ritchie, Christine S.; Roth, David L.; Wingo, Brooks C.; Ard, Jamy; Locher, Julie L.

2014-01-01

We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling, obese, older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose tissue deposition (Specific Aim #1: To compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition, namely visceral adipose tissue (VAT)), cardiometabolic disease risk (Specific Aim #2: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on cardiometabolic disease risk), functional status and quality of life (Specific Aim #3: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on functional status and quality of life). Participants were randomly assigned to one of three groups: Exercise Only (Control) Intervention, Exercise + Diet Quality + Weight Maintenance Intervention, or Exercise + Diet Quality + Weight Loss Intervention. CROSSROADS utilized a lifestyle intervention approach consisting of exercise, dietary, and behavioral components. The development and implementation of the CROSSROADS protocol, including a description of the methodology, detailing specific elements of the lifestyle intervention, assurances of treatment fidelity, and participant retention; outcome measures and adverse event monitoring; as well as unique data management features of the trial results, are presented in this article. PMID:25424512

Calorie restriction in overweight seniors: response of older adults to a dieting study: the CROSSROADS randomized controlled clinical trial.

PubMed

Haas, Marilyn C; Bodner, Eric V; Brown, Cynthia J; Bryan, David; Buys, David R; Keita, Akilah Dulin; Flagg, Lee Anne; Goss, Amy; Gower, Barbara; Hovater, Martha; Hunter, Gary; Ritchie, Christine S; Roth, David L; Wingo, Brooks C; Ard, Jamy; Locher, Julie L

2014-01-01

We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling obese older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose tissue deposition (Specific Aim #1: To compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition, namely visceral adipose tissue), cardiometabolic disease risk (Specific Aim #2: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on cardiometabolic disease risk), and functional status and quality of life (Specific Aim #3: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on functional status and quality of life). Participants were randomly assigned to one of three groups: Exercise Only (Control) Intervention, Exercise + Diet Quality + Weight Maintenance Intervention, or Exercise + Diet Quality + Weight Loss Intervention. CROSSROADS utilized a lifestyle intervention approach consisting of exercise, dietary, and behavioral components. The development and implementation of the CROSSROADS protocol, including a description of the methodology, detailing specific elements of the lifestyle intervention, assurances of treatment fidelity, and participant retention; outcome measures and adverse event monitoring; as well as unique data management features of the trial results, are presented in this article.

A randomized, controlled clinical trial of a geriatric consultation team. Compliance with recommendations.

PubMed

Allen, C M; Becker, P M; McVey, L J; Saltz, C; Feussner, J R; Cohen, H J

1986-05-16

As part of a prospective, randomized, controlled study of the effectiveness of a geriatric consultation team, we examined compliance by the house staff with recommendations made by the team. Recommendations were formulated for 185 patients, aged 75 years or older, who were randomized into intervention (n = 92) and control (n = 93) groups. In the control group, only 27.1% of the actions that would have been recommended by the team were implemented independently by the house staff. Problems commonly neglected included polypharmacy, sensory impairment, confusion, and depression. In the intervention group, overall compliance was 71.7%. Highest compliance occurred for recommendations addressing instability and falls (95.0%) and discharge planning (94.3%). We conclude that a geriatric consultation team contributes substantial additional input into the care of older patients. Furthermore, relatively high compliance can be achieved with recommendations made by a geriatric consultation team, thereby overcoming the first barrier to the establishment of such a service.

Kids Identifying and Defeating Stroke (KIDS): design of a school-based intervention to improve stroke awareness.

PubMed

Gonzales, Nicole R; Brown, Devin L; Maddox, Katherine E; Conley, Kathleen M; Espinosa, Nina; Pary, Jennifer K; Karim, Asha P; Moyé, Lemuel A; Grotta, James C; Morgenstern, Lewis B

2007-01-01

We describe the design and baseline data of an educational intervention targeting predominantly Mexican American middle school students and their parents in an effort to improve stroke awareness. Increasing awareness in this group may increase the number of patients eligible for acute stroke treatment by encouraging emergency medical services (EMS) activation. This is a prospective, randomized study in which six middle schools were randomly assigned to receive a stroke education program or the standard health class. Primary outcome measures are the percentage of students and parents who recognize stroke symptoms and express the intent to activate EMS upon recognition of these findings. A total of 547 students (271 control, 276 intervention) and 484 parents (231 control, 253 intervention) have been enrolled. Pretests were administered. The intervention has been successfully carried out in the parent and student cohorts over a three-year period. Posttests and persistence test results are pending. Implementing a school-based stroke education initiative is feasible. Followup testing will demonstrate whether this educational initiative translates into a measurable and persistent improvement in stroke knowledge and behavioral intent to activate EMS upon recognition of stroke symptoms.

Communication training for advanced medical students improves information recall of medical laypersons in simulated informed consent talks--a randomized controlled trial.

PubMed

Werner, Anne; Holderried, Friederike; Schäffeler, Norbert; Weyrich, Peter; Riessen, Reimer; Zipfel, Stephan; Celebi, Nora

2013-02-01

Informed consent talks are mandatory before invasive interventions. However, the patients' information recall has been shown to be rather poor. We investigated, whether medical laypersons recalled more information items from a simulated informed consent talk after advanced medical students participated in a communication training aiming to reduce a layperson's cognitive load. Using a randomized, controlled, prospective cross-over-design, 30 5th and 6th year medical students were randomized into two groups. One group received communication training, followed by a comparison intervention (early intervention group, EI); the other group first received the comparison intervention and then communication training (late intervention group, LI). Before and after the interventions, the 30 medical students performed simulated informed consent talks with 30 blinded medical laypersons using a standardized set of information. We then recorded the number of information items the medical laypersons recalled. After the communication training both groups of medical laypersons recalled significantly more information items (EI: 41 ± 9% vs. 23 ± 9%, p < .0001, LI 49 ± 10% vs. 35 ± 6%, p < .0001). After the comparison intervention the improvement was modest and significant only in the LI (EI: 42 ± 9% vs. 40 ± 9%, p = .41, LI 35 ± 6% vs. 29 ± 9%, p = .016). Short communication training for advanced medical students improves information recall of medical laypersons in simulated informed consent talks.

Effects of Progressive Muscle Relaxation Exercises Accompanied by Music on Low Back Pain and Quality of Life During Pregnancy.

PubMed

Akmeşe, Zehra Baykal; Oran, Nazan Tuna

2014-01-01

Back pain is commonly experienced by pregnant women. Evidence suggests that progressive muscle relaxation (PMR) therapy, a complementary therapy widely used by pregnant women, may improve the physical and psychological outcomes of pregnancy. The aim of this study was to investigate the effects of PMR training accompanied by music on perceived pain and quality of life (QOL) in pregnant women with low back pain (LBP). This was a prospective randomized controlled trial. The study was designed to examine the effects of PMR accompanied by music on pregnant women with LBP. In total, 66 pregnant women were assigned randomly to a PMR group or a control group (33 women in each). A personal information form was used as a data collection tool; a visual analog scale was used for measuring pain; and the Short Form-36 was used to evaluate QOL. The control and intervention groups were comparable at baseline. Significant differences were observed between the 2 groups after 4 and 8 weeks of intervention. The intervention group showed significant improvement in all QOL subscales after the intervention. The intervention group, but not the control group, showed significant improvement in perceived pain after the intervention. The intervention group experienced a greater decrease in perceived pain and improved QOL than the control group. Our findings show that PMR accompanied by music may be an effective therapy for improving pain and QOL in pregnant women with LBP. Large randomized studies are recommended to confirm these results. © 2014 by the American College of Nurse‐Midwives.

Communication training for advanced medical students improves information recall of medical laypersons in simulated informed consent talks – a randomized controlled trial

PubMed Central

2013-01-01

Background Informed consent talks are mandatory before invasive interventions. However, the patients’ information recall has been shown to be rather poor. We investigated, whether medical laypersons recalled more information items from a simulated informed consent talk after advanced medical students participated in a communication training aiming to reduce a layperson’s cognitive load. Methods Using a randomized, controlled, prospective cross-over-design, 30 5th and 6th year medical students were randomized into two groups. One group received communication training, followed by a comparison intervention (early intervention group, EI); the other group first received the comparison intervention and then communication training (late intervention group, LI). Before and after the interventions, the 30 medical students performed simulated informed consent talks with 30 blinded medical laypersons using a standardized set of information. We then recorded the number of information items the medical laypersons recalled. Results After the communication training both groups of medical laypersons recalled significantly more information items (EI: 41 ± 9% vs. 23 ± 9%, p < .0001, LI 49 ± 10% vs. 35 ± 6%, p < .0001). After the comparison intervention the improvement was modest and significant only in the LI (EI: 42 ± 9% vs. 40 ± 9%, p = .41, LI 35 ± 6% vs. 29 ± 9%, p = .016). Conclusion Short communication training for advanced medical students improves information recall of medical laypersons in simulated informed consent talks. PMID:23374907

A Prospective Randomized Controlled Trial to Study the Impact of a Nutrition-Sensitive Intervention on Adult Women With Cancer Cachexia Undergoing Palliative Care in India

PubMed Central

Kapoor, Neha; Naufahu, Jane; Tewfik, Sundus; Bhatnagar, Sushma; Garg, Rakesh; Tewfik, Ihab

2016-01-01

Purpose. Advanced cancer patients with disease progression develop cachexia. Nevertheless, cancer patients at nutritional risk have shown improved body weight and quality of life with oral nutritional supplements. Method. This was a randomized controlled trial in adult female cancer patients (n = 63) attending palliative clinics, with symptoms of cachexia. Eligible patients were randomly distributed into control (n = 33) and intervention (n = 30) groups. Both groups were provided with nutritional and physical activity counseling, but the intervention group received an additional 100 g of Improved Atta (IAtta) for 6 months daily consumption. This study was designed to assess the efficacy of IAtta (with counseling) in enhancing the health status of cachexic patients. Anthropometric measurements, dietary intake, physical activity level and quality of life parameters were assessed at baseline, after 3 months, and at the end of 6 months. Results. Patients in the control group (n = 15) had significantly decreased body weight (P = .003), mid–upper-arm circumference (P = .002), and body fat (P = .002) by the end of intervention. A trend of body weight gain in the intervention group (n = 17; P = .08) and significant increase of body fat (P = .002) was observed; moreover, patients reported a significant improvement in fatigue (P = .002) and appetite scores (P = .006) under quality-of-life domains at the end of intervention. Conclusions. Embedding a nutrition-sensitive intervention ( IAtta ) within Indian palliative care therapy may improve quality of life and stabilize body weight in cancer cachexia patients. PMID:27252077

Causal assessment of dietary acid load and bone disease: a systematic review & meta-analysis applying Hill's epidemiologic criteria for causality

PubMed Central

2011-01-01

Background Modern diets have been suggested to increase systemic acid load and net acid excretion. In response, alkaline diets and products are marketed to avoid or counteract this acid, help the body regulate its pH to prevent and cure disease. The objective of this systematic review was to evaluate causal relationships between dietary acid load and osteoporosis using Hill's criteria. Methods Systematic review and meta-analysis. We systematically searched published literature for randomized intervention trials, prospective cohort studies, and meta-analyses of the acid-ash or acid-base diet hypothesis with bone-related outcomes, in which the diet acid load was altered, or an alkaline diet or alkaline salts were provided, to healthy human adults. Cellular mechanism studies were also systematically examined. Results Fifty-five of 238 studies met the inclusion criteria: 22 randomized interventions, 2 meta-analyses, and 11 prospective observational studies of bone health outcomes including: urine calcium excretion, calcium balance or retention, changes of bone mineral density, or fractures, among healthy adults in which acid and/or alkaline intakes were manipulated or observed through foods or supplements; and 19 in vitro cell studies which examined the hypothesized mechanism. Urine calcium excretion rates were consistent with osteoporosis development; however calcium balance studies did not demonstrate loss of whole body calcium with higher net acid excretion. Several weaknesses regarding the acid-ash hypothesis were uncovered: No intervention studies provided direct evidence of osteoporosis progression (fragility fractures, or bone strength as measured using biopsy). The supporting prospective cohort studies were not controlled regarding important osteoporosis risk factors including: weight loss during follow-up, family history of osteoporosis, baseline bone mineral density, and estrogen status. No study revealed a biologic mechanism functioning at physiological pH. Finally, randomized studies did not provide evidence for an adverse role of phosphate, milk, and grain foods in osteoporosis. Conclusions A causal association between dietary acid load and osteoporotic bone disease is not supported by evidence and there is no evidence that an alkaline diet is protective of bone health. PMID:21529374

Causal assessment of dietary acid load and bone disease: a systematic review & meta-analysis applying Hill's epidemiologic criteria for causality.

PubMed

Fenton, Tanis R; Tough, Suzanne C; Lyon, Andrew W; Eliasziw, Misha; Hanley, David A

2011-04-30

Modern diets have been suggested to increase systemic acid load and net acid excretion. In response, alkaline diets and products are marketed to avoid or counteract this acid, help the body regulate its pH to prevent and cure disease. The objective of this systematic review was to evaluate causal relationships between dietary acid load and osteoporosis using Hill's criteria. Systematic review and meta-analysis. We systematically searched published literature for randomized intervention trials, prospective cohort studies, and meta-analyses of the acid-ash or acid-base diet hypothesis with bone-related outcomes, in which the diet acid load was altered, or an alkaline diet or alkaline salts were provided, to healthy human adults. Cellular mechanism studies were also systematically examined. Fifty-five of 238 studies met the inclusion criteria: 22 randomized interventions, 2 meta-analyses, and 11 prospective observational studies of bone health outcomes including: urine calcium excretion, calcium balance or retention, changes of bone mineral density, or fractures, among healthy adults in which acid and/or alkaline intakes were manipulated or observed through foods or supplements; and 19 in vitro cell studies which examined the hypothesized mechanism. Urine calcium excretion rates were consistent with osteoporosis development; however calcium balance studies did not demonstrate loss of whole body calcium with higher net acid excretion. Several weaknesses regarding the acid-ash hypothesis were uncovered: No intervention studies provided direct evidence of osteoporosis progression (fragility fractures, or bone strength as measured using biopsy). The supporting prospective cohort studies were not controlled regarding important osteoporosis risk factors including: weight loss during follow-up, family history of osteoporosis, baseline bone mineral density, and estrogen status. No study revealed a biologic mechanism functioning at physiological pH. Finally, randomized studies did not provide evidence for an adverse role of phosphate, milk, and grain foods in osteoporosis. A causal association between dietary acid load and osteoporotic bone disease is not supported by evidence and there is no evidence that an alkaline diet is protective of bone health.

[Rethinking clinical research in surgical oncology. From comic opera to quality control].

PubMed

Evrard, Serge

2016-01-01

The evidence base for the effectiveness of surgical interventions is relatively poor and data from large, randomized prospective studies are rare with often a poor quality. Many efforts have been made to increase the number of high quality randomized trials in surgery and theoretical proposals have been put forward to improve the situation, but practical implementation of these proposals is seriously lacking. The consequences of this policy are not trivial; with very few patients included in surgical oncology trials, this represents wasted opportunity for advances in cancer treatment. In this review, we cover the difficulties inherent to clinical research in surgical oncology, such as quality control, equipoise, accrual, and funding and promote alternative designs to the randomized controlled trial. Although the classic randomized controlled trial has a valid but limited place in surgical oncology, other prospective designs need to be promoted as a new deal. This new deal not only implicates surgeons but also journal editors, tender jury, as well as regulatory bodies to cover legal gaps currently surrounding surgical innovation. Copyright © 2015 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

The addition of vildagliptin to metformin prevents the elevation of interleukin 1ß in patients with type 2 diabetes and coronary artery disease: a prospective, randomized, open-label study.

PubMed

Younis, Arwa; Eskenazi, Dana; Goldkorn, Ronen; Leor, Jonathan; Naftali-Shani, Nili; Fisman, Enrique Z; Tenenbaum, Alexander; Goldenberg, Ilan; Klempfner, Robert

2017-05-22

Patients with type 2 diabetes present with an accelerated atherosclerotic process. Animal evidence indicates that dipeptidyl peptidase-4 inhibitors (gliptins) have anti-inflammatory and anti-atherosclerotic effects, yet clinical data are scarcely available. A prospective, randomized, open-label study was performed in 60 patients with coronary artery disease (CAD) and type 2 diabetes, who participated in a cardiac rehabilitation program. After a washout period of 3 weeks, patients were randomized in a 2:1 ratio to receive combined vildagliptin/metformin therapy (intervention group: n = 40) vs. metformin alone (control group: n = 20) for a total of 12 weeks. Blinded assessment of interleukin-1ß (IL-1ß, the primary endpoint), hemoglobin A1c (HbA1c), and high sensitivity C reactive protein (hsCRP), were performed at baseline and after 12 weeks. Mean age of study patients was 67 ± 9 years, 75% were males, and baseline HbA1c and inflammatory markers levels were similar between the two groups. At 12 weeks of follow up, levels of IL-1ß, hsCRP, and HbA1c were significantly lower in the intervention group as compared with the control group. There was a continuous elevation of IL-1ß among the control group, which was not observed in the intervention group (49 vs. 4%, respectively; p < 0.001). The hsCRP was lowered by 60% in the vildagliptin/metformin group vs. 23% in the metformin group (p < 0.01). Moreover, a significant relative reduction of the HbA1c was seen in the intervention group (7% reduction, p < 0.03). The addition of vildagliptin to metformin treatment in patients with type 2 diabetes and CAD led to a significant suppression of the IL-1ß elevation during follow up. A significant relative reduction of hsCRP and HbA1c in the intervention group was also observed. Trial registration NCT01604213.

Effects of Multiple Cleaning and Disinfection Interventions on Infectious Diseases in Children: A Group Randomized Trial in China.

PubMed

Ban, Hai Qun; Li, Tao; Shen, Jin; Li, Jin; Peng, Pin Zhang; Ye, Heng Ping; Zhang, Liu Bo

2015-11-01

To assess the effectiveness of multiple cleaning and disinfection interventions in the homes and kindergartens, in reducing gastrointestinal and respiratory illnesses of children. From October 2010 to September 2011, we performed a prospective, controlled study in China. 408 children under 5 years old were recruited and group randomized into intervention and control groups. Families and kindergartens in the intervention group were provided with antibacterial products for hand hygiene and surface cleaning or disinfection for one year. Each child's illness symptoms and sick leave were recorded every day. A total of 393 children completed the study, with similar baseline demographics in each of the 2 groups. Except for abdominal pain, the odds of symptoms (fever, cough and expectoration, runny nose and nasal congestion, diarrhea), illness (acute respiratory illness and gastrointestinal illness), and sick leave per person each month were significantly reduced by interventions. The rates of fever, diarrhea, acute respiratory illness, gastrointestinal illness and sick leave per person per year were significantly decreased as well. Not only the acute respiratory and gastrointestinal illness but the sick leave rate in children were significantly reduced by multiple interventions. Copyright © 2015 The Editorial Board of Biomedical and Environmental Sciences. Published by China CDC. All rights reserved.

Rationale, design and baseline characteristics of a randomized controlled trial of a web-based computer-tailored physical activity intervention for adults from Quebec City.

PubMed

Boudreau, François; Walthouwer, Michel Jean Louis; de Vries, Hein; Dagenais, Gilles R; Turbide, Ginette; Bourlaud, Anne-Sophie; Moreau, Michel; Côté, José; Poirier, Paul

2015-10-09

The relationship between physical activity and cardiovascular disease (CVD) protection is well documented. Numerous factors (e.g. patient motivation, lack of facilities, physician time constraints) can contribute to poor PA adherence. Web-based computer-tailored interventions offer an innovative way to provide tailored feedback and to empower adults to engage in regular moderate- to vigorous-intensity PA. To describe the rationale, design and content of a web-based computer-tailored PA intervention for Canadian adults enrolled in a randomized controlled trial (RCT). 244 men and women aged between 35 and 70 years, without CVD or physical disability, not participating in regular moderate- to vigorous-intensity PA, and familiar with and having access to a computer at home, were recruited from the Quebec City Prospective Urban and Rural Epidemiological (PURE) study centre. Participants were randomized into two study arms: 1) an experimental group receiving the intervention and 2) a waiting list control group. The fully automated web-based computer-tailored PA intervention consists of seven 10- to 15-min sessions over an 8-week period. The theoretical underpinning of the intervention is based on the I-Change Model. The aim of the intervention was to reach a total of 150 min per week of moderate- to vigorous-intensity aerobic PA. This study will provide useful information before engaging in a large RCT to assess the long-term participation and maintenance of PA, the potential impact of regular PA on CVD risk factors and the cost-effectiveness of a web-based computer-tailored intervention. ISRCTN36353353 registered on 24/07/2014.

Protection of xenon against postoperative oxygen impairment in adults undergoing Stanford Type-A acute aortic dissection surgery: Study protocol for a prospective, randomized controlled clinical trial.

PubMed

Jin, Mu; Cheng, Yi; Yang, Yanwei; Pan, Xudong; Lu, Jiakai; Cheng, Weiping

2017-08-01

The available evidence shows that hypoxemia after Stanford Type-A acute aortic dissection (AAD) surgery is a frequent cause of several adverse consequences. The pathogenesis of postoperative hypoxemia after AAD surgery is complex, and ischemia/reperfusion and inflammation are likely to be underlying risk factors. Xenon, recognized as an ideal anesthetic and anti-inflammatory treatment, might be a possible treatment for these adverse effects. The trial is a prospective, double-blind, 4-group, parallel, randomized controlled, a signal-center clinical trial. We will recruit 160 adult patients undergoing Stanford type-A AAD surgery. Patients will be allocated a study number and will be randomized on a 1:1:1:1 basis to receive 1 of the 3 treatment options (pulmonary inflated with 50% xenon, 75% xenon, or 100% xenon) or no treatment (control group, pulmonary inflated with 50% nitrogen). The aims of this study are to clarify the lung protection capability of xenon and its possible mechanisms in patients undergoing the Stanford type-A AAD surgery. This trial uses an innovative design to account for the xenon effects of postoperative oxygen impairment, and it also delineates the mechanism for any benefit from xenon. The investigational xenon group is considered a treatment intervention, as it includes 3 groups of pulmonary static inflation with 50%, 75%, and 100% xenon. It is suggested that future trials might define an appropriate concentration of xenon for the best practice intervention.

Conformable covered versus uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction: a randomized prospective study.

PubMed

Lim, Sun Gyo; Kim, Jin Hong; Lee, Kee Myung; Shin, Sung Jae; Kim, Chan Gyoo; Kim, Kyung Ho; Kim, Ho Gak; Yang, Chang Heon

2014-07-01

A conformable self-expandable metallic stent was developed to overcome the limitation of previous self-expandable metallic stents. The aim of this study was to evaluate outcomes after placement of conformable covered and uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction. A single-blind, randomized, parallel-group, prospective study were conducted in 4 medical centres between March 2009 and July 2012. 134 patients with unresectable malignant gastroduodenal obstruction were assigned to a covered double-layered (n=66) or uncovered unfixed-cell braided (n=68) stent placement group. Primary analysis was performed to compare re-intervention rates between two groups. 120 patients were analysed (59 in the covered group and 61 in the uncovered group). Overall rates of re-intervention were not significantly different between the two groups: 13/59 (22.0%) in the covered group vs. 13/61 (21.3%) in the uncovered group, p=0.999. Stent migration was more frequent in the covered group than in the uncovered group (p=0.003). The tumour ingrowth rate was higher in the uncovered group than in the covered group (p=0.016). The rates of re-intervention did not significantly differ between the two stents. Conformable covered double-layered and uncovered unfixed-cell braided stents were associated with different patterns of stent malfunction. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Evaluation of motivationally tailored vs. standard self-help physical activity interventions at the workplace.

PubMed

Marcus, B H; Emmons, K M; Simkin-Silverman, L R; Linnan, L A; Taylor, E R; Bock, B C; Roberts, M B; Rossi, J S; Abrams, D B

1998-01-01

This study compares the efficacy of a self-help intervention tailored to the individual's stage of motivational readiness for exercise adoption with a standard self-help exercise promotion intervention. Interventions were delivered at baseline and 1 month; assessments were collected at baseline and 3 months. Eleven worksites participating in the Working Healthy Research Trial. Participants (n = 1559) were a subsample of employees at participating worksites, individually randomized to one of two treatment conditions. Printed self-help exercise promotion materials either (1) matched to the individual's stage of motivational readiness for exercise adoption (motivationally tailored), or (2) standard materials (standard). Measures of stage of motivational readiness for exercise and items from the 7-Day Physical Activity Recall. Among intervention completers (n = 903), chi-square analyses showed that, compared to the standard intervention, those receiving the motivationally tailored intervention were significantly more likely to show increases (37% vs. 27%) and less likely to show either no change (52% vs. 58%) or regression (11% vs. 15%) in stage of motivational readiness. Multivariate analyses of variance showed that changes in stage of motivational readiness were significantly associated with changes in self-reported time spent in exercise. This is the first prospective, randomized, controlled trial demonstrating the efficacy of a brief motivationally tailored intervention compared to a standard self-help intervention for exercise adoption. These findings appear to support treatment approaches that tailor interventions to the individual's stage of motivational readiness for exercise adoption.

Building and analyzing an innovative community-centered dengue-ecosystem management intervention in Yogyakarta, Indonesia

PubMed Central

Tana, Susilowati; Umniyati, SittiRahmah; Petzold, Max; Kroeger, Axel; Sommerfeld, Johannes

2012-01-01

Background and Objectives Dengue is an important public health problem in Yogyakarta city, Indonesia. The aim of this study was to build an innovative community-centered dengue-ecosystem management intervention in the city and to assess the process and results. Methods For describing the baseline situation, entomological surveys and household surveys were carried out in six randomly selected neighborhoods in Yogyakarta city, documents were analyzed and different stakeholders involved in dengue control and environmental management were interviewed. Then a community-centered dengue-ecosystem management intervention was built up in two of the neighborhoods (Demangan and Giwangan) whereas two neighborhoods served as controls with no intervention (Tahunan and Bener). Six months after the intervention follow up surveys (household interviews and entomological) were conducted as well as focus group discussions and key informant interviews. FIindings The intervention results included: better community knowledge, attitude and practices in dengue prevention; increased household and community participation; improved partnership including a variety of stakeholders with prospects for sustainability; vector control efforts refocused on environmental and health issues; increased community ownership of dengue vector management including broader community development activities such as solid waste management and recycling. Conclusion The community-centred approach needs a lot of effort at the beginning but has better prospects for sustainability than the vertical “top-down” approach. PMID:23318239

A random urine test can identify patients at risk of mesalamine non-adherence: a prospective study.

PubMed

Gifford, Anne E; Berg, Anders H; Lahiff, Conor; Cheifetz, Adam S; Horowitz, Gary; Moss, Alan C

2013-02-01

Mesalamine non-adherence is common among patients with ulcerative colitis (UC), and can be difficult to identify in practice. We sought to determine whether a random urine test for salicylates could be used as a marker of 5-aminosalicylic acid (5-ASA) ingestion and identify patients at risk of non-adherence. Our aim is to determine whether measurement of salicylates in a random urine sample correlates with 5-ASA levels, and predicts an individual's risk of mesalamine non-adherence. Prospective observational study. Urinary salicylates (by colorimetry) and 5-ASA (by liquid chromatography and tandem-mass spectrometry) were measured in a random urine sample at baseline in patients and controls. Mesalamine adherence was quantified by patient self-reports at enrollment and pharmacy refills of mesalamine over 6 months. A total of 93 patients with UC taking mesalamine maintenance therapy were prospectively enrolled from the clinic. Random urine salicylate levels (by colorimetry) were highly correlated with urine 5-ASA metabolite levels (by mass spectrometry; R2=0.9). A random urine salicylate level above 15 mg/dl distinguished patients who had recently taken mesalamine from controls (area under the curve value 0.9, sensitivity 95%, specificity 77%). A significant proportion of patients (27%) who self-identified as "high adherers" by an adherence questionnaire (Morisky Medication Adherence Scale-8) had random levels of urine salicylate below this threshold. These patients were at higher risk of objectively measured non-adherence to mesalamine over the subsequent 6 months (RR: 2.7, 95% CI: 1.1-7.0). A random urine salicylate level measured in the clinic can identify patients who have not recently taken mesalamine, and who are at higher risk of longitudinal non-adherence. This test could be used to screen patients who may warrant interventions to improve adherence and prevent disease relapse.

Prospective registration trends, reasons for retrospective registration and mechanisms to increase prospective registration compliance: descriptive analysis and survey

PubMed Central

Seidler, Anna Lene; Askie, Lisa M

2018-01-01

Objectives To analyse prospective versus retrospective trial registration trends on the Australian New Zealand Clinical Trials Registry (ANZCTR) and to evaluate the reasons for non-compliance with prospective registration. Design Part 1: Descriptive analysis of trial registration trends from 2006 to 2015. Part 2: Online registrant survey. Participants Part 1: All interventional trials registered on ANZCTR from 2006 to 2015. Part 2: Random sample of those who had retrospectively registered a trial on ANZCTR between 2010 and 2015. Main outcome measures Part 1: Proportion of prospective versus retrospective clinical trial registrations (ie, registration before versus after enrolment of the first participant) on the ANZCTR overall and by various key metrics, such as sponsor, funder, recruitment country and sample size. Part 2: Reasons for non-compliance with prospective registration and perceived usefulness of various proposed mechanisms to improve prospective registration compliance. Results Part 1: Analysis of the complete dataset of 9450 trials revealed that compliance with prospective registration increased from 48% (216 out of 446 trials) in 2006 to 63% (723/1148) in 2012 and has since plateaued at around 64%. Patterns of compliance were relatively consistent across sponsor and funder types (industry vs non-industry), type of intervention (drug vs non-drug) and size of trial (n<100, 100–500, >500). However, primary sponsors from Australia/New Zealand were almost twice as likely to register prospectively (62%; 4613/7452) compared with sponsors from other countries with a WHO Network Registry (35%; 377/1084) or sponsors from countries without a WHO Registry (29%; 230/781). Part 2: The majority (56%; 84/149) of survey respondents cited lack of awareness as a reason for not registering their study prospectively. Seventy-four per cent (111/149) stated that linking registration to ethics approval would facilitate prospective registration. Conclusions Despite some progress, compliance with prospective registration remains suboptimal. Linking registration to ethics approval was the favoured strategy among those sampled for improving compliance. PMID:29496896

Tackling inequalities in obesity: a protocol for a systematic review of the effectiveness of public health interventions at reducing socioeconomic inequalities in obesity among adults.

PubMed

Bambra, Clare L; Hillier, Frances C; Moore, Helen J; Cairns-Nagi, Joanne-Marie; Summerbell, Carolyn D

2013-05-10

Socioeconomic inequalities in obesity and associated risk factors for obesity are widening throughout developed countries worldwide. Tackling obesity is high on the public health agenda both in the United Kingdom and internationally. However, what works in terms of interventions that are able to reduce inequalities in obesity is lacking. The review will examine public health interventions at the individual, community and societal level that might reduce inequalities in obesity among adults aged 18 years and over, in any setting and in any country. The following electronic databases will be searched: MEDLINE, EMBASE, CINAHL, PsycINFO, Social Science Citation Index, ASSIA, IBSS, Sociological Abstracts, and the NHS Economic Evaluation Database. Database searches will be supplemented with website and gray literature searches. No studies will be excluded based on language, country or publication date. Randomized and non-randomized controlled trials, prospective and retrospective cohort studies (with/without control groups) and prospective repeat cross-sectional studies (with/without control groups) that have a primary outcome that is a proxy for body fatness and have examined differential effects with regard to socioeconomic status (education, income, occupation, social class, deprivation, poverty) or where the intervention has been targeted specifically at disadvantaged groups or deprived areas will be included. Study inclusion, data extraction and quality appraisal will be conducted by two reviewers. Meta-analysis and narrative synthesis will be conducted. The main analysis will examine the effects of 1) individual, 2) community and 3) societal level public health interventions on socioeconomic inequalities in adult obesity. Interventions will be characterized by their level of action and their approach to tackling inequalities. Contextual information on how such public health interventions are organized, implemented and delivered will also be examined. The review will provide evidence, and reveal any gaps in the evidence base, of public health strategies which reduce and prevent inequalities in the prevalence of obesity in adults and provide information on the organization, implementation and delivery of such interventions. PROSPERO registration number: CRD42013003612.

Primary prevention of stroke and cardiovascular disease in the community (PREVENTS): Methodology of a health wellness coaching intervention to reduce stroke and cardiovascular disease risk, a randomized clinical trial.

PubMed

Mahon, Susan; Krishnamurthi, Rita; Vandal, Alain; Witt, Emma; Barker-Collo, Suzanne; Parmar, Priya; Theadom, Alice; Barber, Alan; Arroll, Bruce; Rush, Elaine; Elder, Hinemoa; Dyer, Jesse; Feigin, Valery

2018-02-01

Rationale Stroke is a major cause of death and disability worldwide, yet 80% of strokes can be prevented through modifications of risk factors and lifestyle and by medication. While management strategies for primary stroke prevention in high cardiovascular disease risk individuals are well established, they are underutilized and existing practice of primary stroke prevention are inadequate. Behavioral interventions are emerging as highly promising strategies to improve cardiovascular disease risk factor management. Health Wellness Coaching is an innovative, patient-focused and cost-effective, multidimensional psychological intervention designed to motivate participants to adhere to recommended medication and lifestyle changes and has been shown to improve health and enhance well-being. Aims and/or hypothesis To determine the effectiveness of Health Wellness Coaching for primary stroke prevention in an ethnically diverse sample including Māori, Pacific Island, New Zealand European and Asian participants. Design A parallel, prospective, randomized, open-treatment, single-blinded end-point trial. Participants include 320 adults with absolute five-year cardiovascular disease risk ≥ 10%, calculated using the PREDICT web-based clinical tool. Randomization will be to Health Wellness Coaching or usual care groups. Participants randomized to Health Wellness Coaching will receive 15 coaching sessions over nine months. Study outcomes A substantial relative risk reduction of five-year cardiovascular disease risk at nine months post-randomization, which is defined as 10% relative risk reduction among those at moderate five-year cardiovascular disease risk (10-15%) and 25% among those at high risk (>15%). Discussion This clinical trial will determine whether Health Wellness Coaching is an effective intervention for reducing modifiable risk factors, and hence decrease the risk of stroke and cardiovascular disease.

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.

Prevention of emergency physician migratory contamination in a cluster randomized trial to increase tissue plasminogen activator use in stroke (the INSTINCT trial).

PubMed

Weston, Victoria C; Meurer, William J; Frederiksen, Shirley M; Fox, Allison K; Scott, Phillip A

2014-12-01

Cluster randomized trials (CRTs) are increasingly used to evaluate quality improvement interventions aimed at health care providers. In trials testing emergency department (ED) interventions, migration of emergency physicians (EPs) between hospitals is an important concern, as contamination may affect both internal and external validity. We hypothesized that geographically isolating EDs would prevent migratory contamination in a CRT designed to increase ED delivery of tissue plasminogen activator (tPA) in stroke (the INSTINCT trial). INSTINCT was a prospective, cluster randomized, controlled trial. Twenty-four Michigan community hospitals were randomly selected in matched pairs for study. Contamination was defined at the cluster level, with substantial contamination defined a priori as greater than 10% of EPs affected. Nonadherence, total crossover (contamination+nonadherence), migration distance, and characteristics were determined. Three hundred seven EPs were identified at all sites. Overall, 7 (2.3%) changed study sites. One moved between control sites, leaving 6 (2.0%) total crossovers. Of these, 2 (0.7%) moved from intervention to control (contamination); and 4 (1.3%) moved from control to intervention (nonadherence). Contamination was observed in 2 of 12 control sites, with 17% and 9% contamination of the total site EP workforce at follow-up, respectively. Average migration distance was 42 miles for all EPs moving in the study and 35 miles for EPs moving from intervention to control sites. The mobile nature of EPs should be considered in the design of quality improvement CRTs. Increased reporting of contamination in CRTs is encouraged to clarify thresholds and facilitate CRT design. Copyright © 2014 Elsevier Inc. All rights reserved.

Design and implementation of a factorial randomized controlled trial of methadone maintenance therapy and an evidence-based behavioral intervention for incarcerated people living with HIV and opioid dependence in Malaysia.

PubMed

Bazazi, Alexander R; Wickersham, Jeffrey A; Wegman, Martin P; Culbert, Gabriel J; Pillai, Veena; Shrestha, Roman; Al-Darraji, Haider; Copenhaver, Michael M; Kamarulzaman, Adeeba; Altice, Frederick L

2017-08-01

Incarcerated people living with HIV and opioid dependence face enormous challenges to accessing evidence-based treatment during incarceration and after release into the community, placing them at risk of poor HIV treatment outcomes, relapse to opioid use and accompanying HIV transmission risk behaviors. Here we describe in detail the design and implementation of Project Harapan, a prospective clinical trial conducted among people living with HIV and opioid dependence who transitioned from prison to the community in Malaysia from 2010 to 2014. This trial involved 2 interventions: within-prison initiation of methadone maintenance therapy and an evidence-based behavioral intervention adapted to the Malaysian context (the Holistic Health Recovery Program for Malaysia, HHRP-M). Individuals were recruited and received the interventions while incarcerated and were followed for 12months after release to assess post-release HIV transmission risk behaviors and a range of other health-related outcomes. Project Harapan was designed as a fully randomized 2×2 factorial trial where individuals would be allocated in equal proportions to methadone maintenance therapy and HHRP-M, methadone maintenance therapy alone, HHRP-M alone, or control. Partway through study implementation, allocation to methadone maintenance therapy was changed from randomization to participant choice; randomization to HHRP-M continued throughout. We describe the justification for this study; the development and implementation of these interventions; changes to the protocol; and screening, enrollment, treatment receipt, and retention of study participants. Logistical, ethical, and analytic issues associated with the implementation of this study are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

Policy-into-practice for rheumatoid arthritis: randomized controlled trial and cohort study of e-learning targeting improved physiotherapy management.

PubMed

Fary, Robyn E; Slater, Helen; Chua, Jason; Ranelli, Sonia; Chan, Madelynn; Briggs, Andrew M

2015-07-01

To examine the effectiveness of a physiotherapy-specific, web-based e-learning platform, "RAP-el," in best-practice management of rheumatoid arthritis (RA) using a single-blind, randomized controlled trial (RCT) and prospective cohort study. Australian-registered physiotherapists were electronically randomized into intervention and control groups. The intervention group accessed RAP-eL over 4 weeks. Change in self-reported confidence in knowledge and skills was compared between groups at the end of the RCT using linear regression conditioned for baseline scores by a blinded assessor, using intent-to-treat analysis. Secondary outcomes included physiotherapists' satisfaction with RA management and responses to RA-relevant clinical statements and practice-relevant vignettes. Retention was evaluated in a cohort study 8 weeks after the RCT. Eighty physiotherapists were randomized into the intervention and 79 into the control groups. Fifty-six and 48, respectively, provided baseline data. Significant between-group differences were observed for change in confidence in knowledge (mean difference 8.51; 95% confidence interval [95% CI] 6.29, 10.73; effect size 1.62) and skills (mean difference 7.26; 95% CI 5.1, 9.4; effect size 1.54), with the intervention group performing better. Satisfaction in ability to manage RA, 4 of the 6 clinical statements, and responses to vignettes demonstrated significant improvement in the intervention group. Although 8-week scores showed declines in most outcomes, their clinical significance remains uncertain. RAP-eL can improve self-reported confidence, likely practice behaviors and satisfaction in physiotherapists' ability to manage people with RA, and improve their clinical knowledge in several areas of best-practice RA management in the short term. © 2015, American College of Rheumatology.

Study of Tranexamic Acid During Air Medical Prehospital Transport (STAAMP) Trial

DTIC Science & Technology

2017-10-01

Distribution Unlimited The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an...ABSTRACT Multi-center, prospective, randomized, blinded, controlled interventional trial focusing on patients with concern for bleeding who are ...retraining scenarios were provided and are currently being converted into a quiz for distribution to the pre-hospital crews). 4. KEY RESEARCH

Children's postoperative symptoms at home through nurse-led telephone counseling and its effects on parents' anxiety: A randomized controlled trial.

PubMed

Özalp Gerçeker, Gülçin; Karayağız Muslu, Gonca; Yardimci, Figen

2016-10-01

The objective of this study was to evaluate children's postoperative symptoms at home after outpatient surgery through nurse-led telephone counseling and the effects of the nurse-led telephone counseling on parents' state-trait anxiety scores. In this prospective randomized controlled study, nurse-led telephone counseling was provided every day to parents in the intervention group until they came for the follow-up visit. Parents of children (n = 54) ages 3-17 years who had undergone outpatient surgery for appendicitis, cholecystectomy, or ovarian cysts were eligible to participate in the study. On the first postoperative day and at the follow-up visit, the Spielberger State-Trait-Anxiety Inventory (STAI) was administered to parents who were randomly allocated to the intervention (n = 24) and control groups (n = 30). The parents reported on postoperative symptoms such as pain, activity levels, excretion, sleep, nutrition, and wound infection. While there was no difference in STAI scores for parents between the groups at the first postoperative day, there was a significant decrease in STAI scores in the intervention group versus the control group, with parents in the intervention group reporting lower anxiety scores. Our results suggest that nurse-led telephone counseling is effective at reducing anxiety in parents of children after outpatient surgery. © 2016, Wiley Periodicals, Inc.

The impact of brief messages on HSV-2 screening uptake among female defendants in a court setting: a randomized controlled trial utilizing prospect theory.

PubMed

Roth, Alexis M; Van Der Pol, Barbara; Fortenberry, J Dennis; Dodge, Brian; Reece, Michael; Certo, David; Zimet, Gregory D

2015-01-01

Epidemiologic data demonstrate that women involved with the criminal justice system in the United States are at high risk for sexually transmitted infections, including herpes simplex virus type 2 (HSV-2). Female defendants were recruited from a misdemeanor court to assess whether brief framed messages utilizing prospect theory could encourage testing for HSV-2. Participants were randomly assigned to a message condition (gain, loss, or control), completed an interviewer-administered survey assessing factors associated with antibody test uptake/refusal and were offered free point-of-care HSV-2 serologic testing. Although individuals in the loss-frame group accepted testing at the highest rate, an overall statistical difference in HSV-2 testing behavior by group (p ≤ .43) was not detected. The majority of the sample (74.6%) characterized receiving a serological test for HSV-2 as health affirming. However, this did not moderate the effect of the intervention nor was it significantly associated with test acceptance (p ≤ .82). Although the effects of message framing are subtle, the findings have important theoretical implications given the participants' characterization of HSV-2 screening as health affirming despite being a detection behavior. Implications of study results for health care providers interested in brief, low cost interventions are also explored.

Costs of a work-family intervention: evidence from the work, family, and health network.

PubMed

Barbosa, Carolina; Bray, Jeremy W; Brockwood, Krista; Reeves, Daniel

2014-01-01

To estimate the cost to the workplace of implementing initiatives to reduce work-family conflict. Prospective cost analysis conducted alongside a group-randomized multisite controlled experimental study, using a microcosting approach. An information technology firm. Employees (n = 1004) and managers (n = 141) randomized to the intervention arm. STAR (Start. Transform. Achieve. Results.) to enhance employees' control over their work time, increase supervisor support for employees to manage work and family responsibilities, and reorient the culture toward results. A taxonomy of activities related to customization, start-up, and implementation was developed. Resource use and unit costs were estimated for each activity, excluding research-related activities. Economic costing approach (accounting and opportunity costs). Sensitivity analyses on intervention costs. The total cost of STAR was $709,654, of which $389,717 was labor costs and $319,937 nonlabor costs (including $313,877 for intervention contract). The cost per employee participation in the intervention was $340 (95% confidence interval: $330-$351); $597 ($561-$634) for managers and $300 ($292-$308) for other employees (2011 prices). A detailed activity costing approach allows for more accurate cost estimates and identifies key drivers of cost. The key cost driver was employees' time spent on receiving the intervention. Ignoring this cost, which is usual in studies that cost workplace interventions, would seriously underestimate the cost of a workplace initiative.

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

PubMed

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

2017-01-01

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

Assessing the Impact of Community Engagement Interventions on Health Worker Motivation and Experiences with Clients in Primary Health Facilities in Ghana: A Randomized Cluster Trial

PubMed Central

Alhassan, Robert Kaba; Nketiah-Amponsah, Edward; Spieker, Nicole; Arhinful, Daniel Kojo; Rinke de Wit, Tobias F.

2016-01-01

Background Health worker density per 1000 population in Ghana is one of the lowest in the world estimated to be 2.3, below the global average of 9.3. Low health worker motivation induced by poor working conditions partly explain this challenge. Albeit the wage bill for public sector health workers is about 90% of domestic government expenditure on health in countries such as Ghana, staff motivation and performance output remain a challenge, suggesting the need to complement financial incentives with non-financial incentives through a community-based approach. In this study, a systematic community engagement (SCE) intervention was implemented to engage community groups in healthcare quality assessment to promote mutual collaboration between clients and healthcare providers, and enhance health worker motivation levels. SCE involves structured use of existing community groups and associations to assess healthcare quality in health facilities. Identified quality gaps are discussed with healthcare providers, improvements made and rewards given to best performing facilities for closing quality care gaps. Purpose To evaluate the effect of SCE interventions on health worker motivation and experiences with clients. Methods The study is a cluster randomized trial involving health workers in private (n = 38) and public (n = 26) primary healthcare facilities in two administrative regions in Ghana. Out of 324 clinical and non-clinical staff randomly interviewed at baseline, 234 (72%) were successfully followed at end-line and interviewed on workplace motivation factors and personal experiences with clients. Propensity score matching and difference-in-difference estimations were used to estimate treatment effect of the interventions on staff motivation. Results Intrinsic (non-financial) work incentives including cordiality with clients and perceived career prospects appeared to be prime sources of motivation for health staff interviewed in intervention health facilities while financial incentives were ranked lowest. Intervention health facilities that were assessed by female community groups (Coef. = 0.2720, p = 0.0118) and informal groups with organized leadership structures like Artisans (Coef. = 0.2268, p = 0.0368) associated positively with higher intrinsic motivation levels of staff. Conclusion Community-based approach to health worker motivation is a potential complementary strategy that needs policy deliberation to explore its prospects. Albeit financial incentives remain critical sources of staff motivation, innovative non-financial approaches like SCE should complement the latter. PMID:27439012

Assessing the Impact of Community Engagement Interventions on Health Worker Motivation and Experiences with Clients in Primary Health Facilities in Ghana: A Randomized Cluster Trial.

PubMed

Alhassan, Robert Kaba; Nketiah-Amponsah, Edward; Spieker, Nicole; Arhinful, Daniel Kojo; Rinke de Wit, Tobias F

2016-01-01

Health worker density per 1000 population in Ghana is one of the lowest in the world estimated to be 2.3, below the global average of 9.3. Low health worker motivation induced by poor working conditions partly explain this challenge. Albeit the wage bill for public sector health workers is about 90% of domestic government expenditure on health in countries such as Ghana, staff motivation and performance output remain a challenge, suggesting the need to complement financial incentives with non-financial incentives through a community-based approach. In this study, a systematic community engagement (SCE) intervention was implemented to engage community groups in healthcare quality assessment to promote mutual collaboration between clients and healthcare providers, and enhance health worker motivation levels. SCE involves structured use of existing community groups and associations to assess healthcare quality in health facilities. Identified quality gaps are discussed with healthcare providers, improvements made and rewards given to best performing facilities for closing quality care gaps. To evaluate the effect of SCE interventions on health worker motivation and experiences with clients. The study is a cluster randomized trial involving health workers in private (n = 38) and public (n = 26) primary healthcare facilities in two administrative regions in Ghana. Out of 324 clinical and non-clinical staff randomly interviewed at baseline, 234 (72%) were successfully followed at end-line and interviewed on workplace motivation factors and personal experiences with clients. Propensity score matching and difference-in-difference estimations were used to estimate treatment effect of the interventions on staff motivation. Intrinsic (non-financial) work incentives including cordiality with clients and perceived career prospects appeared to be prime sources of motivation for health staff interviewed in intervention health facilities while financial incentives were ranked lowest. Intervention health facilities that were assessed by female community groups (Coef. = 0.2720, p = 0.0118) and informal groups with organized leadership structures like Artisans (Coef. = 0.2268, p = 0.0368) associated positively with higher intrinsic motivation levels of staff. Community-based approach to health worker motivation is a potential complementary strategy that needs policy deliberation to explore its prospects. Albeit financial incentives remain critical sources of staff motivation, innovative non-financial approaches like SCE should complement the latter.

Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial.

PubMed

Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A

2016-12-01

To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO 2 ), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (p<0.05). A multivariate mixed-effects model analysis that included patients who completed ≥2 days of the intervention (n=28) demonstrated significant decreases in HR, RR, VAS-A, and VAS-D and a significant increase in daily weaning duration on music days (p<0.05). Providing patient selected music during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

A nurse-delivered advice intervention can reduce chronic non-steroidal anti-inflammatory drug use in general practice: a randomized controlled trial.

PubMed

Jones, A C; Coulson, L; Muir, K; Tolley, K; Lophatananon, A; Everitt, L; Pringle, M; Doherty, M

2002-01-01

To find out whether a nurse-delivered educational package can reduce chronic oral non-steroidal anti-inflammatory drug (NSAID) usage in general practice. A prospective randomized controlled trial with assessment of economic cost/benefits was carried out in five general practices in Nottinghamshire with computerized prescribing systems, representing a mix of rural/urban and fundholding/non-fundholding practices. Patients suffering from non-malignant, non-inflammatory musculoskeletal pain received repeat prescriptions for oral NSAIDs. Two hundred and twenty-two patients were randomized to a control group (simple advice regarding NSAID use) or an intervention group (asked to withdraw their NSAIDs and employ appropriate alternative drug and non-drug therapies). All advice was supported by patient literature and delivered by a nurse practitioner trained in musculoskeletal assessment. The primary outcome measure was change in NSAID use 6 months after the intervention. Secondary outcome measures were changes in health and quality of life (SF-36 and EQ-5D questionnaires) and drug, health service and patient costs. An extra 28% of patients in the intervention group either stopped taking oral NSAIDs or reduced dosage by > or =50% at 6 months compared with controls. There was no detrimental effect on health and well-being. Oral NSAID prescription costs were significantly lowered in the intervention group but not in the control group. A non-significant increase in total drug prescription costs occurred in both groups. Nurse-based intervention can reduce chronic NSAID usage and costs in primary care and would be cost-effective if maintained in the long term. This intervention package would be readily applicable in primary care.

Findings From a Prospective Randomized Controlled Trial of an Individualized Music Listening Program for Persons With Dementia.

PubMed

Kwak, Jung; Anderson, Keith; O'Connell Valuch, Katharine

2018-06-01

Music & Memory (M&M) is a passive music intervention that uses personalized music playlists delivered on digital music players. This program has been increasingly adopted in nursing homes across the United States to facilitate communication, engagement, and socialization among persons with dementia (PWDs); however, few studies have evaluated the program's effect on PWDs' outcomes. In the present study, a randomized controlled crossover design was used to examine the impact of the M&M program on 59 PWDs in 10 nursing homes over a 14-week period. Residents' evaluated outcomes included agitation, behavioral symptoms, and use of psychotropic medications. Although trends supported the positive effects of M&M, no statistically significant differences were found in any of the outcomes measured over time. Methodological limitations withstanding, these findings call into question the effectiveness of the M&M program and the ability of facility staff to implement this intervention with fidelity.

Adolescent depressive disorders and family based interventions in the Family Options multicenter evaluation: study protocol for a randomized controlled trial.

PubMed

Lewis, Andrew J; Bertino, Melanie D; Skewes, Joanna; Shand, Lyndel; Borojevic, Nina; Knight, Tess; Lubman, Dan I; Toumbourou, John W

2013-11-13

There is increasing community and government recognition of the magnitude and impact of adolescent depression. Family based interventions have significant potential to address known risk factors for adolescent depression and could be an effective way of engaging adolescents in treatment. The evidence for family based treatments of adolescent depression is not well developed. The objective of this clinical trial is to determine whether a family based intervention can reduce rates of unipolar depressive disorders in adolescents, improve family functioning and engage adolescents who are reluctant to access mental health services. The Family Options study will determine whether a manualized family based intervention designed to target both individual and family based factors in adolescent depression (BEST MOOD) will be more effective in reducing unipolar depressive disorders than an active (standard practice) control condition consisting of a parenting group using supportive techniques (PAST). The study is a multicenter effectiveness randomized controlled trial. Both interventions are delivered in group format over eight weekly sessions, of two hours per session. We will recruit 160 adolescents (12 to 18 years old) and their families, randomized equally to each treatment condition. Participants will be assessed at baseline, eight weeks and 20 weeks. Assessment of eligibility and primary outcome will be conducted using the KID-SCID structured clinical interview via adolescent and parent self-report. Assessments of family mental health, functioning and therapeutic processes will also be conducted. Data will be analyzed using Multilevel Mixed Modeling accounting for time x treatment effects and random effects for group and family characteristics. This trial is currently recruiting. Challenges in design and implementation to-date are discussed. These include diagnosis and differential diagnosis of mental disorders in the context of adolescent development, non-compliance of adolescents with requirements of assessment, questionnaire completion and treatment attendance, breaking randomization, and measuring the complexity of change in the context of a family-based intervention. Australia and New Zealand Clinical Trials Registry Title: engaging youth with high prevalence mental health problems using family based interventions; number 12612000398808. Prospectively registered on 10 April 2012.

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

PubMed Central

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

2017-01-01

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

Protecting children from the consequences of divorce: A longitudinal study of the effects of parenting on children's coping processes

PubMed Central

Vélez, Clorinda E.; Wolchik, Sharlene A.; Tein, Jenn-Yun; Sandler, Irwin

2010-01-01

This study examined whether intervention-induced changes in mother-child relationship quality and discipline led to short-term (6 months) and long-term (6 years) changes in children's coping processes in a sample of 240 youth aged 9-12 years when assessed initially. Data were from a randomized, experimental trial of a parenting-focused preventive intervention designed to improve children's post-divorce adjustment. Three-wave prospective mediational analyses revealed that intervention-induced improvements in relationship quality led to increases in coping efficacy at 6 months and to increases in coping efficacy and active coping at 6 years. Tests of the mediated effects were significant for all 3 indirect paths. Results are discussed in terms of pathways to adaptive coping and implications for the implementation of preventive interventions targeting coping. PMID:21291440

Recovery of ovarian activity in women with functional hypothalamic amenorrhea who were treated with cognitive behavior therapy.

PubMed

Berga, Sarah L; Marcus, Marsha D; Loucks, Tammy L; Hlastala, Stefanie; Ringham, Rebecca; Krohn, Marijane A

2003-10-01

To determine whether cognitive behavior therapy (CBT) targeted to problematic attitudes common among women with functional hypothalamic amenorrhea would restore ovarian function. Randomized, prospective, controlled intervention. Clinical research center in an academic medical institution. Sixteen women participated who had functional hypothalamic amenorrhea; were of normal body weight; and did not report psychiatric conditions, eating disorders, or excessive exercise. Subjects were randomized to CBT or observation for 20 weeks. Serum levels of E(2) and P and vaginal bleeding were monitored. Of eight women treated with CBT, six resumed ovulating, one had partial recovery of ovarian function without evidence of ovulation, and one did not display return of ovarian function. Of those randomized to observation, one resumed ovulating, one had partial return of ovarian function, and six did not recover. Thus, CBT resulted in a higher rate of ovarian activity (87.5%) than did observation (25.0%), chi(2) = 7.14. A cognitive behavioral intervention designed to minimize problematic attitudes linked to hypothalamic allostasis was more likely to result in resumption of ovarian activity than observation. The prompt ovarian response to CBT suggests that a tailored behavioral intervention offers an efficacious treatment option that also avoids the pitfalls of pharmacological modalities.

Anxiety sensitivity risk reduction in smokers: A randomized control trial examining effects on panic

PubMed Central

Schmidt, Norman B.; Raines, Amanda M.; Allan, Nicholas P.; Zvolensky, Michael J.

2016-01-01

Empirical evidence has identified several risk factors for panic psychopathology, including smoking and anxiety sensitivity (AS; the fear of anxiety-related sensations). Smokers with elevated AS are therefore a particularly vulnerable population for panic. Yet, there is little knowledge about how to reduce risk of panic among high AS smokers. The present study prospectively evaluated panic outcomes within the context of a controlled randomized risk reduction program for smokers. Participants (N = 526) included current smokers who all received a state-of-the-art smoking cessation intervention with approximately half randomized to the AS reduction intervention termed Panic-smoking Program (PSP). The primary hypotheses focus on examining the effects of a PSP on panic symptoms in the context of this vulnerable population. Consistent with prediction, there was a significant effect of treatment condition on AS, such that individuals in the PSP condition, compared to those in the control condition, demonstrated greater decreases in AS throughout treatment and the follow-up period. In addition, PSP treatment resulted in lower rates of panic-related symptomatology. Moreover, mediation analyses indicated that reductions in AS resulted in lower panic symptoms. The present study provides the first empirical evidence that brief, targeted psychoeducational interventions can mitigate panic risk among smokers. PMID:26752327

Anxiety sensitivity risk reduction in smokers: A randomized control trial examining effects on panic.

PubMed

Schmidt, Norman B; Raines, Amanda M; Allan, Nicholas P; Zvolensky, Michael J

2016-02-01

Empirical evidence has identified several risk factors for panic psychopathology, including smoking and anxiety sensitivity (AS; the fear of anxiety-related sensations). Smokers with elevated AS are therefore a particularly vulnerable population for panic. Yet, there is little knowledge about how to reduce risk of panic among high AS smokers. The present study prospectively evaluated panic outcomes within the context of a controlled randomized risk reduction program for smokers. Participants (N = 526) included current smokers who all received a state-of-the-art smoking cessation intervention with approximately half randomized to the AS reduction intervention termed Panic-smoking Program (PSP). The primary hypotheses focus on examining the effects of a PSP on panic symptoms in the context of this vulnerable population. Consistent with prediction, there was a significant effect of treatment condition on AS, such that individuals in the PSP condition, compared to those in the control condition, demonstrated greater decreases in AS throughout treatment and the follow-up period. In addition, PSP treatment resulted in lower rates of panic-related symptomatology. Moreover, mediation analyses indicated that reductions in AS resulted in lower panic symptoms. The present study provides the first empirical evidence that brief, targeted psychoeducational interventions can mitigate panic risk among smokers. Copyright © 2015 Elsevier Ltd. All rights reserved.

A systematic review of psychological interventions for adult and pediatric patients with vocal cord dysfunction.

PubMed

Guglani, Loveleen; Atkinson, Sarah; Hosanagar, Avinash; Guglani, Lokesh

2014-01-01

Vocal cord dysfunction (VCD) or paradoxical vocal-fold motion (PVFM) is a functional disorder of the vocal cords that requires multidisciplinary treatment. Besides relaxation techniques, the use of psychological interventions can help treat the underlying psychological co-morbidities. There is currently no literature that examines the effectiveness of psychological interventions for VCD/PVFM. To review the evidence for psychological interventions used for the treatment of patients with VCD/PVFM. We searched electronic databases for English medical literature using Pubmed (Medline), PsycInfo, Cochrane Database of Systematic Reviews, Cochrane Central Registry of Controlled Trials, and Clinicaltrials.gov. The date range for our search is from June 1964 to June 2014. We included studies that reported the use of psychological interventions in both adults and children diagnosed with VCD/PVFM. We included randomized controlled trials, case-control studies, retrospective chart reviews, prospective case series, and individual case reports. Most reported studies are small case series or individual case reports that have described the use of interventions such as psychotherapy, behavioral therapy, use of anti-anxiety and anti-depressant medications, and hypnotherapy in conjunction with breathing exercises taught by speech therapists for symptomatic relief. Among the various psychological interventions that have been reported, there is no data regarding effectiveness and/or superiority of one approach over another in either adult or pediatric patients. Psychological interventions have a role to play in the management of adult and pediatric patients with VCD/PVFM. Future prospective studies using uniform approaches for treatment of associated psychopathology may help address this question.

Improving transparency and reproducibility through registration: The status of intervention trials published in clinical psychology journals.

PubMed

Cybulski, Lukasz; Mayo-Wilson, Evan; Grant, Sean

2016-09-01

Prospective registration increases the validity of randomized controlled trials (RCTs). In the United States, registration is a legal requirement for drugs and devices regulated by the Food and Drug Administration (FDA), and many biomedical journals refuse to publish trials that are not registered. Trials in clinical psychology have not been subject to these requirements; it is unknown to what extent they are registered. We searched the 25 highest-impact clinical psychology journals that published at least 1 RCT of a health-related psychological intervention in 2013. For included trials, we evaluated their registration status (prospective, retrospective, not registered) and the completeness of their outcome definitions. We identified 163 articles that reported 165 RCTs; 73 (44%) RCTs were registered, of which only 25 (15%) were registered prospectively. Of registered RCTs, only 42 (58%) indicated their registration status in the publication. Only 2 (1% of all trials) were registered prospectively and defined their primary outcomes completely. For the primary outcome(s), 72 (99%) of all registrations defined the domain, 67 (92%) the time frame, and 48 (66%) the specific measurements. Only 19 (26%) and 5 (7%) defined the specific metric and method of aggregation, respectively, for all primary outcomes. Very few reports of RCTs published in clinical psychology journals were registered prospectively and completely. Clinical psychology journals could improve transparency and reproducibility, as well as reduce bias, by requiring complete prospective trial registration for publication and by including trial registration numbers in all reports of RCTs. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Effectiveness of short-term, enhanced, infection control support in improving compliance with infection control guidelines and practice in nursing homes: a cluster randomized trial.

PubMed

Gopal Rao, G; Jeanes, A; Russell, H; Wilson, D; Atere-Roberts, E; O'Sullivan, D; Donaldson, N

2009-10-01

In this prospective cluster randomized controlled trial we evaluated the impact of short-term provision of enhanced infection control support on infection control practice in nursing homes in South London. Twelve nursing homes were recruited, six each in intervention (300 residents) and control (265 residents) groups. Baseline observations of hand hygiene facilities, environmental cleanliness and safe disposal of clinical waste showed poor compliance in both groups. Post-intervention observations showed improvement in both groups. There was no statistical difference between the two groups in the compliance for hand hygiene facilities (P=0.69); environmental cleanliness (P=0.43) and safe disposal of clinical waste (P=0.96). In both groups, greatest improvement was in compliance with safe disposal of clinical waste and the least improvement was in hand hygiene facilities. Since infection control practice improved in intervention and control groups, we could not demonstrate that provision of short-term, enhanced, infection control support in nursing homes had a significant impact in infection control practice.

Web-based cognitive rehabilitation for survivors of adult cancer: A randomised controlled trial.

PubMed

Mihuta, Mary E; Green, Heather J; Shum, David H K

2018-04-01

Cognitive dysfunction associated with cancer is frequently reported and can reduce quality of life. This study evaluated a Web-based cognitive rehabilitation therapy program (eReCog) in cancer survivors compared with a waitlist control group. Adult cancer survivors with self-reported cognitive symptoms who had completed primary treatment at least 6 months prior were recruited. Participants completed telephone screening and were randomly allocated to the 4-week online intervention or waitlist. Primary outcome was perceived cognitive impairment assessed with the Functional Assessment of Cancer Therapy-Cognitive Function version 3. Secondary outcomes were additional measures of subjective cognitive functioning, objective cognitive functioning, and psychosocial variables. Seventy-six women were allocated to the intervention (n = 40) or waitlist (n = 36). A significant interaction was found on the instrumental activities of daily living measure of self-reported prospective memory whereby the intervention group reported a greater reduction in prospective memory failures than the waitlist group. Interaction trends were noted on perceived cognitive impairments (P = .089) and executive functioning (P = .074). No significant interactions were observed on other measures of objective cognitive functioning or psychosocial variables. The Web-based intervention shows promise for improving self-reported cognitive functioning in adult cancer survivors. Further research is warranted to better understand the mechanisms by which the intervention might contribute to improved self-reported cognition. Copyright © 2017 John Wiley & Sons, Ltd.

Mindfulness-based interventions for adults who are overweight or obese: a meta-analysis of physical and psychological health outcomes.

PubMed

Rogers, Jeffrey M; Ferrari, Madeleine; Mosely, Kylie; Lang, Cathryne P; Brennan, Leah

2017-01-01

The aim of this study was to evaluate the impact of mindfulness-based interventions on psychological and physical health outcomes in adults who are overweight or obese. We searched 14 electronic databases for randomized controlled trials and prospective cohort studies that met eligibility criteria. Comprehensive Meta-analysis software was used to compute the effect size estimate Hedge's g. Fifteen studies measuring post-treatment outcomes of mindfulness-based interventions in 560 individuals were identified. The average weight loss was 4.2 kg. Overall effects were large for improving eating behaviours (g = 1.08), medium for depression (g = 0.64), anxiety (g = 0.62) and eating attitudes (g = 0.57) and small for body mass index (BMI; g = 0.47) and metacognition (g = 0.38) outcomes. Therapeutic effects for BMI (g = 0.43), anxiety (g = 0.53), eating attitudes (g = 0.48) and eating behaviours (g = 0.53) remained significant when examining results from higher quality randomized control trials alone. There was no efficacy advantage for studies exceeding the median dose of 12 h of face-to-face intervention. Studies utilizing an Acceptance and Commitment Therapy approach provided the only significant effect for improving BMI (g = 0.66), while mindfulness approaches produced great variation from small to large (g = 0.30-1.68) effects across a range of psychological health and eating-related constructs. Finally, the limited longitudinal data suggested maintenance of BMI (g = 0.85) and eating attitudes (g = 0.75) gains at follow-up were only detectable in lower quality prospective cohort studies. Mindfulness-based interventions may be both physically and psychologically beneficial for adults who are overweight or obese, but further high-quality research examining the mechanisms of action are encouraged. © 2016 World Obesity Federation.

Cognitive aid for neonatal resuscitation: a prospective single-blinded randomized controlled trial.

PubMed

Bould, M D; Hayter, M A; Campbell, D M; Chandra, D B; Joo, H S; Naik, V N

2009-10-01

Retention of skills and knowledge after neonatal resuscitation courses (NRP) is known to be problematic. The use of cognitive aids is mandatory in industries such as aviation, to avoid dependence on memory when decision-making in critical situations. We aimed to prospectively investigate the effect of a cognitive aid on the performance of simulated neonatal resuscitation. Thirty-two anaesthesia residents were recruited. The intervention group had a poster detailing the NRP algorithm and the control group did not. Video recordings of each of the performances were analysed using a previously validated checklist by a peer, an expert anaesthetist, and an expert neonatologist. The median (IQR) checklist score in the control group [18.2 (15.0-20.5)] was not significantly different from that in the intervention group [20.3 (18.3-21.3)] (P=0.08). When evaluated by the neonatologist, none of the subjects correctly performed all life-saving interventions necessary to pass the checklist. A minority of the intervention group used the cognitive aid frequently. Retention of skills after NRP training is poor. The infrequent use of the cognitive aid may be the reason that it did not improve performance. Further research is required to investigate whether cognitive aids can be useful if their use is incorporated into the NRP training.

A randomized controlled trial to determine the effects of music and relaxation interventions on perceived anxiety in hospitalized patients receiving orthopaedic or cancer treatment.

PubMed

Eckhouse, Diane R; Hurd, Mary; Cotter-Schaufele, Susan; Sulo, Suela; Sokolowski, Malgorzata; Barbour, Laurel

2014-01-01

Nonpharmacological interventions, including combinations of music, education, coping skills, and relaxation techniques, have been found to have a positive effect on patients' perceived anxiety in many settings. However, few research studies have assessed and compared the effectiveness of music and relaxation interventions in reducing the anxiety levels of orthopaedic and oncology patients. We conducted a prospective, randomized, controlled study to examine the effectiveness of music and relaxation interventions on perceived anxiety during initial hospitalization for patients receiving orthopaedic or cancer care treatment at a Midwestern teaching hospital. This was a pre-test/post-test study design utilizing the State-Trait Anxiety Inventory. One hundred twelve patients were randomized into 3 study groups. Thirty-eight subjects (34%) were randomized in the music-focused relaxation group, 35 subjects (31%) in the music and video group, and 39 (35%) subjects in the control group. Fifty-seven (51%) were orthopaedic patients and 55 (49%) were oncology patients. Comparison of the 3 study groups showed no statistically significant differences with regard to patients' demographics. Although reduced anxiety levels were reported for all 3 groups postintervention, the differences were not statistically significant (p > .05). Also, there was no significant difference found between the perceived anxiety levels of patients admitted to the orthopaedic and oncology care units (p > .05). Finally, the results of the intragroup comparisons (regardless of the group assignment) showed a significant decrease in anxiety levels reported by all patients postintervention (p < .001). Music and relaxation interventions could be an additional tool in assisting patients to become less anxious during their hospital stay. Music focused relaxation and music and video are both valuable and cost-effective strategies that can assist the orthopaedic and oncology patient population. Identifying opportunities to make these interventions easily accessible to healthcare professionals can assist in the management of patient anxiety during hospitalization.

Epidemiological evaluation quality of life in patients suffering from early rheumatoid arthritis: a pragmatic, prospective, randomized, blind allocation controlled of a modular program group intervention

PubMed Central

2015-01-01

OBJECTIVES: Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA). METHODS: Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS), patient general health (GH) on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group. RESULTS: The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%), tobacco usage (25% vs. 19.8%), mean age (42.6±13.2 years vs. 46.6±10.9 years), and disease duration (15.3±6.7 months vs. 14.5±6.6 months). The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits. CONCLUSIONS: Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities. PMID:26552423

Epidemiological evaluation quality of life in patients suffering from early rheumatoid arthritis: a pragmatic, prospective, randomized, blind allocation controlled of a modular program group intervention.

PubMed

Yousefi, Hadi; Chopra, Arvind; Farrokhseresht, Reza; Sarmukaddam, Sanjeev; Noghabi, Fariba Asadi; Bedekar, Nilima; Madani, Abdolhosain

2015-01-01

Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA). Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS), patient general health (GH) on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group. The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%), tobacco usage (25% vs. 19.8%), mean age (42.6±13.2 years vs. 46.6±10.9 years), and disease duration (15.3±6.7 months vs. 14.5±6.6 months). The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits. Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities.

Effect of Oral Carbohydrate Intake on Labor Progress: Randomized Controlled Trial

PubMed Central

Rahmani, R; Khakbazan, Z; Yavari, P; Granmayeh, M; Yavari, L

2012-01-01

Background Lack of information regarding biochemical changes in women during labor and its outcomes on maternal and neonatal health still is an unanswered question. This study aims to explore the effectiveness of oral carbohydrate intake during labor on the duration of the active phase and other maternal and neonatal outcomes. Methods: A parallel prospective randomized controlled trial, conducted at the University Affiliated Teaching Hospital in Gonabad. Totally, 190 women were randomly assigned to an intervention (N=87) or control (N=90) group. Inclusion criteria were low-risk women with singleton cephalic presentation; and cervical dilatation 3–4 cm. Randomization was used by random number generator on every day. Odd numbers was used for intervention and even numbers for control group. Intervention was based on the preferences between: 3 medium dates plus 110 ml water; 3 dates plus 110 ml light tea without sugar; or 110 ml orange juice. The protocol is only run once but women ate and drank gradually before second stage of labor. Control group were fasted as routine practice. Neither participants nor care givers or staff could be blinded to group allocation. Differences between duration of the active phase of labor were assessed as primary outcome measure. Results: There was significant difference in the length of second stage of labor (P <.05). The effect size for this variable was 0.48. There were no significant differences in other maternal and neonatal outcomes. Conclusions: Oral intake of carbohydrate was an effective method for shortening the duration of second stage of labor in low-risk women. PMID:23304677

Social-Emotional Development of Toddlers: Randomized Controlled Trial of an Office-Based Intervention.

PubMed

Hallas, Donna; Koslap-Petraco, Mary; Fletcher, Jason

During the toddler years, temper tantrums and impulsive behaviors are the norm. These behaviors can frustrate even the most experienced mothers. A prospective, double blind, randomized controlled trial using pre-test/post-test experimental design was used to examine the effectiveness of an office-based educational program to improve maternal confidence and the social-emotional development of toddlers. The Toddler Care Questionnaire (TCQ) was administered to all mothers as a pre and post intervention test. The treatment intervention was a videotaped (DVD) parenting skills intervention on the social-emotional development of toddlers and on maternal confidence in caring for toddlers. Sixty mothers and 60 toddlers entered the study with 29 mothertoddler dyads randomized to the treatment group and 31 to the control group. Twenty-six (26) mother-toddler dyads in the treatment and 25 mother-toddler dyads in the control group completed the study. Pairwise comparisons of adjusted means showed significant improvements for both toddler groups on the Brigance toddler screen, and no statistically significant difference in gains between the groups. The mixed model results for the TCQ showed an overall significant improvement from preto post-test, and a non-significant interaction between group and time indicting no significant difference in gains seen by treatment groups. Brief educational programs on DVD's are an efficient way to offer information to mothers while in the office waiting area. Pediatric nurses who encounter mothers who struggle with caring for their toddlers may find brief-office based interventions a valuable tool for educating parents. Copyright © 2016 Elsevier Inc. All rights reserved.

An Interactive Web-Based Intervention to Achieve Healthy Weight in Young Children.

PubMed

Wald, Ellen R; Ewing, Linda J; Moyer, Stacey C L; Eickhoff, Jens C

2018-05-01

This prospective, randomized, controlled trial for parents of overweight and obese 3- to 7-year-olds was performed to assess the feasibility of a program promoting healthy eating and lifestyle by targeting parents as agents of change. The intervention was composed of 6-in-person group sessions and a customized website over 12 months. The control group received customary care. The primary outcome was feasibility of the intervention to promote healthy behavior change measured by attendance. The secondary outcome was effectiveness assessed by attaining reduced body mass index (BMI) z scores, healthy behavior changes and increased parent self-efficacy. Seventy-three child-parent dyads were enrolled; 14 parents never attended any sessions. Participation in follow-up assessments did not meet the hypothesized level. Ultimate BMI z scores did not differ between control and intervention groups. Parenting skills did not improve in the intervention group. This intervention to achieve healthy lifestyle changes in children via their parents as "change agents" was unsuccessful.

Kids Identifying and Defeating Stroke (KIDS): development and implementation of a multiethnic health education intervention to increase stroke awareness among middle school students and their parents.

PubMed

Mullen Conley, Kathleen; Juhl Majersik, Jennifer; Gonzales, Nicole R; Maddox, Katherine E; Pary, Jennifer K; Brown, Devin L; Moyé, Lemuel A; Espinosa, Nina; Grotta, James C; Morgenstern, Lewis B

2010-01-01

The Kids Identifying and Defeating Stroke (KIDS) project is a 3-year prospective, randomized, controlled, multiethnic school-based intervention study. Project goals include increasing knowledge of stroke signs and treatment and intention to immediately call 911 among Mexican American (MA) and non-Hispanic White (NHW) middle school students and their parents. This article describes the design, implementation, and interim evaluation of this theory-based intervention. Intervention students received a culturally appropriate stroke education program divided into four 50-minute classes each year during the sixth, seventh, and eighth grades. Each class session also included a homework assignment that involved the students' parents or other adult partners. Interim-test results indicate that this educational intervention was successful in improving students' stroke symptom and treatment knowledge and intent to call 911 upon witnessing a stroke compared with controls. The authors conclude that this school-based educational intervention to reduce delay time to hospital arrival for stroke shows early promise.

Impact of a community based fire prevention intervention on fire safety knowledge and behavior in elementary school children

PubMed Central

Hwang, V; Duchossois, G P; Garcia‐Espana, J F; Durbin, D R

2006-01-01

The objective of this study was to determine the impact of a community based fire prevention intervention directed only to parents on the fire safety knowledge and behavior in elementary school children. This was a prospective, quasi‐randomized controlled study in which third and fourth grade students from two elementary schools in an urban, poor, minority community completed knowledge/behavior surveys at baseline and following completion of the intervention. The intervention group received an in‐home visit from fire department personnel who installed free lithium smoke detectors and provided a fire escape plan. After accounting for a small difference in baseline summary scores of knowledge and behavior between the control and intervention groups, this study found a modest improvement in fire safety behavior among children whose families received a fire prevention intervention reflecting a change in household fire safety practices. However, there was no significant change in fire safety knowledge. PMID:17018679

Tribulus terrestris versus placebo in the treatment of erectile dysfunction: A prospective, randomized, double blind study.

PubMed

Santos, C A; Reis, L O; Destro-Saade, R; Luiza-Reis, A; Fregonesi, A

2014-05-01

To evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels. Prospective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way. The groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = .36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = .0004), however, there was no difference between the two groups (P = .7914). At the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total testosterone. Copyright © 2013 AEU. Published by Elsevier Espana. All rights reserved.

Respiratory Outcomes of the Surfactant Positive Pressure and Oximetry Randomized Trial

PubMed Central

Stevens, Timothy P.; Finer, Neil N.; Carlo, Waldemar A.; Szilagyi, Peter G.; Phelps, Dale L.; Walsh, Michele C.; Gantz, Marie G.; Laptook, Abbot R.; Yoder, Bradley A.; Faix, Roger G.; Newman, Jamie E.; Das, Abhik; Do, Barbara T.; Schibler, Kurt; Rich, Wade; Newman, Nancy S.; Ehrenkranz, Richard A.; Peralta-Carcelen, Myriam; Vohr, Betty R.; Wilson-Costello, Deanne E.; Yolton, Kimberly; Heyne, Roy J.; Evans, Patricia W.; Vaucher, Yvonne E.; Adams-Chapman, Ira; McGowan, Elisabeth C.; Bodnar, Anna; Pappas, Athina; Hintz, Susan R.; Acarregui, Michael J.; Fuller, Janell; Goldstein, Ricki F.; Bauer, Charles R.; O’Shea, T. Michael; Myers, Gary J.; Higgins, Rosemary D.

2014-01-01

Objective To explore the early childhood pulmonary outcomes of infants who participated in the NICHD SUPPORT Trial, using a factorial design that randomized extremely preterm infants to lower vs. higher oxygen saturation targets and delivery room CPAP vs. intubation/surfactant, found no significant difference in the primary composite outcome of death or BPD. Study design The Breathing Outcomes Study, a prospective secondary to SUPPORT, assessed respiratory morbidity at 6 month intervals from hospital discharge to 18–22 months corrected age (CA). Two pre-specified primary outcomes, wheezing more than twice per week during the worst 2 week period and cough longer than 3 days without a cold were compared between each randomized intervention. Results One or more interviews were completed for 918 of 922 eligible infants. The incidence of wheezing and cough were 47.9% and 31.0%, respectively, and did not differ between study arms of either randomized intervention. Infants randomized to lower vs. higher oxygen saturation targets had similar risks of death or respiratory morbidities (except for croup, treatment with oxygen or diuretics at home). Infants randomized to CPAP vs. intubation/surfactant had fewer episodes of wheezing without a cold (28.9% vs. 36.5%, p<0.05), respiratory illnesses diagnosed by a doctor (47.7% vs. 55.2%, p<0.05) and physician or emergency room visits for breathing problems (68.0% vs. 72.9%, p<0.05) by 18–22 months CA. Conclusion Treatment with early CPAP rather than intubation/surfactant is associated with less respiratory morbidity by 18–22 months CA. Longitudinal assessment of pulmonary morbidity is necessary to fully evaluate the potential benefits of respiratory interventions for neonates. PMID:24725582

Phase II prospective randomized trial of weight loss prior to radical prostatectomy.

PubMed

Henning, Susanne M; Galet, Colette; Gollapudi, Kiran; Byrd, Joshua B; Liang, Pei; Li, Zhaoping; Grogan, Tristan; Elashoff, David; Magyar, Clara E; Said, Jonathan; Cohen, Pinchas; Aronson, William J

2017-12-04

Obesity is associated with poorly differentiated and advanced prostate cancer and increased mortality. In preclinical models, caloric restriction delays prostate cancer progression and prolongs survival. We sought to determine if weight loss (WL) in men with prostate cancer prior to radical prostatectomy affects tumor apoptosis and proliferation, and if WL effects other metabolic biomarkers. In this Phase II prospective trial, overweight and obese men scheduled for radical prostatectomy were randomized to a 5-8 week WL program consisting of standard structured energy-restricted meal plans (1200-1500 Kcal/day) and physical activity or to a control group. The primary endpoint was apoptotic index in the radical prostatectomy malignant epithelium. Secondary endpoints were proliferation (Ki67) in the radical prostatectomy tissue, body weight, body mass index (BMI), waist to hip ratio, body composition, and serum PSA, insulin, triglyceride, cholesterol, testosterone, estradiol, leptin, adiponectin, interleukin 6, interleukin 8, insulin-like growth factor 1, and IGF binding protein 1. In total 23 patients were randomized to the WL intervention and 21 patients to the control group. Subjects in the intervention group had significantly more weight loss (WL:-3.7 ± 0.5 kg; Control:-1.6 ± 0.5 kg; p = 0.007) than the control group and total fat mass was significantly reduced (WL:-2.1 ± 0.4; Control: 0.1 ± 0.3; p = 0.015). There was no significant difference in apoptotic or proliferation index between the groups. Among the other biomarkers, triglyceride, and insulin levels were significantly decreased in the WL compared with the control group. In summary, this short-term WL program prior to radical prostatectomy resulted in significantly more WL in the intervention vs. the control group and was accompanied by significant reductions in body fat mass, circulating triglycerides, and insulin. However, no significant changes were observed in malignant epithelium apoptosis or proliferation. Future studies should consider a longer term or more intensive weight loss intervention.

Cardioprotective Effects of Intracoronary Morphine in ST-Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention: A Prospective, Randomized Trial.

PubMed

Gwag, Hye Bin; Kim, Eun Kyoung; Park, Taek Kyu; Lee, Joo Myung; Yang, Jeong Hoon; Song, Young Bin; Choi, Jin-Ho; Choi, Seung-Hyuk; Lee, Sang Hoon; Chang, Sung-A; Park, Sung-Ji; Lee, Sang-Chol; Park, Seung Woo; Jang, Woo Jin; Lee, Mirae; Chun, Woo Jung; Oh, Ju Hyeon; Park, Yong Hwan; Choe, Yeon Hyeon; Gwon, Hyeon-Cheol; Hahn, Joo-Yong

2017-04-03

A cardioprotective role of morphine acting via opioid receptors has been demonstrated, and previous preclinical studies have reported that morphine could reduce reperfusion injury and myocardial infarct size in a way similar to that of ischemic periconditioning. This study aimed to evaluate the effect of intracoronary morphine on myocardial infarct size in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. This study was designed as a 2-center, prospective, randomized, open-label, blinded end point trial. A total of 91 ST-elevation myocardial infarction patients with thrombolysis in myocardial infarction flow grade of 0 to 1 undergoing primary percutaneous coronary intervention were randomly assigned to a morphine or control group at a 1:1 ratio. The morphine group received 3 mg of morphine sulfate diluted with 3 mL of normal saline, and the control group received 3 mL of normal saline into a coronary artery immediately after restoration of coronary flow. The primary end point was myocardial infarct size assessed by cardiac magnetic resonance imaging The cardiac magnetic resonance images were evaluated for 42 and 38 patients in the morphine and control groups, respectively. Myocardial infarct size was not different between the 2 groups (25.6±11.2% versus 24.6±10.5%, P =0.77), nor was the extent of microvascular obstruction or myocardial salvage index (6.0±6.3% versus 5.1±4.6%, P =0.91; 31.1±15.2% versus 30.3±10.9%, P =0.75, respectively). There was no difference in peak creatine kinase-MB level, final thrombolysis in myocardial infarction flow, myocardial brush grade, or complete resolution of ST-segment. Intracoronary morphine administration could not reduce myocardial infarct size in ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01738100. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

A Randomized Controlled Trial of a CPR and Intubation Video Decision Support Tool for Hospitalized Patients.

PubMed

El-Jawahri, Areej; Mitchell, Susan L; Paasche-Orlow, Michael K; Temel, Jennifer S; Jackson, Vicki A; Rutledge, Renee R; Parikh, Mihir; Davis, Aretha D; Gillick, Muriel R; Barry, Michael J; Lopez, Lenny; Walker-Corkery, Elizabeth S; Chang, Yuchiao; Finn, Kathleen; Coley, Christopher; Volandes, Angelo E

2015-08-01

Decisions about cardiopulmonary resuscitation (CPR) and intubation are a core part of advance care planning, particularly for seriously ill hospitalized patients. However, these discussions are often avoided. We aimed to examine the impact of a video decision tool for CPR and intubation on patients' choices, knowledge, medical orders, and discussions with providers. This was a prospective randomized trial conducted between 9 March 2011 and 1 June 2013 on the internal medicine services at two hospitals in Boston. One hundred and fifty seriously ill hospitalized patients over the age of 60 with an advanced illness and a prognosis of 1 year or less were included. Mean age was 76 and 51% were women. Three-minute video describing CPR and intubation plus verbal communication of participants' preferences to their physicians (intervention) (N = 75) or control arm (usual care) (N = 75). The primary outcome was participants' preferences for CPR and intubation (immediately after viewing the video in the intervention arm). Secondary outcomes included: orders to withhold CPR/intubation, documented discussions with providers during hospitalization, and participants' knowledge of CPR/ intubation (five-item test, range 0-5, higher scores indicate greater knowledge). Intervention participants (vs. controls) were more likely not to want CPR (64% vs. 32%, p <0.0001) and intubation (72% vs. 43%, p < 0.0001). Intervention participants (vs. controls) were also more likely to have orders to withhold CPR (57% vs. 19%, p < 0.0001) and intubation (64% vs.19%, p < 0.0001) by hospital discharge, documented discussions about their preferences (81% vs. 43%, p < 0.0001), and higher mean knowledge scores (4.11 vs. 2.45; p < 0.0001). Seriously ill patients who viewed a video about CPR and intubation were more likely not to want these treatments, be better informed about their options, have orders to forgo CPR/ intubation, and discuss preferences with providers. Clinicaltrials.gov NCT01325519 Registry Name: A prospective randomized trial using video images in advance care planning in seriously ill hospitalized patients.

Effects of a caregiver-inclusive assistive technology intervention: a randomized controlled trial.

PubMed

Ben Mortenson, W; Demers, Louise; Fuhrer, Marcus J; Jutai, Jeffrey W; Bilkey, Jessica; Plante, Michelle; DeRuyter, Frank

2018-04-18

The principal aim of this study was to investigate whether a caregiver-inclusive assistive technology intervention improved older care recipients' functional autonomy and decreased the perceived burden of their family caregivers compared to customary care. The study was a single-blind, mixed-methods, randomized controlled trial with baseline data collection and follow-ups at 6-, 22-, and 58-weeks after baseline evaluation, which was prospectively registered ( ClinicalTrials.gov Identifier: NCT01640470. Registered 11/21/2011). Dyads comprising a care recipient and family caregiver were randomly assigned to either a caregiver-inclusive experimental group (N = 44) or a customary-care comparison group (N = 46). Eligible care recipients were aged ≥55 years and had one or more limitations with mobility or daily activities, and family caregivers provided at least four hours per week of assistance. Outcome measures were administered to both groups at baseline and at the three follow-up time points. The data collectors were blinded regarding participants' intervention group. The primary outcome measures were the Functional Autonomy Measurement System to assess care recipients' functional performance, and the Caregiver Assistive Technology Outcome Measure to assess caregivers' burden. Qualitative interviews examined participants' perceptions of the caregiver-inclusive and customary care interventions. The experimental intervention addressed significantly more dyad-identified problematic activities, but caregiver involvement was evident in both groups and outcomes were not significantly different over time. In both groups, care recipients' functional autonomy declined significantly (P < .01), and caregivers' activity-specific and overall burden decreased significantly (P < .01). Given the unintended congruence between the caregiver-inclusive and customary care interventions, the overall findings lend support for the provision of assistive technology to reduce caregiver burden.

Effect of animal-assisted interventions on depression, agitation and quality of life in nursing home residents suffering from cognitive impairment or dementia: a cluster randomized controlled trial.

PubMed

Olsen, Christine; Pedersen, Ingeborg; Bergland, Astrid; Enders-Slegers, Marie-José; Patil, Grete; Ihlebaek, Camilla

2016-12-01

The prevalence of neuropsychiatric symptoms in cognitively impaired nursing home residents is known to be very high, with depression and agitation being the most common symptoms. The possible effects of a 12-week intervention with animal-assisted activities (AAA) in nursing homes were studied. The primary outcomes related to depression, agitation and quality of life (QoL). A prospective, cluster randomized multicentre trial with a follow-up measurement 3 months after end of intervention was used. Inclusion criteria were men and women aged 65 years or older, with a diagnosis of dementia or having a cognitive deficit. Ten nursing homes were randomized to either AAA with a dog or a control group with treatment as usual. In total, 58 participants were recruited: 28 in the intervention group and 30 in the control group. The intervention consisted of a 30-min session with AAA twice weekly for 12 weeks in groups of three to six participants, led by a qualified dog handler. Norwegian versions of the Cornell Scale for Depression, the Brief Agitation Rating Scale and the Quality of Life in Late-stage Dementia scale were used. A significant effect on depression and QoL was found for participants with severe dementia at follow-up. For QoL, a significant effect of AAA was also found immediately after the intervention. No effects on agitation were found. Animal-assisted activities may have a positive effect on symptoms of depression and QoL in older people with dementia, especially those in a late stage. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study.

PubMed

Belle, Loic; Motreff, Pascal; Mangin, Lionel; Rangé, Grégoire; Marcaggi, Xavier; Marie, Antoine; Ferrier, Nadine; Dubreuil, Olivier; Zemour, Gilles; Souteyrand, Géraud; Caussin, Christophe; Amabile, Nicolas; Isaaz, Karl; Dauphin, Raphael; Koning, René; Robin, Christophe; Faurie, Benjamin; Bonello, Laurent; Champin, Stanislas; Delhaye, Cédric; Cuilleret, François; Mewton, Nathan; Genty, Céline; Viallon, Magalie; Bosson, Jean Luc; Croisille, Pierre

2016-03-01

Delayed stent implantation after restoration of normal epicardial flow by a minimalist immediate mechanical intervention aims to decrease the rate of distal embolization and impaired myocardial reperfusion after percutaneous coronary intervention. We sought to confirm whether a delayed stenting (DS) approach (24-48 hours) improves myocardial reperfusion, versus immediate stenting, in patients with acute ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. In the prospective, randomized, open-label minimalist immediate mechanical intervention (MIMI) trial, patients (n=140) with ST-segment-elevation myocardial infarction ≤12 hours were randomized to immediate stenting (n=73) or DS (n=67) after Thrombolysis In Myocardial Infarction 3 flow restoration by thrombus aspiration. Patients in the DS group underwent a second coronary arteriography for stent implantation a median of 36 hours (interquartile range 29-46) after randomization. The primary end point was microvascular obstruction (% left ventricular mass) on cardiac magnetic resonance imaging performed 5 days (interquartile range 4-6) after the first procedure. There was a nonsignificant trend toward lower microvascular obstruction in the immediate stenting group compared with DS group (1.88% versus 3.96%; P=0.051), which became significant after adjustment for the area at risk (P=0.049). Median infarct weight, left ventricular ejection fraction, and infarct size did not differ between groups. No difference in 6-month outcomes was apparent for the rate of major cardiovascular and cerebral events. The present findings do not support a strategy of DS versus immediate stenting in patients with ST-segment-elevation infarction undergoing primary percutaneous coronary intervention and even suggested a deleterious effect of DS on microvascular obstruction size. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360242. © 2016 American Heart Association, Inc.

Effect of increased exercise in school children on physical fitness and endothelial progenitor cells: a prospective randomized trial.

PubMed

Walther, Claudia; Gaede, Luise; Adams, Volker; Gelbrich, Götz; Leichtle, Alexander; Erbs, Sandra; Sonnabend, Melanie; Fikenzer, Kati; Körner, Antje; Kiess, Wieland; Bruegel, Mathias; Thiery, Joachim; Schuler, Gerhard

2009-12-01

The aim of this prospective, randomized study was to examine whether additional school exercise lessons would result in improved peak oxygen uptake (primary end point) and body mass index-standard deviation score, motor and coordinative abilities, circulating progenitor cells, and high-density lipoprotein cholesterol (major secondary end points). Seven sixth-grade classes (182 children, aged 11.1+/-0.7 years) were randomized to an intervention group (4 classes with 109 students) with daily school exercise lessons for 1 year and a control group (3 classes with 73 students) with regular school sports twice weekly. The significant effects of intervention estimated from ANCOVA adjusted for intraclass correlation were the following: increase of peak o(2) (3.7 mL/kg per minute; 95% confidence interval, 0.3 to 7.2) and increase of circulating progenitor cells evaluated by flow cytometry (97 cells per 1 x 10(6) leukocytes; 95% confidence interval, 13 to 181). No significant difference was seen for body mass index-standard deviation score (-0.08; 95% confidence interval, -0.28 to 0.13); however, there was a trend to reduction of the prevalence of overweight and obese children in the intervention group (from 12.8% to 7.3%). No treatment effect was seen for motor and coordinative abilities (4; 95% confidence interval, -1 to 8) and high-density lipoprotein cholesterol (0.03 mmol/L; 95% confidence interval, -0.08 to 0.14). Regular physical activity by means of daily school exercise lessons has a significant positive effect on physical fitness (o(2)max). Furthermore, the number of circulating progenitor cells can be increased, and there is a positive trend in body mass index-standard deviation score reduction and motor ability improvement. Therefore, we conclude that primary prevention by means of increasing physical activity should start in childhood. URL: http://www.clinicaltrials.gov. Identifier: NCT00176371.

Development and Feasibility of a COPD Self-Management Intervention Delivered with Motivational Interviewing Strategies

PubMed Central

Benzo, Roberto; Vickers, Kristin; Ernst, Denise; Tucker, Sharon; McEvoy, Charlene; Lorig, Kate

2013-01-01

BACKGROUND Self-management (SM) is proposed as the standard of care in chronic obstructive pulmonary disease (COPD) but details of the process and training required to deliver effective SM are not widely available. In addition, recent data suggest that patient engagement and motivation are critical ingredients for effective self-management. This manuscript carefully describes a self-management intervention using Motivational Interviewing skills, aimed to increase engagement and commitment in severe COPD patients. METHODS The intervention was developed and pilot tested for fidelity to protocol, for patient and interventionist feedback (qualitative) and effect on quality of life. Engagement between patient and interventionists was measured by the Working Alliance Inventory. The intervention was refined based in the results of the pilot study and delivered in the active arm of a prospective randomized study. RESULTS The pilot study suggested improvements in quality of life, fidelity to theory and patient acceptability. The refined self-management intervention was delivered 540 times in the active arm of a randomized study. We observed a retention rate of 86% (patients missing or not available for only 14% the scheduled encounters). CONCLUSIONS A self-management intervention, that includes motivational interviewing as the way if guiding patient into behavior change, is feasible in severe COPD and may increase patient engagement and commitment to self-management. This provides a very detailed description of the SM process for (the specifics of training and delivering the intervention) that facilitates replicability in other settings and could be translated to cardiac rehabilitation. PMID:23434613

Evaluation of a needle social marketing strategy to control HIV among injecting drug users in China.

PubMed

Wu, Zunyou; Luo, Wei; Sullivan, Sheena G; Rou, Keming; Lin, Peng; Liu, Wei; Ming, Zhongqiang

2007-12-01

To evaluate the effectiveness of a needle social marketing strategy to reduce needle sharing and hepatitis C Virus (HCV)/HIV transmission among injecting drug users (IDU) in China. Two-armed, prospective, community-randomized prevention trial. Four counties/townships in Guangxi and Guangdong provinces; one randomized to intervention the other to control in each province. Injecting drug users: 823 (443 intervention, 382 control) at baseline and 852 (415 intervention, 407 control) at the second cross-sectional survey 12 months later. A needle social marketing programme, including promotion of safe injection norms and increased access to clean needles over a 12 month period. Cross sectional surveys at baseline and follow-up compared changes in drug using behaviours and HIV and HCV rates in the intervention and control communities. Needle sharing behaviours were similar in the two groups at baseline (68.4 vs. 67.8%), and dropped significantly to 35.3% in the intervention community and remained relatively stable in the control community (62.3%; P < 0.001). In a subset of cohort of new injectors, the incidence of HCV was significant lower in intervention than in control in both provinces (P < 0.001, P = 0.014) and overall (P < 0.001) but HIV was only significantly lower in intervention in Guangdong (P = 0.011). Needle social marketing can reduce risky injecting behaviour and HIV/HCV transmission among injecting drug users in China and should be expanded.

Effects of a multifactorial injury prevention intervention in physical education teachers: A randomized controlled trial.

PubMed

Vercruysse, Sien; Haerens, Leen; Verhagen, Evert; Goossens, Lennert; De Clercq, Dirk

2016-10-01

Physical education (PE) teachers are at a high risk of musculoskeletal sports or work-related injuries because of the physical activity as inherent part of their profession. Such injuries have a negative impact on work and leisure time activities, and effective injury prevention interventions are needed. The present study aimed at testing the effectiveness of an injury prevention intervention that was developed and optimized according to PE teachers' wishes and values. Fifty-five PE teachers were randomly assigned to intervention or control group. Intervention group teachers engaged in two days of training during which they familiarized with eight injury prevention strategies (seven intrinsic and one extrinsic). A special feature of the intervention was that the way of delivery was based on the self-determination theory in order to stimulate participants' motivation to adhere to the proposed strategies. Prospective registrations during one school year were conducted concerning injuries and preventive behaviours. Results showed that the intervention group teachers had a lower number of injuries per 1000 h time of exposure (TOE) than the controls (INT: 0.49, CON: 1.14 injuries/1000 h TOE, OR: 2.32, 95% CI: 1.06-5.07), and applied a broader variety of strategies including dynamic and static stretching, core stability, balance and strength training, when compared to the controls who mainly engaged in warming-up. In conclusion, with the same amount of time, an injury reduction was found in PE teachers through a more balanced use of provided preventive strategies.

Pharmacological intervention based on fecal calprotectin levels in patients with ulcerative colitis at high risk of a relapse: A prospective, randomized, controlled study

PubMed Central

Öhman, Lena; Stotzer, Per-Ove; Isaksson, Stefan; Überbacher, Otto; Ung, Kjell-Arne; Strid, Hans

2015-01-01

Background Targeted therapy, using biomarkers to assess disease activity in ulcerative colitis (UC), has been proposed. Objective The objective of this study was to evaluate whether pharmacological intervention guided by fecal calprotectin (FC) prolongs remission in patients with UC. Methods A total of 91 adults with UC in remission were randomized to an intervention group or a control group. Analysis of FC was performed monthly, during 18 months. A FC value of 300 µg/g was set as the cut-off for intervention, which was a dose escalation of the oral 5-aminosalicylate (5-ASA) agent. The primary study end-point was the number of patients to have relapsed by month 18. Results There were relapses in 18 (35.3%) and 20 (50.0%) patients in the intervention and the control groups, respectively (p = 0.23); and 28 (54.9%) patients in the intervention group and 28 (70.0%) patients in the control group had a FC > 300 µg/g, of which 8 (28.6%) and 16 (57.1%) relapsed, respectively (p < 0.05). Conclusion Active intervention significantly reduced relapse rates, although no significant difference was reached between the groups overall. Thus, FC-levels might be used to identify patients with UC at risk for a flare, and a dose escalation of their 5-ASA agent is a therapeutic option for these patients. PMID:25653861

Brief hypnotherapeutic-behavioral intervention for functional abdominal pain and irritable bowel syndrome in childhood: a randomized controlled trial.

PubMed

Gulewitsch, Marco Daniel; Müller, Judith; Hautzinger, Martin; Schlarb, Angelika Anita

2013-08-01

Functional abdominal pain and irritable bowel syndrome are two prevalent disorders in childhood which are associated with recurrent or chronic abdominal pain, disabilities in daily functioning, and reduced quality of life. This study aimed to evaluate a brief hypnotherapeutic-behavioral intervention program in a prospective randomized controlled design. Thirty-eight children, 6 to 12 years of age, and their parents were randomly assigned to a standardized hypnotherapeutic-behavioral treatment (n = 20) or to a waiting list condition (n = 18). Both groups were reassessed 3 months after beginning. Primary outcome variables were child-completed pain measures and pain-related disability. Secondary outcome variables were parent-completed measures of their children's pain and pain-related disability. Health-related quality of life from both perspectives also served as a secondary outcome. In the treatment group, 11 of 20 children (55.0%) showed clinical remission (>80% improvement), whereas only one child (5.6%) in the waiting list condition was classified as responder. Children in the treatment group reported a significantly greater reduction of pain scores and pain-related disability than children of the waiting list condition. Parental ratings also showed a greater reduction of children's abdominal pain and pain-related disability. Health-related quality of life did not increase significantly. Hypnotherapeutic and behavioral interventions are effective in treating children with long-standing AP. Treatment success of this brief program should be further evaluated against active interventions with a longer follow-up.

Protecting children from the consequences of divorce: a longitudinal study of the effects of parenting on children's coping processes.

PubMed

Vélez, Clorinda E; Wolchik, Sharlene A; Tein, Jenn-Yun; Sandler, Irwin

2011-01-01

This study examines whether intervention-induced changes in mother-child relationship quality and discipline led to short-term (6 months) and long-term (6 years) changes in children's coping processes in a sample of 240 youth aged 9-12 years when assessed initially. Data were from a randomized, experimental trial of a parenting-focused preventive intervention designed to improve children's postdivorce adjustment. Three-wave prospective mediational analyses revealed that intervention-induced improvements in relationship quality led to increases in coping efficacy at 6 months and to increases in coping efficacy and active coping at 6 years. Tests of the mediated effects were significant for all 3 indirect paths. Results are discussed in terms of pathways to adaptive coping and implications for the implementation of preventive interventions targeting coping. © 2011 The Authors. Child Development © 2011 Society for Research in Child Development, Inc.

The Impact of Brief Messages on HSV-2 Screening Uptake Among Female Defendants in a Court Setting: A Randomized Controlled Trial Utilizing Prospect Theory

PubMed Central

ROTH, ALEXIS M.; VAN DER POL, BARBARA; FORTENBERRY, J. DENNIS; DODGE, BRIAN; REECE, MICHAEL; CERTO, DAVID; ZIMET, GREGORY D.

2015-01-01

Epidemiologic data demonstrate that women involved with the criminal justice system in the United States are at high risk for sexually transmitted infections, including herpes simplex virus type 2 (HSV-2). Female defendants were recruited from a misdemeanor court to assess whether brief framed messages utilizing prospect theory could encourage testing for HSV-2. Participants were randomly assigned to a message condition (gain, loss, or control), completed an interviewer-administered survey assessing factors associated with antibody test uptake/refusal and were offered free point-of-care HSV-2 serologic testing. Although individuals in the loss-frame group accepted testing at the highest rate, an overall statistical difference in HSV-2 testing behavior by group (p ≤.43) was not detected. The majority of the sample (74.6%) characterized receiving a serological test for HSV-2 as health affirming. However, this did not moderate the effect of the intervention nor was it significantly associated with test acceptance (p ≤.82). Although the effects of message framing are subtle, the findings have important theoretical implications given the participants’ characterization of HSV-2 screening as health affirming despite being a detection behavior. Implications of study results for health care providers interested in brief, low cost interventions are also explored. PMID:25494832

Effect of health promotion and fluoride varnish on dental caries among Australian Aboriginal children: results from a community-randomized controlled trial*

PubMed Central

Slade, Gary D; Bailie, Ross S; Roberts-Thomson, Kaye; Leach, Amanda J; Raye, Iris; Endean, Colin; Simmons, Bruce; Morris, Peter

2011-01-01

Objectives We tested a dental health program in remote Aboriginal communities of Australia's Northern Territory, hypothesizing that it would reduce dental caries in preschool children. Methods In this 2-year, prospective, cluster-randomized, concurrent controlled, open trial of the dental health program compared to no such program, 30 communities were allocated at random to intervention and control groups. All residents aged 18–47 months were invited to participate. Twice per year for 2 years in the 15 intervention communities, fluoride varnish was applied to children's teeth, water consumption and daily tooth cleaning with toothpaste were advocated, dental health was promoted in community settings, and primary health care workers were trained in preventive dental care. Data from dental examinations at baseline and after 2 years were used to compute net dental caries increment per child (d3mfs). A multi-level statistical model compared d3mfs between intervention and control groups with adjustment for the clustered randomization design; four other models used additional variables for adjustment. Results At baseline, 666 children were examined; 543 of them (82%) were re-examined 2 years later. The adjusted d3mfs increment was significantly lower in the intervention group compared to the control group by an average of 3.0 surfaces per child (95% CI = 1.2, 4.9), a prevented fraction of 31%. Adjustment for additional variables yielded caries reductions ranging from 2.3 to 3.5 surfaces per child and prevented fractions of 24–36%. Conclusions These results corroborate findings from other studies where fluoride varnish was efficacious in preventing dental caries in young children. PMID:20707872

Pharmacologic intervention for retained placenta: a systematic review and meta-analysis.

PubMed

Duffy, James M N; Mylan, Sophie; Showell, Marian; Wilson, Matthew J A; Khan, Khalid S

2015-03-01

To assess the effectiveness and safety of pharmacologic interventions for the treatment of retained placenta (when the placenta remains undelivered after 30 minutes of active management of the third stage of labor). We searched: 1) Cochrane Central Register of Controlled Trials (CENTRAL), 2) Cochrane Pregnancy and Childbirth Group's Trials Register, 3) EMBASE, and 4) MEDLINE from inception to June 2014. Randomized controlled trials comparing a pharmacologic intervention(s) with a placebo for the treatment of retained placenta were included. Sixteen randomized controlled trials, including 1,683 participants, were included. Study characteristics and quality were recorded. The meta-analysis was based on random-effects methods for pooled data. There were no statistically significant differences in the requirement to perform manual removal of a placenta in patients treated with oxytocin (55% compared with 60%; relative risk [RR] 0.86, 95% confidence interval [CI] 0.73-1.02; 10 randomized controlled trials [RCTs]), prostaglandins (44% compared with 55%; RR 0.82, 95% CI 0.58-1.15; four RCTs), nitroglycerin (85% compared with 80%; RR 1.06, 95% CI 0.80-1.41; one RCT), or oxytocin and nitroglycerin (52% compared with 79%; RR 0.23, 95% CI 0.01-8.48; two RCTs) compared with placebo. There was limited reporting of secondary outcomes. As opposed to the use of oxytocin as part of the active management of the third stage of labor that has been shown to diminish bleeding in the third stage, once the diagnosis of retained placenta has been made, no pharmacologic treatment has been shown to be effective. When retained placenta is diagnosed, immediate manual removal of the placenta should be considered. PROSPERO International Prospective Register of Systematic Reviews, http://www.crd.york.ac.uk/PROSPERO/, CRD42014010641.

CITRUS, cervical cancer screening trial by randomization of HPV testing intervention for upcoming screening: Design, methods and baseline data of 18,471 women.

PubMed

Morisada, Tohru; Teramoto, Katsuhiro; Takano, Hirokuni; Sakamoto, Ikuko; Nishio, Hiroshi; Iwata, Takashi; Hashi, Akihiko; Katoh, Ryohei; Okamoto, Aikou; Sasaki, Hiroshi; Nakatani, Eiji; Teramukai, Satoshi; Aoki, Daisuke

2017-10-01

To assess the efficacy of screening with concurrent liquid-based cytology and human papillomavirus (HPV) testing for primary cervical cancer screening, we initiated a randomized trial entitled CervIcal cancer screening Trial by Randomization of HPV testing intervention for Upcoming Screening (CITRUS). Between June 2013 and March 2015, women aged 30-64 years of age who participated in a regular cervical cancer screening program (every 2 years) were invited to enrollment of our study. After giving their informed consent, 18,402 women were randomly assigned to liquid-based cytology as the control group (n=9145) or to HPV DNA testing with liquid-based cytology as the intervention group (n=9257). We subsequently compared the incidence rate of cervical intraepithelial neoplasia (CIN), the rate of false positive tests and the rate of overdiagnosis, as well as assessing the risks and benefits of receiving screening for women in both groups. The primary outcome of our study was the incidence of cervical intraepithelial neoplasia grade 3 or worse (CIN3+) during the study period of around 6 years. In the control group, 97.9% of women were NILM, and 2.06% ASC-US or worse (ASC-US+). In the intervention group, 87.13% of women were NILM/HPV negative, 0.72% ASC-US/HPV negative, 10.34% NILM/HPV positive, 0.69% ASC-US/HPV positive, 0.90% worse than ASC-US/either HPV. Positive HPV testing was not linearly related to age in our study. Insights from CITRUS will provide future prospects for cervical cancer screening focused on the use of HPV testing in Japan. NCT01895517, UMIN000010843, TRIUC1312. Copyright © 2017 Elsevier Ltd. All rights reserved.

Carotid artery stenting vs. carotid endarterectomy in the management of carotid artery stenosis: Lessons learned from randomized controlled trials

PubMed Central

Salem, Mohamed M.; Alturki, Abdulrahman Y.; Fusco, Matthew R.; Thomas, Ajith J.; Carter, Bob S.; Chen, Clark C.; Kasper, Ekkehard M.

2018-01-01

Background: Carotid artery stenosis, both symptomatic and asymptomatic, has been well studied with several multicenter randomized trials. The superiority of carotid endarterectomy (CEA) to medical therapy alone in both symptomatic and asymptomatic carotid artery stenosis has been well established in previous trials in the 1990s. The consequent era of endovascular carotid artery stenting (CAS) has offered another option for treating carotid artery stenosis. A series of randomized trials have now been conducted to compare CEA and CAS in the treatment of carotid artery disease. The large number of similar trials has created some confusion due to inconsistent results. Here, the authors review the trials that compare CEA and CAS in the management of carotid artery stenosis. Methods: The PubMed database was searched systematically for randomized controlled trials published in English that compared CEA and CAS. Only human studies on adult patients were assessed. The references of identified articles were reviewed for additional manuscripts to be included if inclusion criteria were met. The following terms were used during search: carotid stenosis, endarterectomy, stenting. Retrospective or single-center studies were excluded from the review. Results: Thirteen reports of seven large-scale prospective multicenter studies, comparing both interventions for symptomatic or asymptomatic extracranial carotid artery stenosis, were identified. Conclusions: While the superiority of intervention to medical management for symptomatic patients has been well established in the literatures, careful selection of asymptomatic patients for intervention should be undertaken and only be pursued after institution of appropriate medical therapy until further reports on trials comparing medical therapy to intervention in this patient group are available. PMID:29740506

Arthroscopic Surgical Procedures Versus Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears: Study Protocol for a Randomized Controlled Trial (HIPARTI) and a Prospective Cohort Study (HARP).

PubMed

Risberg, May Arna; Ageberg, Eva; Nilstad, Agnethe; Lund, Bent; Nordsletten, Lars; Løken, Sverre; Ludvigsen, Tom; Kierkegaard, Signe; Carsen, Sasha; Kostogiannis, Ioannis; Crossley, Kay M; Glyn-Jones, Sion; Kemp, Joanne L

2018-04-01

Study Design Study protocol for a randomized controlled trial and a prospective cohort. Background The number of arthroscopic surgical procedures for patients with femoroacetabular impingement syndrome (FAIS) has significantly increased worldwide, but high-quality evidence of the effect of such interventions is lacking. Objectives The primary objective will be to determine the efficacy of hip arthroscopic procedures compared to sham surgery on patient-reported outcomes for patients with FAIS (HIP ARThroscopy International [HIPARTI] Study). The secondary objective will be to evaluate prognostic factors for long-term outcome after arthroscopic surgical interventions in patients with FAIS (Hip ARthroscopy Prospective [HARP] Study). Methods The HIPARTI Study will include 140 patients and the HARP Study will include 100 patients. The international Hip Outcome Tool-33 will be the primary outcome measure at 1 year. Secondary outcome measures will be the Hip disability and Osteoarthritis Outcome Score, Arthritis Self-Efficacy Scale, fear of movement (Tampa Scale of Kinesiophobia), Patient-Specific Functional Scale, global rating of change score, and expectations. Other outcomes will include active hip range of motion, hip muscle strength tests, functional performance tests, as well as radiological assessments using radiographs and magnetic resonance imaging. Conclusion To determine the true effect of surgery, beyond that of placebo, double-blinded placebo-controlled trials including sham surgery are needed. The HIPARTI Study will direct future evidence-based treatment of FAIS. Predictors for long-term development and progression of degenerative changes in the hip are also needed for this young patient group with FAIS; hence, responders and nonresponders to treatment could be determined. J Orthop Sports Phys Ther 2018;48(4):325-335. doi:10.2519/jospt.2018.7931.

Prospective registration trends, reasons for retrospective registration and mechanisms to increase prospective registration compliance: descriptive analysis and survey.

PubMed

Hunter, Kylie Elizabeth; Seidler, Anna Lene; Askie, Lisa M

2018-03-01

To analyse prospective versus retrospective trial registration trends on the Australian New Zealand Clinical Trials Registry (ANZCTR) and to evaluate the reasons for non-compliance with prospective registration. Part 1: Descriptive analysis of trial registration trends from 2006 to 2015. Part 2: Online registrant survey. Part 1: All interventional trials registered on ANZCTR from 2006 to 2015. Part 2: Random sample of those who had retrospectively registered a trial on ANZCTR between 2010 and 2015. Part 1: Proportion of prospective versus retrospective clinical trial registrations (ie, registration before versus after enrolment of the first participant) on the ANZCTR overall and by various key metrics, such as sponsor, funder, recruitment country and sample size. Part 2: Reasons for non-compliance with prospective registration and perceived usefulness of various proposed mechanisms to improve prospective registration compliance. Part 1: Analysis of the complete dataset of 9450 trials revealed that compliance with prospective registration increased from 48% (216 out of 446 trials) in 2006 to 63% (723/1148) in 2012 and has since plateaued at around 64%. Patterns of compliance were relatively consistent across sponsor and funder types (industry vs non-industry), type of intervention (drug vs non-drug) and size of trial (n<100, 100-500, >500). However, primary sponsors from Australia/New Zealand were almost twice as likely to register prospectively (62%; 4613/7452) compared with sponsors from other countries with a WHO Network Registry (35%; 377/1084) or sponsors from countries without a WHO Registry (29%; 230/781). Part 2: The majority (56%; 84/149) of survey respondents cited lack of awareness as a reason for not registering their study prospectively. Seventy-four per cent (111/149) stated that linking registration to ethics approval would facilitate prospective registration. Despite some progress, compliance with prospective registration remains suboptimal. Linking registration to ethics approval was the favoured strategy among those sampled for improving compliance. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Rationale of a novel study design for the BIOFLOW V study, a prospective, randomized multicenter study to assess the safety and efficacy of the Orsiro sirolimus-eluting coronary stent system using a Bayesian approach.

PubMed

Doros, Gheorghe; Massaro, Joseph M; Kandzari, David E; Waksman, Ron; Koolen, Jacques J; Cutlip, Donald E; Mauri, Laura

2017-11-01

Traditional study design submitted to the Food and Drug Administration to test newer drug-eluting stents (DES) for marketing approval is the prospective randomized controlled trial. However, several DES have extensive clinical data from trials conducted outside the United States that have led to utilization of a novel design using the Bayesian approach. This design was proposed for testing DES with bioresorbable polymer compared with DES most commonly in use today that use durable polymers for drug elution. This prospective, multicenter, randomized, controlled trial is designed to assess the safety and efficacy of the Orsiro bioresorbable polymer sirolimus-eluting stent (BP SES). Up to 1,334 subjects with up to 3 de novo or restenotic coronary artery lesions who qualify for percutaneous coronary intervention with stenting will be randomized 2:1 to the BP SES versus the Xience durable polymer everolimus-eluting stent (DP EES). Data from this trial will be combined with data from 2 similarly designed trials that also randomize subjects to BP SES and DP EES (BIOFLOW II, N=452 and BIOFLOW IV, N=579) by using a Bayesian approach. The primary end point is target lesion failure at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a test of noninferiority of the BP SES versus DP EES on the primary end point according to a noninferiority delta of 3.85%. Secondary end points include stent thrombosis and the individual components of target lesion failure. Subjects will be followed for 5 years after randomization. The BIOFLOW V trial offers an opportunity to assess clinical outcomes in patients treated with coronary revascularization using the Orsiro BP SES relative to a commonly used DP EES. The use of a Bayesian analysis combines a large randomized cohort of patients 2 two smaller contributing randomized trials to augment the efficiency of the comparison. Copyright © 2017 Elsevier Inc. All rights reserved.

Mindfulness-based yoga intervention for women with depression.

PubMed

Schuver, Katie J; Lewis, Beth A

2016-06-01

The purpose of this study was to examine the efficacy of a 12-week mindfulness-based yoga intervention on depressive symptoms and rumination among depressed women. Prospective, randomized, controlled 12 week intervention pilot study. Depressive symptoms were assessed at baseline, post-intervention (12 weeks), and one-month follow-up. Women with a history of diagnosed depression and currently depressed were randomized to a mindfulness-based yoga condition or a walking control. The mindfulness-based yoga intervention consisted of a home-based yoga asana, pranayama and meditation practice with mindfulness education sessions delivered over the telephone. The walking control condition consisted of home-based walking sessions and health education sessions delivered over the phone. The Beck Depression Inventory (BDI) and Ruminative Responses Scale (RRS). Both groups reported decreases in depressive symptoms from baseline to post-intervention, f(1,33)=34.83, p<0.001, and from baseline to one-month follow-up, f(1,33)=37.01, p<0.001. After controlling for baseline, there were no significant between group differences on depression scores at post-intervention and the one-month follow-up assessment. The mindfulness-based yoga condition reported significantly lower levels of rumination than the control condition at post-intervention, after controlling for baseline levels of rumination, f(1,31)=6.23, p<0.01. These findings suggest that mindfulness-based yoga may provide tools to manage ruminative thoughts among women with elevated depressive symptoms. Future studies, with larger samples are needed to address the effect of yoga on depression and further explore the impact on rumination. Copyright © 2016 Elsevier Ltd. All rights reserved.

Efficacy of the Fun For Wellness Online Intervention to Promote Well-Being Actions: A Secondary Data Analysis.

PubMed

Myers, Nicholas D; Dietz, Samantha; Prilleltensky, Isaac; Prilleltensky, Ora; McMahon, Adam; Rubenstein, Carolyn L; Lee, Seungmin

2018-04-30

Fun For Wellness (FFW) is a new online intervention designed to promote growth in well-being by providing capability-enhancing learning opportunities (e.g., play an interactive game) to participants. The purpose of this study was to provide an initial evaluation of the efficacy of the FFW intervention to increase well-being actions. The study design was a secondary data analysis of a large-scale prospective, double-blind, parallel-group randomized controlled trial. Data were collected at baseline and 30 and 60 days postbaseline. A total of 479 adult employees at a major university in the southeast of the United States of America were enrolled. Participants who were randomly assigned to the FFW group were provided with 30 days of 24-hour access to the intervention. A two-class linear regression model with complier average causal effect estimation was fitted to well-being actions scores at 30 and 60 days. Intent-to-treat analysis provided evidence that the effect of being assigned to the FFW intervention, without considering actual participation in the FFW intervention, had a null effect on each dimension of well-being actions at 30 and 60 days. Participants who complied with the FFW intervention, however, had significantly higher well-being actions scores, compared to potential compliers in the Usual Care group, in the interpersonal dimension at 60 days, and the physical dimension at 30 days. Results from this secondary data analysis provide some supportive evidence for both the efficacy of and possible revisions to the FFW intervention in regard to promoting well-being actions.

Development and Prospective Federal State-Wide Evaluation of a Device for Height-Based Dose Recommendations in Prehospital Pediatric Emergencies: A Simple Tool to Prevent Most Severe Drug Errors.

PubMed

Kaufmann, Jost; Roth, Bernhard; Engelhardt, Thomas; Lechleuthner, Alex; Laschat, Michael; Hadamitzky, Christoph; Wappler, Frank; Hellmich, Martin

2018-01-01

Drug dosing errors pose a particular threat to children in prehospital emergency care. With the Pediatric emergency ruler (PaedER), we developed a simple height-based dose recommendation system and evaluated its effectiveness in a pre-post interventional trial as the Ethics Committee disapproved randomization due to the expected positive effect of the PaedER on outcome. Pre-interventional data were retrospectively retrieved from the electronic records and medical protocols of the Cologne Emergency Medical Service over a two-year period prior to the introduction of the PaedER. Post-interventional data were collected prospectively over a six-year period in a federal state-wide open trial. The administered doses of either intravenous or intraosseous fentanyl, midazolam, ketamine or epinephrine were recorded. Primary outcome measure was the number and severity of drug dose deviation from recommended dose (DRD) based on the patient's weight. Fifty-nine pre-interventional and 91 post-interventional prehospital drug administrations in children were analyzed. The rate of DRD > 300% overall medications were 22.0% in the pre- and 2.2% in the post-interventional group (p < 0.001). All administrations of epinephrine occurred excessive (DRD > 300%) in pre-interventional and none in post-interventional patients (p < 0.001). The use of the PaedER resulted in a 90% reduction of medication errors (95% CI: 57% to 98%; p < 0.001) and prevented all potentially life-threatening errors associated with epinephrine administration. There is an urgent need to increase the safety of emergency drug dosing in children during emergencies. A simple height-based system can support health care providers and helps to avoid life-threatening medication errors.

Hypothetical midlife interventions in women and risk of type 2 diabetes.

PubMed

Danaei, Goodarz; Pan, An; Hu, Frank B; Hernán, Miguel A

2013-01-01

Randomized trials have examined short-term effects of lifestyle interventions for diabetes prevention only among high-risk individuals. Prospective studies have examined the associations between lifestyle factors and diabetes in healthy populations but have not characterized the intervention. We estimated the long-term effects of hypothetical lifestyle interventions on diabetes in a prospective study of healthy women, using the parametric g-formula. Using data from the Nurses' Health Study, we followed 76,402 women from 1984 to 2008. We estimated the risk of type 2 diabetes under eight hypothetical interventions: quitting smoking, losing weight by 5% every 2 years if overweight/obese, exercising at least 30 minutes a day, eating less than three servings a week of red meat, eating at least two servings a day of whole grain, drinking two or more cups of coffee a day, drinking five or more grams of alcohol a day, and drinking less than one serving of soda a week. The 24-year risk of diabetes was 9.6% under no intervention and 4.3% when all interventions were imposed (55% lower risk [95% confidence interval = 47 to 63%]). The most effective interventions were weight loss (24% lower risk), physical activity (19%), and moderate alcohol use (19%). Overweight/obese women would benefit the most, with 10.8 percentage point reduction in 24-year risk of diabetes. The validity of these estimates relies on the absence of unmeasured confounding, measurement error, and model misspecification. A combination of dietary and nondietary lifestyle modifications, begun in midlife or later in relatively healthy women, could have prevented at least half of the cases of type 2 diabetes in this cohort of U.S. women.

The role of a personalized dietary intervention in managing gestational weight gain: a prospective, controlled study in a low-risk antenatal population.

PubMed

Di Carlo, Costantino; Iannotti, Giuseppina; Sparice, Stefania; Chiacchio, Maria Pia; Greco, Elena; Tommaselli, Giovanni Antonio; Nappi, Carmine

2014-04-01

To compare the efficacy of a personal dietary intervention on gestational weight gain control with a general intervention promoting healthy eating. Prospective, controlled study including 154 low-risk pregnant women randomly allocated to two groups: 77 receiving a personalized diet plan and a close follow-up by a dietician (intervention group), 77 receiving standard dietary care by means of a brochure on healthy eating during pregnancy (control group). Pre-pregnancy weight, gestational age, height, weight and BMI at baseline, weight at term, gestational age at delivery and newborn weight were recorded for all participants. The primary end-point was the difference in body weight between baseline and term. Secondary end-points were the difference in body weight between pre-pregnancy and term and in newborn weights. Maternal weight gain at term was significantly lower both as compared to pre-pregnancy weight (8.2 ± 4.0 vs. 13.4 ± 4.2 kg; p < 0.001) and to weight at baseline (7.7 ± 3.8 vs. 13.7 ± 4.3 kg; p < 0.001) in the intervention group as compared to controls. A positive, significant correlation between the delta weight between baseline and term and newborn weight was observed in both groups, but stronger in patients from the intervention group (intervention group R = 0.76, p < 0.001; control group R = 0.35, p = 0.01). This study suggests that a personalized nutritional intervention, in which the dietician plays an active role within the obstetric team, may represent a successful approach in limiting weight gain in pregnant women.

Cost-effectiveness analysis of a randomized trial comparing care models for chronic kidney disease.

PubMed

Hopkins, Robert B; Garg, Amit X; Levin, Adeera; Molzahn, Anita; Rigatto, Claudio; Singer, Joel; Soltys, George; Soroka, Steven; Parfrey, Patrick S; Barrett, Brendan J; Goeree, Ron

2011-06-01

Potential cost and effectiveness of a nephrologist/nurse-based multifaceted intervention for stage 3 to 4 chronic kidney disease are not known. This study examines the cost-effectiveness of a chronic disease management model for chronic kidney disease. Cost and cost-effectiveness were prospectively gathered alongside a multicenter trial. The Canadian Prevention of Renal and Cardiovascular Endpoints Trial (CanPREVENT) randomized 236 patients to receive usual care (controls) and another 238 patients to multifaceted nurse/nephrologist-supported care that targeted factors associated with development of kidney and cardiovascular disease (intervention). Cost and outcomes over 2 years were examined to determine the incremental cost-effectiveness of the intervention. Base-case analysis included disease-related costs, and sensitivity analysis included all costs. Consideration of all costs produced statistically significant differences. A lower number of days in hospital explained most of the cost difference. For both base-case and sensitivity analyses with all costs included, the intervention group required fewer resources and had higher quality of life. The direction of the results was unchanged to inclusion of various types of costs, consideration of payer or societal perspective, changes to the discount rate, and levels of GFR. The nephrologist/nurse-based multifaceted intervention represents good value for money because it reduces costs without reducing quality of life for patients with chronic kidney disease.

Reducing suicidal ideation and depressive symptoms in depressed older primary care patients: a randomized controlled trial.

PubMed

Bruce, Martha L; Ten Have, Thomas R; Reynolds, Charles F; Katz, Ira I; Schulberg, Herbert C; Mulsant, Benoit H; Brown, Gregory K; McAvay, Gail J; Pearson, Jane L; Alexopoulos, George S

2004-03-03

Suicide rates are highest in late life; the majority of older adults who die by suicide have seen a primary care physician in preceding months. Depression is the strongest risk factor for late-life suicide and for suicide's precursor, suicidal ideation. To determine the effect of a primary care intervention on suicidal ideation and depression in older patients. Randomized controlled trial known as PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial) with patient recruitment from 20 primary care practices in New York City, Philadelphia, and Pittsburgh regions, May 1999 through August 2001. Two-stage, age-stratified (60-74, > or =75 years) depression screening of randomly sampled patients; enrollment included patients who screened positive and a random sample of screened negative patients. This analysis included patients with a depression diagnosis (N = 598). Treatment guidelines tailored for the elderly with care management compared with usual care. Assessment of suicidal ideation and depression severity at baseline, 4 months, 8 months, and 12 months. Rates of suicidal ideation declined faster (P =.01) in intervention patients compared with usual care patients; at 4 months, in the intervention group, raw rates of suicidal ideation declined 12.9% points (29.4% to 16.5%) compared with 3.0% points (20.1% to 17.1% in usual care [P =.01]). Among patients reporting suicidal ideation, resolution of ideation was faster among intervention patients (P =.03); differences peaked at 8 months (70.7% vs 43.9% resolution; P =.005). Intervention patients had a more favorable course of depression in both degree and speed of symptom reduction; group difference peaked at 4 months. The effects on depression were not significant among patients with minor depression unless suicidal ideation was present. Evidence of the intervention's effectiveness in community-based primary care with a heterogeneous sample of depressed patients introduces new challenges related to its sustainability and dissemination. The intervention's effectiveness in reducing suicidal ideation, regardless of depression severity, reinforces its role as a prevention strategy to reduce risk factors for suicide in late life.

Effectiveness of a Self-monitoring Device for Urinary Sodium-to-Potassium Ratio on Dietary Improvement in Free-Living Adults: a Randomized Controlled Trial.

PubMed

Iwahori, Toshiyuki; Ueshima, Hirotsugu; Ohgami, Naoto; Yamashita, Hideyuki; Miyagawa, Naoko; Kondo, Keiko; Torii, Sayuki; Yoshita, Katsushi; Shiga, Toshikazu; Ohkubo, Takayoshi; Arima, Hisatomi; Miura, Katsuyuki

2018-01-05

Reducing the urinary sodium-to-potassium ratio is important for reducing both blood pressure and risk of cardiovascular disease. Among free-living Japanese individuals, we carried out a randomized trial to clarify the effect of lifestyle modification for lowering urinary sodium-to-potassium ratio using a self-monitoring device. This was an open, prospective, parallel randomized, controlled trial. Ninety-two individuals were recruited from Japanese volunteers. Participants were randomly allocated into intervention and control groups. A month-long dietary intervention on self-monitoring urinary sodium-to-potassium ratio was carried out using monitors (HEU-001F, OMRON Healthcare Co., Ltd., Kyoto, Japan). All participants had brief dietary education and received a leaflet as usual care. Monitors were handed out to the intervention group, but not to the control group. The intervention group was asked to measure at least one spot urine sodium-to-potassium ratio daily, and advised to lower their sodium-to-potassium ratio toward the target of less than 1. Outcomes included changes in 24-hour urinary sodium-to-potassium ratio, sodium excretion, potassium excretion, blood pressure, and body weight in both groups. Mean measurement frequency of monitoring was 2.8 times/day during the intervention. Changes in urinary sodium-to-potassium ratio were -0.55 in the intervention group and -0.06 in the control group (P = 0.088); respective sodium excretion changes were -18.5 mmol/24 hours and -8.7 mmol/24 hours (P = 0.528); and corresponding potassium excretion was 2.6 mmol/24 hours and -1.5 mmol/24 hours (P = 0.300). No significant reductions were observed in either blood pressure or body weight after the intervention. Providing the device to self-monitor a sodium-to-potassium ratio did not achieve the targeted reduction of the ratio in "pure self-management" settings, indicating further needs to study an effective method to enhance the synergetic effect of dietary programs and self-monitoring practice to achieve the reduction. However, we cannot deny the possibility of reducing sodium-to-potassium ratio using a self-monitoring device.

Design of the study: how can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care.

PubMed

Nordin, Karin; Rissanen, Ritva; Ahlgren, Johan; Burell, Gunilla; Fjällskog, Marie-Louise; Börjesson, Susanne; Arving, Cecilia

2012-05-04

A life threatening illness such as breast cancer can lead to a secondary diagnosis of PTSD (post traumatic stress disorder) with intrusive thoughts and avoidance as major symptoms. In a former study by the research group, 80% of the patients with breast cancer reported a high level of stress symptoms close to the diagnosis, such as intrusive thoughts and avoidance behavior. These symptoms remained high throughout the study. The present paper presents the design of a randomized study evaluating the effectiveness and cost-effectiveness of a stress management intervention using a stepped-care design. Female patients over the age of 18, with a recent diagnosis of breast cancer and scheduled for adjuvant treatment in the form of chemotherapy, radiation therapy and/or hormonal therapy are eligible and will consecutively be included in the study. The study is a prospective longitudinal intervention study with a stepped-care approach, where patients will be randomised to one of two interventions in the final stage of treatment. The first step is a low intensity stress-management intervention that is given to all patients. Patients who do not respond to this level are thereafter given more intensive treatment at later steps in the program and will be randomized to more intensive stress-management intervention in a group setting or individually. The primary out-come is subjective distress (intrusion and avoidance) assessed by the Impact of Event Scale (IES). According to the power-analyses, 300 patients are planned to be included in the study and will be followed for one year. Other outcomes are anxiety, depression, quality of life, fatigue, stress in daily living and utilization of hospital services. This will be assessed with well-known psychometric tested questionnaires. Also, the cost-effectiveness of the intervention given in group or individually will be evaluated. This randomized clinical trial will provide additional empirical evidence regarding the effectiveness of a stress-management program given in group or individually during adjuvant therapy in terms of decreased stress, minimizing fatigue, and maintaining or enhancing patients' quality of life and psychological well-being. ClinicalTrials.gov Identifier: NCT01555645.

Effect of virtual reality training on walking distance and physical fitness in individuals with Parkinson's disease.

PubMed

de Melo, Gileno Edu Lameira; Kleiner, Ana Francisca Rozin; Lopes, Jamile Benite Palma; Dumont, Arislander Jonathan Lopes; Lazzari, Roberta Delasta; Galli, Manuela; Oliveira, Claudia Santos

2018-04-07

To evaluate the effects of gait training with virtual reality (VR) on walking distance and physical fitness in individuals with Parkinson's Disease (PD). Thirty-seven individuals with PD participated in this prospective, randomized, controlled clinical trial. They were randomly allocated to a control group submitted to conventional training (n = 12), a treadmill group submitted to gait training on a treadmill (n = 13) and a VR group submitted to gait training using the XboxTM (n = 12). Clinical measures, gait variables and the Six-Minute Walk Test (6MWT) were evaluated: pre-intervention, after one intervention session, post-intervention and follow up (30 days after intervention). The VR and treadmill groups travelled longer distances on the 6MWT and had faster gait speed in comparison to the control group. The VR and treadmill groups demonstrated an increase in pre-6MWT HR. The VR group had more intense HR after the first session and throughout training, but these gains were not maintained at the follow-up. The present findings demonstrate that gait training with a VR program is as effective as treadmill training with regard to gains in walking distance and improvements in temporal gait variables in individuals with PD.

An integrated intervention program to control diabetes in overweight Chinese women and men with type 2 diabetes.

PubMed

Sun, Jianqin; Wang, Yanfang; Chen, Xiafei; Chen, Yanqiu; Feng, Ying; Zhang, Xinyi; Pan, Yiru; Hu, Ting; Xu, Jianhua; Du, Luyuan; Zhou, Wei; Zhao, Huiping; Riley, Rosemary E; Mustad, Vikkie A

2008-01-01

This study evaluated a structured and integrated intervention program on diabetes management in individuals with type 2 diabetes in Shanghai, China. Men and women with type 2 diabetes and body mass index > 23 kg/m2 were randomized into a 24-week, prospective, randomized clinical trial. The Reference Group (n=50) received diabetes education including diet and physical activity instruction only; the Intervention Group (n=100) received more intensive intervention, including diabetes education with frequent blood glucose monitoring, nutritional counseling, meal plans with diabetes-specific nutritional meal replacement, and weekly progress updates with study staff. Major study assessments were obtained at baseline, and after 12 and/or 24 weeks of intervention. The Intervention Group improved fasting blood glucose, insulin, systolic and diastolic blood pressures compared to Reference Group ( p <0.05). Importantly, HbA1c was lower ( p <0.001) in the Intervention Group at 12 weeks (-0.6 +/- 0.1%) and 24 weeks (-0.8 +/- 0.1%). Weight loss was modest, but significant differences were observed between groups ( p <0.05). Weight change from baseline after 12 and 24 weeks was -2.8 +/- 0.2% and -3.7 +/- 0.3%, respectively, in the Intervention Group vs -1.8 +/- 0.4% and -2.5 +/- 0.4% in the Reference Group. Additionally, waist and hip circumferences and waist:hip ratio decreased in the Intervention compared to the Reference Group ( p <0.05). In conclusion, this study demonstrates that Chinese men and women with type 2 diabetes following an integrated intervention program including diabetes education, frequent blood glucose monitoring and daily use of a diabetes-specific meal replacement, can achieve significant improvements in glycemic control and markers of cardiovascular health.

Physical function outcome in cervical radiculopathy patients after physiotherapy alone compared with anterior surgery followed by physiotherapy: a prospective randomized study with a 2-year follow-up.

PubMed

Peolsson, Anneli; Söderlund, Anne; Engquist, Markus; Lind, Bengt; Löfgren, Håkan; Vavruch, Ludek; Holtz, Anders; Winström-Christersson, Annelie; Isaksson, Ingrid; Öberg, Birgitta

2013-02-15

Prospective randomized study. To investigate differences in physical functional outcome in patients with radiculopathy due to cervical disc disease, after structured physiotherapy alone (consisting of neck-specific exercises with a cognitive-behavioral approach) versus after anterior cervical decompression and fusion (ACDF) followed by the same structured physiotherapy program. No earlier studies have evaluated the effectiveness of a structured physiotherapy program or postoperative physical rehabilitation after ACDF for patients with magnetic resonance imaging-verified nerve compression due to cervical disc disease. Our prospective randomized study included 63 patients with radiculopathy and magnetic resonance imaging-verified nerve root compression, who were randomized to receive either ACDF in combination with physiotherapy or physiotherapy alone. For 49 of these patients, an independent examiner measured functional outcomes, including active range of neck motion, neck muscle endurance, and hand-related functioning before treatment and at 3-, 6-, 12-, and 24-month follow-ups. There were no significant differences between the 2 treatment alternatives in any of the measurements performed (P = 0.17-0.91). Both groups showed improvements over time in neck muscle endurance (P ≤ 0.01), manual dexterity (P ≤ 0.03), and right-handgrip strength (P = 0.01). Compared with a structured physiotherapy program alone, ACDF followed by physiotherapy did not result in additional improvements in neck active range of motion, neck muscle endurance, or hand-related function in patients with radiculopathy. We suggest that a structured physiotherapy program should precede a decision for ACDF intervention in patients with radiculopathy, to reduce the need for surgery. 2.

A Prospective, Randomized, Open-Label, Blinded, Endpoint Study Exploring Platelet Response to Half-Dose Prasugrel and Ticagrelor in Patients with the Acute Coronary Syndrome: HOPE-TAILOR Study.

PubMed

Jin, Cai De; Kim, Moo Hyun; Bang, Junghee; Serebruany, Victor

The optimal dosing of novel oral P2Y12 receptor platelet inhibitors such as prasugrel or ticagrelor is unclear and especially challenging in East Asians. We hypothesize that half-dose prasugrel and ticagrelor may be sufficient for long-term maintenance management in Korean patients with the acute coronary syndrome (ACS) compared with conventional dosages. HOPE-TAILOR (Half Dose of Prasugrel and Ticagrelor in Platelet Response after Acute Coronary Syndromes) is a prospective, randomized, open-label, blinded, endpoint (PROBE) single-center, clinical trial. A total of 100 patients with ACS undergoing drug-eluting stent implantation will be randomly assigned to prasugrel, ticagrelor, or clopidogrel, and the patients in each treatment group will receive 1-month therapy with 100 mg q.d. aspirin plus prasugrel 10 mg q.d., ticagrelor 90 mg b.i.d., or clopidogrel 75 mg q.d., followed by half-dose prasugrel 5 mg q.d. or ticagrelor 45 mg b.i.d. for maintenance treatment but without clopidogrel dose reduction. The primary endpoint will be optimal platelet reactivity 3 months after coronary intervention, defined by VerifyNow Analyzer (PRU: 85-208) and vasodilator-stimulated phosphoprotein P2Y12 flow cytometry assay (platelet reactivity indices: 16-50%). Clinical outcomes will also be assessed, including major efficacy (composite of cardiac death, nonfatal myocardial infarction, repeat revascularization, or stroke) and safety (bleeding ≥2 according to the Bleeding Academic Research Consortium). HOPE-TAILOR is a prospective, randomized, open-label, blinded, endpoint study to explore the efficacy and safety of novel P2Y12 receptor inhibitors administered orally at half the dose in Korean patients with ACS. The results will be available late in 2017. © 2017 S. Karger AG, Basel.

Foot osteoarthritis: latest evidence and developments

PubMed Central

Roddy, Edward; Menz, Hylton B.

2018-01-01

Foot osteoarthritis (OA) is a common problem in older adults yet is under-researched compared to knee or hand OA. Most existing studies focus on the first metatarsophalangeal joint, with evidence relating to midfoot OA being particularly sparse. Symptomatic radiographic foot OA affects 17% of adults aged 50 years and over. The first metatarsophalangeal joint is most commonly affected, followed by the second cuneometatarsal and talonavicular joints. Epidemiological studies suggest the existence of distinct first metatarsophalangeal joint and polyarticular phenotypes, which have differing clinical and risk factor profiles. There are few randomized controlled trials in foot OA. Existing trials provide some evidence of the effectiveness for pain relief of physical therapy, rocker-sole shoes, foot orthoses and surgical interventions in first metatarsophalangeal joint OA and prefabricated orthoses in midfoot OA. Prospective epidemiological studies and randomized trials are needed to establish the incidence, progression and prognosis of foot OA and determine the effectiveness of both commonly used and more novel interventions. PMID:29619094

Text messaging versus email for emergency medicine residents’ knowledge retention: a pilot comparison in the United States

PubMed Central

2016-01-01

We evaluated the effectiveness of text messaging versus email, as a delivery method to enhance knowledge retention of emergency medicine (EM) content in EM residents. We performed a multi-centered, prospective, randomized study consisting of postgraduate year (PGY) 1 to PGY 3 & 4 residents in three United States EM residency programs in 2014. Fifty eight residents were randomized into one delivery group: text message or email. Participants completed a 40 question pre- and post-intervention exam. Primary outcomes were the means of pre- and post-intervention exam score differences. Data were analyzed using descriptive statistics, paired t-test, and multiple linear regressions. No significant difference was found between the primary outcomes of the two groups (P=0.51). PGY 2 status had a significant negative effect (P=0.01) on predicted exam score difference. Neither delivery method enhanced resident knowledge retention. Further research on implementation of mobile technology in residency education is required. PMID:27780350

Text messaging versus email for emergency medicine residents' knowledge retention: a pilot comparison in the United States.

PubMed

Hoonpongsimanont, Wirachin; Kulkarni, Miriam; Tomas-Domingo, Pedro; Anderson, Craig; McCormack, Denise; Tu, Khoa; Chakravarthy, Bharath; Lotfipour, Shahram

2016-01-01

We evaluated the effectiveness of text messaging versus email, as a delivery method to enhance knowledge retention of emergency medicine (EM) content in EM residents. We performed a multi-centered, prospective, randomized study consisting of postgraduate year (PGY) 1 to PGY 3 & 4 residents in three United States EM residency programs in 2014. Fifty eight residents were randomized into one delivery group: text message or email. Participants completed a 40 question pre- and post-intervention exam. Primary outcomes were the means of pre- and post-intervention exam score differences. Data were analyzed using descriptive statistics, paired t-test, and multiple linear regressions. No significant difference was found between the primary outcomes of the two groups (P=0.51). PGY 2 status had a significant negative effect (P=0.01) on predicted exam score difference. Neither delivery method enhanced resident knowledge retention. Further research on implementation of mobile technology in residency education is required.

Substantial improvement of primary cardiovascular prevention by a systematic score-based multimodal approach: A randomized trial: The PreFord-Study.

PubMed

Gysan, Detlef Bernd; Millentrup, Stefanie; Albus, Christian; Bjarnason-Wehrens, Birna; Latsch, Joachim; Gohlke, Helmut; Herold, Gerd; Wegscheider, Karl; Heming, Christian; Seyfarth, Melchior; Predel, Hans-Georg

2017-09-01

Trial design Prospective randomized multicentre interventional study. Methods Individual cardiovascular risk assessment in Ford Company, Germany employees ( n = 4.196), using the European Society of Cardiology-Systematic Coronary Risk Evaluation (ESC-SCORE) for classification into three risk groups. Subjects assigned to ESC high-risk group (ESC-SCORE ≥ 5%), without a history of cardiovascular disease were eligible for randomization to a multimodal 15-week intervention programme (INT) or to usual care and followed up for 36 months. Objectives Evaluation of the long-term effects of a risk-adjusted multimodal intervention in high-risk subjects. Primary endpoint: reduction of ESC-SCORE in INT versus usual care. Secondary endpoints: composite of fatal and non-fatal cardiovascular events and time to first cardiovascular event. intention-to-treat and per-protocol analysis. Results Four hundred and forty-seven subjects were randomized to INT ( n = 224) or to usual care ( n = 223). After 36 months ESC-SCORE development favouring INT was observed (INT: 8.70% to 10.03% vs. usual care: 8.49% to 12.09%; p = 0.005; net difference: 18.50%). Moreover, a significant reduction in the composite cardiovascular events was observed: (INT: n = 11 vs. usual care: n = 27). Hazard ratio of intervention versus control was 0.51 (95% confidence interval 0.25-1.03; p = 0.062) in the intention-to-treat analysis and 0.41 (95% confidence interval 0.18-0.90; p = 0.026) in the per-protocol analysis, respectively. No intervention-related adverse events or side-effects were observed. Conclusions Our results demonstrate the efficiency of identifying cardiovascular high-risk subjects by the ESC-SCORE in order to enrol them to a risk adjusted primary prevention programme. This strategy resulted in a significant improvement of ESC-SCORE, as well as a reduction in predefined cardiovascular endpoints in the INT within 36 months. (ISRCTN 23536103.).

Prevention of Insulin Resistance by Dietary Intervention among Pregnant Mothers: A Randomized Controlled Trial.

PubMed

Goodarzi-Khoigani, Masoomeh; Mazloomy Mahmoodabad, Seyed Saeed; Baghiani Moghadam, Mohammad Hossein; Nadjarzadeh, Azadeh; Mardanian, Farahnaz; Fallahzadeh, Hossein; Dadkhah-Tirani, Azam

2017-01-01

Chronic insulin resistance (IR) is a basic part of the pathophysiology of gestational diabetes mellitus. Nutrition significantly impacts IR and weight loss reduces insulin levels, whereas weight gain increases the concentrations. Therefore, we surveyed the effect of nutrition intervention on IR in pregnant women and whether this effect is irrespective of weight gaining in accordance with Institute of Medicine limits. This prospective, randomized clinical trial was carried out among 150 primiparous pregnant mothers in fifteen health centers, five hospitals, and 15 private obstetrical offices in Isfahan. The nutrition intervention included education of healthy diet with emphasize on 50%-55% of total energy intake from carbohydrate (especially complex carbohydrates), 25%-30% from fat (to increase mono unsaturated fatty acids and decrease saturated and trans-fatty acids), and 15%-20% from protein during pregnancy for experimental group. The controls received the usual prenatal care by their health-care providers. This trial decreased pregnancy-induced insulin increases ( P = 0.01) and IR marginally ( P = 0.05). ANCOVA demonstrated that control of gestational weight gaining was more effective to decrease IR ( P = 0.02) while insulin values decreased by nutrition intervention and irrespective of weight control ( P = 0.06). Fasting plasma glucose (FPG) concentrations did not decrease by intervention ( P = 0.56) or weight management ( P = 0.15). The current intervention was effective to decrease pregnancy-induced insulin increases and IR. Considering study results on FPG levels and incidence of GDM, we suggest repeat of study design in a larger sample.

Using a claims data-based sentinel system to improve compliance with clinical guidelines: results of a randomized prospective study.

PubMed

Javitt, Jonathan C; Steinberg, Gregory; Locke, Todd; Couch, James B; Jacques, Jeffrey; Juster, Iver; Reisman, Lonny

2005-02-01

To demonstrate the potential effect of deploying a sentinel system that scans administrative claims information and clinical data to detect and mitigate errors in care and deviations from best medical practices. Members (n = 39 462; age range, 12-64 years) of a midwestern managed care plan were randomly assigned to an intervention or a control group. The sentinel system was programmed with more than 1000 decision rules that were capable of generating clinical recommendations. Clinical recommendations triggered for subjects in the intervention group were relayed to treating physicians, and those for the control group were deferred to study end. Nine hundred eight clinical recommendations were issued to the intervention group. Among those in both groups who triggered recommendations, there were 19% fewer hospital admissions in the intervention group compared with the control group (P < .001). Charges among those whose recommendations were communicated were dollar 77.91 per member per month (pmpm) lower and paid claims were dollar 68.08 pmpm lower than among controls compared with the baseline values (P = .003 for both). Paid claims for the entire intervention group (with or without recommendations) were dollar 8.07 pmpm lower than those for the entire control group. In contrast, the intervention cost dollar 1.00 pmpm, suggesting an 8-fold return on investment. Ongoing use of a sentinel system to prompt clinically actionable, patient-specific alerts generated from administratively derived clinical data was associated with a reduction in hospitalization, medical costs, and morbidity.

Reduction of shunt obstructions by using a peel-away sheath technique? A multicenter prospective randomized trial.

PubMed

Kehler, Uwe; Langer, Niels; Gliemroth, Jan; Meier, Ullrich; Lemcke, Johannes; Sprung, Christian; Schlosser, Hans-Georg; Kiefer, Michael; Eymann, Regina; Heese, Oliver

2012-05-01

Shunt obstructions may partly be caused by brain debris, which intrude into the ventricular catheter during ventricle puncture. Avoiding contact between the catheter and brain tissue, by using a peel-away sheath, should reduce the number of shunt failures caused by obstruction. To test this hypothesis, we conducted a randomized, prospective multicenter study. 201 patients from 6 different neurosurgical centers in Germany receiving a ventriculo-peritoneal shunt were included in this study. Of these, 177 patients completed a 1-year follow-up period. Surgery was randomized in a 1 to 1 fashion, such that out of 177 procedures, 91 were performed using a peel-away sheath and 86 were performed without. The rate of surgical re-interventions and shunt obstructions within a 12-month period was recorded. Within 1 year post-surgery, 17 shunt obstructions (9.6%) leading to shunt revisions were recorded. However, no difference was found between surgeries performed using a peel-away sheath (9.9%) or not (9.3%). The overall shunt infection rate was 2.8% and the shunt revision rate for overdrainage was 3.9%. The theoretical advantages attributed to the use of a peel-away sheath to introduce a ventricular catheter could not be confirmed in this randomized study, suggesting that the proposed role of brain debris in shunt obstructions may be overestimated. Copyright © 2011 Elsevier B.V. All rights reserved.

Physical activity intervention for elderly patients with reduced physical performance after acute coronary syndrome (HULK study): rationale and design of a randomized clinical trial.

PubMed

Tonet, Elisabetta; Maietti, Elisa; Chiaranda, Giorgio; Vitali, Francesco; Serenelli, Matteo; Bugani, Giulia; Mazzoni, Gianni; Ruggiero, Rossella; Myers, Jonathan; Villani, Giovanni Quinto; Corvi, Ursula; Pasanisi, Giovanni; Biscaglia, Simone; Pavasini, Rita; Lucchi, Giulia Ricci; Sella, Gianluigi; Ferrari, Roberto; Volpato, Stefano; Campo, Gianluca; Grazzi, Giovanni

2018-05-21

Reduced physical performance and impaired mobility are common in elderly patients after acute coronary syndrome (ACS) and they represent independent risk factors for disability, morbidity, hospital readmission and mortality. Regular physical exercise represents a means for improving functional capacity. Nevertheless, its clinical benefit has been less investigated in elderly patients in the early phase after ACS. The HULK trial aims to investigate the clinical benefit of an early, tailored low-cost physical activity intervention in comparison to standard of care in elderly ACS patients with reduced physical performance. HULK is an investigator-initiated, prospective multicenter randomized controlled trial (NCT03021044). After successful management of the ACS acute phase and uneventful first 1 month, elderly (≥70 years) patients showing reduced physical performance are randomized (1:1 ratio) to either standard of care or physical activity intervention. Reduced physical performance is defined as a short physical performance battery (SPPB) score of 4-9. The early, tailored, low-cost physical intervention includes 4 sessions of physical activity with a supervisor and an home-based program of physical exercise. The chosen primary endpoint is the 6-month SPPB value. Secondary endpoints briefly include quality of life, on-treatment platelet reactivity, some laboratory data and clinical adverse events. To demonstrate an increase of at least one SPPB point in the experimental arm, a sample size of 226 patients is needed. The HULK study will test the hypothesis that an early, tailored low-cost physical activity intervention improves physical performance, quality of life, frailty status and outcome in elderly ACS patients with reduced physical performance. Clinicaltrials.gov, identifier NCT03021044 , first posted January, 13th 2017.

Prospective randomized trial to assess effects of continuing hormone therapy on cerebral function in postmenopausal women at risk for dementia.

PubMed

Rasgon, Natalie L; Geist, Cheri L; Kenna, Heather A; Wroolie, Tonita E; Williams, Katherine E; Silverman, Daniel H S

2014-01-01

The objective of this study was to examine the effects of estrogen-based hormone therapy (HT) on regional cerebral metabolism in postmenopausal women (mean age = 58, SD = 5) at risk for development of dementia. The prospective clinical trial design included pre- and post-intervention neuroimaging of women randomized to continue (HT+) or discontinue (HT-) therapy following an average of 10 years of use. The primary outcome measure was change in brain metabolism during the subsequent two years, as assessed with fluorodeoxyglucose-18 positron emission tomography (FDG-PET). Longitudinal FDG-PET data were available for 45 study completers. Results showed that women randomized to continue HT experienced relative preservation of frontal and parietal cortical metabolism, compared with women randomized to discontinue HT. Women who discontinued 17-β estradiol (17βE)-based HT, as well as women who continued conjugated equine estrogen (CEE)-based HT, exhibited significant decline in metabolism of the precuneus/posterior cingulate cortical (PCC) area. Significant decline in PCC metabolism was additionally seen in women taking concurrent progestins (with either 17βE or CEE). Together, these findings suggest that among postmenopausal subjects at risk for developing dementia, regional cerebral cortical metabolism is relatively preserved for at least two years in women randomized to continue HT, compared with women randomized to discontinue HT. In addition, continuing unopposed 17βE therapy is associated specifically with preservation of metabolism in PCC, known to undergo the most significant decline in the earliest stages of Alzheimer's disease. ClinicalTrials.gov NCT00097058.

Clinical Evaluation of a Royal Jelly Supplementation for the Restoration of Dry Eye: A Prospective Randomized Double Blind Placebo Controlled Study and an Experimental Mouse Model

PubMed Central

Inoue, Sachiko; Kawashima, Motoko; Hisamura, Ryuji; Imada, Toshihiro; Izuta, Yusuke; Nakamura, Shigeru; Ito, Masataka; Tsubota, Kazuo

2017-01-01

Background Dry eye is a multifactorial disease characterized by ocular discomfort and visual impairment. Lacrimal gland function has been shown to decrease with aging, a known potent risk factor for dry eye. We have previously found that orally administrated royal jelly (RJ) restored tear secretion in a rat model of dry eye. Methods and Findings We examined the effects of RJ oral administration on dry eye in this prospective, randomized, double-blind, placebo-controlled study. Forty-three Japanese patients aged 20–60 years with subjective dry eye symptoms were randomized to an RJ group (1200 mg/tablet, six tablets daily) or a placebo group for 8 weeks. Keratoconjunctival epithelial damage, tear film break-up time, tear secretion volume, meibum grade, biochemical data, and subjective dry eye symptoms based on a questionnaire were investigated at baseline, and at 4 and 8 weeks after intervention. Adverse events were reported via medical interviews. In the RJ group, tear volume significantly increased after intervention (p = 0.0009). In particular, patients with a baseline Schirmer value of ≤10 mm showed a significant increase compared with baseline volume (p = 0.0005) and volume in the placebo group (p = 0.0051). No adverse events were reported. We also investigated the effect of RJ (300 mg/kg per day) administration using a mouse model of dry eye. Orally repeated administration of RJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands. Conclusion Our results suggest that RJ improves tear volume in patients with dry eye. Trial Registration Registered NO. the University Hospital Medical Information Network in Japan (UMIN000014446) PMID:28060936

A prospective randomized blister prevention trial assessing paper tape in endurance distances (Pre-TAPED).

PubMed

Lipman, Grant S; Ellis, Mark A; Lewis, Erica J; Waite, Brandee L; Lissoway, John; Chan, Garrett K; Krabak, Brian J

2014-12-01

Friction foot blisters are a common injury occurring in up to 39% of marathoners, the most common injury in adventure racing, and represent more than 70% of medical visits in multi-stage ultramarathons. The goal of the study was to determine whether paper tape could prevent foot blisters in ultramarathon runners. This prospective randomized trial was undertaken during RacingThePlanet 155-mile (250-km), 7-day self-supported ultramarathons in China, Australia, Egypt, Chile, and Nepal in 2010 and 2011. Paper tape was applied prerace to one randomly selected foot, with the untreated foot acting as the own control. The study end point was development of a hot spot or blister on any location of either foot. One hundred thirty-six participants were enrolled with 90 (66%) having completed data for analysis. There were 36% women, with a mean age of 40 ± 9.4 years (range, 25-40 years) and pack weight of 11 ± 1.8 kg (range, 8-16 kg). All participants developed blisters, with 89% occurring by day 2 and 59% located on the toes. No protective effect was observed by the intervention (47 versus 35; 52% versus 39%; P = .22), with fewer blisters occurring around the tape on the experimental foot than under the tape (23 vs 31; 25.6% versus 34.4%), yet 84% of study participants when queried would choose paper tape for blister prevention in the future. Although paper tape was not found to be significantly protective against blisters, the intervention was well tolerated with high user satisfaction. Copyright © 2014 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

Clinical Evaluation of a Royal Jelly Supplementation for the Restoration of Dry Eye: A Prospective Randomized Double Blind Placebo Controlled Study and an Experimental Mouse Model.

PubMed

Inoue, Sachiko; Kawashima, Motoko; Hisamura, Ryuji; Imada, Toshihiro; Izuta, Yusuke; Nakamura, Shigeru; Ito, Masataka; Tsubota, Kazuo

2017-01-01

Dry eye is a multifactorial disease characterized by ocular discomfort and visual impairment. Lacrimal gland function has been shown to decrease with aging, a known potent risk factor for dry eye. We have previously found that orally administrated royal jelly (RJ) restored tear secretion in a rat model of dry eye. We examined the effects of RJ oral administration on dry eye in this prospective, randomized, double-blind, placebo-controlled study. Forty-three Japanese patients aged 20-60 years with subjective dry eye symptoms were randomized to an RJ group (1200 mg/tablet, six tablets daily) or a placebo group for 8 weeks. Keratoconjunctival epithelial damage, tear film break-up time, tear secretion volume, meibum grade, biochemical data, and subjective dry eye symptoms based on a questionnaire were investigated at baseline, and at 4 and 8 weeks after intervention. Adverse events were reported via medical interviews. In the RJ group, tear volume significantly increased after intervention (p = 0.0009). In particular, patients with a baseline Schirmer value of ≤10 mm showed a significant increase compared with baseline volume (p = 0.0005) and volume in the placebo group (p = 0.0051). No adverse events were reported. We also investigated the effect of RJ (300 mg/kg per day) administration using a mouse model of dry eye. Orally repeated administration of RJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands. Our results suggest that RJ improves tear volume in patients with dry eye. Registered NO. the University Hospital Medical Information Network in Japan (UMIN000014446).

Effect of preemptive intra-articular morphine and ketamine on pain after arthroscopic rotator cuff repair: a prospective, double-blind, randomized controlled study.

PubMed

Khashan, M; Dolkart, O; Amar, E; Chechik, O; Sharfman, Z; Mozes, G; Maman, E; Weinbroum, A A

2016-02-01

Rotator cuff tear is a leading etiology of shoulder pain and disability. Surgical treatment is indicated in patients with persistent pain who fail a trial of non-surgical treatment. Pain reduction following rotator cuff repair, particularly within the first 24-48 h, is a major concern to both doctors and patients. This study aimed to compare the postoperative antinociceptive additive effects of pre-incisional intra-articular (IA) ketamine when combined with morphine with two times the dose of morphine or saline. In this prospective, randomized, double blind, controlled trial patients undergoing arthroscopic rotator cuff tear repair (ARCR) under general anesthesia were enrolled. Patients were randomly assigned to one of the three intervention groups. Twenty minutes prior to incision, morphine (20 mg/10 ml), ketamine (50 mg + morphine 10 mg/10 ml), or saline (0.9 % 10 ml) (n = 15/group), were administered to all patients. First 24 h postoperative analgesia consisted of intravenous patient controlled analgesia (IV-PCA) morphine and oral rescue paracetamol 1000 mg or oxycodone 5 mg. 24-h, 2-week and 3-month patient rated pain numeric rating scale (NRS) and analgesics consumption were documented. Patients' demographic and perioperative data were similar among all groups. The 24-h and the 2-week NRSs were significantly (p < 0.05) lower in both treatment groups compared to placebo, but were not significantly different between the two intervention groups. PCA-morphine and oral analgesics were consumed similarly among the groups throughout the study phases. Pre-incisional intra-articular morphine reduced pain in the first 2 weeks after arthroscopic rotator cuff repair. Further research is warranted to elucidate the optimal timing and dosing of IA ketamine and morphine for postoperative analgesic effects.

Positive or negative fructose breath test results do not predict response to fructose restricted diet in children with recurrent abdominal pain: results from a prospective randomized trial.

PubMed

Wirth, S; Klodt, C; Wintermeyer, P; Berrang, J; Hensel, K; Langer, T; Heusch, A

2014-09-01

To perform a prospective, blinded, randomized interventional trial in patients with recurrent abdominal pain. The primary endpoint was to determine the abdominal pain intensity after 2 weeks of fructose restricted diet. Secondary endpoints were changes of pain frequency and a secondary symptom score (SSS). 103 individuals with recurrent abdominal pain for more than 3 months were randomized. 51 patients were allocated to group A (diet) and 52 to group B (no diet). 2 weeks later the patients underwent hydrogen breath test and were assigned to the test positive or negative group to identify patients with fructose malabsorption. 2 weeks after intervention the pain score decreased significantly from a median 5.5 in group A to 4 and did not change significantly in group B (5.3 to 5). In group A both patients with positive and negative breath tests had a significant lower pain score (-2 and -1.75, respectively). Frequency of abdominal pain decreased in both groups but without significant difference, SSS improved only in group A from median 6 to 3.5. Positive breath test was no predicting factor, neither was abdominal pain during the test. Fructose restricted diet in children and adolescents with recurrent abdominal pain may be of benefit to improve both abdominal pain symptoms and other secondary symptoms. Since a negative breath test result does not exclude a positive response to fructose restriction, the hydrogen breath test does not seem to be the appropriate diagnostic mean to predict the response to the diet. © Georg Thieme Verlag KG Stuttgart · New York.

Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS): rationale and design for meta-analyses of individual patient data of randomized controlled trials that evaluate the effect of physical activity and psychosocial interventions on health-related quality of life in cancer survivors

PubMed Central

2013-01-01

Background Effective interventions to improve quality of life of cancer survivors are essential. Numerous randomized controlled trials have evaluated the effects of physical activity or psychosocial interventions on health-related quality of life of cancer survivors, with generally small sample sizes and modest effects. Better targeted interventions may result in larger effects. To realize such targeted interventions, we must determine which interventions that are presently available work for which patients, and what the underlying mechanisms are (that is, the moderators and mediators of physical activity and psychosocial interventions). Individual patient data meta-analysis has been described as the ‘gold standard’ of systematic review methodology. Instead of extracting aggregate data from study reports or from authors, the original research data are sought directly from the investigators. Individual patient data meta-analyses allow for adequate statistical analysis of intervention effects and moderators of such effects. Here, we report the rationale and design of the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) Consortium. The primary aim of POLARIS is 1) to conduct meta-analyses based on individual patient data to evaluate the effect of physical activity and psychosocial interventions on the health-related quality of life of cancer survivors; 2) to identify important demographic, clinical, personal, or intervention-related moderators of the effect; and 3) to build and validate clinical prediction models identifying the most relevant predictors of intervention success. Methods/Design We will invite investigators of randomized controlled trials that evaluate the effects of physical activity and/or psychosocial interventions on health-related quality of life compared with a wait-list, usual care or attention control group among adult cancer survivors to join the POLARIS consortium and share their data for use in pooled analyses that will address the proposed aims. We are in the process of identifying eligible randomized controlled trials through literature searches in four databases. To date, we have identified 132 eligible and unique trials. Discussion The POLARIS consortium will conduct the first individual patient data meta-analyses in order to generate evidence essential to targeting physical activity and psychosocial programs to the individual survivor’s characteristics, capabilities, and preferences. Registration PROSPERO: International prospective register of systematic reviews, CRD42013003805 PMID:24034173

A combination SMS and transportation reimbursement intervention to improve HIV care following abnormal CD4 test results in rural Uganda: a prospective observational cohort study.

PubMed

Siedner, Mark J; Santorino, Data; Lankowski, Alexander J; Kanyesigye, Michael; Bwana, Mwebesa B; Haberer, Jessica E; Bangsberg, David R

2015-07-06

Up to 50 % of HIV-infected persons in sub-Saharan Africa are lost from care between HIV diagnosis and antiretroviral therapy (ART) initiation. Structural barriers, including cost of transportation to clinic and poor communication systems, are major contributors. We conducted a prospective, pragmatic, before-and-after clinical trial to evaluate a combination mobile health and transportation reimbursement intervention to improve care at a publicly operated HIV clinic in Uganda. Patients undergoing CD4 count testing were enrolled, and clinicians selected a result threshold that would prompt early return for ART initiation or further care. Participants enrolled in the pre-intervention period (January - August 2012) served as a control group. Participants in the intervention period (September 2012 - November 2013) were randomized to receive daily short message service (SMS) messages for up to seven days in one of three formats: 1) messages reporting an abnormal result directly, 2) personal identification number-protected messages reporting an abnormal result, or 3) messages reading "ABCDEFG" to confidentially convey an abnormal result. Participants returning within seven days of their first message received transportation reimbursements (about $6USD). Our primary outcomes of interest were time to return to clinic and time to ART initiation. There were 45 participants in the pre-intervention period and 138 participants in the intervention period (46, 49, and 43 in the direct, PIN, and coded groups, respectively) with low CD4 count results. Median time to clinic return was 33 days (IQR 11-49) in the pre-intervention period and 6 days (IQR 3-16) in the intervention period (P < 0.001); and median time to ART initiation was 47 days (IQR 11-75) versus 12 days (IQR 5-19), (P < 0.001). In multivariable models, participants in the intervention period had earlier return to clinic (AHR 2.32, 95 %CI 1.53 to 3.51) and earlier time to ART initiation (AHR 2.27, 95 %CI 1.38 to 3.72). All three randomized message formats improved time to return to clinic and time to ART initiation (P < 0.01 for all comparisons versus the pre-intervention period). A combination of an SMS laboratory result communication system and transportation reimbursements significantly decreased time to clinic return and time to ART initiation after abnormal CD4 test results. Clinicaltrials.gov NCT01579214 , approved 13 April 2012.

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 .

A randomized trial of automated electronic alerts demonstrating improved reimbursable anesthesia time documentation.

PubMed

Freundlich, Robert E; Barnet, Caryn S; Mathis, Michael R; Shanks, Amy M; Tremper, Kevin K; Kheterpal, Sachin

2013-03-01

To investigate whether alerting providers to errors results in improved documentation of reimbursable anesthesia care. Prospective randomized controlled trial. Operating room (OR) of a university hospital. Anesthesia cases were evaluated to determine whether they met the definition for appropriate anesthesia start time over 4 separate, 45-day calendar cycles: the pre-study period, study period, immediate post-study period, and 3-year follow-up period. During the study period, providers were randomly assigned to either a control or an alert group. Providers in the alert cohort received an automated alphanumeric page if the anesthesia start time occurred concurrently with the patient entering the OR, or more than 30 minutes before entering the OR. Three years after the intervention period, overall compliance was analyzed to assess learned behavior. Baseline compliance was 33% ± 5%. During the intervention period, providers in the alert group showed 87% ± 6% compliance compared with 41% ± 7% compliance in the control group (P < 0.001). Long-term follow-up after cessation of the alerts showed 85% ± 4% compliance. Automated electronic reminders for time-based billing charges are effective and result in improved ongoing reimbursement. Copyright © 2013 Elsevier Inc. All rights reserved.

A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial).

PubMed

Paajanen, Hannu; Grönroos, Juha M; Rautio, Tero; Nordström, Pia; Aarnio, Markku; Rantanen, Tuomo; Hurme, Saija; Dean, Kirsti; Jartti, Airi; Mecklin, Jukka-Pekka; Sand, Juhani; Salminen, Paulina

2013-02-08

Although the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial. The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18-60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point. The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75-85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting in major cost savings.

Resource-enhancing group intervention against depression at workplace: who benefits? A randomised controlled study with a 7-month follow-up.

PubMed

Ahola, Kirsi; Vuori, Jukka; Toppinen-Tanner, Salla; Mutanen, Pertti; Honkonen, Teija

2012-12-01

The aim of the present study was to investigate whether participation in a structured resource-enhancing group intervention at work would act as primary prevention against depression. The authors analysed whether the intervention resulted in universal, selected or indicated prevention. A total of 566 persons participated in a prospective, within-organisation, randomly assigned field experimental study, which consisted of 34 workshops in 17 organisations. The participants filled in a questionnaire, were randomly assigned to either intervention (n=296) or comparison (n=324) groups and returned another questionnaire 7 months later. The intervention, lasting four half-day sessions, was delivered by trainers from occupational health services and human resources. The aim of the structured programme was to enhance participants' career management preparedness by strengthening self-efficacy and inoculation against setbacks. The comparison group received a literature package. The authors measured depressive symptoms using the short version of the Beck Depression Inventory. A high number of depressive symptoms (over 9 points) were used as a proxy for depression. At follow-up, the odds of depression were lower in the intervention group (OR=0.40, 95% CI 0.19 to 0.85) than in the comparison group when adjusted for baseline depressive symptoms, job strain and socio-demographics. In addition, the odds of depression among those with job strain (OR=0.15, 95% CI 0.03-0.81) at baseline were lower after the intervention. The intervention had no statistically significant effect on those with depressive symptoms (over 4 points) at baseline. The resource-enhancing group intervention appeared to be successful as universal and selective prevention of potential depression.

Prospective, Randomized Study on the Use of a Prosthetic Mesh for Prevention of Parastomal Hernia of Permanent Colostomy.

PubMed

Vierimaa, Mika; Klintrup, Kai; Biancari, Fausto; Victorzon, Mikael; Carpelan-Holmström, Monika; Kössi, Jyrki; Kellokumpu, Ilmo; Rauvala, Erkki; Ohtonen, Pasi; Mäkelä, Jyrki; Rautio, Tero

2015-10-01

Prophylactic placement of a mesh has been suggested to prevent parastomal hernia, but evidence to support this approach is scarce. The aim of this study was to evaluate whether laparoscopic placement of a prophylactic, dual-component, intraperitoneal onlay mesh around a colostomy is safe and prevents parastomal hernia formation after laparoscopic abdominoperineal resection. This is a prospective, multicenter, randomized controlled clinical trial. This study was conducted at 2 university and 3 central Finnish hospitals. From 2010 to 2013, 83 patients undergoing laparoscopic abdominoperineal resection for rectal cancer were recruited. After withdrawals and exclusions, the outcome of 70 patients, 35 patients in each study group, could be examined. In the intervention group, an end colostomy was created with placement of a intraperitoneal, dual-component onlay mesh and compared with a group with a traditional stoma. The main outcome measures were the incidence of clinically and radiologically detected parastomal hernias and their extent 12 months after surgery. Stoma-related morbidity and the need for surgical repair of parastomal hernia were secondary outcome measures. Parastomal hernia was observed by clinical inspection in 5 intervention patients (14.3%) and in 12 control patients (32.3%; p = 0.049). Surgical repair of parastomal hernia was performed in 1 control patient (3.2%) and in none of the patients in the intervention group. CT detected parastomal hernia in 18 intervention patients (51.4%) and in 17 control patients (53.1%; p = 1.00). The extent of hernias was similar according to European Hernia Society classification (p = 0.41). Colostomy-related morbidity (32.3% vs 14.3%; p = 0.140) did not differ between the study groups. The study was limited by its small size and short follow-up time. Prophylactic laparoscopic placement of intraperitoneal onlay mesh does not significantly reduce the overall risk of radiologically detected parastomal hernia after laparoscopic abdominoperineal resection. However, prophylactic mesh repair was associated with significantly lower risk of clinically detected parastomal hernia.

The effect of two lottery-style incentives on response rates to postal questionnaires in a prospective cohort study in preschool children at high risk of asthma: a randomized trial.

PubMed

van der Mark, Lonneke B; van Wonderen, Karina E; Mohrs, Jacob; Bindels, Patrick Je; Puhan, Milo A; Ter Riet, Gerben

2012-12-18

In research with long-term follow-up and repeated measurements, quick and complete response to questionnaires helps ensure a study's validity, precision and efficiency. Evidence on the effect of non-monetary incentives on response rates in observational longitudinal research is scarce. To study the impact of two strategies to enhance completeness and efficiency in observational cohort studies with follow-up durations of around 2 years. METHOD AND INTERVENTION: In a factorial design, 771 children between 2 and 5 years old and their parents participating in a prospective cohort study were randomized to three intervention groups and a control group. Three types of lotteries were run: (i) daytrip tickets for the whole family to a popular amusement park if they returned all postal questionnaires, (ii) €12.50-worth gift vouchers for sending back the questionnaire on time after each questionnaire round and (iii) a combination of (i) and (ii). Primary outcome was the proportion of participants who returned all questionnaires without any reminder. Secondary outcomes were '100% returned with or without reminder', 'probability of 100% non-response', 'probability of withdrawal', 'proportion of returned questionnaires' and 'overall number of reminders sent'. After testing for interaction between the two lottery interventions, the two trials were analysed separately. We calculated risk differences (RD) and numbers needed to "treat" and their 95% confidence intervals. Daytrip nor voucher intervention had an effect on the proportion of participants who returned all questionnaires (RD -0.01; 95% CI-0.07 - 0.06) and (RD 0.02; 95% CI-0.50 - 0.08), respectively. No effects were found on the secondary outcomes. Our findings do not support the idea that lottery-style incentives lead to more complete response to postal questionnaires in observational cohort studies with repeated data collection and follow-up durations of around 2 years.

Lifestyle Modification for Resistant Hypertension: The TRIUMPH Randomized Clinical Trial

PubMed Central

Blumenthal, James A.; Sherwood, Andrew; Smith, Patrick J.; Mabe, Stephanie; Watkins, Lana; Lin, Pao-Hwa; Craighead, Linda W.; Babyak, Michael; Tyson, Crystal; Young, Kenlyn; Ashworth, Megan; Kraus, William; Liao, Lawrence; Hinderliter, Alan

2015-01-01

Background Resistant hypertension (RH) is a growing health burden in this country affecting as many as one in five adults being treated for hypertension. RH is associated with increased risk of adverse cardiovascular disease (CVD) events and all-cause mortality. Strategies to reduce blood pressure in this high risk population are a national priority. Methods TRIUMPH is a single site, prospective, randomized clinical trial (RCT) to evaluate the efficacy of a center-based lifestyle intervention consisting of exercise training, reduced sodium and calorie DASH eating plan, and weight management compared to standardized education and physician advice in treating patients with RH. Patients (N=150) will be randomized in a 2:1 ratio to receive either a 4-month supervised lifestyle intervention delivered in the setting of a cardiac rehabilitation center or to a standardized behavioral counseling session to simulate real-world medical practice. The primary end point is clinic blood pressure; secondary endpoints include ambulatory blood pressure and an array of CVD biomarkers including left ventricular hypertrophy, arterial stiffness, baroreceptor reflex sensitivity, insulin resistance, lipids, sympathetic nervous system activity, and inflammatory markers. Lifestyle habits, blood pressure and CVD risk factors also will be measured at one year follow-up. Conclusions The TRIUMPH randomized clinical trial (ClinicalTrials.gov NCT02342808) is designed to test the efficacy of an intensive, center-based lifestyle intervention compared to a standardized education and physician advice counseling session on blood presssure and CVD biomarkers in patients with RH after 4 months of treatment, and will determine whether lifestyle changes can be maintained for a year. PMID:26542509

Effect of transcranial direct current stimulation combined with gait and mobility training on functionality in children with cerebral palsy: study protocol for a double-blind randomized controlled clinical trial

PubMed Central

2013-01-01

Background The project proposes three innovative intervention techniques (treadmill training, mobility training with virtual reality and transcranial direct current stimulation that can be safely administered to children with cerebral palsy. The combination of transcranial stimulation and physical therapy resources will provide the training of a specific task with multiple rhythmic repetitions of the phases of the gait cycle, providing rich sensory stimuli with a modified excitability threshold of the primary motor cortex to enhance local synaptic efficacy and potentiate motor learning. Methods/design A prospective, double-blind, randomized, controlled, analytical, clinical trial will be carried out.Eligible participants will be children with cerebral palsy classified on levels I, II and III of the Gross Motor Function Classification System between four and ten years of age. The participants will be randomly allocated to four groups: 1) gait training on a treadmill with placebo transcranial stimulation; 2) gait training on a treadmill with active transcranial stimulation; 3) mobility training with virtual reality and placebo transcranial stimulation; 4) mobility training with virtual reality and active transcranial stimulation. Transcranial direct current stimulation will be applied with the anodal electrode positioned in the region of the dominant hemisphere over C3, corresponding to the primary motor cortex, and the cathode positioned in the supraorbital region contralateral to the anode. A 1 mA current will be applied for 20 minutes. Treadmill training and mobility training with virtual reality will be performed in 30-minute sessions five times a week for two weeks (total of 10 sessions). Evaluations will be performed on four occasions: one week prior to the intervention; one week following the intervention; one month after the end of the intervention;and 3 months after the end of the intervention. The evaluations will involve three-dimensional gait analysis, analysis of cortex excitability (motor threshold and motor evoked potential), Six-Minute Walk Test, Timed Up-and-Go Test, Pediatric Evaluation Disability Inventory, Gross Motor Function Measure, Berg Balance Scale, stabilometry, maximum respiratory pressure and an effort test. Discussion This paper offers a detailed description of a prospective, double-blind, randomized, controlled, analytical, clinical trial aimed at demonstrating the effect combining transcranial stimulation with treadmill and mobility training on functionality and primary cortex excitability in children with Cerebral Palsy classified on Gross Motor Function Classification System levels I, II and III. The results will be published and will contribute to evidence regarding the use of treadmill training on this population. Trial registration ReBEC RBR-9B5DH7 PMID:24112817

Mindfulness-based Intervention for Female Adolescents with Chronic Pain: A Pilot Randomized Trial

PubMed Central

Chadi, Nicholas; McMahon, Audrey; Vadnais, Majorie; Malboeuf-Hurtubise, Catherine; Djemli, Anissa; Dobkin, Patricia L.; Lacroix, Jacques; Luu, Thuy Mai; Haley, Nancy

2016-01-01

Objective To test the feasibility of a randomized-controlled trial measuring the impact of an adapted mindfulness-based intervention (MBI) in female adolescents with chronic pain. Methods This was a single center, single-blind, prospective, experimental, longitudinal trial conducted in a pediatric tertiary care center. Participants had a history of chronic pain during at least three months. They were randomized into an intervention group or a wait-list control group. Both groups successively followed an adapted eight-week MBI designed specifically for adolescents with chronic pain. Pre-determined criteria were established to assess the feasibility, validity and acceptability of the study model. Data evaluating changes in quality of life, depression, anxiety, pain perception, psychological distress and salivary cortisol were collected throughout the 4-month study period. Results Nineteen female participants completed the study and had a mean age of 15.8 years (range 13.9 -17.8). Attrition rate was low (17%). Attendance to mindfulness sessions (84%) and compliance to study protocol (100%) were high. All participants reported a positive change in the way they coped with pain. No changes in quality of life, depression, anxiety, pain perception, and psychological distress were detected. Significant reductions in pre-and post-mindfulness session salivary cortisol levels were observed (p<0.001). Conclusions Mindfulness is a promising therapeutic approach for which limited data exist in adolescents with chronic pain. Our study indicates the feasibility of conducting such interventions in teenage girls. A large trial is needed to demonstrate the efficacy and bio-physiological impacts of MBIs in teenagers with chronic pain. PMID:27924146

Effect of Prayer on Intensity of Migraine Headache: A Randomized Clinical Trial.

PubMed

Tajadini, Haleh; Zangiabadi, Nasser; Divsalar, Kouros; Safizadeh, Hossein; Esmaili, Zahra; Rafiei, Hossein

2017-01-01

Migraine is a common form of headache that affects patients quality of life negatively. In addition to pharmacologic treatment, there are a variety of nonpharmacologic treatments for migraine headache. In present study, we examined the effect of prayer on intensity of migraine pain. In a prospective, randomized, controlled trial from October 2013 to June 2014, this study has been conducted in Kerman, Iran. We randomly assigned 92 patients in 2 groups to receive either 40 mg of propranolol twice a day for 2 month (group "A") or 40 mg of propranolol twice a day for 2 months with prayer (group "B"). At the beginning of study and 3 months after intervention, patients' pain was measured using the visual analogue scale. At the beginning of study and before intervention, the mean score of pain in patients in groups A and B were 5.7 ± 1.6 and 6.5 ± 1.9, respectively. According to results of independent t test, mean score of pain intensity at the beginning of study were similar between patients in 2 groups (P > .05). Three month after intervention, mean score of pain intensity decreased in patients in both groups. At this time, the mean scores of pain intensity were 5.4 ± 1.1 and 4.2 ± 2.3 in patients in groups A and B, respectively. This difference between groups was statistically significant (P < .001). The present study revealed that prayer can be used as a nonpharmacologic pain coping strategy in addition to pharmacologic intervention for this group of patients. © The Author(s) 2016.

Effect of preoperative incentive spirometry patient education on patient outcomes in the knee and hip joint replacement population.

PubMed

Bergin, Carole; Speroni, Karen Gabel; Travis, Tom; Bergin, John; Sheridan, Michael J; Kelly, Karen; Daniel, Marlon G

2014-02-01

This study examined the effects of preoperative incentive spirometry (IS) education (POISE) on postoperative outcomes for knee and hip total joint replacement patients. In this prospective study, 140 patients were randomized to Group 1 (POISE intervention = 50 completing) or Group 2 (no intervention = 56 completing) (34 dropped). The Group 1 intervention consisted of formal instruction preoperatively for IS home use, postoperative use, and IS volumes documentation. Group 2 patients received no intervention. Patients recorded postoperative IS volumes, which were used to determine return to baseline volume. One hundred six patients completed the study. Most were Caucasian females averaging 64 years. Although IS return to baseline volume time was not significantly different between groups, POISE patients had fewer postoperative complications, hospital days, and charges. POISE patients ranked the intervention as helpful. Although IS volumes were not significantly different between groups, POISE patients had better outcomes and ranked the intervention as helpful. Copyright © 2014 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

Kids Identifying and Defeating Stroke (KIDS): Development and Implementation of a Multi-Ethnic Health Education Intervention to Increase Stroke Awareness Among Middle School Students and Their Parents

PubMed Central

Conley, Kathleen M; Majersik, Jennifer; Gonzales, Nicole R; Maddox, Katherine E; Pary, Jennifer K; Brown, Devin L; Moyé, Lemuel A; Espinosa, Nina; Grotta, James C; Morgenstern, Lewis B

2009-01-01

The KIDS (Kids Identifying and Defeating Stroke) Program is a three-year prospective, randomized, controlled, multiethnic school-based intervention study. Program goals include increasing knowledge of stroke signs and treatment and intention to immediately call 911 among Mexican American (MA) and non-Hispanic white (NHW) middle school students and their parents. This article describes the design, implementation and interim evaluation of this theory-based intervention. Intervention students received a culturally appropriate stroke education program divided into four 50-minute classes each year during the 6th, 7th, and 8th grades. Each class session also included a homework assignment that involved the students’ parents or other adult partners. Interim-test results indicate that this educational intervention was successful in improving students’ stroke symptom and treatment knowledge and intent to call 911 upon witnessing a stroke compared with controls (p<0.001). We conclude that this school-based educational intervention to reduce delay time to hospital arrival for stroke shows early promise. PMID:18332150

Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis--a feasibility study.

PubMed

Zelen, Charles M; Poka, Attila; Andrews, James

2013-10-01

Specialized treatment of plantar fasciitis that can reduce inflammation and promote healing may be a possible alternative prior to surgical intervention. We report the results of a randomized clinical trial examining the efficacy of micronized dehydrated human amniotic/chorionic membrane (mDHACM) injection as a treatment for chronic refractory plantar fasciitis. An institutional review board-approved, prospective, randomized, single-center clinical trial was performed. Forty-five patients were randomized to receive injection of 2 cc 0.5% Marcaine plain, then either 1.25 cc saline (controls), 0.5 cc mDHACM, or 1.25 cc mDHACM. Follow-up visits occurred over 8 weeks to measure function, pain, and functional health and well-being. Significant improvement in plantar fasciitis symptoms was observed in patients receiving 0.5 cc or 1.25 cc mDHACM versus controls within 1 week of treatment and throughout the study period. At 1 week, American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot scores increased by a mean of 2.2 ± 17.4 points for controls versus 38.7 ± 11.4 points for those receiving 0.5 cc mDHACM (P < .001) and 33.7 ± 14.0 points for those receiving 1.25 cc mDHACM (P < .001). By week 8 AOFAS Hindfoot scores increased by a mean of 12.9 ± 16.9 points for controls versus 51.6 ± 10.1 and 53.3 ± 9.4 for those receiving 0.5 cc and 1.25 cc mDHACM, respectively (both P < .001). No significant difference in treatment response was observed in patients receiving 0.5 cc versus 1.25 cc mDHACM. In patients with refractory plantar fasciitis, mDHACM is a viable treatment option. Larger studies are needed to confirm our findings. Level I, prospective randomized study.

mHealth Intervention to Improve Diabetes Risk Behaviors in India: A Prospective, Parallel Group Cohort Study.

PubMed

Pfammatter, Angela; Spring, Bonnie; Saligram, Nalini; Davé, Raj; Gowda, Arun; Blais, Linelle; Arora, Monika; Ranjani, Harish; Ganda, Om; Hedeker, Donald; Reddy, Sethu; Ramalingam, Sandhya

2016-08-05

In low/middle income countries like India, diabetes is prevalent and health care access limited. Most adults have a mobile phone, creating potential for mHealth interventions to improve public health. To examine the feasibility and initial evidence of effectiveness of mDiabetes, a text messaging program to improve diabetes risk behaviors, a global nonprofit organization (Arogya World) implemented mDiabetes among one million Indian adults. A prospective, parallel cohort design was applied to examine whether mDiabetes improved fruit, vegetable, and fat intakes and exercise. Intervention participants were randomly selected from the one million Nokia subscribers who elected to opt in to mDiabetes. Control group participants were randomly selected from non-Nokia mobile phone subscribers. mDiabetes participants received 56 text messages in their choice of 12 languages over 6 months; control participants received no contact. Messages were designed to motivate improvement in diabetes risk behaviors and increase awareness about the causes and complications of diabetes. Participant health behaviors (exercise and fruit, vegetable, and fat intake) were assessed between 2012 and 2013 via telephone surveys by blinded assessors at baseline and 6 months later. Data were cleaned and analyzed in 2014 and 2015. 982 participants in the intervention group and 943 in the control group consented to take the phone survey at baselne. At the end of the 6-month period, 611 (62.22%) in the intervention and 632 (67.02%) in the control group completed the follow-up telephone survey. Participants receiving texts demonstrated greater improvement in a health behavior composite score over 6 months, compared with those who received no messages F(1, 1238) = 30.181, P<.001, 95% CI, 0.251-0.531. Fewer intervention participants demonstrated health behavior decline compared with controls. Improved fruit, vegetable, and fat consumption (P<.01) but not exercise were observed in those receiving messages, as compared with controls. A text messaging intervention was feasible and showed initial evidence of effectiveness in improving diabetes-related health behaviors, demonstrating the potential to facilitate population-level behavior change in a low/middle income country. Australian New Zealand Clinical Trials Registry (ACTRN): 12615000423516; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367946&isReview=true (Archived by WebCite at http://www.webcitation.org/6j5ptaJgF).

Effectiveness and cost-effectiveness of a blended exercise intervention for patients with hip and/or knee osteoarthritis: study protocol of a randomized controlled trial.

PubMed

Kloek, Corelien J J; Bossen, Daniël; Veenhof, Cindy; van Dongen, Johanna M; Dekker, Joost; de Bakker, Dinny H

2014-08-08

Exercise therapy in patients with hip and/or knee osteoarthritis is effective in reducing pain, increasing physical activity and physical functioning, but costly and a burden for the health care budget. A web-based intervention is cheap in comparison to face-to-face exercise therapy and has the advantage of supporting in home exercises because of the 24/7 accessibility. However, the lack of face-to-face contact with a professional is a disadvantage of web-based interventions and is probably one of the reasons for low adherence rates. In order to combine the best of two worlds, we have developed the intervention e-Exercise. In this blended intervention face-to-face contacts with a physical therapist are partially replaced by a web-based exercise intervention. The aim of this study is to investigate the short- (3 months) and long-term (12 months) (cost)-effectiveness of e-Exercise compared to usual care physical therapy. Our hypothesis is that e-Exercise is more effective and cost-effective in increasing physical functioning and physical activity compared to usual care. This paper presents the protocol of a prospective, single-blinded, multicenter cluster randomized controlled trial. In total, 200 patients with OA of the hip and/or knee will be randomly allocated into either e-Exercise or usual care (physical therapy). E-Exercise is a 12-week intervention, consisting of maximum five face-to-face physical therapy contacts supplemented with a web-based program. The web-based program contains assignments to gradually increase patients' physical activity, strength and stability exercises and information about OA related topics. Primary outcomes are physical activity and physical functioning. Secondary outcomes are health related quality of life, self-perceived effect, pain, tiredness and self-efficacy. All measurements will be performed at baseline, 3 and 12 months after inclusion. Retrospective cost questionnaires will be sent at 3, 6, 9 and 12 months and used for the cost-effectiveness and cost-utility analysis. This study is the first randomized controlled trial in the (cost)-effectiveness of a blended exercise intervention for patients with osteoarthritis of the hip and/or knee. The findings will help to improve the treatment of patients with osteoarthritis. NTR4224.

A single-center randomized, controlled trial investigating the efficacy of a mHealth ECG technology intervention to improve the detection of atrial fibrillation: the iHEART study protocol.

PubMed

Hickey, Kathleen T; Hauser, Nicole R; Valente, Laura E; Riga, Teresa C; Frulla, Ashton P; Masterson Creber, Ruth; Whang, William; Garan, Hasan; Jia, Haomiao; Sciacca, Robert R; Wang, Daniel Y

2016-07-16

Atrial fibrillation is a major public health problem and is the most common cardiac arrhythmia, affecting an estimated 2.7 million Americans. The true prevalence of atrial fibrillation is likely underestimated because episodes are often sporadic; therefore, it is challenging to detect and record an occurrence in a "real world" setting. To date, mobile health tools that promote earlier detection and treatment of atrial fibrillation and improvement in self-management behaviors and knowledge have not been evaluated. This study will be the first to address the epidemic problem of atrial fibrillation with a novel approach utilizing advancements in mobile health electrocardiogram technology to empower patients to actively engage in their healthcare and to evaluate impact on quality of life and quality-adjusted life years. Furthermore, sending a daily electrocardiogram transmission, coupled with receiving educational and motivational text messages aimed at promoting self-management and a healthy lifestyle may improve the management of chronic cardiovascular conditions (e.g., hypertension, diabetes, heart failure, etc.). Therefore, we are currently conducting a randomized controlled trial to assess the efficacy of a mobile health intervention, iPhone® Helping Evaluate Atrial fibrillation Rhythm through Technology (iHEART) versus usual cardiac care. The iHEART study is a single center, prospective, randomized controlled trial. A total of 300 participants with a recent history of atrial fibrillation will be enrolled. Participants will be randomized 1:1 to receive the iHEART intervention, receiving an iPhone® equipped with an AliveCor® Mobile ECG and accompanying Kardia application and behavioral altering motivational text messages or usual cardiac care for 6 months. This will be the first study to investigate the utility of a mobile health intervention in a "real world" setting. We will evaluate the ability of the iHEART intervention to improve the detection and treatment of recurrent atrial fibrillation and assess the intervention's impact on improving clinical outcomes, quality of life, quality-adjusted life-years and disease-specific knowledge. NCT02731326 ; Verified April 2016.

Effects of ergonomic intervention on work-related upper extremity musculoskeletal disorders among computer workers: a randomized controlled trial.

PubMed

Esmaeilzadeh, Sina; Ozcan, Emel; Capan, Nalan

2014-01-01

The aim of the study was to determine effects of ergonomic intervention on work-related upper extremity musculoskeletal disorders (WUEMSDs) among computer workers. Four hundred computer workers answered a questionnaire on work-related upper extremity musculoskeletal symptoms (WUEMSS). Ninety-four subjects with WUEMSS using computers at least 3 h a day participated in a prospective, randomized controlled 6-month intervention. Body posture and workstation layouts were assessed by the Ergonomic Questionnaire. We used the Visual Analogue Scale to assess the intensity of WUEMSS. The Upper Extremity Function Scale was used to evaluate functional limitations at the neck and upper extremities. Health-related quality of life was assessed with the Short Form-36. After baseline assessment, those in the intervention group participated in a multicomponent ergonomic intervention program including a comprehensive ergonomic training consisting of two interactive sessions, an ergonomic training brochure, and workplace visits with workstation adjustments. Follow-up assessment was conducted after 6 months. In the intervention group, body posture (p < 0.001) and workstation layout (p = 0.002) improved over 6 months; furthermore, intensity (p < 0.001), duration (p < 0.001), and frequency (p = 0.009) of WUEMSS decreased significantly in the intervention group compared with the control group. Additionally, the functional status (p = 0.001), and physical (p < 0.001), and mental (p = 0.035) health-related quality of life improved significantly compared with the controls. There was no improvement of work day loss due to WUEMSS (p > 0.05). Ergonomic intervention programs may be effective in reducing ergonomic risk factors among computer workers and consequently in the secondary prevention of WUEMSDs.

Feasibility of event-related potential (ERP) biomarker use to study effects of mother's voice exposure on speech sound differentiation of preterm infants.

PubMed

D Chorna, Olena; L Hamm, Ellyn; Shrivastava, Hemang; Maitre, Nathalie L

2018-01-01

Atypical maturation of auditory neural processing contributes to preterm-born infants' language delays. Event-related potential (ERP) measurement of speech-sound differentiation might fill a gap in treatment-response biomarkers to auditory interventions. We evaluated whether these markers could measure treatment effects in a quasi-randomized prospective study. Hospitalized preterm infants in passive or active, suck-contingent mother's voice exposure groups were not different at baseline. Post-intervention, the active group had greater increases in/du/-/gu/differentiation in left frontal and temporal regions. Infants with brain injury had lower baseline/ba/-/ga/and/du/-/gu/differentiation than those without. ERP provides valid discriminative, responsive, and predictive biomarkers of infant speech-sound differentiation.

A crossover randomized prospective pilot study evaluating a central venous catheter team in reducing catheter-related bloodstream infections in pediatric oncology patients.

PubMed

Secola, Rita; Azen, Colleen; Lewis, Mary Ann; Pike, Nancy; Needleman, Jack; Sposto, Richard; Doering, Lynn

2012-01-01

Treatment for most children with cancer includes the use of a central venous catheter (CVC). CVCs provide reliable venous access for delivery of chemotherapy and supportive care. This advantage is mitigated by an increased risk of bloodstream infections (BSIs). Despite the ubiquitous use of CVCs, few prospective studies have been conducted to address infection prevention strategies in pediatric oncology patients. Prospective, crossover pilot study of a CVC team intervention versus standard care. Two inpatient oncology units in a metropolitan children's hospital. A total of 41 patients/135 admissions for the experimental unit (EU) and 41/129 admissions for the control unit (CU). Patients received a CVC blood draw bundle procedure by a CVC registered nurse (RN) team member (experimental intervention: EU) for 6 months and by the assigned bedside RN (standard care: CU) for 6 months. Feasibility of implementing a CVC RN team; a significant difference in CVC-related BSIs between the team intervention versus standard care and risk factors associated in the development of CVC-related BSIs were determined. There were 7 CVC-related BSIs/1238 catheter days in the EU group (5.7/1000 catheter days) versus 3 CVC-related BSIs/1419 catheter days in the CU group (2.1/1000 catheter days; P = .97). Selected risk factors were not significantly associated with the development of a CVC-related BSI. A CVC team in the care of pediatric oncology patients is feasible; however, a larger cohort will be required to adequately determine the effectiveness of the team reducing CVC-related BSIs.

The "ick" Factor Matters: Disgust Prospectively Predicts Avoidance in Chemotherapy Patients.

PubMed

Reynolds, Lisa M; Bissett, Ian P; Porter, David; Consedine, Nathan S

2016-12-01

Chemotherapy can be physically and psychologically demanding. Avoidance and withdrawal are common among patients coping with these demands. This report compares established emotional predictors of avoidance during chemotherapy (embarrassment; distress) with an emotion (disgust) that has been unstudied in this context. This report outlines secondary analyses of an RCT where 68 cancer patients undergoing chemotherapy were randomized to mindfulness or relaxation interventions. Self-reported baseline disgust (DS-R), embarrassment (SES-SF), and distress (Distress Thermometer) were used to prospectively predict multiple classes of avoidance post-intervention and at 3 months follow-up. Measures assessed social avoidance, cognitive and emotional avoidance (IES Avoidance), as well as information seeking and treatment adherence (General Adherence Scale). Repeated-measures ANOVAs evaluated possible longitudinal changes in disgust and forward entry regression models contrasted the ability of the affective variables to predict avoidance. Although disgust did not change over time or vary between groups, greater disgust predicted greater social, cognitive, and emotional avoidance, as well as greater information seeking. Social avoidance was predicted by trait embarrassment and distress predicted non-adherence. This report represents the first investigation of disgust's ability to prospectively predict avoidance in people undergoing chemotherapy. Compared to embarrassment and distress, disgust was a more consistent predictor across avoidance domains and its predictive ability was evident across a longer period of time. Findings highlight disgust's role as an indicator of likely avoidance in this health context. Early identification of cancer patients at risk of deleterious avoidance may enable timely interventions and has important clinical implications (ACTRN12613000238774).

The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial.

PubMed

Fleming, Jennifer; Ownsworth, Tamara; Doig, Emmah; Hutton, Lauren; Griffin, Janelle; Kendall, Melissa; Shum, David H K

2017-01-05

Impairment of prospective memory (PM) is common following traumatic brain injury (TBI) and negatively impacts on independent living. Compensatory approaches to PM rehabilitation have been found to minimize the impact of PM impairment in adults with TBI; however, poor self-awareness after TBI poses a major barrier to the generalization of compensatory strategies in daily life. Metacognitive skills training (MST) is a cognitive rehabilitation approach that aims to facilitate the development of self-awareness in adults with TBI. This paper describes the protocol of a study that aims to evaluate the efficacy of a MST approach to compensatory PM rehabilitation for improving everyday PM performance and psychosocial outcomes after TBI. This randomized controlled trial has three treatment groups: compensatory training plus metacognitive skills training (COMP-MST), compensatory training only (COMP), and waitlist control. Participants in the COMP-MST and COMP groups will complete a 6-week intervention consisting of six 2-h weekly training sessions. Each 1.5-h session will involve compensatory strategy training and 0.5 h will incorporate either MST (COMP-MST group) or filler activity as an active control (COMP group). Participants in the waitlist group receive care as usual for 6 weeks, followed by the COMP-MST intervention. Based on the sample size estimate, 90 participants with moderate to severe TBI will be randomized into the three groups using a stratified sampling approach. The primary outcomes include measures of PM performance in everyday life and level of psychosocial reintegration. Secondary outcomes include measures of PM function on psychometric testing, strategy use, self-awareness, and level of support needs following TBI. Blinded assessments will be conducted pre and post intervention, and at 3-month and 6-month follow-ups. This study seeks to determine the efficacy of COMP-MST for improving and maintaining everyday PM performance and level of psychosocial integration in adults with moderate to severe TBI. The findings will advance theoretical understanding of the role of self-awareness in compensatory PM rehabilitation and skills generalization. COMP-MST has the potential to reduce the cost of rehabilitation and lifestyle support following TBI because the intervention could enhance generalization success and lifelong application of PM compensatory strategies. New Zealand Clinical Trials Registry, ACTRN12615000996561 . Registered on 23 September 2015; retrospectively registered 2 months after commencement.

Evaluation of a nurse practitioner disease management model for chronic heart failure: a multi-site implementation study.

PubMed

Lowery, Julie; Hopp, Faith; Subramanian, Usha; Wiitala, Wyndy; Welsh, Deborah E; Larkin, Angela; Stemmer, Karen; Zak, Cassandra; Vaitkevicius, Peter

2012-01-01

While disease management appears to be effective in selected, small groups of CHF patients from randomized controlled trials, its effectiveness in a broader CHF patient population is not known. This prospective, quasi-experimental study compared patient outcomes under a nurse practitioner-led disease management model (intervention group) with outcomes under usual care (control group) in both primary and tertiary medical centers. The study included 969 veterans (458 intervention, 511 control) treated for CHF at six VA medical centers. Intervention patients had significantly fewer (p<0.05) CHF and all-cause admissions at one-year follow-up, and lower mortality at both one- and two-year follow-up. These data provide support for the potential effectiveness of the intervention, and suggest that the evidence from RCTs of disease management models for CHF can be translated into clinical practice, even without the benefits of a selected patient population and dedicated resources often found in RCTs. © 2011 Wiley Periodicals, Inc.

Impact of a Comprehensive Workplace Hand Hygiene Program on Employer Health Care Insurance Claims and Costs, Absenteeism, and Employee Perceptions and Practices

PubMed Central

Arbogast, James W.; Moore-Schiltz, Laura; Jarvis, William R.; Harpster-Hagen, Amanda; Hughes, Jillian; Parker, Albert

2016-01-01

Objective: The aim of this study was to determine the efficacy of a multimodal hand hygiene intervention program in reducing health care insurance claims for hygiene preventable infections (eg, cold and influenza), absenteeism, and subjective impact on employees. Methods: A 13.5-month prospective, randomized cluster controlled trial was executed with alcohol-based hand sanitizer in strategic workplace locations and personal use (intervention group) and brief hand hygiene education (both groups). Four years of retrospective data were collected for all participants. Results: Hygiene-preventable health care claims were significantly reduced in the intervention group by over 20% (P < 0.05). Absenteeism was positively impacted overall for the intervention group. Employee survey data showed significant improvements in hand hygiene behavior and perception of company concern for employee well-being. Conclusion: Providing a comprehensive, targeted, yet simple to execute hand hygiene program significantly reduced the incidence of health care claims and increased employee workplace satisfaction. PMID:27281645

Impact of a Comprehensive Workplace Hand Hygiene Program on Employer Health Care Insurance Claims and Costs, Absenteeism, and Employee Perceptions and Practices.

PubMed

Arbogast, James W; Moore-Schiltz, Laura; Jarvis, William R; Harpster-Hagen, Amanda; Hughes, Jillian; Parker, Albert

2016-06-01

The aim of this study was to determine the efficacy of a multimodal hand hygiene intervention program in reducing health care insurance claims for hygiene preventable infections (eg, cold and influenza), absenteeism, and subjective impact on employees. A 13.5-month prospective, randomized cluster controlled trial was executed with alcohol-based hand sanitizer in strategic workplace locations and personal use (intervention group) and brief hand hygiene education (both groups). Four years of retrospective data were collected for all participants. Hygiene-preventable health care claims were significantly reduced in the intervention group by over 20% (P < 0.05). Absenteeism was positively impacted overall for the intervention group. Employee survey data showed significant improvements in hand hygiene behavior and perception of company concern for employee well-being. Providing a comprehensive, targeted, yet simple to execute hand hygiene program significantly reduced the incidence of health care claims and increased employee workplace satisfaction.

Contingency Management Voucher Redemption as an Indicator of Delayed Gratification

PubMed Central

Fletcher, Jesse B.; Dierst-Davies, Rhodri; Reback, Cathy J.

2014-01-01

This prospective analysis tested whether frequency of voucher redemptions during a contingency management (CM) substance use intervention was significantly associated with participants’ ongoing substance use. Homeless, substance-dependent men who have sex with men (N=131) were randomized into either a “full” or “lite” voucher-based CM intervention. All participants earned vouchers for attendance and participation; participants in the CM-full condition also received vouchers for substance abstinence and enactment of prosocial and/or health-promoting behaviors. Multivariate longitudinal negative binomial regression analyses (n = 118) assessed the association between substance use during the intervention and frequency of voucher redemptions. Participants who used methamphetamine (IRR = 0.66; 95% CI=0.44–0.99) and/or opiates (IRR=0.60; 95% CI=0.40–0.99) during the intervention exhibited less time between voucher redemptions than individuals who achieved abstinence from these substances. Voucher redemption logs can be cost-effective and unobtrusive tools for measuring study participants’ tendency to delay gratification. PMID:24674235

Diabetes disease management in Medicare Advantage reduces hospitalizations and costs.

PubMed

Rosenzweig, James L; Taitel, Michael S; Norman, Gordon K; Moore, Tim J; Turenne, Wendy; Tang, Pei

2010-07-01

To evaluate the effectiveness of a telephonic diabetes disease management intervention in a Medicare Advantage population with comorbid diabetes and coronary artery disease (CAD). Prospective unequal randomization design of 526 members from a Medicare Advantage segment of one region of a large national health plan from May 2005 through April 2007. High-risk and high-cost patients with diabetes and CAD who were enrolled in telephonic diabetes disease management were compared with a randomly selected comparison group receiving usual care. Wilcoxon signed-rank tests were used to compare the groups on all-cause hospital admissions, diabetes-related hospital admissions, all-cause and diabetes-related emergency department (ED) visits, and all-cause medical costs. Changes in self-reported clinical outcomes also were measured in the intervention group. Patients receiving telephonic diabetes disease management had significantly decreased all-cause hospital admissions and diabetes-related hospital admissions (P <.05). The intervention group had decreased all-cause and diabetes-related ED visits, although the difference was not statistically significant. The comparison group had increased ED utilization. The intervention group decreased their all-cause total medical costs by $984.87 per member per year (PMPY) compared with a $4547.06 PMPY increase in the comparison group (P <.05). All clinical measures significantly improved (P <.05) in the intervention group. A disease management program for high-risk patients with diabetes and CAD was effective in reducing hospital inpatient admission and total costs in a Medicare Advantage population.

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.

Methods for a Randomized Trial of Weight-Supported Treadmill Training versus Conventional Training for Walking during Inpatient Rehabilitation after Incomplete Traumatic Spinal Cord Injury

PubMed Central

Dobkin, Bruce H.; Apple, David; Barbeau, Hugues; Basso, Michele; Behrman, Andrea; Deforge, Dan; Ditunno, John; Dudley, Gary; Elashoff, Robert; Fugate, Lisa; Harkema, Susan; Saulino, Michael; Scott, Michael

2014-01-01

The authors describe the rationale and methodology for the first prospective, multicenter, randomized clinical trial (RCT) of a task-oriented walking intervention for subjects during early rehabilitation for an acute traumatic spinal cord injury (SCI). The experimental strategy, body weight–supported treadmill training (BWSTT), allows physical therapists to systematically train patients to walk on a treadmill at increasing speeds typical of community ambulation with increasing weight bearing. The therapists provide verbal and tactile cues to facilitate the kinematic, kinetic, and temporal features of walking. Subjects were randomly assigned to a conventional therapy program for mobility versus the same intensity and duration of a combination of BWSTT and over-ground locomotor retraining. Subjects had an incomplete SCI (American Spinal Injury Association grades B, C, and D) from C-4 to T-10 (upper motoneuron group) or from T-11 to L-3 (lower motoneuron group). Within 8 weeks of a SCI, 146 subjects were entered for 12 weeks of intervention. The 2 single-blinded primary outcome measures are the level of independence for ambulation and, for those who are able to walk, the maximal speed for walking 50 feet, tested 6 and 12 months after randomization. The trial’s methodology offers a model for the feasibility of translating neuroscientific experiments into a RCT to develop evidence-based rehabilitation practices. PMID:14503436

A prospective randomized clinical trial to investigate the effect of silicone gel sheeting (Cica-Care) on post-traumatic hypertrophic scar among the Chinese population.

PubMed

Li-Tsang, Cecilia W P; Lau, Joy C M; Choi, Jenny; Chan, Chetwyn C C; Jianan, Li

2006-09-01

This study aimed to determine the efficacy of silicone gel (Cica-Care) on severe post-traumatic hypertophic scars among the Chinese population. A randomized clinical trial (RCT) was conducted on 45 Chinese patients with post-traumatic hypertrophic scars. Twenty-two subjects were placed in the experimental group with silicone gel sheeting (SGS) applied 24h per day for 6 months while all subjects were taught to massage the scar daily for 15 min serving as the control intervention. Scar assessments were conducted regularly to measure the changes in thickness, pigmentation, vascularity, pliability, itchiness and pain. Two-way repeated ANOVA showed a significant difference between MT group and SGS group on scar thickness. The post hoc comparison analysis showed that the difference was significant at the post-2-month (p=0.008) and post-6-month (p<0.001) intervention. The SGS group also showed changes in pigmentation which resembled normal skin but no statistical significance was found. Pain, itchiness and pliability were also improved after intervention. This study indicated that silicone gel sheeting (Cica-Care) was effective to reduce thickness, pain, itchiness and pliability of the severe hypertrophic scar among the Chinese population. The moisturization effect of the tough and hard scar might contribute to the reduction of the skin thickness after 6 month's intervention.

Long-term multiple risk factor interventions in Japanese elderly diabetic patients: the Japanese Elderly Diabetes Intervention Trial--study design, baseline characteristics and effects of intervention.

PubMed

Araki, Atsushi; Iimuro, Satoshi; Sakurai, Takashi; Umegaki, Hiroyuki; Iijima, Katsuya; Nakano, Hiroshi; Oba, Kenzo; Yokono, Koichi; Sone, Hirohito; Yamada, Nobuhiro; Ako, Junya; Kozaki, Koichi; Miura, Hisayuki; Kashiwagi, Atsunori; Kikkawa, Ryuichi; Yoshimura, Yukio; Nakano, Tadasumi; Ohashi, Yasuo; Ito, Hideki

2012-04-01

To evaluate long-term, multiple risk factor intervention on physical, psychological and mental prognosis, and development of complications and cardiovascular disease in elderly type 2 diabetes patients. Our randomized, controlled, multicenter, prospective intervention trial included 1173 elderly type 2 diabetes patients who were enrolled from 39 Japanese institutions and randomized to an intensive or conservative treatment group. Glycemic control, dyslipidemia, hypertension, obesity, diabetic complications and atherosclerotic disease were measured annually. Instrumental activity of daily living, cognitive impairment, depressive symptoms and diabetes burden were assessed at baseline and 3 years. There was no significant difference in clinical or cognitive parameters at baseline between the two groups. The prevalence of low activities of daily living, depressive symptoms and cognitive impairment was 13%, 28% and 4%, respectively, and was similar in the two groups. A small, but significant difference in HbA1c between the two groups was observed at 1 year after the start of intervention (7.9% vs 8.1%, P < 0.05), although this significant difference was not observed after the second year. With the exception of coronary revascularization, there was no significant difference in fatal or non-fatal events between the two groups. Composite events were also similar in the two groups. This study showed no significant differences in fatal or non-fatal events between intensive and conventional treatment. The present study might clarify whether treatment of risk factors influences function and quality of life in elderly diabetic patients. © 2012 Japan Geriatrics Society.

Lifestyle modifications in the development of diabetes mellitus and metabolic syndrome in Chinese women who had gestational diabetes mellitus: a randomized interventional trial.

PubMed

Shek, Noel Wan Man; Ngai, Cora Suk Wai; Lee, Chin Peng; Chan, Jane Yuk Chun; Lao, Terence Tzu Hsi

2014-02-01

To study whether lifestyle intervention can reduce the development of type II diabetes mellitus (DM) and metabolic syndrome (MS) among Chinese women who had gestational diabetes mellitus (GDM). A prospective randomized controlled interventional trial of 450 women who had GDM and impaired glucose tolerance (IGT) postpartum. Advice on diet and exercise was given to the intervention group and reinforced in each follow-up visit. Women in both arms were followed for 36 months. Blood pressure and anthropometry were measured at each visit and blood tests were repeated. Fewer women in the intervention group developed DM (15 versus 19 %) but this was not statistically significant, and there was a lower incidence of DM among women over 40 years old. No difference was found in fasting glucose, insulin and homeostasis model assessment (HOMA) index. Both systolic and diastolic blood pressures, and triglyceride level, were lower but the significance was inconsistent among visits. BMI and percentage body fat were also significantly lower in the later visits. There was no difference in waist-hip ratio and basal metabolic rate. Our results demonstrate a trend towards lower incidence of type II DM within 3 years postpartum in GDM women given lifestyle advice, which also potentially offers protection against development of MS, in terms of lower blood pressure and triglyceride level. Women over 40 years old are more likely to benefit. Future studies should address ways to maximize compliance to lifestyle intervention as its potential benefits can be undermined by challenges of motherhood.

Tailored activities to manage neuropsychiatric behaviors in persons with dementia and reduce caregiver burden: a randomized pilot study.

PubMed

Gitlin, Laura N; Winter, Laraine; Burke, Janice; Chernett, Nancy; Dennis, Marie P; Hauck, Walter W

2008-03-01

To test whether the Tailored Activity Program (TAP) reduces dementia-related neuropsychiatric behaviors, promotes activity engagement, and enhances caregiver well-being. Prospective, two-group (treatment, wait-list control), randomized, controlled pilot study with 4 months as main trial endpoint. At 4 months, controls received the TAP intervention and were reassessed 4 months later. Patients' homes. Sixty dementia patients and family caregivers. The eight-session occupational therapy intervention involved neuropsychological and functional testing, selection, and customization of activities to match capabilities identified in testing, and instruction to caregivers in use of activities. Behavioral occurrences, activity engagement, and quality of life in dementia patients; objective and subjective burden and skill enhancement in caregivers. At 4 months, compared with controls, intervention caregivers reported reduced frequency of problem behaviors, and specifically for shadowing and repetitive questioning, and greater activity engagement including the ability to keep busy. Fewer intervention caregivers reported agitation or argumentation. Caregiver benefits included fewer hours doing things and being on duty, greater mastery, self-efficacy, and skill enhancement. Wait-list control participants following intervention showed similar benefits for reductions in behavioral frequency and caregiver hours doing things for the patient and mastery. Caregivers with depressed symptoms derived treatment benefits similar to nondepressed caregivers. Tailoring activities to the capabilities of dementia patients and training families in activity use resulted in clinically relevant benefits for patients and caregivers. Treatment minimized trigger behaviors for nursing home placement and reduced objective caregiver burden. Noteworthy is that depressed caregivers effectively engaged in and benefited from the intervention.

The design and rationale of an interdisciplinary, non-prescriptive, and Health at Every Size®-based clinical trial: The "Health and Wellness in Obesity" study.

PubMed

Ulian, Mariana D; Gualano, Bruno; Benatti, Fabiana B; de Campos-Ferraz, Patricia Lopes; Coelho, Desire; Roble, Odilon J; Sabatini, Fernanda; Perez, Isabel; Aburad, Luiz; Pinto, Ana Jéssica; Vessoni, André; Victor, Jhessica Campos; Lima, Victoria Kupper; Unsain, Ramiro Fernandez; de Morais Sato, Priscila; Rogero, Marcelo Macedo; Toporcov, Tatiana Natasha; Scagliusi, Fernanda B

2017-12-01

This manuscript describes the design and rationale of a clinical trial that aims to investigate the multiple physiological, attitudinal, nutritional, and behavioral effects of a new interdisciplinary intervention based on the Health at Every Size® (HAES®) approach in obese women. This will be a prospective, 7-month, randomized (2:1), mixed-method clinical trial. Obese women will be recruited and randomly allocated into two groups. The intervention group (I-HAES®; proposed n = 40) will undertake a novel HAES®-based intervention. Participants will take part in an exercise program, nutrition counseling sessions, and philosophical workshops, all aligned with the principles of the HAES® approach. The control group (CTRL; proposed n = 20) will participate in a program using a traditional HAES®-based group format, characterized by bimonthly lectures about the same topics offered to the experimental group, encouraging the adoption of a healthy lifestyle. The following multiple quantitative outcomes will be assessed pre and post intervention: health-related quality of life, cardiovascular risk factors, anthropometric assessments, physical activity level, physical capacity and function, and psychological and behavioral assessments. Qualitative analysis will be used to evaluate the experiences of the participants throughout the intervention, as assessed by focus groups and semi-structured interviews. The interdisciplinary research team leading this study has varied and complementary expertise. The knowledge arising from this study will help to guide new interdisciplinary interventions with the potential to holistically improve the health of obese individuals. This trial is registered at Clinicaltrials.gov (NCT02102061).

Spirituality, religiosity and addiction recovery: current perspectives.

PubMed

Castaldelli-Maia, Joao Mauricio; Beraldo, Livia; Ventriglio, Antonio; de Andrade, Arthur Guerra; da Silva, Antonio Geraldo; Torales, Julio; Goncalves, Priscila Dib; Bhugra, Dinesh

2018-06-11

Substance use disorders are an important public health problem with a multifactorial etiology and limited effective treatment options. Within this context, spirituality-based approaches may provide interesting and useful options in managing substance use disorders. This kind of intervention can have positive effects in alleviating some core symptoms associated with substance use, such as aggressiveness. Improvement in cessation rates for alcohol, cocaine and opioid use disorders have also been described in some clinical studies. However, spirituality may not play a beneficial role in some subgroups, such as among individuals with crack cocaine and cannabis use disorders. A widely available intervention for alcohol use disorders is Alcoholics Anonymous (AA), which can be seen as a spirituality-based intervention. Spirituality also seems to be especially beneficial for minorities such as Latinos, African-Americans and Native-Americans. Moreover, spiritual-based interventions are also helpful alternatives in many rural environments where conventional healthcare for substance use disorders may not be easily available. However, spiritual-based interventions may be considered as a possible adjunctive therapeutic option to conventional treatments. There is a need for prospective studies outside U.S., especially where spiritual-based approaches are available. It may be difficult to carry out randomized controlled trials because of the nature of the spiritual/religious dimensions. However, prospective studies that evaluate mediation effect of spirituality and religiosity on recovery would be helpful. Qualitative studies combined with quantitative design offer excellent options to evaluate the recovery process, especially among special populations. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Effectiveness of an Intervention to Promote Self-Efficacy on Quality of Life of Patients with Nasopharyngeal Carcinoma of the Zhuang Tribe Minority in Guangxi, China: A Prospective Study

PubMed Central

Lu, Jiamei; Zeng, Xiaofen; Liao, Jinlian; Zhang, Yong; Yang, Li; Li, Yuming; Lv, Jun

2017-01-01

Background Nasopharyngeal carcinoma (NPC) is endemic in China and patient self-management is poor. Minorities may suffer from psychological problems during treatments for NPC. This study aimed to implement an intervention to promote self-efficacy of minority patients (Zhuang tribe, Guangxi, China) with NPC to improve their quality of life (QOL). Material/Methods This was a prospective study of 120 patients with NPC treated at the First Affiliated Hospital of Guangxi Medical University (Guangxi, China), randomized to conventional care (n=60, controls) or conventional care plus self-efficacy interventions based on health education, behavior therapy, and psychological intervention (n=60, self-efficacy group). Self-efficacy was evaluated using the general self-efficacy scale, and QOL using the EORTC QLQ-C30. The questionnaires were completed at discharge, at 6 months, and at 1 and 2 years. The primary outcome was QOL. Results There was no difference in QOL at baseline. From study start to hospital discharge, overall QOL scores decreased in both groups, but this decrease was more important in the control group (controls: −39.31 vs. self-efficacy: −27.04, P<0.05). After discharge, each functional field QOL scores and overall QOL increased with time in the 2 groups, and they were significantly higher in the self-efficacy group. Conclusions This intervention promoting self-efficacy could increase patients’ own potential and initiative, enhance their confidence and ability to solve health problems, improve their coping with adverse effects of treatments, and have positive effects on their QOL. Self-efficacy theory-based interventions could be worth popularization during the treatment and recovery of minority patients with NPC. PMID:28832557

Prospective Trial of House Staff Time to Response and Intervention in a Surgical Intensive Care Unit: Pager vs. Smartphone.

PubMed

Tatum, James M; White, Terris; Kang, Christopher; Ley, Eric J; Melo, Nicolas; Bloom, Matthew; Alban, Rodrigo F

The objective of the study was to characterize house staff time to response and intervention when notified of a patient care issue by pager vs. smartphone. We hypothesized that smartphones would reduce house staff time to response and intervention. Prospective study of all electronic communications was conducted between nurses and house staff between September 2015 and October 2015. The 4-week study period was randomly divided into two 2-week study periods where all electronic communications between intensive care unit nurses and intensive care unit house staff were exclusively by smartphone or by pager, respectively. Time of communication initiation, time of house staff response, and time from response to clinical intervention for each communication were recorded. Outcomes are time from nurse contact to house staff response and intervention. Single-center surgical intensive care unit of Cedars-Sinai Medical Center in Los Angeles, California, an academic tertiary care and level I trauma center. All electronic communications occurring between nurses and house staff in the study unit during the study period were considered. During the study period, 205 nurse-house staff electronic communications occurred, 100 in the phone group and 105 in the pager group. House staff response to communication time was significantly shorter in the phone group (0.5 [interquartile range = 1.7] vs. 2 [3]min, p < 0.001). Time to house staff intervention after response was also significantly more rapid in the phone group (0.8 [1.7] vs. 1 [2]min, p = 0.003). Dedicated clinical smartphones significantly decrease time to house staff response after electronic nursing communications compared with pagers. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Embedding a randomized clinical trial into an ongoing registry infrastructure: unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women).

PubMed

Hess, Connie N; Rao, Sunil V; Kong, David F; Aberle, Laura H; Anstrom, Kevin J; Gibson, C Michael; Gilchrist, Ian C; Jacobs, Alice K; Jolly, Sanjit S; Mehran, Roxana; Messenger, John C; Newby, L Kristin; Waksman, Ron; Krucoff, Mitchell W

2013-09-01

Women are at higher risk than men for bleeding and vascular complications after percutaneous coronary intervention (PCI). Compared with femoral access, radial access reduces these complications but may be more challenging in women because of higher rates of radial artery spasm, tortuosity, and occlusion as well as lower rates of procedure success. Whether the safety advantages of radial versus femoral access in women undergoing PCI are outweighed by reduced effectiveness has not been studied. The Study of Access site For Enhancement of PCI for Women is a prospective, randomized clinical trial comparing radial with femoral arterial access in women undergoing PCI. In conjunction with the US Food and Drug Administration's Critical Path Cardiac Safety Research Consortium, this study embeds the randomized clinical trial into the existing infrastructure of the National Cardiovascular Data Registry CathPCI Registry through the National Institute of Health's National Cardiovascular Research Infrastructure. The primary efficacy end point is a composite of bleeding (Bleeding Academic Research Consortium types 2, 3, or 5) or vascular complication requiring intervention occurring at 72 hours after PCI or by hospital discharge. The primary feasibility end point is procedure success. Secondary end points include procedure duration, contrast volume, radiation dose, quality of life, and a composite of 30-day death, vascular complication, or unplanned revascularization. © 2013.

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

PubMed

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

2018-03-01

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

A smart-phone intervention to address mental health stigma in the construction industry: A two-arm randomised controlled trial.

PubMed

Milner, A; Law, P C F; Mann, C; Cooper, T; Witt, K; LaMontagne, A D

2018-04-01

High levels of self-stigma are associated with a range of adverse mental health, treatment, and functional outcomes. This prospective study examined the effects of an electronic mental health stigma reduction intervention on self-stigma (self-blame, shame, and help-seeking inhibition) among male construction workers in Australia. Male construction workers (N = 682) were randomly assigned to receive either the intervention condition or the wait list control over a six-week period. Self-stigma was assessed using the Self-Stigma of Depression Scale at post-intervention. We conducted linear regression to assess the effectiveness of the intervention on self-stigma, adjusting for relevant covariates. Self-stigma was relatively low in the sample. The intervention had no significant effect on self-stigma, after adjusting for confounders. There were reductions in stigma in both the intervention and control groups at 6-week follow-up. Process evaluation indicated that participants generally enjoyed the program and felt that it was beneficial to their mental health. These observations underscore the need for further research to elucidate understanding of the experience of self-stigma among employed males.

Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma

PubMed Central

Wechsler, Michael E.; Kelley, John M.; Boyd, Ingrid O.E.; Dutile, Stefanie; Marigowda, Gautham; Kirsch, Irving; Israel, Elliot; Kaptchuk, Ted J.

2011-01-01

BACKGROUND In prospective experimental studies in patients with asthma, it is difficult to determine whether responses to placebo differ from the natural course of physiological changes that occur without any intervention. We compared the effects of a bronchodilator, two placebo interventions, and no intervention on outcomes in patients with asthma. METHODS In a double-blind, crossover pilot study, we randomly assigned 46 patients with asthma to active treatment with an albuterol inhaler, a placebo inhaler, sham acupuncture, or no intervention. Using a block design, we administered one each of these four interventions in random order during four sequential visits (3 to 7 days apart); this procedure was repeated in two more blocks of visits (for a total of 12 visits by each patient). At each visit, spirometry was performed repeatedly over a period of 2 hours. Maximum forced expiratory volume in 1 second (FEV1) was measured, and patients’ self-reported improvement ratings were recorded. RESULTS Among the 39 patients who completed the study, albuterol resulted in a 20% increase in FEV1, as compared with approximately 7% with each of the other three interventions (P<0.001). However, patients’ reports of improvement after the intervention did not differ significantly for the albuterol inhaler (50% improvement), placebo inhaler (45%), or sham acupuncture (46%), but the subjective improvement with all three of these interventions was significantly greater than that with the no-intervention control (21%) (P<0.001). CONCLUSIONS Although albuterol, but not the two placebo interventions, improved FEV1 in these patients with asthma, albuterol provided no incremental benefit with respect to the self-reported outcomes. Placebo effects can be clinically meaningful and can rival the effects of active medication in patients with asthma. However, from a clinical-management and research-design perspective, patient self-reports can be unreliable. An assessment of untreated responses in asthma may be essential in evaluating patient-reported outcomes. (Funded by the National Center for Complementary and Alternative Medicine; ClinicalTrials.gov number, NCT01143688.) PMID:21751905

Active albuterol or placebo, sham acupuncture, or no intervention in asthma.

PubMed

Wechsler, Michael E; Kelley, John M; Boyd, Ingrid O E; Dutile, Stefanie; Marigowda, Gautham; Kirsch, Irving; Israel, Elliot; Kaptchuk, Ted J

2011-07-14

In prospective experimental studies in patients with asthma, it is difficult to determine whether responses to placebo differ from the natural course of physiological changes that occur without any intervention. We compared the effects of a bronchodilator, two placebo interventions, and no intervention on outcomes in patients with asthma. In a double-blind, crossover pilot study, we randomly assigned 46 patients with asthma to active treatment with an albuterol inhaler, a placebo inhaler, sham acupuncture, or no intervention. Using a block design, we administered one each of these four interventions in random order during four sequential visits (3 to 7 days apart); this procedure was repeated in two more blocks of visits (for a total of 12 visits by each patient). At each visit, spirometry was performed repeatedly over a period of 2 hours. Maximum forced expiratory volume in 1 second (FEV(1)) was measured, and patients' self-reported improvement ratings were recorded. Among the 39 patients who completed the study, albuterol resulted in a 20% increase in FEV(1), as compared with approximately 7% with each of the other three interventions (P<0.001). However, patients' reports of improvement after the intervention did not differ significantly for the albuterol inhaler (50% improvement), placebo inhaler (45%), or sham acupuncture (46%), but the subjective improvement with all three of these interventions was significantly greater than that with the no-intervention control (21%) (P<0.001). Although albuterol, but not the two placebo interventions, improved FEV(1) in these patients with asthma, albuterol provided no incremental benefit with respect to the self-reported outcomes. Placebo effects can be clinically meaningful and can rival the effects of active medication in patients with asthma. However, from a clinical-management and research-design perspective, patient self-reports can be unreliable. An assessment of untreated responses in asthma may be essential in evaluating patient-reported outcomes. (Funded by the National Center for Complementary and Alternative Medicine.).

Adherence to Behavioral Interventions for Urge Incontinence When Combined With Drug Therapy: Adherence Rates, Barriers, and Predictors

PubMed Central

Burgio, Kathryn L.; Goode, Patricia S.; Markland, Alayne D.; Kenton, Kimberly; Balasubramanyam, Aarthi; Stoddard, Anne M.

2010-01-01

Background Behavioral intervention outcomes for urinary incontinence (UI) depend on active patient participation. Objective The purpose of this study was to describe adherence to behavioral interventions (pelvic-floor muscle [PFM] exercises, UI prevention strategies, and delayed voiding), patient-perceived exercise barriers, and predictors of exercise adherence in women with urge-predominant UI. Design This was a prospectively planned secondary data analysis from a 2-stage, multicenter, randomized clinical trial. Patients and Intervention Three hundred seven women with urge-predominant UI were randomly assigned to receive either 10 weeks of drug therapy only or 10 weeks of drug therapy combined with a behavioral intervention for UI. One hundred fifty-four participants who received the combined intervention were included in this analysis. Measurements Pelvic-floor muscle exercise adherence and exercise barriers were assessed during the intervention phase and 1 year afterward. Adherence to UI prevention strategies and delayed voiding were assessed during the intervention only. Results During intervention, 81% of women exercised at least 5 to 6 days per week, and 87% performed at least 30 PFM contractions per day. Ninety-two percent of the women used the urge suppression strategy successfully. At the 12-month follow-up, only 32% of the women exercised at least 5 to 6 days per week, and 56% performed 15 or more PFM contractions on the days they exercised. The most persistent PFM exercise barriers were difficulty remembering to exercise and finding time to exercise. Similarly, difficulty finding time to exercise persisted as a predictor of PFM exercise adherence over time. Limitations Co-administration of medication for UI may have influenced adherence. Conclusions Most women adhered to exercise during supervised intervention; however, adherence declined over the long term. Interventions to help women remember to exercise and to integrate PFM exercises and UI prevention strategies into daily life may be useful to promote long-term adherence. PMID:20671098

The china patient-centered evaluative assessment of cardiac events (PEACE) prospective study of percutaneous coronary intervention: Study design.

PubMed

Du, Xue; Pi, Yi; Dreyer, Rachel P; Li, Jing; Li, Xi; Downing, Nicholas S; Li, Li; Feng, Fang; Zhan, Lijuan; Zhang, Haibo; Guan, Wenchi; Xu, Xiao; Li, Shu-Xia; Lin, Zhenqiu; Masoudi, Frederick A; Spertus, John A; Krumholz, Harlan M; Jiang, Lixin

2016-12-01

The number of percutaneous coronary interventions (PCI) in China has increased more than 20-fold over the last decade. Consequently, there is a need for national-level information to characterize PCI indications and long-term patient outcomes, including health status, to understand and improve evolving practice patterns. This nationwide prospective study of patients receiving PCI is to: (1) measure long-term clinical outcomes (including death, acute myocardial infarction [AMI], and/or revascularization), patient-reported outcomes (PROs), cardiovascular risk factor control and adherence to medications for secondary prevention; (2) determine patient- and hospital-level factors associated with care process and outcomes; and (3) assess the appropriateness of PCI procedures. The China Patient-centered Evaluative Assessment of Cardiac Events (PEACE) Prospective Study of PCI has enrolled 5,000 consecutive patients during 2012-2014 from 34 diverse hospitals across China undergoing PCI for any indication. We abstracted details of patient's medical history, treatments, and in-hospital outcomes from medical charts, and conducted baseline, 1-, 6-, and 12-month interviews to characterize patient demographics, risk factors, clinical presentation, healthcare utilization, and health status using validated PRO measures. The primary outcome, a composite measure of death, AMI and/or revascularization, as well as PROs, medication adherence and cardiovascular risk factor control, was assessed throughout the 12-month follow-up. Blood and urine samples were collected at baseline and 12 months and stored for future analyses. To validate reports of coronary anatomy, 2,000 angiograms are randomly selected and read by two independent core laboratories. Hospital characteristics regarding their facilities, processes and organizational characteristics are assessed by site surveys. China PEACE Prospective Study of PCI will be the first study to generate novel, high-quality, comprehensive national data on patients' socio-demographic, clinical, treatment, and metabolic/genetic factors, and importantly, their long-term outcomes following PCI, including health status. This will build the foundation for PCI performance improvement efforts in China. © 2016 The Authors. Catheterization and Cardiovascular Interventions. Published by Wiley Periodicals, Inc. © 2016 The Authors. Catheterization and Cardiovascular Interventions. Published by Wiley Periodicals, Inc.

The influence of social networking sites on health behavior change: a systematic review and meta-analysis

PubMed Central

Laranjo, Liliana; Arguel, Amaël; Neves, Ana L; Gallagher, Aideen M; Kaplan, Ruth; Mortimer, Nathan; Mendes, Guilherme A; Lau, Annie Y S

2015-01-01

Objective Our aim was to evaluate the use and effectiveness of interventions using social networking sites (SNSs) to change health behaviors. Materials and methods Five databases were scanned using a predefined search strategy. Studies were included if they focused on patients/consumers, involved an SNS intervention, had an outcome related to health behavior change, and were prospective. Studies were screened by independent investigators, and assessed using Cochrane's ‘risk of bias’ tool. Randomized controlled trials were pooled in a meta-analysis. Results The database search retrieved 4656 citations; 12 studies (7411 participants) met the inclusion criteria. Facebook was the most utilized SNS, followed by health-specific SNSs, and Twitter. Eight randomized controlled trials were combined in a meta-analysis. A positive effect of SNS interventions on health behavior outcomes was found (Hedges’ g 0.24; 95% CI 0.04 to 0.43). There was considerable heterogeneity (I2 = 84.0%; T2 = 0.058) and no evidence of publication bias. Discussion To the best of our knowledge, this is the first meta-analysis evaluating the effectiveness of SNS interventions in changing health-related behaviors. Most studies evaluated multi-component interventions, posing problems in isolating the specific effect of the SNS. Health behavior change theories were seldom mentioned in the included articles, but two particularly innovative studies used ‘network alteration’, showing a positive effect. Overall, SNS interventions appeared to be effective in promoting changes in health-related behaviors, and further research regarding the application of these promising tools is warranted. Conclusions Our study showed a positive effect of SNS interventions on health behavior-related outcomes, but there was considerable heterogeneity. Protocol registration The protocol for this systematic review is registered at http://www.crd.york.ac.uk/PROSPERO with the number CRD42013004140. PMID:25005606

Effectiveness of a Self-monitoring Device for Urinary Sodium-to-Potassium Ratio on Dietary Improvement in Free-Living Adults: a Randomized Controlled Trial

PubMed Central

Ueshima, Hirotsugu; Ohgami, Naoto; Yamashita, Hideyuki; Miyagawa, Naoko; Kondo, Keiko; Torii, Sayuki; Yoshita, Katsushi; Shiga, Toshikazu; Ohkubo, Takayoshi; Arima, Hisatomi; Miura, Katsuyuki

2018-01-01

Background Reducing the urinary sodium-to-potassium ratio is important for reducing both blood pressure and risk of cardiovascular disease. Among free-living Japanese individuals, we carried out a randomized trial to clarify the effect of lifestyle modification for lowering urinary sodium-to-potassium ratio using a self-monitoring device. Methods This was an open, prospective, parallel randomized, controlled trial. Ninety-two individuals were recruited from Japanese volunteers. Participants were randomly allocated into intervention and control groups. A month-long dietary intervention on self-monitoring urinary sodium-to-potassium ratio was carried out using monitors (HEU-001F, OMRON Healthcare Co., Ltd., Kyoto, Japan). All participants had brief dietary education and received a leaflet as usual care. Monitors were handed out to the intervention group, but not to the control group. The intervention group was asked to measure at least one spot urine sodium-to-potassium ratio daily, and advised to lower their sodium-to-potassium ratio toward the target of less than 1. Outcomes included changes in 24-hour urinary sodium-to-potassium ratio, sodium excretion, potassium excretion, blood pressure, and body weight in both groups. Results Mean measurement frequency of monitoring was 2.8 times/day during the intervention. Changes in urinary sodium-to-potassium ratio were −0.55 in the intervention group and −0.06 in the control group (P = 0.088); respective sodium excretion changes were −18.5 mmol/24 hours and −8.7 mmol/24 hours (P = 0.528); and corresponding potassium excretion was 2.6 mmol/24 hours and −1.5 mmol/24 hours (P = 0.300). No significant reductions were observed in either blood pressure or body weight after the intervention. Conclusions Providing the device to self-monitor a sodium-to-potassium ratio did not achieve the targeted reduction of the ratio in “pure self-management” settings, indicating further needs to study an effective method to enhance the synergetic effect of dietary programs and self-monitoring practice to achieve the reduction. However, we cannot deny the possibility of reducing sodium-to-potassium ratio using a self-monitoring device. PMID:29093302

Nonoperative management in children with early acute appendicitis: A systematic review.

PubMed

Xu, Jane; Adams, Susan; Liu, Yingrui Cyril; Karpelowsky, Jonathan

2017-09-01

Appendectomy has remained the gold standard treatment of acute appendicitis for more than 100years. Nonoperative management (NOM) has been shown to be a valid treatment alternative for acute uncomplicated appendicitis in adults. A systematic review of available evidence comparing operative management (OM) and NOM in children with acute uncomplicated appendicitis was performed. Systematic searches of MedLine, Embase, and a clinical trial register (https://clinicaltrials.gov/) were performed in March 2016. Only articles that studied NOM for uncomplicated appendicitis in children were included. Data generation was performed independently by two authors, and quality was assessed using the rating schema by the Oxford Centre for Evidence-Based Medicine. 15 articles were selected: four retrospective analyses, four prospective cohort studies, four prospective nonrandomized comparative trials and one randomized controlled trial (RCT). Initial success of the NOM groups (a cure within two weeks of intervention) ranged from 58 to 100%, with 0.1-31.8% recurrence at one year. Although present literature is scarce, publications support the feasibility of further studies investigating NOM of acute uncomplicated appendicitis in children. Higher quality prospective RCTs with larger sample sizes and robust randomization methods, studying the noninferiority of NOM with antibiotics compared with OM are required to establish its utility. This manuscript is a systematic review and thus assigned the lowest evidence used from the manuscripts analyzed which is a Level IV. Copyright © 2017. Published by Elsevier Inc.

A randomized trial of maternal influenza immunization decision-making: A test of persuasive messaging models.

PubMed

Frew, Paula M; Kriss, Jennifer L; Chamberlain, Allison T; Malik, Fauzia; Chung, Yunmi; Cortés, Marielysse; Omer, Saad B

2016-08-02

We sought to examine the effectiveness of persuasive communication interventions on influenza vaccination uptake among black/African American pregnant women in Atlanta, Georgia. We recruited black/African American pregnant women ages 18 to 50 y from Atlanta, GA to participate in a prospective, randomized controlled trial of influenza immunization messaging conducted from January to April 2013. Eligible participants were randomized to 3 study arms. We conducted follow-up questionnaires on influenza immunization at 30-days post-partum with all groups. Chi-square and t tests evaluated group differences, and outcome intention-to-treat assessment utilized log-binomial regression models. Of the 106 enrolled, 95 women completed the study (90% retention), of which 31 were randomly assigned to affective messaging intervention ("Pregnant Pause" video), 30 to cognitive messaging intervention ("Vaccines for a Healthy Pregnancy" video), and 34 to a comparison condition (receipt of the Influenza Vaccine Information Statement). The three groups were balanced on baseline demographic characteristics and reported health behaviors. At baseline, most women (63%, n = 60) reported no receipt of seasonal influenza immunization during the previous 5 y. They expressed a low likelihood (2.1 ± 2.8 on 0-10 scale) of obtaining influenza immunization during their current pregnancy. At 30-days postpartum follow-up, influenza immunization was low among all participants (7-13%) demonstrating no effect after a single exposure to either affective messaging (RR = 1.10; 95% CI: 0.30-4.01) or cognitive messaging interventions (RR = 0.57; 95% CI: 0.11-2.88). Women cited various reasons for not obtaining maternal influenza immunizations. These included concern about vaccine harm (47%, n = 40), low perceived influenza infection risk (31%, n = 26), and a history of immunization nonreceipt (24%, n = 20). The findings reflect the limitations associated with a single exposure to varying maternal influenza immunization message approaches on vaccine behavior. For this population, repeated influenza immunization exposures may be warranted with alterations in message format, content, and relevance for coverage improvement.

Whole body vibration exercise for chronic low back pain: study protocol for a single-blind randomized controlled trial.

PubMed

Wang, Xue-Qiang; Pi, Yan-Lin; Chen, Pei-Jie; Chen, Bin-Lin; Liang, Lei-Chao; Li, Xin; Wang, Xiao; Zhang, Juan

2014-04-02

Low back pain affects approximately 80% of people at some stage in their lives. Exercise therapy is the most widely used nonsurgical intervention for low back pain in practice guidelines. Whole body vibration exercise is becoming increasingly popular for relieving musculoskeletal pain and improving health-related quality of life. However, the efficacy of whole body vibration exercise for low back pain is not without dispute. This study aims to estimate the effect of whole body vibration exercise for chronic low back pain. We will conduct a prospective, single-blind, randomized controlled trial of 120 patients with chronic low back pain. Patients will be randomly assigned into an intervention group and a control group. The intervention group will participate in whole body vibration exercise twice a week for 3 months. The control group will receive general exercise twice a week for 3 months. Primary outcome measures will be the visual analog scale for pain, the Oswestry Disability Index and adverse events. The secondary outcome measures will include muscle strength and endurance of spine, trunk proprioception, transversus abdominis activation capacity, and quality of life. We will conduct intention-to-treat analysis if any participants withdraw from the trial. Important features of this study include the randomization procedures, single-blind, large sample size, and a standardized protocol for whole body vibration in chronic low back pain. This study aims to determine whether whole body vibration exercise produces more beneficial effects than general exercise for chronic low back pain. Therefore, our results will be useful for patients with chronic low back pain as well as for medical staff and health-care decision makers. Chinese Clinical Trial Registry: ChiCTR-TRC-13003708.

Effects of weight management program on postural stability and neuromuscular function among obese children: study protocol for a randomized controlled trial.

PubMed

Sun, Fenghua; Wang, Li-Juan; Wang, Lin

2015-04-10

Childhood obesity is one of the most critical public health problems in the world. It is associated with low neuromuscular function and postural deformities. Whether weight loss can improve postural stability and neuromuscular control, benefit daily activities, or prevent injury is unknown. Therefore, this study attempts to investigate the effect of a 6 month weight management program on postural stability and neuromuscular control among obese children. We will conduct a prospective, single-blind, randomized controlled trial with 120 prepubescent obese children. Participants will be randomly assigned to a weight management group or a control group. The weight management group will participate in a dietary and exercise program. The control group will receive health education. After the intervention, participants will be followed for 6 months with no active intervention. The primary and secondary outcomes will be assessed at the baseline, and after 6 months and 12 months. Primary outcome measures will include body weight, body height, body mass index, waist circumference, hip circumference, and body fat percentage. Secondary outcome measures will include three-dimensional functional biomechanics in different tasks, proprioception tests of the knee and ankle, neuromuscular response of the leg muscles, and muscle strength tests of the knee and ankle. Furthermore, adverse events will be recorded and analyzed. An intention-to-treat analysis will be performed if any participants withdraw from the trial. The important features of this trial include the randomization procedures and large sample size. This study attempts to estimate the effect of weight loss intervention on outcomes, including daily life function, postural stability, and neuromuscular control in prepubescent obese children. Therefore, our results can be useful for obese children, medical staff, and healthcare decision makers. Chinese Clinical Trial Registry ChiCTR-IOB-15005874.

Multicenter, randomized trial of quantitative pretest probability to reduce unnecessary medical radiation exposure in emergency department patients with chest pain and dyspnea.

PubMed

Kline, Jeffrey A; Jones, Alan E; Shapiro, Nathan I; Hernandez, Jackeline; Hogg, Melanie M; Troyer, Jennifer; Nelson, R Darrel

2014-01-01

Use of pretest probability can reduce unnecessary testing. We hypothesize that quantitative pretest probability, linked to evidence-based management strategies, can reduce unnecessary radiation exposure and cost in low-risk patients with symptoms suggestive of acute coronary syndrome and pulmonary embolism. This was a prospective, 4-center, randomized controlled trial of decision support effectiveness. Subjects were adults with chest pain and dyspnea, nondiagnostic ECGs, and no obvious diagnosis. The clinician provided data needed to compute pretest probabilities from a Web-based system. Clinicians randomized to the intervention group received the pretest probability estimates for both acute coronary syndrome and pulmonary embolism and suggested clinical actions designed to lower radiation exposure and cost. The control group received nothing. Patients were followed for 90 days. The primary outcome and sample size of 550 was predicated on a significant reduction in the proportion of healthy patients exposed to >5 mSv chest radiation. A total of 550 patients were randomized, and 541 had complete data. The proportion with >5 mSv to the chest and no significant cardiopulmonary diagnosis within 90 days was reduced from 33% to 25% (P=0.038). The intervention group had significantly lower median chest radiation exposure (0.06 versus 0.34 mSv; P=0.037, Mann-Whitney U test) and lower median costs ($934 versus $1275; P=0.018) for medical care. Adverse events occurred in 16% of controls and 11% in the intervention group (P=0.06). Provision of pretest probability and prescriptive advice reduced radiation exposure and cost of care in low-risk ambulatory patients with symptoms of acute coronary syndrome and pulmonary embolism. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01059500.

Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions

PubMed Central

2014-01-01

Background The Medical Research Councils’ framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable. Methods We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions. Results Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework. Conclusions Incorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex interventions, thereby increasing the likelihood that the intervention will be ultimately effective, sustainable and scalable. We urge researchers developing and evaluating complex interventions to consider using this approach, to evaluate its usefulness and to build an evidence base to further refine the methodology. Trial registration Clinical trials.gov: NCT02160249 PMID:24996765

Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions.

PubMed

De Silva, Mary J; Breuer, Erica; Lee, Lucy; Asher, Laura; Chowdhary, Neerja; Lund, Crick; Patel, Vikram

2014-07-05

The Medical Research Councils' framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable. We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions. Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework. Incorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex interventions, thereby increasing the likelihood that the intervention will be ultimately effective, sustainable and scalable. We urge researchers developing and evaluating complex interventions to consider using this approach, to evaluate its usefulness and to build an evidence base to further refine the methodology. Clinical trials.gov: NCT02160249.

Study Protocol for a Randomized Clinical Trial of a Fatherhood Intervention for African American Non-resident Fathers: Can we Improve Father and Child Outcomes?

PubMed Central

Julion, Wrenetha A.; Sumo, Jen’nea; Bounds, Dawn T.; Breitenstein, Susan M.; Schoeny, Michael; Gross, Deborah; Fogg, Louis

2016-01-01

Purpose African American (AA) fathers who live apart from their children face multiple obstacles to consistent and positive involvement with their children. Consequently, significant numbers of children are bereft of their father’s positive involvement. Intervention research that is explicitly focused on promoting the positive involvement of non-resident AA fathers with their young children is limited. The purpose of this article is to describe the study protocol of a randomized trial (RCT) designed to test the Building Bridges to Fatherhood program against a financial literacy comparison condition; and discuss early implementation challenges. Methods Fathers (n = 180) are recruited to attend 10 group meetings, reimbursed for transportation, given dinner and activity vouchers for spending time with their child, and incentivized with a $40 gift card at each data collection time point. Mothers are incentivized ($40 gift card) at data collection and must be amenable to father child interaction. Intervention targets include father psychological well-being, parenting competence, communication, problem-solving ability; father-mother relationship quality; and child behavioral and emotional/social development. Results To date, 57 fathers have been randomized to study condition. Recruitment has been influenced by father and mother hesitancy and the logistics of reaching and maintaining contact with participants. Strategies to surmount challenges to father and mother recruitment and engagement have been developed. Conclusions The prospective benefits of positive father involvement to children, fathers and families outweigh the challenges associated with community-based intervention research. The findings from this RCT can inform the body of knowledge on engaging AA non-resident fathers in culturally relevant fatherhood programming. PMID:27241687

Serum anti-Müllerian hormone and ovarian morphology assessed by magnetic resonance imaging in response to acupuncture and exercise in women with polycystic ovary syndrome: secondary analyses of a randomized controlled trial.

PubMed

Leonhardt, Henrik; Hellström, Mikael; Gull, Berit; Lind, Anna-Karin; Nilsson, Lars; Janson, Per Olof; Stener-Victorin, Elisabet

2015-03-01

To investigate whether electro-acupuncture or physical exercise influence serum anti-Müllerian hormone (AMH), antral follicle count (AFC) or ovarian volume in women with polycystic ovary syndrome (PCOS). Secondary analyses of a prospective, randomized controlled clinical trial. University Hospital, Sweden. Seventy-four women with PCOS recruited from the general population. Women with PCOS were randomized to 16 weeks of electro-acupuncture (14 treatments), exercise (at least three times/week), or no intervention. Serum AMH recorded at baseline, after 16 weeks of intervention, and at follow up at 32 weeks. AFC, and ovarian volume assessed by magnetic resonance imaging at baseline and at follow up at 32 weeks. After 16 weeks of intervention, serum levels of AMH were significantly decreased in the electro-acupuncture group by 17.5% (p < 0.001), and differed from the change in the exercise group. AMH remained decreased by 15% (p = 0.004) also at follow up at 32 weeks, but did not differ from the exercise or the no intervention groups. There was a decrease by 8.5% (p = 0.015) in ovarian volume between baseline and follow up in the electro-acupuncture group, and by 11.7% (p = 0.01) in AFC in the physical exercise group. No other variables were affected. This study is the first to demonstrate that acupuncture reduces serum AMH levels and ovarian volume. Physical exercise did not influence circulating AMH or ovarian volume. Despite a within-group decrease in AFC, exercise did not lead to a between-group difference. © 2014 Nordic Federation of Societies of Obstetrics and Gynecology.

Study protocol for a randomized clinical trial of a fatherhood intervention for African American non-resident fathers: Can we improve father and child outcomes?

PubMed

Julion, Wrenetha A; Sumo, Jen'nea; Bounds, Dawn T; Breitenstein, Susan M; Schoeny, Michael; Gross, Deborah; Fogg, Louis

2016-07-01

African American (AA) fathers who live apart from their children face multiple obstacles to consistent and positive involvement with their children. Consequently, significant numbers of children are bereft of their father's positive involvement. Intervention research that is explicitly focused on promoting the positive involvement of non-resident AA fathers with their young children is limited. The purpose of this article is to describe the study protocol of a randomized trial (RCT) designed to test the Building Bridges to Fatherhood program against a financial literacy comparison condition; and discuss early implementation challenges. Fathers (n=180) are recruited to attend 10 group meetings, reimbursed for transportation, given dinner and activity vouchers for spending time with their child, and incentivized with a $40 gift card at each data collection time point. Mothers are incentivized ($40 gift card) at data collection and must be amenable to father child interaction. Intervention targets include father psychological well-being, parenting competence, communication, problem-solving ability; father-mother relationship quality; and child behavioral and emotional/social development. To date, 57 fathers have been randomized to study condition. Recruitment has been influenced by father and mother hesitancy and the logistics of reaching and maintaining contact with participants. Strategies to surmount challenges to father and mother recruitment and engagement have been developed. The prospective benefits of positive father involvement to children, fathers and families outweigh the challenges associated with community-based intervention research. The findings from this RCT can inform the body of knowledge on engaging AA non-resident fathers in culturally relevant fatherhood programming. Copyright © 2016 Elsevier Inc. All rights reserved.

Breaking Bad News in obstetrics: a randomized trial of simulation followed by debriefing or lecture.

PubMed

Karkowsky, Chavi Eve; Landsberger, Ellen J; Bernstein, Peter S; Dayal, Ashlesha; Goffman, Dena; Madden, Robert C; Chazotte, Cynthia

2016-11-01

Although communication skills represent an increasingly important aspect of medical care, little has been done to assess the best method of teaching these skills. Our study was designed to assess simulation-debriefing compared to lecture in teaching skills for Breaking Bad News (BBN) in obstetrics. This is a randomized prospective trial of house staff from a large academic medical center. Subjects initially underwent baseline simulation, followed by evaluation on BBN skills by themselves, a faculty observer, and the standardized patient (SP). The subjects were then immediately randomized to a debriefing session by faculty or to a lecture about BBN. Subsequently, both groups underwent a second simulation with the same three assessments, yielding post-intervention data. 35 subjects completed both simulations. Both debriefing and lecture curricula showed improvement in scores by self (p = 0.010) and faculty (p < 0.001). The debriefing group improved significantly more than the lecture group for self-evaluation; additionally, improvements were greater for the debrief group in verbal and nonverbal skills. Long-term follow-up three months after both interventions demonstrated continued improvement in BBN. Simulation training with debriefing is effective for teaching communication skills, and superior to lecture for self-perceived improvement. Long-term follow-up suggested retention of confidence in BBN skills.

Applications of Data Mining Methods in the Integrative Medical Studies of Coronary Heart Disease: Progress and Prospect

PubMed Central

Wang, Yixin; Guo, Fang

2014-01-01

A large amount of studies show that real-world study has strong external validity than the traditional randomized controlled trials and can evaluate the effect of interventions in a real clinical setting, which open up a new path for researches of integrative medicine in coronary heart disease. However, clinical data of integrative medicine in coronary heart disease are large in amount and complex in data types, making exploring the appropriate methodology a hot topic. Data mining techniques are to analyze and dig out useful information and knowledge from the mass data to guide people's practices. The present review provides insights for the main features of data mining and their applications of integrative medical studies in coronary heart disease, aiming to analyze the progress and prospect in this field. PMID:25544853

Evaluation of a health promotion program in children: Study protocol and design of the cluster-randomized Baden-Württemberg primary school study [DRKS-ID: DRKS00000494

PubMed Central

2012-01-01

Background Increasing prevalences of overweight and obesity in children are known problems in industrialized countries. Early prevention is important as overweight and obesity persist over time and are related with health problems later in adulthood. "Komm mit in das gesunde Boot - Grundschule" is a school-based program to promote a healthier lifestyle. Main goals of the intervention are to increase physical activity, decrease the consumption of sugar-sweetened beverages, and to decrease time spent sedentary by promoting active choices for healthy lifestyle. The program to date is distributed by 34 project delivery consultants in the state of Baden-Württemberg and is currently implemented in 427 primary schools. The efficacy of this large scale intervention is examined via the Baden-Württemberg Study. Methods/Design The Baden-Württemberg Study is a prospective, stratified, cluster-randomized, and longitudinal study with two groups (intervention group and control group). Measurements were taken at the beginning of the academic years 2010/2011 and 2011/2012. Efficacy of the intervention is being assessed using three main outcomes: changes in waist circumference, skinfold thickness and 6 minutes run. Stratified cluster-randomization (according to class grade level) was performed for primary schools; pupils, teachers/principals, and parents were investigated. An approximately balanced number of classes in intervention group and control group could be reached by stratified randomization and was maintained at follow-up. Discussion At present, "Komm mit in das Gesunde Boot - Grundschule" is the largest school-based health promotion program in Germany. Comparative objective main outcomes are used for the evaluation of efficacy. Simulations showed sufficient power with the existing sample size. Therefore, the results will show whether the promotion of a healthier lifestyle in primary school children is possible using a relatively low effort within a school-based program involving children, teachers and parents. The research team anticipates that not only efficacy will be proven in this study but also expects many other positive effects of the program. Trial registration German Clinical Trials Register (DRKS), DRKS-ID: DRKS00000494 PMID:22394693

Evaluation of a health promotion program in children: Study protocol and design of the cluster-randomized Baden-Württemberg primary school study [DRKS-ID: DRKS00000494].

PubMed

Dreyhaupt, Jens; Koch, Benjamin; Wirt, Tamara; Schreiber, Anja; Brandstetter, Susanne; Kesztyüs, Dorothea; Wartha, Olivia; Kobel, Susanne; Kettner, Sarah; Prokopchuk, Dmytro; Hundsdörfer, Verena; Klepsch, Melina; Wiedom, Martina; Sufeida, Sabrina; Fischbach, Nanette; Muche, Rainer; Seufert, Tina; Steinacker, Jürgen Michael

2012-03-06

Increasing prevalences of overweight and obesity in children are known problems in industrialized countries. Early prevention is important as overweight and obesity persist over time and are related with health problems later in adulthood. "Komm mit in das gesunde Boot - Grundschule" is a school-based program to promote a healthier lifestyle. Main goals of the intervention are to increase physical activity, decrease the consumption of sugar-sweetened beverages, and to decrease time spent sedentary by promoting active choices for healthy lifestyle. The program to date is distributed by 34 project delivery consultants in the state of Baden-Württemberg and is currently implemented in 427 primary schools. The efficacy of this large scale intervention is examined via the Baden-Württemberg Study. The Baden-Württemberg Study is a prospective, stratified, cluster-randomized, and longitudinal study with two groups (intervention group and control group). Measurements were taken at the beginning of the academic years 2010/2011 and 2011/2012. Efficacy of the intervention is being assessed using three main outcomes: changes in waist circumference, skinfold thickness and 6 minutes run. Stratified cluster-randomization (according to class grade level) was performed for primary schools; pupils, teachers/principals, and parents were investigated. An approximately balanced number of classes in intervention group and control group could be reached by stratified randomization and was maintained at follow-up. At present, "Komm mit in das Gesunde Boot - Grundschule" is the largest school-based health promotion program in Germany. Comparative objective main outcomes are used for the evaluation of efficacy. Simulations showed sufficient power with the existing sample size. Therefore, the results will show whether the promotion of a healthier lifestyle in primary school children is possible using a relatively low effort within a school-based program involving children, teachers and parents. The research team anticipates that not only efficacy will be proven in this study but also expects many other positive effects of the program. German Clinical Trials Register (DRKS), DRKS-ID: DRKS00000494.

Effects of moderate red wine consumption on liver fat and blood lipids: a prospective randomized study.

PubMed

Kechagias, Stergios; Zanjani, Sepehr; Gjellan, Solveig; Leinhard, Olof Dahlqvist; Kihlberg, Johan; Smedby, Orjan; Johansson, Lars; Kullberg, Joel; Ahlström, Håkan; Lindström, Torbjörn; Nystrom, Fredrik H

2011-11-01

There have been no human prospective randomized studies of the amount of alcohol that can induce hepatic steatosis. Thirty-two healthy women and twelve healthy men (34 ± 9 years of age) were randomized to consume 150 ml of red wine/day for women (16 g ethanol/day) or double that amount for men (33 g ethanol/day), or to alcohol abstention for 90 days. Participants underwent proton-nuclear magnetic-resonance spectroscopy for measurement of hepatic triglyceride content (HTGC). Blood samples for assessment of cardiovascular risk were drawn before and after the intervention. After exclusion of three subjects with steatosis at baseline a trend towards increased HTGC was apparent for red wine (before median: 1.1%, range 0.2-3.9%, after median: 1.1%, range 0.5-5.2 %, P = 0.059) a difference that was statistically significant compared with abstainers (p = 0.02). However, no subject developed hepatic steatosis. Low-density lipoprotein (LDL)-cholesterol was lowered by red wine (-0.3 mmol/l, SE -0.1, 95% CI -0.6 to -0.04). Moderate consumption of red wine during three months increased HTGC in subjects without steatosis at baseline. However, since not a single participant developed steatosis we suggest that the threshold of alcohol consumption to define nonalcoholic fatty liver disease should not be lower than the amount in our study.

Increasing Kyphosis Predicts Worsening Mobility in Older Community-Dwelling Women: A Prospective Cohort Study

PubMed Central

Katzman, Wendy B.; Vittinghoff, Eric; Ensrud, Kris; Black, Dennis M.; Kado, Deborah M.

2013-01-01

OBJECTIVES To determine whether increasing kyphosis angle was independently associated with poorer mobility as measured according to the Timed Up and Go Test (TUG), after controlling for other established risk factors. DESIGN Prospective cohort study. SETTING Eleven clinical centers in the United States. PARTICIPANTS Two thousand seven hundred seventy-seven women aged 55 to 80 randomized to the placebo arms of the Fracture Intervention Trial, a randomized controlled trial of the effect of alendronate on risk for osteoporotic fractures. MEASUREMENTS The primary predictor was change in kyphosis angle, measured using the Debrunner Kyphometer; the outcome was change in mobility, measured as performance time on the TUG. Covariates were baseline age, kyphosis angle, body mass index (BMI), self-reported health status, grip strength, change in total hip bond mineral density (BMD), and number of vertebral fractures over a mean of 4.4 years. RESULTS Greater kyphosis angle predicted longer mobility performance times (P<.001), independent of other significant predictors of worsening mobility including age, baseline kyphosis, health status, grip strength, BMI, change in hip BMD, and new vertebral fractures. TUG performance times increased by 0.02 seconds (95% confidence interval (CI) =0.01–0.03) for every 5° increase in kyphosis angle, more than the increase in mobility time of 0.01 seconds (95% CI =0.005–0.03) over 1 year observed in this cohort. CONCLUSION Increasing kyphosis angle is independently associated with worsening mobility. Interventions are needed to prevent or reduce increasing kyphosis and mobility decline. PMID:21198460

A systematic review on the relations between pasta consumption and cardio-metabolic risk factors.

PubMed

Huang, M; Li, J; Ha, M-A; Riccardi, G; Liu, S

2017-11-01

The traditional Italian dish pasta is a major food source of starch with low glycemic index (GI) and an important low-GI component of the Mediterranean diet. This systematic review aimed at assessing comprehensively and in-depth the potential benefit of pasta on cardio-metabolic disease risk factors. Following a standard protocol, we conducted a systematic literature search of PubMed, CINAHL, and Cochrane Central Register of Controlled Trials for prospective cohort studies and randomized controlled dietary intervention trials that examined pasta and pasta-related fiber and grain intake in relation to cardio-metabolic risk factors of interest. Studies comparing postprandial glucose response to pasta with that to bread or potato were quantitatively summarized using meta-analysis of standardized mean difference. Evidence from studies with pasta as part of low-GI dietary intervention and studies investigating different types of pasta were qualitatively summarized. Pasta meals have significantly lower postprandial glucose response than bread or potato meals, but evidence was lacking in terms of how the intake of pasta can influence cardio-metabolic disease risk. More long-term randomized controlled trials are needed where investigators directly contrast the cardio-metabolic effects of pasta and bread or potato. Long-term prospective cohort studies with required data available should also be analyzed regarding the effect of pasta intake on disease endpoints. Copyright © 2017 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

Effectiveness of a tailor-made intervention for pregnancy-related pelvic girdle and/or low back pain after delivery: Short-term results of a randomized clinical trial [ISRCTN08477490

PubMed Central

Bastiaenen, Caroline HG; de Bie, Rob A; Wolters, Pieter MJC; Vlaeyen, Johan WS; Leffers, Pieter; Stelma, Foekje; Bastiaanssen, Janneke M; Essed, Gerard GM; van den Brandt, Piet A

2006-01-01

Background For the moment, scientific evaluation of programs on treatment of pregnancy-related pelvic girdle and/or low back pain after delivery is hardly available with only one study with a positive result, suggesting uncertainty about the optimal approach. Investigators draw particular attention to biomedical factors but there is growing evidence that biopsychosocial factors appear to be even more important as a basis of an intervention program. Methods We studied the effectiveness of a tailor-made program with respect to biopsychosocial factors (intervention group) in women with pregnancy-related pelvic girdle and/ or low back pain versus usual care based on a pain contingent basis (control group) shortly after delivery in a randomized controlled trial. Women with severe complaints shortly after delivery were selected from a longitudinal prospective cohort study (n = 7526), aimed at pregnancy-related pelvic girdle and/or low back pain in the Netherlands. A concealed block randomization was performed after collecting baseline data. Researchers were blinded to treatment assignment. Outcomes were evaluated within the domains of the biopsychosocial approach. Primary outcome concerned limitations in activities (RDQ). Follow-up measurements were performed 12 weeks after delivery. Results Since May 2001 until July 2003, 869 women out of the cohort made a request for treatment by a physiotherapist, 10 days after delivery. Because of a quick recovery in two weeks time, we included only 126 women three weeks after delivery. There was a statistically significant and clinically relevant difference in improvement on the primary outcome (RDQ) between the two groups in favor of the experimental intervention. Conclusion The results favored the hypotheses. Women's worries about their condition were major targets in the experimental intervention. The prognosis after delivery, especially in de first weeks, turned out to be favorable. PMID:16504165

A prospective cluster-randomized trial to implement the Canadian CT Head Rule in emergency departments

PubMed Central

Stiell, Ian G.; Clement, Catherine M.; Grimshaw, Jeremy M.; Brison, Robert J.; Rowe, Brian H.; Lee, Jacques S.; Shah, Amit; Brehaut, Jamie; Holroyd, Brian R.; Schull, Michael J.; McKnight, R. Douglas; Eisenhauer, Mary A.; Dreyer, Jonathan; Letovsky, Eric; Rutledge, Tim; MacPhail, Iain; Ross, Scott; Perry, Jeffrey J.; Ip, Urbain; Lesiuk, Howard; Bennett, Carol; Wells, George A.

2010-01-01

Background The Canadian CT Head Rule was developed to allow physicians to be more selective when ordering computed tomography (CT) imaging for patients with minor head injury. We sought to evaluate the effectiveness of implementing this validated decision rule at multiple emergency departments. Methods We conducted a matched-pair cluster-randomized trial that compared the outcomes of 4531 patients with minor head injury during two 12-month periods (before and after) at hospital emergency departments in Canada, six of which were randomly allocated as intervention sites and six as control sites. At the intervention sites, active strategies, including education, changes to policy and real-time reminders on radiologic requisitions were used to implement the Canadian CT Head Rule. The main outcome measure was referral for CT scan of the head. Results Baseline characteristics of patients were similar when comparing control to intervention sites. At the intervention sites, the proportion of patients referred for CT imaging increased from the “before” period (62.8%) to the “after” period (76.2%) (difference +13.3%, 95% CI 9.7%–17.0%). At the control sites, the proportion of CT imaging usage also increased, from 67.5% to 74.1% (difference +6.7%, 95% CI 2.6%–10.8%). The change in mean imaging rates from the “before” period to the “after” period for intervention versus control hospitals was not significant (p = 0.16). There were no missed brain injuries or adverse outcomes. Interpretation Our knowledge–translation-based trial of the Canadian CT Head Rule did not reduce rates of CT imaging in Canadian emergency departments. Future studies should identify strategies to deal with barriers to implementation of this decision rule and explore more effective approaches to knowledge translation. (ClinicalTrials.gov trial register no. NCT00993252) PMID:20732978

Does random urine drug testing reduce illicit drug use in chronic pain patients receiving opioids?

PubMed

Manchikanti, Laxmaiah; Manchukonda, Rajeev; Pampati, Vidyasagar; Damron, Kim S; Brandon, Doris E; Cash, Kim A; McManus, Carla D

2006-04-01

Prescription drug abuse and illicit drug use are common in chronic pain patients. Adherence monitoring with screening tests, and urine drug testing, periodic monitoring with prescription monitoring programs, has become a common practice in recent years. Random drug testing for appropriate use of opioids and use of illicit drugs is often used in pain management practices. Thus, it is expected that random urine drug testing will deter use of illicit drugs, and also improve compliance. To study the prevalence of illicit drug use in patients receiving opioids for chronic pain management and to compare the results of illicit drug use with the results from a previous study. A prospective, consecutive study. Interventional pain management practice setting in the United States. A total of 500 consecutive patients on opioids, considered to be receiving stable doses of opioids supplemental to their interventional techniques, were studied by random drug testing. Testing was performed by rapid drug screen. Results were considered positive if one or more of the monitored illicit drugs including cocaine, marijuana (THC), methamphetamine or amphetamines were present. Illicit drug use was evident in 80 patients, or 16%, with marijuana in 11%, cocaine in 5%, and methamphetamine and/or amphetamines in 2%. When compared with previous data, the overall illicit drug use was significantly less. Illicit drug use in elderly patients was absent. The prevalence of illicit drug abuse in patients with chronic pain receiving opioids continues to be a common occurence. This study showed significant reductions in overall illicit drug use with adherence monitoring combined with random urine drug testing.

A Pilot Randomized Controlled Trial on the Effects of a Progressive Exercise Program on the Range of Motion and Upper Extremity Grip Strength in Young Adults With Breast Cancer.

PubMed

Ibrahim, Marize; Muanza, Thierry; Smirnow, Nadia; Sateren, Warren; Fournier, Beatrice; Kavan, Petr; Palumbo, Michael; Dalfen, Richard; Dalzell, Mary-Ann

2018-02-01

The diagnosis of breast cancer in young women (aged 18-45 years) has been increasing. Women are commonly left coping with treatment-related disabilities of the upper limb that can persist for > 2 years postoperatively. A total of 59 young breast cancer patients (29 in the intervention group and 30 in the control group) participated in a pilot prospective randomized controlled trial to determine whether a 12-week postradiation exercise program would improve long-term arm mobility, pain, and handgrip strength. During an 18-month period, range of motion, handgrip strength, and pain with shoulder movements were evaluated at 6 points. Although the differences were not statistically significant, external rotation and horizontal abduction of the shoulder improved in the intervention group immediately after the exercise intervention (3 months) and showed a trend toward less pain on movement. However, at 18 months after radiation the control and intervention groups both retained a residual loss of range and persistent pain with movement. Radiation to the axilla and/or chest wall yielded long-term (18 months) limitations in flexion and horizontal abduction compared with hypofractionation, which resulted in greater flexion and external rotation at 18 months. The median grip strength of the study participants corresponded to the 10th percentile of healthy aged-matched white women. The exercise intervention timed shortly after radiation improved short-term shoulder mobility and pain; however, these gains were not sustained at 18 months after radiation. Copyright © 2017 Elsevier Inc. All rights reserved.

Behavior management for children and adolescents with acquired brain injury.

PubMed

Slifer, Keith J; Amari, Adrianna

2009-01-01

Behavioral problems such as disinhibition, irritability, restlessness, distractibility, and aggression are common after acquired brain injury (ABI). The persistence and severity of these problems impair the brain-injured individual's reintegration into family, school, and community life. Since the early 1980s, behavior analysis and therapy have been used to address the behavioral sequelae of ABI. These interventions are based on principles of learning and behavior that have been robustly successful when applied across a broad range of other clinical populations. Most of the research on behavioral treatment after ABI has involved clinical case studies or studies employing single-subject experimental designs across a series of cases. The literature supports the effectiveness of these interventions across ages, injury severities, and stages of recovery after ABI. Recommended guidelines for behavior management include: direct behavioral observations, systematic assessment of environmental and within-patient variables associated with aberrant behavior, antecedent management to minimize the probability of aberrant behavior, provision of functionally equivalent alternative means of controlling the environment, and differential reinforcement to shape positive behavior and coping strategies while not inadvertently shaping emergent, disruptive sequelae. This package of interventions requires direction by a highly skilled behavioral psychologist or therapist who systematically monitors target behavior to evaluate progress and guide treatment decisions. A coordinated multisite effort is needed to design intervention protocols that can be studied prospectively in randomized controlled trials. However, there will continue to be an important role for single subject experimental design for studying the results of individualized interventions and obtaining pilot data to guide subsequent randomized controlled trails. (c) 2009 Wiley-Liss, Inc.

Tailored Activities to Manage Neuropsychiatric Behaviors in Persons with Dementia and Reduce Caregiver Burden: A Randomized Pilot Study

PubMed Central

Gitlin, Laura N.; Winter, Laraine; Burke, Janice; Chernett, Nancy; Dennis, Marie P.; Hauck, Walter W.

2009-01-01

Objective To test whether the Tailored Activity Program for at-home dementia patients reduces neuropsychiatric behaviors and caregiver burden. Method A prospective, two-group controlled pilot study with 60 dyads randomized to treatment or wait-list control. Dyads were interviewed at baseline and 4 months (trial endpoint); control participants then received intervention and were reassessed 4 months later. The 8-session occupational therapy intervention involved neuropsychological and functional testing from which activities were customized and instruction in use provided to caregivers. Results At 4-months, compared to controls, intervention caregivers reported reduced frequency of behaviors (p = .010; Cohen’s d = .72), specifically for shadowing (p = .003, Cohen’s d = 3.10) and repetitive questioning (p = .23, Cohen’s d = 1.22); greater activity engagement (p = .029, Cohen’s d = .61); and ability to keep busy (p = .017, Cohen’s d = .71). Also, fewer intervention caregivers reported agitation (p = .014, Cohen’s d = .75) or argumentation (p = .010, Cohen’s d = .77). Caregiver benefits included fewer hours doing things (p = .005, Cohen’s d = 1.14) and being on duty (p = .001, Cohen’s d = 1.01), greater mastery (p = .013, Cohen’s d = .55), self-efficacy (p = .011, Cohen’s d = .74), and use of simplification techniques (p = .023, Cohen’s d = .71). Wait-list control participants showed similar benefits for behavioral frequency following intervention. Conclusions Results suggest clinically-relevant benefits for both dementia patients and caregivers, with treatment minimizing the occurrence of behaviors that commonly trigger nursing home placement. PMID:18310553

Early Intensive Leg Training to Enhance Walking in Children With Perinatal Stroke: Protocol for a Randomized Controlled Trial.

PubMed

Hurd, Caitlin; Livingstone, Donna; Brunton, Kelly; Teves, Michelle; Zewdie, Ephrem; Smith, Allison; Ciechanski, Patrick; Gorassini, Monica A; Kirton, Adam; Watt, Man-Joe; Andersen, John; Yager, Jerome; Yang, Jaynie F

2017-08-01

Development of motor pathways is modulated by activity in these pathways, when they are maturing (ie, critical period). Perinatal stroke injures motor pathways, including the corticospinal tracts, reducing their activity and impairing motor function. Current intervention for the lower limb emphasizes passive approaches (stretching, braces, botulinum toxin injections). The study hypothesis was that intensive, early, child-initiated activity during the critical period will enhance connectivity of motor pathways to the legs and improve motor function. The study objective was to determine whether early intervention with intensive activity is better than standard care, intervention delivered during the proposed critical period is better than after, and the outcomes are different when the intervention is delivered by a physical therapist in an institution vs. a parent at home. A prospective, delay-group, single-blind, randomized controlled trial (RCT) and a parallel, cohort study of children living beyond commuting distance and receiving an intervention delivered by their parent. The RCT intervention was provided in university laboratories, and parent training was provided in the childs home. Children 8 months to 3 years old with MRI-confirmed perinatal ischemic stroke and early signs of hemiparesis. Intensive, play-based leg activity with weights for the affected leg and foot, 1 hour/day, 4 days/week for 12 weeks. The primary outcome was the Gross Motor Function Measure-66 score. Secondary outcomes were motion analysis of walking, full-day step counts, motor evoked potentials from transcranial magnetic stimulation, and patellar tendon reflexes. Inter-individual heterogeneity in the severity of the stroke and behavioral differences are substantial but measurable. Differences in intervention delivery and assessment scoring are minimized by standardization and training. The intervention, contrary to current practice, could change physical therapy interventions for children with perinatal stroke. © 2017 American Physical Therapy Association

Factors Influencing Functional Outcomes and Return-to-Work After Amputation: A Review of the Literature.

PubMed

Darter, Benjamin J; Hawley, Carolyn E; Armstrong, Amy J; Avellone, Lauren; Wehman, Paul

2018-02-03

Purpose Amputation is a life changing event that can significantly impact an individual's physical and mental well-being. Our objective was to review literature exploring the impact of amputation upon a person's functioning and inclusion in the workplace. Methods Medline, CINAHL, and PsycINFO were searched using keywords related to amputation, employment and community reintegration. Eligible studies were published since 2000 and one of the following study designs: randomized controlled trial, non-randomized controlled trial, retrospective study, prospective study, concurrent cohort study, or cross sectional study. Studies for civilians with amputation as well as service members and Veterans with amputation were considered for inclusion. Results The search identified 995 articles, 25 of which met inclusion/exclusion criteria and were included in the review. While strong evidence for correlations and predictors of outcomes after amputation were limited, multiple factors were identified as contributing to physical functioning and employment after amputation. Conclusions Outcomes after amputation can vary widely with many potentially inter-related factors contributing. The factors identified may also serve to inform the development of interventions aiming to improve functional performance and reintegration after amputation. Furthermore, the review highlights the need for more high quality prospective studies.

Online self-administered training for post-traumatic stress disorder treatment providers: design and methods for a randomized, prospective intervention study

PubMed Central

2012-01-01

This paper presents the rationale and methods for a randomized controlled evaluation of web-based training in motivational interviewing, goal setting, and behavioral task assignment. Web-based training may be a practical and cost-effective way to address the need for large-scale mental health training in evidence-based practice; however, there is a dearth of well-controlled outcome studies of these approaches. For the current trial, 168 mental health providers treating post-traumatic stress disorder (PTSD) were assigned to web-based training plus supervision, web-based training, or training-as-usual (control). A novel standardized patient (SP) assessment was developed and implemented for objective measurement of changes in clinical skills, while on-line self-report measures were used for assessing changes in knowledge, perceived self-efficacy, and practice related to cognitive behavioral therapy (CBT) techniques. Eligible participants were all actively involved in mental health treatment of veterans with PTSD. Study methodology illustrates ways of developing training content, recruiting participants, and assessing knowledge, perceived self-efficacy, and competency-based outcomes, and demonstrates the feasibility of conducting prospective studies of training efficacy or effectiveness in large healthcare systems. PMID:22583520

PRotective Effect on the coronary microcirculation of patients with DIabetes by Clopidogrel or Ticagrelor (PREDICT): study rationale and design. A randomized multicenter clinical trial using intracoronary multimodal physiology.

PubMed

Cerrato, Enrico; Quirós, Alicia; Echavarría-Pinto, Mauro; Mejia-Renteria, Hernan; Aldazabal, Andres; Ryan, Nicola; Gonzalo, Nieves; Jimenez-Quevedo, Pilar; Nombela-Franco, Luis; Salinas, Pablo; Núñez-Gil, Iván J; Rumoroso, José Ramón; Fernández-Ortiz, Antonio; Macaya, Carlos; Escaned, Javier

2017-05-19

In diabetic patients a predisposed coronary microcirculation along with a higher risk of distal particulate embolization during primary percutaneous intervention (PCI) increases the risk of peri-procedural microcirculatory damage. However, new antiplatelet agents, in particular Ticagrelor, may protect the microcirculation through its adenosine-mediated vasodilatory effects. PREDICT is an original, prospective, randomized, multicenter controlled study designed to investigate the protective effect of Ticagrelor on the microcirculation during PCI in patient with diabetes mellitus type 2 or pre-diabetic status. The primary endpoints of this study aim to test (i) the decrease in microcirculatory resistance with antiplatelet therapy (Ticagrelor > Clopidogrel; mechanistic effect) and (ii) the relative microcirculatory protection of Ticagrelor compared to Clopidogrel during PCI (Ticagrelor < Clopidogrel; protective effect). PREDICT will be the first multicentre clinical trial to test the adenosine-mediated vasodilatory effect of Ticagrelor on the microcirculation during PCI in diabetic patients. The results will provide important insights into the prospective beneficial effect of this drug in preventing microvascular impairment related to PCI ( http://www.clinicaltrials.gov No. NCT02698618).

Micronutrients and Leptospirosis: A Review of the Current Evidence

PubMed Central

Herman, Heather S.; Mehta, Saurabh; Cárdenas, Washington B.; Stewart-Ibarra, Anna M.

2016-01-01

Background Leptospirosis is one of the most widespread zoonoses and represents a major threat to human health. Due to the high burden of disease, limitations in diagnostics, and limited coverage and availability of effective human and veterinary vaccines, leptospirosis remains an important neglected zoonotic disease. Improved surveillance and identification of modifiable risk factors for leptospirosis are urgently needed to inform preventive interventions and reduce the risk and severity of Leptospira infection. Methodology/Principal Findings This review was conducted to examine the evidence that links micronutrient status and Leptospira infection. A total of 56 studies were included in this review: 28 in vitro, 17 animal, and 11 observational human studies. Findings indicated that Leptospira infection is associated with higher iron and calcium concentrations and hypomagnesemia. Conclusions/Significance Few prospective studies and no randomized trials have been conducted to date to examine the potential role of micronutrients in Leptospira infection. The limited literature in this area constrains our ability to make specific recommendations; however, the roles of iron, calcium, and magnesium in leptospirosis represent important areas for future research. The role of micronutrients in leptospirosis risk and severity needs to be elucidated in larger prospective human studies to inform public health interventions. PMID:27387046

Impact of nursing interventions on adherence to treatment with antituberculosis drugs in children and young people: A non-randomized controlled trial.

PubMed

Guix-Comellas, Eva Maria; Rozas-Quesada, Librada; Velasco-Arnaiz, Eneritz; Ferres-Canals, Ariadna; Estrada-Masllorens, Joan Maria; Force-Sanmartín, Enriqueta; Noguera-Julian, Antoni

2018-05-03

To evaluate the association of a new nursing intervention on the adherence to antituberculosis treatment in a pediatric cohort (<18 years). Tuberculosis remains a public health problem worldwide. The risk of developing tuberculosis after primary infection and its severity are higher in children. Proper adherence to antituberculosis treatment is critical for disease control. Non-randomized controlled trial; Phase 1, retrospective (2011-2013), compared with Phase 2, prospective with intervention (2015-2016), in a referral center for pediatric tuberculosis in Spain (NCT03230409). A total of 359 patients who received antituberculosis drugs after close contact with a smear-positive patient (primary chemoprophylaxis) or were treated for latent tuberculosis infection or tuberculosis disease were included, 261 in Phase 1 and 98 in Phase 2. In phase 2, a new nurse-led intervention was implemented in all patients and included two educational steps (written information in the child's native language and follow-up telephone calls) and two monitoring steps (Eidus-Hamilton test and follow-up questionnaire) that were exclusively carried out by nurses. Adherence to antituberculosis treatment increased from 74.7% in Phase 1 to 87.8% in Phase 2 (p=0.014; Chi-square test), after the implementation of the nurse-led intervention. In Phase 2, non-adherence was only associated with being born abroad (28.6% versus 7.8%; p=0.019; Chi-square test) and with foreign origin families (27.3% versus 0%; p<0.0001; Chi-square test). The nurse-led intervention was associated to an increase in adherence to antituberculosis treatment. Immigrant-related variables remained major risk factors for sub-optimal adherence in a low-endemic setting. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Against colorectal cancer in our neighborhoods (ACCION): A comprehensive community-wide colorectal cancer screening intervention for the uninsured in a predominantly Hispanic community.

PubMed

Shokar, Navkiran K; Byrd, Theresa; Salaiz, Rebekah; Flores, Silvia; Chaparro, Maria; Calderon-Mora, Jessica; Reininger, Belinda; Dwivedi, Alok

2016-10-01

Colorectal cancer (CRC) is the second leading cause of cancer deaths in the USA. Screening is widely recommended but underutilized, particularly among the low income, the uninsured, recent immigrants and Hispanics. The study objective was to determine the effectiveness of a comprehensive community-wide, bilingual, CRC screening intervention among uninsured predominantly Hispanic individuals. This prospective study was embedded in a CRC screening program and utilized a quasi-experimental design. Recruitment occurred from Community and clinic sites. Inclusion criteria were aged 50-75years, uninsured, due for CRC screening, Texas address and exclusions were a history of CRC, or recent rectal bleeding. Eligible subjects were randomized to either promotora (P), video (V), or combined promotora and video (PV) education, and also received no-cost screening with fecal immunochemical testing or colonoscopy and navigation. The non-randomly allocated controls recruited from a similar county, received no intervention. The main outcome was 6month self-reported CRC screening. Per protocol and worst case scenario analyses, and logistic regression with covariate adjustment were performed. 784 subjects (467 in intervention group, 317 controls) were recruited; mean age was 56.8years; 78.4% were female, 98.7% were Hispanic and 90.0% were born in Mexico. In the worst case scenario analysis (n=784) screening uptake was 80.5% in the intervention group and 17.0% in the control group [relative risk 4.73, 95% CI: 3.69-6.05, P<0.001]. No educational group differences were observed. Covariate adjustment did not significantly alter the effect. A multicomponent community-wide, bilingual, CRC screening intervention significantly increased CRC screening in an uninsured predominantly Hispanic population. Copyright © 2016 Elsevier Inc. All rights reserved.

Neuromuscular exercise and counseling decrease absenteeism due to low back pain in young conscripts: a randomized, population-based primary prevention study.

PubMed

Suni, Jaana H; Taanila, Henri; Mattila, Ville M; Ohrankämmen, Olli; Vuorinen, Petteri; Pihlajamäki, Harri; Parkkari, Jari

2013-03-01

Controlled intervention with group randomization. To investigate the effectiveness of a 6-month neuromuscular exercise and counseling program for reducing the incidence of low back pain (LBP) and disability in young conscripts, with a healthy back at the beginning of their compulsory military service. Basic military training is physically demanding on the back and requires adequate physical fitness. LBP causes significant morbidity and absence from military service. Participants were conscripts of 4 successive age cohorts (n = 1409). In the prestudy year, before adoption of the intervention, 2 successive cohorts of conscripts of 4 companies (n = 719) were followed prospectively for 6 months to study the baseline incidence of different categories of LBP. In the intervention year, conscripts (n = 690) of 2 new cohorts of the same companies (intervention group: antitank, engineer; control group: signal, mortar) were followed for 6 months. The intervention program aimed to improve conscripts' control of their lumbar neutral zone and specifically to avoid full lumbar flexion in all daily tasks. Total number and incidence of off-duty days due to LBP were significantly decreased in the intervention companies compared with controls (adjusted hazard ratio = 0.42, 95% confidence interval = 0.18-0.94, P = 0.035). The number of LBP cases, number of health clinic visits due to LBP, and number of the most severe cases showed a similar decreasing trend but without statistical significance. These findings provide evidence that exercise and education to improve control of the lumbar neutral zone have a prophylactic effect on LPB-related off-duty service days in the military environment when implemented as part of military service among young healthy men.

Social Media Interventions to Promote HIV Testing, Linkage, Adherence, and Retention: Systematic Review and Meta-Analysis

PubMed Central

Gupta, Somya; Wang, Jiangtao; Hightow-Weidman, Lisa B; Muessig, Kathryn E; Tang, Weiming; Pan, Stephen; Pendse, Razia; Tucker, Joseph D

2017-01-01

Background Social media is increasingly used to deliver HIV interventions for key populations worldwide. However, little is known about the specific uses and effects of social media on human immunodeficiency virus (HIV) interventions. Objective This systematic review examines the effectiveness of social media interventions to promote HIV testing, linkage, adherence, and retention among key populations. Methods We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist and Cochrane guidelines for this review and registered it on the International Prospective Register of Systematic Reviews, PROSPERO. We systematically searched six databases and three conference websites using search terms related to HIV, social media, and key populations. We included studies where (1) the intervention was created or implemented on social media platforms, (2) study population included men who have sex with men (MSM), transgender individuals, people who inject drugs (PWID), and/or sex workers, and (3) outcomes included promoting HIV testing, linkage, adherence, and/or retention. Meta-analyses were conducted by Review Manager, version 5.3. Pooled relative risk (RR) and 95% confidence intervals were calculated by random-effects models. Results Among 981 manuscripts identified, 26 studies met the inclusion criteria. We found 18 studies from high-income countries, 8 in middle-income countries, and 0 in low-income countries. Eight were randomized controlled trials, and 18 were observational studies. All studies (n=26) included MSM; five studies also included transgender individuals. The focus of 21 studies was HIV testing, four on HIV testing and linkage to care, and one on antiretroviral therapy adherence. Social media interventions were used to do the following: build online interactive communities to encourage HIV testing/adherence (10 studies), provide HIV testing services (9 studies), disseminate HIV information (9 studies), and develop intervention materials (1 study). Of the studies providing HIV self-testing, 16% of participants requested HIV testing kits from social media platforms. Existing social media platforms such as Facebook (n=15) and the gay dating app Grindr (n=10) were used most frequently. Data from four studies show that HIV testing uptake increased after social media interventions (n=1283, RR 1.50, 95% CI 1.28-1.76). In the studies where social media interventions were participatory, HIV testing uptake was higher in the intervention arm than the comparison arm (n=1023, RR 1.64, 95% CI 1.19-2.26). Conclusions Social media interventions are effective in promoting HIV testing among MSM in many settings. Social media interventions to improve HIV services beyond HIV testing in low- and middle-income countries and among other key populations need to be considered. Trial Registration International Prospective Register of Systematic Reviews (PROSPERO): CRD42016048073; http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42016048073 (Archived by WebCite at http://www. webcitation.org/6usLCJK3v) PMID:29175811

Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report.

PubMed

Berger, Marc L; Dreyer, Nancy; Anderson, Fred; Towse, Adrian; Sedrakyan, Art; Normand, Sharon-Lise

2012-01-01

In both the United States and Europe there has been an increased interest in using comparative effectiveness research of interventions to inform health policy decisions. Prospective observational studies will undoubtedly be conducted with increased frequency to assess the comparative effectiveness of different treatments, including as a tool for "coverage with evidence development," "risk-sharing contracting," or key element in a "learning health-care system." The principle alternatives for comparative effectiveness research include retrospective observational studies, prospective observational studies, randomized clinical trials, and naturalistic ("pragmatic") randomized clinical trials. This report details the recommendations of a Good Research Practice Task Force on Prospective Observational Studies for comparative effectiveness research. Key issues discussed include how to decide when to do a prospective observational study in light of its advantages and disadvantages with respect to alternatives, and the report summarizes the challenges and approaches to the appropriate design, analysis, and execution of prospective observational studies to make them most valuable and relevant to health-care decision makers. The task force emphasizes the need for precision and clarity in specifying the key policy questions to be addressed and that studies should be designed with a goal of drawing causal inferences whenever possible. If a study is being performed to support a policy decision, then it should be designed as hypothesis testing-this requires drafting a protocol as if subjects were to be randomized and that investigators clearly state the purpose or main hypotheses, define the treatment groups and outcomes, identify all measured and unmeasured confounders, and specify the primary analyses and required sample size. Separate from analytic and statistical approaches, study design choices may strengthen the ability to address potential biases and confounding in prospective observational studies. The use of inception cohorts, new user designs, multiple comparator groups, matching designs, and assessment of outcomes thought not to be impacted by the therapies being compared are several strategies that should be given strong consideration recognizing that there may be feasibility constraints. The reasoning behind all study design and analytic choices should be transparent and explained in study protocol. Execution of prospective observational studies is as important as their design and analysis in ensuring that results are valuable and relevant, especially capturing the target population of interest, having reasonably complete and nondifferential follow-up. Similar to the concept of the importance of declaring a prespecified hypothesis, we believe that the credibility of many prospective observational studies would be enhanced by their registration on appropriate publicly accessible sites (e.g., clinicaltrials.gov and encepp.eu) in advance of their execution. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Management of acute perianal sepsis in neutropenic patients with hematological malignancy.

PubMed

Baker, B; Al-Salman, M; Daoud, F

2014-04-01

In neutropenic patients with acute perianal sepsis in the setting of hematological malignancy, the classical clinical features of abscess formation are lacking. Additionally, the role of surgical intervention is not well established. In this review, we discuss the challenges and controversy regarding diagnosis and optimal management when clear surgical guidelines are absent. In the literature, there is great diversity in the surgical approach to these patients, which leads to a high percentage of diagnostic errors, risks of complications, and unnecessary interventions. We review the literature and assess whether surgical intervention produces better outcomes than a non-surgical approach. Studies published on perianal sepsis in neutropenic cancer patients were identified by searching PubMed using the following key words: "perianal sepsis/abscesses, anorectal sepsis/abscess, neutropenia, hematological malignancy, cancer". No randomized or prospective studies on the management of acute perianal sepsis in hematological malignancies were found. The largest retrospective study and most comprehensive clinical data demonstrated that 42% of patients were treated successfully without surgical intervention and without morbidity or mortality related to treatment chosen. Small retrospective studies advocated surgical intervention, while the majority of successes were in a non-operative treatment. It is difficult to formulate a conclusion given the small retrospective series on management of neutropenic patients with hematological malignancies. While there is no evidence mandating a routine surgical approach in this category of patients, non-surgical management including careful follow-up to determine whether the patient's condition is deteriorating or treatment has failed is an acceptable approach in selected patients without pathognomonic features of abscess. Comprehensive and well-designed prospective studies are needed to firmly establish the guidelines of treatment protocols.

Risk reduction of brain infarction during carotid endarterectomy or stenting using sonolysis - Prospective randomized study pilot data

NASA Astrophysics Data System (ADS)

Kuliha, Martin; Školoudík, David; Martin Roubec, Martin; Herzig, Roman; Procházka, Václav; Jonszta, Tomáš; Krajča, Jan; Czerný, Dan; Hrbáč, Tomáš; Otáhal, David; Langová, Kateřina

2012-11-01

Sonolysis is a new therapeutic option for the acceleration of arterial recanalization. The aim of this study was to confirm risk reduction of brain infarction during endarterectomy (CEA) and stenting (CAS) of the internal carotid artery (ICA) using sonolysis with continuous transcranial Doppler (TCD) monitoring by diagnostic 2 MHz probe, additional interest was to assess impact of new brain ischemic lesions on cognitive functions. Methods: All consecutive patients 1/ with ICA stenosis >70%, 2/ indicated to CEA or CAS, 3/ with signed informed consent, were enrolled to the prospective study during 17 months. Patients were randomized into 2 groups: Group 1 with sonolysis during intervention and Group 2 without sonolysis. Neurological examination, assessment of cognitive functions and brain magnetic resonance imaging (MRI) were performed before and 24 hours after intervention in all patients. Occurrence of new brain infarctions (including infarctions >0.5 cm3), and the results of Mini-Mental State Examination, Clock Drawing and Verbal Fluency tests were statistically evaluated using T-test. Results: 97 patients were included into the study. Out of the 47 patients randomized to sonolysis group (Group 1) 25 underwent CEA (Group 1a) and 22 CAS (Group 1b). Out of the 50 patients randomized to control group (Group 2), 22 underwent CEA (Group 2a) and 28 CAS (Group 2b). New ischemic brain infarctions on follow up MRI were found in 14 (29.8%) patients in Group 1-4 (16.0%) in Group 1a and 10 (45.5%) in Group 1b. In Group 2, new ischemic brain infarctions were found in 18 (36.0%) patients-6 (27.3%) in Group 2a and 12 (42.9%) in Group 2b (p>0.05 in all cases). New ischemic brain infarctions >0.5 cm3 were found in 4 (8.5 %) patients in Group 1 and in 11 (22.0 %) patients in Group 2 (p= 0.017). No significant differences were found in cognitive tests results between subgroups (p>0.05 in all tests). Conclusion: Sonolysis seems to be effective in the prevention of large ischemic brain infarctions during CEA and CAS.

The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial.

PubMed

Huang, Jia; Lin, Zhengkun; Wang, Qin; Liu, Feiwen; Liu, Jiao; Fang, Yunhua; Chen, Shanjia; Zhou, Xiaoxuan; Hong, Wenjun; Wu, Jinsong; Madrigal-Mora, Natalia; Zheng, Guohua; Yang, Shanli; Tao, Jing; Chen, Lidian

2015-06-16

Post-stroke cognitive impairment (PSCI) lessens quality of life, restricts the rehabilitation of stroke, and increases the social and economic burden stroke imposes on patients and their families. Therefore effective treatment is of paramount importance. However, the treatment of PSCI is very limited. The primary aim of this protocol is to propose a lower cost and more effective therapy, and to confirm the long-term effectiveness of a therapeutic regimen of Traditional Chinese Medicine (TCM) rehabilitation for PSCI. A prospective, multicenter, large sample, randomized controlled trial will be conducted. A total of 416 eligible patients will be recruited from seven inpatient and outpatient stroke rehabilitation units and randomly allocated into a therapeutic regimen of TCM rehabilitation group or cognitive training (CT) control group. The intervention period of both groups will last 12 weeks (30 minutes per day, five days per week). Primary and secondary outcomes will be measured at baseline, 12 weeks (at the end of the intervention), and 36 weeks (after the 24-week follow-up period). This protocol presents an objective design of a multicenter, large sample, randomized controlled trial that aims to put forward a lower cost and more effective therapy, and confirm the long-term effectiveness of a therapeutic regimen of TCM rehabilitation for PSCI through subjective and objective assessments, as well as highlight its economic advantages. This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-14004872 ) on 23 June 2014.

Distraction osteogenesis versus orthognathic surgery for the treatment of maxillary hypoplasia in cleft lip and palate patients: a systematic review.

PubMed

Austin, S L; Mattick, C R; Waterhouse, P J

2015-05-01

To compare the effectiveness of distraction osteogenesis to orthognathic surgery for the treatment of maxillary hypoplasia in individuals with cleft lip and palate. A systematic review of prospective randomized, quasi-randomized or controlled clinical trials. MEDLINE, EMBASE, Scopus, Web of Science, CINAHL, CENTRAL, trial registers and grey literature were searched. Hand searching of five relevant journals was completed. Two reviewers independently completed inclusion assessment. Data extraction and risk of bias assessment were completed by a single reviewer and checked by a second reviewer. Five publications all reporting different outcomes of a single randomized controlled trial are included within the review. The quality of the evidence was low with a high risk of bias. Both surgical interventions produce significant soft tissue improvement. Horizontal relapse of the maxilla was statistically significantly greater following orthognathic surgery. There was no statistically significant difference in speech and velo-pharyngeal function between the interventions. Maxillary distraction initially lowered social self-esteem, but this improved with time resulting in higher satisfaction with life in the long term. The low quality of evidence included within the review means there is insufficient evidence to conclude whether there is a difference in effectiveness between maxillary distraction and osteotomy for the treatment of cleft-related maxillary hypoplasia. There is a need for further high-quality randomized controlled trials to allow conclusive recommendations to be made. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Proactive tobacco cessation outreach to smokers of low socioeconomic status: a randomized clinical trial.

PubMed

Haas, Jennifer S; Linder, Jeffrey A; Park, Elyse R; Gonzalez, Irina; Rigotti, Nancy A; Klinger, Elissa V; Kontos, Emily Z; Zaslavsky, Alan M; Brawarsky, Phyllis; Marinacci, Lucas X; St Hubert, Stella; Fleegler, Eric W; Williams, David R

2015-02-01

Widening socioeconomic disparities in mortality in the United States are largely explained by slower declines in tobacco use among smokers of low socioeconomic status (SES) than among those of higher SES, which points to the need for targeted tobacco cessation interventions. Documentation of smoking status in electronic health records (EHRs) provides the tools for health systems to proactively offer tobacco treatment to socioeconomically disadvantaged smokers. To evaluate a proactive tobacco cessation strategy that addresses sociocontextual mediators of tobacco use for low-SES smokers. This prospective, randomized clinical trial included low-SES adult smokers who described their race and/or ethnicity as black, Hispanic, or white and received primary care at 1 of 13 practices in the greater Boston area (intervention group, n = 399; control group, n = 308). We analyzed EHRs to identify potentially eligible participants and then used interactive voice response (IVR) techniques to reach out to them. Consenting patients were randomized to either receive usual care from their own health care team or enter an intervention program that included (1) telephone-based motivational counseling, (2) free nicotine replacement therapy (NRT) for 6 weeks, (3) access to community-based referrals to address sociocontextual mediators of tobacco use, and (4) integration of all these components into their normal health care through the EHR system. Self-reported past-7-day tobacco abstinence 9 months after randomization ("quitting"), assessed by automated caller or blinded study staff. The intervention group had a higher quit rate than the usual care group (17.8% vs 8.1%; odds ratio, 2.5; 95% CI, 1.5-4.0; number needed to treat, 10). We examined whether use of intervention components was associated with quitting among individuals in the intervention group: individuals who participated in the telephone counseling were more likely to quit than those who did not (21.2% vs 10.4%; P < .001). There was no difference in quitting by use of NRT. Quitting did not differ by a request for a community referral, but individuals who used their referral were more likely to quit than those who did not (43.6% vs 15.3%; P < .001). Proactive, IVR-facilitated outreach enables engagement with low-SES smokers. Providing counseling, NRT, and access to community-based resources to address sociocontextual mediators among smokers reached in this setting is effective. clinicaltrials.gov Identifier: NCT01156610.

Circular instead of hierarchical: methodological principles for the evaluation of complex interventions

PubMed Central

Walach, Harald; Falkenberg, Torkel; Fønnebø, Vinjar; Lewith, George; Jonas, Wayne B

2006-01-01

Background The reasoning behind evaluating medical interventions is that a hierarchy of methods exists which successively produce improved and therefore more rigorous evidence based medicine upon which to make clinical decisions. At the foundation of this hierarchy are case studies, retrospective and prospective case series, followed by cohort studies with historical and concomitant non-randomized controls. Open-label randomized controlled studies (RCTs), and finally blinded, placebo-controlled RCTs, which offer most internal validity are considered the most reliable evidence. Rigorous RCTs remove bias. Evidence from RCTs forms the basis of meta-analyses and systematic reviews. This hierarchy, founded on a pharmacological model of therapy, is generalized to other interventions which may be complex and non-pharmacological (healing, acupuncture and surgery). Discussion The hierarchical model is valid for limited questions of efficacy, for instance for regulatory purposes and newly devised products and pharmacological preparations. It is inadequate for the evaluation of complex interventions such as physiotherapy, surgery and complementary and alternative medicine (CAM). This has to do with the essential tension between internal validity (rigor and the removal of bias) and external validity (generalizability). Summary Instead of an Evidence Hierarchy, we propose a Circular Model. This would imply a multiplicity of methods, using different designs, counterbalancing their individual strengths and weaknesses to arrive at pragmatic but equally rigorous evidence which would provide significant assistance in clinical and health systems innovation. Such evidence would better inform national health care technology assessment agencies and promote evidence based health reform. PMID:16796762

Effects of hydration combined with Shenfu injection on contrast-induced acute kidney injury in acute coronary syndrome patients undergoing percutaneous coronary intervention.

PubMed

Guo, Zhen; Niu, Dandan; Yu, Yaren; Zhen, Di; Li, Wenhua

2017-11-01

The aim of the present study was to evaluate the efficacy and safety of the Shenfu injection (SFI) in the prevention of contrast-induced acute kidney injury (CI-AKI) in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). A single-center prospective and randomized controlled trial was performed and 148 ACS patients undergoing PCI were divided randomly into control (n=74; receiving only 0.9% sodium chloride solution for routine hydration) and intervention (n=74; based upon routine hydration and receiving SFI) groups. Serum creatinine (Scr), blood urea nitrogen and urinary neutrophil gelatinase-associated lipocalin (NGAL) were evaluated at the start, and 1 and 2 days after PCI. Among the 148 patients, 14 (9.4%) experienced CI-AKI subsequent to the procedure. CI-AKI occurred in 2.7% of the SFI group and 16.2% of the control group (P<0.05). The incidence of CI-AKI was lower in the intervention group when compared with the control. No serious adverse effects were observed in all patients. No differences between the levels of Scr and estimated glomerular filtration rate in the two groups were identified. However, 12 h after PCI, the urinary NGAL level in the control group was significantly higher than that in the SFI group (P<0.05). Thus, hydration combined with SFI was identified to be more effective than hydration with sodium chloride in the prevention of CI-AKI in ACS patients undergoing PCI.

Impact of an academic-community partnership in medical education on community health: evaluation of a novel student-based home visitation program.

PubMed

Rock, John A; Acuña, Juan M; Lozano, Juan Manuel; Martinez, Iveris L; Greer, Pedro J; Brown, David R; Brewster, Luther; Simpson, Joe L

2014-04-01

Current US healthcare delivery systems do not adequately address healthcare demands. Physicians are integral but rarely emphasize prevention as a primary tool to change health outcomes. Home visitation is an effective method for changing health outcomes in some populations. The Florida International University Herbert Wertheim College of Medicine Green Family Foundation NeighborhoodHELP service-learning program assigns medical students to be members of interprofessional teams that conduct household visits to determine their healthcare needs. We performed a prospective evaluation of 330 households randomly assigned to one of two groups: visitation from a student team (intervention group) or limited intervention (control group). The program design allowed randomly selected control households to replace intervention-group households that left the program of their own volition. All of the households were surveyed at baseline and after 1 year of participation in the study. After 1 year in the program and after adjustment for confounders, intervention group households proved more likely (P ≤ 0.05) than control households to have undergone physical examinations, blood pressure monitoring, and cervical cytology screenings. Cholesterol screenings and mammograms were borderline significant (P = 0.05 and P = 0.06, respectively). This study supports the value of home visitation by interprofessional student teams as an effective way to increase the use of preventive health measures. The study underscores the important role interprofessional student teams may play in improving the health of US communities, while students concurrently learn about primary prevention and primary care.

Limited shock wave therapy vs sham treatment in men with Peyronie's disease: results of a prospective randomized controlled double-blind trial.

PubMed

Chitale, Sudhanshu; Morsey, Mohammed; Swift, Louise; Sethia, Krishna

2010-11-01

To assess the role of extracorporeal shock wave therapy (SWT), in a prospective randomized controlled trial, comparing limited SWT vs sham therapy in men with Peyronie's disease. In all, 36 men were randomized to six sessions of SWT or sham treatment. Geometrical measurements of penile length and deformity, and the abridged International Index of Erectile Function (IIEF) score and visual analogue score (VAS) were recorded and re-evaluated at 6 months. The patient and assessor were unaware of the treatment type. Standard nonparametric tests were used for the statistical analysis. A full set of outcome data was obtained for 16 patients in the intervention group and 20 in the sham/control group (mean age 58 and 60 years, respectively, mean duration of symptoms 15 and 33 months). There was no significant difference in the mean change between the control and intervention groups on any outcome measure. There were improvements in the mean (sd) dorsal and lateral angle, of 5.3 (11.66)° and 3.5 (17.38)° in the control group, and a deterioration of 0.9 (16.01)° and 0.9 (15.56)° in SWT group. Mean improvements in curved and straight lengths were 0.2 (0.58) and 0.1 (0.8) cm in the control and mean reductions of 0.1 (0.9) and 0.1 (1.49) cm in the SWT group. The mean changes in the IIEF and VAS scores were 0.1 (3.32) and -0.8 (1.77) for control and 0.56 (2.6) and -1.05 (1.79) for SWT group. There were no significant differences in changes of variables in Peyronie's disease treated with short-term SWT. © 2010 THE AUTHORS. JOURNAL COMPILATION © 2010 BJU INTERNATIONAL.

Reduced duration of dual antiplatelet therapy using an improved drug-eluting stent for percutaneous coronary intervention of the left main artery in a real-world, all-comer population: Rationale and study design of the prospective randomized multicenter IDEAL-LM trial.

PubMed

Lemmert, Miguel E; Oldroyd, Keith; Barragan, Paul; Lesiak, Maciej; Byrne, Robert A; Merkulov, Evgeny; Daemen, Joost; Onuma, Yoshinobu; Witberg, Karen; van Geuns, Robert-Jan

2017-05-01

Continuous improvements in stent technology make percutaneous coronary intervention (PCI) a potential alternative to surgery in selected patients with unprotected left main coronary artery (uLMCA) disease. The optimal duration of dual antiplatelet therapy (DAPT) in these patients remains undetermined, and in addition, new stent designs using a bioabsorbable polymer might allow shorter duration of DAPT. IDEAL-LM is a prospective, randomized, multicenter study that will enroll 818 patients undergoing uLMCA PCI. Patients will be randomized in a 1:1 fashion to intravascular ultrasound-guided PCI with the novel everolimus-eluting platinum-chromium Synergy stent with a biodegradable polymer (Boston Scientific, Natick, MA) followed by 4 months of DAPT or the everolimus-eluting cobalt-chromium Xience stent (Abbott Vascular, Santa Clara, CA) followed by 12 months of DAPT. The total follow-up period will be 5 years. A subset of 100 patients will undergo optical coherence tomography at 3 months. The primary end point will be major adverse cardiovascular events (composite of all-cause mortality, myocardial infarction, and ischemia-driven target vessel revascularization) at 2 years. Secondary end points will consist of the individual components of the primary end point, procedural success, a device-oriented composite end point, stent thrombosis as per Academic Research Consortium criteria, and bleeding as per Bleeding Academic Research Consortium criteria. IDEAL-LM is designed to assess the safety and efficacy of the novel Synergy stent followed by 4 months of DAPT vs the Xience stent followed by 12 months of DAPT in patients undergoing uLMCA PCI. The study will provide novel insights regarding optimal treatment strategy for patients undergoing PCI of uLMCA disease (www.clinicaltrials.gov, NCT 02303717). Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

Systematic Review of the Effectiveness of Physical Therapy Modalities in Women With Provoked Vestibulodynia.

PubMed

Morin, Mélanie; Carroll, Marie-Soleil; Bergeron, Sophie

2017-07-01

Pelvic floor muscle physical therapy is recommended in clinical guidelines for women with provoked vestibulodynia (PVD). Including isolated or combined treatment modalities, physical therapy is viewed as an effective first-line intervention, yet no systematic review concerning the effectiveness of physical therapy has been conducted. To systematically appraise the current literature on the effectiveness of physical therapy modalities for decreasing pain during intercourse and improving sexual function in women with PVD. A systematic literature search using PubMed, Scopus, CINHAL, and PEDro was conducted until October 2016. Moreover, a manual search from reference lists of included articles was performed. Ongoing trials also were reviewed using clinicaltrial.gov and ISRCTNregistry. Randomized controlled trials, prospective and retrospective cohorts, and case reports evaluating the effect of isolated or combined physical therapy modalities in women with PVD were included in the review. Main outcome measures were pain during intercourse, sexual function, and patient's perceived improvement. The literature search resulted in 43 eligible studies including 7 randomized controlled trials, 20 prospective studies, 5 retrospective studies, 6 case reports, and 6 study protocols. Most studies had a high risk of bias mainly associated with the lack of a comparison group. Another common bias was related to insufficient sample size, non-validated outcomes, non-standardized intervention, and use of other ongoing treatment. The vast majority of studies showed that physical therapy modalities such as biofeedback, dilators, electrical stimulation, education, multimodal physical therapy, and multidisciplinary approaches were effective for decreasing pain during intercourse and improving sexual function. The positive findings for the effectiveness of physical therapy modalities in women with PVD should be investigated further in robust and well-designed randomized controlled trials. Morin M, Carroll M-S, Bergeron S. Systematic Review of the Effectiveness of Physical Therapy Modalities in Women With Provoked Vestibulodynia. Sex Med Rev 2017;5:295-322. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Evaluation of a Nationwide Pharmacist-Led Phone Outreach Program to Improve Osteoporosis Management in Older Women with Recently Sustained Fractures.

PubMed

Tso, Luke S; Loi, Danmy; Mosley, David G; Yi, David; Stockl, Karen M; Lew, Heidi C; Solow, Brian K

2015-09-01

Osteoporosis-related fractures are a considerable economic burden on the U.S. health care system. Since 2008, the Centers for Medicare Medicaid Services have adopted a Medicare Part C Five-Star Quality Rating measure to ensure that a woman's previously unaddressed osteoporosis is managed appropriately after a fracture. Despite the effort to improve this gap in care, the 2013 CMS plan ratings fact sheet reported an average star rating of 1.4 stars for the osteoporosis measure, the lowest score for any measure across all health plans. To evaluate the impact of conducting a pharmacist-led, telephone outreach program to members or their providers to improve osteoporosis management in elderly women after experiencing fractures.  This was a prospective, randomized study to evaluate the effectiveness of 3 different intervention strategies within a nationwide managed care population. Women aged 66 years and older who experienced a new bone fracture between January 1, 2012-August 31, 2012, were identified through medical claims. Women who were treated with an osteoporosis medication or received a bone mineral density (BMD) test within a year of their fractures were excluded. Study patients were randomized into 3 intervention cohorts: (1) baseline intervention consisting of member educational mailing and provider educational mail or fax notification; (2) baseline intervention plus a live outbound intervention call to members by a pharmacist; and (3) baseline intervention plus a pharmacist call to members' providers to recommend starting osteoporosis therapy and/or a bone mineral density (BMD) test. An intent-to-treat and per protocol analyses were employed, and appropriate osteoporosis management (initiation of osteoporosis therapy and/or BMD testing) 120 days after the baseline intervention and 180 days after a fracture were measured. The study identified 6,591 members who were equally randomized into 3 cohorts. The baseline demographics in each cohort were similar. Results of the intent-to-treat analysis showed more members in cohort 3 receiving appropriate osteoporosis management (13.0%) compared with those in cohort 2 (10.3%, P  less than  0.005) or compared with those in cohort 1 (9.1%, P  less than  0.001). No difference was detected between those receiving additional member calls (cohort 2) and those receiving only the baseline intervention (cohort 1). Similar results were observed utilizing the 180 days after fracture time frame.  The effectiveness of a pharmacist-led telephone intervention directed at providers or members was examined in this randomized study. Pharmacist calls to members did not improve osteoporosis management over member and provider mail and fax notifications. Greater impact was demonstrated by performing a pharmacist call intervention with providers rather than with members.

Long-Term Outcomes of Medication Intervention Using the Screening Tool of Older Persons Potentially Inappropriate Prescriptions Screening Tool to Alert Doctors to Right Treatment Criteria.

PubMed

Frankenthal, Dvora; Israeli, Avi; Caraco, Yoseph; Lerman, Yaffa; Kalendaryev, Edward; Zandman-Goddard, Gisele; Lerman, Yehuda

2017-02-01

To compare 24-month outcomes of participants of a prospective randomized controlled trial (RCT) assigned to undergo a medication intervention of orally communicated recommendations based on Screening Tool of Older Persons potentially inappropriate Prescriptions (STOPP) and Screening Tool to Alert Doctors to Right Treatment (START) (intervention group) with outcomes of those assigned to undergo written medication review (control group). Retrospective cohort study. Chronic care geriatric facility. Of 359 participants from a prospective RCT conducted between April 2012 and September 2013, 306 were evaluable for another 12-month follow-up. Outcomes at 24-month follow-up included quality of prescribing (assessed according to STOPP/START), hospitalizations, falls, costs of medications, and all-cause mortality. Outcomes were compared with those reported at the beginning (baseline) and end (12-month follow-up) of the RCT. There was a significant rise in potentially inappropriate prescriptions (PIPs) (P = .01) and potentially prescriptions omissions (PPOs) (P < .001) in the intervention group between 12 and 24 months, although the prevalence of PIPs was significantly lower in the intervention group (33.3%) than the control group (48.4%) at 24-month follow-up (P = .02). Costs of medications were significantly lower in the intervention group than the control group (P < .001) at 24-month follow-up. The average number of falls in both groups dropped significantly between baseline and study closure (P = .04 and P = .008, respectively). There was no significant difference in hospitalizations and mortality between the two groups at 24-month follow-up. The effect of an orally communicated medication intervention with the STOPP/START criteria on falls was maintained over time. Direct communication between pharmacists and prescribing physicians is more efficient than written medication review and is recommended every 6 months in geriatric facilities. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

A Prospective Randomized Controlled Trial of Nonpharmacological Pain Management During Intravenous Cannulation in a Pediatric Emergency Department.

PubMed

Miller, Kate; Tan, Xianghong; Hobson, Andrew Dillon; Khan, Asaduzzaman; Ziviani, Jenny; OʼBrien, Eavan; Barua, Kim; McBride, Craig A; Kimble, Roy M

2016-07-01

Intravenous (IV) cannulation is commonly performed in pediatric emergency departments (EDs). The busy ED environment is often not conducive to conventional nonpharmacological pain management. This study assessed the use of Ditto (Diversionary Therapy Technologies, Brisbane, Australia), a handheld electronic device which provides procedural preparation and distraction, as a means of managing pain and distress during IV cannulation performed in the pediatric ED. A randomized controlled trial with 98 participants, aged 3 to 12 years, was conducted in a pediatric ED. Participants were recruited and randomized into 5 intervention groups as follows: (1) Standard Distraction, (2) PlayStation Portable Distraction, (3) Ditto Distraction, (4) Ditto Procedural Preparation, and (5) Ditto Preparation and Distraction. Children's pain and distress levels were assessed via self-reports and observational reports by caregivers and nursing staff across the following 3 time points: (1) before, (2) during, and (3) after IV cannulation. Caregivers and nursing staff reported significantly reduced pain and distress levels in children accessing the combined preparation and distraction Ditto protocol, as compared to standard distraction (P ≤ 0.01). This intervention also saw the greatest reduction in pain and distress as reported by the child. Caregiver reports indicate that using the combined Ditto protocol was most effective in reducing children's pain experiences while undergoing IV cannulation in the ED. The use of Ditto offers a promising opportunity to negotiate barriers to the provision of nonpharmacological approaches encountered in the busy ED environment, and provide nonpharmacological pain-management interventions in pediatric EDs.

Effectiveness of breastfeeding peer counseling in a low-income, predominantly Latina population: a randomized controlled trial.

PubMed

Chapman, Donna J; Damio, Grace; Young, Sara; Pérez-Escamilla, Rafael

2004-09-01

Breastfeeding peer counseling has improved breastfeeding rates in developing countries; however, its impact in this country has not been adequately evaluated. To evaluate the effectiveness of an existing, breastfeeding peer counseling program within the United States. Randomized, prospective, controlled trial in which participants were recruited prenatally and randomly assigned to receive either routine breastfeeding education or routine breastfeeding education plus peer counseling. An urban hospital serving a large population of low-income Latinas. Pregnant women (< or =26 weeks' gestation) were recruited from the hospital's prenatal clinic. Inclusion criteria specified that participants be low income, be considering breastfeeding, have delivered a healthy, full-term singleton, and have access to a telephone. Intervention Breastfeeding peer counseling services included 1 prenatal home visit, daily perinatal visits, 3 postpartum home visits, and telephone contact as needed. Breastfeeding rates at birth and 1, 3, and 6 months postpartum. The proportion not initiating breastfeeding was significantly lower in the intervention group than among controls (8/90 [9%] vs 17/75 [23%]; relative risk, 0.39; 95% confidence interval, 0.18-0.86). The probability of stopping breastfeeding also tended to be lower in the intervention group at both 1 month (36% vs 49%; relative risk, 0.72; 95% confidence interval, 0.50-1.05) and 3 months (56% vs 71%; relative risk, 0.78; 95% confidence interval, 0.61-1.00). These findings demonstrate that, in the United States, peer counselors can significantly improve breastfeeding initiation rates and have an impact on breastfeeding rates at 1 and 3 months post partum.

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

PubMed Central

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

2018-01-01

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

Placebo effect of medication cost in Parkinson disease: a randomized double-blind study.

PubMed

Espay, Alberto J; Norris, Matthew M; Eliassen, James C; Dwivedi, Alok; Smith, Matthew S; Banks, Christi; Allendorfer, Jane B; Lang, Anthony E; Fleck, David E; Linke, Michael J; Szaflarski, Jerzy P

2015-02-24

To examine the effect of cost, a traditionally "inactive" trait of intervention, as contributor to the response to therapeutic interventions. We conducted a prospective double-blind study in 12 patients with moderate to severe Parkinson disease and motor fluctuations (mean age 62.4 ± 7.9 years; mean disease duration 11 ± 6 years) who were randomized to a "cheap" or "expensive" subcutaneous "novel injectable dopamine agonist" placebo (normal saline). Patients were crossed over to the alternate arm approximately 4 hours later. Blinded motor assessments in the "practically defined off" state, before and after each intervention, included the Unified Parkinson's Disease Rating Scale motor subscale, the Purdue Pegboard Test, and a tapping task. Measurements of brain activity were performed using a feedback-based visual-motor associative learning functional MRI task. Order effect was examined using stratified analysis. Although both placebos improved motor function, benefit was greater when patients were randomized first to expensive placebo, with a magnitude halfway between that of cheap placebo and levodopa. Brain activation was greater upon first-given cheap but not upon first-given expensive placebo or by levodopa. Regardless of order of administration, only cheap placebo increased activation in the left lateral sensorimotor cortex and other regions. Expensive placebo significantly improved motor function and decreased brain activation in a direction and magnitude comparable to, albeit less than, levodopa. Perceptions of cost are capable of altering the placebo response in clinical studies. This study provides Class III evidence that perception of cost is capable of influencing motor function and brain activation in Parkinson disease. © 2015 American Academy of Neurology.

Long-term benefits of education by emergency care nurses at discharge of patients with atrial fibrillation.

PubMed

Fuenzalida, Carolina; Hernández, Gritzel; Ferro, Inés; Siches, Carme; Ambrós, Àngels; Coll-Vinent, Blanca

2017-11-01

Health education improves the prognosis of many diseases. A previous study in patients with atrial fibrillation (AF) showed that an educational intervention by nurses at discharge from the emergency room (ER) decreased AF-related complications at 3-month follow-up. Our objective was to determine whether this intervention had a long-term effect. A prospective study assessed the outcomes of an intervention carried out upon discharge from the ER. Patients with a diagnosis of AF were randomized into two groups: the intervention group and the control group. The intervention consisted of a basic explanation about the arrhythmia and its treatment, precautions and warning signs, a training to take their pulse, and an individualized informational leaflet. At one year of follow-up, the clinical records for all participants were reviewed. The primary variable was the combined endpoint of AF-related or treatment-related complications and death. The study included 240 patients (116 intervention and 124 control), mean age 76.1±10.9years. The primary variable was significantly lower in the intervention group (31.9% vs 48.4%; p=0.005). Education by ER nurses at patient discharge helped to decrease AF-related complications at one year of follow-up. Copyright © 2017. Published by Elsevier Ltd.

Resident Physician Burnout: Is There Hope?

PubMed Central

McCray, Laura W.; Cronholm, Peter F.; Bogner, Hillary R.; Gallo, Joseph J.; Neill, Richard A.

2010-01-01

Background Prevalent among resident physicians, burnout has been associated with absenteeism, low job satisfaction, and medical errors. Little is known about the number and quality of interventions used to combat burnout. Methods We performed a systematic review of the literature using MEDLINE and PubMed databases. We included English-language articles published between 1966 and 2007 identified using combinations of the following medical subject heading terms: burnout, intervention studies, program evaluation, internship and residency, graduate medical education, medical student, health personnel, physician, resident physician, resident work hours, and work hour limitations. Additional articles were also identified from the reference lists of manuscripts. The quality of research was graded with the Strength of Evidence Taxonomy (SORT) from highest (level A) to lowest (level C). Results Out of 190 identified articles, 129 were reviewed. Nine studies met inclusion criteria, only two of which were randomized, controlled trials. Interventions included workshops, a resident assistance program, a self-care intervention, support groups, didactic sessions, or stress-management/coping training either alone or in various combinations. None of the studied interventions achieved an A-level SORT rating. Conclusions Despite the potentially serious personal and professional consequences of burnout, few interventions exist to combat this problem. Prospective, controlled studies are needed to examine the effect of interventions to manage burnout among resident physicians. PMID:18830837

The role of vitamin D in the prevention of late-life depression.

PubMed

Okereke, Olivia I; Singh, Ankura

2016-07-01

In this article, we review current evidence regarding potential benefits of vitamin D for improving mood and reducing depression risk in older adults. We summarize gaps in knowledge and describe future efforts that may clarify the role of vitamin D in late-life depression prevention. MEDLINE and PsychINFO databases were searched for all articles on vitamin D and mood that had been published up to and including May 2015. Observational studies and randomized trials with 50 or more participants were included. We excluded studies that involved only younger adults and/or exclusively involved persons with current depression. Twenty observational (cross-sectional and prospective) studies and 10 randomized trials (nine were randomized placebo-controlled trials [RCTs]; one was a randomized blinded comparison trial) were reviewed. Inverse associations of vitamin D blood level or vitamin D intake with depression were found in 13 observational studies; three identified prospective relations. Results from all but one of the RCTs showed no statistically significant differences in depression outcomes between vitamin D and placebo groups. Observational studies were mostly cross-sectional and frequently lacked adequate control of confounding. RCTs often featured low treatment doses, suboptimal post-intervention changes in biochemical levels of vitamin D, and/or short trial durations. Vitamin D level-mood associations were observed in most, but not all, observational studies; results indicated that vitamin D deficiency may be a risk factor for late-life depression. However, additional data from well-designed RCTs are required to determine the impact of vitamin D in late-life depression prevention. Copyright © 2016 Elsevier B.V. All rights reserved.

Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT): rationale and study design of the randomized TWENTE III multicenter trial.

PubMed

Lam, Ming Kai; Sen, Hanim; Tandjung, Kenneth; van Houwelingen, K Gert; de Vries, Arie G; Danse, Peter W; Schotborgh, Carl E; Scholte, Martijn; Löwik, Marije M; Linssen, Gerard C M; Ijzerman, Maarten J; van der Palen, Job; Doggen, Carine J M; von Birgelen, Clemens

2014-04-01

To evaluate the safety and efficacy of 2 novel drug-eluting stents (DES) with biodegradable polymer-based coatings versus a durable coating DES. BIO-RESORT is an investigator-initiated, prospective, patient-blinded, randomized multicenter trial in 3540 Dutch all-comers with various clinical syndromes, requiring percutaneous coronary interventions (PCI) with DES implantation. Randomization (stratified for diabetes mellitus) is being performed in a 1:1:1 ratio between ORSIRO sirolimus-eluting stent with circumferential biodegradable coating, SYNERGY everolimus-eluting stent with abluminal biodegradable coating, and RESOLUTE INTEGRITY zotarolimus-eluting stent with durable coating. The primary endpoint is the incidence of the composite endpoint target vessel failure at 1 year, consisting of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Power calculation assumes a target vessel failure rate of 8.5% with a 3.5% non-inferiority margin, giving the study a power of 85% (α level .025 adjusted for multiple testing). The impact of diabetes mellitus on post-PCI outcome will be evaluated. The first patient was enrolled on December 21, 2012. BIO-RESORT is a large, prospective, randomized, multicenter trial with three arms, comparing two DES with biodegradable coatings versus a reference DES with a durable coating in 3540 all-comers. The trial will provide novel insights into the clinical outcome of modern DES and will address the impact of known and so far undetected diabetes mellitus on post-PCI outcome. Copyright © 2014 The Authors. Published by Mosby, Inc. All rights reserved.

High prevalence of skin and wound care of hospitalized elderly in Brazil: a prospective observational study.

PubMed

da Rosa Silva, Carleara Ferreira; Santana, Rosimere Ferreira; de Oliveira, Beatriz Guitton Renaud Baptista; do Carmo, Thalita Gomes

2017-02-02

Skin changes caused by aging increase the risk of skin damages, such as pressure ulcers, during hospitalization of elderly patients. There is few information about the cost of wound treatment in Brazil. Conversely, skin and wound problems are highly reported among hospitalized elderly patients and caregivers. The purpose is to analyze the socio-demographic and clinical profile associated with skin and wound care in hospitalized elderly. This is a prospective observational study. The sample consisted of 75 patients, aged 60 years or more, randomly selected in three hospitals in Rio de Janeiro, Brazil. Data extraction from nursing records of the sample, using cross mapping with Nursing Interventions Classification. Data Synthesis supported by SAS 6.11 (SAS Institute, Inc. Cary North Carolina) in association with SPSS version 14.0 and statistics analysis. The findings were: age standard deviation 7.8, with minimum as 60, and maximum as 91 years old. Prevalence of women and married seniors. High prevalence of long-term hospitalization. There were 21 Nursing Interventions in the nursing records and seventeen of them related to skin and wound care. They were described in 57 nursing activities, present during 376 evaluations and repeated 1756 times. A significant difference was obtained between age and the presence of the nursing interventions "Positioning" (p-0.004), Eye Care/Hygiene (p- < 0.0001) and Oral Health Maintenance (p-0.0003). The skin care to prevention and treatment of skin damages represented the major demand of nursing interventions in different clinical conditions of hospitalized elderly.

Impact of a Rewards-Based Incentive Program on Promoting Fruit and Vegetable Purchases

PubMed Central

Phipps, Etienne J.; Braitman, Leonard E.; Stites, Shana D.; Singletary, S. Brook; Wallace, Samantha L.; Hunt, Lacy; Axelrod, Saul; Glanz, Karen; Uplinger, Nadine

2015-01-01

Objectives. We assessed the impact of a rewards-based incentive program on fruit and vegetable purchases by low-income families. Methods. We conducted a 4-phase prospective cohort study with randomized intervention and wait-listed control groups in Philadelphia, Pennsylvania, in December 2010 through October 2011. The intervention provided a rebate of 50% of the dollar amount spent on fresh or frozen fruit and vegetables, reduced to 25% during a tapering phase, then eliminated. Primary outcome measures were number of servings of fruit and of vegetables purchased per week. Results. Households assigned to the intervention purchased an average of 8 (95% confidence interval [CI] = 1.5, 16.9) more servings of vegetables and 2.5 (95% CI = 0.3, 9.5) more servings of fruit per week than did control households. In longitudinal price-adjusted analyses, when the incentive was reduced and then discontinued, the amounts purchased were similar to baseline. Conclusions. Investigation of the financial costs and potential benefits of incentive programs to supermarkets, government agencies, and other stakeholders is needed to identify sustainable interventions. PMID:24625144

The effect of a sweet potato, footbath, and acupressure intervention in preventing constipation in hospitalized patients with acute coronary syndromes.

PubMed

Ren, Kai; Qiu, Jingbo; Wang, Xiaohua; Niu, Fenglin; Jiang, Tingbo

2012-01-01

Constipation is a common health problem that adversely affects quality of life and the prognosis of hospitalized patients with acute coronary syndromes (ACS). The purpose of this study was to develop and test the sweet potato/footbath/acupressure massage (SFA) intervention as a safe treatment for prevention of constipation and to increase satisfaction with bowel emptying in hospitalized patients with ACS. The study was a prospective, randomized controlled trial with a sample of 93 patients (SFA group, n = 44; usual care group, n = 49). Patients in the SFA group received SFA intervention combined with usual care. The results showed that there were statistical differences between the two groups in terms of (1) the incidence of constipation; (2) the use of laxatives and enemas; (3) patients' subjective satisfaction with their bowel emptying during hospitalization; and (4) sensation of incomplete evacuation and anorectal obstruction/blockade. The SFA intervention was more effective, economical, and practical than usual care alone in managing constipation and satisfaction with defecation in patients hospitalized with ACS.

Evaluating the Effectiveness of an Antimicrobial Stewardship Program on Reducing the Incidence Rate of Healthcare-Associated Clostridium difficile Infection: A Non-Randomized, Stepped Wedge, Single-Site, Observational Study.

PubMed

DiDiodato, Giulio; McArthur, Leslie

2016-01-01

The incidence rate of healthcare-associated Clostridium difficile infection (HA-CDI) is estimated at 1 in 100 patients. Antibiotic exposure is the most consistently reported risk factor for HA-CDI. Strategies to reduce the risk of HA-CDI have focused on reducing antibiotic utilization. Prospective audit and feedback is a commonly used antimicrobial stewardship intervention (ASi). The impact of this ASi on risk of HA-CDI is equivocal. This study examines the effectiveness of a prospective audit and feedback ASi on reducing the risk of HA-CDI. Single-site, 339 bed community-hospital in Barrie, Ontario, Canada. Primary outcome is HA-CDI incidence rate. Daily prospective and audit ASi is the exposure variable. ASi implemented across 6 wards in a non-randomized, stepped wedge design. Criteria for ASi; any intravenous antibiotic use for ≥ 48 hrs, any oral fluoroquinolone or oral second generation cephalosporin use for ≥ 48 hrs, or any antimicrobial use for ≥ 5 days. HA-CDI cases and model covariates were aggregated by ward, year and month starting September 2008 and ending February 2016. Multi-level mixed effect negative binomial regression analysis was used to model the primary outcome, with intercept and slope coefficients for ward-level random effects estimated. Other covariates tested for inclusion in the final model were derived from previously published risk factors. Deviance residuals were used to assess the model's goodness-of-fit. The dataset included 486 observation periods, of which 350 were control periods and 136 were intervention periods. After accounting for all other model covariates, the estimated overall ASi incidence rate ratio (IRR) was 0.48 (95% 0.30, 0.79). The ASi effect was independent of antimicrobial utilization. The ASi did not seem to reduce the risk of Clostridium difficile infection on the surgery wards (IRR 0.87, 95% CI 0.45, 1.69) compared to the medicine wards (IRR 0.42, 95% CI 0.28, 0.63). The ward-level burden of Clostridium difficile as measured by the ward's previous month's total CDI cases (CDI Lag) and the ward's current month's community-associated CDI cases (CA-CDI) was significantly associated with an increased risk of HA-CDI, with the estimated CDI Lag IRR of 1.21 (95% 1.15, 1.28) and the estimated CA-CDI IRR of 1.10 (95% CI 1.01, 1.20). The ward-level random intercept and slope coefficients were not significant. The final model demonstrated good fit. In this study, a daily prospective audit and feedback ASi resulted in a significant reduction in the risk of HA-CDI on the medicine wards, however, this effect was independent of an overall reduction in antibiotic utilization. In addition, the ward-level burden of Clostridium difficile was shown to significantly increase the risk of HA-CDI, reinforcing the importance of the environment as a source of HA-CDI.

Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study

DTIC Science & Technology

2016-08-01

AWARD NUMBER: W81XWH-15-2-0030 TITLE: Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study...20164. TITLE AND SUBTITLE Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay 5a. CONTRACT NUMBER R ognition and Prevention Study...be recruited and many have completed the proficiency phase of this project and will be moving on to AIM 1. 15. SUBJECT TERMS Robotic Surgery

Intervention to Increase HIV Testing Among Substance-Using Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

PubMed

Stephenson, Rob; Bonar, Erin E; Carrico, Adam; Hunter, Alexis; Connochie, Daniel; Himmelstein, Rebecca; Bauermeister, Jose

2018-04-30

Young men who have sex with men (YMSM) and transgender people in the Detroit Metro Area are the only risk group for whom the incidence of HIV and sexually transmitted infections (STI) has increased since 2000, with HIV incidence nearly doubling among youth. Substance use (including alcohol), which is relatively frequent among YMSM and transgender people, creates barriers to the optimal delivery of HIV prevention and care services. Standard HIV counseling, testing, and referral (CTR) is limited in providing strategies to identify and address substance use. Hence, in its current form, CTR may not be serving the prevention needs of substance-using YMSM and transgender people. Brief counseling interventions, grounded in principles of motivational interviewing, may offer a mechanism to meet the HIV prevention and care needs of substance-using YMSM and transgender people. This prospective, 4-arm, factorial randomized controlled trial aims to examine the efficacy of an motivational interviewing-based substance use brief intervention (SUBI) on participants' substance use and engagement in HIV prevention. The research implements a prospective randomized controlled trial (Project Swerve) of 600 YMSM and transgender people recruited both online and in person. Eligibility criteria include participants who (1) are between the ages of 15 to 29 years, (2) live in the Detroit Metro Area, (3) self-identify as a man or transgender man or woman, (4) have had sexual contact with a man in the 6 months before enrollment, (5) self-report binge drinking or any substance use in the 3 months before enrollment, and (6) self-report an unknown or negative HIV status upon enrollment. Participants are randomized to receive, 3-months apart starting at baseline, 2 individual sessions. Sessions are CTR-only, SUBI-only, CTR followed by SUBI, or SUBI followed by CTR. Project Swerve was launched in April 2017 and enrollment is ongoing. Incorporating a SUBI that utilizes the principles of motivational interviewing into HIV CTR provides an opportunity to tailor counseling services for YMSM and transgender people to address additional client barriers to HIV and STI testing. ClinicalTrials.gov NCT02945436; http://clinicaltrials.gov/ct2/show/NCT02945436 (Archived by WebCite at http://www.webcitation.org/6yFyOK57w). ©Rob Stephenson, Erin E Bonar, Adam Carrico, Alexis Hunter, Daniel Connochie, Rebecca Himmelstein, Jose Bauermeister. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 30.04.2018.

Jump starting skeletal health: a 4-year longitudinal study assessing the effects of jumping on skeletal development in pre and circum pubertal children.

PubMed

Gunter, Katherine; Baxter-Jones, Adam D G; Mirwald, Robert L; Almstedt, Hawley; Fuller, Arwen; Durski, Shantel; Snow, Christine

2008-04-01

Evidence suggests bone mineral increases attributable to exercise training prior to puberty may confer a significant advantage into adulthood. However, there is a dearth of supportive prospective longitudinal data. The purpose of this study was to assess bone mineral content (BMC) of the whole body (WB), total hip (TH), femoral neck (FN) and lumbar spine (LS) over four years in pre-pubertal boys and girls following a 7-month jumping intervention. The study population included 107 girls and 98 boys aged 8.6+/-0.88 years at baseline. Participating schools were randomly assigned as either intervention or control school. Children at the intervention school (n=101) participated in a jumping intervention embedded within the standard PE curriculum. The control school children (n=104) had similar exposure to PE without the jumping intervention. BMC was assessed by DXA at baseline, at 7-month post intervention, and annually thereafter for three years totaling 5 measurement opportunities. Multi-level random effects models were constructed and used to predict change from study entry in BMC parameters at each measurement occasion. A significant intervention effect was found at all bone sites. The effect was greatest immediately following the intervention (at 7 months) but still significant three years after the intervention. At 7 months, intervention participants had BMC values that were 7.9%, 8.4%, 7.7% and 7.3% greater than the controls at the LS, TH, FN and WB, respectively (p<0.05), when the confounders of age, maturity and tissue mass were controlled. Three years after the intervention had concluded the intervention group had 2.3%, 3.2%, 4.4% and 2.9% greater BMC than controls at the LS, TH, FN and WB respectively (p<0.05), when the confounders of age, maturity and tissue mass were controlled. This provides evidence that short-term high impact exercise in pre-puberty has a persistent effect over and above the effects of normal growth and development. If the benefits are sustained until BMC plateaus in early adulthood, this could have substantial effects on fracture risk.

Explaining the effects of a 1-year intervention promoting a low fat diet in adolescent girls: a mediation analysis.

PubMed

Haerens, Leen; Cerin, Ester; Deforche, Benedicte; Maes, Lea; De Bourdeaudhuij, Ilse

2007-11-09

Although it is important to investigate how interventions work, no formal mediation analyses have been conducted to explain behavioral outcomes in school-based fat intake interventions in adolescents. The aim of the present study was to examine mediation effects of changes in psychosocial determinants of dietary fat intake (attitude, social support, self-efficacy, perceived benefits and barriers) on changes in fat intake in adolescent girls. Data from a 1-year prospective intervention study were used. A random sample of 804 adolescent girls was included in the study. Girls in the intervention group (n = 415) were exposed to a multi-component school-based intervention program, combining environmental changes with a computer tailored fat intake intervention and parental support. Fat intake and psychosocial determinants of fat intake were measured with validated self-administered questionnaires. To assess mediating effects, a product-of-coefficient test, appropriate for cluster randomized controlled trials, was used. None of the examined psychosocial factors showed a reliable mediating effect on changes in fat intake. The single-mediator model revealed a statistically significant suppression effect of perceived barriers on changes in fat intake (p = 0.011). In the multiple-mediator model, this effect was no longer significant, which was most likely due to changes in perceived barriers being moderately related to changes in self-efficacy (-0.30) and attitude (-0.25). The overall mediated-suppressed effect of the examined psychosocial factors was virtually zero (total mediated effect = 0.001; SE = 7.22; p = 0.992). Given the lack of intervention effects on attitudes, social support, self-efficacy and perceived benefits and barriers, it is suggested that future interventions should focus on the identification of effective strategies for changing these theoretical mediators in the desired direction. Alternatively, it could be argued that these constructs need not be targeted in interventions aimed at adolescents, as they may not be responsible for the intervention effects on fat intake. To draw any conclusions regarding mediators of fat-intake change in adolescent' girls and regarding optimal future intervention strategies, more systematic research on the mediating properties of psychosocial variables is needed.

Effect of animal-assisted activity on balance and quality of life in home-dwelling persons with dementia.

PubMed

Olsen, Christine; Pedersen, Ingeborg; Bergland, Astrid; Enders-Slegers, Marie-José; Ihlebæk, Camilla

2016-01-01

Purpose of the study was to examine if animal-assisted activity with a dog (AAA) in home-dwelling persons with dementia (PWDs) attending day-care centers would have an effect on factors related to risk of fall accidents, with balance (Berg balance scale) and quality of life (Quality of Life in Late-stage Dementia) as main outcome. The project was conducted as a prospective and cluster-randomized multicenter trial with a follow-up. 16 adapted day-care centers recruited respectively 42 (intervention group) and 38 (control group with treatment as usual) home-dwelling PWDs. The intervention consisted of 30 min sessions with AAA led by a qualified dog handler twice a week for 12 weeks in groups of 3-7 participants. The significant positive effect on balance indicates that AAA might work as a multifactorial intervention in dementia care and have useful clinical implication by affecting risk of fall. ClinicalTrial.gov; NCT02008630. Copyright © 2016 Elsevier Inc. All rights reserved.

Lymphedema following treatment for breast cancer: a new approach to an old problem.

PubMed

O'Toole, Jean; Jammallo, Lauren S; Skolny, Melissa N; Miller, Cynthia L; Elliott, Krista; Specht, Michelle C; Taghian, Alphonse G

2013-11-01

Lymphedema following treatment for breast cancer can be an irreversible condition with a profound negative impact on quality of life. The lack of consensus regarding standard definitions of clinically significant lymphedema and optimal methods of measurement and quantification are unresolved problems. Inconsistencies persist regarding the appropriate timing of intervention and what forms of treatment should be the standard of care. There are reports that early detection and intervention can prevent progression, however,the Level 1 evidence to support this hypothesis has yet to be generated. To assess these controversies, we propose the implementation of a screening program to detect early lymphedema in conjunction with a randomized, prospective trial designed to generate Level 1 evidence regarding the efficacy of early intervention and appropriate treatment strategies. Collaboration among institutions that manage breast cancer patients is essential to establish a standardized approach to lymphedema and to establish guidelines for best practice. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Efficacy of Multivitamin/mineral Supplementation to Reduce Chronic Disease Risk: A Critical Review of the Evidence from Observational Studies and Randomized Controlled Trials.

PubMed

Angelo, Giana; Drake, Victoria J; Frei, Balz

2015-01-01

We reviewed recent scientific evidence regarding the effects of multivitamin/mineral (MVM) supplements on risk of chronic diseases, including cancer, cardiovascular disease, and age-related eye diseases. Data from randomized controlled trials (RCTs) and observational, prospective cohort studies were examined. The majority of scientific studies investigating the use of MVM supplements in chronic disease risk reduction reported no significant effect. However, the largest and longest RCT of MVM supplements conducted to date, the Physicians' Health Study II (PHS II), found a modest and significant reduction in total and epithelial cancer incidence in male physicians, consistent with the Supplémentation en Vitamines et Minéraux Antioxydants (SU.VI.MAX) trial. In addition, PHS II found a modest and significant reduction in the incidence of nuclear cataract, in agreement with several other RCTs and observational, prospective cohort studies. The effects of MVM use on other subtypes of cataract and age-related macular degeneration remain unclear. Neither RCTs nor prospective cohort studies are without their limitations. The placebo-controlled trial design of RCTs may be inadequate for nutrient interventions, and residual confounding, measurement error, and the possibility of reverse causality are inherent to any observational study. National surveys show that micronutrient inadequacies are widespread in the US and that dietary supplements, of which MVMs are the most common type, help fulfill micronutrient requirements in adults and children.

Clamp-Crushing versus stapler hepatectomy for transection of the parenchyma in elective hepatic resection (CRUNSH) - A randomized controlled trial (NCT01049607)

PubMed Central

2011-01-01

Background Hepatic resection is still associated with significant morbidity. Although the period of parenchymal transection presents a crucial step during the operation, uncertainty persists regarding the optimal technique of transection. It was the aim of the present randomized controlled trial to evaluate the efficacy and safety of hepatic resection using the technique of stapler hepatectomy compared to the simple clamp-crushing technique. Methods/Design The CRUNSH Trial is a prospective randomized controlled single-center trial with a two-group parallel design. Patients scheduled for elective hepatic resection without extrahepatic resection at the Department of General-, Visceral- and Transplantation Surgery, University of Heidelberg are enrolled into the trial and randomized intraoperatively to hepatic resection by the clamp-crushing technique and stapler hepatectomy, respectively. The primary endpoint is total intraoperative blood loss. A set of general and surgical variables are documented as secondary endpoints. Patients and outcome-assessors are blinded for the treatment intervention. Discussion The CRUNSH Trial is the first randomized controlled trial to evaluate efficacy and safety of stapler hepatectomy compared to the clamp-crushing technique for parenchymal transection during elective hepatic resection. Trial Registration ClinicalTrials.gov: NCT01049607 PMID:21888669

The effects and costs of the universal parent group program – all children in focus: a study protocol for a randomized wait-list controlled trial

PubMed Central

2013-01-01

Background In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children’s positive development with the parent–child relationship as the target. There is currently no randomized controlled trial existing of the program. Methods/Design A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3–12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. Discussion This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes health economic and qualitative analyses to deepen the knowledge of the program. We further discuss some issues regarding the implementation of the program in municipalities and city districts. Trial registration Current Controlled Trials ISRCTN70202532 PMID:23890316

The effects and costs of the universal parent group program - all children in focus: a study protocol for a randomized wait-list controlled trial.

PubMed

Lindberg, Lene; Ulfsdotter, Malin; Jalling, Camilla; Skärstrand, Eva; Lalouni, Maria; Lönn Rhodin, Kajsa; Månsdotter, Anna; Enebrink, Pia

2013-07-29

In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children's positive development with the parent-child relationship as the target. There is currently no randomized controlled trial existing of the program. A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3-12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes health economic and qualitative analyses to deepen the knowledge of the program. We further discuss some issues regarding the implementation of the program in municipalities and city districts. Current Controlled Trials ISRCTN70202532.

The Role of Prospective Memory in Medication Adherence: A Review of an Emerging Literature

PubMed Central

Zogg, Jennifer B.; Woods, Steven Paul; Sauceda, John A.; Wiebe, John S.; Simoni, Jane M.

2013-01-01

Although neurocognitive impairment is an established risk factor for medication non-adherence, standard neurocognitive tests developed for clinical purposes may not fully capture the complexities of non-adherence behavior or effectively inform theory-driven interventions. Prospective memory, an innovative cognitive construct describing one’s ability to remember to do something at a later time, is an understudied factor in the detection and remediation of medication non-adherence. This review orients researchers to the construct of prospective memory, summarizes empirical evidence for prospective memory as a risk factor for non-adherence, discusses the relative merits of current measurement techniques, and highlights potential prospective memory-focused intervention strategies. A comprehensive literature review was conducted of published empirical studies investigating prospective memory and medication adherence. Overall, reviewed studies suggest that prospective memory is an important component of medication adherence, providing incremental ecological validity over established predictors. Findings indicate that prospective memory-based interventions might be an effective means of improving adherence. PMID:21487722

Need-based intervention is an effective strategy for improving the nutritional status of older people living in a nursing home: a randomized controlled trial.

PubMed

Lee, Li-Chin; Tsai, Alan C; Wang, Jiun-Yi; Hurng, Baai-Shyun; Hsu, Hui-Chuan; Tsai, Hsin-Jen

2013-12-01

Nutrition is a key element in geriatric health. Protein-energy malnutrition is common in institutionalized persons. This study examined the effectiveness of a need-based "routine screening and timely intervention" strategy in improving the nutritional status of persons living in nursing homes. A 24-week randomized, double-blind, controlled trial. A privately managed geriatric nursing home in Taiwan. Ninety-two ≥65-year old persons who were ≤25kg/m(2), >1 month residence, able to self-feed or receive oral feeding, without acute infection and non-bed-ridden. Prospective participants were stratified by gender and then randomly assigned to either the control group (n=45) or the intervention group (n=47). Each subject in the intervention group was given a 50g/day soy-protein-based nutritional supplement if he/she was rated as undernourished according to the Mini Nutritional Assessment (MNA, score ≤24) and BMI ≤24kg/m(2). The supplement contained 9.5g protein, 250kcal energy and all essential micro-nutrients. The supplementation would be suspended once either one of the "at risk" condition was corrected. Nutritional rating with the MNA took place at baseline and every 4 weeks during the trial. Biochemical indicators were measured at baseline, mid-point (week-12) and end-point (week-24). Results were analyzed with the two-sample t-test, and the generalized estimating equations (GEE) controlled for demographic and health-related variables. Of the 92 subjects, 82 completed the trial; 7 withdrew and 3 died during the trial. Results showed that the need-based intervention was an effective and appropriate strategy for improving the nutritional status of persons at risk of undernourishment. The intervention significantly improved body weight, BMI, mid-arm circumference, calf circumference, and serum albumin and cholesterol concentrations at all intervals (all p<0.05). However, the intervention did not significantly improve hematocrit, hemoglobin or lymphocyte count status. Results suggest that the need-based nutritional intervention can be a practical and useful strategy for improving the nutritional status of persons living in nursing homes and save on healthcare cost. The potential application of this strategy deserves the attention of health planners. Copyright © 2013 Elsevier Ltd. All rights reserved.

Virtual reality to augment robot-assisted gait training in non-ambulatory patients with a subacute stroke: a pilot randomized controlled trial.

PubMed

Bergmann, Jeannine; Krewer, Carmen; Bauer, Petra; Koenig, Alexander; Riener, Robert; Müller, Friedemann

2018-06-01

Active performance is crucial for motor learning, and, together with motivation, is believed to be associated with a better rehabilitation outcome. Virtual reality (VR) is an innovative approach to engage and motivate patients during training. There is promising evidence for its efficiency in retraining upper limb function. However, there is insufficient proof for its effectiveness in gait training. To evaluate the acceptability of robot-assisted gait training (RAGT) with and without VR and the feasibility of potential outcome measures to guide the planning of a larger randomized controlled trial (RCT). Single-blind randomized controlled pilot trial with two parallel arms. Rehabilitation hospital. Twenty subacute stroke patients (64±9 years) with a Functional Ambulation Classification (FAC) ≤2. Twelve sessions (over 4 weeks) of either VR-augmented RAGT (intervention group) or standard RAGT (control group). Acceptability of the interventions (drop-out rate, questionnaire), patients' motivation (Intrinsic Motivation Inventory [IMI], individual mean walking time), and feasibility of potential outcome measures (completion rate and response to interventions) were determined. We found high acceptability of repetitive VR-augmented RAGT. The drop-out rate was 1/11 in the intervention and 4/14 in the control group. Patients of the intervention group spent significantly more time walking in the robot than the control group (per session and total walking time; P<0.03). In both groups, motivation measured with the IMI was high over the entire intervention period. The felt pressure and tension significantly decreased in the intervention group (P<0.01) and was significantly lower than in the control group at the last therapy session (r=-0.66, P=0.005). The FAC is suggested as a potential primary outcome measure for a definitive RCT, as it could be assessed in all patients and showed significant response to interventions (P<0.01). We estimated a sample size of 44 for a future RCT. VR-augmented RAGT resulted in high acceptability and motivation, and in a reduced drop-out rate and an extended training time compared to standard RAGT. This pilot trial provides guidance for a prospective RCT on the effectiveness of VR-augmented RAGT. VR might be a promising approach to enrich and improve gait rehabilitation after stroke.

Prediction of motivational impairment: 12-month follow-up of the randomized-controlled trial on extended early intervention for first-episode psychosis.

PubMed

Chang, W C; Kwong, V W Y; Chan, G H K; Jim, O T T; Lau, E S K; Hui, C L M; Chan, S K W; Lee, E H M; Chen, E Y H

2017-03-01

Amotivation is prevalent in first-episode psychosis (FEP) patients and is a major determinant of functional outcome. Prediction of amotivation in the early stage of psychosis, however, is under-studied. We aimed to prospectively examine predictors of amotivation in FEP patients in a randomized-controlled trial comparing a 1-year extension of early intervention (Extended EI, 3-year EI) with step-down psychiatric care (SC, 2-year EI). One hundred sixty Chinese patents were recruited from a specialized EI program for FEP in Hong Kong after they have completed this 2-year EI service, randomly allocated to Extended EI or SC, and followed up for 12 months. Assessments on premorbid adjustment, onset profiles, baseline symptom severity and treatment characteristics were conducted. Data analysis was based on 156 subjects who completed follow-up assessments. Amotivation at 12-month follow-up was associated with premorbid adjustment, allocated treatment condition, and levels of positive symptoms, disorganization, amotivation, diminished expression (DE) and depression at study intake. Hierarchical multiple regression analysis revealed that Extended EI and lower levels of DE independently predicted better outcome on 12-month amotivation. Our findings indicate a potentially critical therapeutic role of an extended specialized EI on alleviating motivational impairment in FEP patients. The longer-term effect of Extended EI on amotivation merits further investigation. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

eEduHeart I: A Multicenter, Randomized, Controlled Trial Investigating the Effectiveness of a Cardiac Web-Based eLearning Platform - Rationale and Study Design.

PubMed

Frederix, Ines; Vandenberk, Thijs; Janssen, Leen; Geurden, Anne; Vandervoort, Pieter; Dendale, Paul

Cardiac telerehabilitation includes, in its most comprehensive format, telemonitoring, telecoaching, social interaction, and eLearning. The specific role of eLearning, however, was seldom assessed. The aim of eEduHeart I is to investigate the medium-term effectiveness of the addition of a cardiac web-based eLearing platform to conventional cardiac care. In this prospective, multicenter randomized, controlled trial, 1,000 patients with coronary artery disease will be randomized 1:1 to an intervention group (receiving 1-month unrestricted access to the cardiac eLearning platform in addition to conventional cardiac care) or to conventional cardiac care alone. The primary endpoint is health-related quality of life, assessed by the HeartQoL questionnaire at the 1- and 3-month follow-ups. Secondary endpoints include pathology-specific knowledge and self-reported eLearning platform user experience. Data on the eLearning platform usage will be gathered through web logging during the study period. eEduHeart I will be one of the first studies to report on the added value of eLearning. If the intervention is proven effective, current cardiac telerehabilitation programs can be augmented by including eLearning, too. The platform can then be used as a model for other chronic diseases in which patient education plays a key role. © 2016 S. Karger AG, Basel.

A Cluster-randomized Trial of a Centralized Clinical Pharmacy Cardiovascular Risk Service to Improve Guideline Adherence

PubMed Central

Carter, Barry L.; Coffey, Christopher S.; Chrischilles, Elizabeth A.; Ardery, Gail; Ecklund, Dixie; Gryzlak, Brian; Vander Weg, Mark W.; James, Paul A.; Christensen, Alan J.; Parker, Christopher P.; Gums, Tyler; Finkelstein, Rachel J; Uribe, Liz; Polgreen, Linnea A.

2015-01-01

Background Numerous studies have demonstrated the value of including pharmacists in team-based care to improve adherence to cardiovascular (CV) guidelines, medication adherence and risk factor control but there is limited information on whether these models can be successfully implemented more widely in diverse settings and populations. The purpose of this study is to evaluate whether a centralized, web-based CV risk service (CVRS) managed by clinical pharmacists will improve guideline adherence in multiple primary care medical offices with diverse geographic and patient characteristics. Methods This study is a prospective trial in 20 primary care offices stratified by the percent of under-represented minorities and then randomized to either the CVRS intervention or usual care. The intervention will last for 12 months and all subjects will have research visits at baseline and 12 months. The primary outcome is the difference in guideline adherence between groups. Data will also be abstracted from the medical record at 24 months to determine if the intervention effect is sustained after it is discontinued. Conclusions This study expects to enroll subjects through 2016 with results expected in 2019. This study will provide information on whether a distant, centralized CV risk service can be implemented in large numbers of medical offices, if it is effective in diverse populations, and if the effect can be sustained long-term. PMID:26111939

The effectiveness of a clinical and home-based physical activity program and simple lymphatic drainage in the prevention of breast cancer-related lymphedema: A prospective randomized controlled study.

PubMed

Dönmez, Ayşe Arıkan; Kapucu, Sevgisun

2017-12-01

To investigate the effectiveness of a clinical and home-based, nurse-led physical activity program (PAP) and simple lymphatic drainage (SLD) in the prevention of breast cancer-related lymphedema. A total of 52 breast cancer patients were randomized to either a PAP and SLD program (n = 25) or a control group (n = 27). Patients in both groups were also provided training for lymphedema. The PAP and SLD were administered through home visits by the investigators, twice a week for six weeks, in the intervention group. The control group did not undergo intervention. The circumference of the upper extremity, symptom severity, and physical function were measured in both groups. The upper extremity circumference increased by about two times from the baseline, in the control group, especially in the sixth week (p < 0.05). Lymphedema-related symptom severity scores were found to decrease significantly in the intervention group, compared to those at the baseline (p < 0.05). It was recommended that PAP and SLD, with a follow-up program, be used for patients who planned to undergo breast cancer surgery, starting from before surgery and continuing until after, to prevent breast cancer-related lymphedema. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

PubMed

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

2015-07-01

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

Past and Present ARDS Mortality Rates: A Systematic Review.

PubMed

Máca, Jan; Jor, Ondřej; Holub, Michal; Sklienka, Peter; Burša, Filip; Burda, Michal; Janout, Vladimír; Ševčík, Pavel

2017-01-01

ARDS is severe form of respiratory failure with significant impact on the morbidity and mortality of critical care patients. Epidemiological data are crucial for evaluating the efficacy of therapeutic interventions, designing studies, and optimizing resource distribution. The goal of this review is to present general aspects of mortality data published over the past decades. A systematic search of the MEDLINE/PubMed was performed. The articles were divided according to their methodology, type of reported mortality, and time. The main outcome was mortality. Extracted data included study duration, number of patients, and number of centers. The mortality trends and current mortality were calculated for subgroups consisting of in-hospital, ICU, 28/30-d, and 60-d mortality over 3 time periods (A, before 1995; B, 1995-2000; C, after 2000). The retrospectivity and prospectivity were also taken into account. Moreover, we present the most recent mortality rates since 2010. One hundred seventy-seven articles were included in the final analysis. General mortality rates ranged from 11 to 87% in studies including subjects with ARDS of all etiologies (mixed group). Linear regression revealed that the study design (28/30-d or 60-d) significantly influenced the mortality rate. Reported mortality rates were higher in prospective studies, such as randomized controlled trials and prospective observational studies compared with retrospective observational studies. Mortality rates exhibited a linear decrease in relation to time period (P < .001). The number of centers showed a significant negative correlation with mortality rates. The prospective observational studies did not have consistently higher mortality rates compared with randomized controlled trials. The mortality trends over 3 time periods (before 1995, 1995-2000, and after 2000) yielded variable results in general ARDS populations. However, a mortality decrease was present mostly in prospective studies. Since 2010, the overall rates of in-hospital, ICU, and 28/30-d and 60-d mortality were 45, 38, 30, and 32%, respectively. Copyright © 2017 by Daedalus Enterprises.

Comprehensive nutrition and lifestyle education improves weight loss and physical activity in Hispanic Americans following gastric bypass surgery: a randomized controlled trial.

PubMed

Nijamkin, Monica Petasne; Campa, Adriana; Sosa, Jorge; Baum, Marianna; Himburg, Susan; Johnson, Paulette

2012-03-01

As morbid obesity increasingly affects Hispanic Americans, the incidence of bariatric procedures among this population is rising. Despite this, prospective research on the effects of comprehensive postoperative education-centered interventions on weight loss and physical activity focused on Hispanic Americans is lacking. To examine whether a comprehensive nutrition education and behavior modification intervention improves weight loss and physical activity in Hispanic Americans with obesity following Roux-en-Y gastric bypass surgery (RYGB). A prospective randomized-controlled trial was conducted between November 2008 and April 2010. At 6 months following RYGB, 144 Hispanic Americans with obesity were randomly assigned to a comprehensive nutrition and lifestyle educational intervention (n=72) or a noncomprehensive approach (comparison group n=72). Those in the comprehensive group received education sessions every other week for 6 weeks in small groups and frequent contact with a registered dietitian. Those in the comparison group received brief, printed healthy lifestyle guidelines. Patients were reassessed at 12 months following surgery. Main outcome measures were excess weight loss and physical activity changes over time. Statistical analyses used t test, ?(2) test, Wilcoxon signed rank, Mann-Whitney U test, and intent-to-treat analysis, significance P<0.05. Participants (mean age 44.5 ± 13.5 years) were mainly Cuban-born women (83.3%). Mean preoperative excess weight and body mass index (calculated as kg/m(2)) were 72.20 ± 27.81 kg and 49.26 ± 9.06, respectively. At 12 months following surgery, both groups lost weight significantly, but comprehensive group participants experienced greater excess weight loss (80% vs 64% from preoperative excess weight; P<0.001) and greater body mass index reduction (6.48 ± 4.37 vs 3.63 ± 3.41; P<0.001) than comparison group participants. Comprehensive group participants were significantly more involved in physical activity (+14 min/wk vs ?4 min/wk; P<0.001) than comparison group participants. Mean protein intake was significantly lower in the comparison group than that in the comprehensive group (P<0.024). Findings support the importance of comprehensive nutrition education for achieving more effective weight reduction in Hispanic Americans following RYGB. Copyright © 2012 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

Tourniquet application after local forearm warming to improve venodilation for peripheral intravenous cannulation in young and middle-aged adults: A single-blind prospective randomized controlled trial.

PubMed

Yamagami, Yuki; Tomita, Kohei; Tsujimoto, Tomomi; Inoue, Tomoko

2017-07-01

Local forearm warming before tourniquet application is often used to promote venodilation for peripheral intravenous cannulation; however, few studies have compared the effect of tourniquet application with and without local warming on vein size. To evaluate the effectiveness of tourniquet application after local forearm warming with that of tourniquet application alone in young and middle-aged adults. A single-blind, prospective, parallel group, randomized controlled trial. A national university in Japan. Seventy-two volunteers aged 20-64 years. Participants were randomly allocated to one of two groups: tourniquet application for 30s after forearm application of a heat pack warmed to 40°C±2°C for 15min (active warming group; n=36) or tourniquet application for 30s after applying a non-warmed heat pack for 15min (passive warming group; n=36). The primary outcomes were vein cross-sectional area on the forearm, measured after the intervention by blinded research assistants using ultrasound. Secondary outcomes were shortest diameter, and longest diameter of vein on the forearm, forearm skin temperature, body temperature, pulse, systolic blood pressure, and diastolic blood pressure. All outcomes were assessed at the same site before and immediately after the intervention, once per participant. Vein cross-sectional area, shortest vein diameter, and longest vein diameter were significantly increased in the active warming group compared with the passive warming group (p <0.01). Tourniquet application after local warming was superior to tourniquet application alone in increasing vein cross-sectional, shortest diameter, and longest diameter (between-group differences of 2.2mm 2 , 0.5mm, and 0.5mm, respectively), and in raising skin temperature (between-group difference: 5.2°C). However, there were no significant differences in body temperature, pulse, or systolic or diastolic blood pressure between the groups. There were no adverse events associated with either intervention. Tourniquet application after local warming was associated with increased forearm vein size when compared with tourniquet application alone, and was demonstrated as being safe. Thus, with demonstrable effects on vein size, we recommend local warming before tourniquet application as a safe and effective technique for improving venodilation. Copyright © 2017 Elsevier Ltd. All rights reserved.

Maintenance effects of working memory intervention (Cogmed) in children with symptomatic epilepsy.

PubMed

Fuentes, Amanda; Kerr, Elizabeth N

2017-02-01

To extend previous research documenting the benefits of working memory (WM) intervention (Cogmed) immediately post-intervention in children with epilepsy by assessing the 3-month maintenance effects. Participants involved in a previous randomized clinical trial (RCT) were invited to participate if they completed Cogmed within the last 3months (n=15) and additional participants (n=13) were prospectively recruited. Standardized assessments of near-transfer effects (i.e., visual and auditory attention and WM) were completed prior to and immediately after intervention and at 3-month follow-up. An additional measure assessing the far-transfer effect of fluid reasoning was administered prior to intervention and at 3-month follow-up. Participants exhibited gains in auditory and visual attention and WM immediately following intervention and gains were generally sustained at 3-month follow-up. Intervention did not improve visual-verbal WM or fluid reasoning. The clinical variables studied (i.e., age of seizure onset, seizure frequency, epilepsy duration, and overall intellectual functioning) did not elucidate reliable relationships with intervention. Working memory training is possibly efficacious in improving related skills which are maintained for 3months in children with active epilepsy. No transfer to fluid reasoning was documented. Further investigation by means of a large-scale RCT which includes a placebo and both objective and subjective measures of the impact of training on daily functioning is warranted. Copyright © 2016 Elsevier Inc. All rights reserved.

Complications of fluoroscopically directed facet joint nerve blocks: a prospective evaluation of 7,500 episodes with 43,000 nerve blocks.

PubMed

Manchikanti, Laxmaiah; Malla, Yogesh; Wargo, Bradley W; Cash, Kimberly A; Pampati, Vidyasagar; Fellows, Bert

2012-01-01

Chronic spinal pain is common along with numerous modalities of diagnostic and therapeutic interventions utilized, creating a health care crisis. Facet joint injections and epidural injections are the 2 most commonly utilized interventions in managing chronic spinal pain. While the literature addressing the effectiveness of facet joint nerve blocks is variable and emerging, there is paucity of literature on adverse effects of facet joint nerve blocks. A prospective, non-randomized study of patients undergoing interventional techniques from May 2008 to December 2009. A private interventional pain management practice, a specialty referral center in the United States. Investigation of the incidence in characteristics of adverse effects and complications of facet joint nerve blocks. The study was carried out over a period of 20 months including almost 7,500 episodes of 43,000 facet joint nerve blocks with 3,370 episodes in the cervical region, 3,162 in the lumbar region, and 950 in the thoracic region. All facet joint nerve blocks were performed under fluoroscopic guidance in an ambulatory surgery center by 3 physicians. The complications encountered during the procedure and postoperatively were evaluated prospectively. This study was carried out over a period of 20 months and included over 7,500 episodes or 43,000 facet joint nerve blocks. All of the interventions were performed under fluoroscopic guidance in an ambulatory surgery center by one of 3 physicians. The complications encountered during the procedure and postoperatively were prospectively evaluated. Measurable outcomes employed were intravascular entry of the needle, profuse bleeding, local hematoma, dural puncture and headache, nerve root or spinal cord irritation with resultant injury, and infectious complications. There were no major complications. Multiple side effects and complications observed included overall intravascular penetration in 11.4% of episodes with 20% in cervical region, 4% in lumbar region, and 6% in thoracic region; local bleeding in 76.3% of episodes with highest in thoracic region and lowest in cervical region; oozing with 19.6% encounters with highest in cervical region and lowest in lumbar region; with local hematoma seen only in 1.2% of the patients with profuse bleeding, bruising, soreness, nerve root irritation, and all other effects such as vasovagal reactions observed in 1% or less of the episodes. Limitations of this study include lack of contrast injection, use of intermittent fluoroscopy and also an observational nature of the study. This study illustrate that major complications are extremely rare and minor side effects are common.

Developing Prospective Elementary Teachers' Abilities to Identify Evidence of Student Mathematical Achievement

ERIC Educational Resources Information Center

Spitzer, Sandy M.; Phelps, Christine M.; Beyers, James E. R.; Johnson, Delayne Y.; Sieminski, Elizabeth M.

2011-01-01

This study investigated the effects of a classroom intervention on prospective elementary teachers' ability to evaluate evidence of student achievement of mathematical learning goals. The intervention was informed by a framework for teacher education which aims to provide prospective teachers (PTs) with the skills needed to systematically learn…

CT fluoroscopy-assisted puncture of thoracic and abdominal masses: a randomized trial.

PubMed

Kirchner, Johannes; Kickuth, Ralph; Laufer, Ulf; Schilling, Esther Maria; Adams, Stephan; Liermann, Dieter

2002-03-01

We investigated the benefit of real-time guidance of interventional punctures by means of computed tomography fluoroscopy (CTF) compared with the conventional sequential acquisition guidance. In a prospective randomized trial, 75 patients underwent either CTF-guided (group A, n = 50) or sequential CT-guided (group B, n = 25) punctures of thoracic (n = 29) or abdominal (n = 46) masses. CTF was performed on the CT machine (Somatom Plus 4 Power, Siemens Corp., Forchheim, Germany) equipped with the C.A.R.E. Vision application (tube voltage 120 kV, tube current 50 mA, rotational time 0.75 s, slice thickness 10 mm, 8 frames/s). The average procedure time showed a statistically significant difference between the two study groups (group A: 564 s, group B 795 s, P = 0.0032). The mean total mAs was 7089 mAs for the CTF and 4856 mAs for the sequential image-guided intervention, respectively. The sensitivity was 71% specificity 100% positive predictive value 100% and negative predictive value 60% for the CTF-guided puncture, and 68, 100, 100 and 50% for sequential CT, respectively. CTF guidance realizes a time-saving but increases the radiation exposure dosage.

Using practical and social information to influence flood adaptation behavior

NASA Astrophysics Data System (ADS)

Allaire, Maura C.

2016-08-01

As the prospect for more frequent and severe extreme weather events gains scientific support, many nations are evaluating mitigation and adaptation options. Insurance and home retrofits could reduce household welfare losses due to flood events. Yet even after disasters, households often fail to take risk mitigation actions. This paper presents the first randomized field experiment that tests the effect of information provision on household uptake of flood insurance and home retrofits. A sample of 364 flood-prone households in Bangkok was randomly split into treatment and control groups. The treatment group received practical details on home retrofits and flood insurance as well as social information regarding the insurance purchase decisions of peers. Results indicate that the information intervention increased insurance purchases by about five percentage points, while no effect was detected for home retrofits. This effect is nearly equal to the increase in uptake that the national insurance program in Thailand has achieved through all other means since its establishment in 2012. If scaled up to include all uninsured, flood-prone households in Bangkok, nearly 70,000 additional households could be insured. The results suggest that well-designed information interventions could increase uptake of flood insurance, without additional premium subsidies or mandates.

Red and processed meat intake and risk of breast cancer: a meta-analysis of prospective studies.

PubMed

Guo, Jingyu; Wei, Wei; Zhan, Lixing

2015-05-01

Epidemiological studies regarding the association between red and processed meat intake and the risk of breast cancer have yielded inconsistent results. Therefore, we conducted an updated and comprehensive meta-analysis which included 14 prospective studies to evaluate the association of red and processed meat intake with breast cancer risk. Relevant prospective cohort studies were identified by searching PubMed through October 31, 2014, and by reviewing the reference lists of retrieved articles. Study-specific relative risk (RR) estimates were pooled using a random-effects model. Fourteen prospective studies on red meat (involving 31,552 cases) and 12 prospective studies on processed meat were included in the meta-analysis. The summary RRs (95 % CI) of breast cancer for the highest versus the lowest categories were 1.10 (1.02, 1.19) for red meat, and 1.08 (1.01, 1.15) for processed meat. The estimated summary RRs (95 % CI) were 1.11 (1.05, 1.16) for an increase of 120 g/day of red meat, and 1.09 (1.03, 1.16) for an increase of 50 g/day of processed meat. Our findings indicate that increased intake of red and processed meat is associated with an increased risk of breast cancer. Further research with well-designed cohort or interventional studies is needed to confirm the association.

A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions.

PubMed

Werner, Gerald S; Martin-Yuste, Victoria; Hildick-Smith, David; Boudou, Nicolas; Sianos, Georgios; Gelev, Valery; Rumoroso, Jose Ramon; Erglis, Andrejs; Christiansen, Evald Høj; Escaned, Javier; di Mario, Carlo; Hovasse, Thomas; Teruel, Luis; Bufe, Alexander; Lauer, Bernward; Bogaerts, Kris; Goicolea, Javier; Spratt, James C; Gershlick, Anthony H; Galassi, Alfredo R; Louvard, Yves

2018-05-02

The clinical value of percutaneous coronary intervention (PCI) for chronic coronary total occlusions (CTOs) is not established by randomized trials. This study should compare the benefit of PCI vs. optimal medical therapy (OMT) on the health status in patients with at least one CTO. Three hundred and ninety-six patients were enrolled in a prospective randomized, multicentre, open-label, and controlled clinical trial to compare the treatment by PCI with OMT with a 2:1 randomization ratio. The primary endpoint was the change in health status assessed by the Seattle angina questionnaire (SAQ) between baseline and 12 months follow-up. Fifty-two percent of patients have multi-vessel disease in whom all significant non-occlusive lesions were treated before randomization. An intention-to-treat analysis was performed including 13.4% failed procedures in the PCI group and 7.3% cross-overs in the OMT group. At 12 months, a greater improvement of SAQ subscales was observed with PCI as compared with OMT for angina frequency [5.23, 95% confidence interval (CI) 1.75; 8.71; P = 0.003], and quality of life (6.62, 95% CI 1.78-11.46; P = 0.007), reaching the prespecified significance level of 0.01 for the primary endpoint. Physical limitation (P = 0.02) was also improved in the PCI group. Complete freedom from angina was more frequent with PCI 71.6% than OMT 57.8% (P = 0.008). There was no periprocedural death or myocardial infarction. At 12 months, major adverse cardiac events were comparable between the two groups. Percutaneous coronary intervention leads to a significant improvement of the health status in patients with stable angina and a CTO as compared with OMT alone. NCT01760083.

The business case for pediatric asthma quality improvement in low-income populations: examining a provider-based pay-for-reporting intervention.

PubMed

Reiter, Kristin L; Lemos, Kristin Andrews; Williams, Charlotte E; Esposito, Dominick; Greene, Sandra B

2015-06-01

To measure the return on investment (ROI) for a pediatric asthma pay-for-reporting intervention initiated by a Medicaid managed care plan in New York State. Practice-level, randomized prospective evaluation. Twenty-five primary care practices providing care to children enrolled in the Monroe Plan for Medical Care (the Monroe Plan). Practices were randomized to either treatment (13 practices, 11 participated) or control (12 practices). For each of its eligible members assigned to a treatment group practice, the Monroe plan paid a low monthly incentive fee to the practice. To receive the incentive, treatment group practices were required to conduct, and report to the Monroe Plan, the results of chart audits on eligible members. Chart audits were conducted by practices every 6 months. After each chart audit, the Monroe Plan provided performance feedback to each practice comparing its adherence to asthma care guidelines with averages from all other treatment group practices. Control practices continued with usual care. Intervention implementation and operating costs and per member, per month claims costs. ROI was measured by net present value (discounted cash flow analysis). The ROI to the Monroe Plan was negative, primarily due to high intervention costs and lack of reductions in spending on emergency department and hospital utilization for children in treatment relative to control practices. A pay-for-reporting, chart audit intervention is unlikely to achieve the meaningful reductions in utilization of high-cost services that would be necessary to produce a financial ROI in 2.5 years. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

A randomized controlled multimodal behavioral intervention trial for improving antiepileptic drug adherence.

PubMed

Pakpour, Amir H; Gholami, Maryam; Esmaeili, Ravanbakhsh; Naghibi, Seyed Abolhasan; Updegraff, John A; Molloy, Gerard J; Dombrowski, Stephan U

2015-11-01

Medication nonadherence is one of the most important reasons for treatment failure in patients with epilepsy. The present study investigated the effectiveness of a multicomponent intervention to improve adherence to antiepileptic drug (AED) medication in patients with epilepsy. In a prospective, randomized multicenter trial, three sessions of face-to-face motivational interviewing (MI) in combination with complementary behavior change techniques were compared with standard care. Motivational interviewing prompted change talk and self-motivated statements from the patients, planning their own medication intake regimen and also identifying and overcoming barriers that may prevent adherence. Participants were provided with calendars to self-monitor their medication taking behavior. A family member and the health-care team were invited to attend the last session of MI in order to improve the collaboration and communication between patients, their caregiver or family member, and their health-care provider. At baseline and 6-month follow-up, psychosocial variables and medical adherence were assessed. In total, 275 participants were included in the study. Compared with the active control group, patients in the intervention group reported significantly higher medication adherence, as well as stronger intention and perceptions of control for taking medication regularly. The intervention group also reported higher levels of action planning, coping planning, self-monitoring, and lower medication concerns. This study shows that MI can be effective in clinical practice to improve medication adherence in patients with epilepsy. It also provides evidence that combining volitional interventions, including action planning, coping planning, and self-monitoring with motivational interviewing can promote the effectiveness of the medical treatments for epilepsy by improving adherence. Copyright © 2015 Elsevier Inc. All rights reserved.

Treatment of pregnancy-related pelvic girdle and/or low back pain after delivery design of a randomized clinical trial within a comprehensive prognostic cohort study [ISRCTN08477490

PubMed Central

Bastiaenen, Caroline HG; de Bie, Rob A; Wolters, Pieter MJC; Vlaeyen, Johan WS; Bastiaanssen, Janneke M; Klabbers, Aldegonda BA; Heuts, Annie; van den Brandt, Piet A; Essed, Gerard GM

2004-01-01

Background Pregnancy-related pelvic girdle and/or low back pain is a controversial syndrome because insight in etiology and prognosis is lacking. The controversy relates to factors eliciting pain and some prognostic factors such as the interpretation of pain at the symphysis. Recent research about treatment strategies also reflects those various opinions, in fact suggesting there is professional uncertainty about the optimal approach. Currently, physiotherapists often prescribe a pain-contingent treatment regime of relative rest and avoiding several day-to-day activities. Additionally, treatment more often includes an exercise program to guide rectification of the muscle imbalance and alignment of the pelvic girdle. Effectiveness of those interventions is not proven and the majority of the studies are methodologically flawed. Investigators draw particular attention to biomedical factors but there is growing evidence that important prognostic issues such as biopsychosocial factors appear to be even more important as point of action in a treatment program. Methods/design This pragmatic randomized controlled trial is designed to evaluate the effectiveness of a tailor-made treatment program with respect to biopsychosocial factors in primary care. The effect of the experimental intervention and usual care are evaluated as they are applied in primary health care. The trial is embedded in a cohort study that is designed as a longitudinal, prospective study, which studies prevalence, etiology, severity and prognosis during pregnancy until one year after delivery. The present paper focuses on choices regarding recruitment procedures, in-/exclusion criteria and the development of a well-timed intervention. Discussion This section briefly discusses the actions taken to minimize bias in the design, the proper time-window for the experimental intervention and the contrast between the experimental intervention and usual care. PMID:15619331

Imagery rescripting and cognitive dissonance: A randomized controlled trial of two brief online interventions for women at risk of developing an eating disorder.

PubMed

Pennesi, Jamie-Lee; Wade, Tracey D

2018-05-01

This pilot study compared two brief online interventions, imagery rescripting and cognitive dissonance, to an assessment-only control condition in a sample of body-dissatisfied young women at risk of developing an eating disorder. We examined the degree to which each intervention reduced disordered eating and modified risk and protective factors for eating disorders. Female university students (N = 107, 17-28 years of age) completed a screening questionnaire, followed by random allocation to one of the three conditions, followed by a baseline assessment, body dissatisfaction induction, and brief online intervention. Participants in the active conditions then completed online daily home practice and a postintervention questionnaire. Findings provide qualified support for the imagery rescripting intervention, with participants reporting higher body image acceptance (Cohen's d = 0.49) than the cognitive dissonance condition, and higher self-compassion (d = 0.59) and lower levels of disordered eating (d = 0.59) than the control condition, at postintervention. There was no significant impact of cognitive dissonance on any factors. Change in body image acceptance and self-compassion mediated the relationship between allocated condition and change in disordered eating at postintervention. These findings provide preliminary support for the use of online-adapted imagery-based techniques (e.g., imagery rescripting) to reduce risk for the development of an eating disorder by strengthening protective factors (i.e., body image acceptance and self-compassion) and reducing disordered eating. Further exploration of the use of imagery strategies in the prevention of disordered eating is required, including prospective tests of the mechanisms of action. © 2018 Wiley Periodicals, Inc.

A prospective interrupted time series study of interventions to improve the quality, rating, framing and structure of goal-setting in community-based brain injury rehabilitation.

PubMed

Hassett, Leanne; Simpson, Grahame; Cotter, Rachel; Whiting, Diane; Hodgkinson, Adeline; Martin, Diane

2015-04-01

To investigate whether the introduction of an electronic goals system followed by staff training improved the quality, rating, framing and structure of goals written by a community-based brain injury rehabilitation team. Interrupted time series design. Two interventions were introduced six months apart. The first intervention comprised the introduction of an electronic goals system. The second intervention comprised a staff goal training workshop. An audit protocol was devised to evaluate the goals. A random selection of goal statements from the 12 months prior to the interventions (Time 1 baseline) were compared with all goal statements written after the introduction of the electronic goals system (Time 2) and staff training (Time 3). All goals were de-identified for client and time-period, and randomly ordered. A total of 745 goals (Time 1 n = 242; Time 2 n = 283; Time 3 n = 220) were evaluated. Compared with baseline, the introduction of the electronic goals system alone significantly increased goal rating, framing and structure (χ(2) tests 144.7, 18.9, 48.1, respectively, p < 0.001). The addition of staff training meant that the improvement in goal quality, which was only a trend at Time 2, was statistically significant at Time 3 (χ(2) 15.0, p ≤ 001). The training also led to a further significant increase in the framing and structuring of goals over the electronic goals system (χ(2) 11.5, 12.5, respectively, p ≤ 0.001). An electronic goals system combined with staff training improved the quality, rating, framing and structure of goal statements. © The Author(s) 2014.

Comparison of Estimates between Cohort and Case-Control Studies in Meta-Analyses of Therapeutic Interventions: A Meta-Epidemiological Study.

PubMed

Lanza, Amy; Ravaud, Philippe; Riveros, Carolina; Dechartres, Agnes

2016-01-01

Observational studies are increasingly being used for assessing therapeutic interventions. Case-control studies are generally considered to have greater risk of bias than cohort studies, but we lack evidence of differences in effect estimates between the 2 study types. We aimed to compare estimates between cohort and case-control studies in meta-analyses of observational studies of therapeutic interventions by using a meta-epidemiological study. We used a random sample of meta-analyses of therapeutic interventions published in 2013 that included both cohort and case-control studies assessing a binary outcome. For each meta-analysis, the ratio of estimates (RE) was calculated by comparing the estimate in case-control studies to that in cohort studies. Then, we used random-effects meta-analysis to estimate a combined RE across meta-analyses. An RE < 1 indicated that case-control studies yielded larger estimates than cohort studies. The final analysis included 23 meta-analyses: 138 cohort and 133 case-control studies. Treatment effect estimates did not significantly differ between case-control and cohort studies (combined RE 0.97 [95% CI 0.86-1.09]). Heterogeneity was low, with between-meta-analysis variance τ2 = 0.0049. Estimates did not differ between case-control and prospective or retrospective cohort studies (RE = 1.05 [95% CI 0.96-1.15] and RE = 0.99 [95% CI, 0.83-1.19], respectively). Sensitivity analysis of studies reporting adjusted estimates also revealed no significant difference (RE = 1.03 [95% CI 0.91-1.16]). Heterogeneity was also low for these analyses. We found no significant difference in treatment effect estimates between case-control and cohort studies assessing therapeutic interventions.

Efficacy of the Fun For Wellness Online Intervention to Promote Multidimensional Well-Being: a Randomized Controlled Trial.

PubMed

Myers, Nicholas D; Prilleltensky, Isaac; Prilleltensky, Ora; McMahon, Adam; Dietz, Samantha; Rubenstein, Carolyn L

2017-11-01

Subjective well-being refers to people's level of satisfaction with life as a whole and with multiple dimensions within it. Interventions that promote subjective well-being are important because there is evidence that physical health, mental health, substance use, and health care costs may be related to subjective well-being. Fun For Wellness (FFW) is a new online universal intervention designed to promote growth in multiple dimensions of subjective well-being. The purpose of this study was to provide an initial evaluation of the efficacy of FFW to increase subjective well-being in multiple dimensions in a universal sample. The study design was a prospective, double-blind, parallel group randomized controlled trial. Data were collected at baseline and 30 and 60 days-post baseline. A total of 479 adult employees at a major university in the southeast of the USA were enrolled. Recruitment, eligibility verification, and data collection were conducted online. Measures of interpersonal, community, occupational, physical, psychological, economic (i.e., I COPPE), and overall subjective well-being were constructed based on responses to the I COPPE Scale. A two-class linear regression model with complier average causal effect estimation was imposed for each dimension of subjective well-being. Participants who complied with the FFW intervention had significantly higher subjective well-being, as compared to potential compliers in the Usual Care group, in the following dimensions: interpersonal at 60 days, community at 30 and 60 days, psychological at 60 days, and economic at 30 and 60 days. Results from this study provide some initial evidence for both the efficacy of, and possible revisions to, the FFW intervention.

Comparative analysis of the effects of two chest physical therapy interventions in patients with bronchiolitis during hospitalization period

PubMed Central

Remondini, Renata; dos Santos, Adriana Zamprônio; de Castro, Giselle; do Prado, Cristiane; da Silva, Luiz Vicente Ribeiro Ferreira

2014-01-01

Objective To evaluate and compare the effects of two chest physiotherapy interventions in patients hospitalized due to acute bronchiolitis. Methods Prospective randomized study with a sample of 83 calls for 29 patients aged between 3 months and 1 year hospitalized for acute bronchiolitis. Patients were distributed randomly into two groups: Group 1, submitted to postural drainage, tapping and tracheal aspiration; and Group 2, submitted to postural drainage, expiratory acceleration flow and tracheal aspiration. Assessments were made before and 10 and 60 minutes after the end of therapy. Patients also underwent drug treatment. The endpoint was to compare two physical therapy interventions as to clinical improvement in infants with acute bronchiolitis by means of oxygen saturation and the Respiratory Distress Assessment Instrument score. The parents/guardians was requested to answer a questionnaire about the treatment applied before the last evaluation in order to measure their satisfaction related to the interventions made. Results The groups were similar regarding the use of antibiotics and bronchodilators. A greater number of patients used corticosteroids in Group 2. A relevant improvement was observed on Respiratory Distress Assessment Instrument score with physical therapy, with reduction of the score 10 minutes after interventions, and the same score 60 minutes later, with no differences between techniques applied. There was no significant variation of pulse oximetry after chest physiotherapy. Most items assessed by the questionnaire had satisfactory answers. Conclusion No differences were observed between groups regarding the items assessed (time required to discharge from study, pulse oximetry in room air and disease severity according to the Respiratory Distress Assessment Instrument score). Parents answered positively about the effects of therapy in the majority of items in the questionnaire, both for the expiratory acceleration flow technique and for tapping. PMID:25628196

Evaluation of the efficacy of an exercise program for pregnant women with low back and pelvic pain: a prospective randomized controlled trial.

PubMed

Ozdemir, Serpil; Bebis, Hatice; Ortabag, Tulay; Acikel, Cengizhan

2015-08-01

To evaluate the effect of exercise programs on pregnant women with pregnancy-related low back and pelvic pain. Low back and pelvic pain during pregnancy is a major health problem due to its frequent occurrence and such pain can limit pregnant women in many of their daily activities. A randomized trial with a control group (n = 48) and an intervention group (n = 48). Trial registration number NCT02189356. Department of Obstetrics and Gynecology, between December 2011-May 2012, an Education and Research Hospital in Turkey. Based on the intention-to-treat principle, all pregnant women were analysed according to the group they were assigned to, regardless of whether they received the intervention or not. Participants in the intervention group received health counselling and exercised regarding low back and pelvic pain for four weeks. The pregnant women in the control group received usual care, comprised of routine clinical practice for pregnancy-related low back and pelvic pain. According to Mann-Whitney U test analysis results, there was a statistically significant difference between the control and intervention groups' Visual Analogue Scale during relaxation scores and Visual Analogue Scale during activity scores at the end of the study. According to Mann-Whitney U test analysis results, the change in the mean Oswestry Disability Index score for the intervention group and the difference in the mean scores between the two groups was statistically significant. A four-week exercise program including individualized health counselling to relieve low back and pelvic pain improved the functional status in pregnant women. © 2015 John Wiley & Sons Ltd.

Intervention effects on kindergarten and first-grade teachers' classroom food practices and food-related beliefs in American Indian reservation schools.

PubMed

Arcan, Chrisa; Hannan, Peter J; Himes, John H; Fulkerson, Jayne A; Rock, Bonnie Holy; Smyth, Mary; Story, Mary

2013-08-01

Prevalence of obesity among American Indian children is higher than the general US population. The school environment and teachers play important roles in helping students develop healthy eating habits. The aim of this prospective study was to examine teachers' classroom and school food practices and beliefs and the effect of teacher training on these practices and beliefs. Data were used from the Bright Start study, a group-randomized, school-based trial that took place on the Pine Ridge American Indian reservation (fall 2005 to spring 2008). Kindergarten and first-grade teachers (n=75) from 14 schools completed a survey at the beginning and end of the school year. Thirty-seven survey items were evaluated using mixed-model analysis of variance to examine the intervention effect for each teacher-practice and belief item (adjusting for teacher type and school as random effect). At baseline, some teachers reported classroom and school food practices and beliefs that supported health and some that did not. The intervention was significantly associated with lower classroom use of candy as a treat (P=0.0005) and fast-food rewards (P=0.008); more intervention teachers disagreed that fast food should be offered as school lunch alternatives (P=0.019), that it would be acceptable to sell unhealthy foods as part of school fundraising (P=0.006), and that it would not make sense to limit students' food choices in school (P=0.035). School-based interventions involving teacher training can result in positive changes in teachers' classroom food practices and beliefs about the influence of the school food environment in schools serving American Indian children on reservations. Copyright © 2013 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

Intervention effects on kindergarten and 1st grade teachers’ classroom food practices and food-related beliefs in American Indian reservation schools

PubMed Central

Arcan, Chrisa; Hannan, Peter J.; Himes, John H.; Fulkerson, Jayne A.; Rock, Bonnie Holy; Smyth, Mary; Story, Mary

2013-01-01

Prevalence of obesity among American Indian (AI) children is higher than the general US population. The school environment and teachers play important roles in helping students develop healthy eating habits. The aim of this prospective study was to examine teachers’ classroom and school food practices and beliefs and the effect of teacher training on these practices and beliefs. Data were used from the Bright Start study, a group-randomized, school-based trial on the Pine Ridge AI reservation (Fall 2005 to Spring 2008). Kindergarten and first grade teachers (n=75) from 14 schools completed a survey at the beginning and end of the school year. Thirty-seven survey items were evaluated using mixed-model analysis of variance to examine the intervention effect for each teacher-practice and belief item (adjusting for teacher type and school as random effect). At baseline, some teachers reported classroom and school food practices and beliefs that supported health and some that did not. The intervention was significantly associated with lower classroom use of candy as a treat (p=0.0005) and fast food rewards (p=0.008); more intervention teachers disagreed that fast food should be offered as school lunch alternatives (p=0.019), that it would be acceptable to sell unhealthy foods as part of school fund-raising (p=0.006), and that it would not make sense to limit students’ food choices in school (p=0.035). School-based interventions involving teacher training can result in positive changes in teachers’ classroom food practices and beliefs about the influence of the school food environment in schools serving AI children on reservations. PMID:23885704

Does teaching crisis resource management skills improve resuscitation performance in pediatric residents?*.

PubMed

Blackwood, Jaime; Duff, Jonathan P; Nettel-Aguirre, Alberto; Djogovic, Dennis; Joynt, Chloe

2014-05-01

The effect of teaching crisis resource management skills on the resuscitation performance of pediatric residents is unknown. The primary objective of this pilot study was to determine if teaching crisis resource management to residents leads to improved clinical and crisis resource management performance in simulated pediatric resuscitation scenarios. A prospective, randomized control pilot study. Simulation facility at tertiary pediatric hospital. Junior pediatric residents. Junior pediatric residents were randomized to 1 hour of crisis resource management instruction or no additional training. Time to predetermined resuscitation tasks was noted in simulated resuscitation scenarios immediately after intervention and again 3 months post intervention. Crisis resource management skills were evaluated using the Ottawa Global Rating Scale. Fifteen junior residents participated in the study, of which seven in the intervention group. The intervention crisis resource management group placed monitor leads 24.6 seconds earlier (p = 0.02), placed an IV 47.1 seconds sooner (p = 0.04), called for help 50.4 seconds faster (p = 0.03), and checked for a pulse after noticing a rhythm change 84.9 seconds quicker (p = 0.01). There was no statistically significant difference in time to initiation of cardiopulmonary resuscitation (p = 0.264). The intervention group had overall crisis resource management performance scores 1.15 points higher (Ottawa Global Rating Scale [out of 7]) (p = 0.02). Three months later, these differences between the groups persisted. A 1-hour crisis resource management teaching session improved time to critical initial steps of pediatric resuscitation and crisis resource management performance as measured by the Ottawa Global Rating Scale. The control group did not develop these crisis resource management skills over 3 months of standard training indicating that obtaining these skills requires specific education. Larger studies of crisis resource education are required.

A Pilot Study of CPAP Adherence Promotion by Peer Buddies with Sleep Apnea

PubMed Central

Parthasarathy, Sairam; Wendel, Christopher; Haynes, Patricia L.; Atwood, Charles; Kuna, Samuel

2013-01-01

Study Objectives: To evaluate patient ratings of the acceptability of a peer buddy system (PBS). To promote continuous positive airway pressure (CPAP) therapy adherence in patients with obstructive sleep apnea (OSA). To obtain preliminary data on the effectiveness of PBS on sleep-specific health-related quality of life and CPAP adherence. Design: Prospective, randomized, and controlled study. Setting: Academic Center. Participants: Thirty-nine patients with OSA and 13 patients with OSA who were experienced CPAP users. Interventions: Recently diagnosed patients with OSA were randomly assigned to either the PBS to promote CPAP adherence (intervention group) or usual care (control group). Measurements: Patient satisfaction, Functional Outcomes of Sleep Questionnaire (FOSQ), CPAP adherence, vigilance, self-efficacy, and patient activation were measured. Results: Ninety-one percent of the subjects rated the PBS as very satisfactory (68%) or satisfactory (23%). During the 90 days of therapy, weekly CPAP adherence was greater in the intervention than the usual care group (MANOVA; F = 2.29; p = 0.04). Patient satisfaction was positively correlated with CPAP adherence (R2 = 0.14; p = 0.02). We did not find any group differences for FOSQ, vigilance, self-efficacy, or patient activation in this pilot study. Conclusion: Our pilot study suggests that the PBS intervention is feasible and received high patient satisfaction ratings. CPAP adherence may be improved by peer-driven intervention, but a larger, adequately powered study is needed. Clinical Trial Information: ClinicalTrials.gov identifier: NCT01164683. Commentary: A commentary on this article appears in this issue on page 551. Citation: Parthasarathy S; Wendel C; Haynes PL; Atwood C; Kuna S. A pilot study of CPAP adherence promotion by peer buddies with sleep apnea. J Clin Sleep Med 2013;9(6):543-550. PMID:23772186

Strategies for improving memory: a randomized trial of memory groups for older people, including those with mild cognitive impairment.

PubMed

Kinsella, Glynda J; Ames, David; Storey, Elsdon; Ong, Ben; Pike, Kerryn E; Saling, Michael M; Clare, Linda; Mullaly, Elizabeth; Rand, Elizabeth

2016-01-01

Governments are promoting the importance of maintaining cognitive health into older age to minimize risk of cognitive decline and dementia. Older people with amnestic mild cognitive impairment (aMCI) are particularly vulnerable to memory challenges in daily activities and are seeking ways to maintain independent living. To evaluate the effectiveness of memory groups for improving memory strategies and memory ability of older people, especially those with aMCI. 113 healthy older adults (HOA) and 106 adults with aMCI were randomized to a six-week memory group or a waitlist control condition. Outcome was evaluated through knowledge and use of memory strategies, memory ability (self-report and neuropsychological tests), and wellbeing. Assessments included a six-month follow-up. Using intention to treat analyses, there were intervention effects for HOA and aMCI groups in strategy knowledge (HOA: η2= 0.20; aMCI: η2= 0.06), strategy use (HOA: η2= 0.18; aMCI: η2= 0.08), and wellbeing (HOA: η2= 0.11; aMCI: η2= 0.05). There were also intervention effects in the HOA group, but not the aMCI group, in self-reported memory ability (η2= 0.06) and prospective memory tests (η2= 0.02). By six-month follow-up, gains were found on most HOA outcomes. In the aMCI group gains were found in strategy use, and by this stage, gains in prospective memory were also found. Memory groups can engage older people in techniques for maintaining cognitive health and improve memory performance, but more modest benefits are seen for older adults with aMCI.

Effect of an orally formulated processed black cumin, from Iranian traditional medicine pharmacopoeia, in relieving symptoms of knee osteoarthritis: A prospective, randomized, double-blind and placebo-controlled clinical trial.

PubMed

Salimzadeh, Ahmad; Ghourchian, Anahita; Choopani, Rasool; Hajimehdipoor, Homa; Kamalinejad, Mohammad; Abolhasani, Maryam

2017-06-01

Osteoarthritis is a global health problem, especially for the elderly. A good replacement for non-surgical treatments is the use of traditional medicines. We selected a revere plant (Nigella sativa L.), a widely utilized medicinal herb for the treatment of inflammatory conditions, from the Iranian traditional medicine (ITM) pharmacopoeia with proven anti-inflammatory and analgesic actions. We performed a prospective, randomized, double-blind, and placebo-controlled clinical trial, in order to investigate whether the herb is useful in alleviating the symptoms of knee osteoarthritis. American College of Rheumatology clinical criteria were the basis of diagnosis, while the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire was considered as the main outcome measure. One hundred and ten eligible patients were assigned to receive a placebo or an active intervention (2 g/day of processed N. sativa seed powder in divided doses). Acetaminophen tablets were the rescue medicine. Finally, 40 patients in the placebo group and 37 patients in the active group completed the trial and were included in the statistical analysis. Both cohorts demonstrated statistically significant within-group differences (P < 0.05) in some subscales that were more prominent in the active group without any considerable adverse effects. Nevertheless, KOOS score results and the mean number of acetaminophen tablets used by patients showed no statistically significant between-group differences. It can be concluded that future programmed studies with larger sample sizes, longer follow-up periods, and other forms of N. sativa seeds as an active intervention is necessary to evaluate its efficacy in relieving the symptoms of knee osteoarthritis. © 2017 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

Evaluation of the impact of preoperative education in ambulatory laparoscopic cholecystectomy. A prospective, double-blind randomized trial.

PubMed

Subirana Magdaleno, Helena; Caro Tarragó, Aleidis; Olona Casas, Carles; Díaz Padillo, Alba; Franco Chacón, Mario; Vadillo Bargalló, Jordi; Saludes Serra, Judit; Jorba Martín, Rosa

2018-02-01

Outpatient laparoscopic cholecystectomy is a safe procedure and provides a better use of health resources and perceived satisfaction without affecting quality of care. Preoperative education has shown less postoperative stress, pain and nausea in some interventions. The principal objective of this study is to assess the impact of preoperative education on postoperative pain in patients undergoing ambulatory laparoscopic cholecystectomy. Secondary objectives were: to evaluate presence of nausea, morbidity, hospital admissions, readmissions rate, quality of life and satisfaction. Prospective, randomized, and double blind study. Between April 2014 and May 2016, 62 patients underwent outpatient laparoscopic cholecystectomy. ASA I-II, age 18-75, outpatient surgery criteria, abdominal ultrasonography with cholelithiasis. Patient randomization in two groups, group A: intensified preoperative education and group B: control. Sixty-two patients included, 44 women (71%), 18 men (29%), mean age 46,8 years (20-69). Mean BMI 27,5. Outpatient rate 92%. Five cases required admission, two due to nausea. Pain scores obtained using a VAS was at 24-hour, 2,9 in group A and 2,7 in group B. There were no severe complications or readmissions. Results of satisfaction and quality of life scores were similar for both groups. We did not find differences due to intensive preoperative education. However, we think that a correct information protocol should be integrated into the patient's preoperative preparation. Registered in ISRCTN number ISRCTN83787412. Copyright © 2017 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Enhancing blood donation intentions using multimedia donor education materials.

PubMed

France, Christopher R; France, Janis L; Wissel, Mary Ellen; Kowalsky, Jennifer M; Bolinger, Elizabeth M; Huckins, Jamie L

2011-08-01

Prior research has shown that education materials that directly address prospective donor concerns and provide specific coping suggestions are particularly effective at enhancing donation attitudes and intentions to give blood. This study compared the effect of donor coping materials, provided in written and audiovisual formats, as potential tools to enhance recruitment of prospective blood donors. The role of initial attitudes toward blood donation on responses to these materials was also considered. Young adults (62% female; mean [SD] age=19.1 [1.4]; mean [range] prior blood donations=1.32 [0-13]) were randomly assigned to 1) read a brochure addressing common blood donor concerns and suggesting specific coping strategies, 2) view a video addressing blood donor concerns and illustrating coping techniques, 3) read the brochure and view the video, or 4) read a control brochure on healthy eating and exercise. Measures of blood donation attitudes, anxiety, confidence, and intentions to give blood were completed before and after the intervention. Relative to the control brochure, all the intervention groups showed larger reductions in anxiety, more positive changes in attitude, and greater increases in donation confidence and intentions. The combination of the brochure and video outperformed either intervention alone in further improving donation attitudes among participants with high initial donation attitudes. Blood donation coping materials, presented in either written or audiovisual formats, significantly enhance willingness to donate blood among young adults regardless of their initial attitudes toward blood donation. © 2011 American Association of Blood Banks.

Embracing the heart: perioperative management of patients undergoing off-pump coronary artery bypass grafting using the octopus tissue stabilizer.

PubMed

Nierich, A P; Diephuis, J; Jansen, E W; van Dijk, D; Lahpor, J R; Borst, C; Knape, J T

1999-04-01

To describe hemodynamic alterations during coronary artery bypass grafting (CABG) without extracorporeal circulation using the Octopus Tissue Stabilizer, and to describe the two anesthetic management protocols based on either general anesthesia with opioids (34 patients) or general anesthesia with high thoracic epidural anesthesia (TEA; 66 patients). A prospective observational report. An academic university heart center. First 100 patients undergoing CABG using the Octopus Tissue Stabilizer. None. Current management provided satisfactory results in preventing hypoperfusion of the heart and inadequate systemic circulation without the use of major pharmacologic interventions. Movement of the heart to reach the target site of anastomosis caused hemodynamic alterations. These could easily be corrected by anesthetic interventions, such as fluid load and low doses of inotropes. High TEA allows earlier extubation compared with the opioid anesthesia technique (0.9 v 4.5 hours). Perioperative management and the incidence of postoperative complications did not differ between anesthetic techniques. Major complications, such as death, intraoperative myocardial infarction, and stroke, did not occur. Both anesthetic protocols are safe and effective in handling these patients. Off-pump CABG surgery requires anesthetic interventions because hemodynamic alterations are caused by the presentation of the heart to the surgeon. The complication rate is low but needs to be evaluated, compared with conventional CABG, in a prospective randomized study. High thoracic epidural anesthesia allows early recovery, but improved outcome could not be proved in this patient group.

Treating major depression with yoga: A prospective, randomized, controlled pilot trial.

PubMed

Prathikanti, Sudha; Rivera, Renee; Cochran, Ashly; Tungol, Jose Gabriel; Fayazmanesh, Nima; Weinmann, Eva

2017-01-01

Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression. Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI). At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22-72), and mean BDI score 22.4 (SD = 4.5). Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES) and Rosenberg Self-Esteem Scale (RSES) at baseline and at 8 weeks. In intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034). In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018). Effect size of yoga in reducing BDI scores was large, per Cohen's d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for either the GSES or RSES. In adults with mild-to-moderate major depression, an 8-week hatha yoga intervention resulted in statistically and clinically significant reductions in depression severity. ClinicalTrials.gov NCT01210651.

Treating major depression with yoga: A prospective, randomized, controlled pilot trial

PubMed Central

Rivera, Renee; Cochran, Ashly; Tungol, Jose Gabriel; Fayazmanesh, Nima; Weinmann, Eva

2017-01-01

Background Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression. Methods Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14–28 on Beck Depression Inventory-II (BDI). At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22–72), and mean BDI score 22.4 (SD = 4.5). Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES) and Rosenberg Self-Esteem Scale (RSES) at baseline and at 8 weeks. Results In intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034). In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018). Effect size of yoga in reducing BDI scores was large, per Cohen’s d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for either the GSES or RSES. Conclusion In adults with mild-to-moderate major depression, an 8-week hatha yoga intervention resulted in statistically and clinically significant reductions in depression severity. Trial registration ClinicalTrials.gov NCT01210651 PMID:28301561

A randomized trial of maternal influenza immunization decision-making: A test of persuasive messaging models

PubMed Central

Frew, Paula M.; Kriss, Jennifer L.; Chamberlain, Allison T.; Malik, Fauzia; Chung, Yunmi; Cortés, Marielysse; Omer, Saad B.

2016-01-01

ABSTRACT Objective: We sought to examine the effectiveness of persuasive communication interventions on influenza vaccination uptake among black/African American pregnant women in Atlanta, Georgia. Methods: We recruited black/African American pregnant women ages 18 to 50 y from Atlanta, GA to participate in a prospective, randomized controlled trial of influenza immunization messaging conducted from January to April 2013. Eligible participants were randomized to 3 study arms. We conducted follow-up questionnaires on influenza immunization at 30-days post-partum with all groups. Chi-square and t tests evaluated group differences, and outcome intention-to-treat assessment utilized log-binomial regression models. Results: Of the 106 enrolled, 95 women completed the study (90% retention), of which 31 were randomly assigned to affective messaging intervention (“Pregnant Pause” video), 30 to cognitive messaging intervention (“Vaccines for a Healthy Pregnancy” video), and 34 to a comparison condition (receipt of the Influenza Vaccine Information Statement). The three groups were balanced on baseline demographic characteristics and reported health behaviors. At baseline, most women (63%, n = 60) reported no receipt of seasonal influenza immunization during the previous 5 y. They expressed a low likelihood (2.1 ± 2.8 on 0-10 scale) of obtaining influenza immunization during their current pregnancy. At 30-days postpartum follow-up, influenza immunization was low among all participants (7-13%) demonstrating no effect after a single exposure to either affective messaging (RR = 1.10; 95% CI: 0.30-4.01) or cognitive messaging interventions (RR = 0.57; 95% CI: 0.11-2.88). Women cited various reasons for not obtaining maternal influenza immunizations. These included concern about vaccine harm (47%, n = 40), low perceived influenza infection risk (31%, n = 26), and a history of immunization nonreceipt (24%, n = 20). Conclusion: The findings reflect the limitations associated with a single exposure to varying maternal influenza immunization message approaches on vaccine behavior. For this population, repeated influenza immunization exposures may be warranted with alterations in message format, content, and relevance for coverage improvement. PMID:27322154

Balance training program is highly effective in improving functional status and reducing the risk of falls in elderly women with osteoporosis: a randomized controlled trial

PubMed Central

Madureira, M. M.; Takayama, L.; Gallinaro, A. L.; Caparbo, V. F.; Costa, R. A.

2006-01-01

Introduction The purpose of this study was to investigate the effect of a 12-month Balance Training Program on balance, mobility and falling frequency in women with osteoporosis. Methods Sixty-six consecutive elderly women were selected from the Osteometabolic Disease Outpatient Clinic and randomized into 2 groups: the ‘Intervention’, submitted for balance training; and the ‘Control’, without intervention. Balance, mobility and falling frequency were evaluated before and at the end of the trial, using the Berg Balance Scale (BBS), the Clinical Test Sensory Interaction Balance (CTSIB) and the Timed “Up & Go” Test (TUGT). Intervention used techniques to improve balance consisting of a 1-hour session each week and a home-based exercise program. Results Sixty women completed the study and were analyzed. The BBS difference was significant higher in the Intervention group compared to Control (5.5 ± 5.67 vs −0.5 ± 4.88 score, p < 0.001). Similarly, the number of patients in the Intervention group presented improvement in two conditions of CTSIB compared to Control (eyes closed and unstable surface condition: 13 vs one patient, p < 0.001 and eyes open, visual conflict and unstable surface condition: 12 vs one patient, p < 0.001). Additionally, the differences between the TUGT were reduced in the Intervention group compared to Control (−3.65 ± 3.61 vs 2.27 ± 7.18 seconds, p< 0.001). Notably, this improvement was paralleled by a reduction in the number of falls/patient in the Intervention group compared to Control (−0.77 ± 1.76 vs 0.33 ± 0.96, p = 0.018). Conclusion This longitudinal prospective study demonstrated that an intervention using balance training is effective in improving functional and static balance, mobility and falling frequency in elderly women with osteoporosis. PMID:17089080

The influence of social networking sites on health behavior change: a systematic review and meta-analysis.

PubMed

Laranjo, Liliana; Arguel, Amaël; Neves, Ana L; Gallagher, Aideen M; Kaplan, Ruth; Mortimer, Nathan; Mendes, Guilherme A; Lau, Annie Y S

2015-01-01

Our aim was to evaluate the use and effectiveness of interventions using social networking sites (SNSs) to change health behaviors. Five databases were scanned using a predefined search strategy. Studies were included if they focused on patients/consumers, involved an SNS intervention, had an outcome related to health behavior change, and were prospective. Studies were screened by independent investigators, and assessed using Cochrane's 'risk of bias' tool. Randomized controlled trials were pooled in a meta-analysis. The database search retrieved 4656 citations; 12 studies (7411 participants) met the inclusion criteria. Facebook was the most utilized SNS, followed by health-specific SNSs, and Twitter. Eight randomized controlled trials were combined in a meta-analysis. A positive effect of SNS interventions on health behavior outcomes was found (Hedges' g 0.24; 95% CI 0.04 to 0.43). There was considerable heterogeneity (I(2) = 84.0%; T(2) = 0.058) and no evidence of publication bias. To the best of our knowledge, this is the first meta-analysis evaluating the effectiveness of SNS interventions in changing health-related behaviors. Most studies evaluated multi-component interventions, posing problems in isolating the specific effect of the SNS. Health behavior change theories were seldom mentioned in the included articles, but two particularly innovative studies used 'network alteration', showing a positive effect. Overall, SNS interventions appeared to be effective in promoting changes in health-related behaviors, and further research regarding the application of these promising tools is warranted. Our study showed a positive effect of SNS interventions on health behavior-related outcomes, but there was considerable heterogeneity. Protocol registration The protocol for this systematic review is registered at http://www.crd.york.ac.uk/PROSPERO with the number CRD42013004140. © The Author 2014. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.comFor numbered affiliations see end of article.

Psoriasis increases risk of new-onset atrial fibrillation: a systematic review and meta-analysis of prospective observational studies.

PubMed

Upala, Sikarin; Shahnawaz, Afeefa; Sanguankeo, Anawin

2017-08-01

Psoriasis is a common chronic immune-mediated dermatological disease that increases the risk of cardiovascular disease. We conducted a systematic review and meta-analysis to evaluate the association between psoriasis and atrial fibrillation from prospective observational studies. A comprehensive search of the databases of the MEDLINE and EMBASE was performed from inception through November 2015. The inclusion criterion was the prospective observational study that assessed the risk of new-onset atrial fibrillation in adults with psoriasis. Outcome was the adjusted hazard ratio (HR) of atrial fibrillation comparison between patients with psoriasis and controls. Pooled HR and 95% confidence intervals (CI) were calculated using a random-effects model. The initial search yielded 176 articles. Fifteen articles underwent full-length review and data were extracted from 4 observational studies. Incidence of atrial fibrillation was ascertained by cardiologist-reviewed electrocardiograms. There was a significant increased risk of new-onset atrial fibrillation in patients with psoriasis compared to controls with a pooled HR 1.42 (95%CI 1.22-1.65). Our meta-analysis of prospective studies demonstrated that patients with psoriasis have increased risk of new-onset atrial fibrillation. Future interventional studies addressing the impact of psoriasis treatment and prevention of atrial fibrillation should be performed.

Social Media Interventions to Promote HIV Testing, Linkage, Adherence, and Retention: Systematic Review and Meta-Analysis.

PubMed

Cao, Bolin; Gupta, Somya; Wang, Jiangtao; Hightow-Weidman, Lisa B; Muessig, Kathryn E; Tang, Weiming; Pan, Stephen; Pendse, Razia; Tucker, Joseph D

2017-11-24

Social media is increasingly used to deliver HIV interventions for key populations worldwide. However, little is known about the specific uses and effects of social media on human immunodeficiency virus (HIV) interventions. This systematic review examines the effectiveness of social media interventions to promote HIV testing, linkage, adherence, and retention among key populations. We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist and Cochrane guidelines for this review and registered it on the International Prospective Register of Systematic Reviews, PROSPERO. We systematically searched six databases and three conference websites using search terms related to HIV, social media, and key populations. We included studies where (1) the intervention was created or implemented on social media platforms, (2) study population included men who have sex with men (MSM), transgender individuals, people who inject drugs (PWID), and/or sex workers, and (3) outcomes included promoting HIV testing, linkage, adherence, and/or retention. Meta-analyses were conducted by Review Manager, version 5.3. Pooled relative risk (RR) and 95% confidence intervals were calculated by random-effects models. Among 981 manuscripts identified, 26 studies met the inclusion criteria. We found 18 studies from high-income countries, 8 in middle-income countries, and 0 in low-income countries. Eight were randomized controlled trials, and 18 were observational studies. All studies (n=26) included MSM; five studies also included transgender individuals. The focus of 21 studies was HIV testing, four on HIV testing and linkage to care, and one on antiretroviral therapy adherence. Social media interventions were used to do the following: build online interactive communities to encourage HIV testing/adherence (10 studies), provide HIV testing services (9 studies), disseminate HIV information (9 studies), and develop intervention materials (1 study). Of the studies providing HIV self-testing, 16% of participants requested HIV testing kits from social media platforms. Existing social media platforms such as Facebook (n=15) and the gay dating app Grindr (n=10) were used most frequently. Data from four studies show that HIV testing uptake increased after social media interventions (n=1283, RR 1.50, 95% CI 1.28-1.76). In the studies where social media interventions were participatory, HIV testing uptake was higher in the intervention arm than the comparison arm (n=1023, RR 1.64, 95% CI 1.19-2.26). Social media interventions are effective in promoting HIV testing among MSM in many settings. Social media interventions to improve HIV services beyond HIV testing in low- and middle-income countries and among other key populations need to be considered. International Prospective Register of Systematic Reviews (PROSPERO): CRD42016048073; http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42016048073 (Archived by WebCite at http://www. webcitation.org/6usLCJK3v). ©Bolin Cao, Somya Gupta, Jiangtao Wang, Lisa B Hightow-Weidman, Kathryn E Muessig, Weiming Tang, Stephen Pan, Razia Pendse, Joseph D. Tucker. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 24.11.2017.

Effect of Prayer on Intensity of Migraine Headache

PubMed Central

Tajadini, Haleh; Zangiabadi, Nasser; Divsalar, Kouros; Safizadeh, Hossein; Esmaili, Zahra; Rafiei, Hossein

2016-01-01

Background and Aim. Migraine is a common form of headache that affects patients quality of life negatively. In addition to pharmacologic treatment, there are a variety of nonpharmacologic treatments for migraine headache. In present study, we examined the effect of prayer on intensity of migraine pain. Methods. In a prospective, randomized, controlled trial from October 2013 to June 2014, this study has been conducted in Kerman, Iran. We randomly assigned 92 patients in 2 groups to receive either 40 mg of propranolol twice a day for 2 month (group “A”) or 40 mg of propranolol twice a day for 2 months with prayer (group “B”). At the beginning of study and 3 months after intervention, patients’ pain was measured using the visual analogue scale. Results. At the beginning of study and before intervention, the mean score of pain in patients in groups A and B were 5.7 ± 1.6 and 6.5 ± 1.9, respectively. According to results of independent t test, mean score of pain intensity at the beginning of study were similar between patients in 2 groups (P > .05). Three month after intervention, mean score of pain intensity decreased in patients in both groups. At this time, the mean scores of pain intensity were 5.4 ± 1.1 and 4.2 ± 2.3 in patients in groups A and B, respectively. This difference between groups was statistically significant (P < .001). Conclusions. The present study revealed that prayer can be used as a nonpharmacologic pain coping strategy in addition to pharmacologic intervention for this group of patients. PMID:26865602

Randomized clinical trial of nutritional counseling for malnourished hospital patients.

PubMed

Casals, C; García-Agua-Soler, N; Vázquez-Sánchez, M Á; Requena-Toro, M V; Padilla-Romero, L; Casals-Sánchez, J L

2015-01-01

Malnutrition is associated with an increased risk of mortality and morbidity, longer hospital stays and general loss of quality of life. The aim of this study is to assess the impact of dietary counseling for malnourished hospital patients. Prospective, randomized, open-label study of 106 hospital patients with malnutrition (54 in the control group and 52 in the intervention group). The intervention group received dietary counseling, and the control group underwent standard treatment. We determined the patients' nutritional state (body mass index, laboratory parameters, malnutrition universal screening tool), degree of dependence (Barthel index), quality of life (SF-12), degree of satisfaction (CSQ-8), the number and length of readmissions and mortality. The patients who underwent the "intervention" increased their weight at 6 months, while the controls lost weight (difference in body mass index, 2.14kg/m(2); p<.001). The intervention group had better results when compared with the control group in the Malnutrition Universal Screening Tool scores (difference, -1.29; p<.001), Barthel index (difference, 7.49; p=.025), SF-12 (difference, 13.72; p<.001) and CSQ-8 (difference, 4.34, p<.001) and required fewer readmissions (difference, -0.37; p=.04) and shorter stays for readmissions (difference, -6.75; p=.035). Mortality and laboratory parameters were similar for the 2 groups. Nutritional counseling improved the patients' nutritional state, quality of life and degree of dependence and decreased the number of hospital readmissions. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Medicina Interna (SEMI). All rights reserved.

A randomized controlled trial on early physiotherapy intervention versus usual care in acute care unit for elderly: potential benefits in light of dietary intakes.

PubMed

Blanc-Bisson, C; Dechamps, A; Gouspillou, G; Dehail, P; Bourdel-Marchasson, I

2008-01-01

To evaluate effects of early intensive physiotherapy during acute illness on post hospitalization activity daily living autonomy (ADL). Prospective randomized controlled trial of intensive physiotherapy rehabilitation on day 1 to 2 after admission until clinical stability or usual care. acute care geriatric medicine ward. A total of 76 acutely ill patients, acutely bedridden or with reduced mobility but who were autonomous for mobility within the previous 3 months. Patients in palliative care or with limiting mobility pathology were excluded. Mean age was 85.4 (SD 6.6) years. At admission, at clinical stability and one month later: anthropometry, energy and protein intakes, hand grip strength, ADL scores, and baseline inflammatory parameters. An exploratory principal axis analysis was performed on the baseline characteristics and general linear models were used to explore the course of ADL and nutritional variables. A 4-factor solution was found explaining 71.7% of variance with a factor "nutrition", a factor "function" (18.8% of variance) for ADL, handgrip strength, bedridden state, energy and protein intakes, serum albumin and C-reactive protein concentrations; a factor "strength" and a fourth factor . During follow-up, dietary intakes, handgrip strength, and ADL scores improved but no changes occurred for anthropometric variables. Intervention was associated only with an increase in protein intake. Better improvement in ADL was found in intervention group when model was adjusted on "function" factor items. Physical intervention programs should be proposed according to nutritional intakes with the aim of preventing illness induced disability.

Maintaining nutrition in aged care residents with a train-the-trainer intervention and Nutrition Coordinator.

PubMed

Gaskill, D; Isenring, E A; Black, L J; Hassall, S; Bauer, J D

2009-12-01

To investigate the impact of a train-the-trainer program on the nutritional status of older people in residential care. Prospective, randomized controlled study. Eight nursing homes in Southeast Queensland, Australia. A total of 352 residents participated - 245 were female (69.6%). The mean age was 84.2 years and the majority (79.4%) were classified as high dependency. Residents from four nursing homes were randomly selected for a nutrition education program coordinated by Nutrition Coordinators. Residents from the other four nursing homes (control) received usual care. The Subjective Global Assessment was used to determine prevalence of malnutrition at baseline and six months post intervention. The Resident Classification Scale measured functional dependency. Prescribed diet, fluids, oral hygiene status and allied health referrals were obtained by chart audit. Approximately half the residents were well nourished with 49.4% moderately or severely malnourished. Residents in the intervention group were more likely to maintain or improve their nutritional status compared with the control group who were more likely to experience a deterioration (P=0.027). The odds of the control group being malnourished post test was 1.6 times more likely compared with the intervention group but this did not reach statistical significance (P=0.1). The results of the study encourage the implementation of a Nutrition Coordinator program to maintain nutritional status of aged care residents. Nevertheless, malnutrition rates continue to be unacceptably high. In a rapidly aging society, the aged care sector needs to confront malnutrition and provide better resources for staff to take measures against this problem.

Systematic literature review: xerostomia in advanced cancer patients.

PubMed

Hanchanale, Sarika; Adkinson, Lucy; Daniel, Sunitha; Fleming, Michelle; Oxberry, Stephen G

2015-03-01

Dry mouth (xerostomia) is one of the commonest symptoms in cancer patients and can adversely affect quality of life. The aim of this review was to determine the effectiveness of pharmacological and non-pharmacological interventions in treating xerostomia in adult advanced cancer patients. The literature search was performed in February 2014 using databases including EMBASE, MEDLINE, CINAHL, BNI and Cochrane library. The search was carried out using standard MeSH terms and was limited to adult population and English language. Studies investigating xerostomia secondary to head and neck cancer treatment and autoimmune disease were excluded. Titles and abstracts were screened and reviewed for eligibility. Only studies involving primary research were included in the analysis. Six studies met the eligibility criteria for review: three randomized controlled trials and three prospective studies. The quality assessment and reporting was performed using PRISMA, Jadad and STROBE. These studies compared acupuncture, pilocarpine, Saliva Orthana and chewing gum with each other or with placebo. All interventions were considered effective in treating xerostomia. However, effectiveness versus placebo could not be demonstrated for Saliva Orthana. Meta-analysis could not be performed due to heterogeneity of the study type and intervention. Limited published data exists reporting the effectiveness of measures in the treatment of xerostomia in cancer patients. Based on primary research of low quality, firm conclusions cannot be drawn. However, pilocarpine, artificial saliva, chewing gum and acupuncture can be tried based on the available data. This highlights the explicit need to improve our evidence base. Properly constructed randomized controlled trials demonstrating effectiveness of pharmacological and non-pharmacological interventions for dry mouth are required.

Clinical, metabolic and psychological outcomes and treatment costs of a prospective randomized trial based on different educational strategies to improve diabetes care (PRODIACOR).

PubMed

Gagliardino, J J; Lapertosa, S; Pfirter, G; Villagra, M; Caporale, J E; Gonzalez, C D; Elgart, J; González, L; Cernadas, C; Rucci, E; Clark, C

2013-09-01

To evaluate the effect of system interventions (formalized data collection and 100% coverage of medications and supplies) combined with physician and/or patient education on therapeutic indicators and costs in Type 2 diabetes. This was a randomized 2 × 2 design in public health, social security or private prepaid primary care clinics in Corrientes, Argentina. Thirty-six general practitioners and 468 adults with Type 2 diabetes participated. Patients of nine participating physicians were selected randomly and assigned to one of four structured group education programmes (117 patients each): control (group 1), physician education (group 2), patient education (group 3), and both physician education and patient education (group 4), with identical system interventions in all four groups. Outcome measures included HbA(1c), BMI, blood pressure, fasting glucose, lipid profile, drug consumption, resource use and patient well-being at baseline and every 6 months up to 42 months. HbA(1c) decreased significantly from 4 mmol/mol to 10 mmol/mol by 42 months (P < 0.05); the largest and more consistent decrease was in the groups where patients and physicians were educated. Blood pressure and triglycerides decreased significantly in all groups; the largest changes were recorded in the combined education group. The World Health Organization-5 Lowe score showed significant improvements, without differences among groups. The lowest treatment cost was seen in the combined education group. In a primary care setting, educational interventions combined with comprehensive care coverage resulted in long-term improvement in clinical, metabolic and psychological outcomes at the best cost-effectiveness ratio. © 2013 The Authors. Diabetic Medicine © 2013 Diabetes UK.

Progressive Muscle Relaxation Combined with Chinese Medicine Five-Element Music on Depression for Cancer Patients: A Randomized Controlled Trial.

PubMed

Liao, Juan; Wu, Yu; Zhao, Yang; Zhao, Yuan-Chen; Zhang, Xu; Zhao, Nan; Lee, Chun-Ging; Yang, Yu-Fei

2018-05-01

To evaluate the effects of progressive muscle relaxation training (PMRT) combined with fifive elements music therapy of Chinese medicine (CM) for improving anxiety and depression of cancer patients. From June 2015 to March 2016, 60 cancer patients were included into the study. The patients were randomly assigned to a control group and a treatment group by envelope randomization, receiving PMRT and PMRT plus CM five elements music therapy, respectively, for 8 weeks. Hospital Anxiety and Depression Scale (HADS), Benefit Finding Scales (BFS), Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp), and Intervention Expectations Questionnaire (IEQU) were adopted to assess the depression of the two groups before and after the treatment. Four cases dropped out during the study, and 29 cases in the treatment group and 27 in the control group were included in the fifinal analysis. Prior to the treatments, the baselines of the 4 questionnaires in the two groups showed no difference. After the 8-week treatment, the treatment group presented better levels of HADS, BFS and FACIT-Sp scores compared with the control group (P<0.05). Among the single items of HADS, 4 items involving vexation, feeling fifidgeted, pleasure and prospecting the future in the treatment group were improved compared with the control group (P<0.05). As a simple and reliable and effective intervention, PMRT combined with fifive elements music therapy mitigated anxiety and depression of cancer patients. Cancer patients have been found to respond well to psychological intervention in areas regarding stabilisation of emotions, disease awareness, and therapeutic compliance. This brings about a great difference in improving their quality of life and psychological state, offers an effective approach to better self-management in cancer treatment.

Randomized Control Trial Assessing Impact of Increased Sunlight Exposure versus Vitamin D Supplementation on Lipid Profile in Indian Vitamin D Deficient Men

PubMed Central

Patwardhan, Vivek G.; Mughal, Zulf M.; Padidela, Raja; Chiplonkar, Shashi A.; Khadilkar, Vaman V.; Khadilkar, Anuradha V.

2017-01-01

Background: Despite abundance of sunshine in India, Vitamin D deficiency is common and therefore there is an increasing trend toward taking Vitamin D supplements either as prescription medicine or as a nutritional supplement. Studies have suggested that duration of sun exposure may influence serum lipid profile. Objectives: To study the effect of increased sunlight exposure versus Vitamin D supplementation on Vitamin D status and lipid profile in individuals with Vitamin D deficiency (25-hydroxyvitamin-D [25OHD] <50 nmol/L). Design: A prospective, randomized open-label trial was carried out in apparently healthy Indian men (40–60 years). Based on 25OHD concentrations, individuals were divided into control (>50 nmol/L, n = 50) and intervention (<50 nmol/L, n = 100) groups. Individuals from intervention group were randomly allocated to two groups; either “increased sunlight exposure group” (n = 50, received at least 20 min sunlight exposure to forearms and face between 11 a.m. and 3 p.m. over and above their current exposure) or “cholecalciferol supplement group” (n = 50, received oral cholecalciferol 1000 IU/day). Results: Significant increase in 25OHD concentrations was seen in both intervention groups (P < 0.01). Significant decrease in total cholesterol (TC), high-density-lipoprotein cholesterol (HDL-C), and low-density-lipoprotein cholesterol (LDL-C) was seen in individuals with increased sunlight exposure (P < 0.05). Cholecalciferol supplement group showed a significant increase in TC and HDL-C (P < 0.05) and insignificant increase in LDL-C. Conclusions: Increase in Vitamin D concentrations through sunlight exposure significantly reduced TC, LDL-C, and HDL-C concentrations, and cholecalciferol supplementation increased TC and HDL-C concentrations. PMID:28553593

The china patient‐centered evaluative assessment of cardiac events (PEACE) prospective study of percutaneous coronary intervention: Study design

PubMed Central

Du, Xue; Pi, Yi; Dreyer, Rachel P.; Li, Jing; Li, Xi; Downing, Nicholas S.; Li, Li; Feng, Fang; Zhan, Lijuan; Zhang, Haibo; Guan, Wenchi; Xu, Xiao; Li, Shu‐Xia; Lin, Zhenqiu; Masoudi, Frederick A.; Spertus, John A.; Krumholz, Harlan M.

2016-01-01

Background The number of percutaneous coronary interventions (PCI) in China has increased more than 20‐fold over the last decade. Consequently, there is a need for national‐level information to characterize PCI indications and long‐term patient outcomes, including health status, to understand and improve evolving practice patterns. Objectives: This nationwide prospective study of patients receiving PCI is to: (1) measure long‐term clinical outcomes (including death, acute myocardial infarction [AMI], and/or revascularization), patient‐reported outcomes (PROs), cardiovascular risk factor control and adherence to medications for secondary prevention; (2) determine patient‐ and hospital‐level factors associated with care process and outcomes; and (3) assess the appropriateness of PCI procedures. Methods: The China Patient‐centered Evaluative Assessment of Cardiac Events (PEACE) Prospective Study of PCI has enrolled 5,000 consecutive patients during 2012–2014 from 34 diverse hospitals across China undergoing PCI for any indication. We abstracted details of patient's medical history, treatments, and in‐hospital outcomes from medical charts, and conducted baseline, 1‐, 6‐, and 12‐month interviews to characterize patient demographics, risk factors, clinical presentation, healthcare utilization, and health status using validated PRO measures. The primary outcome, a composite measure of death, AMI and/or revascularization, as well as PROs, medication adherence and cardiovascular risk factor control, was assessed throughout the 12‐month follow‐up. Blood and urine samples were collected at baseline and 12 months and stored for future analyses. To validate reports of coronary anatomy, 2,000 angiograms are randomly selected and read by two independent core laboratories. Hospital characteristics regarding their facilities, processes and organizational characteristics are assessed by site surveys. Conclusion: China PEACE Prospective Study of PCI will be the first study to generate novel, high‐quality, comprehensive national data on patients’ socio‐demographic, clinical, treatment, and metabolic/genetic factors, and importantly, their long‐term outcomes following PCI, including health status. This will build the foundation for PCI performance improvement efforts in China. © 2016 The Authors. Catheterization and Cardiovascular Interventions. Published by Wiley Periodicals, Inc. PMID:26945565

A Medical Student-Delivered Smoking Prevention Program, Education Against Tobacco, for Secondary Schools in Germany: Randomized Controlled Trial

PubMed Central

Owczarek, Andreas Dawid; Seeger, Werner; Groneberg, David Alexander; Brieske, Christian Martin; Jansen, Philipp; Klode, Joachim; Stoffels, Ingo; Schadendorf, Dirk; Izar, Benjamin; Fries, Fabian Norbert; Hofmann, Felix Johannes

2017-01-01

Background More than 8.5 million Germans suffer from chronic diseases attributable to smoking. Education Against Tobacco (EAT) is a multinational network of medical students who volunteer for school-based prevention in the classroom setting, amongst other activities. EAT has been implemented in 28 medical schools in Germany and is present in 13 additional countries around the globe. A recent quasi-experimental study showed significant short-term smoking cessation effects on 11-to-15-year-old adolescents. Objective The aim of this study was to provide the first randomized long-term evaluation of the optimized 2014 EAT curriculum involving a photoaging software for its effectiveness in reducing the smoking prevalence among 11-to-15-year-old pupils in German secondary schools. Methods A randomized controlled trial was undertaken with 1504 adolescents from 9 German secondary schools, aged 11-15 years in grades 6-8, of which 718 (47.74%) were identifiable for the prospective sample at the 12-month follow-up. The experimental study design included measurements at baseline (t1), 6 months (t2), and 12 months postintervention (t3), via questionnaire. The study groups consisted of 40 randomized classes that received the standardized EAT intervention (two medical student-led interactive modules taking 120 minutes total) and 34 control classes within the same schools (no intervention). The primary endpoint was the difference in smoking prevalence from t1 to t3 in the control group versus the difference from t1 to t3 in the intervention group. The differences in smoking behavior (smoking onset, quitting) between the two groups, as well as gender-specific effects, were studied as secondary outcomes. Results None of the effects were significant due to a high loss-to-follow-up effect (52.26%, 786/1504). From baseline to the two follow-up time points, the prevalence of smoking increased from 3.1% to 5.2% to 7.2% in the control group and from 3.0% to 5.4% to 5.8% in the intervention group (number needed to treat [NNT]=68). Notable differences were observed between the groups for the female gender (4.2% to 9.5% for control vs 4.0% to 5.2% for intervention; NNT=24 for females vs NNT=207 for males), low educational background (7.3% to 12% for control vs 6.1% to 8.7% for intervention; NNT=30), and migrational background (students who claimed that at least one parent was not born in Germany) at the 12-month follow-up. The intervention appears to prevent smoking onset (NNT=63) but does not appear to initiate quitting. Conclusions The intervention appears to prevent smoking, especially in females and students with a low educational background. PMID:28588007

Randomized controlled trial to evaluate the effects of combined progressive exercise on metabolic syndrome in breast cancer survivors: rationale, design, and methods.

PubMed

Dieli-Conwright, Christina M; Mortimer, Joanne E; Schroeder, E Todd; Courneya, Kerry; Demark-Wahnefried, Wendy; Buchanan, Thomas A; Tripathy, Debu; Bernstein, Leslie

2014-04-03

Metabolic syndrome (MetS) is increasingly present in breast cancer survivors, possibly worsened by cancer-related treatments, such as chemotherapy. MetS greatly increases risk of cardiovascular disease and diabetes, co-morbidities that could impair the survivorship experience, and possibly lead to cancer recurrence. Exercise has been shown to positively influence quality of life (QOL), physical function, muscular strength and endurance, reduce fatigue, and improve emotional well-being; however, the impact on MetS components (visceral adiposity, hyperglycemia, low serum high-density lipoprotein cholesterol, hypertriglyceridemia, and hypertension) remains largely unknown. In this trial, we aim to assess the effects of combined (aerobic and resistance) exercise on components of MetS, as well as on physical fitness and QOL, in breast cancer survivors soon after completing cancer-related treatments. This study is a prospective randomized controlled trial (RCT) investigating the effects of a 16-week supervised progressive aerobic and resistance exercise training intervention on MetS in 100 breast cancer survivors. Main inclusion criteria are histologically-confirmed breast cancer stage I-III, completion of chemotherapy and/or radiation within 6 months prior to initiation of the study, sedentary, and free from musculoskeletal disorders. The primary endpoint is MetS; secondary endpoints include: muscle strength, shoulder function, cardiorespiratory fitness, body composition, bone mineral density, and QOL. Participants randomized to the Exercise group participate in 3 supervised weekly exercise sessions for 16 weeks. Participants randomized to the Control group are offered the same intervention after the 16-week period of observation. This is the one of few RCTs examining the effects of exercise on MetS in breast cancer survivors. Results will contribute a better understanding of metabolic disease-related effects of resistance and aerobic exercise training and inform intervention programs that will optimally improve physiological and psychosocial health during cancer survivorship, and that are ultimately aimed at improving prognosis. NCT01140282; June 10, 2010.

Teaching Residents How to Talk About Death and Dying: A Mixed-Methods Analysis of Barriers and Randomized Educational Intervention.

PubMed

Miller, David C; Sullivan, Amy M; Soffler, Morgan; Armstrong, Brett; Anandaiah, Asha; Rock, Laura; McSparron, Jakob I; Schwartzstein, Richard M; Hayes, Margaret M

2018-01-01

We present a pilot study exploring the effects of a brief, 30-minute educational intervention targeting resident communication surrounding dying in the intensive care unit (ICU). We sought to determine whether simulation or didactic educational interventions improved resident-reported comfort, preparation, and skill acquisition. We also sought to identify resident barriers to using the word "dying." In this mixed-methods prospective study, second- and third-year medical residents were randomized to participate in a simulation-based communication training or a didactic session. Residents completed a pre-post survey after the sessions evaluating the sessions and reflecting on their use of the word "dying" in family meetings. Forty-five residents participated in the study. Residents reported increases in comfort (Mean [M]-pre = 3.3 [standard deviation: 0.6], M-post = 3.7 [0.7]; P < .01, Cohen d = 0.75) and preparation (M-pre = 3.4 [0.7], M-post = 3.9 [0.6]; P < .01, d = 1.07) using the word "dying" after both the simulation and didactic versions. Residents randomized to the simulation reported they were more likely to have learned new skills as compared to residents in the didactic (M-simulation = 2.2 [0.4], M-didactic = 1.9 [0.3]; P = .015, d = 0.80). They estimated that they used the word "dying" in 50% of their end-of-life (EOL) conversations and identified uncertain prognosis as the main barrier to explicitly stating the word "dying." A 30-minute educational intervention improves internal medicine residents' self-reported comfort and preparation in talking about death and dying in the ICU. Residents in simulation-based training were more likely to report they learned new skills as compared to the didactic session. Residents report multiple barriers to using the word "dying" EOL conversations.

Impact of a stress coping strategy on perceived stress levels and performance during a simulated cardiopulmonary resuscitation: a randomized controlled trial

PubMed Central

2013-01-01

Background Cardiopulmonary resuscitation (CPR) causes significant stress for the rescuers which may cause deficiencies in attention and increase distractibility. This may lead to misjudgements of priorities and delays in CPR performance, which may further increase mental stress (vicious cycle). This study assessed the impact of a task-focusing strategy on perceived stress levels and performance during a simulated CPR scenario. Methods This prospective, randomized-controlled trial was conducted at the simulator-center of the University Hospital Basel, Switzerland. A total of 124 volunteer medical students were randomized to receive a 10 minute instruction to cope with stress by loudly posing two task-focusing questions (“what is the patient’s condition?”, “what immediate action is needed?”) when feeling overwhelmed by stress (intervention group) or a control group. The primary outcome was the perceived levels of stress and feeling overwhelmed (stress/overload); secondary outcomes were hands-on time, time to start CPR and number of leadership statements. Results Participants in the intervention group reported significantly less stress/overload levels compared to the control group (mean difference: -0.6 (95% CI −1.3, -0.1), p=0.04). Higher stress/overload was associated with less hands-on time. Leadership statements did not differ between groups, but the number of leadership statements did relate to performance. Hands-on time was longer in the intervention- group, but the difference was not statistically significant (difference 5.5 (95% CI −3.1, 14.2), p=0.2); there were no differences in time to start CPR (difference −1.4 (95% CI −8.4, 5.7), p=0.71). Conclusions A brief stress-coping strategy moderately decreased perceived stress without significantly affecting performance in a simulated CPR. Further studies should investigate more intense interventions for reducing stress. Trial registration NCT01645566 PMID:23607331

Evaluation of two health education interventions to improve the varicella vaccination: a randomized controlled trial from a province in the east China.

PubMed

Hu, Yu; Li, Qian; Chen, Yaping

2018-01-16

We evaluated the effect of two Elaboration Likelihood Model (ELM)-based health educational interventions on varicella vaccine (VarV) vaccination among pregnant women in a province in the east China. A prospective randomized controlled trial was conducted among 200 pregnant women with ≥12 gestation weeks to test two interventions, including a messaging video and a messaging booklet. The participants were randomly assigned into the control group, the video group or the booklet group. The VarV coverage at 12 and 24 months old was compared among the children of the three groups and relative risks (RRs) were calculated, by using the coverage of the control group as reference. The timeliness of VarV was also assessed. Furthermore, differences in the effects on the knowledge and attitude of VarV vaccination between the two interventions was evaluated. The VarV coverage of their children by 24 months of age was 86.4%, 76.1% and 56.7% for the video group, the booklet group and the control group, respectively. The relative risks (RRs) for the coverage of VarV at 24 months of age were 4.8 (95% CI: 2.06-11.3) for the video group and 2.4 (95% CI: 1.2-5.1) for the booklet group. The means of delays were 57.3 days in the video group, 76.9 days in the booklet group, and 100.6 days in the control group. The proportion of women who intended to vaccinate their children with VarV was higher in the video group than the booklet group (93.9% vs. 82.1%, p < 0.05). Our findings indicated that perinatal health education through booklet or video could improve the coverage and schedule adherence for children's VarV vaccination.

Randomized Trial of Intelligent Sensor System for Early Illness Alerts in Senior Housing.

PubMed

Rantz, Marilyn; Phillips, Lorraine J; Galambos, Colleen; Lane, Kari; Alexander, Gregory L; Despins, Laurel; Koopman, Richelle J; Skubic, Marjorie; Hicks, Lanis; Miller, Steven; Craver, Andy; Harris, Bradford H; Deroche, Chelsea B

2017-10-01

Measure the clinical effectiveness and cost effectiveness of using sensor data from an environmentally embedded sensor system for early illness recognition. This sensor system has demonstrated in pilot studies to detect changes in function and in chronic diseases or acute illnesses on average 10 days to 2 weeks before usual assessment methods or self-reports of illness. Prospective intervention study in 13 assisted living (AL) communities of 171 residents randomly assigned to intervention (n=86) or comparison group (n=85) receiving usual care. Intervention participants lived with the sensor system an average of one year. Continuous data collected 24 hours/7 days a week from motion sensors to measure overall activity, an under mattress bed sensor to capture respiration, pulse, and restlessness as people sleep, and a gait sensor that continuously measures gait speed, stride length and time, and automatically assess for increasing fall risk as the person walks around the apartment. Continuously running computer algorithms are applied to the sensor data and send health alerts to staff when there are changes in sensor data patterns. The randomized comparison group functionally declined more rapidly than the intervention group. Walking speed and several measures from GaitRite, velocity, step length left and right, stride length left and right, and the fall risk measure of functional ambulation profile (FAP) all had clinically significant changes. The walking speed increase (worse) and velocity decline (worse) of 0.073 m/s for comparison group exceeded 0.05 m/s, a value considered to be a minimum clinically important difference. No differences were measured in health care costs. These findings demonstrate that sensor data with health alerts and fall alerts sent to AL nursing staff can be an effective strategy to detect and intervene in early signs of illness or functional decline. Copyright © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

A home-based exercise program for children with congenital heart disease following interventional cardiac catheterization: study protocol for a randomized controlled trial.

PubMed

Du, Qing; Salem, Yasser; Liu, Hao Howe; Zhou, Xuan; Chen, Sun; Chen, Nan; Yang, Xiaoyan; Liang, Juping; Sun, Kun

2017-01-23

Cardiac catheterization has opened an innovative treatment field for cardiac disease; this treatment is becoming the most popular approach for pediatric congenital heart disease (CHD) and has led to a significant growth in the number of children with cardiac catheterization. Unfortunately, based on evidence, it has been demonstrated that the majority of children with CHD are at an increased risk of "non-cardiac" problems. Effective exercise therapy could improve their functional status significantly. As studies identifying the efficacy of exercise therapy are rare in this field, the aims of this study are to (1) identify the efficacy of a home-based exercise program to improve the motor function of children with CHD with cardiac catheterization, (2) reduce parental anxiety and parenting burden, and (3) improve the quality of life for parents whose children are diagnosed with CHD with cardiac catheterization through the program. A total of 300 children who will perform a cardiac catheterization will be randomly assigned to two groups: a home-based intervention group and a control group. The home-based intervention group will carry out a home-based exercise program, and the control group will receive only home-based exercise education. Assessments will be undertaken before catheterization and at 1, 3, and 6 months after catheterization. Motor ability quotients will be assessed as the primary outcomes. The modified Ross score, cardiac function, speed of sound at the tibia, functional independence of the children, anxiety, quality of life, and caregiver burden of their parents or the main caregivers will be the secondary outcome measurements. The proposed prospective randomized controlled trial will evaluate the efficiency of a home-based exercise program for children with CHD with cardiac catheterization. We anticipate that the home-based exercise program may represent a valuable and efficient intervention for children with CHD and their families. http://www.chictr.org.cn/ on: ChiCTR-IOR-16007762 . Registered on 13 January 2016.

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

PubMed

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

2013-02-01

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

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

PubMed Central

2013-01-01

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

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.

Effects of mineralocorticoid receptor antagonists in patients with hypertension and diabetes mellitus: a systematic review and meta-analysis.

PubMed

Takahashi, S; Katada, J; Daida, H; Kitamura, F; Yokoyama, K

2016-09-01

Blood pressure (BP) control is important to ameliorate cardiovascular events in patients with diabetes mellitus (DM). However, achieving the target BP with a single drug is often difficult. The objective of this study was to evaluate the antihypertensive effects of mineralocorticoid receptor antagonists (MRAs) as add-on therapy to renin-angiotensin system (RAS) inhibitor(s) in patients with hypertension and DM. Studies were searched through October 2014 in MEDLINE, Embase and the Cochrane Central Register of Controlled Trials. Randomized, controlled trials or prospective, observational studies regarding concomitant administration of MRA and RAS inhibitor(s) in patients with DM were included. Articles were excluded if the mean systolic BP (SBP) was <130 mm Hg before randomization for interventional studies or at baseline for prospective cohort studies. We identified nine eligible studies (486 patients): five randomized placebo-controlled trials; three randomized active drug-controlled trials; and one single-arm observational study. The mean differences in office SBP and diastolic BP (DBP) between the MRA and placebo groups were -9.4 (95% confidence interval (CI) -12.9 to -5.9) and -3.8 (95% CI, -5.5 to -2.2) mm Hg, respectively. Subgroup analysis results for study type, age, baseline office SBP and follow-up duration were similar to those of the main analysis. MRA mildly increased serum potassium (0.4 mEq l(-1); 95% CI, 0.3-0.5 mEq l(-1)). A consistent reduction of albuminuria across these studies was also demonstrated. MRA further reduced SBP and DBP in patients with hypertension and DM already taking RAS inhibitors. Serum potassium levels should be monitored to prevent hyperkalemia.

Perspectives on the American College of Cardiology/American Heart Association guidelines for the prevention of infective endocarditis.

PubMed

Bach, David S

2009-05-19

In 2007, the American Heart Association published a guideline statement dramatically changing its previous position on the use of antibiotic prophylaxis in patients at risk of infective endocarditis (IE). This year, these views were incorporated in an update of the 2006 American College of Cardiology/American Heart Association Guidelines for the Management of Patients With Valvular Heart Disease. The new recommendations represent a dramatic shift with regard to which patients should receive antibiotic prophylaxis for prevention of IE and for what procedures. The shift in recommendations is striking in that the recommendations are based not on new data, but on no data. (There are no large, prospective, randomized double-blind trials testing the efficacy of IE prophylaxis.) However, available data suggest that there may be no real risk associated with IE prophylaxis. Even if few cases of IE are successfully prevented using antibiotic prophylaxis, those few cases may represent a favorable risk-benefit ratio. On an individual basis, patients with organic heart valve disease who are trying to delay or avoid surgical intervention have something very real to risk if they develop IE, and a very real benefit if they avoid it. Pending data from prospective randomized trials, a strategy of individual decision-making by informed patients may be best.

Idiopathic intracranial hypertension: ongoing clinical challenges and future prospects

PubMed Central

Julayanont, Parunyou; Karukote, Amputch; Ruthirago, Doungporn; Panikkath, Deepa; Panikkath, Ragesh

2016-01-01

Idiopathic intracranial hypertension (IIH) is an uncommon disorder characterized by increased intracranial pressure without radiological or laboratory evidence of intracranial pathology except empty sella turcica, optic nerve sheath with filled out cerebrospinal fluid spaces, and smooth-walled nonflow-related venous sinus stenosis or collapse. This condition typically affects obese women. The incidence of IIH is increasing with the rising prevalence of obesity. Persistent headache is the most common symptom. Visual impairment is a serious complication that may not be recognized by the patients. This paper reviews clinical manifestations, diagnostic challenges, and current treatments of IIH in adults. Various imaging modalities have been studied on their validity for detection of IIH and papilledema. This review also includes new studies on medical, surgical, and interventional management of this condition. Acetazolamide and topiramate are the only two medications that have been studied in randomized controlled trials about their efficacy in treatment of IIH. In patients who have severe visual impairment or progressive visual deterioration despite medical management, surgical or interventional treatment may be considered. The efficacy and complications of cerebrospinal fluid diversion, optic nerve sheath fenestration, and endovascular venous stenting reported in the last 3 decades have been summarized in this review. Finally, the prospective aspects of biomarkers and treatments are proposed for future research. PMID:26929666

A systematic review of the effectiveness of food taxes and subsidies to improve diets: understanding the recent evidence.

PubMed

Thow, Anne Marie; Downs, Shauna; Jan, Stephen

2014-09-01

There has been significant growth in political, public, media, and academic interest in taxes and subsidies to encourage healthy food consumption over the past 3 years. The present systematic review, including an assessment of study quality, was conducted on new evidence published between January 2009 and March 2012 for the effect of food taxes and subsidies on consumption. Forty-three reports representing 38 studies met the inclusion criteria. Two of these were prospective randomized controlled trials that showed price changes were effective in both grocery store purchasing (subsidy) and away-from-home food purchasing (tax) contexts. The most robust modeled studies (considering substitution) showed larger effects for taxes on noncore foods or beverages for which there are close untaxed substitutes (such as soft drinks or "unhealthy" foods, based on nutrient profiling). Taxes and subsidies are likely to be an effective intervention to improve consumption patterns associated with obesity and chronic disease, with evidence showing a consistent effect on consumption across a range of tax rates emerging. Future research should use prospective study methods to determine the effect of taxes on diets and focus on the effect of taxation in conjunction with other interventions as part of a multisectoral strategy to improve diets and health. © 2014 International Life Sciences Institute.

Improving care of patients with diabetes and CKD: a pilot study for a cluster-randomized trial.

PubMed

Cortés-Sanabria, Laura; Cabrera-Pivaral, Carlos E; Cueto-Manzano, Alfonso M; Rojas-Campos, Enrique; Barragán, Graciela; Hernández-Anaya, Moisés; Martínez-Ramírez, Héctor R

2008-05-01

Family physicians may have the main role in managing patients with type 2 diabetes mellitus with early nephropathy. It is therefore important to determine the clinical competence of family physicians in preserving renal function of patients. The aim of this study is to evaluate the effect of an educational intervention on family physicians' clinical competence and subsequently determine the impact on kidney function of their patients with type 2 diabetes mellitus. Pilot study for a cluster-randomized trial. Primary health care units of the Mexican Institute of Social Security, Guadalajara, Mexico. The study group was composed of 21 family physicians from 1 unit and a control group of 19 family physicians from another unit. 46 patients treated by study physicians and 48 treated by control physicians also were evaluated. An educative strategy based on a participative model used during 6 months in the study group. Allocation of units to receive or not receive the educative intervention was randomly established. Clinical competence of family physicians and kidney function of patients. To evaluate clinical competence, a validated questionnaire measuring family physicians' capability to identify risk factors, integrate diagnosis, and correctly use laboratory tests and therapeutic resources was applied to all physicians at the beginning and end of educative intervention (0 and 6 months). In patients, serum creatinine level, estimated glomerular filtration rate, and albuminuria were evaluated at 0, 6, and 12 months. At the end of the intervention, more family physicians from the study group improved clinical competence (91%) compared with controls (37%; P = 0.001). Family physicians in the study group who increased their competence improved renal function significantly better than physicians in the same group who did not increase competence and physicians in the control group (with or without increase in competence): change in estimated glomerular filtration rate, 0.9 versus -33, -21, and -16 mL/min/1.73 m(2) (P < 0.05); and change in urinary albumin excretion of -18 versus 226, 142, and 288 mg/d, respectively (P < 0.05). Compared with other groups, study family physicians with clinical competence also controlled systolic blood pressure significantly better and were more likely to increase the use of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and statins and to discontinue nonsteroidal anti-inflammatory drugs. Our analysis did not adjust for clustering. Physicians in only 2 units were randomly assigned; thus, it is not possible to distinguish the effect of the intervention from the effect of the unit. Educative intervention to primary physicians is feasible. Our data may be the basis for additional prospective studies with a cluster-randomized trial design and larger numbers of centers, physicians, and patients.

The impact of community health educators on uptake of cervical and breast cancer prevention services in Nigeria.

PubMed

Chigbu, Chibuike O; Onyebuchi, Azubuike K; Onyeka, Tonia C; Odugu, Boniface U; Dim, Cyril C

2017-06-01

To determine the impact of trained community health educators on the uptake of cervical and breast cancer screening, and HPV vaccination in rural communities in southeast Nigeria. A prospective population-based intervention study, with a before-and-after design, involved four randomly selected communities in southeast Nigeria from February 2014 to February 2016. Before the intervention, baseline data were collected on the uptake of cervical and breast cancer prevention services. The intervention was house-to-house education on cervical cancer and breast cancer prevention. Postintervention outcome measures included the uptake of cervical and breast cancer screening, and HPV vaccination within 6 months of intervention. In total, 1327 women were enrolled. Before the intervention, 42 (3.2%) women had undergone cervical cancer screening; afterwards, 897 (67.6%) women had received screening (P<0.001). Clinical breast examination was performed for 59 (4.4%) women before and 897 (67.6%) after the intervention (P<0.001). Only 2 (0.9%) of 214 children eligible for HPV vaccination had received the vaccine before versus 71 (33.2%) after the intervention (P<0.001). The use of community health educators for house-to-house cervical and breast cancer prevention education was associated with significant increases in the uptake of cervical cancer screening, clinical breast examination, and HPV vaccination. © 2017 International Federation of Gynecology and Obstetrics.

The development of search filters for adverse effects of surgical interventions in medline and Embase.

PubMed

Golder, Su; Wright, Kath; Loke, Yoon Kong

2018-06-01

Search filter development for adverse effects has tended to focus on retrieving studies of drug interventions. However, a different approach is required for surgical interventions. To develop and validate search filters for medline and Embase for the adverse effects of surgical interventions. Systematic reviews of surgical interventions where the primary focus was to evaluate adverse effect(s) were sought. The included studies within these reviews were divided randomly into a development set, evaluation set and validation set. Using word frequency analysis we constructed a sensitivity maximising search strategy and this was tested in the evaluation and validation set. Three hundred and fifty eight papers were included from 19 surgical intervention reviews. Three hundred and fifty two papers were available on medline and 348 were available on Embase. Generic adverse effects search strategies in medline and Embase could achieve approximately 90% relative recall. Recall could be further improved with the addition of specific adverse effects terms to the search strategies. We have derived and validated a novel search filter that has reasonable performance for identifying adverse effects of surgical interventions in medline and Embase. However, we appreciate the limitations of our methods, and recommend further research on larger sample sizes and prospective systematic reviews. © 2018 The Authors Health Information and Libraries Journal published by John Wiley & Sons Ltd on behalf of Health Libraries Group.

MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results.

PubMed

Staats, Peter S; Benyamin, Ramsin M

2016-02-01

Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Prospective, multi-center, randomized controlled clinical trial. Twenty-six US interventional pain management centers. To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group. At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P < 0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies. Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population. NCT02093520.

Role of Psychotropic Medications in the Management of Anorexia Nervosa: Rationale, Evidence and Future Prospects

PubMed Central

Frank, Guido K.W.; Shott, Megan E.

2016-01-01

Anorexia nervosa is a severe psychiatric disorder without approved medication intervention. Every class of psychoactive medication has been tried to improve treatment outcome; however, randomized controlled trials have been ambiguous at best and across studies have not shown robust improvements in weight gain and recovery. Here we review the available literature on pharmacological interventions since anorexia nervosa came to greater public recognition in the 1960s. This will include a critical review of why those trials may not have been successful. We further provide a neurobiological background for the disorder and discuss how cognition, learning and emotion-regulating circuits could become treatment targets in the future. Making every effort to develop effective pharmacological treatment options for anorexia nervosa is imperative, as it continues to be a complex psychiatric disorder with high disease burden and mortality. PMID:27106297

Surgical Treatment of Adolescent Clavicle Fractures: Results and Complications.

PubMed

McIntosh, Amy L

2016-06-01

No level 1 evidence is available to guide the surgical treatment of adolescent clavicle fractures. Adult literature is not applicable as adolescent mid-diaphyseal clavicle fractures do not develop nonunions, and only a small percentage (10% to 20%) are symptomatic from malunions. Current indications for operative fixation are: (1) completely displaced midshaft fracture with shortening of >2 cm; (2) superior displacement with skin tenting and/or an impending open fracture; (3) associated neurovascular injury; (4) open clavicular fracture; and (5) floating shoulder with a completely displaced clavicular fracture. Future large prospective randomized studies will need to be performed to accurately define which adolescent patients will "truly" benefit from surgical intervention.

Intraoperative oxygen concentration and neurocognition after cardiac surgery: study protocol for a randomized controlled trial.

PubMed

Shaefi, Shahzad; Marcantonio, Edward R; Mueller, Ariel; Banner-Goodspeed, Valerie; Robson, Simon C; Spear, Kyle; Otterbein, Leo E; O'Gara, Brian P; Talmor, Daniel S; Subramaniam, Balachundhar

2017-12-19

Postoperative cognitive dysfunction (POCD) is a common complication of cardiac surgery. Studies have identified potentially injurious roles for cardiopulmonary bypass (CPB) and subsequent reperfusion injury. Cognitive dysfunction has also been linked to the deleterious effects of hyperoxia following ischemia-reperfusion injuries in several disease states, but there has been surprisingly little study into the role of hyperoxia in reperfusion injury after CPB. The potential for tightly regulated intraoperative normoxia to ameliorate the neurocognitive decline following cardiac surgery has not been investigated in a prospective manner. We hypothesize that the use of a protocolized management strategy aimed towards maintenance of an intraoperative normoxic level of oxygen, as opposed to hyperoxia, will reduce the incidence of POCD in older patients undergoing cardiac surgery. One hundred patients aged 65 years and older undergoing non-emergency coronary artery bypass grafting surgery on cardiopulmonary bypass will be enrolled in this prospective, randomized, controlled trial. Subjects will be randomized to receive a fraction of inspired oxygen of either 35% or 100% while under general anesthesia throughout the intraoperative period. The primary outcome measure will be the incidence of POCD in the acute postoperative phase and up to 6 months. The assessment of neurocognition will be undertaken by trained personnel, blinded to study group, with the telephone Montreal Cognitive Assessment (t-MoCA) tool. Secondary outcome measures will include assessment of delirium using the Confusion Assessment Method (CAM and CAM-ICU), as well as time to extubation, days of mechanical ventilation, length of ICU and hospital stay and mortality at 6 months. With the aim of later identifying mechanistic aspects of the effect of oxygen tension, blood, urine, and atrial tissue specimens will be taken at various time points during the perioperative period and later analyzed. This trial will be one of the first randomized controlled studies to prospectively assess the relationship between intraoperative oxygen levels and postoperative neurocognition in cardiac surgery. It addresses a promising biological avenue of intervention in this vulnerable aging population. ClinicalTrials.gov Identifier: NCT02591589 , registered February 13, 2015.

Prophylaxis of Venous Thromboembolism in Geriatric Settings: A Cluster-Randomized Multicomponent Interventional Trial.

PubMed

Rwabihama, Jean Paul; Audureau, Etienne; Laurent, Marie; Rakotoarisoa, Lalaina; Jegou, Marc; Saddedine, Sofiane; Krypciak, Sébastien; Herbaud, Stéphane; Benzengli, Hind; Segaux, Lauriane; Guery, Esther; Ambime, Gabin; Rabus, Marie-Thérèse; Perilliat, Jean-Guy; David, Jean-Philippe; Paillaud, Elena

2018-06-01

To evaluate the efficacy of an intervention on the practice of venous thromboembolism prevention. A multicenter, prospective, controlled, cluster-randomized, multifaceted intervention trial consisting of educational lectures, posters, and pocket cards reminding physicians of the guidelines for thromboprophylaxis use. Twelve geriatric departments with 1861 beds total, of which 202, 803, and 856 in acute care, post-acute care, and long-term care wards, respectively. Patients hospitalized between January 1 and May 31, 2015, in participating departments. The primary endpoint was the overall adequacy of thromboprophylaxis prescription at the patient level, defined as a composite endpoint consisting of indication, regimen, and duration of treatment. Geriatric departments were divided into an intervention group (6 departments) and control group (6 departments). The preintervention period was 1 month to provide baseline practice levels, the intervention period 2 months, and the postintervention period 1 month in acute care and post-acute care wards or 2 months in long-term care wards. Multivariable regression was used to analyze factors associated with the composite outcome. We included 2962 patients (1426 preintervention and 1536 postintervention), with median age 85 [79;90] years. For the overall 18.9% rate of inadequate thromboprophylaxis, 11.1% was attributable to underuse and 7.9% overuse. Intervention effects were more apparent in post-acute and long-term care wards although not significantly [odds ratio 1.44 (95% confidence interval 0.78;2.66), P = .241; and 1.44 (0.68, 3.06), P = .345]. Adequacy rates significantly improved in the postintervention period for the intervention group overall (from 78.9% to 83.4%; P = .027) and in post-acute care (from 75.4% to 86.3%; P = .004) and long-term care (from 87.0% to 91.7%; P = .050) wards, with no significant trend observed in the control group. This study failed to demonstrate improvement in prophylaxis adequacy with our intervention. However, the intervention seemed to improve practices in post-acute and long-term care but not acute care wards. Copyright © 2018 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Intrathecal Drug Delivery and Spinal Cord Stimulation for the Treatment of Cancer Pain.

PubMed

Xing, Fangfang; Yong, R Jason; Kaye, Alan David; Urman, Richard D

2018-02-05

The purpose of the present investigation is to summarize the body and quality of evidence including the most recent studies in support of intrathecal drug delivery systems and spinal cord stimulation for the treatment of cancer-related pain. In the past 3 years, a number of prospective studies have been published supporting intrathecal drug delivery systems for cancer pain. Additional investigation with adjuvants to morphine-based analgesia including dexmedetomidine and ziconotide support drug-induced benefits of patient-controlled intrathecal analgesia. A study has also been recently published regarding cost-savings for intrathecal drug delivery system compared to pharmacologic management, but an analysis in the Ontario, Canada healthcare system projects additional financial costs. Finally, the Polyanalgesic Consensus Committee has updated its recommendations regarding clinical guidelines for intrathecal drug delivery systems to include new information on dosing, trialing, safety, and systemic opioid reduction. There is still a paucity of clinical evidence for spinal cord stimulation in the treatment of cancer pain. There are new intrathecal drugs under investigation including various conopeptides and AYX1. Large, prospective, modern, randomized controlled studies are still needed to support the use of both intrathecal drug delivery systems as well as spinal cord stimulation for cancer pain populations. There are multiple prospective and small randomized controlled studies that highlight a potential promising future for these interventional modalities. Related to the challenge and urgency of cancer pain, the pain practitioner community is moving toward a multimodal approach that includes discussions regarding the role of intrathecal therapies and spinal cord stimulation to the individualized treatment of patients.

PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial.

PubMed

Crétel-Durand, Elodie; Nouguerède, Emilie; Le Caer, Hervé; Rousseau, Frédérique; Retornaz, Frédérique; Guillem, Olivier; Couderc, Anne-Laure; Greillier, Laurent; Norguet, Emmanuelle; Cécile, Maud; Boulahssass, Rabia; Le Caer, Francoise; Tournier, Sandrine; Butaud, Chantal; Guillet, Pierre; Nahon, Sophie; Poudens, Laure; Kirscher, Sylvie; Loubière, Sandrine; Diaz, Nadine; Dhorne, Jean; Auquier, Pascal; Baumstarck, Karine

2017-04-12

Cancer incidence and social isolation increase along with advanced age, and social isolation potentiates the relative risk of death by cancer. Once spotted, social isolation can be averted with the intervention of a multidisciplinary team. Techniques of automation and remote assistance have already demonstrated their positive impact on falls prevention and quality of life (QoL), though little is known about their impact on socially isolated elderly patients supported for cancer. The primary objective of the PREDOMOS study is to evaluate the impact of establishing a Program of Social intervention associated with techniques of Domotic and Remote assistance (PS-DR) on the improvement of QoL of elderly isolated patients, treated for locally advanced or metastatic cancer. The secondary objectives include treatment failure, tolerance, survival, and autonomy. This trial is a multicenter, prospective, randomized, placebo-controlled, open-label, two-parallel group study. The setting is 10 French oncogeriatric centers. Inclusion criteria are patients aged at least 70 years with a social isolation risk and a histological diagnosis of cancer, locally advanced or metastatic disease. The groups are (1) the control group, receiving usual care; (2) the experimental group, receiving usual care associating with monthly social assistance, domotic, and remote assistance. Participants are randomized in a 1:1 allocation ratio. Evaluation times involve inclusion (randomization) and follow-up (12 months). The primary endpoint is QoL at 3 months (via European Organization for Research and Treatment of Cancer (EORTC) QLQ C30); secondary endpoints are social isolation, time to treatment failure, toxicity, dose response-intensity, survival, autonomy, and QoL at 6 months. For the sample size, 320 individuals are required to obtain 90% power to detect a 10-point difference (standard deviation 25) in QoL score between the two groups (20% loss to follow-up patients expected). The randomized controlled design is the most appropriate design to demonstrate the efficacy of a new experimental strategy (Evidence-Based Medicine Working Group classification). National and international recommendations could be updated based on the findings of this study. ClinicalTrials.gov, NCT02829762 . Registered on 29 June 2016.

Randomized clinical trial of Appendicitis Inflammatory Response score-based management of patients with suspected appendicitis.

PubMed

Andersson, M; Kolodziej, B; Andersson, R E

2017-10-01

The role of imaging in the diagnosis of appendicitis is controversial. This prospective interventional study and nested randomized trial analysed the impact of implementing a risk stratification algorithm based on the Appendicitis Inflammatory Response (AIR) score, and compared routine imaging with selective imaging after clinical reassessment. Patients presenting with suspicion of appendicitis between September 2009 and January 2012 from age 10 years were included at 21 emergency surgical centres and from age 5 years at three university paediatric centres. Registration of clinical characteristics, treatments and outcomes started during the baseline period. The AIR score-based algorithm was implemented during the intervention period. Intermediate-risk patients were randomized to routine imaging or selective imaging after clinical reassessment. The baseline period included 1152 patients, and the intervention period 2639, of whom 1068 intermediate-risk patients were randomized. In low-risk patients, use of the AIR score-based algorithm resulted in less imaging (19·2 versus 34·5 per cent; P < 0·001), fewer admissions (29·5 versus 42·8 per cent; P < 0·001), and fewer negative explorations (1·6 versus 3·2 per cent; P = 0·030) and operations for non-perforated appendicitis (6·8 versus 9·7 per cent; P = 0·034). Intermediate-risk patients randomized to the imaging and observation groups had the same proportion of negative appendicectomies (6·4 versus 6·7 per cent respectively; P = 0·884), number of admissions, number of perforations and length of hospital stay, but routine imaging was associated with an increased proportion of patients treated for appendicitis (53·4 versus 46·3 per cent; P = 0·020). AIR score-based risk classification can safely reduce the use of diagnostic imaging and hospital admissions in patients with suspicion of appendicitis. Registration number: NCT00971438 ( http://www.clinicaltrials.gov). © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

Fractionated bipolar radiofrequency and bipolar radiofrequency potentiated by infrared light for treating striae: A prospective randomized, comparative trial with objective evaluation.

PubMed

Harmelin, Yona; Boineau, Dominique; Cardot-Leccia, Nathalie; Fontas, Eric; Bahadoran, Philippe; Becker, Anne-Lise; Montaudié, Henri; Castela, Emeline; Perrin, Christophe; Lacour, Jean-Philippe; Passeron, Thierry

2016-03-01

Very few treatments for striae are based on prospective randomized trials. The objective of this study was to assess the efficacy of bipolar fractional radiofrequency and bipolar radiofrequency potentiated with infrared light, alone or combined, for treating abdominal stretch marks. Bicentric prospective interventional randomized controlled trial in the department of Dermatology of University Hospital of Nice and Aesthetics Laser Center of Bordeaux, France. Men and women of age 18 years or above, who presented for the treatment of mature or immature abdominal striae were included. The patients' abdomens were divided into four equal quadrants. Bipolar radiofrequency potentiated with infrared light and fractional bipolar radiofrequency were applied, alone or combined, and compared to the remaining untreated quadrant. The main criterion of evaluation was the measurement of depth of striae, using 3D photography at 6 months follow-up. A global assessment was also rated by the physician performing the treatment and by the patients. Histological analysis and confocal laser microscopy were additionally performed. A total of 22 patients were enrolled, and 384 striae were measured. In per protocol analysis mean striae depth was decreased by 21.64%, observed at 6 months follow-up with the combined approach, compared to an increase of 1.73% in the control group (P < 0.0001). No significant difference in striae width was observed between the treated or control quadrants. Global assessment by the physician who performed the treatment and by the patient both showed greater improved with the combination treatment compared to control areas (P = 0.004 and P = 0.01, respectively). A more homogeneous interlacing pattern and thicker collagen fibers with a decreased proportion of elastic fibers was observed after treatment. Fractional bipolar radiofrequency, combined with bipolar radiofrequency potentiated by infrared light, is an effective treatment of both immature and mature striae of the abdomen. © 2016 Wiley Periodicals, Inc.

A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial.

PubMed

Stone, Gregg W; Teirstein, Paul S; Meredith, Ian T; Farah, Bruno; Dubois, Christophe L; Feldman, Robert L; Dens, Joseph; Hagiwara, Nobuhisa; Allocco, Dominic J; Dawkins, Keith D

2011-04-19

We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI). Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received ≥1 assigned study stent), powered for noninferiority. The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, p(noninferiority) = 0.001, p(superiority) = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00). In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Study Protocol: The Norfolk Diabetes Prevention Study [NDPS]: a 46 month multi - centre, randomised, controlled parallel group trial of a lifestyle intervention [with or without additional support from lay lifestyle mentors with Type 2 diabetes] to prevent transition to Type 2 diabetes in high risk groups with non - diabetic hyperglycaemia, or impaired fasting glucose.

PubMed

Pascale, Melanie; Murray, Nikki; Bachmann, Max; Barton, Garry; Clark, Allan; Howe, Amanda; Greaves, Colin; Sampson, Mike

2017-01-06

This 7 year NIHR programme [2011-2018] tests the primary hypothesis that the NDPS diet and physical activity intervention will reduce the risk of transition to type 2 diabetes (T2DM) in groups at high risk of Type 2 diabetes. The NDPS programme recognizes the need to reduce intervention costs through group delivery and the use of lay mentors with T2DM, the realities of normal primary care, and the complexity of the current glycaemic categorisation of T2DM risk. NDPS identifies people at highest risk of T2DM on the databases of 135 general practices in the East of England for further screening with ab fasting plasma glucose and glycosylated haemoglobin [HbA1c]. Those with an elevated fasting plasma glucose [impaired fasting glucose or IFG] with or without an elevated HbA1c [non -diabetic hyperglycaemia; NDH] are randomised into three treatment arms: a control arm receiving no trial intervention, an arm receiving an intensive bespoke group-based diet and physical activity intervention, and an arm receiving the same intervention with enhanced support from people with T2DM trained as diabetes prevention mentors [DPM]. The primary end point is cumulative transition rates to T2DM between the two intervention groups, and between each intervention group and the control group at 46 months. Participants with screen detected T2DM are randomized into an equivalent prospective controlled trial with the same intervention and control arms with glycaemic control [HbA1c] at 46 months as the primary end point. Participants with NDH and a normal fasting plasma glucose are randomised into an equivalent prospective controlled intervention trial with follow up for 40 months. The intervention comprises six education sessions for the first 12 weeks and then up to 15 maintenance sessions until intervention end, all delivered in groups, with additional support from a DPM in one treatment arm. The NDPS programme reports in 2018 and will provide trial outcome data for a group delivered diabetes prevention intervention, supported by lay mentors with T2DM, with intervention in multiple at risk glycaemic categories, and that takes into account the realities of normal clinical practice. ISRCTN34805606 (Retrospectively registered 16.3.16).

Text messaging interventions for individuals with mental health disorders including substance use: A systematic review.

PubMed

Watson, Tyler; Simpson, Scot; Hughes, Christine

2016-09-30

We completed a systematic review of the literature to characterize the impact of text messaging interventions on medication adherence or mental health related outcomes in people with mental health disorders including substance use. Four electronic databases were searched from January 1999 to October 2015. Seven studies met our inclusion criteria: three studies evaluated text messaging in patients with schizophrenia or schizoaffective disorder diagnosis, two studies evaluated text messaging in patients with chronic alcohol dependence, and two studies reviewed text messaging in patients with mood disorders. Six studies were randomized controlled trials and one was a prospective pilot study with pre-post intervention design. Text messaging frequency ranged from once weekly to twelve per day. The effect of text messaging on medication adherence was measured in five studies; one study reporting significant improvements in the text messaging intervention group. The effect of text messaging on mental health related outcomes was measured in all seven studies, with five studies showing significant improvements in a variety of psychiatric and social functioning assessments. Collectively, these studies suggest text messaging is a promising tool to support management of patients with mental illness. Further research examining theory-based text messaging interventions in larger samples of patients is required. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Neck-specific training with a cognitive behavioural approach compared with prescribed physical activity in patients with cervical radiculopathy: a protocol of a prospective randomised clinical trial.

PubMed

Dedering, Åsa; Halvorsen, Marie; Cleland, Joshua; Svensson, Mikael; Peolsson, Anneli

2014-08-12

Patients with cervical radiculopathy often have neck- and arm pain, neurological changes, activity limitations and difficulties in returning to work. Most patients are not candidates for surgery but are often treated with different conservative approaches and may be sick-listed for long periods. The purpose of the current study is to compare the effectiveness of neck-specific training versus prescribed physical activity. The current protocol is a two armed intervention randomised clinical trial comparing the outcomes of patients receiving neck specific training or prescribed physical activity. A total of 144 patients with cervical radiculopathy will be randomly allocated to either of the two interventions. The interventions will be delivered by experienced physiotherapists and last 14 weeks. The primary outcome variable is neck- and arm pain intensity measured with a Visual Analogue Scale accompanied with secondary outcome measures of impairments and subjective health measurements collected before intervention and at 3, 6, 12 and 24 months after base-line assessment. We anticipate that the results of this study will provide evidence to support recommendations as to the effectiveness of conservative interventions for patients with cervical radiculopathy. ClinicalTrials.gov identifier: NCT01831271.

Assessment of Clinical Effect of Perioperative Comprehensive Nursing Intervention Pattern in 23G Minimally Invasive Vitreous Surgery.

PubMed

Shen, Jie; Li, Su-Yan; Wang, Jian-Yu; Chen, Jing; Wang, Wen

2016-01-01

We observed the clinical effects of comprehensive nursing intervention pattern in 23G minimally invasive vitreous surgery according to the comprehensive nursing intervention table developed by our hospital, which would supply a basis for its clinical application. In this prospective study, we followed 120 patients undergoing 23G minimally invasive vitreous surgery from Xuzhou First People's Hospital from February 2013 to February 2015 and divided them into control and observation groups by a random number table (60 patients in each group). A regular nursing pattern was adopted for the control group, and a comprehensive nursing intervention pattern was adopted for the observation group. After that, a comparative analysis was made to identify the differences between the clinical effects of the two groups. Scores of cognition ratio, patient compliance and comfort level of patients in the observation group were higher than those of the control group were, and there was significant difference between the groups (P< 0.05). Complication incidence of the observation group is significantly lower than that of the control group (P<0.05). The comprehensive nursing intervention pattern developed by our hospital can improve clinical effects notably, which is of application value .We recommend it to be applied in eye diseases.

Effect of mobile phone reminder messages on adherence of stent removal or exchange in patients with benign pancreaticobiliary diseases: a prospectively randomized, controlled study.

PubMed

Gu, Yong; Wang, Limei; Zhao, Lina; Liu, Zhiguo; Luo, Hui; Tao, Qin; Zhang, Rongchun; He, Shuixiang; Wang, Xiangping; Huang, Rui; Zhang, Linhui; Pan, Yanglin; Guo, Xuegang

2016-08-26

Plastic and covered metal stents need to be removed or exchanged within appropriate time in case of undesirable complications. However, it is not uncommon that patients do not follow the recommendation for further stent management after Endoscopic Retrograde Cholangiopancreatography (ERCP). The effect of short message service (SMS) intervention monthly on the stent removal/exchange adherence in patients after ERCP is unknown at this time. A prospective, randomized controlled study was conducted. After receiving regular instructions, patients were randomly assigned to receive SMS reminding monthly (SMS group) for stent removal/exchange or not (control group). The primary outcome was stent removal/exchange adherence within appropriate time (4 months for plastic stent or 7 months for covered stent). Multivariate analysis was performed to assess factors associated with stent removal/exchange adherence within appropriate time. Intention-to-treat analysis was used. A total of 48 patients were randomized, 23 to the SMS group and 25 to the control. Adherence to stent removal/exchange was reported in 78.2 % (18/23) of patients receiving the SMS intervention compared with 40 % (10/25) in the control group (RR 1.98, 95 % CI 1.16-3.31; p = 0 · 010). Among patients with plastic stent insertion, the median interval time from stent implantation to stent removal/exchange were 90 days in the SMS group and 136 days in the control respectively (HR 0.36, 95 % CI 0.16-0.84, p = 0.018). No difference was found between the two groups regarding late-stage stent-related complications. The rate of recurrent abdominal pain tended to be lower in SMS group without significant difference (8.7 vs 28 %, p = 0.144). Multivariate logistic regression analyses revealed that SMS reminding was the only factor associated with adherence of stent removal/exchange (OR 6.73, 95 % CI 1.64-27.54, p = 0.008). This first effectiveness trial demonstrated that SMS reminding monthly could significantly increase the patient adherence to stent removal/exchange after ERCP. The study was respectively registered on July 10 in 2016 at ClinicalTrials.gov ( NCT02831127 ).

COMplex Fracture Orthopedic Rehabilitation (COMFORT) - Real-time visual biofeedback on weight bearing versus standard training methods in the treatment of proximal femur fractures in the elderly: study protocol for a multicenter randomized controlled trial.

PubMed

Raaben, Marco; Redzwan, Syaiful; Augustine, Robin; Blokhuis, Taco Johan

2018-04-12

Proximal femur fractures are a common injury after low energy trauma in the elderly. Most rehabilitation programs are based on restoring mobility and early resumption of weight-bearing. However, therapy compliance is low in patients following lower extremity fractures. Moreover, little is known about the relevance of gait parameters and how to steer the rehabilitation after proximal femur fractures in the elderly. Therefore, the aim of this prospective, randomized controlled trial is to gain insight in gait parameters and evaluate if real-time visual biofeedback can improve therapy compliance after proximal femur fractures in the elderly. This is a two-arm, parallel-design, prospective, randomized controlled trial. Inclusion criteria are age ≥ 60 years, a proximal femur fracture following low energy trauma, and unrestricted-weight bearing. Exclusion criteria are cognitive impairment and limited mobility before trauma. Participants are randomized into either the control group, which receives care as usual, or the intervention group, which receives real-time visual biofeedback about weight-bearing during gait in addition to care as usual. Spatiotemporal gait parameters will be measured in 94 participants per group during a 30-m walk with an ambulatory biofeedback system (SensiStep). The progress of rehabilitation will be evaluated by the primary outcome parameters maximum peak load and step duration in relation to the discharge date. Secondary outcome parameters include other spatiotemporal gait parameters in relation to discharge date. Furthermore, the gait parameters will be related to three validated clinical tests: Elderly Mobility Scale; Functional Ambulation Categories; and Visual Analogue Scale. The primary hypothesis is that participants in the intervention group will show improved and faster rehabilitation compared to the control group. The first aim of this multicenter trial is to investigate the normal gait patterns after proximal femur fractures in the elderly. The use of biofeedback systems during rehabilitation after proximal femur fractures in the elderly is promising; therefore, the second aim is to investigate the effect of real-time visual biofeedback on gait after proximal femur fractures in the elderly. This could lead to improved outcome. In addition, analysis of the population may indicate characteristics of subgroups that benefit from feedback, making a differentiated approach in rehabilitation strategy possible. TrialRegister.nl, NTR6794 . Registered on 31 October 2017.

3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents.

PubMed

Alfonso, Fernando; Pérez-Vizcayno, María José; Cuesta, Javier; García Del Blanco, Bruno; García-Touchard, Arturo; López-Mínguez, José Ramón; Masotti, Mónica; Zueco, Javier; Cequier, Angel; Velázquez, Maite; Moreno, Raúl; Mainar, Vicente; Domínguez, Antonio; Moris, Cesar; Molina, Eduardo; Rivero, Fernando; Jiménez-Quevedo, Pilar; Gonzalo, Nieves; Fernández-Pérez, Cristina

2018-05-28

This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES). Treatment of patients with DES-ISR remains a challenge. The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study. A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01). Three-year clinical follow-up was obtained in all enrolled patients (100%). The combined clinical outcome measure of cardiac death, myocardial infarction and target lesion revascularization was significantly reduced in the EES arm (19 [12.3%] vs. 31 [20.1%]; p = 0.04; hazard ratio: 0.57 [95% confidence interval: 0.34 to 0.96]), driven by a lower need for target lesion revascularization (11 [7.1%] vs. 24 [15.6%]; p = 0.015; hazard ratio: 0.43 [95% confidence interval: 0.21 to 0.87]). The need for "late" (>1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms. The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940). Published by Elsevier Inc.

Does low-energy sweetener consumption affect energy intake and body weight? A systematic review, including meta-analyses, of the evidence from human and animal studies

PubMed Central

Rogers, P J; Hogenkamp, P S; de Graaf, C; Higgs, S; Lluch, A; Ness, A R; Penfold, C; Perry, R; Putz, P; Yeomans, M R; Mela, D J

2016-01-01

By reducing energy density, low-energy sweeteners (LES) might be expected to reduce energy intake (EI) and body weight (BW). To assess the totality of the evidence testing the null hypothesis that LES exposure (versus sugars or unsweetened alternatives) has no effect on EI or BW, we conducted a systematic review of relevant studies in animals and humans consuming LES with ad libitum access to food energy. In 62 of 90 animal studies exposure to LES did not affect or decreased BW. Of 28 reporting increased BW, 19 compared LES with glucose exposure using a specific ‘learning' paradigm. Twelve prospective cohort studies in humans reported inconsistent associations between LES use and body mass index (−0.002 kg m−2 per year, 95% confidence interval (CI) −0.009 to 0.005). Meta-analysis of short-term randomized controlled trials (129 comparisons) showed reduced total EI for LES versus sugar-sweetened food or beverage consumption before an ad libitum meal (−94 kcal, 95% CI −122 to −66), with no difference versus water (−2 kcal, 95% CI −30 to 26). This was consistent with EI results from sustained intervention randomized controlled trials (10 comparisons). Meta-analysis of sustained intervention randomized controlled trials (4 weeks to 40 months) showed that consumption of LES versus sugar led to relatively reduced BW (nine comparisons; −1.35 kg, 95% CI –2.28 to −0.42), and a similar relative reduction in BW versus water (three comparisons; −1.24 kg, 95% CI –2.22 to −0.26). Most animal studies did not mimic LES consumption by humans, and reverse causation may influence the results of prospective cohort studies. The preponderance of evidence from all human randomized controlled trials indicates that LES do not increase EI or BW, whether compared with caloric or non-caloric (for example, water) control conditions. Overall, the balance of evidence indicates that use of LES in place of sugar, in children and adults, leads to reduced EI and BW, and possibly also when compared with water. PMID:26365102

Post-intervention effects on screen behaviours and mediating effect of parental regulation: the HEalth In Adolescents study – a multi-component school-based randomized controlled trial

PubMed Central

2014-01-01

Background To improve effectiveness of future screen behaviour interventions, one needs to know whether an intervention works via the proposed mediating mechanisms and whether the intervention is equally effective among subgroups. Parental regulation is identified as a consistent correlate of screen behaviours, but prospective evidence as well as the mediation role of parental regulation is largely lacking. This study investigated post-intervention main effects on screen behaviours in the HEIA-intervention – a Norwegian school-based multiple-behaviour study, as well as mediation effects of parental regulation by adolescents’ and parents’ report. In addition, moderating effects of gender and weight status on the intervention and mediating effects were explored. Methods Participating schools were randomized to control (n = 25) or intervention (n = 12) condition. Adolescents (n = 908 Control; 510 Intervention) self-reported their weekday and weekend TV-viewing and computer/game-use. Change in adolescents’ behaviours was targeted through school and parents. Adolescents, mothers (n = 591 Control; 244 Interventions) and fathers (n = 469 Control; 199 Intervention) reported parental regulation of the screen behaviours post-intervention (at 20 month). The product-of-coefficient test using linear regression analysis was conducted to examine main and mediating effects. Results There was no intervention effect on the screen behaviours in the total sample. Gender moderated effect on weekend computer/game-use, while weight status moderated the effect on weekday TV-viewing and computer/game-use. Stratified analyses showed a small favourable intervention effect on weekday TV-viewing among the normal weight. Parental regulation did not mediate change in the screen behaviours. However, stronger parental regulation was associated with less TV-viewing and computer/game-use with effects being conditional on adolescents’ versus parental reports. Parental regulation of the screen behaviours, primarily by the parental report, was associated with change in the respective behaviours. Conclusion Multiple behaviour intervention may not affect all equally well, and the effect may differ by weight status and gender. In future interventions parents should be encouraged to regulate their adolescents’ TV-viewing and computer/game-use on both weekdays and weekends as parental regulation was identified as a determinant of these screen behaviours. However, future intervention studies may need to search for more effective intervention strategies targeting parental regulation. Trial registration Current Controlled Trials ISRCTN98552879 PMID:24568125

Evaluation of two vaccine education interventions to improve pertussis vaccination among pregnant African American women: A randomized controlled trial.

PubMed

Kriss, Jennifer L; Frew, Paula M; Cortes, Marielysse; Malik, Fauzia A; Chamberlain, Allison T; Seib, Katherine; Flowers, Lisa; Ault, Kevin A; Howards, Penelope P; Orenstein, Walter A; Omer, Saad B

2017-03-13

Vaccination coverage with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in pregnancy or immediately postpartum has been low. Limited data exist on rigorously evaluated interventions to increase maternal vaccination, including Tdap. Tailored messaging based on the Elaboration Likelihood Model (ELM) framework has been successful in improving uptake of some public health interventions. We evaluated the effect of two ELM-based vaccine educational interventions on Tdap vaccination among pregnant African American women, a group of women who tend to have lower vaccine uptake compared with other groups. We conducted a prospective randomized controlled trial to pilot test two interventions - an affective messaging video and a cognitive messaging iBook - among pregnant African American women recruited during routine prenatal care visits. We measured Tdap vaccination during the perinatal period (during pregnancy and immediately postpartum), reasons for non-vaccination, and intention to receive Tdap in the next pregnancy. Among the enrolled women (n=106), 90% completed follow-up. Tdap vaccination in the perinatal period was 18% in the control group; 50% in the iBook group (Risk Ratio [vs. control group]: 2.83; 95% CI, 1.26-6.37), and 29% in the video group (RR: 1.65; 95% CI, 0.66-4.09). From baseline to follow-up, women's reported intention to receive Tdap during the next pregnancy improved in all three groups. Among unvaccinated women, the most common reason reported for non-vaccination was lack of a recommendation for Tdap by the woman's physician. Education interventions that provide targeted information for pregnant women in an interactive manner may be useful to improve Tdap vaccination during the perinatal period. However, larger studies including multiple racial and ethnic groups are needed to evaluate robustness of our findings. clinicaltrials.gov Identifier: NCT01740310. Copyright © 2017 Elsevier Ltd. All rights reserved.

A Perioperative Smoking Cessation Intervention With Varenicline, Counseling, and Fax Referral to a Telephone Quitline Versus a Brief Intervention: A Randomized Controlled Trial.

PubMed

Wong, Jean; Abrishami, Amir; Riazi, Sheila; Siddiqui, Naveed; You-Ten, Eric; Korman, Jennifer; Islam, Sazzadul; Chen, Xin; Andrawes, Maged S M; Selby, Peter; Wong, David T; Chung, Frances

2017-08-01

The effectiveness of perioperative interventions to quit smoking with varenicline has not been compared with brief interventions. Our objective was to determine the efficacy of a comprehensive smoking cessation program versus a brief intervention for smoking cessation. In this prospective, multicenter study, 296 patients were randomized to participate in a smoking cessation program (one 10- to 15-minute counseling session, pharmacotherapy with varenicline, an educational pamphlet, and a fax referral to a telephone quitline); or brief advice and self-referral to a telephone quitline. The primary outcome was the 7-day point prevalence (PP) abstinence at 12 months after surgery. Secondary outcomes included abstinence at 1, 3, and 6 months. Multivariable generalized linear regression was used to identify independent variables related to abstinence. The 7-day PP abstinence for the smoking cessation program versus brief advice group was 42.4% vs 26.2% (relative risk [RR], 1.62; 95% confidence interval [CI], 1.16-2.25; P = .003) at 12 months. The 7-day PP abstinence at 1, 3, and 6 months was higher in the smoking cessation group versus the brief advice group: 45.7% vs 25.5% (RR, 1.79; 95% CI, 1.29-2.49; P < .001), 46.4% vs 26.9% (RR, 1.72; 95% CI, 1.25-2.37; P< .001), and 45.0% vs 26.2% (RR, 1.72; 95% CI, 1.24-2.38; P < .001), respectively. Participating in the smoking cessation group predicted abstinence at 12 months (RR, 1.58; 95% CI, 1.12-2.21; P = .0087). A perioperative smoking cessation program with counseling, pharmacotherapy with varenicline, an educational pamphlet, and a fax referral to a quitline increased abstinence from smoking 1, 3, 6, and 12 months after surgery versus a brief intervention.

Micro-Randomized Trials: An Experimental Design for Developing Just-in-Time Adaptive Interventions

PubMed Central

Klasnja, Predrag; Hekler, Eric B.; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A.

2015-01-01

Objective This paper presents an experimental design, the micro-randomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals’ health behaviors. Micro-randomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. Methods The paper describes the micro-randomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Results Micro-randomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Conclusions Micro-randomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions’ effects, enabling creation of more effective JITAIs. PMID:26651463

A Systematic Review of Antimicrobial Stewardship Interventions in the Emergency Department.

PubMed

Losier, Mia; Ramsey, Tasha D; Wilby, Kyle John; Black, Emily K

2017-09-01

To improve antimicrobial utilization, development and implementation of antimicrobial stewardship programs in the emergency department (ED) has been recommended. The primary objective of this review was to characterize antimicrobial stewardship (AMS) in the ED and to identify interventions that improve patient outcomes or process of care and/or reduce consequences of antimicrobial use. This study was completed as a systematic review. The following databases were searched from inception through November, 2016: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Scopus, and Web of Science. Randomized controlled trials, nonrandomized controlled trials, controlled and uncontrolled before-and-after studies, interrupted time series studies, and repeated-measures studies evaluating AMS interventions in the ED were included in the review. Studies published in languages other than English were excluded. A total of 43 studies meeting inclusion criteria were identified from our search. Patient or provider education and guideline or clinical pathway implementation were the most commonly reported interventions. Few studies reported on audit and feedback, and no study evaluated preauthorization. Impact of interventions showed variable results. Where identified, benefits of AMS interventions primarily included improvement in delivery of care or a decrease in antimicrobial utilization; however, most studies were rated as having unclear or high risk of bias. AMS interventions in the ED may improve patient care. However, the optimal combination of interventions is unclear. Additional studies with more rigorous design evaluating core components of AMS programs, including prospective audit and feedback are needed.

A cluster-randomized effectiveness trial of a physician-pharmacist collaborative model to improve blood pressure control.

PubMed

Carter, Barry L; Clarke, William; Ardery, Gail; Weber, Cynthia A; James, Paul A; Vander Weg, Mark; Chrischilles, Elizabeth A; Vaughn, Thomas; Egan, Brent M

2010-07-01

Numerous studies have demonstrated the value of team-based care to improve blood pressure (BP) control, but there is limited information on whether these models would be adopted in diverse populations. The purpose of this study was to evaluate whether a collaborative model between physicians and pharmacists can improve BP control in multiple primary care medical offices with diverse geographic and patient characteristics and whether long-term BP control can be sustained. This study is a randomized prospective trial in 27 primary care offices first stratified by the percentage of underrepresented minorities and the level of clinical pharmacy services within the office. Each office is then randomized to either a 9- or 24-month intervention or a control group. Patients will be enrolled in this study until 2012. The results of this study should provide information on whether this model can be implemented in large numbers of diverse offices, if it is effective in diverse populations, and whether BP control can be sustained long term. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00935077.

The efficacy of gum chewing in reducing postoperative ileus: a multisite randomized controlled trial.

PubMed

Forrester, David Anthony Tony; Doyle-Munoz, Janet; McTigue, Toni; D'Andrea, Stephanie; Natale-Ryan, Angela

2014-01-01

The purpose of this prospective, attention-controlled, randomized study was to determine whether postoperative gum chewing reduces the duration of postoperative ileus symptoms following elective open or laparoscopic sigmoid colectomy when compared with standard care or an attention-control intervention. Forty-seven subjects scheduled for either an open or laparoscopic colon resection participated in the study. Subjects were recruited preoperatively at the preadmission learning centers of the 2 acute care medical centers that comprised the study settings. Subjects were randomized to 3 groups: (1) standard postoperative care (n = 18); (2) standard care and a silicone-adhesive patch applied to the deltoid region of the upper arm as an attention control (n = 16); and (3) standard care and gum chewing (n = 13). Standard postoperative care included removal of the nasogastric tube, early ambulation, nothing by mouth with ice chips only until the first passage of flatus, and then advancement of diet until tolerance of solid food. No statistically significant differences were found among the 3 study groups for the 4 postoperative outcome variables measured: (1) first passage of flatus; (2) first bowel movement; (3) return of hunger; and (4) ability to tolerate solid food for one meal. Postoperative gum chewing was not found to be more effective than standard postoperative care or our attention-control intervention in reducing the duration of postoperative ileus symptoms, length of stay, or complications among patients following open/laparoscopic sigmoid colectomy.

Supreme Laryngeal Mask Airway versus Face Mask during Neonatal Resuscitation: A Randomized Controlled Trial.

PubMed

Trevisanuto, Daniele; Cavallin, Francesco; Nguyen, Loi Ngoc; Nguyen, Tien Viet; Tran, Linh Dieu; Tran, Chien Dinh; Doglioni, Nicoletta; Micaglio, Massimo; Moccia, Luciano

2015-08-01

To assess the effectiveness of supreme laryngeal mask airway (SLMA) over face mask ventilation for preventing need for endotracheal intubation at birth. We report a prospective, randomized, parallel 1:1, unblinded, controlled trial. After a short-term educational intervention on SLMA use, infants ≥34-week gestation and/or expected birth weight ≥1500 g requiring positive pressure ventilation (PPV) at birth were randomized to resuscitation by SLMA or face mask. The primary outcome was the success rate of the resuscitation devices (SLMA or face mask) defined as the achievement of an effective PPV preventing the need for endotracheal intubation. We enrolled 142 patients (71 in SLMA and 71 in face mask group, respectively). Successful resuscitation rate was significantly higher with the SLMA compared with face mask ventilation (91.5% vs 78.9%; P = .03). Apgar score at 5 minutes was significantly higher in SLMA than in face mask group (P = .02). Neonatal intensive care unit admission rate was significantly lower in SLMA than in face mask group (P = .02). No complications related to the procedure occurred. In newborns with gestational age ≥34 weeks and/or expected birth weight ≥1500 g needing PPV at birth, the SLMA is more effective than face mask to prevent endotracheal intubation. The SLMA is effective in clinical practice after a short-term educational intervention. Registered with ClinicalTrials.gov: NCT01963936. Copyright © 2015 Elsevier Inc. All rights reserved.

Music and biological stress dampening in mechanically-ventilated patients at the intensive care unit ward-a prospective interventional randomized crossover trial.

PubMed

Beaulieu-Boire, Genevieve; Bourque, Solange; Chagnon, Frederic; Chouinard, Lucie; Gallo-Payet, Nicole; Lesur, Olivier

2013-08-01

To evaluate the impact of slow-tempo music listening periods in mechanically ventilated intensive care unit patients. A randomized crossover study was performed in a 16-bed, adult critical care unit at a tertiary care hospital. Still-sedated patients, mandating at least 3 more days of mechanical ventilation, were included. The intervention consisted in two 1-hour daily periods of music-vs-sham-MP3 listening which were performed on Day 1 or 3 post-inclusion, with a Day 2 wash-out. "Before-after" collection of vital signs, recording of daily sedative drug consumption and measurement of stress and inflammatory blood markers were performed. Of 55 randomized patients, 49 were included in the final analyses. Along with music listening, (i) vital signs did not consistently change, whereas narcotic consumption tended to decrease to a similar sedation (P = .06 vs sham-MP3); (ii) cortisol and prolactin blood concentrations decreased, whereas Adreno Cortico Trophic Hormone (ACTH)/cortisol ratio increased (P = .02; P = .038; and P = .015 vs sham-MP3, respectively), (iii) cortisol responders exhibited reversed associated changes in blood mehionine (MET)-enkephalin content (P = .01). In the present trial, music listening is a more sensitive stress-reliever in terms of biological vs clinical response. The hypothalamus-pituitary adrenal axis stress axis is a quick sensor of music listening in responding mechanically ventilated intensive care unit patients, through a rapid reduction in blood cortisol. Copyright © 2013 Elsevier Inc. All rights reserved.

Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: long-term symptomatic follow-up of a prospective randomized controlled trial.

PubMed

Kummerow Broman, Kristy; Phillips, Sharon E; Faqih, Adil; Kaiser, Joan; Pierce, Richard A; Poulose, Benjamin K; Richards, William O; Sharp, Kenneth W; Holzman, Michael D

2018-04-01

Our prior randomized controlled trial of Heller myotomy alone versus Heller plus Dor fundoplication for achalasia from 2000 to 2004 demonstrated comparable postoperative resolution of dysphagia but less gastroesophageal reflux after Heller plus Dor. Patient-reported outcomes are needed to determine whether the findings are sustained long-term. We actively engaged participants from the prior randomized cohort, making up to six contact attempts per person using telephone, mail, and electronic messaging. We collected patient-reported measures of dysphagia and gastroesophageal reflux using the Dysphagia Score and the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) instrument. Patient-reported re-interventions for dysphagia were verified by obtaining longitudinal medical records. Among living participants, 27/41 (66%) were contacted and all completed the follow-up study at a mean of 11.8 years postoperatively. Median Dysphagia Scores and GERD-HRQL scores were slightly worse for Heller than Heller plus Dor but were not statistically different (6 vs 3, p = 0.08 for dysphagia, 15 vs 13, p = 0.25 for reflux). Five patients in the Heller group and 6 in Heller plus Dor underwent re-intervention for dysphagia with most occurring more than five years postoperatively. One patient in each group underwent redo Heller myotomy and subsequent esophagectomy. Nearly all patients (96%) would undergo operation again. Long-term patient-reported outcomes after Heller alone and Heller plus Dor for achalasia are comparable, providing support for either procedure.

Stroke treatment academic industry roundtable: research priorities in the assessment of neurothrombectomy devices.

PubMed

Saver, Jeffrey L; Jovin, Tudor G; Smith, Wade S; Albers, Gregory W; Baron, Jean-Claude; Boltze, Johannes; Broderick, Joseph P; Davis, Lisa A; Demchuk, Andrew M; DeSena, Salvatore; Fiehler, Jens; Gorelick, Philip B; Hacke, Werner; Holt, Bill; Jahan, Reza; Jing, Hui; Khatri, Pooja; Kidwell, Chelsea S; Lees, Kennedy R; Lev, Michael H; Liebeskind, David S; Luby, Marie; Lyden, Patrick; Megerian, J Thomas; Mocco, J; Muir, Keith W; Rowley, Howard A; Ruedy, Richard M; Savitz, Sean I; Sipelis, Vitas J; Shimp, Samuel K; Wechsler, Lawrence R; Wintermark, Max; Wu, Ona; Yavagal, Dileep R; Yoo, Albert J

2013-12-01

The goal of the Stroke Treatment Academic Industry Roundtable (STAIR) meetings is to advance the development of stroke therapies. At STAIR VIII, consensus recommendations were developed for clinical trial strategies to demonstrate the benefit of endovascular reperfusion therapies for acute ischemic stroke. Prospects for success with forthcoming endovascular trials are robust, because new neurothrombectomy devices have superior reperfusion efficacy compared with earlier-generation interventions. Specific recommendations are provided for trial designs in 3 populations: (1) patients undergoing intravenous fibrinolysis, (2) early patients ineligible for or having failed intravenous fibrinolysis, and (3) wake-up and other late-presenting patients. Among intravenous fibrinolysis-eligible patients, key principles are that CT or MRI confirmation of target arterial occlusions should precede randomization; endovascular intervention should be pursued with the greatest rapidity possible; and combined intravenous and neurothrombectomy therapy is more promising than neurothrombectomy alone. Among patients ineligible for or having failed intravenous fibrinolysis, scientific equipoise was affirmed and the need to randomize all eligible patients emphasized. Vessel imaging to confirm occlusion is mandatory, and infarct core and penumbral imaging is desirable in later time windows. Additional STAIR VIII recommendations include approaches to test multiple devices in a single trial, utility weighting of disability end points, and adaptive designs to delineate time and tissue injury thresholds at which benefits from intervention no longer accrue. Endovascular research priorities in acute ischemic stroke are to perform trials testing new, highly effective neuro thrombectomy devices rapidly deployed in patients confirmed to have target vessel occlusions.

Encouraging the installation of rollover protective structures in New York State: the design of a social marketing intervention.

PubMed

Sorensen, Julie A; May, John; Ostby-Malling, Ronne; Lehmen, Tom; Strand, John; Stenlund, Hans; Weinehall, Lars; Einehall, Lars W; Emmelin, Maria

2008-11-01

Increasing the percentage of rollover protective structure (ROPS) equipped tractors has been the focus of many agricultural safety campaigns. Traditionally efforts have attempted to persuade farmers through education or community awareness interventions. These efforts have lead to marginal change. In response, a social marketing approach was tested as a means for increasing interest in ROPS retrofitting in New York. An initial phone survey was conducted with a random sample of New York farmers to identify a potential target population. Following target selection, in-depth interviews were conducted to isolate barriers and motivators to retrofitting. This information was used to develop message prototypes which were tested in small focus group discussions. Selected and revised messages, as well as various other incentives developed in response to feedback from interviews, were then tested in a prospective, quasi-randomized controlled trial. Small crop and livestock farms were selected as the intervention target since they represent 86% of New York farms with none or only one ROPS protected tractor. Barriers to retrofitting which were identified in interviews were: 1) constant exposures normalize risk, 2) risk is modeled by significant others and 3) safety in general and retrofitting in particular requires too much time and money. The piloting of ROPS incentives led to a marked increase in ROPS sales in New York. Social Marketing provides a promising framework for the design of agricultural injury prevention programs. The potential implications for other health initiatives seeking to promote behaviour change are also discussed.

[Impact of an educational program for parents of children with cancer on the increased knowledge of their children's disease and the decrease in anxiety].

PubMed

de la Maza L, Verónica; Fernández C, Maria; Concha R, Lorena; Santolaya D, María Elena; Villarroel C, Milena; Castro C, Magdalena; Torres T, Juan Pablo

2015-01-01

To determine the impact of an educational program provided by a nurse to parents of children with cancer to improve the level of knowledge of the disease and to decrease the levels of anxiety. A prospective randomized study was conducted on parents of children recently diagnosed with cancer and treated in the Hospital Luis Calvo Mackenna. After informed consent, parents were randomized in two groups: one receiving the educational program and another without intervention. Both groups completed a questionnaire on social risk, and three tests to assess the levels of knowledge and anxiety. A total of 96 parents were enrolled (July 2010-November 2011). When comparing the number of correct responses on day 10, and day 90 after the intervention, a significant increase was observed in the level of parental knowledge in the group that received the educational program (P<.0001). No significant differences were observed in the levels of anxiety (P=.06) between both groups. An educational program provided by nurses to parents of children recently diagnosed with cancer, increased the knowledge of their children's disease. However there was no effect on the levels of anxiety. A feasible educational intervention is proposed that could be implemented at other cancer centers for children. Copyright © 2015 Sociedad Chilena de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.

Impact of an Electronic Monitoring Intervention to Improve Adherence to Inhaled Medication in Patients with Asthma and Chronic Obstructive Pulmonary Disease: Study Protocol for a Randomized Controlled Trial

PubMed Central

Dieterle, Thomas; Dürr, Selina; Arnet, Isabelle; Hersberger, Kurt E; Leuppi, Jörg D

2017-01-01

Background Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among patients with asthma and chronic obstructive pulmonary disease (COPD) is high and patients are frequently hospitalized due to exacerbations. Reasons for uncontrolled diseases are manifold, but are often associated with poor inhalation technique and non-adherence to the prescribed treatment plan. This causes substantial mortality, morbidity, and costs to the healthcare system. In this respect, the study of causes for non-adherence and the development of measures to increase and maintain treatment adherence in chronic diseases is of major clinical importance. Objective The primary objective of this study is to investigate the impact of using specific, validated electronic devices on adherence to inhaled medication in patients with chronic obstructive lung diseases such as asthma and COPD. Furthermore, it aims to assess the impact of a reminder and close supervision of the course of disease and quality of life. Methods In this ongoing prospective, single-blind, randomized controlled study, adherence to inhaled medication is analyzed over a 6-month period in at least 154 in- and outpatients with asthma or COPD who have experienced at least 1 exacerbation during the last year. Adherence is measured using electronic data capture devices, which save the date and time of each inhalative device actuation and transfer these data daily via a wireless connection to a Web-based database. Patients are randomly assigned to either the intervention or the control group. The clinical intervention consists of an automated and personal reminder. The intervention group receives an audio reminder and support calls in case medication has not been taken as prescribed or if rescue medication is used more frequently than pre-specified in the study protocol. During the study, participants are assessed every 2 months in the form of clinical visits. Results Recruitment started in January 2014. To date, a total of 169 patients have been recruited. Follow-up assessments are still ongoing. The study will be concluded in the first quarter of 2017. Data analysis will take place during 2017. Conclusions Few studies have investigated medication adherence in patients with chronic obstructive lung diseases. With this prospective study design and the use of state-of-the-art devices for measuring adherence, we expect scientifically relevant and clinically meaningful results that will have a substantial and positive impact on the provision of healthcare in chronically ill patients suffering from asthma or COPD. Trial Registration ClinicalTrials.gov: NCT02386722; https://clinicaltrials.gov/ct2/show/NCT02386722 (Archived by WebCite at http://www.webcitation.org/6oJq1fel0) PMID:29061556

Long-term effects of food supplementation and psychosocial intervention on the physical growth of Colombian infants at risk of malnutrition.

PubMed

Super, C M; Herrera, M G; Mora, J O

1990-02-01

280 Colombian infants at risk of malnutrition were randomly assigned to 1 of 4 experimental groups formed by the presence/absence of 2 interventions: (1) food supplementation for the entire family, from mid-pregnancy until the target child was 3 years old, and (2) a twice-weekly home-visiting program to promote cognitive development, from birth until age 3. All families received free medical care and were studied prospectively. At 3 years of age, children who had received food supplementation averaged 2.6 cm and 642 grams larger than controls. Home visiting and supplementation together reduced the number of children with severe growth retardation. 3 years after intervention (age 6), supplementation effects remained. Children in the home visit condition had become larger than controls, by 1.7 cm and 448 grams. The interactive effect to reduce stunting was marginally significant at this age, and the overall distribution of scores was improved. Other results suggest that changes in family functioning as well as biological mechanisms account for the observed pattern of results.

The effect of technology-based interventions on pain, depression, and quality of life in patients with cancer: a systematic review of randomized controlled trials.

PubMed

Agboola, Stephen O; Ju, Woong; Elfiky, Aymen; Kvedar, Joseph C; Jethwani, Kamal

2015-03-13

The burden of cancer is increasing; projections over the next 2 decades suggest that the annual cases of cancer will rise from 14 million in 2012 to 22 million. However, cancer patients in the 21st century are living longer due to the availability of novel therapeutic regimens, which has prompted a growing focus on maintaining patients' health-related quality of life. Telehealth is increasingly being used to connect with patients outside of traditional clinical settings, and early work has shown its importance in improving quality of life and other clinical outcomes in cancer care. The aim of this study was to systematically assess the literature for the effect of supportive telehealth interventions on pain, depression, and quality of life in cancer patients via a systematic review of clinical trials. We searched PubMed, EMBASE, Google Scholar, CINAHL, and PsycINFO in July 2013 and updated the literature search again in January 2015 for prospective randomized trials evaluating the effect of telehealth interventions in cancer care with pain, depression, and quality of life as main outcomes. Two of the authors independently reviewed and extracted data from eligible randomized controlled trials, based on pre-determined selection criteria. Methodological quality of studies was assessed by the Cochrane Collaboration risk of bias tool. Of the 4929 articles retrieved from databases and relevant bibliographies, a total of 20 RCTs were included in the final review. The studies were largely heterogeneous in the type and duration of the intervention as well as in outcome assessments. A majority of the studies were telephone-based interventions that remotely connected patients with their health care provider or health coach. The intervention times ranged from 1 week to 12 months. In general, most of the studies had low risk of bias across the domains of the Cochrane Collaboration risk of bias tool, but most of the studies had insufficient information about the allocation concealment domain. Two of the three studies focused on pain control reported significant effects of the intervention; four of the nine studies focus on depression reported significant effects, while only the studies that were focused on quality of life reported significant effects. This systematic review demonstrates the potential of telehealth interventions in improving outcomes in cancer care. However, more high-quality large-sized trials are needed to demonstrate cogent evidence of its effectiveness.

The Effect of Technology-Based Interventions on Pain, Depression, and Quality of Life in Patients With Cancer: A Systematic Review of Randomized Controlled Trials

PubMed Central

Elfiky, Aymen; Kvedar, Joseph C; Jethwani, Kamal

2015-01-01

Background The burden of cancer is increasing; projections over the next 2 decades suggest that the annual cases of cancer will rise from 14 million in 2012 to 22 million. However, cancer patients in the 21st century are living longer due to the availability of novel therapeutic regimens, which has prompted a growing focus on maintaining patients’ health-related quality of life. Telehealth is increasingly being used to connect with patients outside of traditional clinical settings, and early work has shown its importance in improving quality of life and other clinical outcomes in cancer care. Objective The aim of this study was to systematically assess the literature for the effect of supportive telehealth interventions on pain, depression, and quality of life in cancer patients via a systematic review of clinical trials. Methods We searched PubMed, EMBASE, Google Scholar, CINAHL, and PsycINFO in July 2013 and updated the literature search again in January 2015 for prospective randomized trials evaluating the effect of telehealth interventions in cancer care with pain, depression, and quality of life as main outcomes. Two of the authors independently reviewed and extracted data from eligible randomized controlled trials, based on pre-determined selection criteria. Methodological quality of studies was assessed by the Cochrane Collaboration risk of bias tool. Results Of the 4929 articles retrieved from databases and relevant bibliographies, a total of 20 RCTs were included in the final review. The studies were largely heterogeneous in the type and duration of the intervention as well as in outcome assessments. A majority of the studies were telephone-based interventions that remotely connected patients with their health care provider or health coach. The intervention times ranged from 1 week to 12 months. In general, most of the studies had low risk of bias across the domains of the Cochrane Collaboration risk of bias tool, but most of the studies had insufficient information about the allocation concealment domain. Two of the three studies focused on pain control reported significant effects of the intervention; four of the nine studies focus on depression reported significant effects, while only the studies that were focused on quality of life reported significant effects. Conclusions This systematic review demonstrates the potential of telehealth interventions in improving outcomes in cancer care. However, more high-quality large-sized trials are needed to demonstrate cogent evidence of its effectiveness. PMID:25793945

Effectiveness of Evidence-Based Asthma Interventions.

PubMed

Kennedy, Suzanne; Bailey, Ryan; Jaffee, Katy; Markus, Anne; Gerstein, Maya; Stevens, David M; Lesch, Julie Kennedy; Malveaux, Floyd J; Mitchell, Herman

2017-06-01

Researchers often struggle with the gap between efficacy and effectiveness in clinical research. To bridge this gap, the Community Healthcare for Asthma Management and Prevention of Symptoms (CHAMPS) study adapted an efficacious, randomized controlled trial that resulted in evidence-based asthma interventions in community health centers. Children (aged 5-12 years; N = 590) with moderate to severe asthma were enrolled from 3 intervention and 3 geographically/capacity-matched control sites in high-risk, low-income communities located in Arizona, Michigan, and Puerto Rico. The asthma intervention was tailored to the participant's allergen sensitivity and exposure, and it comprised 4 visits over the course of 1 year. Study visits were documented and monitored prospectively via electronic data capture. Asthma symptoms and health care utilization were evaluated at baseline, and at 6 and 12 months. A total of 314 intervention children and 276 control children were enrolled in the study. Allergen sensitivity testing (96%) and home environmental assessments (89%) were performed on the majority of intervention children. Overall study activity completion (eg, intervention visits, clinical assessments) was 70%. Overall and individual site participant symptom days in the previous 4 weeks were significantly reduced compared with control findings (control, change of -2.28; intervention, change of -3.27; difference, -0.99; P < .001), and this result was consistent with changes found in the rigorous evidence-based interventions. Evidence-based interventions can be successfully adapted into primary care settings that serve impoverished, high-risk populations, reducing the morbidity of asthma in these high-need populations. Copyright © 2017 by the American Academy of Pediatrics.

Long term effects of a health promotion intervention in low socioeconomic Arab- Israeli kindergartens

PubMed Central

2013-01-01

Background Obesity is the most common chronic pediatric disease in westernized, especially low socioeconomic societies. We previously demonstrated the beneficial effects of a randomized prospective school-based health education program for low socioeconomic status Arab-Israeli kindergarten children. Methods To examine whether the effects of our program on nutrition and physical activity knowledge and preferences, anthropometric measures, and fitness persisted one year after the end of intervention. We were able to perform the one year follow-up in 203 kindergarten children (59% of our 342 original cohort; 85 control, 118 intervention). Results At one year following the intervention BMI and BMI percentiles approached baseline level in both the intervention (16.4±0.2 kg/m2 and 61.5±2.4%, respectively) and control group participants (16.5±0.2 kg/m2 and 58.5±3.3%, respectively). Yet, a year after the end of the intervention, the decrease in BMI%ile from baseline was significantly greater in the intervention group (-7.8±1.5 vs. -1.9±1.9, p<0.012). Nutritional and physical activity knowledge and preferences, and physical fitness remained significantly elevated in the intervention compared to the control group participants. Conclusions The beneficial effects of a kindergarten dietary-physical activity intervention applied by the kindergarten teachers, on nutrition and physical activity knowledge and preferences, fitness, and BMI percentile were evident one year after the end of intervention. This promising program may play a role in health promotion, prevention and treatment of childhood obesity. PMID:23547765

Costs of a motivational enhancement therapy coupled with cognitive behavioral therapy versus brief advice for pregnant substance users.

PubMed

Xu, Xiao; Yonkers, Kimberly A; Ruger, Jennifer P

2014-01-01

To determine and compare costs of a nurse-administered behavioral intervention for pregnant substance users that integrated motivational enhancement therapy with cognitive behavioral therapy (MET-CBT) to brief advice (BA) administered by an obstetrical provider. Both interventions were provided concurrent with prenatal care. We conducted a micro-costing study that prospectively collected detailed resource utilization and unit cost data for each of the two intervention arms (MET-CBT and BA) within the context of a randomized controlled trial. A three-step approach for identifying, measuring and valuing resource utilization was used. All cost estimates were inflation adjusted to 2011 U.S. dollars. A total of 82 participants received the MET-CBT intervention and 86 participants received BA. From the societal perspective, the total cost (including participants' time cost) of the MET-CBT intervention was $120,483 or $1,469 per participant. In contrast, the total cost of the BA intervention was $27,199 or $316 per participant. Personnel costs (nurse therapists and obstetric providers) for delivering the intervention sessions and supervising the program composed the largest share of the MET-CBT intervention costs. Program set up costs, especially intervention material design and training costs, also contributed substantially to the overall cost. Implementation of an MET-CBT program to promote drug abstinence in pregnant women is associated with modest costs. Future cost effectiveness and cost benefit analyses integrating costs with outcomes and benefits data will enable a more comprehensive understanding of the intervention in improving the care of substance abusing pregnant women.

Biodegradable Polymer Biolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents in Patients With Coronary Artery Disease: Final 5-Year Report From the COMPARE II Trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent).

PubMed

Vlachojannis, Georgios J; Smits, Pieter C; Hofma, Sjoerd H; Togni, Mario; Vázquez, Nicolás; Valdés, Mariano; Voudris, Vassilis; Slagboom, Ton; Goy, Jean-Jaques; den Heijer, Peter; van der Ent, Martin

2017-06-26

This analysis investigates the 5-year outcomes of the biodegradable polymer biolimus-eluting stent (BP-BES) and durable polymer everolimus-eluting stent (DP-EES) in an all-comers population undergoing percutaneous coronary intervention. Recent 1- and 3-year results from randomized trials have indicated similar safety and efficacy outcomes of BP-BES and DP-EES. Whether benefits of the biodegradable polymer device arise over longer follow-up is unknown. Moreover, in-depth, prospective, long-term follow-up data on metallic drug-eluting stents with durable or biodegradable polymers are scarce. The COMPARE II trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent) was a prospective, randomized, multicenter, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BP-BES or DP-EES. The pre-specified endpoint at 5 years was major adverse cardiac events, a composite of cardiac death, nonfatal myocardial infarction, or target vessel revascularization. Five-year follow-up was available in 2,657 patients (98%). At 5 years, major adverse cardiac events occurred in 310 patients (17.3%) in the BP-BES group and 142 patients (15.6%) in the DP-EES group (p = 0.26). The rate of the combined safety endpoint all-cause death or myocardial infarction was 15.0% in the BP-BES group versus 14.8% in the DP-EES group (p = 0.90), whereas the efficacy measure target vessel revascularization was 10.6% versus 9.0% (p = 0.18), respectively. Interestingly, definite stent thrombosis rates did not differ between groups (1.5% for BP-BES vs. 0.9% for DP-EES; p = 0.17). The 5-year analysis comparing biodegradable polymer-coated BES and the durable polymer-coated EES confirms the initial early- and mid-term results regarding similar safety and efficacy outcomes in this all-comers percutaneous coronary intervention population. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

The role of Rajyoga meditation for modulation of anxiety and serum cortisol in patients undergoing coronary artery bypass surgery: A prospective randomized control study.

PubMed

Kiran, Usha; Ladha, Suruchi; Makhija, Neeti; Kapoor, Poonam Malhotra; Choudhury, Minati; Das, Sambhunath; Gharde, Parag; Malik, Vishwas; Airan, Balram

2017-01-01

Rajyoga meditation is a form of mind body intervention that is promoted by the Brahma Kumaris World Spiritual University. This form of meditation can be easily performed without rituals or mantras and can be practiced anywhere at any time. The practice of Rajyoga meditation can have beneficial effects on modulating anxiety and cortisol level in patients undergoing major cardiac surgery. A prospective randomized control study was carried out in a single tertiary care center. One hundred and fifty patients undergoing elective coronary artery bypass surgery were enrolled in the study. The patients were randomized in two groups namely, Group 1 (Rajyoga group) and Group 2 (Control Group). Anxiety was measured on a visual analog scale 1-10 before the start of Rajyoga training or patient counseling (T1), on the morning of the day of surgery (T2), on the 2nd postoperative day (T3), and on the 5th postoperative day (T4). The serum cortisol level was measured in the morning of the day of surgery (T1), on the 2nd postoperative day (T2) and on the 5th postoperative day (T3), respectively. In the study, it was seen that the anxiety level of the patients before the surgery (T1) and on the day of surgery (T2) were comparable between the two groups. However on the 2nd postoperative day (T3), the patients who underwent Rajyoga training had lower anxiety level in comparison to the control group (3.12 ± 1.45 vs. 6.12 ± 0.14, P < 0.05) and on the 5th postoperative day (T4) it was seen that Rajyoga practice had resulted in significant decline in anxiety level (0.69 ± 1.1 vs. 5.6 ± 1.38, P < 0.05). The serum cortisol level was also favorably modulated by the practice of Rajyoga meditation. Mindbody intervention is found to effective in reducing the anxiety of the patients and modulating the cortisol level in patients undergoing wellknown stressful surgery like coronary artery bypass surgery.

Effectiveness for pain after laparoscopic cholecystectomy of 0.5% bupivacaine-soaked Tabotamp placed in the gallbladder bed: a prospective, randomized, clinical trial.

PubMed

Feroci, Francesco; Kröning, Katrin Christel; Scatizzi, Marco

2009-10-01

Some scientific studies, with controversial results, have evaluated the efficacy in reducing pain of some different local anesthetic molecules, which were administered at different dosages and in different ways. The primary goal of this randomized, controlled, prospective study (Clinical Trials.gov ID NCT00599144) was to assess the effectiveness of 0.5% bupivacaine for pain control after video-laparoscopic cholecystectomy at its optimal dosage of 2 mg/kg infiltrated in the muscular fasciae of the trocars, or positioned in the gallbladder soaking a sheet of regenerated oxidized cellulose (Tabotamp). A total of 45 patients underwent elective video-laparoscopic cholecystectomy. They were randomized in three groups each made of 15 patients: group A (bupivacaine-soaked Tabotamp positioned in the gallbladder bed), group B (bupivacaine infiltrated in the muscular fasciae of the trocars' seat), group C (control group, not using local anesthetic). Six and twenty-four hours after the intervention, the nature of the pain and its intensity were recorded with the use of a Visual Analogue Scale (VAS). Six hours after the intervention, VAS average was 29.6 +/- 10.92 for group A, 25.86 +/- 16.06 for group B, and 36.13 +/- 16.62 for group C. At 24 h, we recorded 19.26 +/- 15.81, 18.53 +/- 12.3, and 20.46 +/- 20.08 for groups A, B, and C, respectively (p > 0.05). Comparing groups A and B between them and with the control group at 6 and 24 h, we deduced how only the first group showed a statistically significant advantage (p < 0.05) in reducing visceral and shoulder pain compared with the two other groups. Wound infiltration resulted in being statistically favorable in reducing parietal pain only when compared with Group A. For groups A and B, bupivacaine significantly reduced the use of postoperative pain killers. Bupivacaine, either infiltrated in trocars' wounds or kept soaked in a regenerated oxidized cellulose sheet positioned in the gallbladder bed, although safe and not economically demanding, can increase postoperative comfort.

A Multi-centric, Double-blind, Placebo-controlled, Randomized, Prospective Study to Evaluate the Efficacy and Safety of Carica papaya Leaf Extract, as Empirical Therapy for Thrombocytopenia associated with Dengue Fever.

PubMed

Kasture, Prabhu Nagnathappa; Nagabhushan, K H; Kumar, Arun

2016-06-01

Dengue is a rapidly expanding global health problem. Approximately 2.5 billion people live in dengue-risk regions with about 100 million new cases each year worldwide. The cumulative dengue diseases burden has attained an unprecedented proportion in recent times with sharp increase in the size of human population at risk. The management of dengue virus infection is essentially supportive and symptomatic and no specific treatment is available for increasing the fallen platelets, which have a significant role in causing the mortality of dengue patient.This study was conducted to evaluate the platelet increasing efficacy of Carica papaya leaf extract (CPLE) in patients with dengue fever (DF). The administration of Carica papaya leaf extract should significantly increase the platelet count in cases of thrombocytopenia associated with dengue, preventing the patient to go in DHF or DSS conditions. A Multi-centric, Double blind, Placebo controlled, Randomized, prospective study was conducted in 300 patients across 5 centres', to evaluate the Efficacy and Safety of Carica Papaya Leaf Extract, as empirical therapy for thrombocytopenia associated with dengue fever. The subjects were randomized into two groups, as control and intervention group. Both the groups were managed by the standard management guidelines for dengue except steroid administration. In addition to this, the intervention group received CPLE tablet three times daily for five days. All of them were followed daily with platelet monitoring. This study has been registered in the clinical trial registry-India (CTRI Registration number: CTRI/2015/05/005806). The results indicate that CPLE had significant increase(p< 0.01) in the platelet count over the therapy duration, in dengue fever patients, confirming CPLE accelerates the increase in platelet count compared to the control group. There were few adverse events related to GI disturbance like nausea and vomiting which were similar in both groups. Thus this study concluded that Carica papaya leaf extract (CPLE) does significantly increase the platelet count in patients with thrombocytopenia associated with dengue with fewer side effects and good tolerability.

A randomized controlled trial of very early rehabilitation in speech after stroke.

PubMed

Godecke, Erin; Armstrong, Elizabeth A; Rai, Tapan; Middleton, Sandy; Ciccone, Natalie; Whitworth, Anne; Rose, Miranda; Holland, Audrey; Ellery, Fiona; Hankey, Graeme J; Cadilhac, Dominique A; Bernhardt, Julie

2016-07-01

The efficacy of rehabilitation therapy for aphasia caused by stroke is uncertain. The Very Early Rehabilitation of Speech (VERSE) trial aims to determine if intensive prescribed aphasia therapy (VERSE) is more effective and cost saving than non-prescribed, intensive (usual care-plus) and non-intensive usual care (UC) therapy when started within 15 days of stroke onset and continued daily over four weeks. We hypothesize that aphasia therapy when started very early after stroke and delivered daily could enhance recovery of communication compared with UC. A total of 246 participants (82 per arm) will provide 80% power to detect a 4.4% improvement on aphasia quotient between VERSE and UC plus at a significance level of α = 0.05. Acute-care hospitals and accompanying rehabilitation services throughout Australia, 2014-2017. Three-arm, prospective, randomized, parallel group, open-label, blinded endpoint assessment (PROBE) trial. Acute stroke in previous 14 days and aphasia diagnosed by aphasia quotient (AQ) of the Western Aphasia Battery (WAB). Computer-generated blocked randomization procedure stratified by aphasia severity according to Western Aphasia Battery, to one of three arms. All participants receive UC-usual ward-based aphasia therapy. Arm 1: UC-no additional therapy; Arm 2: UC-plus usual ward-based therapy; Arm 3: VERSE therapy-a prescribed and structured aphasia therapy program. Arms 2 and 3 receive a total of 20 additional sessions (45-60 min, provided daily) of aphasia therapy. The additional intervention must be provided before day 50 post stroke. The aphasia quotient of Western Aphasia Battery at 12 weeks post stroke. Secondary outcomes include discourse measures, the Stroke and Aphasia Quality of Life Scale-39 and the Aphasia Depression Rating Scale at 12 and 26 weeks. Incremental cost-effectiveness ratios at 26 weeks will be reported. This trial is designed to test whether the intensive and prescribed VERSE intervention is effective in promoting maximum recovery and preventing costly health complications in a vulnerable population of survivors of stroke. It will also provide novel, prospective, aphasia specific cost-effectiveness data to guide future policy development for this population. © 2016 World Stroke Organization.

Effects of elastic resistance exercise on body composition and physical capacity in older women with sarcopenic obesity: A CONSORT-compliant prospective randomized controlled trial.

PubMed

Liao, Chun-De; Tsauo, Jau-Yih; Lin, Li-Fong; Huang, Shih-Wei; Ku, Jan-Wen; Chou, Lin-Chuan; Liou, Tsan-Hon

2017-06-01

Sarcopenia is associated with loss of muscle mass and an increased risk of physical disability in elderly people. However, the prevalence of sarcopenia has increased in obese elderly populations. The purpose of this study was to identify the clinical efficacy of elastic resistance exercise training (RET) in patients with sarcopenic obesity. This study was conducted at the rehabilitation center of a university-based teaching hospital and was designed as a prospective and randomized controlled trial with an intention-to-treat analysis. A total of 46 women aged 67.3 (5.2) years were randomly assigned to an experimental group (EG) and control group (CG). The EG underwent elastic RET for 12 weeks, and the CG received no RET intervention. All outcome measures were assessed at the baseline and posttest, including body composition measured using dual-energy X-ray absorptiometry, muscle quality (MQ) defined as a ratio of muscular strength to muscle mass, and physical capacity assessed using functional mobility tests. One-way analysis of covariance and Pearson correlation were used to compare outcomes between the 2 groups and to identify the relationship between changes in body composition and physical outcomes, respectively. A chi-square test was performed to identify differences in qualitative data between the 2 groups. At the posttest, a significant between-group difference was observed in fat-free mass, MQ, and physical capacity (all P < .05); and a significant correlation was found between leg-lean-mass change and gait speed (r = 0.36; P < .05). After 12 weeks of elastic RET intervention, the EG had significantly fewer patients exhibiting sarcopenia (P < .05) and experiencing physical difficulty (P < .001) than the CG. The present data suggest that elastic resistance exercise exerted benefits on the body composition, MQ, and physical function in patients with sarcopenic obesity. Regular exercise incorporating elastic RET should be used to attenuate muscle mass loss and prevent physical difficulty in obese older adults with sarcopenia on reconditioning therapy. Chinese Clinical Trial Registry, ChiCTR-IPR-15006069.

The Role of Rajyoga Meditation for Modulation of Anxiety and Serum Cortisol in Patients Undergoing Coronary Artery Bypass Surgery: A Prospective Randomized Control Study

PubMed Central

Kiran, Usha; Ladha, Suruchi; Makhija, Neeti; Kapoor, Poonam Malhotra; Choudhury, Minati; Das, Sambhunath; Gharde, Parag; Malik, Vishwas; Airan, Balram

2017-01-01

Introduction: Rajyoga meditation is a form of mind body intervention that is promoted by the Brahma Kumaris World Spiritual University. This form of meditation can be easily performed without rituals or mantras and can be practiced anywhere at any time. The practice of Rajyoga meditation can have beneficial effects on modulating anxiety and cortisol level in patients undergoing major cardiac surgery. Materials and Methods: A prospective randomized control study was carried out in a single tertiary care center. One hundred and fifty patients undergoing elective coronary artery bypass surgery were enrolled in the study. The patients were randomized in two groups namely, Group 1 (Rajyoga group) and Group 2 (Control Group). Anxiety was measured on a visual analog scale 1–10 before the start of Rajyoga training or patient counseling (T1), on the morning of the day of surgery (T2), on the 2nd postoperative day (T3), and on the 5th postoperative day (T4). The serum cortisol level was measured in the morning of the day of surgery (T1), on the 2nd postoperative day (T2) and on the 5th postoperative day (T3), respectively. Results: In the study, it was seen that the anxiety level of the patients before the surgery (T1) and on the day of surgery (T2) were comparable between the two groups. However on the 2nd postoperative day (T3), the patients who underwent Rajyoga training had lower anxiety level in comparison to the control group (3.12 ± 1.45 vs. 6.12 ± 0.14, P < 0.05) and on the 5th postoperative day (T4) it was seen that Rajyoga practice had resulted in significant decline in anxiety level (0.69 ± 1.1 vs. 5.6 ± 1.38, P < 0.05). The serum cortisol level was also favorably modulated by the practice of Rajyoga meditation. Conclusion: Mindbody intervention is found to effective in reducing the anxiety of the patients and modulating the cortisol level in patients undergoing wellknown stressful surgery like coronary artery bypass surgery. PMID:28393774

CARbon DIoxide for the treatment of Febrile seizures: rationale, feasibility, and design of the CARDIF-study

PubMed Central

2013-01-01

Background 2-8% of all children aged between 6 months and 5 years have febrile seizures. Often these seizures cease spontaneously, however depending on different national guidelines, 20-40% of the patients would need therapeutic intervention. For seizures longer than 3-5 minutes application of rectal diazepam, buccal midazolam or sublingual lorazepam is recommended. Benzodiazepines may be ineffective in some patients or cause prolonged sedation and fatigue. Preclinical investigations in a rat model provided evidence that febrile seizures may be triggered by respiratory alkalosis, which was subsequently confirmed by a retrospective clinical observation. Further, individual therapeutic interventions demonstrated that a pCO2-elevation via re-breathing or inhalation of 5% CO2 instantly stopped the febrile seizures. Here, we present the protocol for an interventional clinical trial to test the hypothesis that the application of 5% CO2 is effective and safe to suppress febrile seizures in children. Methods The CARDIF (CARbon DIoxide against Febrile seizures) trial is a monocentric, prospective, double-blind, placebo-controlled, randomized study. A total of 288 patients with a life history of at least one febrile seizure will be randomized to receive either carbogen (5% CO2 plus 95% O2) or placebo (100% O2). As recurrences of febrile seizures mainly occur at home, the study medication will be administered by the parents through a low-pressure can fitted with a respiratory mask. The primary outcome measure is the efficacy of carbogen to interrupt febrile seizures. As secondary outcome parameters we assess safety, practicability to use the can, quality of life, contentedness, anxiousness and mobility of the parents. Prospect The CARDIF trial has the potential to develop a new therapy for the suppression of febrile seizures by redressing the normal physiological state. This would offer an alternative to the currently suggested treatment with benzodiazepines. This study is an example of academic translational research from the study of animal physiology to a new therapy. Trial registration ClinicalTrials.gov identifier: NCT01370044 PMID:23806032

Endovascular vs medical management of acute ischemic stroke

PubMed Central

Ding, Dale; Starke, Robert M.; Mehndiratta, Prachi; Crowley, R. Webster; Liu, Kenneth C.; Southerland, Andrew M.; Worrall, Bradford B.

2015-01-01

Objective: To compare the outcomes between endovascular and medical management of acute ischemic stroke in recent randomized controlled trials (RCT). Methods: A systematic literature review was performed, and multicenter, prospective RCTs published from January 1, 2013, to May 1, 2015, directly comparing endovascular therapy to medical management for patients with acute ischemic stroke were included. Meta-analyses of modified Rankin Scale (mRS) and mortality at 90 days and symptomatic intracranial hemorrhage (sICH) for endovascular therapy and medical management were performed. Results: Eight multicenter, prospective RCTs (Interventional Management of Stroke [IMS] III, Local Versus Systemic Thrombolysis for Acute Ischemic Stroke [SYNTHESIS] Expansion, Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy [MR RESCUE], Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands [MR CLEAN], Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness [ESCAPE], Extending the Time for Thrombolysis in Emergency Neurological Deficits–Intra-Arterial [EXTEND-IA], Solitaire With the Intention For Thrombectomy as Primary Endovascular Treatment [SWIFT PRIME], and Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours [REVASCAT]) comprising 2,423 patients were included. Meta-analysis of pooled data demonstrated functional independence (mRS 0–2) at 90 days in favor of endovascular therapy (odds ratio [OR] = 1.71; p = 0.005). Subgroup analysis of the 6 trials with large vessel occlusion (LVO) criteria also demonstrated functional independence at 90 days in favor of endovascular therapy (OR = 2.23; p < 0.00001). Subgroup analysis of the 5 trials that primarily utilized stent retriever devices (≥70%) in the intervention arm demonstrated functional independence at 90 days in favor of endovascular therapy (OR = 2.39; p < 0.00001). No difference was found for mortality at 90 days and sICH between endovascular therapy and medical management in all analyses and subgroup analyses. Conclusions: This meta-analysis provides strong evidence that endovascular intervention combined with medical management, including IV tissue plasminogen activator for eligible patients, improves the outcomes of appropriately selected patients with acute ischemic stroke in the setting of LVO. PMID:26537058

Qualitative bacteriology in malignant wounds--a prospective, randomized, clinical study to compare the effect of honey and silver dressings.

PubMed

Lund-Nielsen, Betina; Adamsen, Lis; Gottrup, Finn; Rorth, Mikael; Tolver, Anders; Kolmos, Hans Jorn

2011-07-01

 Between 5% and 10% of cancer patients develop malignant wounds. In vitro and some clinical studies suggest that silver- or honey-coated dressings may have an antibacterial effect in nonmalignant wounds, but their possible antibacterial effect in malignant wounds remains unknown. A prospective, randomized, single-blind controlled clinical study was conducted to evaluate the bacteriology of malignant wounds and compare the effect of a honey-coated (Group A) to a silver-coated (Group B) dressing on the qualitative bacteriology of malignant wounds. All wound interventions were performed by the same healthcare professional. Swab cultures were obtained at baseline and following a 4-week intervention and were evaluated without information about the patient treatment group. Of the 75 patients with advanced cancer and malignant wounds identified, 67 (34 in group A, 33 in group B; median age 64 years, range 47-92) consented to participate and completed the 4-week study. The majority were women (88%) with breast cancer (79%). No statistically significant differences were found between the type and number of different wound pathogens in the wounds during the course of the study or between Group A and Group B. Neither anti-neoplastic nor antibiotic treatment influenced the presence of wound pathogens. Staphylococci were found in 42%, enteric bacteria in 34%, anaerobic bacteria in 16%, Pseudomonas in 10%, and hemolytic streptococci in 6% of wounds at baseline; in total, 25 different bacterial species were identified. Sixty-one percent (61%) of wounds decreased in size following treatment, but no significant differences were observed between the type and variety of wound pathogens and whether wound size decreased. Although quantitative bacteriological changes may have occurred, the possible antibacterial effect of the honey or silver dressing could not be confirmed in these malignant wounds. Routine wound swabbing of malignant wounds is of little value and should be restricted to cases where signs of infection requiring antibiotic intervention are observed or where resistant organisms require special infection control measures.

Prevention of hospital infections by intervention and training (PROHIBIT): results of a pan-European cluster-randomized multicentre study to reduce central venous catheter-related bloodstream infections.

PubMed

van der Kooi, Tjallie; Sax, Hugo; Pittet, Didier; van Dissel, Jaap; van Benthem, Birgit; Walder, Bernhard; Cartier, Vanessa; Clack, Lauren; de Greeff, Sabine; Wolkewitz, Martin; Hieke, Stefanie; Boshuizen, Hendriek; van de Kassteele, Jan; Van den Abeele, Annemie; Boo, Teck Wee; Diab-Elschahawi, Magda; Dumpis, Uga; Ghita, Camelia; FitzGerald, Susan; Lejko, Tatjana; Leleu, Kris; Martinez, Mercedes Palomar; Paniara, Olga; Patyi, Márta; Schab, Paweł; Raglio, Annibale; Szilágyi, Emese; Ziętkiewicz, Mirosław; Wu, Albert W; Grundmann, Hajo; Zingg, Walter

2018-01-01

To test the effectiveness of a central venous catheter (CVC) insertion strategy and a hand hygiene (HH) improvement strategy to prevent central venous catheter-related bloodstream infections (CRBSI) in European intensive care units (ICUs), measuring both process and outcome indicators. Adult ICUs from 14 hospitals in 11 European countries participated in this stepped-wedge cluster randomised controlled multicentre intervention study. After a 6 month baseline, three hospitals were randomised to one of three interventions every quarter: (1) CVC insertion strategy (CVCi); (2) HH promotion strategy (HHi); and (3) both interventions combined (COMBi). Primary outcome was prospective CRBSI incidence density. Secondary outcomes were a CVC insertion score and HH compliance. Overall 25,348 patients with 35,831 CVCs were included. CRBSI incidence density decreased from 2.4/1000 CVC-days at baseline to 0.9/1000 (p < 0.0001). When adjusted for patient and CVC characteristics all three interventions significantly reduced CRBSI incidence density. When additionally adjusted for the baseline decreasing trend, the HHi and COMBi arms were still effective. CVC insertion scores and HH compliance increased significantly with all three interventions. This study demonstrates that multimodal prevention strategies aiming at improving CVC insertion practice and HH reduce CRBSI in diverse European ICUs. Compliance explained CRBSI reduction and future quality improvement studies should encourage measuring process indicators.

Outcomes of therapeutic TMD interventions on oral health related quality of life: A qualitative systematic review.

PubMed

Song, Yi Lin; Yap, Adrian U-Jin

2018-04-26

This systematic review aims to determine the impact of temporomandibular disorder (TMD) therapeutic interventions on patients' oral health related quality of life (OHRQoL) and to recommend approaches that improve QoL. A systematic search of the literature was performed between January 2007 and October 2017 to identify articles on TMD interventions and OHRQoL. Randomized controlled trials, and retrospective and prospective cohort studies that mentioned dedicated tools for measurement of OHRQoL changes in TMD patients after therapeutic interventions were included. Abstracts of studies that did not mention any form of measurement of OHRQoL in their treatment outcome were excluded. The initial screening yielded 171 articles. After evaluation of abstracts and full text articles, five articles fulfilled all selection criteria and were included. Most TMD treatment interventions seem to improve QoL to some extent, but no single treatment modality can be advocated as the sole approach to managing TMD. Psychotherapy, occlusal appliance therapy, arthrocentesis, and orthodontics/ orthognathic surgery (in subjects with severe malocclusion) appear to improve OHRQoL of TMD patients. Recommendation on the best TMD intervention for improving QoL could not be made due to the diverse TMD subtypes and non-disease specific OHRQoL instruments employed. More studies incorporating TMD-specific OHRQoL measures and targeting explicit TMD subtypes based on internationally accepted diagnostic criteria are warranted in this area of research.

Impact of implementation of a novel antimicrobial stewardship tool on antibiotic use in nursing homes: a prospective cluster randomized control pilot study.

PubMed

Fleet, Elizabeth; Gopal Rao, G; Patel, Bharat; Cookson, Barry; Charlett, Andre; Bowman, Clive; Davey, Peter

2014-08-01

To evaluate the impact of 'Resident Antimicrobial Management Plan' (RAMP), a novel antimicrobial stewardship tool on systemic antibiotic use for treatment of infection in nursing homes (NHs). A pilot cluster randomized control study was conducted in 30 NHs in London. Pre-intervention, we collected point prevalence data on antimicrobial use on three occasions and total antimicrobial consumption for a 12 week period. Post-intervention data were collected in the same manner and included assessment of compliance with RAMP in the intervention group (IG). The number of residents included was 1628 pre-intervention [825 IG/803 control group (CG)] and 1610 post-intervention (838 IG/772 CG). The corresponding pre- and post-intervention point prevalence of systemic antibiotic prescribing for treatment of infection was 6.46% and 6.52% in the IG [estimated prevalence ratio: 1.01 (95% CI: 0.81-1.25), P = 0.94] compared with 5.27% and 5.83%, respectively, in the CG [estimated prevalence ratio: 1.11 (95% CI: 0.87-1.41), P = 0.4]. Total antibiotic consumption was 69.78 defined daily doses/1000 residents/day (DRD) pre-intervention and 66.53 DRD post-intervention in the IG compared with 49.68 and 51.92 DRD, respectively, in the CG. There was a significant decrease of 4.9% (3.25 DRD) in the IG (95% CI: 1.0%-8.6%) (P = 0.02) compared with a significant increase of 5.1% (2.24 DRD) in the CG (95% CI: 0.2%-10.2%) (P = 0.04). Main indications for antibiotics were lower respiratory tract infections (34.1%), urinary tract infections (28.5%) and skin/soft tissue infections (25.1%). This pilot study demonstrated that use of RAMP was associated with a statistically significant decrease in total antibiotic consumption and has the potential to be an important antimicrobial stewardship tool for NHs. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Prospective, randomized, controlled trial using best-selling smoking-cessation book.

PubMed

Foshee, James P; Oh, Anita; Luginbuhl, Adam; Curry, Joseph; Keane, William; Cognetti, David

2017-07-01

Our prospective, randomized, controlled trial aimed to evaluate the efficacy of the self-help book, The Easy Way to Stop Smoking, by Allen Carr, in promoting smoking cessation in patients with head and neck cancer. We assessed active smokers for their willingness to read a smoking cessation book. Participants were randomized to either receive the book from our department or recommended to purchase the book. All patients received smoking cessation counseling at recruitment. Phone surveys were conducted at short- and long-term intervals to determine if the patients had purchased and/or read the book and whether they were still smoking. One hundred twelve patients were recruited, 52 of whom completed follow-up surveys. Those who received the book for free were more likely to read the book (p = 0.05). Reading the book did not correlate with successful smoking cessation (p = 0.81). Some 26% of the 27 patients who received the book quit smoking compared with 32% of the 25 patients who were recommended the book (p = 0.76). Patients who indicated motivation to quit smoking were more likely to succeed. In our study, smoking cessation did not appear to be influenced by reading The Easy Way to Stop Smoking. Despite 80.8% of the cohort indicating at least a readiness to quit smoking at recruitment, only 28.8% of patients managed to achieve successful smoking cessation at long-term follow-up. Patient motivation remains an important factor in achieving long-term smoking abstinence. Quitting smoking remains a daunting challenge for patients, with multiple interventions likely needed to achieve cessation.

Effectiveness of the Simultaneous Stretching of the Achilles Tendon and Plantar Fascia in Individuals With Plantar Fasciitis.

PubMed

Engkananuwat, Phoomchai; Kanlayanaphotporn, Rotsalai; Purepong, Nithima

2018-01-01

Since the plantar fascia and the Achilles tendon are anatomically connected, it is plausible that stretching of both structures simultaneously will result in a better outcome for plantar fasciitis. Fifty participants aged 40 to 60 years with a history of plantar fasciitis greater than 1 month were recruited. They were prospectively randomized into 2 groups. Group 1 was instructed to stretch the Achilles tendon while group 2 simultaneously stretched the Achilles tendon and plantar fascia. After 4 weeks of both stretching protocols, participants in group 2 demonstrated a significantly greater pressure pain threshold than participants in group 1 ( P = .040) with post hoc analysis. No significant differences between groups were demonstrated in other variables ( P > .05). Concerning within-group comparisons, both interventions resulted in significant reductions in pain at first step in the morning and average pain at the medial plantar calcaneal region over the past 24 hours, while there were increases in the pressure pain threshold, visual analog scale-foot and ankle score, and range of motion in ankle dorsiflexion ( P < .001). More participants in group 2 described their symptoms as being much improved to being completely improved than those in group 1. The simultaneous stretching of the Achilles tendon and plantar fascia for 4 weeks was a more effective intervention for plantar fasciitis. Patients who reported complete relief from symptoms at the end of the 4-week intervention in the simultaneous stretching group (n = 14; 56%) were double that of the stretching of the Achilles tendon-only group (n = 7; 28%). II, lesser quality RCT or prospective comparative study.

Mobile phone intervention for increasing adherence to treatment for type 2 diabetes in an urban area of Bangladesh: protocol for a randomized controlled trial.

PubMed

Islam, Sheikh Mohammed Shariful; Lechner, Andreas; Ferrari, Uta; Froeschl, Guenter; Alam, Dewan Shamsul; Holle, Rolf; Seissler, Jochen; Niessen, Louis W

2014-11-26

Mobile phone technologies including SMS (short message service) have been used to improve the delivery of health services in many countries. However, data on the effects of mobile health technology on patient outcomes in resource-limited settings are limited. The aim of this study therefore is to measure the impact of a mobile phone SMS service on treatment success of newly diagnosed type 2 diabetes in an urban area of Bangladesh. This is a single-centred randomized controlled intervention trial (prospective) comparing standard-of-care with standard-of-care plus a mobile phone-based SMS intervention for 6 months. A total of 216 participants with newly diagnosed type 2 diabetes will be recruited. Data will be collected at the outpatient department of Bangladesh Institute of Health Science (BIHS) hospital at baseline and after 6 months. The primary outcome measure will be change in HbA1c between baseline and 6 months. The secondary outcome measures are self-reported medication adherence, clinic attendance, self-reported adoption of healthy behaviours, diabetes knowledge, quality of life and cost effectiveness of the SMS intervention. The inclusion criteria will be as follows: diagnosed as patients with type 2 diabetes by the BIHS physician, using oral medication therapy, living in Dhaka city, registered with the BIHS hospital, using a mobile phone, willing to return for follow up after 6 months and providing written informed consent. Participants will be allocated to control and intervention arms after recruitment using a randomization software. Data will be collected on socio-demographic and economic information, mobile phone use and habits, knowledge of prevention, management and complications of diabetes, self-perceived quality of life assessment, self-reported diseases, medical history, family history of diseases, medication history, medication adherence, health seeking behaviour, tobacco use, physical activity, diet, mental health status, life events and disability, anthropometric measurements of weight, height, blood pressure and blood tests for HbA1c. Mobile phone SMS services have the potential to communicate with diabetes patients and to build awareness about the disease, improve self-management and avoid complications also in resource-limited setting. If this intervention proves to be efficient and cost-effective in the current trial, large-scale implementation could be undertaken. DRKS00005188 .

Multiple brief interventions in police custody: The MuBIC randomized controlled study for primary prevention in police custody. Protocol and preliminary results of a feasibility study in the Paris metropolitan area, France.

PubMed

Lefèvre, Thomas; Denis, Céline; Marchand, Claire; Vidal, Camille; Gagnayre, Rémi; Chariot, Patrick

2018-07-01

The 15- to 35-year-old population has little contact with the health care system and is exposed to risk factors. Several studies demonstrated the feasibility of brief interventions (BIs) in different settings, e.g., in addiction medicine during police custody, where arrestees are entitled to a medical examination. Approximately 700,000 individuals are detained in police custody in France annually, and custody is an opportunity for young people to be medically examined. The characteristics of the detainees and previous experience with BIs suggest that custody is an opportunity to contribute to primary prevention. We propose to investigate the feasibility of such a contribution. The aim of this article is to present a study protocol and some preliminary results. The primary research objective is to assess the feasibility of performing brief interventions without a specific topic in police custody settings in arrestees aged 15-35 years. The secondary research objectives include i) testing four strategies for engaging in BIs that maximize the chances of success of the BI; ii) identifying the determinants that can orient the practitioner's choice to use a specific strategy over another one; and iii) analysing the differences between individuals who engage in BIs and those who do not and, in those who do engage, the determinants of success of the intervention. A two-step randomized and prospective study: i) randomization of eligible patients into 4 groups of 500 patients each; analysis of the response rates for each strategy; performance of the BI; and analyses of the associated factors and ii) a real-life, full-scale phase study evaluating the effectiveness of BIs performance of the BI; and analyses of the interventions. Analyses of the determinants of a positive response to BI, of success and of the topic of intervention will be conducted. The rates of BI performed, rates of success, and characteristics associated with response and with success are the main expected results. Additionally, the development and assessment of filter questions and an improved BI dedicated to primary prevention for police custody settings will be attained. Copyright © 2016 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

Effectiveness of Internet-Based Interventions on Glycemic Control in Patients With Type 2 Diabetes: Meta-Analysis of Randomized Controlled Trials

PubMed Central

Shen, Ying; Wang, Fengbin; Zhang, Xing; Zhu, Xiaorou; Sun, Qiudan; Fisher, Edwin

2018-01-01

Background The popularity of internet as an area of research has grown manifold over the years. Given its rapid development and increasing coverage worldwide, internet-based interventions seem to offer a promising option to ameliorate huge burdens brought by type 2 diabetes mellitus. However, studies conducted by different researchers have provided contradictory results on the effect of internet-based interventions in glycemic control. Objective This meta-analysis aims to summarize currently available evidence and evaluate the overall impact of internet-based interventions on glycemic management of type 2 diabetic patients. Methods A systematic literature search was performed in PubMed, ScienceDirect, and Web of Science. Randomized controlled trials that used glycosylated hemoglobin values as the outcome measure of glycemic control were considered. Risk of bias and publication bias were evaluated. Results Of the 492 studies, 35 were included in meta-analysis, and results indicated that the weighted mean difference (WMD) between usual care and internet-based interventions at endpoint was –0.426% (95% CI –0.540 to –0.312; P<.001). Subgroup analyses revealed that intervention duration ≤3 months yielded optimal performance (WMD –0.51%; 95% CI –0.71 to –0.31; P<.001). Combined mobile and website interventions were substantially superior to solely Web-based and mobile-based interventions in glycemic control (combined WMD –0.77%, 95% CI –1.07 to –0.47; P<.001; Web only: WMD –0.48%; 95% CI –0.71 to –0.24, P<.001; mobile only WMD –0.31%, 95% CI –0.49 to –0.14; P<.001). Furthermore, the effect of interventions with automated feedbacks was similar to those with manual feedbacks, and studies with internet-based educational contents were more effective in glycemic control. The assessment revealed a low risk of bias. Conclusions In conclusion, utilization of internet-based intervention is beneficial for patients with type 2 diabetes mellitus, and taking full advantage of this type of intervention may substantially reduce the incidence of complications and improve quality of life. Trial Registration International Prospective Register of Systematic Reviews (PROSPERO): CRD42017058032; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=58032 (Archived by WebCite at http://www.webcitation.org/6yY7eQNHr) PMID:29735475

Design of the Physical exercise during Adjuvant Chemotherapy Effectiveness Study (PACES): a randomized controlled trial to evaluate effectiveness and cost-effectiveness of physical exercise in improving physical fitness and reducing fatigue.

PubMed

van Waart, Hanna; Stuiver, Martijn M; van Harten, Wim H; Sonke, Gabe S; Aaronson, Neil K

2010-12-07

Cancer chemotherapy is frequently associated with a decline in general physical condition, exercise tolerance, and muscle strength and with an increase in fatigue. While accumulating evidence suggests that physical activity and exercise interventions during chemotherapy treatment may contribute to maintaining cardiorespiratory fitness and strength, the results of studies conducted to date have not been consistent. Additional research is needed to determine the optimal intensity of exercise training programs in general and in particular the relative effectiveness of supervised, outpatient (hospital- or physical therapy practice-based) versus home-based programs. This multicenter, prospective, randomized trial will evaluate the effectiveness of a low to moderate intensity, home-based, self-management physical activity program, and a high intensity, structured, supervised exercise program, in maintaining or enhancing physical fitness (cardiorespiratory fitness and muscle strength), in minimizing fatigue and in enhancing the health-related quality of life (HRQoL). Patients receiving adjuvant chemotherapy for breast or colon cancer (n = 360) are being recruited from twelve hospitals in the Netherlands, and randomly allocated to one of the two treatment groups or to a 'usual care' control group. Performance-based and self-reported outcomes are assessed at baseline, at the end of chemotherapy and at six month follow-up. This large, multicenter, randomized clinical trial will provide additional empirical evidence regarding the effectiveness of physical exercise during adjuvant chemotherapy in enhancing physical fitness, minimizing fatigue, and maintaining or enhancing patients' quality of life. If demonstrated to be effective, exercise intervention programs will be a welcome addition to the standard program of care offered to patients with cancer receiving chemotherapy. This study is registered at the Netherlands Trial Register (NTR 2159).

Evaluation of a cancer patient navigation program ("Onkolotse") in terms of hospitalization rates, resource use and healthcare costs: rationale and design of a randomized, controlled study.

PubMed

Porzig, Ralf; Neugebauer, Sina; Heckmann, Thomas; Adolf, Daniela; Kaskel, Peter; Froster, Ursula G

2018-06-05

Concepts for the nursing and care of cancer patients through a "navigation service" have attracted much interest. However, there is still room for improvement in terms of their funding and coverage. The Saxon Cancer Society designed a prospective, randomized, multicenter, longitudinal study with a view to determining the positive effects of a cancer patient navigator program. The objective of this ongoing study is to evaluate the impact of the cancer patient navigation program on cancer patients and cost bearers in Germany. The study population in this evaluation comprises cancer patients with gastric carcinoma, pancreatic carcinoma, colorectal cancer, melanoma or gynecological cancer who have been hospitalized at least once at one of the study centers as well as their relatives, outpatient and inpatient physicians, and cancer nurses. It is planned to randomize 340 cancer patients (stomach, colonic/rectal cancer, gynecological cancer, melanoma) at five centers to an intervention group (care by patient navigators based on standardized operating procedures) or a control group in a one-to-one ratio. The primary target parameter is the number of hospitalizations within the 12-month intervention period. The participants are asked to complete various questionnaires on patient-related outcomes at baseline and at 3 and 12 months (SF 36, HADS, PAM 13, and others). Data on drug therapy, utilization of health services, and medical expenses will also be analyzed. For the first time, the study will provide data on the effectiveness of a patient support program in cancer care in Germany from a randomized trial with a high level of evidence. The study has been registered under DRKS00013199 in the German Clinical Trials Register.

The Palliative Care in Heart Failure (PAL-HF) Trial: Rationale and Design

PubMed Central

Mentz, Robert J.; Tulsky, James A.; Granger, Bradi B.; Anstrom, Kevin J.; Adams, Patricia A.; Dodson, Gwen C.; Fiuzat, Mona; Johnson, Kimberly S.; Patel, Chetan B.; Steinhauser, Karen E.; Taylor, Donald H.; O’Connor, Christopher M.; Rogers, Joseph G.

2014-01-01

Background The progressive nature of heart failure (HF) coupled with high mortality and poor quality of life mandates greater attention to palliative care as a routine component of advanced HF management. Limited evidence exists from randomized, controlled trials supporting the use of interdisciplinary palliative care in HF. Methods The Palliative Care in Heart Failure trial (PAL-HF) is a prospective, controlled, unblinded, single-center study of an interdisciplinary palliative care intervention in 200 patients with advanced HF estimated to have a high likelihood of mortality or re-hospitalization in the ensuing 6 months. The 6-month PAL-HF intervention focuses on physical and psychosocial symptom relief, attention to spiritual concerns and advanced care planning. The primary endpoint is health-related quality of life measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale score at 6 months. Secondary endpoints include changes in anxiety/depression, spiritual well-being, caregiver satisfaction, cost and resource utilization, and a composite of death, HF hospitalization and quality of life. Conclusions PAL-HF is a randomized, controlled clinical trial that will help evaluate the efficacy and cost-effectiveness of palliative care in advanced HF using a patient-centered outcome as well as clinical and economic endpoints. PMID:25440791

The palliative care in heart failure trial: rationale and design.

PubMed

Mentz, Robert J; Tulsky, James A; Granger, Bradi B; Anstrom, Kevin J; Adams, Patricia A; Dodson, Gwen C; Fiuzat, Mona; Johnson, Kimberly S; Patel, Chetan B; Steinhauser, Karen E; Taylor, Donald H; O'Connor, Christopher M; Rogers, Joseph G

2014-11-01

The progressive nature of heart failure (HF) coupled with high mortality and poor quality of life mandates greater attention to palliative care as a routine component of advanced HF management. Limited evidence exists from randomized, controlled trials supporting the use of interdisciplinary palliative care in HF. PAL-HF is a prospective, controlled, unblinded, single-center study of an interdisciplinary palliative care intervention in 200 patients with advanced HF estimated to have a high likelihood of mortality or rehospitalization in the ensuing 6 months. The 6-month PAL-HF intervention focuses on physical and psychosocial symptom relief, attention to spiritual concerns, and advanced care planning. The primary end point is health-related quality of life measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale score at 6 months. Secondary end points include changes in anxiety/depression, spiritual well-being, caregiver satisfaction, cost and resource utilization, and a composite of death, HF hospitalization, and quality of life. PAL-HF is a randomized, controlled clinical trial that will help evaluate the efficacy and cost effectiveness of palliative care in advanced HF using a patient-centered outcome as well as clinical and economic end points. Copyright © 2014 Elsevier Inc. All rights reserved.

Ibuprofen and paracetamol for pain relief during medical abortion: a double-blind randomized controlled study.

PubMed

Livshits, Anna; Machtinger, Ronit; David, Liat Ben; Spira, Maya; Moshe-Zahav, Aliza; Seidman, Daniel S

2009-05-01

To determine the efficacy of a nonsteroidal anti-inflammatory drug vs. paracetamol in pain relief during medical abortion and to evaluate whether nonsteroidal anti-inflammatory drugs interfere with the action of misoprostol. A prospective double-blind controlled study. University-affiliated tertiary hospital. One hundred twenty women who underwent first-trimester termination of pregnancy. Patients received 600 mg mifepristone orally, followed by 400 microg of oral misoprostol 2 days later. They were randomized to receive ibuprofen or paracetamol when pain relief was necessary. Patients completed a questionnaire about side effects and pain score and returned for an ultrasound follow-up examination 10-14 days after medical abortion. Success rates, as defined by no surgical intervention, and pain scores were assessed. Ibuprofen was found to be statistically significantly more effective for pain relief after medical abortion compared with paracetamol. There was no difference in the failure rate of medical abortion, and the frequency of surgical intervention was slightly higher in the group that received paracetamol (16.3% vs. 8.5%). Ibuprofen was found to be more effective than paracetamol for pain reduction during medical abortion. A history of surgical or medical abortion was predictive for high pain scores. Despite its anti-prostaglandin effects, ibuprofen use did not interfere with the action of misoprostol.

Management of symphysis pubis dysfunction during pregnancy using exercise and pelvic support belts.

PubMed

Depledge, Jill; McNair, Peter J; Keal-Smith, Cheryl; Williams, Maynard

2005-12-01

Symphysis pubis pain is a significant problem for some pregnant women. The purpose of this study was to investigate the effects of exercise, advice, and pelvic support belts on the management of symphysis pubis dysfunction during pregnancy. Ninety pregnant women with symphysis pubis dysfunction were randomly assigned to 3 treatment groups. A randomized masked prospective experimental clinical trial was conducted. Specific muscle strengthening exercises and advice concerning appropriate methods for performing activities of daily living were given to the 3 groups, and 2 of the groups were given either a rigid pelvic support belt or a nonrigid pelvic support belt. The dependent variables, which were measured before and after the intervention, were a Roland-Morris Questionnaire score, a Patient-Specific Functional Scale score, and a pain score (101-point numerical rating score). After the intervention, there was a significant reduction in the Roland-Morris Questionnaire score, the Patient-Specific Functional Scale score, and the average and worst pain scores in all groups. With the exception of average pain, there were no significant differences between groups for the other measures. The findings indicate that the use of either a rigid or a nonrigid pelvic support belt did not add to the effects provided by exercise and advice.

The impact of group counseling on depression, post-traumatic stress and function outcomes: a prospective comparison study in the Peter C. Alderman trauma clinics in northern Uganda.

PubMed

Nakimuli-Mpungu, Etheldreda; Okello, James; Kinyanda, Eugene; Alderman, Stephen; Nakku, Juliet; Alderman, Jeffrey S; Pavia, Alison; Adaku, Alex; Allden, Kathleen; Musisi, Seggane

2013-10-01

The effectiveness of group interventions for adults with mental distress in post-conflict settings is less clear in sub-Saharan Africa. To assess the impact of group counseling intervention on depression, post-traumatic stress and function outcomes among adults attending the Peter C. Alderman Foundation (PCAF) trauma clinics in northern Uganda. 631 War affected adults were enrolled into PCAF trauma clinics. Using a quasi-experimental design, assessments were conducted at baseline, at 3 and 6 months following initiation of care. Multivariate longitudinal regression models were used to determine change in depression, post-traumatic stress and function scores over time among group counseling participants and non-participants. In comparison to non-participants, participants had faster reduction in depression scores during the 6-month follow-up period [β=-1.84, 95%CI (-3.38 to -0.30), p=0.019] and faster reduction in post-traumatic stress scores during the 3-month follow-up period [β=-2.14, 95%CI (-4.21 to -0.10), p=0.042]. At 3-month follow up, participants who attended two or more sessions had faster increase in function scores [β=3.51, 95%CI (0.61-6.40), p=0.018] than participants who attended only one session. Selection bias due to the use of non-random samples. Substantial attrition rates and small sample sizes may have resulted in insufficient statistical power to determine meaningful differences. The group counseling intervention offered in the PCAF clinics may have considerable mental health benefits over time. There is need for more research to structure, standardize and test the efficacy of this intervention using a randomized controlled trial. © 2013 Elsevier B.V. All rights reserved.

"What did you say?" Using review of tape-recorded interactions to increase social acknowledgments by trainees in a community-based vocational program.

PubMed

Grossi, T A; Kimball, J W; Heward, W L

1994-01-01

Dana and Rick, two adults with developmental disabilities enrolled in a restaurant training program, had poor prospects for long-term employment because of inappropriate social behavior. They often made no response, mumbled inaudibly, or made a negative remark when spoken to by their supervisors or other employees. Each trainee's Individual Vocational Plan (IVP) included goals of prompt and polite acknowledgement of coworker initiations. Previous efforts to improve Dana and Rick's acknowledging behavior had been unsuccessful. Throughout the study, each trainee's responses to 20 verbal initiations by coworkers (i.e., requests, questions, corrective feedback, praise, and social comments) were recorded during each of two observation periods per workshift. Throughout one of the observation periods during the intervention phases, the trainees carried in their work aprons a small, audio cassette recorder that recorded their interactions with coworkers. The primary intervention consisted of a preworkshift meeting in which the trainee and experimenter reviewed five randomly selected interactions recorded during the previous day's shift. The review included self-evaluation, praise, corrective feedback, and role-play. A multiple baseline across subjects design showed each trainee acknowledged a greater number of coworker initiations as a function of the intervention. Each trainee also acknowledged more coworker initiations during the second observation period when the tape recorder was never worn. In a subsequent intervention phase, Dana reviewed her tape-recorded interactions prior to randomly selected shifts. Rick's acknowledgments increased to a socially valid level when the review procedure was supplemented with graphic feedback. Both trainees continued to acknowledge their coworkers' initiations at levels equal to nondisabled restaurant employees when they no longer wore the tape recorder during a final phase and during follow-up observations 4 to 8 weeks later.

The effect of music with and without binaural beat audio on operative anxiety in patients undergoing cataract surgery: a randomized controlled trial

PubMed Central

Wiwatwongwana, D; Vichitvejpaisal, P; Thaikruea, L; Klaphajone, J; Tantong, A; Wiwatwongwana, A

2016-01-01

Purpose To investigate the anxiolytic effects of binaural beat embedded audio in patients undergoing cataract surgery under local anesthesia. Methods This prospective RCT included 141 patients undergoing cataract surgery under local anesthesia. The patients were randomized into three groups; the Binaural beat music group (BB), the plain music intervention group (MI), and a control group (ear phones with no music). Blood pressure (BP) and heart rate were measured on admission, at the beginning of and 20 min after the start of the operation. Peri-operative anxiety level was assessed using the State-Trait Anxiety Inventory questionnaire (STAI). Results The BB and MI groups comprised 44 patients each and the control group 47. Patients in the MI group and BB group showed significant reduction of STAI state scores after music intervention compared with the control group (P<0.001) but the difference was not significant between the MI and BB group (STAI-S score MI group −7.0, BB group −9.0, P=0.085). Systolic BP was significantly lower in both MI (P=0.043) and BB (0.040) groups although there was no difference between the two groups (P=1.000). A significant reduction in heart rate was seen only in the BB group (BB vs control P=0.004, BB vs MI P=0.050, MI vs control P=0.303). Conclusion Music, both with and without binaural beat, was proven to decrease anxiety level and lower systolic BP. Patients who received binaural beat audio showed additional decrease in heart rate. Binaural beat embedded musical intervention may have benefit over musical intervention alone in decreasing operative anxiety. PMID:27740618

Health promotion for patients with diabetes: health coaching or formal health education?

PubMed

Basak Cinar, Ayse; Schou, Lone

2014-02-01

The purpose of this study was to determine if a Health Coaching (HC) approach compared with formal health education (HE) resulted in better health outcomes among type II diabetes (T2DM) patients in improving glycaemic control and oral health, by use of clinical and subjective outcome measures. The study is part of a prospective intervention among randomly selected T2DM patients (n = 186) in Istanbul, Turkey. The data analysed were clinical [glycated haemoglobin (HbA(1C)), clinical attachment loss (CAL)] and psychological measures [tooth-brushing self efficacy (TBSES)]. Data were collected initially and at the end of intervention. Participants were allocated randomly to HC (intervention) (n = 77) and HE (control) (n = 111) groups. At baseline, there was no statistical difference between HC and HE regarding clinical and psychological measures, (P > 0.05). At post-intervention the HC group had significantly lower HBA(1C) and CAL (reduction: 7%, 56%) than the HE group (reduction: HbA(1C) 0%; CAL 26%), (P ≤ 0.01). Similarly, HC group, compared with HE group, had better TBSES (increase: 61% vs. 25%) and stress (reduction: 16% vs. 1%), (P ≤ 0.01). Among high-risk group patients, the HC patients had significant improvements compared with the HE group (reduction: HbA(1C) 16% vs. 5%; CAL 63% vs. 18%; stress 39% vs. 2%; fold increase: TBSES 6.6 vs. 3.6) (P ≤ 0.01). The present findings may imply that HC has a significantly greater impact on better management of oral health and glycaemic control than HE. It is notable that the impact was more significant among high-risk group patients, thus HC may be recommended especially for high-risk group patients. © 2013 FDI World Dental Federation.

Disease management to promote blood pressure control among African Americans.

PubMed

Brennan, Troyen; Spettell, Claire; Villagra, Victor; Ofili, Elizabeth; McMahill-Walraven, Cheryl; Lowy, Elizabeth J; Daniels, Pamela; Quarshie, Alexander; Mayberry, Robert

2010-04-01

African Americans have a higher prevalence of hypertension and poorer cardiovascular and renal outcomes than white Americans. The objective of this study was to determine whether a telephonic nurse disease management (DM) program designed for African Americans is more effective than a home monitoring program alone to increase blood pressure (BP) control among African Americans enrolled in a national health plan. A prospective randomized controlled study (March 2006-December 2007) was conducted, with 12 months of follow-up on each subject. A total of 5932 health plan members were randomly selected from the population of self-identified African Americans, age 23 and older, in health maintenance organization plans, with hypertension; 954 accepted, 638 completed initial assessment, and 485 completed follow-up assessment. The intervention consisted of telephonic nurse DM (intervention group) including educational materials, lifestyle and diet counseling, and home BP monitor vs. home BP monitor alone (control group). Measurements included proportion with BP < 120/80, mean systolic BP, mean diastolic BP, and frequency of BP self-monitoring. Results revealed that systolic BP was lower in the intervention group (adjusted means 123.6 vs. 126.7 mm Hg, P = 0.03); there was no difference for diastolic BP. The intervention group was 50% more likely to have BP in control (odds ratio [OR] = 1.50, 95% confidence interval [CI] 0.997-2.27, P = 0.052) and 46% more likely to monitor BP at least weekly (OR 1.46, 95% CI 1.07-2.00, P = 0.02) than the control group. A nurse DM program tailored for African Americans was effective at decreasing systolic BP and increasing the frequency of self-monitoring of BP to a greater extent than home monitoring alone. Recruitment and program completion rates could be improved for maximal impact.

VERifyNow in DIabetes high-on-treatment platelet reactivity: a pharmacodynamic study on switching from clopidogrel to prasugrel.

PubMed

Cubero Gómez, José M; Acosta Martínez, Juan; Mendias Benítez, Crsitina; Díaz De La Llera, Luis S; Fernández-Quero, Mónica; Guisado Rasco, Agustí; Villa Gil-Ortega, Manuel; Sánchez González, Ángel

2015-12-01

Diabetic patients with an acute coronary syndrome undergoing percutaneous coronary intervention frequently exhibit high platelet reactivity while on clopidogrel. We hypothesized that in diabetic patients undergoing percutaneous coronary intervention, who exhibit high-platelet-reactivity after standard treatment with clopidogrel, a 60-mg prasugrel loading dose is superior to standard treatment with clopidogrel for optimal P2Y12 inhibition within the first 24-36 h post-angioplasty. VERDI was a prospective, randomized, single-centre, single-blind, parallel-design study (NCT01684813). Consecutive diabetic patients with an non-ST-segment elevation acute coronary syndrome undergoing percutaneous coronary intervention and loaded with clopidogrel were considered for platelet reactivity assessment immediately before angioplasty with the VerifyNow assay measured in P2Y12 reaction units (PRU). Fifty of 63 screened patients (79.4%) had high platelet reactivity (PRU ≥ 208) and were randomized to receive a 60-mg prasugrel loading dose (n = 25) versus clopidogrel standard dose (n = 25). Platelet function was assessed again 24 hours post-angioplasty. Prasugrel achieved greater platelet inhibition than clopidogrel 24 hours post-angioplasty (median [interquartile range], 38 [9-72] vs 285 [240-337], respectively; P < 0.001). The non-high-platelet-reactivity rate (PRU < 208) at 24 h post-angioplasty (primary end point) was higher with prasugrel; 25 patients (100%) in the prasugrel group achieved optimal antiaggregation vs 4 patients (16%) in the clopidogrel group (P < 0.001). No significant acute bleeding was documented in either group. Among type 2 diabetic patients suffering an acute coronary syndrome with high-platelet-reactivity undergoing percutaneous coronary intervention, switching from clopidogrel to prasugrel was superior to standard treatment with clopidogrel for the achievement of optimal antiaggregation within the first 24 hours post-angioplasty.

Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus.

PubMed

Goday, A; Bellido, D; Sajoux, I; Crujeiras, A B; Burguera, B; García-Luna, P P; Oleaga, A; Moreno, B; Casanueva, F F

2016-09-19

Brackground:The safety and tolerability of very low-calorie-ketogenic (VLCK) diets are a current concern in the treatment of obese type 2 diabetes mellitus (T2DM) patients. Evaluating the short-term safety and tolerability of a VLCK diet (<50 g of carbohydrate daily) in an interventional weight loss program including lifestyle and behavioral modification support (Diaprokal Method) in subjects with T2DM. Eighty-nine men and women, aged between 30 and 65 years, with T2DM and body mass index between 30 and 35 kg m(-)(2) participated in this prospective, open-label, multi-centric randomized clinical trial with a duration of 4 months. Forty-five subjects were randomly assigned to the interventional weight loss (VLCK diet), and 44 to the standard low-calorie diet. No significant differences in the laboratory safety parameters were found between the two study groups. Changes in the urine albumin-to-creatinine ratio in VLCK diet were not significant and were comparable to control group. Creatinine and blood urea nitrogen did not change significantly relative to baseline nor between groups. Weight loss and reduction in waist circumference in the VLCK diet group were significantly larger than in control subjects (both P<0.001). The decline in HbA1c and glycemic control was larger in the VLCK diet group (P<0.05). No serious adverse events were reported and mild AE in the VLCK diet group declined at last follow-up. The interventional weight loss program based on a VLCK diet is most effective in reducing body weight and improvement of glycemic control than a standard hypocaloric diet with safety and good tolerance for T2DM patients.

A Prospective Randomized Trial on the Effect of Using an Electronic Monitoring Drug Dispensing Device to Improve Adherence and Compliance.

PubMed

Henriksson, Jarmo; Tydén, Gunnar; Höijer, Jonas; Wadström, Jonas

2016-01-01

Outcome after renal transplantation depends on patient compliance and adherence for early detection of complications and identification of intervention opportunities. Compliance describes the degree to which patients follow medical advice and take their medications. Adherence has been defined as the extent to which a patients' behavior coincides with clinical prescriptions. Patients were randomized 7 to 14 days after transplantation into groups with (n = 40) and without (n = 40) an electronic medication dispenser (EMD). The EMD, which was used for the 1-year study period, recorded the date and time the patient took their medications and was monitored via a web-based application. Patients were monitored for 1 year regarding outpatient follow-up visits, emergency hospitalizations, renal biopsies, rejection episodes, renal function, and blood concentration of medications. Compliance in the intervention group was 97.8% (the control group was not assessed). Number of missed doses varied significantly by weekday (P = 0.033); patients were most likely to miss doses on Saturdays and Thursdays. Patients missed a total of 11 follow-up visits. During the study, 92 biopsies were performed on 55 patients (intervention group: 32 [17]; control group, 60 [38]). Biopsy-verified rejection was three times more common among controls (13 patients vs. 4; P = 0.054, not significant). Average P-creatinine level was slightly lower in the intervention group than the control group (131 vs. 150 μmol/L, not significant), whereas mean tacrolimus was similar (7.32 vs. 7.22 ng/mL, n.s.). The EMD is associated with high compliance, and there are also indications of a lower rejection rate.

Exercise-based pre-habilitation is feasible and effective in radical cystectomy pathways-secondary results from a randomized controlled trial.

PubMed

Jensen, Bente Thoft; Laustsen, Sussie; Jensen, Jørgen Bjerggaard; Borre, Michael; Petersen, Annemette Krintel

2016-08-01

Physical exercises offer a variety of health benefits to cancer survivors during and post-treatment. However, exercise-based pre-habilitation is not well reported in major uro-oncology surgery. The aim of this study was to investigate the feasibility, the adherence, and the efficacy of a short-term physical pre-habilitation program to patients with invasive bladder cancer awaiting radical cystectomy (RC). A parent prospective randomized controlled clinical trial investigated efficacy of a multidisciplinary rehabilitation program on length of stay following RC. A total of 107 patients were included in the intension-to-treat population revealing 50 patients in the intervention group and 57 patients in the standard group. Pre-operatively, the intervention group was instructed to a standardized exercise program consisting of both muscle strength exercises and endurance training. The number of training sessions and exercise repetitions was patient-reported. Feasibility was expressed as adherence to the program and efficacy as the differences in muscle power within and between treatment groups at time for surgery. A total of 66 % (95 % confidence interval (CI) 51; 78) adhered more than 75 % of the recommended progressive standardized exercise program. In the intervention group, a significant improvement in muscle power of 18 % (p < 0.002) was found at time for surgery. Moreover, muscle power was significantly improved compared to that in the standard group with 0.3 W/kg (95 % CI 0.08; 0.5 %) (p < 0.006). Adherence was not associated with pre-operative BMI, nutritional risk, comorbidity, pain, gender, or age. In patients awaiting RC, a short-term exercise-based pre-habilitation intervention is feasible and effective and should be considered in future survivorship strategies.

The effect of music with and without binaural beat audio on operative anxiety in patients undergoing cataract surgery: a randomized controlled trial.

PubMed

Wiwatwongwana, D; Vichitvejpaisal, P; Thaikruea, L; Klaphajone, J; Tantong, A; Wiwatwongwana, A

2016-11-01

PurposeTo investigate the anxiolytic effects of binaural beat embedded audio in patients undergoing cataract surgery under local anesthesia.MethodsThis prospective RCT included 141 patients undergoing cataract surgery under local anesthesia. The patients were randomized into three groups; the Binaural beat music group (BB), the plain music intervention group (MI), and a control group (ear phones with no music). Blood pressure (BP) and heart rate were measured on admission, at the beginning of and 20 min after the start of the operation. Peri-operative anxiety level was assessed using the State-Trait Anxiety Inventory questionnaire (STAI).ResultsThe BB and MI groups comprised 44 patients each and the control group 47. Patients in the MI group and BB group showed significant reduction of STAI state scores after music intervention compared with the control group (P<0.001) but the difference was not significant between the MI and BB group (STAI-S score MI group -7.0, BB group -9.0, P=0.085). Systolic BP was significantly lower in both MI (P=0.043) and BB (0.040) groups although there was no difference between the two groups (P=1.000). A significant reduction in heart rate was seen only in the BB group (BB vs control P=0.004, BB vs MI P=0.050, MI vs control P=0.303).ConclusionMusic, both with and without binaural beat, was proven to decrease anxiety level and lower systolic BP. Patients who received binaural beat audio showed additional decrease in heart rate. Binaural beat embedded musical intervention may have benefit over musical intervention alone in decreasing operative anxiety.

Acupuncture Combined with Hydrotherapy in Diabetes Patients with Mild Lower-Extremity Arterial Disease: A Prospective, Randomized, Nonblinded Clinical Study.

PubMed

Qi, Zhengqin; Pang, Yan; Lin, Lin; Zhang, Bing; Shao, Juntao; Liu, Xiaodong; Zhang, Xin

2018-05-08

BACKGROUND The aim of this pragmatic study was to explore the intervention of acupuncture combined with hydrotherapy and perceived effects in type 2 diabetic patients with recently diagnosed, mild, lower-extremity arterial disease (LEAD) in comparison with a control group. MATERIAL AND METHODS One hundred twenty-six diabetes patients who were diagnosed mild LEAD according to ankle-brachial blood pressure index (ABPI) and peripheral neuropathy symptom were randomly assigned to either an experimental (n=64) or control group (n=62). The experimental group attended and completed (1) a 30-min session of acupuncture in certain selected points, and (2) a 30-min hydrotherapy exercise every 2 days for 15 weeks. The outcome parameters were assessed at baseline, after intervention, and at 6-week follow-up. RESULTS The intervention was associated with an improvement in leg flow conductance and partial physical capacities, including chair-sit-and-reach, the walking impairment questionnaire (WIQ), and physical component summary score (PCS), compared to the control group. The treatment benefits were sustained throughout the 6-week follow-up endpoint. There was no difference in fasting glucose levels, Hb1Ac, blood pressure, or BMI after the intervention. At the endpoint of 6-week follow-up, acupuncture plus hydrotherapy appeared to reduce inflammatory response by decreasing IL-6, TNF-α, malondialdehyde, and SOD, and increasing glutathione. CONCLUSIONS Acupuncture plus hydrotherapy, without significant glycemic-controlling effects in the type 2 diabetic patients with mild LEAD, exerts a measurable benefit in disease-specific physical functions and health-related quality of life. Our results suggest that the combined therapy regulates the inflammatory process and oxidative stress and contributes to immune protection.

Acupuncture Combined with Hydrotherapy in Diabetes Patients with Mild Lower-Extremity Arterial Disease: A Prospective, Randomized, Nonblinded Clinical Study

PubMed Central

Pang, Yan; Lin, Lin; Zhang, Bing; Shao, Juntao; Liu, Xiaodong; Zhang, Xin

2018-01-01

Background The aim of this pragmatic study was to explore the intervention of acupuncture combined with hydrotherapy and perceived effects in type 2 diabetic patients with recently diagnosed, mild, lower-extremity arterial disease (LEAD) in comparison with a control group. Material/Methods One hundred twenty-six diabetes patients who were diagnosed mild LEAD according to ankle-brachial blood pressure index (ABPI) and peripheral neuropathy symptom were randomly assigned to either an experimental (n=64) or control group (n=62). The experimental group attended and completed (1) a 30-min session of acupuncture in certain selected points, and (2) a 30-min hydrotherapy exercise every 2 days for 15 weeks. The outcome parameters were assessed at baseline, after intervention, and at 6-week follow-up. Results The intervention was associated with an improvement in leg flow conductance and partial physical capacities, including chair-sit-and-reach, the walking impairment questionnaire (WIQ), and physical component summary score (PCS), compared to the control group. The treatment benefits were sustained throughout the 6-week follow-up endpoint. There was no difference in fasting glucose levels, Hb1Ac, blood pressure, or BMI after the intervention. At the endpoint of 6-week follow-up, acupuncture plus hydrotherapy appeared to reduce inflammatory response by decreasing IL-6, TNF-α, malondialdehyde, and SOD, and increasing glutathione. Conclusions Acupuncture plus hydrotherapy, without significant glycemic-controlling effects in the type 2 diabetic patients with mild LEAD, exerts a measurable benefit in disease-specific physical functions and health-related quality of life. Our results suggest that the combined therapy regulates the inflammatory process and oxidative stress and contributes to immune protection. PMID:29735963

Exercise Therapy in Juvenile Idiopathic Arthritis: A Systematic Review and Meta-Analysis.

PubMed

Kuntze, Gregor; Nesbitt, Colleen; Whittaker, Jackie L; Nettel-Aguirre, Alberto; Toomey, Clodagh; Esau, Shane; Doyle-Baker, Patricia K; Shank, Jena; Brooks, Julia; Benseler, Susanne; Emery, Carolyn A

2018-01-01

To conduct a systematic review to evaluate the efficacy of exercise interventions in improving outcomes across domains of functioning and disability in children and adolescents with juvenile idiopathic arthritis (JIA). Seven electronic databases were systematically searched up to November 16, 2016. Original data, analytic prospective design, physical therapy-led exercise intervention evaluation, children and adolescents with JIA, and assessment of functional, structural, activity, participation, or quality of life outcomes. Two authors screened search results, and discrepancies were resolved by consensus. Of 5037 potentially relevant studies, 9 randomized controlled trials and 1 cohort study were included and scored. Study quality (Downs and Black quality assessment tool) and level of evidence (Oxford Centre of Evidence-Based Medicine model) were assessed and meta-analysis conducted where appropriate. Alternatively, a descriptive summary approach was chosen. All randomized controlled trials were moderate-quality intervention studies (level 2b evidence; median Downs and Black score, 20 out of 32; range, 15-27). Interventions included aquatic, strengthening, proprioceptive, aerobic, and Pilates exercises. Pediatric activity capacity (Child Health Assessment Questionnaire) improved with exercise (mean difference, .45; 95% confidence interval, .05-.76). Furthermore, descriptive summaries indicated improved activity capacity, body function and structure (pain and muscle strength), and quality of life outcomes. Exercise therapy appears to be well tolerated and beneficial across clinically relevant outcomes in patients with JIA. The paucity of high-quality evidence and study heterogeneity limited the ability to provide conclusive, generalizing evidence for the efficacy of exercise therapy and to provide specific recommendations for clinical practice at this time. Future research evaluating exercise program implementation using validated outcomes and detailed adherence and safety assessment is needed to optimize clinical decision pathways in patients with JIA. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Effectiveness of an educational feedback intervention on drug prescribing in dental practice.

PubMed

Rauniar, G P; Das, B P; Manandhar, T R; Bhattacharya, S K

2012-01-01

Irrational use of drugs as well as inappropriate and over drug prescribing leads to unnecessary expenditures and emergence of resistant bacterial strains. Feedback intervention on drug prescribing habits and face to face educational intervention of prescription audit would be effective in rationalizing prescribing practices. To measure the impact of educational feedback intervention on the prescribing behavior of dental surgeons. Prospective audit of twelve hundred outpatients prescriptions in dental OPD at BPKIHS of those dental surgeon who attended the educational intervention session was collected randomly by trained persons on customized data collection sheet before and after educational intervention. A total 1200 prescription were collected, 300 before and 300 after intervention period at the internal of one month, three months and six months. Majority of the prescriptions (39.33%) contained four drugs but after intervention, prescriptions contained mostly one drug, 73% in first month, 78.67% in third month and 65.34% in six month. Mean number of drugs per prescription after intervention were decreased. There was increased number of generic names of drugs after intervention. Amoxicillin, Metronidazole, Chlorhexidine, Povidone iodine gargle, Nimesulide, Ibuprofen, Ibuprofen + paracetamol, and Paracetamol were most commonly prescribed by dental prescribers before and after intervention. Selection of antimicrobial was done on empirical basis which was correct because Amoxicillin concentration reaches effectively in gingival crevicular fluid and Metronidazole covered effectively against anaerobic bacteria were found in orodental infection. The uses of topical anti-infective preparation as irrigants of choice that can kill majority of micro-organisms found is root canal and dental tubules and minimize systemic use of antimicrobials. Nimesulide prescribing needs to be rationalized. Feedback educational intervention of prescription audit is effective to improve their prescribing behaviors and rationalize drug utilization pattern for the benefit of the patients.

A prospective, multicenter pilot study to investigate the feasibility and safety of a 1-year controlled exercise training after adjuvant chemotherapy in colorectal cancer patients.

PubMed

Piringer, Gudrun; Fridrik, Michael; Fridrik, Alfred; Leiherer, Andreas; Zabernigg, August; Greil, Richard; Eisterer, Wolfgang; Tschmelitsch, Jörg; Lang, Alois; Frantal, Sophie; Burgstaller, Sonja; Gnant, Michael; Thaler, Josef

2018-04-01

Despite advances in adjuvant chemotherapy, 20-30% of patients in stages II-III colorectal cancer will eventually relapse. Observational studies showed a reduction in relapse rate, colon cancer-specific mortality, and overall mortality by physical activity. Results from prospective randomized interventional studies to confirm these observational data are lacking. The aims of this prospective single-arm multicenter pilot study are to evaluate feasibility and safety of exercise training after adjuvant chemotherapy in colorectal cancer patients. The training was performed three times per week for 1 year and was increased gradually in three phases until reaching 18 metabolic equivalent task hours per week. Overall, 30 patients were included. The planned training intensity could be achieved in all three phases. Patients experienced a performance increase of median 35.5 watt, a weight-loss of a median of 3.0 kg, and a reduction in body fat content of median 1.0% during this exercise training. The analysis showed early study termination due to non-compliance in 10/30 patients (33.3%), disease progression in 4 patients (13.3%), and serious adverse events in 2 patients (6.7%). About half of patients (46.7%) completed the pilot study as planned. Biomarker analysis from 20 patients showed a non-significant reduction in insulin-like growth factor 1 (IGF-1), insulin-like growth factor 2 (IGF-2) and insulin-like growth factor binding protein 3 (IGF-BP3) levels, significant increases in adiponectin and leptin levels, and a non-significant increase in C-peptide levels. Exercise training is feasible in patients with colorectal cancer after completion of adjuvant chemotherapy. The main problem encountered during the study was compliance. To improve compliance of exercise training, several measures were adapted for the upcoming prospective randomized ABCSG C08 Exercise II study.

Seeking to reduce nonbeneficial treatment in the ICU: an exploratory trial of proactive ethics intervention*.

PubMed

Andereck, William S; McGaughey, J Westly; Schneiderman, Lawrence J; Jonsen, Albert R

2014-04-01

To investigate whether the proactive intervention of a clinical ethicist in cases of prolonged lengths of stay in a critical care setting reduces nonbeneficial treatment while increasing perceived patient/surrogate and provider satisfaction and reducing associated costs. Nonbeneficial treatment is defined here as the use of life-sustaining treatments delivered to patients who had been in the ICU for 5 days and did not survive to discharge. Prospective randomized exploratory trial from October 2007 to February 2010 in the adult ICU of a large, urban, not-for-profit community hospital. Medical/surgical ICU of California Pacific Medical Center, a large tertiary not-for-profit hospital in San Francisco, CA. Three hundred eighty-four patients with ICU lengths of stay of five days or greater. Patients were randomized to either an intervention arm (Proactive Ethics Intervention) (n = 174) or control arm (n = 210). There were 56 patients in the intervention arm and 52 patients in the control arm who did not survive to discharge. Proactive ethics intervention involves a trained bioethicist in the care of all ICU patients with a length of stay greater than or equal to 5 days. The intervention used a nine step process model designed to look for manifest or latent ethics conflicts and address them. The primary outcome measures were days in the ICU; overall length of hospital stay; mortality; nonbeneficial treatments, for example, provision of nutritional support; surrogate and survivor satisfaction, and cost. The intervention and control arms showed no significant difference in mortality. Proactive Ethics Intervention, at the 95% CI, was not associated with reductions of overall length of stay (23 d for intervention and 21 d for control, p = 0.74), ICU days (11 in each arm, p = 0.91), life-sustaining treatments (days on ventilator: intervention, 14.6; control, 13.7; p = 0.74; days receiving artificial nutrition and hydration: intervention, 16.5; control, 15.9; p = 0.85), or cost ($167,350.00 for intervention and $164,670.00 for control, p =0.92) in patients who did not survive to discharge. Perceptions of quality of care by patients and providers showed no difference between intervention and control arms. Our study finds that Proactive Ethics Intervention, provided to all patients in a critical care setting for 5 days, and before an ethical conflict has been recognized, is ineffective in reducing overall length of hospital stay, ICU days, nonbeneficial treatments, or hospital costs. It is also not effective in increasing perceptions of quality of care by patients or providers.

Evaluation of the First Polish Web-Based Intervention Aimed at Improving Cancer Prevention (the PORINA Study).

PubMed

Gajda, Maksymilian; Kowalska, Małgorzata; Zejda, Jan E

2018-06-04

The appropriate level of the society's health-oriented knowledge is essential for improving the effectiveness of actions to reduce the number of new cases and deaths caused by cancer. The aim of this study was to identify the role of web-based educational campaigns in the field of cancer prevention in Poland. From 14.05.2015 to 13.11.2016 readers of Polish scientific websites were invited to participate in the "PORINA" prospective interventional study. A total of 1118 volunteers (unrepresentative sample) were recruited and randomized (interventional and control groups). After applying the inclusion and exclusion criteria, 463 participants (41.4% of the recruited) qualified for the final analysis; 207 were allocated to the interventional and 256 to the control group. A specially designed internet platform, a self-reported questionnaire (validated during the study) and educational materials which were prepared by a physician specialized in clinical oncology were used. Assessments of participants' knowledge were based on the authors Cancer Knowledge Index (CKI). The number of subjects with an increase in CKI score was significantly higher for the interventional group with minor changes in the control ( p < 0.001). The highest increase in CKI scores was obtained in the following demographic groups: females, younger participants, those living in smaller villages and also among the less educated. An overall impact of presented web-based educational intervention was moderate. However, the results obtained confirmed that well-organized intervention supported by oncologists may be useful in cancer prevention.

A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

PubMed

Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

2015-01-01

Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P < .001), shoulder abduction (P <.001), shoulder external rotation (P = .01), and elbow flexion (P = .004) ROM from baseline to 6 months as measured with goniometry. Subjects also showed significant gains in elbow flexion (P = .04) during hand to head and shoulder flexion (P = .04) during high reach. There was no difference in ROM gains between the groups. Within group comparison showed that the VGT group had significantly more recovery of ROM during the first 3 weeks than any other timeframe in the study, whereas ST had most gains at 3 months. There was a significant difference between the groups in the subjects' pain response. ST subjects showed an increase in pain during the intervention, whereas VGT subjects did not (VGT: r = .047, ST: r = .18; P = .015). In this study, interactive videogames were equally effective as traditional therapy for overall ROM gains and resulted in quicker recovery of motion with less pain experienced. Such videogames are a useful adjunct to therapy and should be considered as part of a holistic approach to rehabilitation within the hospital and at home after discharge in pediatric patients recovering from burn injury.

Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial.

PubMed

Marsen, Tobias A; Beer, Justinus; Mann, Helmut

2017-02-01

Protein-energy wasting (PEW) is increasingly becoming a clinical problem in maintenance hemodialysis patients and guidelines call for nutritional interventions. Serum prealbumin (transthyretin) represents a critical nutritional marker positively correlated with patient survival and negatively correlated with morbidity. Nutritional counseling, oral supplementation as well as intradialytic parenteral nutrition (IDPN) are recommended to fight PEW, however clinical trials on their use are scarce. We conducted a prospective, multicenter, randomized, open-label, controlled, parallel-group Phase IV clinical trial in 107 maintenance hemodialysis patients suffering from PEW to assess the impact of IDPN on prealbumin and other biochemical and clinical parameters reflecting nutritional status. Patients randomized to the intervention group received standardized nutritional counseling plus IDPN three times weekly over 16 weeks followed by a treatment-free period of 12 weeks. The control group received standardized nutritional counseling only. Main trial inclusion criteria included moderate to severe malnutrition (SGA score B or C), maintenance hemodialysis therapy (3 times per week) for more than six months, and presence of two out of the following three criteria: albumin <35 g/L, prealbumin <250 mg/L, phase angle alpha <4.5° assessed by bioelectrical impedance analysis (BIA). Changes in serum prealbumin, albumin, transferrin, phase angle alpha, subjective global assessment (SGA) score and health-related quality of life using the 12-item short form health survey (SF-12) were investigated. IDPN significantly increased prealbumin (p < 0.05), showing rapid rise within 16 weeks of treatment and sustained response thereafter. In the full analysis set (n = 83), 41.0% of 39 patients receiving IDPN achieved a relevant (i.e., at least ≥15%) increase in prealbumin over baseline at week 4 compared to 20.5% of 44 patients in the control group. Considerably more patients with IDPN therapy achieved an increment of prealbumin >30 mg/L at week 16 (48.7% vs. 31.8%). Prealbumin response to IDPN therapy was more prominent in patients suffering from moderate malnutrition (SGA score B) compared to patients with severe malnutrition (SGA score C). The results of this trial demonstrate for the first time that IDPN therapy, given three times weekly in a 16-week short-term intervention, results in a statistically significant and clinically relevant increase in mean serum prealbumin, a surrogate marker for outcome and survival in hemodialysis patients suffering from PEW, and is superior to nutritional counseling. Clinical trial registry:www.clinicaltrials.gov (NCT00501956). Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Transcranial magnetic stimulation for tinnitus: using the Tinnitus Functional Index to predict benefit in a randomized controlled trial.

PubMed

Theodoroff, Sarah M; Griest, Susan E; Folmer, Robert L

2017-02-09

Identifying characteristics associated with transcranial magnetic stimulation (TMS) benefit would offer insight as to why some individuals experience tinnitus relief following TMS treatment, whereas others do not. The purpose of this study was to use the Tinnitus Functional Index (TFI) and its subscales to identify specific factors associated with TMS treatment responsiveness. Individuals with bothersome tinnitus underwent 2000 pulses of 1-Hz TMS for 10 consecutive business days. The primary outcome measure was the TFI which yields a total score and eight individual subscale scores. Analyses were performed on baseline data from the active arm (n = 35) of a prospective, double-blind, randomized placebo-controlled clinical trial of TMS for tinnitus. Baseline total TFI score and three of the eight TFI subscales were useful in differentiating between responders and nonresponders to TMS intervention for tinnitus. These findings are not definitive, but suggest potential factors that contribute to perceived benefit following TMS. Overall, the main factor associated with TMS benefit was a higher tinnitus severity score for responders at baseline. The TFI subscales helped to clarify the factors that contributed to a higher severity score at baseline. Large-scale prospective research using systematic approaches is needed to identify and describe additional factors associated with tinnitus benefit following TMS. ClinicalTrials.gov, ID: NCT01104207 . Registered on 13 April 2010.

Web-based stress management for newly diagnosed cancer patients (STREAM-1): a randomized, wait-list controlled intervention study.

PubMed

Grossert, Astrid; Urech, Corinne; Alder, Judith; Gaab, Jens; Berger, Thomas; Hess, Viviane

2016-11-03

Being diagnosed with cancer causes major psychological distress, yet the majority of newly diagnosed cancer patients lack psychological support. Internet interventions overcome many barriers for seeking face-to-face support and allow for independence in time and place. We assess efficacy and feasibility of the first web-based stress management intervention (STREAM: STREss-Aktiv-Mindern) for newly diagnosed, German-speaking cancer patients. In a prospective, wait-list controlled trial 120 newly diagnosed cancer patients will be included within 12 weeks of starting anti-cancer treatment and randomized between an immediate (intervention group) or delayed (control group) 8-week, web-based intervention. The intervention consists of eight modules with weekly written feedback by a psychologist ("minimal-contact") based on well-established stress management manuals including downloadable audio-files and exercises. The aim of this study is to evaluate efficacy in terms of improvement in quality of life (FACT-F), as well as decrease in anxiety and depression (HADS), as compared to patients in the wait-list control group. A sample size of 120 patients allows demonstrating a clinically relevant difference of nine points in the FACT score after the intervention (T2) with a two-sided alpha of 0.05 and 80 % power. As this is the first online stress management intervention for German-speaking cancer patients, more descriptive outcomes are equally important to further refine the group of patients with the largest potential for benefit who then will be targeted more specifically in future trials. These descriptive endpoints include: patients' characteristics (type of cancer, type of treatment, socio-demographic factors), dropout rate and dropout reasons, adherence and satisfaction with the program. New technologies open new opportunities: minimal-contact psychological interventions are becoming standard of care in several psychological disorders, where their efficacy is often comparable to face-to-face interventions. With our study we open this field to the population of newly diagnosed cancer patients. We will not only assess clinical efficacy but also further refine the target population who has the most potential to benefit. An internet-based minimal-contact stress management program might be an attractive, time- and cost-effective way to effectively deliver psychological support to newly diagnosed cancer patients and an opportunity to include those who currently are not reached by conventional support. ClinicalTrials.gov NCT02289014 .

Evaluation of the Housing First program in patients with severe mental disorders in France: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Recent studies in North American contexts have suggested that the Housing First model is a promising strategy for providing effective services to homeless people with mental illness. In the context of the highly generous French national health and social care system, which is easily accessible and does not require out-of-pocket payment, the French Health Ministry insists on rigorous techniques, including randomized protocols, to evaluate the impact of Housing First approaches in France. Method and design A prospective randomized trial was designed to assess the impact of a Housing First intervention on health outcomes and costs over a period of 24 months on homeless people with severe mental illness, compared to Treatment-As-Usual. The study is being conducted in four cities in France: Lille, Marseille, Paris and Toulouse. The inclusion criteria are as follows: over 18 years of age, absolutely homeless or in precarious housing, and possessing a ‘high’ level of need: diagnosis of schizophrenia or bipolar disorder and moderate to severe disability according to the Multnomah Community Ability Scale (score ≤ 62) and at least one of the following three criteria: 1) having been hospitalized for mental illness two or more times in any one year during the preceding five years; 2) co-morbid alcohol or substance use; and 3) having been recently arrested or incarcerated. Participants will be randomized to receiving the Housing First intervention or Treatment-As-Usual. The Housing First intervention provides immediate access to independent housing and community care. The primary outcome criterion is the use of high-cost health services (that is,, number of hospital admissions and number of emergency department visits) during the 24-month follow-up period. Secondary outcome measures include health outcomes, social functioning, housing stability and contact with police services. An evaluation of the cost-effectiveness and cost-utility of Housing First will also be conducted. A total of 300 individuals per group will be included. Discussion This is the first study to examine the impact of a Housing First intervention compared to Treatment-As-Usual in France. It should provide key information to policymakers concerning the cost-effectiveness and health outcomes of the Housing First model in the French context. Trial registration The current clinical trial number is NCT01570712 PMID:24063556

Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol.

PubMed

Haslbeck, Friederike Barbara; Bucher, Hans-Ulrich; Bassler, Dirk; Hagmann, Cornelia

2017-01-01

Preterm birth is associated with increased risk of neurological impairment and deficits in cognition, motor function, and behavioral problems. Limited studies indicate that multi-sensory experiences support brain development in preterm infants. Music appears to promote neurobiological processes and neuronal learning in the human brain. Creative music therapy (CMT) is an individualized, interactive therapeutic approach based on the theory and methods of Nordoff and Robbins. CMT may promote brain development in preterm infants via concurrent interaction and meaningful auditory stimulation. We hypothesize that preterm infants who receive creative music therapy during neonatal intensive care admission will have developmental benefits short- and long-term brain function. A prospective, randomized controlled single-center pilot trial involving 60 clinically stable preterm infants under 32 weeks of gestational age is conducted in preparation for a multi-center trial. Thirty infants each are randomized to either standard neonatal intensive care or standard care with CMT. Music therapy intervention is approximately 20 min in duration three times per week. A trained music therapist sings for the infants in lullaby style, individually entrained and adjusted to the infant's rhythm and affect. Primary objectives of this study are feasibility of protocol implementation and investigating the potential mechanism of efficacy for this new intervention. To examine the effect of this new intervention, non-invasive, quantitative magnetic resonance imaging (MRI) methods at corrected age and standardized neurodevelopmental assessments using the Bayley Scales of Infant and Toddler Development third edition at a corrected age of 24 months and Kaufman Assessment Battery for Children at 5 years will be performed. All assessments will be performed and analyzed by blinded experts. To our knowledge, this is the first randomized controlled clinical trial to systematically examine possible effects of creative music therapy on short- and long-term brain development in preterm infants. This project lies at the interface of music therapy, neuroscience, and medical imaging. New insights into the potential role and impact of music on brain function and development may be elucidated. If such a low-cost, low-risk intervention is demonstrated in a future multi-center trial to be effective in supporting brain development in preterm neonates, findings could have broad clinical implications for this vulnerable patient population. ClinicalTrials.gov, NCT02434224.

A Randomized Controlled Trial of a Standardized Behavior Management Intervention for Students with Externalizing Behavior

ERIC Educational Resources Information Center

Forster, Martin; Sundell, Knut; Morris, Richard J.; Karlberg, Martin; Melin, Lennart

2012-01-01

This study reports the results from a Swedish randomized controlled trial of a standardized behavior management intervention. The intervention targeted students with externalizing behavior in a regular education setting. First- and second-grade students (N = 100) from 38 schools were randomly assigned to either the intervention or an active…

Improving patient knowledge and safe use of opioids: a randomized controlled trial.

PubMed

McCarthy, Danielle M; Wolf, Michael S; McConnell, Ryan; Sears, Jill; Chevrier, Allison; Ahlstrom, Eric; Engel, Kirsten G; Cameron, Kenzie A; Adams, James G; Courtney, D Mark

2015-03-01

The use of opioid analgesics in the United States has significantly increased in recent years. However, there is minimal consensus on what discharge counseling should accompany these high-risk prescriptions and large variations in what is done in practice. The objective of this study was to evaluate the effect of a dual-modality (written and spoken) literacy-appropriate educational strategy on patients' knowledge of and safe use of opioid analgesics. This was a prospective, randomized controlled trial. Consecutive discharged patients at an urban academic ED (>88,000 visits) with new prescriptions for hydrocodone-acetaminophen were enrolled. Patients were randomized to receive either usual care or the educational intervention. The educational intervention was a one-page information sheet about hydrocodone-acetaminophen, which was both given to the patients and read aloud by the research assistant (nonblinded). Follow-up phone calls were conducted 4 to 7 days after the visit to assess patient knowledge about the medication and self-report of activities associated with safety of use (e.g., double-dipping with acetaminophen, storage, use with alcohol or while driving). A total of 274 patients were enrolled; 210 completed follow-up (110 usual care and 100 intervention). No significant differences in baseline characteristics emerged between the study arms; 42% were male, and 51% were white, with a median age of 43 years. Half of patients had non-back pain orthopedic injuries (49.5%). On follow-up, overall knowledge was poor, with only 28% able to name both active ingredients in the medication. The intervention group had better knowledge of precautions related to taking additional acetaminophen (usual care 18.2%, 95% confidence interval [CI] = 10.9% to 25.5% vs. intervention 38%, 95% CI = 28.3% to 47.7%; difference = 27.6, 95% CI of difference = 21.5 to 33.7) and knowledge of side effects (usual care median = 1, interquartile range [IQR] 0 to 2 vs. intervention median = 2, IQR = 1 to 2; p < 0.0001). Additionally, those who received the intervention were less likely to have reported driving within 6 hours after taking hydrocodone (usual care 13.6%, 95% CI = 7.2% to 20% vs. intervention 3%, 95% CI = -0.3% to 6.3%; difference = 10.6, 95% CI of difference = 3.4 to 17.9). There was no difference between groups related to knowledge about drinking alcohol while taking hydrocodone (overall 18.1%) or knowledge that the opioid could be addictive (overall 72.4%). This simple strategy improved several, but not all, aspects of patient knowledge and resulted in fewer patients in the intervention arm driving while taking hydrocodone. Integration of a patient education document into conversations about opioids holds promise for improving patient knowledge about these high-risk medications. © 2015 by the Society for Academic Emergency Medicine.

Pharmacists in humanitarian crisis settings: Assessing the impact of pharmacist-delivered home medication management review service to Syrian refugees in Jordan.

PubMed

Al Alawneh, Majdoleen; Nuaimi, Nabeel; Basheti, Iman A

2018-04-10

Refugees all over the world are facing several health-related problems. Chronic diseases among Syrian refugees in Jordan are high. The Home Medication Management Review (HMMR) service could be ideal to optimize refugees' health management. To assess the impact of the HMMR service on the type and frequency of Treatment Related Problems (TRPs) among Syrian refugees living in Jordan. This prospective randomized single blinded intervention-control study was conducted in three main cities in Jordan, between May and October 2016. Syrian refugees with chronic conditions were recruited and randomized into intervention and control groups. The HMMR service was conducted for all patients to identify TRPs at baseline. Data were collected via two home visits for all study participants. Clinical pharmacist's recommendations were written in a letter format to the physicians managing the patients in the intervention group only. Physicians' approved recommendations were conveyed to the patients via the pharmacist. Interventions at the patient level were delivered by the pharmacist directly. Patients were reassessed for their TRPs and satisfaction 3 months after baseline. Syrian refugees (n = 106) were recruited with no significant differences between the intervention (n = 53) and control groups (n = 53). A total of 1141 TRPs were identified for both groups at baseline, with a mean number of 10.8 ± 4.2 TRPs per patient. At follow-up, there was a significant decrease in the number of TRPs among the intervention group (P < 0.001, paired sample t-test) but not among the control group (P = 0.116). Physicians' approval rate of the pharmacist's recommendations was high (82.9%), and more than 70.0% of refugees in the intervention group reported high satisfaction with the HMMR service. Identified TRPs are high amongst Syrian refugees living in Jordan. The HMMR service significantly reduced the number of TRPs, and was highly accepted by the physicians. Refugees reported high satisfaction with this service. Copyright © 2018. Published by Elsevier Inc.

Mental Fitness for patients with acute coronary syndrome: A randomized clinical trial.

PubMed

Chiavarino, Claudia; Cavallero, Erika; Rabellino, Daniela; Palumbo, Luigi; Bianchino, Claudia; Gaita, Fiorenzo; Bergerone, Serena; Bara, Bruno G

2016-09-01

The aim of this study was to verify the efficacy of a manualized, cognitively oriented psychological intervention, called Mental Fitness, in improving the mental and physical health of patients with acute coronary syndrome (ACS). Mental Fitness is a small-group four-session treatment aimed at increasing awareness of one's own bodily perceptions, emotions, and thoughts and is overall tailored on participants' perception of control over their health. Prospective randomized controlled single-blind trial. Patients with ACS were recruited within a week from their acute cardiac event. Patients in the intervention group underwent one of two variants of Mental Fitness, depending on their perceived (internal or external) control over their health. Patients in the control group underwent standard treatment. All the patients were submitted to a clinical and psychological follow-up for 8 months. The patients who underwent the Mental Fitness intervention (N = 31) showed, compared to the control patients (N = 34), increased quality of life in its physical, psychological, social and environmental domains, more functional emotional and problem-centred coping strategies, and higher emotional awareness. They also showed improved high-density lipoprotein cholesterol, triglycerides, heart rate, and left ventricular ejection fraction compared to the controls. In addition, they were more successful in maintaining physical exercise. This study demonstrates the efficacy of Mental Fitness in modifying specific psychological and physical variables conditioning cardiological patients' prognosis. It also confirms the importance of differentiating psychological interventions based on the psychological characteristics of the patients. Statement of contribution What is already known on this subject? Traditional symptom-based interventions in heart disease are aimed at diagnosing and reducing psychological symptomatology (e.g., depression), but recent work has shown the usefulness of orienting psychological interventions to patients' representations of themselves and of the world and to how such representations influence their thoughts, feelings, and behaviours (e.g., Chiavarino et al., ). What does this study add? Mental Fitness, by working on awareness of bodily perceptions, emotions, and thoughts, leads to positive changes in physical and psychological health. Mental Fitness is a cost-effective psychological intervention that adds significantly to the effectiveness of standard medical care. © 2016 The British Psychological Society.

Multidisciplinary approach to management of maternal asthma (MAMMA [copyright]): the PROTOCOL for a randomized controlled trial.

PubMed

Lim, Angelina; Stewart, Kay; Abramson, Michael J; Walker, Susan P; George, Johnson

2012-12-19

Uncontrolled asthma during pregnancy is associated with the maternal hazards of disease exacerbation, and perinatal hazards including intrauterine growth restriction and preterm birth. Interventions directed at achieving better asthma control during pregnancy should be considered a high priority in order to optimise both maternal and perinatal outcomes. Poor compliance with prescribed asthma medications during pregnancy and suboptimal prescribing patterns to pregnant women have both been shown to be contributing factors that jeopardise asthma control. The aim is to design and evaluate an intervention involving multidisciplinary care for women experiencing asthma in pregnancy. A pilot single-blinded parallel-group randomized controlled trial testing a Multidisciplinary Approach to Management of Maternal Asthma (MAMMA©) which involves education and regular monitoring. Pregnant women with asthma will be recruited from antenatal clinics in Victoria, Australia. Recruited participants, stratified by disease severity, will be allocated to the intervention or the usual care group in a 1:1 ratio. Both groups will be followed prospectively throughout pregnancy and outcomes will be compared between groups at three and six months after recruitment to evaluate the effectiveness of this intervention. Outcome measures include Asthma Control Questionnaire (ACQ) scores, oral corticosteroid use, asthma exacerbations and asthma related hospital admissions, and days off work, preventer to reliever ratio, along with pregnancy and neonatal adverse events at delivery. The use of FEV(1)/FEV(6) will be also investigated during this trial as a marker for asthma control. If successful, this model of care could be widely implemented in clinical practice and justify more funding for support services and resources for these women. This intervention will also promote awareness of the risks of poorly controlled asthma and the need for a collaborative, multidisciplinary approach to asthma management during pregnancy. This is also the first study to investigate the use of FEV1/FEV6 as a marker for asthma control during pregnancy. Australian New Zealand Clinical Trials Registry (ACTRN12612000681853).

Effectiveness of body-mind-spirit intervention on well-being, functional impairment and quality of life among depressive patients - a randomized controlled trial.

PubMed

Rentala, Sreevani; Fong, Ted C T; Nattala, Prasanthi; Chan, Cecilia L W; Konduru, Reddemma

2015-09-01

The aim of the study was to examine the efficacy of body-mind-spirit Intervention in improving the outcomes (well-being, quality of life and functional impairment) among depressive patients. Depressive disorders lead to significant dysfunction, disability and poor quality of life among sufferers. Body-mind-spirit intervention has been associated with improvements in the outcomes; however, few studies have examined this among depressive patients. True experimental pre-post equivalent groups design was adopted with longitudinal measurement of outcomes. Participants were 120 adult depressive patients visiting the psychiatric outpatient department in a District Hospital in India. The participants were randomly assigned to either the body-mind-spirit group or the treatment-as-usual group between July 2011-January 2013. The treatment-as-usual group (n = 64) received only routine treatment (antidepressants and structured psycho-education) in the hospital. The body-mind-spirit group (n = 56) received four weekly body-mind-spirit group sessions in addition to the routine treatment. Outcome measures on depression, well-being, functional impairment and quality of life were evaluated for both groups at baseline and at four follow-up assessments in the 1st, 2nd, 3rd and 6th month. Treatment effects of the body-mind-spirit intervention were analysed by repeated-measures analysis of covariance. Compared with the treatment-as-usual group, the body-mind-spirit group showed significant reduction in depression and functional impairment, and significant improvement in the well-being and quality of life scores over the 6-month study period. The present findings provided evidence for the effectiveness of integrating a complementary therapy such as the body-mind-spirit intervention with conventional treatment in improving prospective outcomes among the depressive patients. © 2015 John Wiley & Sons Ltd.

Culturally sensitive patient-centred educational programme for self-management of type 2 diabetes: a randomized controlled trial.

PubMed

Mohamed, Hashim; Al-Lenjawi, Badriya; Amuna, Paul; Zotor, Francis; Elmahdi, Hisham

2013-10-01

To assess the effectiveness of a culturally sensitive, structured education programme (CSSEP) on biomedical, knowledge, attitude and practice measures among Arabs with type two diabetes. A total of 430 patients with type II diabetes mellitus living in Doha, Qatar were enrolled in the study. They were randomized to either intervention (n = 215) or a control group (n = 215). A baseline and one-year interval levels of biomedical variables including HbA1C, lipid profile, urine for microalbuminuria; in addition to knowledge, attitude and practice (KAP) scores were prospectively measured. The intervention was based on theory of empowerment, health belief models and was culturally sensitive in relation to language (Arabic), food habits and health beliefs. It consisted of four educational sessions for each group of patients (10-20 patients per session), lasting for 3-4 h. The first session discussed diabetes pathophysiology and complications; while the second session discussed healthy life style incorporating the Idaho plate method; and the third session dealt with exercise benefits and goal setting and the fourth session concentrated enhancing attitude and practice using counselling techniques. Outcomes were assessed at base line and 12 months after intervention. After 12 months participation in the intervention was shown to have led to a statistically significant reduction in HbA1C in the (CSSEP) group (-0.55 mmol/L, P = 0.012), fasting blood sugar (-0.92 mmol/L, P = 0.022), body mass index (1.70, P = 0.001) and albumin/creatinine ratio (-3.09, P < 0.0001) but not in the control group. The intervention group also had improvement in Diabetes knowledge (5.9%, P < 0.0001), attitude (6.56%, P < 0.0001), and practice (6.52%, P = 0.0001). This study demonstrates the effectiveness of culturally sensitive, structured, group-based diabetes education in enhancing biomedical and behavioural outcomes in Diabetic patients. Copyright © 2013 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Telemonitoring of home exercise cycle training in patients with COPD

PubMed Central

Franke, Karl-Josef; Domanski, Ulrike; Schroeder, Maik; Jansen, Volker; Artmann, Frank; Weber, Uwe; Ettler, Rainer; Nilius, Georg

2016-01-01

Background Regular physical activity is associated with reduced mortality in patients with chronic obstructive pulmonary disease (COPD). Interventions to reduce time spent in sedentary behavior could improve outcomes. The primary purpose was to investigate the impact of telemonitoring with supportive phone calls on daily exercise times with newly established home exercise bicycle training. The secondary aim was to examine the potential improvement in health-related quality of life and physical activity compared to baseline. Methods This prospective crossover-randomized study was performed over 6 months in stable COPD patients. The intervention phase (domiciliary training with supporting telephone calls) and the control phase (training without phone calls) were randomly assigned to the first or the last 3 months. In the intervention phase, patients were called once a week if they did not achieve a real-time monitored daily cycle time of 20 minutes. Secondary aims were evaluated at baseline and after 3 and 6 months. Health-related quality of life was measured by the COPD Assessment Test (CAT), physical activity by the Godin Leisure Time Exercise Questionnaire (GLTEQ). Results Of the 53 included patients, 44 patients completed the study (forced expiratory volume in 1 second 47.5%±15.8% predicted). In the intervention phase, daily exercise time was significantly higher compared to the control phase (24.2±9.4 versus 19.6±10.3 minutes). Compared to baseline (17.6±6.1), the CAT-score improved in the intervention phase to 15.3±7.6 and in the control phase to 15.7±7.3 units. The GLTEQ-score increased from 12.2±12.1 points to 36.3±16.3 and 33.7±17.3. Conclusion Telemonitoring is a simple method to enhance home exercise training and physical activity, improving health-related quality of life. PMID:27956829

A Pilot RCT of an Internet Intervention to Reduce the Risk of Alcohol-Exposed Pregnancy.

PubMed

Ingersoll, Karen; Frederick, Christina; MacDonnell, Kirsten; Ritterband, Lee; Lord, Holly; Jones, Brogan; Truwit, Lauren

2018-06-01

Preventing alcohol-exposed pregnancies (AEPs) could reduce the incidence of fetal alcohol spectrum disorders. Previous face-to-face interventions significantly reduced risk for AEP, but a scalable intervention is needed to reach more women at risk. This study compared a 6 Core automated, interactive, and tailored Internet intervention, the Contraception and Alcohol Risk Reduction Internet Intervention (CARRII), to a static patient education (PE) website for its effect on AEP risk. Participants were recruited online to a pilot randomized clinical trial (RCT) with baseline, 9 weeks posttreatment, and 6-month (6-M) follow-up assessments. Seventy-one women completed online questionnaires and telephone interviews and were randomized to CARRII (n = 36) or PE (n = 35). Primary outcomes were rates of risky drinking, unprotected sex episodes, and AEP risk, collected from online prospective diaries. CARRII participants showed significant reductions in rate of unprotected sex from pretreatment (88.9%) to posttreatment (70.6%) (p < 0.04) and to 6-M follow-up (51.5%) (p = 0.001); rate of risky drinking from pretreatment (75.0%) to posttreatment (50.0%) (p < 0.02), but insignificant change from pretreatment to 6-M follow-up (57.6%) (p < 0.09); and rate of AEP risk from pretreatment (66.7%) to posttreatment (32.4%) (p = 0.001) and to 6-M follow-up (30.3%) (p = 0.005). PE participants demonstrated no significant changes on all 3 variables across all time points. Intent-to-treat group-by-time tests were not significant, but power was limited by missing diaries. Over 72% of CARRII participants completed all 6 Cores. Exploratory analyses suggest that higher program utilization is related to change. These data show that CARRII was acceptable, feasible, promising to reduce AEP risk, and merits further testing in a fully powered RCT. Copyright © 2018 by the Research Society on Alcoholism.

A new mode of community continuing care service for COPD patients in China: participation of respiratory nurse specialists.

PubMed

Li, Pingdong; Gong, Yucui; Zeng, Guangqiao; Ruan, Liang; Li, Guifen

2015-01-01

This study explored a community nursing service mode in which respiratory nurse specialists cared for patients with chronic obstructive pulmonary disease (COPD) in a 12-week period after hospital discharge, with the aim of better preventing acute exacerbations, improving health-related quality of life (HRQOL) and reducing medical expenses in these patients. We carried out a prospective randomized controlled study in which 68 COPD patients discharged were recruited from a general hospital in Guangzhou, China, were randomized divided into two groups. The control group underwent conventional nursing care, and the intervention group received community continuing care by respiratory nurse specialists. The observation period was 12 weeks. The results of intervention were evaluated using the Seattle Obstructive Lung Disease Questionnaire (SOLDQ) and the COPD Self-Efficacy Scale (CSES). In addition, the frequency of acute exacerbations, emergency treatments or hospitalizations, and medical expenses were recorded in the 12-week observation period. After six weeks, the total and subscale scores (P < 0.05) of SOLDQ and CSES significantly improved compared to the baseline ones in the intervention group. The control group had significantly higher scores in the treatment satisfaction (TS) of SOLDQ, the total score, and the weather/environment and behavioral risk factors of CSES. After 12 weeks, the total and subscale scores of SOLDQ and CSES showed a sustained and significant growth in the intervention group (P < 0.05). The control group had significantly higher scores only in the weather/environment risk factor of CSES. During the 12-week observation, the intervention group had significantly fewer acute exacerbations, emergency treatments or re-hospitalizations and significantly lower average medical expenses than the control group (P < 0.05). Community continuing care by respiratory nurse specialists may improve HRQOL, increase self-efficacy, reduce incidence of acute exacerbation, and lower medical expenses in patients with COPD after hospital discharge.

A new mode of community continuing care service for COPD patients in China: participation of respiratory nurse specialists

PubMed Central

Li, Pingdong; Gong, Yucui; Zeng, Guangqiao; Ruan, Liang; Li, Guifen

2015-01-01

Objective: This study explored a community nursing service mode in which respiratory nurse specialists cared for patients with chronic obstructive pulmonary disease (COPD) in a 12-week period after hospital discharge, with the aim of better preventing acute exacerbations, improving health-related quality of life (HRQOL) and reducing medical expenses in these patients. Methods: We carried out a prospective randomized controlled study in which 68 COPD patients discharged were recruited from a general hospital in Guangzhou, China, were randomized divided into two groups. The control group underwent conventional nursing care, and the intervention group received community continuing care by respiratory nurse specialists. The observation period was 12 weeks. The results of intervention were evaluated using the Seattle Obstructive Lung Disease Questionnaire (SOLDQ) and the COPD Self-Efficacy Scale (CSES). In addition, the frequency of acute exacerbations, emergency treatments or hospitalizations, and medical expenses were recorded in the 12-week observation period. Results: After six weeks, the total and subscale scores (P < 0.05) of SOLDQ and CSES significantly improved compared to the baseline ones in the intervention group. The control group had significantly higher scores in the treatment satisfaction (TS) of SOLDQ, the total score, and the weather/environment and behavioral risk factors of CSES. After 12 weeks, the total and subscale scores of SOLDQ and CSES showed a sustained and significant growth in the intervention group (P < 0.05). The control group had significantly higher scores only in the weather/environment risk factor of CSES. During the 12-week observation, the intervention group had significantly fewer acute exacerbations, emergency treatments or re-hospitalizations and significantly lower average medical expenses than the control group (P < 0.05). Conclusions: Community continuing care by respiratory nurse specialists may improve HRQOL, increase self-efficacy, reduce incidence of acute exacerbation, and lower medical expenses in patients with COPD after hospital discharge. PMID:26629091

Doubling Pharmacist Coverage in the Intensive Care Unit: Impact on the Pharmacists' Clinical Activities and Team Members' Satisfaction.

PubMed

McDaniel, Joshua; Bass, Lynn; Pate, Toni; DeValve, Michael; Miller, Susan

2017-09-01

Background: National professional organizations have recognized pharmacists as essential members of the intensive care unit (ICU) team. Critical care pharmacists' clinical activities have been categorized as fundamental, desirable, and optimal, providing a structure for gauging ICU pharmacy services being provided. Objective: To determine the impact the addition of a second ICU pharmacist covering 30 adult ICU beds at a large regional medical center has on the complexity of pharmacists' interventions, the types of clinical activities performed by the pharmacists, and the ICU team members' satisfaction. Methods: A prospective mixed-method descriptive study was conducted. Pharmacists recorded their interventions and clinical activities performed. A focus group composed of randomly selected ICU team members was held to qualitatively describe the impact of the additional pharmacist coverage on patient care, team dynamics, and pharmacy services provided. Results: The baseline period consisted of 33 days, and the intervention period consisted of 20 days. The average complexity of interventions was 1.72 during the baseline period (mode = 2) versus 1.69 (mode = 2) during the intervention period. The number of desirable and optimal clinical activities performed daily increased during the intervention from 8.4 (n = 279) to 16.4 (n = 328) and 2.3 (n = 75) to 8.6 (n = 171) compared with the baseline, respectively. Focus group members qualitatively described additional pharmacist coverage as beneficial. Conclusion: The additional critical care pharmacist did not increase pharmacy intervention complexity; however, more interventions were performed per day. Additional pharmacist coverage increased the daily number of desirable and optimal clinical activities performed and positively impacted ICU team members' satisfaction.

Using the health action process approach to predict and improve health outcomes in individuals with type 2 diabetes mellitus

PubMed Central

MacPhail, Mariana; Mullan, Barbara; Sharpe, Louise; MacCann, Carolyn; Todd, Jemma

2014-01-01

Background The purpose of this study was to explore the predictive utility of the Health Action Process Approach (HAPA) and test a HAPA-based healthy eating intervention, in adults with type 2 diabetes mellitus. Materials and methods The study employed a prospective, randomized, controlled trial design. The 4-month intervention consisted of self-guided HAPA-based workbooks in addition to two telephone calls to assist participants with the program implementation, and was compared to “treatment as usual”. Participants (n=87) completed health measures (diet, body mass index [BMI], waist circumference, blood pressure, blood glucose levels, lipid levels, and diabetes distress) and HAPA measures prior to the intervention and again upon completion 4 months later. Results The overall HAPA model predicted BMI, although only risk awareness and recovery self-efficacy were significant independent contributors. Risk awareness, intentions, and self-efficacy were also independent predictors of health outcomes; however, the HAPA did not predict healthy eating. No significant time × condition interaction effects were found for diet or any HAPA outcome measures. Conclusion Despite the success of HAPA in predicting health outcomes for those with type 2 diabetes mellitus, the intervention was unsuccessful in changing healthy eating or any of the other measured variables, and alternative low-cost health interventions for those with type 2 diabetes mellitus should be explored. PMID:25342914

The influence of whole grain products and red meat on intestinal microbiota composition in normal weight adults: a randomized crossover intervention trial.

PubMed

Foerster, Jana; Maskarinec, Gertraud; Reichardt, Nicole; Tett, Adrian; Narbad, Arjan; Blaut, Michael; Boeing, Heiner

2014-01-01

Intestinal microbiota is related to obesity and serum lipid levels, both risk factors for chronic diseases constituting a challenge for public health. We investigated how a diet rich in whole grain (WG) products and red meat (RM) influences microbiota. During a 10-week crossover intervention study, 20 healthy adults consumed two isocaloric diets, one rich in WG products and one high in RM. Repeatedly data on microbiota were assessed by 16S rRNA based denaturing gradient gel electrophoresis (DGGE). A blood sample and anthropometric data were collected. Mixed models and logistic regression were used to investigate effects. Microbiota showed interindividual variability. However, dietary interventions modified microbiota appearance: 8 bands changed in at least 4 participants during the interventions. One of the bands appearing after WG and one increasing after RM remained significant in regression models and were identified as Collinsella aerofaciens and Clostridium sp. The WG intervention lowered obesity parameters, while the RM diet increased serum levels of uric acid and creatinine. The study showed that diet is a component of major relevance regarding its influence on intestinal microbiota and that WG has an important role for health. The results could guide investigations of diet and microbiota in observational prospective cohort studies. Trial registration: ClinicalTrials.gov NCT01449383.

The Influence of Whole Grain Products and Red Meat on Intestinal Microbiota Composition in Normal Weight Adults: A Randomized Crossover Intervention Trial

PubMed Central

Foerster, Jana; Maskarinec, Gertraud; Reichardt, Nicole; Tett, Adrian; Narbad, Arjan; Blaut, Michael; Boeing, Heiner

2014-01-01

Intestinal microbiota is related to obesity and serum lipid levels, both risk factors for chronic diseases constituting a challenge for public health. We investigated how a diet rich in whole grain (WG) products and red meat (RM) influences microbiota. During a 10-week crossover intervention study, 20 healthy adults consumed two isocaloric diets, one rich in WG products and one high in RM. Repeatedly data on microbiota were assessed by 16S rRNA based denaturing gradient gel electrophoresis (DGGE). A blood sample and anthropometric data were collected. Mixed models and logistic regression were used to investigate effects. Microbiota showed interindividual variability. However, dietary interventions modified microbiota appearance: 8 bands changed in at least 4 participants during the interventions. One of the bands appearing after WG and one increasing after RM remained significant in regression models and were identified as Collinsella aerofaciens and Clostridium sp. The WG intervention lowered obesity parameters, while the RM diet increased serum levels of uric acid and creatinine. The study showed that diet is a component of major relevance regarding its influence on intestinal microbiota and that WG has an important role for health. The results could guide investigations of diet and microbiota in observational prospective cohort studies. Trial registration ClinicalTrials.gov NCT01449383 PMID:25299601

Cardiac Valve Noise Reduction by Non-Drug Interventions Improves the Sleep Quality of Patients after Mechanical Cardiac Valve Implantation.

PubMed

Lin, Yanjuan; Xu, Le; Huang, Xizhen; Jiang, Fei; Lin, Fen; Ye, Qingyang; Lin, Jianling

2016-01-01

To investigate the effects of non-drug interventions on the sleep quality of patients after mechanical cardiac valve implantation. In this prospective, randomized, controlled trial, 64 patients scheduled for mechanical mitral valve replacement were recruited. Patients underwent cognitive behavioral therapy and wore noise cancelling earplugs and eye mask. Sleep quality was evaluated on the 4th after admission and the 5th days after operation. The primary outcome was the total sleep quality score differences between the 4th day after admission and the 5th day after operation. All patients had been suffering from poor sleep quality for a month before admission. There was no difference between both groups on the 4th day after admission. Overall sleep quality in the intervention group was better than in the control group on the 5th day after operation. The subjective sleep quality of the patients in each group was significantly lower on the 5th day after the operation than on the 4th day after admission (P <0.05). Non-drug intervention could improve the sleep quality of patients after mechanical cardiac valve implantation and help the postoperative recovery of the patients. ( ChiCTR-TRC-14004405, 21 March 2014.).

Long-Term Outcomes of Early Intervention in 6-Year-Old Children With Autism Spectrum Disorder

PubMed Central

Estes, Annette; Munson, Jeffrey; Rogers, Sally J.; Greenson, Jessica; Winter, Jamie; Dawson, Geraldine

2015-01-01

Objective We prospectively examine evidence for the sustained effects of early intervention based on a follow-up study of 39 children with ASD who began participation in a randomized clinical trial testing the effectiveness of the Early Start Denver Model (ESDM) at age 18–30 months. The intervention, conducted at a high level of intensity in-home for 2 years, showed evidence of efficacy immediately posttreatment. Method This group of children was assessed at age 6, two years after the intervention ended, across multiple domains of functioning by clinicians naïve to previous intervention group status. Results The ESDM group, on average, maintained gains made in early intervention during the 2-year follow-up period in overall intellectual ability, adaptive behavior, symptom severity, and challenging behavior. No group differences in core autism symptoms were found immediately posttreatment; however, two years later, the ESDM group demonstrated improved core autism symptoms and adaptive behavior as compared with the community-intervention-as-usual (COM) group. The two groups were not significantly different in terms of intellectual functioning at age 6. The two groups received equivalent intervention hours during the original study, but the ESDM group received fewer hours during the follow-up period. Conclusion These results provide evidence that gains from early intensive intervention are maintained 2 years later. Notably, core autism symptoms improved in the ESDM group over the follow-up period relative to the COM group. This improvement occurred at the same time the ESDM group received significantly fewer services. This is the first study to examine the role of early ESDM behavioral intervention initiated below 30 months of age in altering the longer term developmental course of autism. PMID:26088663

Long-Term Outcomes of Early Intervention in 6-Year-Old Children With Autism Spectrum Disorder.

PubMed

Estes, Annette; Munson, Jeffrey; Rogers, Sally J; Greenson, Jessica; Winter, Jamie; Dawson, Geraldine

2015-07-01

We prospectively examined evidence for the sustained effects of early intervention based on a follow-up study of 39 children with ASD who began participation in a randomized clinical trial testing the effectiveness of the Early Start Denver Model (ESDM) at age 18 to 30 months. The intervention, conducted at a high level of intensity in-home for 2 years, showed evidence of efficacy immediately posttreatment. This group of children was assessed at age 6 years, 2 years after the intervention ended, across multiple domains of functioning by clinicians naive to previous intervention group status. The ESDM group, on average, maintained gains made in early intervention during the 2-year follow-up period in overall intellectual ability, adaptive behavior, symptom severity, and challenging behavior. No group differences in core autism symptoms were found immediately posttreatment; however, 2 years later, the ESDM group demonstrated improved core autism symptoms and adaptive behavior as compared with the community-intervention-as-usual (COM) group. The 2 groups were not significantly different in terms of intellectual functioning at age 6 years. Both groups received equivalent intervention hours during the original study, but the ESDM group received fewer hours during the follow-up period. These results provide evidence that gains from early intensive intervention are maintained 2 years later. Notably, core autism symptoms improved in the ESDM group over the follow-up period relative to the COM group. This improvement occurred at the same time that the ESDM group received significantly fewer services. This is the first study to examine the role of early ESDM behavioral intervention initiated at less than 30 months of age in altering the longer-term developmental course of autism. Copyright © 2015 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Effectiveness of an HIV/STD risk-reduction intervention for adolescents when implemented by community-based organizations: a cluster-randomized controlled trial.

PubMed

Jemmott, John B; Jemmott, Loretta S; Fong, Geoffrey T; Morales, Knashawn H

2010-04-01

We evaluated the effectiveness of an HIV/STD risk-reduction intervention when implemented by community-based organizations (CBOs). In a cluster-randomized controlled trial, 86 CBOs that served African American adolescents aged 13 to 18 years were randomized to implement either an HIV/STD risk-reduction intervention whose efficacy has been demonstrated or a health-promotion control intervention. CBOs agreed to implement 6 intervention groups, a random half of which completed 3-, 6-, and 12-month follow-up assessments. The primary outcome was consistent condom use in the 3 months prior to each follow-up assessment, averaged over the follow-up assessments. Participants were 1707 adolescents, 863 in HIV/STD-intervention CBOs and 844 in control-intervention CBOs. HIV/STD-intervention participants were more likely to report consistent condom use (odds ratio [OR] = 1.39; 95% confidence interval [CI] = 1.06, 1.84) than were control-intervention participants. HIV/STD-intervention participants also reported a greater proportion of condom-protected intercourse (beta = 0.06; 95% CI = 0.00, 0.12) than did the control group. This is the first large, randomized intervention trial to demonstrate that CBOs can successfully implement an HIV/STD risk-reduction intervention whose efficacy has been established.

Effectiveness of an HIV/STD Risk-Reduction Intervention for Adolescents When Implemented by Community-Based Organizations: A Cluster-Randomized Controlled Trial

PubMed Central

Jemmott, Loretta S.; Fong, Geoffrey T.; Morales, Knashawn H.

2010-01-01

Objectives. We evaluated the effectiveness of an HIV/STD risk-reduction intervention when implemented by community-based organizations (CBOs). Methods. In a cluster-randomized controlled trial, 86 CBOs that served African American adolescents aged 13 to 18 years were randomized to implement either an HIV/STD risk-reduction intervention whose efficacy has been demonstrated or a health-promotion control intervention. CBOs agreed to implement 6 intervention groups, a random half of which completed 3-, 6-, and 12-month follow-up assessments. The primary outcome was consistent condom use in the 3 months prior to each follow-up assessment, averaged over the follow-up assessments. Results. Participants were 1707 adolescents, 863 in HIV/STD-intervention CBOs and 844 in control-intervention CBOs. HIV/STD-intervention participants were more likely to report consistent condom use (odds ratio [OR] = 1.39; 95% confidence interval [CI] = 1.06, 1.84) than were control-intervention participants. HIV/STD-intervention participants also reported a greater proportion of condom-protected intercourse (β = 0.06; 95% CI = 0.00, 0.12) than did the control group. Conclusions. This is the first large, randomized intervention trial to demonstrate that CBOs can successfully implement an HIV/STD risk-reduction intervention whose efficacy has been established. PMID:20167903

Comparison between intravenous paracetamol and fentanyl for intraoperative and postoperative pain relief in dilatation and evacuation: Prospective, randomized interventional trial.

PubMed

Ali, Muhammad Asghar; Shamim, Faisal; Chughtai, Shakaib

2015-01-01

Dilatation and Evacuation procedure involves pain, for which pain control measures need to be undertaken. The purpose of this study was to compare paracetamol with fentanyl for pain relief in dilatation and curettage procedures. Sixty female patients were randomly included during the period from March 1, 2012 to February 28, 2013. All patients had received oral midazolam 7.5 mg as a premedication 30 min before procedure in the ward. Group P had received intravenous (IV) paracetamol 15 mg/kg in the waiting area of the operating room 15 min before starting the procedure. Group F had received IV fentanyl 2 ug/kg/min at induction of anesthesia. Pain scores on a numerical rating scale at 5, 15, and 30 min intervals after surgery were recorded. Mild pain was commonly observed in both groups, an insignificant difference between groups. The study demonstrates the usefulness of IV paracetamol which may be as effective as fentanyl in dilation and curettage procedures.

Enteral glutamine supplementation in surgical patients with head and neck malignancy: A randomized controlled trial.

PubMed

Azman, Mawaddah; Mohd Yunus, Mohd Razif; Sulaiman, Suhaina; Syed Omar, Syed Nabil

2015-12-01

Glutamine supplementation is a novel approach to perioperative nutritional management. This study was a prospective randomized clinical trial of effects of enteral glutamine supplementation in surgical patients with head and neck malignancy in a tertiary center. This study measured the effects of supplementation within 4 weeks of the postoncologic surgical period in relation to fat-free mass, serum albumin, and quality of life scores. The study population consisted of 44 patients. There was significant difference in serum albumin (p < .001), fat-free mass (p < .001), and quality of life scores (p < .05) between control and interventional groups. Significant correlation exists between fat-free mass and quality of life score difference in our study population (p < .05). Enteral glutamine supplementation significantly improves fat-free mass, serum albumin, and quality of life scores postoperatively and maintenance of lean body mass correlated with improved postoperative outcomes in terms of the patient's quality of life. © 2014 Wiley Periodicals, Inc.

Men with chronic occupational stress benefit from behavioural/psycho-educational group training: a randomized, prospective, controlled trial.

PubMed

Nickel, C; Tanca, S; Kolowos, S; Pedrosa-Gil, F; Bachler, E; Loew, T H; Gross, M; Rother, W K; Nickel, M K

2007-08-01

Overworking is one of the most frequent stressors. The purpose of this study was to determine the effectiveness of behavioural/psycho-educational group training in men who are chronically stressed from overworking. Of 72 male subjects, 36 were randomly assigned to training for 8 weeks and another 36 formed the control group, which received a placebo intervention. Primary outcome measures were systolic blood pressure, salivary cortisol concentration upon awakening, and self-reported changes on the scales of the Trier Inventory for the Assessment of Chronic Stress (TICS), the State-Trait Anger Expression Inventory (STAXI) and the 36-item Short Form Health Survey (SF-36). A significant reduction in mean values was observed in daily systolic blood pressure and salivary cortisol concentration on all the TICS and most of the STAXI and SF-36 scales. Behavioural/psycho-educational group training appears to be effective in the treatment of men suffering from chronic stress due to overworking.

Randomized Controlled Trial for Behavioral Smoking and Weight Control Treatment: Effect of Concurrent versus Sequential Intervention

PubMed Central

Spring, Bonnie; Doran, Neal; Pagoto, Sherry; Schneider, Kristin; Pingitore, Regina; Hedeker, Don

2014-01-01

Prospects for changing multiple health behaviors conjointly remain controversial. We compared effects on tobacco abstinence and weight gain of adding diet and exercise concurrently or after smoking treatment. Female regular smokers (n=315) randomized to 3 conditions received 16 weeks of behavioral smoking treatment, quit at week 5, and were followed for 9 months after the quit date. Weight management was added to the first 8 weeks for Early Diet (ED), the final 8 weeks for Late Diet (LD), and omitted for Control. Both Diet groups tended to show greater bio-verified abstinence than Control although differences were nonsignificant. Compared to Control, ED initially suppressed weight gain but lost that effect over time, whereas LD initially lacked but gradually acquired a weight suppression effect that stabilized [p = .004]. Behavioral weight control did not undermine smoking cessation and slowed the rate of weight gain when initiated after the smoking quit date, supporting a sequential approach to multiple behavior change. PMID:15482037

The effect of combined stimulation of external cold and vibration during immunization on pain and anxiety levels in children.

PubMed

Canbulat Şahiner, Nejla; İnal, Sevil; Sevim Akbay, Ayşe

2015-06-01

Procedures involving needles are the most common and major sources of pain in children. External cold and vibration via Buzzy (MMJ Labs, Atlanta, GA) is a method that combines cooling and vibration. This study investigated the effect of the combined stimulation of skin with external cold and vibration via Buzzy on the pain and anxiety levels in children during immunization. This study was a prospective, randomized controlled trial. Children were randomized into two groups: experimental (external cold and Buzzy) and control (no intervention). The pain and anxiety levels of the children were assessed using the Wong-Baker FACES scale and Children Fear Scale. The experimental group showed significantly lower pain and anxiety levels than the control group during immunization. The combined stimulation of skin with external cold and vibration can be used to reduce pain and anxiety during pediatric immunization. Copyright © 2015 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

Randomized controlled trial to evaluate the effects of combined progressive exercise on metabolic syndrome in breast cancer survivors: rationale, design, and methods

PubMed Central

2014-01-01

Background Metabolic syndrome (MetS) is increasingly present in breast cancer survivors, possibly worsened by cancer-related treatments, such as chemotherapy. MetS greatly increases risk of cardiovascular disease and diabetes, co-morbidities that could impair the survivorship experience, and possibly lead to cancer recurrence. Exercise has been shown to positively influence quality of life (QOL), physical function, muscular strength and endurance, reduce fatigue, and improve emotional well-being; however, the impact on MetS components (visceral adiposity, hyperglycemia, low serum high-density lipoprotein cholesterol, hypertriglyceridemia, and hypertension) remains largely unknown. In this trial, we aim to assess the effects of combined (aerobic and resistance) exercise on components of MetS, as well as on physical fitness and QOL, in breast cancer survivors soon after completing cancer-related treatments. Methods/Design This study is a prospective randomized controlled trial (RCT) investigating the effects of a 16-week supervised progressive aerobic and resistance exercise training intervention on MetS in 100 breast cancer survivors. Main inclusion criteria are histologically-confirmed breast cancer stage I-III, completion of chemotherapy and/or radiation within 6 months prior to initiation of the study, sedentary, and free from musculoskeletal disorders. The primary endpoint is MetS; secondary endpoints include: muscle strength, shoulder function, cardiorespiratory fitness, body composition, bone mineral density, and QOL. Participants randomized to the Exercise group participate in 3 supervised weekly exercise sessions for 16 weeks. Participants randomized to the Control group are offered the same intervention after the 16-week period of observation. Discussion This is the one of few RCTs examining the effects of exercise on MetS in breast cancer survivors. Results will contribute a better understanding of metabolic disease-related effects of resistance and aerobic exercise training and inform intervention programs that will optimally improve physiological and psychosocial health during cancer survivorship, and that are ultimately aimed at improving prognosis. Trial registration NCT01140282; Registration: June 10, 2010 PMID:24708832

Effects of whole body vibration exercise on neuromuscular function for individuals with knee osteoarthritis: study protocol for a randomized controlled trial.

PubMed

Lai, Zhangqi; Wang, Xueqiang; Lee, Seullee; Hou, Xihe; Wang, Lin

2017-09-20

Knee osteoarthritis (KOA) is a leading cause of public disability. Neuromuscular function contributes to the development and/or progression of KOA. Whole body vibration (WBV) exercise improve the neuromuscular function of patients with neurological disorders and even that of older patients with limited exercise options. Therefore, WBV exercise may offer an efficient and alternative treatment for individuals with KOA. However, the effects of WBV training on the neuromuscular function of individuals with KOA remain unclear. Therefore, this study attempts to investigate the effect of a 12-week WBV exercise on the neuromuscular function of individuals with KOA. We will conduct a prospective, single-blind randomized controlled trial on 180 KOA patients. Participants will be randomly assigned to the WBV exercise, lower extremity resistance training, and health education groups. The WBV exercise group will participate in a 12-week WBV training. The lower extremity resistance training group will undergo a 12-week lower extremity resistance training of both lower limbs. The control group will receive health education for 12 weeks. After the intervention, the participants will be followed up for 3 months with no active intervention. Primary outcome measures will include anthropometric measurements, gait analysis during walking and stair climbing, muscle strength test of the knee and ankle, proprioception test of the knee and ankle, and neuromuscular response of the leg muscles. Secondary outcome measures will include self-reported pain and physical functional capacity, and physical performance measures. Furthermore, adverse events will be recorded and analyzed. If any participant withdraws from the trial, intention-to-treat analysis will be performed. Important features of this trial mainly include intervention setting, outcome measure selection, and study duration. This study is intended for estimating the effect of WBV intervention on neuromuscular control outcomes. Study results may provide evidence to support the beneficial effects of WBV exercise on the physical performance and neuromuscular control of individuals with KOA to fill the research gap on the efficacy of WBV. Chinese Clinical Trial Registry, ID: ChiCTR-IOR-16009234 . Registered on 21 September 2016.

A randomized controlled trial of a brief intervention for illicit drugs linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in clients recruited from primary health-care settings in four countries.

PubMed

Humeniuk, Rachel; Ali, Robert; Babor, Thomas; Souza-Formigoni, Maria Lucia O; de Lacerda, Roseli Boerngen; Ling, Walter; McRee, Bonnie; Newcombe, David; Pal, Hemraj; Poznyak, Vladimir; Simon, Sara; Vendetti, Janice

2012-05-01

This study evaluated the effectiveness of a brief intervention (BI) for illicit drugs (cannabis, cocaine, amphetamine-type stimulants and opioids) linked to the World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). The ASSIST screens for problem or risky use of 10 psychoactive substances, producing a score for each substance that falls into either a low-, moderate- or high-risk category. Prospective, randomized controlled trial in which participants were either assigned to a 3-month waiting-list control condition or received brief motivational counselling lasting an average of 13.8 minutes for the drug receiving the highest ASSIST score. Primary health-care settings in four countries: Australia, Brazil, India and the United States. A total of 731 males and females scoring within the moderate-risk range of the ASSIST for cannabis, cocaine, amphetamine-type stimulants or opioids. ASSIST-specific substance involvement scores for cannabis, stimulants or opioids and ASSIST total illicit substance involvement score at baseline and 3 months post-randomization. Omnibus analyses indicated that those receiving the BI had significantly reduced scores for all measures, compared with control participants. Country-specific analyses showed that, with the exception of the site in the United States, BI participants had significantly lower ASSIST total illicit substance involvement scores at follow-up compared with the control participants. The sites in India and Brazil demonstrated a very strong brief intervention effect for cannabis scores (P < 0.005 for both sites), as did the sites in Australia (P < 0.005) and Brazil (P < 0.01) for stimulant scores and the Indian site for opioid scores (P < 0.01). The Alcohol, Smoking and Substance Involvement Screening Test-linked brief intervention aimed at reducing illicit substance use and related risks is effective, at least in the short term, and the effect generalizes across countries. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

The efficacy of GMFM-88 and GMFM-66 to detect changes in gross motor function in children with cerebral palsy (CP): a literature review.

PubMed

Alotaibi, Madawi; Long, Toby; Kennedy, Elizabeth; Bavishi, Siddhi

2014-01-01

The purpose of this study was to review published research on the use of the Gross Motor Function Measure (GMFM-88) and (GMFM-66) as outcome measures to determine if these tools detect changes in gross motor function in children with cerebral palsy (CP) undergoing interventions. A comprehensive literature search was conducted using Medline and PubMed to identify studies published from January 2000 through January 2011 that reported the accuracy of GMFM-88 and GMFM-66 to measure changes over time in children with CP undergoing interventions. The keywords used for the search were "GMFM" and "CP". Two of the authors (M.A. and S.B.) reviewed the titles and abstracts found in the databases. The methodological quality of the studies was assessed by using the Critical Review Form-Quantitative Studies. Of 62 papers initially identified, 21 studies fulfilled the inclusion criteria. These articles consist of three longitudinal studies, six randomized controlled trials, four repeated measure design, six pre-post test design, a case series and one non-randomized prospective study. The included studies were generally of moderate to high methodological quality. The studies included children from a wide age range of 10 months to 16 years. According to the National Health and Medical Research Council, the study designs were level II, III-2, III-3 and IV. The review suggests that the GMFM-88 and GMFM-66 are useful as outcome measures to detect changes in gross motor function in children with CP undergoing interventions. Implications for Rehabilitation Accurate measurement of change in gross motor skill acquisition is important to determine effectiveness of intervention programs in children with cerebral palsy (CP). The Gross Motor Function Measure (GMFM-88 and GMFM-66) are common tools used by rehabilitation specialists to measure gross motor function in children with CP. The GMFM appears to be an effective outcome tool for measuring change in gross motor function according to a small number of randomized control studies utilizing participant populations of convenience.

Exergaming for health: a community-based pediatric weight management program using active video gaming.

PubMed

Christison, Amy; Khan, Huma Ali

2012-04-01

To evaluate the efficacy and feasibility of a multifaceted, community-based weight intervention program for children using exergaming technology (activity-promoting video gaming). This is a prospective observational pilot study. Forty-eight children, between the ages of 8 and 16 years, who are overweight or obese, enrolled in Exergaming for Health, a multidisciplinary weight management program, which used active video gaming. Primary outcome measures were change in body mass index (BMI) z scores. Most children (n = 40, 83%) completed the program and participated in outcome evaluations. The average BMI change was -0.48 kg/m(2) (SD = 0.93), P < .002 (BMI z-score change was -0.072, SD = 0.14, P < .0001). The average Global Self-Worth score improved, screen time and soda intake reduced, and exercise hours per week increased. The Exergaming for Health program may be an effective weight management intervention that is feasible with high participation rates. A larger randomized controlled trial is needed to confirm these results.

Increasing daily water intake and fluid adherence in children receiving treatment for retentive encopresis.

PubMed

Kuhl, Elizabeth S; Hoodin, Flora; Rice, Jennifer; Felt, Barbara T; Rausch, Joseph R; Patton, Susana R

2010-11-01

To examine the efficacy of an enhanced intervention (EI) compared to standard care (SC) in increasing daily water intake and fluid goal adherence in children seeking treatment for retentive encopresis. Changes in beverage intake patterns and fluid adherence were examined by comparing 7-week diet diary data collected during participation in the EI to achieved data for families who had previously completed the SC. Compared to children in SC (n = 19), children in the EI (n = 18) demonstrated a significantly greater increase in daily water intake from baseline to the conclusion of treatment ( p ≤ .001), and were four and six times more likely to meet fluid targets in Phases 1 (Weeks 3-4) and 2 (Weeks 5-6) of fluid intervention, respectively (both p ≤ .001). Enhanced education and behavioral strategies were efficacious in increasing children's intake of water and improving fluid adherence. Future research should replicate the findings in a prospective randomized clinical trial to discern their effectiveness.

Violent behavior of patients admitted in emergency following drug suicidal attempt: a specific staff educational crisis intervention.

PubMed

Cailhol, Lionel; Allen, Michael; Moncany, Anne-Hélène; Cicotti, Andrei; Virgillito, Salvatore; Barbe, Rémy P; Lazignac, Coralie; Damsa, Cristian

2007-01-01

In spite of much effort to create guidelines on the management of violent behavior (VB) in emergency departments, little is known about the impact of such guidelines on a real-life emergency environment. The aim of this study is to investigate the impact of a staff educational crisis intervention (SECI) on the reduction of VB in patients admitted to emergency departments following drug suicidal attempt. The impact of a SECI on VB of patient consulting the ER following a drug suicide attempt was assessed by comparing the occurrence of VB before (5 months) and after (5 months) the introduction of a SECI. A significant reduction in VB (from 17.32% to 7.14%) was found with the comparison of two 5-month periods: before (254 patients) and after (224 patients) the introduction of a SECI program (chi(2)=11.238; P=.0008). These preliminary data suggest the need for further prospective randomized studies aiming to prevent VB in emergency departments by developing specific SECI programs.

Community Pharmacists Assisting in Total Cardiovascular Health (CPATCH): A Cluster-Randomized, Controlled Trial Testing a Focused Adherence Strategy Involving Community Pharmacies.

PubMed

Blackburn, David F; Evans, Charity D; Eurich, Dean T; Mansell, Kerry D; Jorgenson, Derek J; Taylor, Jeff G; Semchuk, William M; Shevchuk, Yvonne M; Remillard, Alfred J; Tran, David A; Champagne, Anne P

2016-10-01

To test a brief intervention for preventing statin nonadherence among community pharmacy patrons. Prospective, cluster-randomized, controlled trial (the Community Pharmacists Assisting in Total Cardiovascular Health [CPATCH] trial). Thirty community pharmacies in Saskatchewan, Canada. Participating pharmacies were randomized to 15 intervention pharmacies where a brief statin adherence intervention was delivered by pharmacists (intervention group [907 patients]) or 15 usual care pharmacies where no statin adherence intervention was delivered (usual care group [999 patients]) to new users of statins (defined as less than 1 yr of statin therapy). Staff (pharmacy managers, staff pharmacists, and technicians) from intervention pharmacies attended a 2.5-hour workshop on the CPATCH program that prepared pharmacists to deal with the adherence barriers most likely associated with statin use (e.g., safety, cost, patient-provider relationship, and tolerability). Intervention pharmacists screened for new statin users and assessed these adherence barriers. Pharmacists were then instructed to tailor their follow-up plan based on the individual patient's situation. Investigators contacted the intervention pharmacies monthly to assess their compliance with the protocol and to offer additional support to motivate ongoing participation. The primary outcome was mean difference in statin adherence between the intervention and usual care groups. Adherence was measured by the proportion of days covered (PDC) between 6 and 12 months following the original prescription fill date. General estimating equations were used to evaluate the difference in mean adherence between groups. Secondary outcomes included the percentage of new statin users exhibiting optimal adherence (defined as PDC of 80% or higher) and the percentage exhibiting nonpersistence (defined as the cessation of all statin dispensations within 3 mo of the first dispensation). Among 1906 eligible patients, no significant differences in mean adherence were observed between those receiving the intervention and those receiving usual care (71.6% vs 70.9%, p=0.64), the percentage of patients achieving optimal adherence (57.3% vs 55.9%, p=0.51), or the percentage exhibiting nonpersistence (9.4% vs 8.3%, p=0.41). However, compliance to the study protocol was extremely low in several intervention pharmacies. In a post hoc analysis, a higher level of protocol compliance among intervention pharmacies was significantly associated with higher adherence (p<0.01 for trend). Pharmacies falling in the highest tertile of compliance to the study protocol exhibited higher mean adherence among their patients compared with those in the usual care group (β = 0.056, 95% confidence interval [CI] 0.010-0.101, p=0.01), and a significantly higher percentage of patients achieving optimal adherence (odds ratio 1.32, 95% CI 1.08-1.61; p<0.01); however, nonpersistence did not significantly differ between the two groups (5.5% vs 8.3%, p=0.27). The CPATCH intervention was ineffective for improving patient adherence to statin therapy in community pharmacies. However, poor effectiveness may have resulted from a failure to deliver the protocol consistently in several intervention pharmacies. © 2016 Pharmacotherapy Publications, Inc.

Adding methylphenidate to prism-adaptation improves outcome in neglect patients. A randomized clinical trial.

PubMed

Luauté, Jacques; Villeneuve, Laurent; Roux, Adeline; Nash, Stuart; Bar, Jean-Yves; Chabanat, Eric; Cotton, François; Ciancia, Sophie; Sancho, Pierre-Olivier; Hovantruc, Patrick; Quelard, François; Sarraf, Thierry; Cojan, Yann; Hadj-Bouziane, Fadila; Farné, Alessandro; Janoly-Dumenil, Audrey; Boisson, Dominique; Jacquin-Courtois, Sophie; Rode, Gilles; Rossetti, Yves

2018-04-04

Spatial neglect is one of the main predictors of poor functional recovery after stroke. Many therapeutic interventions have been developed to alleviate this condition, but to date the evidence of their effectiveness is still scarce. The purpose of this study was to test whether combining prism adaptation (PA) and methylphenidate (MP) could enhance the recovery of neglect patients at a functional level. RITAPRISM is a multicentre, randomized, double-blind, placebo-controlled study comparing PA plus placebo (control) versus PA plus MP. 24 patients were prospectively enrolled (10 in the placebo group and 14 in the MP group). The main result is a long-term functional improvement (on the functional independence measure (FIM) and on Bergego's scale) induced by MP combined with PA. No serious adverse event occurred. The long-term benefit on activities of daily living (ADL) obtained in this randomized controlled trial set this intervention apart from previous attempts and supports with a high level of evidence the value of combining PA and MP in order to improve the autonomy of neglect patients. Further studies will be needed to clarify the mechanism of this improvement. Although not specifically assessed at this stage, a part of the improvement in ADL might be related to the collateral effect of MP on mood, executive functions or fatigue, and/or the combined effect of PA and MP on motor intentional bias of neglect patients. This study provides Class I evidence that adding MP to PA improves the functional outcome of neglect patients. EUCTR2008-000325-20-FR. Copyright © 2018 Elsevier Ltd. All rights reserved.

Effect of a life review program for Chinese patients with advanced cancer: a randomized controlled trial.

PubMed

Xiao, Huimin; Kwong, Enid; Pang, Samantha; Mok, Esther

2013-01-01

Empirical data suggest that life review is an effective psychospiritual intervention. However, it has not been applied to Chinese patients with advanced cancer, and its effects on this population remain unknown. The aim of the study was to determine the effect of a life review program on quality of life among Chinese patients with advanced cancer. In this prospective randomized controlled trial, a total of 80 patients were randomly assigned to the life review program group and the control group. The 3-weekly life review program included reviewing a life and formulating a life review booklet. Outcome data were assessed by a collector who was blinded to group assignment before and immediately after the program and at a 3-week follow-up. Significantly better scores in overall quality of life, support, negative emotions, sense of alienation, existential distress, and value of life were found in the life review group immediately after the program and at the 3-week follow-up. This study provides additional data on the potential role of a life review in improving quality of life, particularly psychospiritual well being; it also indicates that the life review program could enable Chinese patients with advanced cancer to express their views on life and death. The life review program offers advanced cancer patients an opportunity to integrate their whole life experiences and discuss end-of-life issues, which lays the ground for further active intervention in their psychospiritual distress. The program could be integrated into daily home care to enhance the psychospiritual well-being of Chinese patients with advanced cancer.

Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study: Rationale and design for a randomized controlled trial evaluating rheumatoid arthritis risk education to first-degree relatives

PubMed Central

Sparks, Jeffrey A.; Iversen, Maura D.; Kroouze, Rachel Miller; Mahmoud, Taysir G.; Triedman, Nellie A.; Kalia, Sarah S.; Atkinson, Michael L.; Lu, Bing; Deane, Kevin D.; Costenbader, Karen H.; Green, Robert C.; Karlson, Elizabeth W.

2014-01-01

We present the rationale, design features, and protocol of the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study (ClinicalTrials.gov NCT02046005). The PRE-RA Family Study is an NIH-funded prospective, randomized controlled trial designed to compare the willingness to change behaviors in first-degree relatives of rheumatoid arthritis (RA) patients without RA after exposure to RA risk educational programs. Consented subjects are randomized to receive education concerning their personalized RA risk based on demographics, RA-associated behaviors, genetics and biomarkers or to receive standard RA information. Four behavioral factors associated with RA risk were identified from prior studies for inclusion in the risk estimate: cigarette smoking, excess body weight, poor oral health, and low fish intake. Personalized RA risk information is presented through an online tool that collects data on an individual's specific age, gender, family history, and risk-related behaviors; presents genetic and biomarker results; displays relative and absolute risk of RA; and provides personalized feedback and education. The trial outcomes will be changes in willingness to alter behaviors from baseline to 6 weeks, 6 months, and 12 months in the three intervention groups. The design and execution of this trial that targets a special population at risk for RA, while incorporating varied risk factors into a single risk tool, offer distinct challenges. We provide the theoretical rationale for the PRE-RA Family Study and highlight particular design features of this trial that utilize personalized risk education as an intervention. PMID:25151341

More pistachio nuts for improving the blood lipid profile. Systematic review of epidemiological evidence.

PubMed

Lippi, Giuseppe; Cervellin, Gianfranco; Mattiuzzi, Camilla

2016-05-06

Recent evidence suggests that regular intake of nuts may be associated with reduction of all-cause mortality, especially cardiovascular deaths. Among all types of nuts, pistachio displays the most favorable dietary composition. Therefore, we searched Medline and ISI Web of Science to identify interventional studies which evaluated changes of conventional blood lipids after replacing part of normal caloric intake with pistachio nuts in humans. Overall, 9 studies were finally included in our systematical literature review (4 randomized crossover, 3 randomized controlled and 3 prospective). In 6/9 (67%) interventional studies total cholesterol and low-density lipoprotein cholesterol (LDL-C) decreased, whereas high-density lipoprotein cholesterol (HDL-C) increased. In all studies total cholesterol/HDL-C ratio (7/7; 100%) and LDL-C/HDL-C ratio (6/6; 100%) decreased after replacing caloric intake with pistachio nuts for not less than 3 weeks. A significant reduction of triglycerides could only be observed in 2 out of 8 studies (25%). Even more importantly, in no interventional study the intake of pistachio nuts was associated with unfavorable changes of the lipid profile. The results of our literature search provide solid evidence that intake of pistachio nuts may exerts favorable effects on the traditional blood profile, provided that their consumption does not increase the habitual or recommended daily caloric intake. It seems also reasonable to suggest that further studies aimed to investigate the favorable effects of nuts on human diseases should distinguish between one type and the others, since the different nuts exhibit unique dietary composition and may hence produce distinctive biological effects in humans.

The effects of the empowerment education program in older adults with total hip replacement surgery.

PubMed

Huang, Tzu-Ting; Sung, Chia-Chun; Wang, Woan-Shyuan; Wang, Bi-Hwa

2017-08-01

To measure the effectiveness of an education empowerment program on primary (self-efficacy and self-care competence) and secondary outcomes (Activities of Daily Life, mobility, depressive mood and quality of life) for older adults with total hip replacement surgery. Degenerative arthritis is a common and serious chronic illness that impacts the quality of life of older adults. As joints continue to degenerate and the hip damaged by arthritis, activities of daily life will be difficult to perform due to severe hip pain and joint stiffness. Therefore, hip replacement surgery should be considered and effective nursing care should be provided to improve the recovery of older adults. A prospective randomized control trial. A trial was conducted from September 2013 - May 2014 in two hospitals in northern Taiwan. 108 participants were random assigned to either the education empowerment group or in the comparison group. The researchers collected baseline data at admission and outcomes on the day of discharge, one month after and three months after the discharge. After the interventions, the education empowerment group participants demonstrated significantly higher self-care competence and self-efficacy and lower depressive inclinations compared with those in the comparison group. Participants in both groups significantly improved on activities of daily life, mobility and quality of life over the course of the interventions. This education empowerment intervention was very effective in enhancing participants' outcomes. Moreover, involving both older adults and their caregivers for the participation this program is recommended for a greater impact. © 2017 John Wiley & Sons Ltd.

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study.

PubMed

Rahbar, Mohammad H; Fox, Erin E; del Junco, Deborah J; Cotton, Bryan A; Podbielski, Jeanette M; Matijevic, Nena; Cohen, Mitchell J; Schreiber, Martin A; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah J; Reynolds, Robert J; Benjamin-Garner, Ruby; Holcomb, John B

2012-04-01

Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the US. PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1245 patients who received one or more blood transfusions within 6h of Emergency Department (ED) admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study

PubMed Central

Rahbar, Mohammad H.; Fox, Erin E.; del Junco, Deborah J.; Cotton, Bryan A.; Podbielski, Jeanette M.; Matijevic, Nena; Cohen, Mitchell J.; Schreiber, Martin A.; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah; Reynolds, Robert J.; Benjamin-Garner, Ruby; Holcomb, John B.

2011-01-01

Aim Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the U.S. Methods PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Results Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1,245 patients who received one or more blood transfusions within 6 hours of ED admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. Conclusion PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. PMID:22001613

Pulsed Compared to Thermal Radiofrequency to the Medial Calcaneal Nerve for Management of Chronic Refractory Plantar Fasciitis: A Prospective Comparative Study.

PubMed

Osman, Ayman M; El-Hammady, Dina H; Kotb, Mohamed M

2016-01-01

Radiofrequency (RF) treatment is a minimally invasive procedure that has been used for more than 3 decades in treating various chronic pain syndromes. Conventional (continuous) RF treatment occasionally results in worsening or even initiating a new type of pain. The use of pulsed radiofrequency (PRF), which has a non- or minimally neurodestructive neuromodulatory effect, serves as an alternative to conventional RF therapy in many medical situations. To evaluate the effect of applying PRF for 6 minutes vs. thermal radiofrequency (TRF) for 90 seconds to the medial calcaneal nerve for treatment of chronic refractory plantar fasciitis pain. Prospective comparative study. Pain, Orthopedic, and Rheumatology and Rehabilitation Clinics of Assiut University Hospital. Twenty patients with refractory chronic bilateral plantar fasciitis received PRF to the medial calcaneal nerve for 6 minutes for one heel and TRF to the same nerve on the other heel (as their own control) for 90 seconds. Numerical verbal rating scale (NVRS) at waking up from bed and after prolonged walking, and satisfaction score were used for assessment of studied patients at one, 3, 6, 12, and 24 weeks from the intervention. All studied patients showed significant improvement in their pain scale after the intervention that lasted for 24 weeks; however, the PRF heels had significantly better pain scale and satisfaction scores at the first and third weeks assessments when compared to the TRF heels. Effective analgesia was achieved after one week or less after PRF compared to 3 weeks for the TRF (P < 0.001). No randomization. PRF to the medial calcaneal nerve is a safe and effective method for treatment of chronic plantar fasciitis pain. The onset of effective analgesia can be achieved more rapidly with PRF compared to TRF on the same nerve. Further randomized trials are needed to confirm the therapeutic effect and optimizing the dose of RF needed.Key words: Pulsed radiofrequency, thermal radiofrequency, medial calcaneal nerve, plantar fasciitis, plantar aponeurosis, visual analogue scale.