Sino-implant (II) - a levonorgestrel-releasing two-rod implant: systematic review of the randomized controlled trials

PubMed Central

Steiner, Markus J.; Lopez, Laureen M.; Grimes, David A.; Cheng, Linan; Shelton, Jim; Trussell, James; Farley, Timothy M.M.; Dorflinger, Laneta

2013-01-01

Background Sino-implant (II) is a subdermal contraceptive implant manufactured in China. This two-rod levonorgestrel-releasing implant has the same amount of active ingredient (150 mg levonorgestrel) and mechanism of action as the widely available contraceptive implant Jadelle. We examined randomized controlled trials of Sino-implant (II) for effectiveness and side effects. Study design We searched electronic databases for studies of Sino-implant (II), and then restricted our review to randomized controlled trials. The primary outcome of this review was pregnancy. Results Four randomized trials with a total of 15,943 women assigned to Sino-implant (II) had first-year probabilities of pregnancy ranging from 0.0% to 0.1%. Cumulative probabilities of pregnancy during the four years of the product's approved duration of use were 0.9% and 1.06% in the two trials that presented date for four-year use. Five-year cumulative probabilities of pregnancy ranged from 0.7% to 2.1%. In one trial, the cumulative probability of pregnancy more than doubled during the fifth year (from 0.9% to 2.1%), which may be why the implant is approved for four years of use in China. Five-year cumulative probabilities of discontinuation due to menstrual problems ranged from 12.5% to 15.5% for Sino-implant (II). Conclusions Sino-implant (II) is one of the most effective contraceptives available today. These available clinical data, combined with independent laboratory testing, and the knowledge that 7 million women have used this method since 1994, support the safety and effectiveness of Sino-implant (II). The lower cost of Sino-implant (II) compared with other subdermal implants could improve access to implants in resource-constrained settings. PMID:20159174

Results from the Trial Using Motivational Interviewing, Positive Affect, and Self-Affirmation in African Americans with Hypertension (TRIUMPH).

PubMed

Boutin-Foster, Carla; Offidani, Emanuela; Kanna, Balavenkatesh; Ogedegbe, Gbenga; Ravenell, Joseph; Scott, Ebony; Rodriguez, Anna; Ramos, Rosio; Michelen, Walid; Gerber, Linda M; Charlson, Mary

2016-01-21

Our objective was to determine the effectiveness of combining positive affect and self-affirmation strategies with motivational interviewing in achieving blood pressure control among hypertensive African Americans (AA) compared with AA hypertensives in an education-only control group. Randomized trial. Ambulatory practices in the South Bronx and Harlem, New York City. African American adults with uncontrolled hypertension. Participants were randomized to a positive affect and self-affirmation intervention or an education control group. The positive affect and self-affirmation intervention involved having participants think about things that made them happy and that reminded them of their core values on a daily basis. These strategies were reinforced every two months through motivational interviewing. The control arm received a workbook of strategies on blood pressure control. All participants were called every two months for one year. Blood pressure control rate. A total of 238 participants were randomized. The average age was 56 ± 11 years, approximately 70% were female, 80% were not married, and up to 70% had completed high school. There was no difference in control rates between the intervention and the control group. However, at one year, female participants were more likely to be controlled. Participants with high depressive symptoms or high perceived stress at baseline were less likely to be controlled. While this study did not demonstrate an intervention effect, it does provide important insight into the psychosocial factors that may underlie blood pressure control in African Americans. Implications for future behavioral intervention trials are discussed.

Comparative Effectiveness of Sphincter-Sparing Surgery versus Abdominoperineal Resection in Rectal Cancer: Patient-Reported Outcomes in National Surgical Adjuvant Breast and Bowel Project Randomized Trial R-04

PubMed Central

Russell, Marcia M.; Ganz, Patricia A.; Lopa, Samia; Yothers, Greg; Ko, Clifford Y.; Arora, Amit; Atkins, James N.; Bahary, Nathan; Soori, Gamini; Robertson, John M.; Eakle, Janice; Marchello, Benjamin T.; Wozniak, Timothy F.; Beart, Robert W.; Wolmark, Norman

2015-01-01

Objective NSABP R-04 was a randomized controlled trial of neoadjuvant chemoradiotherapy in patients with resectable stage II–III rectal cancer. We hypothesized that patients who underwent abdominoperineal resection (APR) would have a poorer quality of life than those who underwent sphincter-sparing surgery (SSS). Methods To obtain patient-reported outcomes (PROs) we administered two symptom scales at baseline and 1 year postoperatively: the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) and the European Organization for the Research and Treatment of Cancer module for patients with Colorectal Cancer Quality of Life Questionnaire (EORTC QLQ-CR38). Scoring was stratified by non-randomly assigned definitive surgery (APR vs SSS). Analyses controlled for baseline scores and stratification factors: age, gender, stage, intended surgery, and randomly assigned chemoradiotherapy. Results Of 1,608 randomly assigned patients, 987 had data for planned analyses; 62% underwent SSS; 38% underwent APR. FACT-C total and subscale scores were not statistically different by surgery at one year. For the EORTC-QLQ-CR38 functional scales, APR patients reported worse body image (70.3 vs 77.0, P=0.0005) at one year than did SSS patients. Males undergoing APR reported worse sexual enjoyment (43.7 vs 54.7, P=0.02) at one year than did those undergoing SSS. For the EORTC-QLQ-CR38 symptom scale scores, APR patients reported worse micturition symptoms than the SSS group at one year (26.9 vs 21.5, P=0.03). SSS patients reported worse GI tract symptoms than did the APR patients (18.9 vs 15.2, P<0.0001), as well as weight loss (10.1 vs 6.0, P=0.002). Conclusions Symptoms and functional problems were detected at one year by EORTC-QLQ-CR38, reflecting different symptom profiles in patients who underwent APR than those who underwent SSS. Information from these PROs may be useful in counseling patients anticipating surgery for rectal cancer. PMID:24670844

Unity in Diversity: Results of a Randomized Clinical Culturally Tailored Pilot HIV Prevention Intervention Trial in Baltimore, Maryland, for African American Men Who Have Sex with Men

ERIC Educational Resources Information Center

Tobin, Karin; Kuramoto, Satoko J.; German, Danielle; Fields, Errol; Spikes, Pilgrim S.; Patterson, Jocelyn; Latkin, Carl

2013-01-01

Unity in Diversity was a randomized controlled trial of a culturally tailored HIV prevention intervention for African American men who have sex with men. The intervention condition was six group-based sessions and one individual session. The control condition was a single-session HIV prevention review. Participants were aged 18 years or older,…

Omega-3/Omega-6 Fatty Acids for Attention Deficit Hyperactivity Disorder: A Randomized Placebo-Controlled Trial in Children and Adolescents

ERIC Educational Resources Information Center

Johnson, Mats; Ostlund, Sven; Fransson, Gunnar; Kadesjo, Bjorn; Gillberg, Christopher

2009-01-01

Objective: The aim of the study was to assess omega 3/6 fatty acids (eye q) in attention deficit hyperactivity disorder (ADHD). Method: The study included a randomized, 3-month, omega 3/6 placebo-controlled, one-way crossover trial with 75 children and adolescents (8-18 years), followed by 3 months with omega 3/6 for all. Investigator-rated ADHD…

Physical therapy for urinary incontinence in postmenopausal women with osteoporosis or low bone density: a randomized controlled trial.

PubMed

Sran, Meena; Mercier, Joanie; Wilson, Penny; Lieblich, Pat; Dumoulin, Chantale

2016-03-01

To assess the effectiveness of 12 weekly physical therapy sessions for urinary incontinence (UI) compared with a control intervention, for reducing the number of UI episodes measured with the 7-day bladder diary, at 3 months and 1 year postrandomization. A single parallel-group randomized controlled trial was conducted at one outpatient public health center, in postmenopausal women aged 55 years and over with osteoporosis or low bone density and UI. Women were randomized to physical therapy (PT) for UI or osteoporosis education. The primary outcome measure was number of leakage episodes on the 7-day bladder diary, assessed at baseline, after treatment and at 1 year. The secondary outcome measures included the pad test and disease-specific quality of life and self-efficacy questionnaires assessed at the same timepoints. Forty-eight women participated (24 per group). Two participants dropped out of each group and one participant was deceased before 3-month follow-up. Intention-to-treat analysis was undertaken. At 3 months and 1 year, there was a statistically significant difference in the number of leakage episodes on the 7-day bladder diary (3 mo: P = 0.04; 1 y: P = 0.01) in favor of the PT group. The effect size was 0.34 at 1 year. There were no harms reported. After a 12-week course of PT once per week for UI, PT group participants had a 75% reduction in weekly median number of leakage episodes, whereas the control group's condition had no improvement. At 1 year, the PT group participants maintained this improvement, whereas the control group's incontinence worsened.

A randomized controlled trial of laparoscopic Nissen fundoplication versus proton pump inhibitors for the treatment of patients with chronic gastroesophageal reflux disease (GERD): 3-year outcomes.

PubMed

Anvari, Mehran; Allen, Christopher; Marshall, John; Armstrong, David; Goeree, Ron; Ungar, Wendy; Goldsmith, Charles

2011-08-01

A randomized controlled trial (RCT) investigated patients with gastroesophageal reflux disease (GERD) who were stable and symptomatically controlled with long-term medical therapy to compare ongoing optimized medical therapy with laparoscopic Nissen fundoplication (LNF). Of the 180 patients eligible for randomization, 104 gave informed consent, and 3 withdrew from the study immediately after randomization. The patients randomized to medical therapy received optimized treatment with proton pump inhibitors (PPIs) using a standardized management protocol based on best evidence and published guidelines. The surgical patients underwent LNF by one of four surgeons using a previously published technique. The patients underwent symptom evaluation using the GERD symptom scale (GERSS) and the global visual analog scale (VAS) for overall symptom control. They had 24-h esophageal pH monitoring at baseline and after 3 years. The medical patients were evaluated receiving PPI, and the surgical patients were evaluated not receiving PPI. For the 3-year follow-up assessment, 93 patients were available. At 3 years, surgery was associated with more heartburn-free days, showing a mean difference of -1.35 days per week (p = 0.0077) and a lower VAS score (p = 0.0093) than medical management. Surgical patients reported improved quality of life on the general health subscore of the Medical Outcomes Survey Short Form 36 (SF-36) at 3 years, with a mean difference of -12.19 (p = 0.0124). The groups did not differ significantly in terms of GERSS or acid exposure on 24-h esophageal pH monitoring at 3 years. There were six treatment failures (11.8%) in the surgical group and eight treatment failures (16%) in the medical group by 3 years. For patients whose GERD symptoms are stable and controlled with PPI, continuing medical therapy and laparoscopic antireflux surgery are equally effective, although surgery may result in better symptom control and quality of life.

Outcomes from a Randomized Controlled Trial of a Group Intervention for HIV Positive Men and Women Coping with AIDS-Related Loss and Bereavement

ERIC Educational Resources Information Center

Sikkema, Kathleen J.; Hansen, Nathan B.; Kochman, Arlene; Tate, David C.; DiFranceisco, Wayne

2004-01-01

The purpose of this study was to examine the impact of a group coping intervention for HIV-positive men and women who have lost a loved one(s) to AIDS in the past 2 years. Two hundred thirty-five participants, diverse with respect to race/ethnicity and sexual orientation, were randomly assigned to a 12-week cognitive-behavioral group intervention…

Repair of dimethacrylate-based composite restorations by a silorane-based composite: a one-year randomized clinical trial.

PubMed

Popoff, D A V; Santa Rosa, T T A; Ferreira, R C; Magalhães, C S; Moreira, A N; Mjör, I A

2012-01-01

To investigate clinical performance of a low-shrinkage silorane-based composite resin when used for repairing conventional dimethacrylate-based composite restorations. Despite the continued development of resin-based materials, polymerization shrinkage and shrinkage stress still require improvement. A silorane-based monomer system was recently made available for dental restorations. This report refers to the use of this material for making repairs and evaluates the clinical performance of this alternative treatment. One operator repaired the defective dimethacrylate-based composite resin restorations that were randomly assigned to one of two treatment groups: control (n=50) repair with Adper SE Plus (3M/ESPE) and Filtek P60 Posterior Restorative (3M/ESPE), and test (n=50) repair with P90 System Adhesive Self-Etch Primer and Bond (3M/ESPE) and Filtek P90 Low Shrink Posterior Restorative (3M/ESPE). After one week, restorations were finished and polished. Two calibrated examiners (Kw≥0.78) evaluated all repaired restorations, blindly and independently, at baseline and one year. The parameters examined were marginal adaptation, anatomic form, surface roughness, marginal discoloration, postoperative sensitivity, and secondary caries. The restorations were classified as Alpha, Bravo, or Charlie, according to modified US Public Health Service criteria. Mann-Whitney and Wilcoxon tests were used to compare the groups. Of the 100 restorations repaired in this study, 93 were reexamined at baseline. Dropout from baseline to one-year recall was 11%. No statistically significant differences were found between the materials for all clinical criteria, at baseline or at one-year recall (p>0.05). No statistically significant differences were registered (p>0.05) for each material when compared for all clinical criteria at baseline and at one-year recall. The hypothesis tested in this randomized controlled clinical trial was accepted. After the one-year evaluations, the silorane-based composite exhibited a similar performance compared with dimethacrylate-based composite when used to make repairs.

A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial.

PubMed

Kuhlmann, Sophie Merle; Bürger, Arne; Esser, Günter; Hammerle, Florian

2015-02-08

Medical training is very demanding and associated with a high prevalence of psychological distress. Compared to the general population, medical students are at a greater risk of developing a psychological disorder. Various attempts of stress management training in medical school have achieved positive results on minimizing psychological distress; however, there are often limitations. Therefore, the use of a rigorous scientific method is needed. The present study protocol describes a randomized controlled trial to examine the effectiveness of a specifically developed mindfulness-based stress prevention training for medical students that includes selected elements of cognitive behavioral strategies (MediMind). This study protocol presents a prospective randomized controlled trial, involving four assessment time points: baseline, post-intervention, one-year follow-up and five-year follow-up. The aims include evaluating the effect on stress, coping, psychological morbidity and personality traits with validated measures. Participants are allocated randomly to one of three conditions: MediMind, Autogenic Training or control group. Eligible participants are medical or dental students in the second or eighth semester of a German university. They form a population of approximately 420 students in each academic term. A final total sample size of 126 (at five-year follow-up) is targeted. The trainings (MediMind and Autogenic Training) comprise five weekly sessions lasting 90 minutes each. MediMind will be offered to participants of the control group once the five-year follow-up is completed. The allotment is randomized with a stratified allocation ratio by course of studies, semester, and gender. After descriptive statistics have been evaluated, inferential statistical analysis will be carried out with a repeated measures ANOVA-design with interactions between time and group. Effect sizes will be calculated using partial η-square values. Potential limitations of this study are voluntary participation and the risk of attrition, especially concerning participants that are allocated to the control group. Strengths are the study design, namely random allocation, follow-up assessment, the use of control groups and inclusion of participants at different stages of medical training with the possibility of differential analysis. This trial is recorded at German Clinical Trials Register under the number DRKS00005354 (08 November 2013).

Fluoride toothpastes for preventing dental caries in children and adolescents.

PubMed

Marinho, V C; Higgins, J P; Sheiham, A; Logan, S

2003-01-01

Fluoride toothpastes have been widely used for over three decades and remain a benchmark intervention for the prevention of dental caries. To determine the effectiveness and safety of fluoride toothpastes in the prevention of caries in children and to examine factors potentially modifying their effect. We searched the Cochrane Oral Health Group's Trials Register (May 2000), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2000), MEDLINE (1966 to January 2000), plus several other databases. We handsearched journals, reference lists of articles and contacted selected authors and manufacturers. Randomized or quasi-randomized controlled trials with blind outcome assessment, comparing fluoride toothpaste with placebo in children up to 16 years during at least one year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (D(M)FS). Inclusion decisions, quality assessment and data extraction were duplicated in a random sample of one third of studies, and consensus achieved by discussion or a third party. Authors were contacted for missing data. The primary measure of effect was the prevented fraction (PF) that is the difference in caries increments between the treatment and control groups expressed as a percentage of the increment in the control group. Random effects meta-analyses were performed where data could be pooled. Potential sources of heterogeneity were examined in random effects meta-regression analyses. Seventy-four studies were included. For the 70 that contributed data for meta-analysis (involving 42,300 children) the D(M)FS pooled PF was 24% (95% confidence interval (CI), 21 to 28%; p<0.0001). This means that 1.6 children need to brush with a fluoride toothpaste (rather than a non-fluoride toothpaste) over three years to prevent one D(M)FS in populations with caries increment of 2.6 D(M)FS per year. In populations with caries increment of 1.1 D(M)FS per year, 3.7 children will need to use a fluoride toothpaste for three years to avoid one D(M)FS. There was clear heterogeneity, confirmed statistically (p<0.0001). The effect of fluoride toothpaste increased with higher baseline levels of D(M)FS, higher fluoride concentration, higher frequency of use, and supervised brushing, but was not influenced by exposure to water fluoridation. There is little information concerning the deciduous dentition or adverse effects (fluorosis). Supported by more than half a century of research, the benefits of fluoride toothpastes are firmly established. Taken together, the trials are of relatively high quality, and provide clear evidence that fluoride toothpastes are efficacious in preventing caries.

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.

Immediate versus early non-occlusal loading of dental implants placed flapless in partially edentulous patients: a 3-year randomized clinical trial.

PubMed

Merli, Mauro; Moscatelli, Marco; Mariotti, Giorgia; Piemontese, Matteo; Nieri, Michele

2012-02-01

To compare immediate versus early non-occlusal loading of dental implants placed flapless in a 3-year, parallel group, randomized clinical trial. The study was conducted in a private dental clinic between July 2005 and July 2010. Patients 18 years or older were randomized to receive implants for fixed partial dentures in cases of partial edentulism. The test group was represented by immediate non-occlusal implant loading, whereas the control group was represented by early non-occlusal implant loading. The outcome variables were implant failure, complications and radiographic bone level at implant sites 3 years after loading, measured from the implant-abutment junction to the most coronal point of bone-to-implant contact. Randomization was computer-generated with allocation concealment by opaque sequentially numbered sealed envelopes, and the measurer was blinded to group assignment. Sixty patients were randomized: 30 to the immediately loaded group and 30 to the early loaded group. Four patients dropped out; however, the data of all patients were included in the analysis. No implant failure occurred. Two complications occurred in the control group and one in the test group. The mean bone level at 3 years was 1.91 mm for test group and 1.59 mm for control group. The adjusted difference in bone level was 0.26 mm (CI 95% -0.08 to 0.59, p = 0.1232). The null hypothesis of no difference in failure rates, complications and bone level between implants that were loaded immediately or early at 3 years cannot be rejected in this randomized clinical trial. © 2011 John Wiley & Sons A/S.

Low-fat dietary pattern intervention and health-related quality of life: The WHI randomized controlled Dietary Modification trial

PubMed Central

Assaf, Annlouise R.; Beresford, Shirley A.A.; Risica, Patricia Markham; Aragaki, Aaron; Brunner, Robert L.; Bowen, Deborah J.; Naughton, Michelle; Rosal, Milagros C.; Snetselaar, Linda; Wenger, Nanette

2015-01-01

Background Intensive dietary intervention programs may lead to benefits in vitality and other components of health quality. The Women’s Health Initiative (WHI) Dietary Modification (DM) intervention includes a large randomized controlled trial of an intensive intervention. Objective To evaluate whether the intervention is associated with improved health-related quality of life (HRQoL) subscales, overall self-reported health, depressive symptoms, cognitive functioning, and sleep quality. Design Randomized controlled trial was analyzed as intent to treat. Participants Between 1993 and 1998, 48,835 women aged 50 to 79 years were recruited by 40 clinical centers across the United States. Eligibility included having fat intake at baseline ≥32% of total calories, and excluded women with any prior colorectal or breast cancer, recent other cancers, type-1 diabetes, medical conditions with predicted survival less than three years. Intervention Goals were to reduce calories from fat to 20%, increase vegetables and fruit to 5+ servings and increase grain servings to 6+ servings a day. During the first year, 18 group sessions were held, with quarterly sessions thereafter. Main Outcome Measures RAND 36-Item Health Survey was used to assess HRQoL at baseline, year 1, and close-out (about 8 years post randomization), and estimate differential HRQoL subscale change scores. Statistical analysis performed Mean change in HRQoL scores (year 1 minus baseline) were compared by randomization group using linear models. Results At one year, there was a differential change between intervention and comparison group of 1.7 units (1.5, 2.0) in general health associated with the intervention. DM intervention improved physical functioning by 2.0 units (1.7, 2.3), vitality by 1.9 units (1.6, 2.2), and global QOL by 0.09 units (0.07, 0.12). With the exception of global QOL, these effects were significantly modified by BMI at baseline. Conclusions DM intervention was associated with small, but significant improvements in three health related quality of life subscales: general health, physical functioning, and vitality at one year follow-up, with the largest improvements seen in the women with the greatest baseline BMI. PMID:26384466

The Danish Cardiovascular Screening Trial (DANCAVAS): study protocol for a randomized controlled trial.

PubMed

Diederichsen, Axel Cosmus Pyndt; Rasmussen, Lars Melholt; Søgaard, Rikke; Lambrechtsen, Jess; Steffensen, Flemming Hald; Frost, Lars; Egstrup, Kenneth; Urbonaviciene, Grazina; Busk, Martin; Olsen, Michael Hecht; Mickley, Hans; Hallas, Jesper; Lindholt, Jes Sanddal

2015-12-05

The significant increase in the average life expectancy has increased the societal challenge of managing serious age-related diseases, especially cancer and cardiovascular diseases. A routine check by a general practitioner is not sufficient to detect incipient cardiovascular disease. Population-based randomized clinically controlled screening trial. 45,000 Danish men aged 65-74 years living on the Island of Funen, or in the surrounding communities of Vejle and Silkeborg. No exclusion criteria are used. One-third will be invited to cardiovascular seven-faceted screening examinations at one of four locations. The screening will include: (1) low-dose non-contrast CT scan to detect coronary artery calcification and aortic/iliac aneurysms, (2) brachial and ankle blood pressure index to detect peripheral arterial disease and hypertension, (3) a telemetric assessment of the heart rhythm, and (4) a measurement of the cholesterol and plasma glucose levels. Up-to-date cardiovascular preventive treatment is recommended in case of positive findings. To investigate whether advanced cardiovascular screening will prevent death and cardiovascular events, and whether the possible health benefits are cost effective. Registry-based follow-up on all cause death (primary outcome), and costs after 3, 5 and 10 years (secondary outcome). Each of the 45,000 individuals is, by EPIDATA, given a random number from 1-100. Those numbered 67+ will be offered screening; the others will act as a control group. Only those randomized to the screening will be invited to the examination;the remaining participants will not. Numbers randomized: A total of 45,000 men will be randomized 1:2. Recruitment: Enrollment started October 2014. A 5% reduction in overall mortality (HR=0.95), with the risk for a type 1 error=5% and the risk for a type II error=80%, is expected. We expect a 2-year enrollment, a 10-year follow-up, and a median survival of 15 years among the controls. The attendance to screening is assumed to be 70%. The primary aim of this so far stand-alone population-based, randomized trial will be to evaluate the health benefits and costeffectiveness of using non-contrast full truncus computer tomography (CT) scans (to measure coronary artery calcification (CAC) and identify aortic/iliac aneurysms) and measurements of the ankle brachial blood pressure index (ABI) as part of a multifocal screening and intervention program for CVD in men aged 65-74. Attendance rate and compliance to initiated preventive actions must be expected to become of major importance. Current Controlled Trials: ISRCTN12157806 (21 March 2015).

Does Oral Implant Design Affect Marginal Bone Loss? Results of a Parallel-Group Randomized Controlled Equivalence Trial

PubMed Central

Bateli, Maria; Ben Rahal, Ghada; Christmann, Marin; Vach, Kirstin; Kohal, Ralf-Joachim

2018-01-01

Objective To test whether or not the modified design of the test implant (intended to increase primary stability) has an equivalent effect on MBL compared to the control. Methods Forty patients were randomly assigned to receive test or control implants to be installed in identically dimensioned bony beds. Implants were radiographically monitored at installation, at prosthetic delivery, and after one year. Treatments were considered equivalent if the 90% confidence interval (CI) for the mean difference (MD) in MBL was in between −0.25 and 0.25 mm. Additionally, several soft tissue parameters and patient-reported outcome measures (PROMs) were evaluated. Linear mixed models were fitted for each patient to assess time effects on response variables. Results Thirty-three patients (21 males, 12 females; 58.2 ± 15.2 years old) with 81 implants (47 test, 34 control) were available for analysis after a mean observation period of 13.9 ± 4.5 months (3 dropouts, 3 missed appointments, and 1 missing file). The adjusted MD in MBL after one year was −0.13 mm (90% CI: −0.46–0.19; test group: −0.49; control group: −0.36; p = 0.507). Conclusion Both implant systems can be considered successful after one year of observation. Concerning MBL in the presented setup, equivalence of the treatments cannot be concluded. Registration This trial is registered with the German Clinical Trials Register (ID: DRKS00007877). PMID:29610765

Effects of nanotechnologies-based devices on postural control in healthy subjects.

PubMed

Malchiodi Albedi, Giovanna; Corna, Stefano; Aspesi, Valentina; Clerici, Daniela; Parisio, Cinzia; Seitanidis, Jonathan; Cau, Nicola; Brugliera, Luigia; Capodaglio, Paolo

2017-09-05

The aim of the present preliminary randomized controlled study was to ascertain whether the use of newly developed nanotechnologies-based patches can influence posture control of healthy subjects. Thirty healthy female subjects (age 39.4 years, BMI 22.74 kg/m2) were randomly assigned to two groups: one with active patches and a control group with sham patches. Two patches were applied with a tape: one on the subject's sternum and the other on the C7 apophysis. Body sway during quiet upright stance was recorded with a dynamometric platform. Each subject was tested under two visual conditions, eyes open and closed. We used a blocked stratified randomization procedure conducted by a third party. Subjects wearing the sham patches showed a significant increase of the centre of pressure sway area after 4 hours when they performed the habitual moderate-intensity work activities. In the active patch group, a decrease of the sway path was evident, providing evidence of an enhanced balance control. Our preliminary findings on healthy subjects indicate that nanotechnological devices generating ultra-low electromagnetic fields can improve posture control.

Efficacy of early controlled motion of the ankle compared with no motion after non-operative treatment of an acute Achilles tendon rupture: study protocol for a randomized controlled trial.

PubMed

Barfod, Kristoffer Weisskirchner; Hansen, Maria Swennergren; Holmich, Per; Troelsen, Anders; Kristensen, Morten Tange

2016-11-29

Early controlled ankle motion is widely used in the non-operative treatment of acute Achilles tendon rupture, though its safety and efficacy have never been investigated in a randomized setup. The objectives of this study are to investigate if early controlled motion of the ankle affects functional and patient-reported outcomes. The study is performed as a blinded, randomized, controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients aged from 18 to 70 years are eligible for inclusion. The intervention group performs early controlled motion of the ankle in weeks 3-8 after rupture. The control group is immobilized. In total, 130 patients will be included from one big orthopedic center over a period of 2½ years. The primary outcome is the patient-reported Achilles tendon Total Rupture Score evaluated at 12 months post-injury. Secondary outcome measures are the heel-rise work test, Achilles tendon elongation, and the rate of re-rupture. The primary analysis will be conducted as intention-to-treat analyses. This trial is the first to investigate the safety and efficacy of early controlled motion in the treatment of acute Achilles tendon rupture in a randomized setup. The study uses the patient-reported outcome measure, the Achilles tendon Total Rupture Score, as the primary endpoint, as it is believed to be the best surrogate measure for the tendon's actual capability to function in everyday life. ClinicalTrials.gov: NCT02015364 . Registered on 13 December 2013.

Randomized Controlled Trial of BASICS for Heavy Drinking Mandated and Volunteer Undergraduates: 12-Month Outcomes

PubMed Central

Terlecki, Meredith A.; Buckner, Julia D.; Larimer, Mary E.; Copeland, Amy L.

2014-01-01

This is the first randomized trial testing whether heavy drinking undergraduates mandated to the Brief Alcohol Screening and Intervention for College Students (BASICS) program following a campus alcohol violation would benefit as much as heavy drinking volunteers up to one year post-intervention using control groups with high-risk drinkers to model disciplinary-related and naturalistic changes in drinking. Participants (61% male; 51% mandated; 84% Caucasian; Mage = 20.14 years) were screened for heavy drinking and randomized to BASICS (n = 115) or assessment-only control (n = 110). Outcome measures (drinking, alcohol problems) were collected at baseline, 4 weeks, 3, 6, and 12 months post-intervention. At 4 weeks post-intervention, intent-to-treat multilevel longitudinal models showed that regardless of referral group (mandated or volunteer) BASICS significantly decreased weekly drinking, typical drinks, and peak drinks relative to controls (ds = .41-.92). BASICS had a large effect on decreases in alcohol problems (d = .87). At 12 months post-intervention, BASICS participants (regardless of referral group) reported significantly fewer alcohol problems (d = .56) compared to controls. Significant long-term intervention gains for peak and typical drinks were sustained in both referral groups relative to controls (ds = .42; .11). Referral group had no significant main effect and did not interact with intervention condition to predict outcomes. Given that BASICS was associated with less drinking and fewer alcohol problems (even among heavier drinking mandated students up to one year post-intervention), provision of BASICS-style programs within disciplinary settings may help reduce heavy and problematic drinking among at-risk students. PMID:25844834

Mobile diabetes intervention study: testing a personalized treatment/behavioral communication intervention for blood glucose control.

PubMed

Quinn, Charlene C; Gruber-Baldini, Ann L; Shardell, Michelle; Weed, Kelly; Clough, Suzanne S; Peeples, Malinda; Terrin, Michael; Bronich-Hall, Lauren; Barr, Erik; Lender, Dan

2009-07-01

National data find glycemic control is within target (A1c<7.0%) for 37% of patients with diabetes, and only 7% meet recommended glycemic, lipid, and blood pressure goals. To compare active interventions and usual care for glucose control in a randomized clinical trial (RCT) among persons with diabetes cared for by primary care physicians (PCPs) over the course of 1 year. Physician practices (n=36) in 4 geographic areas are randomly assigned to 1 of 4 study groups. The intervention is a diabetes communication system, using mobile phones and patient/physician portals to allow patient-specific treatment and communication. All physicians receive American Diabetes Association (ADA) Guidelines for diabetes care. Patients with poor diabetes control (A1c> or =7.5%) at baseline (n=260) are enrolled in study groups based on PCP randomization. All study patients receive blood glucose (BG) meters and a year's supply of testing materials. Patients in three treatment groups select one of two mobile phone models, receive one-year unlimited mobile phone data and service plan, register on the web-based individual patient portal and receive study treatment phone software based on study assignment. Control group patients receive usual care from their PCP. The primary outcome is mean change in A1c over a 12-month intervention period. Traditional methods of disease management have not achieved adequate control for BG and other conditions important to persons with diabetes. Tools to improve communication between patients and PCPs may improve patient outcomes and be satisfactory to patients and physicians. This RCT is ongoing.

MiDAS ENCORE: Randomized Controlled Study Design and Protocol.

PubMed

Benyamin, Ramsin M; Staats, Peter S

2015-01-01

Epidural steroid injections (ESIs) are commonly used for treatment of symptomatic lumbar spinal stenosis (LSS). ESIs are generally administered after failure of conservative therapy. For LSS patients suffering from neurogenic claudication, the mild® procedure provides an alternative to ESIs via minimally invasive lumbar decompression. Both ESIs and mild offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. Prospective, multi-center, randomized controlled, clinical study. Twenty-six interventional pain management centers throughout the United States. To compare patient outcomes following treatment with either mild or ESIs in LSS patients with neurogenic claudication and having verified ligamentum flavum hypertrophy. Study participants include Medicare beneficiaries who meet study inclusion/exclusion criteria. Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment arms, mild (treatment group) or ESI (control group). Each study group will include approximately 150 patients who have experienced neurogenic claudication symptoms for ≥ 3 months duration who have failed to respond to physical therapy, home exercise programs, and oral analgesics. Those randomized to mild are prohibited from receiving lumbar ESIs during the study period, while those randomized to ESI may receive ESIs up to 4 times per year. Patient assessments will occur at baseline, 6 months, and one year. An additional assessment will be conducted for the mild patient group at 2 years. The primary efficacy outcome measure is the proportion of Oswestry Disability Index (ODI) responders from baseline to one year follow-up in the treatment group (mild) versus the control group (ESI). ODI responders are defined as those patients achieving the validated Minimal Important Change (MIC) of ≥ 10 point improvement in ODI from baseline to follow-up as a clinically significant efficacy threshold. Secondary efficacy outcome measures include the proportion of Zurich Claudication Questionnaire (ZCQ) and Numeric Pain Rating Scale (NPRS) responders from baseline to follow-up using validated MIC thresholds. Improvement in ZCQ domains of ≥ 0.5 is considered significant, and a Patient Satisfaction score of at least 2.5 represents a satisfied patient. A reduction of ≥ 2 points in NPRS is considered significant pain relief. The primary safety outcome measure is the incidence of device- and/or procedure-related adverse events. Descriptive summaries will be presented by randomized group for all outcome measures at baseline and follow-up time points. Inferential statistical analysis will be conducted to determine significant differences related to functional improvement, pain relief, and safety outcomes. Primary study results will be presented based on one-year follow-up data, with an interim analysis report when 6-month follow-up data become available. Patients are not blinded due to significant differences in treatment protocols between study groups. Also, since neither study arm is focused on treatment of radicular pain, there may be a higher non-responder rate for both groups versus standard of care due to study restrictions on adjunctive pain therapies. This prospective, multi-center, randomized controlled study will provide Level I evidence of the safety and effectiveness of mild versus ESIs in managing neurogenic claudication symptoms in LSS patients.

Improving early relationships: a randomized, controlled trial of an age-paced parenting newsletter.

PubMed

Waterston, Tony; Welsh, Brenda; Keane, Brigid; Cook, Margaret; Hammal, Donna; Parker, Louise; McConachie, Helen

2009-01-01

Parenting is recognized as a key mediator in both health and educational outcomes. Much is known on the value of support and group work in benefiting parenting, but little is known on the effect of written information. A randomized, controlled trial was conducted to evaluate the effect of a parenting newsletter, sent monthly to the parents' home from birth to 1 year, on maternal well-being and parenting style. We tested the hypothesis that mothers receiving the newsletter would show less stress and better parenting characteristics than controls. Parents of first infants born in a North East England District General Hospital between February and October 2003 who consented to take part in the study were randomly allocated to either the intervention or control arm. Those in the intervention arm were sent 12 monthly issues of an age-paced parenting newsletter containing information on emotional development, parent-child interaction, and play. Both the intervention and control group received normal parenting support. Mothers in both groups completed the Well-being Index, Parenting Daily Hassles Scale, and the Adult-Adolescent Parenting Inventory at birth and at 1 year. One hundred eighty-five mothers were recruited, with 94 randomly assigned to the intervention group, and 91 controls. Allowing for differences at recruitment, there were significant differences between the groups at 1 year: the intervention mothers had lower frequency and intensity of perceived hassles and fewer inappropriate expectations of the infant on the Adult-Adolescent Parenting Inventory than the control mothers. A monthly parenting newsletter sent directly to the home in the first year of life seems to help parents to understand their infant better and feel less hassled. This intervention is low cost and can be applied to all parents, so it is nonstigmatizing.

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

PubMed

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

2012-07-01

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

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

PubMed Central

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

2009-01-01

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

One-year outcomes of a randomized controlled trial of housing first with ACT in five Canadian cities.

PubMed

Aubry, Tim; Tsemberis, Sam; Adair, Carol E; Veldhuizen, Scott; Streiner, David; Latimer, Eric; Sareen, Jitender; Patterson, Michelle; McGarvey, Kathleen; Kopp, Brianna; Hume, Catharine; Goering, Paula

2015-05-01

Housing First is a groundbreaking approach to ending chronic homelessness among people with mental illness. This article presents one-year findings from a multisite randomized controlled trial (RCT) comparing Housing First with treatment as usual. The study was a nonblind, parallel-group RCT conducted in five Canadian cities. A sample of 950 high-need participants with severe mental illness, who were either absolutely homeless or precariously housed, was randomly assigned to Housing First (N=469) or treatment as usual (N=481). Housing First participants received a rent supplement, assistance to find housing, and assertive community treatment. Treatment-as-usual participants had access to all other existing programs. At one-year follow-up, 73% of Housing First participants and 31% of treatment-as-usual participants resided in stable housing (p<.001, odds ratio=6.35, covariate adjusted difference=42%, 95% confidence interval [CI]=36%-48%). Improvement in overall quality of life was significantly greater among Housing First participants compared with treatment-as-usual participants (p<.001, d=.31, CI=.16-.46). Housing First participants also showed greater improvements in community functioning compared with treatment-as-usual participants (p=.003, d=.25, CI=.09-.41). Compared with treatment as usual, Housing First produced greater improvements in housing stability, quality of life, and community functioning after one year of enrollment. The study provides support for adopting Housing First as an approach for ending chronic homelessness among persons with severe mental illness, even if they are actively symptomatic or using substances.

A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial.

PubMed

Wang, Yanan; Liu, Ruoyan; Zhang, Ze; Xue, Qi; Yan, Jun; Yu, Jiang; Liu, Hao; Zhao, Liying; Mou, Tingyu; Deng, Haijun; Li, Guoxin

2015-11-30

Single-incision laparoscopic surgery (SILS) is an emerging minimally invasive surgery to reduce abdominal incisions. However, despite the increasing clinical application of SILS, no evidence from large-scale, randomized controlled trials is available for assessing the feasibility, short-term safety, oncological safety, and potential benefits of SILS compared with conventional laparoscopic surgery (CLS) for colorectal cancer. This is a single-center, open-label, noninferiority, randomized controlled trial. A total of 198 eligible patients will be randomly assigned to transumbilical single incision plus one port laparoscopic surgery (SILS plus one) group or to a CLS group at a 1:1 ratio. Patients ranging in age from 18 to 80 years with rectosigmoid cancer diagnosed as cT1-4aN0-2 M0 and a tumor size no larger than 5 cm are considered eligible. The primary endpoint is early morbidity, as evaluated by an independent investigator. Secondary outcomes include operative outcomes (operative time, estimated blood loss, and incision length), pathologic outcomes (tumor size, length of proximal and distal resection margins, and number of harvested lymph nodes), postoperative inflammatory and immune responses (white blood cells [WBC], neutrophil percentage [NE %], C-reactive protein [CRP], interleukin-6 [IL-6], and tumor necrosis factor-α [TNF-α]), postoperative recovery (time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay), pain intensity, body image and cosmetic assessment, 3-year disease free survival (DFS), and 5-year overall survival (OS). Follow-up visits are scheduled for 1 and 3 months after surgery, then every 3 months for the first 2 years and every 6 months for the next 3 years. This trial will provide valuable clinical evidence for the objective assessment of the feasibility, safety, and potential benefits of SILS plus one compared with CLS for the radical resection of rectosigmoid cancer. The hypothesis is that SILS plus one is feasible for the radical resection of rectosigmoid cancer and offers short-term safety and long-term oncological safety comparable to that of CLS, and that SILS plus one offers better cosmetic results and faster convalescence compared to CLS. ClinicalTrials.gov: NCT02117557 (registered on 16 April 2014).

Hormone replacement therapy in women with epilepsy: a randomized, double-blind, placebo-controlled study.

PubMed

Harden, Cynthia L; Herzog, Andrew G; Nikolov, Blagovest G; Koppel, Barbara S; Christos, Paul J; Fowler, Kristen; Labar, Douglas R; Hauser, W Allen

2006-09-01

Previous reports have suggested that hormone replacement therapy (HRT) could increase seizure activity in women with epilepsy. We sought to determine whether adding HRT to the medication regimen of postmenopausal women with epilepsy was associated with an increase in seizure frequency. This was a randomized, double-blind, placebo-controlled trial of the effect of HRT on seizure frequency in postmenopausal women with epilepsy, taking stable doses of antiepileptic drugs (AEDs), and within 10 years of their last menses. After a 3-month prospective baseline, subjects were randomized to placebo, Prempro (0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate or CEE/MPA) daily, or double-dose CEE/MPA daily for a 3-month treatment period. Twenty-one subjects were randomized after completing baseline. The subjects' ages ranged from 45 to 62 years (mean, 53 years; SD, +/-5), and the number of AEDs used ranged from none to three (median, one). Five (71%) of seven subjects taking double-dose CEE/MPA had a worsening seizure frequency of at least one seizure type, compared with four (50%) of eight taking single-dose CEE/MPA and one (17%) of six taking placebo (p = 0.05). An increase in seizure frequency of the subject's most severe seizure type was associated with increasing CEE/MPA dose (p = 0.008). An increase in complex partial seizure frequency also was associated with increasing CEE/MPA dose (p = 0.05). Two subjects taking lamotrigine had a decrease in lamotrigine levels of 25-30% while taking CEE/MPA. CEE/MPA is associated with a dose-related increase in seizure frequency in postmenopausal women with epilepsy. CEE/MPA may decrease lamotrigine levels.

The Relative Effects and Equity of Inquiry-Based and Commonplace Science Teaching on Students' Knowledge, Reasoning, and Argumentation

ERIC Educational Resources Information Center

Wilson, Christopher D.; Taylor, Joseph A.; Kowalski, Susan M.; Carlson, Janet

2010-01-01

We conducted a laboratory-based randomized control study to examine the effectiveness of inquiry-based instruction. We also disaggregated the data by student demographic variables to examine if inquiry can provide equitable opportunities to learn. Fifty-eight students aged 14-16 years old were randomly assigned to one of two groups. Both groups of…

Decreasing Divorce in Army Couples: Results from a Randomized Controlled Trial using PREP for Strong Bonds

PubMed Central

Stanley, Scott M.; Allen, Elizabeth S.; Markman, Howard J.; Rhoades, Galena K.; Prentice, Donnella L.

2010-01-01

Findings from a large, randomized controlled trial of couple education are presented in this brief report. Married Army couples were assigned to either PREP for Strong Bonds (n = 248) delivered by Army chaplains or to a no-treatment control group (n = 228). One year after the intervention, couples who received PREP for Strong Bonds had 1/3 the rate of divorce of the control group. Specifically, 6.20% of the control group divorced while 2.03% of the intervention group divorced. These findings suggest that couple education can reduce the risk of divorce, at least in the short run with military couples. PMID:20634994

Do Health Reforms to Improve Quality Have Long-Term Effects? Results of a Follow-Up on a Randomized Policy Experiment in the Philippines.

PubMed

Quimbo, Stella; Wagner, Natascha; Florentino, Jhiedon; Solon, Orville; Peabody, John

2016-02-01

We tracked doctors who had previously participated in a randomized policy experiment in the Philippines. The original experiment involved 30 district hospitals divided equally into one control site and two intervention sites that increased insurance payments (full insurance support for children under 5 years old) or made bonus payments to hospital staff. During the 3 years of the intervention, quality-as measured by clinical performance and value vignettes-improved and was sustained in both intervention sites compared with controls. Five years after the interventions were discontinued, we remeasured the quality of care of the doctors. We found that the intervention sites continued to have significantly higher quality compared with the control sites. The previously documented quality improvement in intervention sites appears to be sustained; moreover, it was subject to a very low (less than 1% per year) rate of decay in quality scores. Copyright © 2015 John Wiley & Sons, Ltd.

Randomized clinical study of wear of enamel antagonists against polished monolithic zirconia crowns

PubMed Central

Esquivel-Upshaw, J.F.; Kim, M.J.; Hsu, S.M.; Abdulhameed, N.; Jenkins, R.; Neal, D.; Ren, F.; Clark, A.E.

2018-01-01

Objectives To test the hypothesis that there is no difference in the in vivo maximum wear of enamel opposing monolithic zirconia crowns, enamel opposing porcelain fused to metal crowns and enamel opposing enamel. Methods Thirty patients needing single crowns were randomized to receive either a monolithic zirconia or metal-ceramic crown. Two non-restored opposing teeth in the same quadrants were identified to serve as enamel controls. After cementation, quadrants were scanned for baseline data. Polyvinylsiloxane impressions were obtained and poured in white stone. Patients were recalled at six-months and one-year for re-impression. Stone models were scanned using a tabletop laserscanner to determine maximum wear. Statistical analysis was performed using Mann-Whitney U to determine any significant differences between the wear of enamel against zirconia and metal-ceramic crowns. Results Sixteen zirconia and 14 metal-ceramic crowns were delivered. There were no statistical differences in mean wear of crown types (p = 0.165); enamel antagonists (p = 0.235) and enamel controls (p = 0.843) after one year. Conclusion Monolithic zirconia exhibited comparable wear of enamel compared with metal-ceramic crowns and control enamel after one year. Significance This study is clinically significant because the use of polished monolithic zirconia demonstrated comparable wear of opposing enamel to metal-ceramic and enamel antagonists. PMID:29042241

Evaluation of a fall-prevention program in older people after femoral neck fracture: a one-year follow-up.

PubMed

Berggren, M; Stenvall, M; Olofsson, B; Gustafson, Y

2008-06-01

A randomized, controlled fall-prevention study including 199 patients operated on for femoral neck fracture reduced inpatient falls and injuries. No statistically significant effects of the intervention program could be detected after discharge. It seems that fall-prevention must be part of everyday life in fall-prone old people. This study evaluates whether a postoperative multidisciplinary, multifactorial fall-prevention program performed by a geriatric team that reduced inpatient falls and injuries had any continuing effect after discharge. The intervention consisted of staff education, systematic assessment and treatment of fall risk factors and vitamin D and calcium supplementation. The randomized, controlled trial with a one-year follow-up at Umeå University Hospital, Sweden, included 199 patients operated on for femoral neck fracture, aged > or = 70 years. After one year 44 participants had fallen 138 times in the intervention group compared with 55 participants and 191 falls in the control group. The crude postoperative fall incidence was 4.16/1,000 days in the intervention group vs. 6.43/1,000 days in the control group. The incidence rate ratio was 0.64 (95% CI: 0.40-1.02, p = 0.063). Seven new fractures occurred in the intervention group and 11 in the control group. A team applying comprehensive geriatric assessment and rehabilitation, including prevention and treatment of fall-risk factors, reduced inpatient falls and injuries, but no statistically significant effects of the program could be detected after discharge. It seems that fall-prevention must be part of everyday life in fall-prone elderly.

A Single Session of Mirror-based Tactile and Motor Training Improves Tactile Dysfunction in Children with Unilateral Cerebral Palsy: A Replicated Randomized Controlled Case Series.

PubMed

Auld, Megan L; Johnston, Leanne M; Russo, Remo N; Moseley, G Lorimer

2017-10-01

This replicated randomized controlled crossover case series investigated the effect of mirror-based tactile and motor training on tactile registration and perception in children with unilateral cerebral palsy (UCP). Six children with UCP (6-18 years; median 10 years, five male, three-left hemiplegia, four-manual ability classification system (MACS) I, one MACS II and one MACS III) participated. They attended two 90-minute sessions - one of mirror-based training and one of standard practice, bimanual therapy - in alternated order. Tactile registration (Semmes Weinstein Monofilaments) and perception (double simultaneous or single-point localization) were assessed before and after each session. Change was estimated using reliable change index (RCI). Tactile perception improved in four participants (RCI > 1.75), with mirror-based training, but was unchanged with bimanual therapy (RCI < 1.0 for all participants). Neither intervention affected tactile registration. Mirror-based training demonstrates potential to improve tactile perception in children with UCP. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Impacts of Social-Emotional Curricula on Three-Year-Olds: Exploratory Findings from the Head Start CARES Demonstration. Research Snapshot. OPRE Report 2014-78

ERIC Educational Resources Information Center

Hsueh, JoAnn; Lowenstein, Amy E.; Morris, Pamela; Mattera, Shira K.; Bangser, Michael

2014-01-01

This report presents exploratory impact findings for 3-year-olds from the Head Start CARES demonstration, a large-scale randomized controlled trial implemented in Head Start centers for one academic year across the country. The study was designed primarily to test the effects of the enhancements on 4-year-olds, but it also provides an opportunity…

The Friendly Schools Friendly Families Programme: Three-Year Bullying Behaviour Outcomes in Primary School Children

ERIC Educational Resources Information Center

Cross, Donna; Waters, Stacey; Pearce, Natasha; Shaw, Therese; Hall, Margaret; Erceg, Erin; Burns, Sharyn; Roberts, Clare; Hamilton, Greg

2012-01-01

Purpose: This three-year group randomized controlled trial assessed whether a multi-age, multi-level bullying prevention and intervention with staff capacity building, can reduce bullying among primary school children. Methods: This study comprised two intervention and one comparison conditions. Student self-report data were collected from 2552…

Smoking Prevention for Students: Findings From a Three-Year Program of Integrated Harm Minimization School Drug Education.

PubMed

Midford, Richard; Cahill, Helen; Lester, Leanne; Foxcroft, David R; Ramsden, Robyn; Venning, Lynne

2016-01-01

This study investigated the impact of the Drug Education in Victorian Schools (DEVS) program on tobacco smoking. The program taught about licit and illicit drugs in an integrated manner over 2 years, with follow up in the third year. It focused on minimizing harm, rather than achieving abstinence, and employed participatory, critical-thinking and skill-based teaching methods. A cluster-randomized, controlled trial of the program was conducted with a student cohort during years 8 (13 years), 9 (14 years), and 10 (15 years). Twenty-one schools were randomly allocated to the DEVS program (14 schools, n = 1163), or their usual drug education program (7 schools, n = 589). One intervention school withdrew in year two. There was a greater increase in the intervention students' knowledge about drugs, including tobacco, in all 3 years. Intervention students talked more with their parents about smoking at the end of the 3-year program. They recalled receiving more education on smoking in all 3 years. Their consumption of cigarettes had not increased to the same extent as controls at the end of the program. Their change in smoking harms, relative to controls, was positive in all 3 years. There was no difference between groups in the proportionate increase of smokers, or in attitudes towards smoking, at any time. These findings indicate that a school program that teaches about all drugs in an integrated fashion, and focuses on minimizing harm, does not increase initiation into smoking, while providing strategies for reducing consumption and harm to those who choose to smoke.

Changing Throwing Pattern: Instruction and Control Parameter

ERIC Educational Resources Information Center

Southard, Dan

2006-01-01

The purpose of this study was to determine the effects of instruction and scaling up a control parameter (velocity of throw) on changes in throwing pattern. Sixty adult female throwers (ages 20-26 years) were randomly placed into one of four practice conditions: (a) scale up on velocity with no instruction, (b) maintain constant velocity with no…

A randomized, controlled comparison of home versus institutional rehabilitation of patients with hip fracture.

PubMed

Kuisma, Raija

2002-08-01

To compare ambulation outcomes between home and institutional rehabilitation of patients with hip fracture. Randomized controlled clinical equivalence trial. The Queen Elizabeth Hospital in Hong Kong. Eighty-one patients with hip fracture. Study group patients (40) were discharged directly home from the acute hospital and visited by a physiotherapist an average of 4.6 times. The control group subjects (41) were discharged to a rehabilitation centre for further treatment lasting on average 36.2 days (SD 14.6) and they received physiotherapy daily. Ambulation ability measured on a categorical scale. The mean age of the subjects was 75 years (SD 8.3 years). Females comprised 60% of all the subjects and majority were retired or home makers. Both groups of patients improved in their ambulation ability during their rehabilitation period but neither group achieved their pre-ambulatory status by the time of completion of the study. The study group achieved significantly higher ambulation scores (p < 0.05) for community and household ambulation compared with the control group by the end of the study, a year after operation. Five visits by a physiotherapist in the patient's home after discharge from an acute hospital after surgical treatment for hip fracture yielded better results in ambulation ability than one month of conventional institution-based rehabilitation.

A randomized controlled trial of home visits by neighborhood mentor mothers to improve children's nutrition in South Africa

PubMed Central

le Roux, Ingrid M.; le Roux, Karl; Mbeutu, Kwanie; Comulada, W. Scott; Desmond, Katherine A.; Rotheram-Borus, Mary Jane

2011-01-01

Malnourished children and babies with birth weights under 2500 g are at high risk for negative outcomes over their lifespans. Philani, a paraprofessional home visiting program, was developed to improve nutritional outcomes for young children in South Africa. One “mentor mother” was recruited from each of 37 neighborhoods in Cape Town, South Africa. Mentor mothers were trained to conduct home visits to weigh children under six years old and to support mothers to problem-solve life challenges, especially around nutrition. Households with underweight children were assigned randomly on a 2:1 ratio to the Philani program (n = 500) or to a standard care condition (n = 179); selection effects occurred and children in the intervention households weighed less at recruitment. Children were evaluated over a one-year period (n = 679 at recruitment and n = 638 with at least one follow-up; 94%). Longitudinal random effects models indicated that, over 12 months, the children in the intervention condition gained significantly more weight than children in the control condition. Mentor mothers who are positive peer deviants may be a viable strategy that is efficacious and can build community, and the use of mentor mothers for other problems in South Africa is discussed. PMID:22299019

Intervening with practitioners to improve the quality of prevention: One year findings from a randomized trial of Assets-Getting To Outcomes

PubMed Central

Chinman, Matthew; Acosta, Joie; Ebener, Patricia; Burkhart, Q; Malone, Patrick; Paddock, Susan M.; Clifford, Michael; Corsello, Maryann; Duffy, Tim; Hunter, Sarah; Jones, Margaret; Lahti, Michel; Phillips, Andrea; Savell, Susan; Scales, Peter C.; Tellett-Royce, Nancy

2013-01-01

There continues to be a gap in prevention outcomes achieved in research trials vs. “real world” practice. This article summarizes interim findings from a randomized trial testing Assets-Getting To Outcomes (AGTO), a two-year intervention to build prevention practitioners’ capacity to implement positive youth development-oriented prevention practices in 12 prevention coalitions in Maine. A survey of coalition members was used to assess change on individual practitioners’ prevention capacity between Baseline and one year later. Structured interviews with 32 program leaders (16 intervention, 16 control) were used to assess changes in prevention practices during the same time period. Change in prevention capacity over time between intervention and control did not differ, however in secondary analyses of only those assigned to the AGTO condition, AGTO users had evidenced greater improvement in their self-efficacy to conduct Assets-based programming and the frequency with which they engaged in AGTO behaviors. Non-users’ self-efficacy of AGTO declined. Interview ratings showed improvement in several key areas of performance among intervention programs. Improvement was associated with the number of technical assistance hours received. These results suggest that, after one year, AGTO is beginning to improve the capacity of community practitioners who make use of it. PMID:23605473

Practising Mental Rotation Using Interactive Desktop Mental Rotation Trainer (iDeMRT)

ERIC Educational Resources Information Center

Rafi, Ahmad; Samsudin, Khairulanuar

2009-01-01

An experimental study involving 30 undergraduates (mean age = 20.5 years) in mental rotation (MR) training was conducted in an interactive Desktop Mental Rotation Trainer (iDeMRT). Stratified random sampling assigned students into one experimental group and one control group. The former trained in iDeMRT and the latter trained in conventional…

Manual Wheelchair Skills Training for Community-Dwelling Veterans with Spinal Cord Injury: A Randomized Controlled Trial.

PubMed

Kirby, R Lee; Mitchell, Doug; Sabharwal, Sunil; McCranie, Mark; Nelson, Audrey L

2016-01-01

To test the hypotheses that community-dwelling veterans with spinal cord injury (SCI) who receive the Wheelchair Skills Training Program (WSTP) in their own environments significantly improve their manual wheelchair-skills capacity, retain those improvements at one year and improve participation in comparison with an Educational Control (EC) group. We carried out a randomized controlled trial, studying 106 veterans with SCI from three Veterans Affairs rehabilitation centers. Each participant received either five one-on-one WSTP or EC sessions 30-45 minutes in duration. The main outcome measures were the total and subtotal percentage capacity scores from the Wheelchair Skills Test 4.1 (WST) and Craig Handicap Assessment and Reporting Technique (CHART) scores. Participants in the WSTP group improved their total and Advanced-level WST scores by 7.1% and 30.1% relative to baseline (p < 0.001) and retained their scores at one year follow-up. The success rates for individual skills were consistent with the total and subtotal WST scores. The CHART Mobility sub-score improved by 3.2% over baseline (p = 0.021). Individualized wheelchair skills training in the home environment substantially improves the advanced and total wheelchair skills capacity of experienced community-dwelling veterans with SCI but has only a small impact on participation.

Manual Wheelchair Skills Training for Community-Dwelling Veterans with Spinal Cord Injury: A Randomized Controlled Trial

PubMed Central

Mitchell, Doug; Sabharwal, Sunil; McCranie, Mark; Nelson, Audrey L.

2016-01-01

Objectives To test the hypotheses that community-dwelling veterans with spinal cord injury (SCI) who receive the Wheelchair Skills Training Program (WSTP) in their own environments significantly improve their manual wheelchair-skills capacity, retain those improvements at one year and improve participation in comparison with an Educational Control (EC) group. Methods We carried out a randomized controlled trial, studying 106 veterans with SCI from three Veterans Affairs rehabilitation centers. Each participant received either five one-on-one WSTP or EC sessions 30–45 minutes in duration. The main outcome measures were the total and subtotal percentage capacity scores from the Wheelchair Skills Test 4.1 (WST) and Craig Handicap Assessment and Reporting Technique (CHART) scores. Results Participants in the WSTP group improved their total and Advanced-level WST scores by 7.1% and 30.1% relative to baseline (p < 0.001) and retained their scores at one year follow-up. The success rates for individual skills were consistent with the total and subtotal WST scores. The CHART Mobility sub-score improved by 3.2% over baseline (p = 0.021). Conclusions Individualized wheelchair skills training in the home environment substantially improves the advanced and total wheelchair skills capacity of experienced community-dwelling veterans with SCI but has only a small impact on participation. PMID:28002472

Effects of combination oral care on oral health, dry mouth and salivary pH of intubated patients: A randomized controlled trial.

PubMed

Jang, Chun Sun; Shin, Yong Soon

2016-10-01

Intubated patients are at risk of oral health problems. Although a variety of oral care regimens for intubated patients have been studied, there is a lack of research on the effects of combination oral care that includes tooth brushing, chlorhexidine and cold water. This open-labelled, randomized, controlled trial aimed to evaluate the effects of combination oral care on oral health status. Participants aged 20 years and older were recruited on the first day after intubation through convenience sampling in a medical intensive care unit. Random assignment was performed using an internet randomization service. The primary outcome was oral health status. Data were collected during May and June 2013. Participants were randomized to one of two groups (23 intervention and 21 control). The final analysis included 18 patients with combination oral care and 17 in the control group. The intervention group had better oral health (effect size = 1.56), less dry mouth and higher salivary pH than the control group. Any additional burden of providing combination oral care to patients who are mechanically ventilated is worthwhile in terms of clinical outcomes. © 2016 John Wiley & Sons Australia, Ltd.

Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia.

PubMed

Chow, Philip I; Ingersoll, Karen S; Thorndike, Frances P; Lord, Holly R; Gonder-Frederick, Linda; Morin, Charles M; Ritterband, Lee M

2018-07-01

The aim of this study was to investigate in a randomized clinical trial the role of sleep-related cognitive variables in the long-term efficacy of an online, fully automated cognitive behavioral therapy intervention for insomnia (CBT-I) (Sleep Healthy Using the Internet [SHUTi]). Three hundred and three participants (M age  = 43.3 years; SD = 11.6) were randomly assigned to SHUTi or an online patient education condition and assessed at baseline, postintervention (nine weeks after baseline), and six and 12 months after the intervention period. Cognitive variables were self-reported internal and chance sleep locus of control, dysfunctional beliefs and attitudes about sleep (DBAS), sleep specific self-efficacy, and insomnia knowledge. Primary outcomes were self-reported online ratings of insomnia severity (Insomnia Severity Index), and sleep onset latency and wake after sleep onset from online sleep diaries, collected 12 months after the intervention period. Those who received SHUTi had, at postassessment, higher levels of insomnia knowledge (95% confidence interval [CI] = 0.10-0.16) and internal sleep locus of control (95% CI = 0.04-0.55) as well as lower DBAS (95% CI = 1.52-2.39) and sleep locus of control attributed to chance (95% CI = 0.15-0.71). Insomnia knowledge, chance sleep locus of control, and DBAS mediated the relationship between condition and at least one 12-month postassessment sleep outcome. Within the SHUTi condition, changes in each cognitive variable (with the exception of internal sleep locus of control) predicted improvement in at least one sleep outcome one year later. Online CBT-I may reduce the enormous public health burden of insomnia by changing underlying cognitive variables that lead to long-term changes in sleep outcomes. Published by Elsevier B.V.

Increasing Water Intake of Children and Parents in the Family Setting: A Randomized, Controlled Intervention Using Installation Theory.

PubMed

Lahlou, Saadi; Boesen-Mariani, Sabine; Franks, Bradley; Guelinckx, Isabelle

2015-01-01

On average, children and adults in developed countries consume too little water, which can lead to negative health consequences. In a one-year longitudinal field experiment in Poland, we compared the impact of three home-based interventions on helping children and their parents/caregivers to develop sustainable increased plain water consumption habits. Fluid consumption of 334 children and their caregivers were recorded over one year using an online specific fluid dietary record. They were initially randomly allocated to one of the three following conditions: Control, Information (child and carer received information on the health benefits of water), or Placement (in addition to information, free small bottles of still water for a limited time period were delivered at home). After three months, half of the non-controls were randomly assigned to Community (child and caregiver engaged in an online community forum providing support on water consumption). All conditions significantly increased the water consumption of children (by 21.9-56.7%) and of adults (by 22-89%). Placement + Community generated the largest effects. Community enhanced the impact of Placement for children and parents, as well as the impact of Information for parents but not children. The results suggest that the family setting offers considerable scope for successful installation of interventions encouraging children and caregivers to develop healthier consumption habits, in mutually reinforcing ways. Combining information, affordances, and social influence gives the best, and most sustainable, results. © 2015 S. Karger AG, Basel.

Assessments of the quality of randomized controlled trials published in International Journal of Urology from 1994 to 2011.

PubMed

Cho, Hee Ju; Chung, Jae Hoon; Jo, Jung Ki; Kang, Dong Hyuk; Cho, Jeong Man; Yoo, Tag Keun; Lee, Seung Wook

2013-12-01

Randomized controlled trials are one of the most reliable resources for assessing the effectiveness and safety of medical treatments. Low quality randomized controlled trials carry a large bias that can ultimately impair the reliability of their conclusions. The present study aimed to evaluate the quality of randomized controlled trials published in International Journal of Urology by using multiple quality assessment tools. Randomized controlled trials articles published in International Journal of Urology were found using the PubMed MEDLINE database, and qualitative analysis was carried out with three distinct assessment tools: the Jadad scale, the van Tulder scale and the Cochrane Collaboration Risk of Bias Tool. The quality of randomized controlled trials was analyzed by publication year, type of subjects, intervention, presence of funding and whether an institutional review board reviewed the study. A total of 68 randomized controlled trial articles were published among a total of 1399 original articles in International Journal of Urology. Among these randomized controlled trials, 10 (2.70%) were from 1994 to 1999, 23 (4.10%) were from 2000 to 2005 and 35 (4.00%) were from 2006 to 2011 (P = 0.494). On the assessment with the Jadad and van Tulder scale, the numbers and percentage of high quality randomized controlled trials increased over time. The studies that had institutional review board reviews, funding resources or that were carried out in multiple institutions had an increased percentage of high quality articles. The numbers and percentage of high-quality randomized controlled trials published in International Journal of Urology have increased over time. Furthermore, randomized controlled trials with funding resources, institutional review board reviews or carried out in multiple institutions have been found to be of higher quality compared with others not presenting these features. © 2013 The Japanese Urological Association.

Effectiveness of a Video-Versus Text-Based Computer-Tailored Intervention for Obesity Prevention after One Year: A Randomized Controlled Trial

PubMed Central

Cheung, Kei Long; Schwabe, Inga; Walthouwer, Michel J. L.; Oenema, Anke; de Vries, Hein

2017-01-01

Computer-tailored programs may help to prevent overweight and obesity, which are worldwide public health problems. This study investigated (1) the 12-month effectiveness of a video- and text-based computer-tailored intervention on energy intake, physical activity, and body mass index (BMI), and (2) the role of educational level in intervention effects. A randomized controlled trial in The Netherlands was conducted, in which adults were allocated to a video-based condition, text-based condition, or control condition, with baseline, 6 months, and 12 months follow-up. Outcome variables were self-reported BMI, physical activity, and energy intake. Mixed-effects modelling was used to investigate intervention effects and potential interaction effects. Compared to the control group, the video intervention group was effective regarding energy intake after 6 months (least squares means (LSM) difference = −205.40, p = 0.00) and 12 months (LSM difference = −128.14, p = 0.03). Only video intervention resulted in lower average daily energy intake after one year (d = 0.12). Educational role and BMI did not seem to interact with this effect. No intervention effects on BMI and physical activity were found. The video computer-tailored intervention was effective on energy intake after one year. This effect was not dependent on educational levels or BMI categories, suggesting that video tailoring can be effective for a broad range of risk groups and may be preferred over text tailoring. PMID:29065545

Does perioperative nutrition and oral carbohydrate load sustainably preserve muscle mass after bariatric surgery? A randomized control trial.

PubMed

Azagury, D E; Ris, F; Pichard, C; Volonté, F; Karsegard, L; Huber, O

2015-01-01

Perioperative nutrition and preoperative oral carbohydrate loading (CHL) have a beneficial impact on the outcomes of gastrointestinal oncological surgery. However no data exists on their effect on morbidly obese patients. Our aim was to establish the short-term and long-term impact of these modalities, notably on metabolically active lean body mass (LBM) - an important factor in maintaining long-term weight loss. Patients undergoing laparoscopic Roux-en-Y gastric bypass were randomized to standard management or intervention: CHL drinks consumed 12 and 2 hours presurgery, and immediate postoperative peripheral parenteral nutrition. The primary outcome measured was LBM, measured by Bioelectrical Impedance Analysis (BIA), one and 12 months postsurgery. Secondary outcomes included excess weight loss (EBWL), 30-day complication rate, and length of stay. Of the 203 randomized patients, 198 were included in the analysis. All 101 patients in the control group completed the one-year follow up and 76 completed the BIA. In the intervention group, 93 of 97 patients completed the one-year follow-up and 71 completed the BIA. At one and 12 months follow-up, body composition, LBM, or EBWL were comparable. There was no difference in operative outcomes, complications rates, or length of stay. There was no adverse effect in the intervention group. In a highly homogeneous group of morbidly obese patients with one-year follow-up, CHL and short-term parenteral nutrition did not lead to significant or sustained LBM preservation or modification in EBWL. There was no significant decrease in complications or length of stay. Our study confirms the safety of these interventions, even in previously unstudied Type 2 diabetic patients. Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Proof-of-principle evaluation of the efficacy of fewer than three doses of a bivalent HPV16/18 vaccine.

PubMed

Kreimer, Aimée R; Rodriguez, Ana Cecilia; Hildesheim, Allan; Herrero, Rolando; Porras, Carolina; Schiffman, Mark; González, Paula; Solomon, Diane; Jiménez, Silvia; Schiller, John T; Lowy, Douglas R; Quint, Wim; Sherman, Mark E; Schussler, John; Wacholder, Sholom

2011-10-05

Three-dose regimens for human papillomavirus (HPV) vaccines are expensive and difficult to complete, especially in settings where the need for cervical cancer prevention is greatest. We evaluated the vaccine efficacy of fewer than three doses of the HPV16/18 vaccine Cervarix in our Costa Rica Vaccine Trial. Women were randomly assigned to receive three doses of the HPV16/18 vaccine or to a control vaccine and were followed for incident HPV16 or HPV18 infection that persisted in visits that were 10 or more months apart (median follow-up 4.2 years). After excluding women who had no follow-up or who were HPV16 and HPV18 DNA positive at enrollment, 5967 women received three vaccine doses (2957 HPV vaccine vs 3010 control vaccine), 802 received two doses (422 HPV vs. 380 control), and 384 received one dose (196 HPV vs. 188 control). Reasons for receiving fewer doses and other pre- and post-randomization characteristics were balanced within each dosage group between women receiving the HPV and control vaccines. Incident HPV16 or HPV18 infections that persisted for 1 year were unrelated to dosage of the control vaccine. Vaccine efficacy was 80.9% for three doses of the HPV vaccine (95% confidence interval [CI] = 71.1% to 87.7%; 25 and 133 events in the HPV and control arms, respectively), 84.1% for two doses (95% CI = 50.2% to 96.3%; 3 and 17 events), and 100% for one dose (95% CI = 66.5% to 100%; 0 and 10 events). Four years after vaccination of women who appeared to be uninfected, this nonrandomized analysis suggests that two doses of the HPV16/18 vaccine, and maybe even one dose, are as protective as three doses.

Four-Year Degree and Employment Findings from a Randomized Controlled Trial of a One-Year Performance-Based Scholarship Program in Ohio

ERIC Educational Resources Information Center

Mayer, Alexander K.; Patel, Reshma; Gutierrez, Melvin

2016-01-01

A college degree is often viewed as a key step toward better employment and higher earnings. Many community college students, however, never graduate and cannot reap the financial benefits associated with a college degree. Although existing research suggests that financial aid interventions can modestly improve students' short-term academic…

Effects of Training Method and Gender on Learning 2D/3D Geometry

ERIC Educational Resources Information Center

Khairulanuar, Samsudin; Nazre, Abd Rashid; Jamilah, H.; Sairabanu, Omar Khan; Norasikin, Fabil

2010-01-01

This article reports the findings of an experimental study involving 36 primary school students (16 girls, 20 boys, Mean age = 9.5 years, age range: 8-10 years) in geometrical understanding of 2D and 3D objects. Students were assigned into two experimental groups and one control group based on a stratified random sampling procedure. The first…

Impacts of Comprehensive Teacher Induction: Results from the Second Year of a Randomized Controlled Study. NCEE 2009-4072

ERIC Educational Resources Information Center

Isenberg, Eric; Glazerman, Steven; Bleeker, Martha; Johnson, Amy; Lugo-Gil, Julieta; Grider, Mary; Dolfin, Sarah; Britton, Edward

2009-01-01

One of the main policy responses to the problems of turnover and inadequate preparation among beginning teachers is to support them with a formal, comprehensive induction program. Congressional interest in formal, comprehensive teacher induction has grown in recent years. The No Child Left Behind Act of 2001 (NCLB), which reauthorized the…

High School Students With Reading Comprehension Difficulties: Results of a Randomized Control Trial of a Two-Year Reading Intervention.

PubMed

Vaughn, Sharon; Roberts, Greg; Wexler, Jade; Vaughn, Michael G; Fall, Anna-Mária; Schnakenberg, Jennifer B

2015-01-01

A 2-year, randomized control trial with 9th to 10th grade students with significant reading problems was provided for 50 minutes a day in small groups. Comparison students were provided an elective class and treatment students the reading intervention. Students were identified as demonstrating reading difficulties through failure on their state accountability test and were randomly assigned to one of three treatment conditions and a business as usual (BAU) condition: reading without dropout prevention, reading with dropout prevention, dropout prevention without reading, or a BAU condition. Findings from the 2-year reading intervention (reading with and without dropout prevention combined and BAU) are reported in this article. Students in reading treatment compared to students in BAU demonstrated significant gains on reading comprehension (effect size = .43), and improved reading was associated with better grades in social studies. Findings from this study provide a rationale for further implementation and investigation of intensive intervention for high school students with reading difficulties. © Hammill Institute on Disabilities 2014.

The PLUNGE randomized controlled trial: evaluation of a games-based physical activity professional learning program in primary school physical education.

PubMed

Miller, Andrew; Christensen, Erin M; Eather, Narelle; Sproule, John; Annis-Brown, Laura; Lubans, David Revalds

2015-05-01

To evaluate the efficacy of the Professional Learning for Understanding Games Education (PLUNGE) program on fundamental movement skills (FMS), in-class physical activity and perceived sporting competence. A cluster-randomized controlled trial involving one year six class each from seven primary schools (n=168; mean age=11.2 years, SD=1.0) in the Hunter Region, NSW, Australia. In September (2013) participants were randomized by school into the PLUNGE intervention (n=97 students) or the 7-week wait-list control (n=71) condition. PLUNGE involved the use of Game Centered curriculum delivered via an in-class teacher mentoring program. Students were assessed at baseline and 8-week follow-up for three object control FMS (Test of Gross Motor Development 2), in-class physical activity (pedometer steps/min) and perceived sporting competence (Self-perception Profile for Children). Linear mixed models revealed significant group-by-time intervention effects (all p<0.05) for object control competency (effect size: d=0.9), and in-class pedometer steps/min (d=1.0). No significant intervention effects (p>0.05) were observed for perceived sporting competence. The PLUNGE intervention simultaneously improved object control FMS proficiency and in-class PA in stage three students. Copyright © 2015 Elsevier Inc. All rights reserved.

Efficacy of closantel against ivermectin- and fenbendazole-resistant Haemonchus sp. in sheep in Ontario, Canada.

PubMed

Westers, T; Jones-Bitton, A; Menzies, P; Van Leeuwen, J; Poljak, Z; Peregrine, A S

2016-09-15

In Ontario, Canada, widespread resistance to ivermectin and fenbendazole, the only readily available ovine anthelmintics, has been documented, primarily in Haemonchus sp. In other parts of the world, closantel has been used to control such infections; however, the drug was not currently licensed for use in Canada and the USA. A randomized controlled trial was conducted on six client-owned farms in Ontario in 2013 and 2014 to determine the efficacy of closantel (Flukiver ® 5% Oral Suspension, Elanco Animal Health, 10mg/kg bodyweight) against ivermectin- and fenbendazole-resistant Haemonchus sp. infections in periparturient ewes and grazing lambs. Three farms were randomly assigned to treat all ewes, and three farms were randomly assigned to selectively treat individual ewes at lambing, using predetermined criteria. Fecal samples were collected from a minimum of 15 randomly selected ewes and 13 lambs per group on each farm at the time of treatment and approximately 14days later. Trichostrongyle-type fecal egg counts (FEC) were performed using a modified McMaster technique with a lower detection limit of 8.3 eggs per gram of feces (epg). Haemonchus-specific FECs were determined by multiplying FECs by the proportion of Haemonchus sp. identified from coproculture for each farm; Haemonchus-specific FEC reductions were calculated for each farm. Twenty grazing lambs had FECs conducted monthly, and when mean monthly FECs surpassed 200 epg, all lambs were randomly allocated to either closantel, positive control (ivermectin, fenbendazole, or levamisole) or negative control groups. Pre-treatment Haemonchus-specific mean FECs ranged from 27 to 3359 epg in ewes and 0-5698 epg in lambs. Efficacy of closantel against Haemonchus sp. ranged from 99% (95% CI: 97%-99%) to 100% in recently lambed ewes on all farms in both years (total n=274 ewes), and from 99% (95% CI: 98%-99%) to 100% in grazing lambs in both years on all but one farm (total n=171 lambs). On the latter farm, a whole flock treated farm, closantel efficacy in grazing lambs was 84% (95%CI: 81%-88%) in the first year, but 100% in the second year. Levamisole was effective against overall GIN in lambs on only two farms. Ivermectin and fenbendazole resistance continued to be present, particularly in Haemonchus sp. Closantel had excellent efficacy against Haemonchus sp. over the two year study period, regardless of treatment group, and therefore should be considered one viable component of sustainable integrated parasite control programs for farms with documented anthelmintic resistance and problems with haemonchosis. Copyright © 2016 Elsevier B.V. All rights reserved.

A controlled trial of web-based diabetes disease management: the MGH diabetes primary care improvement project.

PubMed

Meigs, James B; Cagliero, Enrico; Dubey, Anil; Murphy-Sheehy, Patricia; Gildesgame, Catharyn; Chueh, Henry; Barry, Michael J; Singer, Daniel E; Nathan, David M

2003-03-01

To test effects of a web-based decision support tool, the diabetes Disease Management Application (DMA), developed to improve evidence-based management of type 2 diabetes. We conducted a group randomized controlled trial of 12 intervention and 14 control staff providers and 307 intervention and 291 control patients with type 2 diabetes in a hospital-based internal medicine clinic. Providers were randomly assigned from May 1998 through April 1999 to have access to the DMA (intervention) or not to have access (control). The DMA displays interactive patient-specific clinical data, treatment advice, and links to other web-based care resources. We compared patients in the intervention and control groups for changes in processes and outcomes of care from the year preceding the study through the year of the study by intention-to-treat analysis. The DMA was used for 42% of scheduled patient visits. The number of HbA(1c) tests obtained per year increased significantly in the intervention group (+0.3 tests/year) compared with the control group (-0.04 tests/year, P = 0.008), as did the number of LDL cholesterol tests (intervention, +0.2 tests/year; control, +0.01 tests/year; P = 0.02) and the proportions of patients undergoing at least one foot examination per year (intervention, +9.8%; control, -0.7%; P = 0.003). Levels of HbA(1c) decreased by 0.2 in the intervention group and increased by 0.1 in the control group (P = 0.09); proportions of patients with LDL cholesterol levels <130 mg/dl increased by 20.3% in the intervention group and 10.5% in the control group (P = 0.5). Web-based patient-specific decision support has the potential to improve evidence-based parameters of diabetes care.

Effect of an e-Learning Tool on Expectations and Satisfaction Following Total Knee Arthroplasty: A Randomized Controlled Trial.

PubMed

Culliton, Sharon E; Bryant, Dianne M; MacDonald, Steven J; Hibbert, Kathy M; Chesworth, Bert M

2018-07-01

Orthopedic surgeons recognize patient expectations of total knee arthroplasty (TKA) can be managed through education. E-learning is the application of educational technology. The objective of this study was to evaluate whether an e-learning tool could affect whether patients' expectations were met and they were satisfied 1 year following TKA. Patients with osteoarthritis from the London Health Sciences Centre, Canada, were randomly assigned to either a control group (n = 207) receiving standard patient education or an intervention group (n = 209) using the e-learning tool in addition to the standard. We used a web-based system with permuted block sizes, stratified by surgeon and first or second TKA. Preoperative measures were completed following the patients' preadmission clinic visit. Postoperative patient-reported outcome measures were completed at 6 weeks, 3 months, and 1 year after TKA. One year after TKA, risk difference was used to determine between-group differences for patient satisfaction and expectations being met. One year postoperatively, the risk that expectations of patients were not met was 21.8% in the control group and 21.4% in the intervention group for an adjusted risk difference of 1.3% (95% confidence interval, -7.8% to 10.4%, P = .78). The proportion of patients satisfied with their TKA at 1 year postoperative was 78.6% in the intervention and 78.2% in the control groups. There was no between-group difference at 1 year between intervention and control groups for either the risk that expectations of patients were not met or the proportion of patients who were dissatisfied with their TKA. Copyright © 2018 Elsevier Inc. All rights reserved.

Two-year follow-up results of fluoroscopic cervical epidural injections in chronic axial or discogenic neck pain: a randomized, double-blind, controlled trial.

PubMed

Manchikanti, Laxmaiah; Cash, Kimberly A; Pampati, Vidyasagar; Malla, Yogesh

2014-01-01

A randomized, double-blind, active-controlled trial. To assess the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids for the management of axial or discogenic pain in patients without disc herniation, radiculitis, or facet joint pain. Cervical discogenic pain without disc herniation is a common cause of suffering and disability in the adult population. Once conservative management has failed and facet joint pain has been excluded, cervical epidural injections may be considered as a management tool. Despite a paucity of evidence, cervical epidural injections are one of the most commonly performed nonsurgical interventions in the management of chronic axial or disc-related neck pain. One hundred and twenty patients without disc herniation or radiculitis and negative for facet joint pain as determined by means of controlled diagnostic medial branch blocks were randomly assigned to one of the 2 treatment groups. Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL), whereas Group II patients received 0.5% lidocaine, 4 mL, mixed with 1 mL or 6 mg of nonparticulate betamethasone. The primary outcome measure was ≥ 50% improvement in pain and function. Outcome assessments included numeric rating scale (NRS), Neck Disability Index (NDI), opioid intake, employment, and changes in weight. Significant pain relief and functional improvement (≥ 50%) was present at the end of 2 years in 73% of patients receiving local anesthetic only and 70% receiving local anesthetic with steroids. In the successful group of patients, however, defined as consistent relief with 2 initial injections of at least 3 weeks, significant improvement was illustrated in 78% in the local anesthetic group and 75% in the local anesthetic with steroid group at the end of 2 years. The results reported at the one-year follow-up were sustained at the 2-year follow-up. Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and functioning in patients with chronic discogenic or axial pain that is function-limiting and not related to facet joint pain.

Competency-Based Training and Worker Turnover in Community Supports for People With IDD: Results From a Group Randomized Controlled Study.

PubMed

Bogenschutz, Matthew; Nord, Derek; Hewitt, Amy

2015-06-01

Turnover among direct support professionals (DSPs) in community support settings for individuals with intellectual and developmental disabilities (IDD) has been regarded as a challenge since tracking of this workforce began in the 1980s. This study utilized a group randomized controlled design to test the effects of a competency-based training intervention for DSPs on site-level turnover rates over a one year period. Results suggested that, compared with the control group, sites receiving the training intervention experienced a significant decrease in annual turnover, when multiple factors were controlled. Implications, including the importance of considering quality training as a long term organizational investment and intervention to reduce turnover, are discussed.

One-Year Effects of Project EX in Spain: A Classroom-Based Smoking Prevention and Cessation Intervention Program

PubMed Central

Gonzálvez, María T.; Espada, José P.; Orgilés, Mireia; Soto, Daniel; Sussman, Steve

2015-01-01

Background Tobacco use prevalence rates are high among Spanish adolescents. Programming to counteract tobacco use is needed. Methods and Findings The current study provides a one-year follow-up outcome evaluation of Project EX, an eight-session classroom-based curriculum. The intervention was tested using a randomized controlled trial with 1,546 Spanish students, involving three program and three control schools. Compared to the control condition, the program condition revealed a greater reduction in nicotine dependence (p < .05) and CO ppm levels (p < .001), and lower consumption of cigarettes at last month (p = .03). Conclusions Long-term outcomes of the Project EX classroom-based program are promising for adolescent prevention and possibly cessation in Spain. PMID:26090821

Effect of the Mediterranean diet on blood pressure in the PREDIMED trial: results from a randomized controlled trial

PubMed Central

2013-01-01

Background Hypertension can be prevented by adopting healthy dietary patterns. Our aim was to assess the 4-year effect on blood pressure (BP) control of a randomized feeding trial promoting the traditional Mediterranean dietary pattern. Methods The PREDIMED primary prevention trial is a randomized, single-blinded, controlled trial conducted in Spanish primary healthcare centers. We recruited 7,447 men (aged 55 to 80 years) and women (aged 60 to 80 years) who had high risk for cardiovascular disease. Participants were assigned to a control group or to one of two Mediterranean diets. The control group received education on following a low-fat diet, while the groups on Mediterranean diets received nutritional education and also free foods; either extra virgin olive oil, or nuts. Trained personnel measured participants’ BP at baseline and once yearly during a 4-year follow-up. We used generalized estimating equations to assess the differences between groups during the follow-up. Results The percentage of participants with controlled BP increased in all three intervention groups (P-value for within-group changes: P<0.001). Participants allocated to either of the two Mediterranean diet groups had significantly lower diastolic BP than the participants in the control group (−1.53 mmHg (95% confidence interval (CI) −2.01 to −1.04) for the Mediterranean diet supplemented with extra virgin olive oil, and −0.65 mmHg (95% CI -1.15 to −0.15) mmHg for the Mediterranean diet supplemented with nuts). No between-group differences in changes of systolic BP were seen. Conclusions Both the traditional Mediterranean diet and a low-fat diet exerted beneficial effects on BP and could be part of advice to patients for controlling BP. However, we found lower values of diastolic BP in the two groups promoting the Mediterranean diet with extra virgin olive oil or with nuts than in the control group. Trial registration Current Controlled Trials ISRCTN35739639 PMID:24050803

Human intrabony defect regeneration with micro-grafts containing dental pulp stem cells: A randomized controlled clinical trial.

PubMed

Ferrarotti, Francesco; Romano, Federica; Gamba, Mara Noemi; Quirico, Andrea; Giraudi, Marta; Audagna, Martina; Aimetti, Mario

2018-05-19

The goal of this study was to evaluate if dental pulp stem cells (DPSCs) delivered into intrabony defects in a collagen scaffold would enhance the clinical and radiographic parameters of periodontal regeneration. In this randomized controlled trial, 29 chronic periodontitis patients presenting one deep intrabony defect and requiring extraction of one vital tooth were consecutively enrolled. Defects were randomly assigned to test or control treatments which both consisted of the use of minimally invasive surgical technique. The dental pulp of the extracted tooth was mechanically dissociated to obtain micro-grafts rich in autologous DPSCs. Test sites (n=15) were filled with micro-grafts seeded onto collagen sponge, whereas control sites (n=14) with collagen sponge alone. Clinical and radiographic parameters were recorded at baseline, 6 and 12 months postoperatively. Test sites exhibited significantly more PD reduction (4.9 mm versus 3.4 mm), CAL gain (4.5 versus 2.9 mm) and bone defect fill (3.9 versus 1.6 mm) than controls. Moreover, residual PD < 5 mm (93% versus 50%) and CAL gain ≥ 4 mm (73% versus 29%) was significantly more frequent in the test group. Application of DPSCs significantly improved clinical parameters of periodontal regeneration one year after treatment. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Peer-counseling for women newly diagnosed with breast cancer: A randomized community/research collaboration trial.

PubMed

Giese-Davis, Janine; Bliss-Isberg, Caroline; Wittenberg, Lynne; White, Jennifer; Star, Path; Zhong, Lihong; Cordova, Matthew J; Houston, Debra; Spiegel, David

2016-08-01

We conducted a randomized controlled trial of peer-counseling for newly diagnosed breast cancer (BC) patients as a community/research collaboration testing an intervention developed jointly by a community-based-organization serving women with cancer and university researchers. We recruited 104 women newly diagnosed with BC at any disease stage. Prior to randomization, all received a one-time visit with an oncology nurse who offered information and resources. Afterwards, we randomized half to receive a match with a Navigator with whom they could have contact for up to 6 months. We recruited, trained, and supervised 30 peer counselors who became "Navigators." They were at least one-year post-diagnosis with BC. Controls received no further intervention. We tested the effect of intervention on breast-cancer-specific well-being and trauma symptoms as primary outcomes, and several secondary outcomes. In exploratory analyses, we tested whether responding to their diagnosis as a traumatic stressor moderated outcomes. We found that, compared with the control group, receiving a peer-counseling intervention significantly improved breast-cancer-specific well-being (p=0.01, Cohen's d=0.41) and maintained marital adjustment (p=0.01, Cohen's d=0.45) more effectively. Experiencing the diagnosis as a traumatic stressor moderated outcomes: those with a peer counselor in the traumatic stressor group improved significantly more than controls on well-being, trauma and depression symptoms, and cancer self-efficacy. Having a peer counselor trained and supervised to recognize and work with trauma symptoms can improve well-being and psychosocial morbidity during the first year following diagnosis of BC. Cancer 2016;122:2408-2417. © 2016 American Cancer Society. © 2016 American Cancer Society.

A Randomized Controlled Trial of Mentoring Interventions for Underrepresented Minorities.

PubMed

Lewis, Vivian; Martina, Camille A; McDermott, Michael P; Trief, Paula M; Goodman, Steven R; Morse, Gene D; LaGuardia, Jennifer G; Sharp, Daryl; Ryan, Richard M

2016-07-01

To conduct a randomized controlled trial to evaluate the effects of different mentoring interventions on the basic psychological need satisfaction of underrepresented minorities and women in academia. Participants were 150 mentor/protégé dyads from three academic medical centers and eight other colleges and universities in western and central New York, randomized from 2010 to 2013 into mentor training (using principles of self-determination theory); peer mentoring for protégés; mentor training and peer mentoring for protégés combined; or control/usual practice. Protégé participants were graduate students, fellows, and junior faculty who were from underrepresented groups based on race, ethnicity, gender, or disability.The primary analysis was a comparison of intervention effects on changes in protégés' satisfaction of their basic psychological needs (competence, autonomy, and relatedness) with their mentor. They completed a well-validated, online questionnaire every two months for one year. There was no significant effect at the end of one year of either mentor training or peer mentoring on protégés' psychological basic need satisfaction with mentor specifically or at work in general. Exploratory analyses showed a significant effect of the mentor-based intervention on the protégés' overall psychological need satisfaction with their mentor at two months, the time point closest to completing mentor training. This randomized controlled trial showed a potential short-term effect of mentor training on changing basic psychological need satisfaction of underrepresented scholars with their mentors. Despite the lack of sustained effect of either mentor training or peer mentoring, these short-term changes suggest feasibility and potential for future study.

“Decrease in television viewing predicts lower BMI at one year follow up in adolescents but not adults”

PubMed Central

French, Simone A.; Mitchell, Nathan R.; Hannan, Peter J.

2012-01-01

Objective To examine associations between television viewing, sugar-sweetened beverage consumption, eating out, physical activity and body weight change over 1 year. Design Secondary data analysis from randomized intervention trial. Setting Households in the community. Participants Adults (n=153) and adolescents (n=72) from the same households. Intervention(s) Households were randomized to a home-based obesity prevention intervention or to a no-intervention control group for a one-year period. Main Outcome Measure(s) Self-reported television viewing hours, diet and physical activity. Body mass index computed from measured weight and height (primary outcome measure). Analysis Mixed-model regression. Results Among adolescents, a significant prospective association was observed between decreases in television viewing hours and lower BMI z-score at one year follow-up (decreased TV hours: BMI z-score mean = 0.65; no change or increase TV hrs: BMI zscore = 0.92; p < .02). No significant prospective associations were observed among adults. Conclusions and Implications Reducing television viewing may be an effective strategy to prevent excess weight gain among adolescents. PMID:22591582

Brief Motivational Interviewing Intervention for Peer Violence and Alcohol Use in Teens: One-Year Follow-up

PubMed Central

Chermack, Stephen T.; Zimmerman, Marc A.; Shope, Jean T.; Bingham, C. Raymond; Blow, Frederic C.; Walton, Maureen A.

2012-01-01

BACKGROUND AND OBJECTIVES: Emergency department (ED) visits present an opportunity to deliver brief interventions (BIs) to reduce violence and alcohol misuse among urban adolescents at risk for future injury. Previous analyses demonstrated that a BI resulted in reductions in violence and alcohol consequences up to 6 months. This article describes findings examining the efficacy of BIs on peer violence and alcohol misuse at 12 months. METHODS: Patients (14–18 years of age) at an ED reporting past year alcohol use and aggression were enrolled in the randomized control trial, which included computerized assessment, random assignment to control group or BI delivered by a computer or therapist assisted by a computer. The main outcome measures (at baseline and 12 months) included violence (peer aggression, peer victimization, violence-related consequences) and alcohol (alcohol misuse, binge drinking, alcohol-related consequences). RESULTS: A total of 3338 adolescents were screened (88% participation). Of those, 726 screened positive for violence and alcohol use and were randomly selected; 84% completed 12-month follow-up. In comparison with the control group, the therapist assisted by a computer group showed significant reductions in peer aggression (P < .01) and peer victimization (P < .05) at 12 months. BI and control groups did not differ on alcohol-related variables at 12 months. CONCLUSIONS: Evaluation of the SafERteens intervention 1 year after an ED visit provides support for the efficacy of computer-assisted therapist brief intervention for reducing peer violence. PMID:22614776

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

PubMed

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

2014-06-01

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

Independent exercise for glottal incompetence to improve vocal problems and prevent aspiration pneumonia in the elderly: a randomized controlled trial.

PubMed

Fujimaki, Yoko; Tsunoda, Koichi; Kobayashi, Rika; Tonghyo, Chong; Tanaka, Fujinobu; Kuroda, Hiroyuki; Numata, Tsutomu; Ishii, Toyota; Kuroda, Reiko; Masuda, Sawako; Hashimoto, Sho; Misawa, Hayato; Shindo, Naoko; Mori, Takahiro; Mori, Hiroko; Uchiyama, Naoki; Kamei, Yuichirou; Tanaka, Masashi; Hamaya, Hironobu; Funatsuki, Shingo; Usui, Satoko; Ito, Ikuno; Hamada, Kohei; Shindo, Akihito; Tokumaru, Yutaka; Morita, Yoko; Ueha, Rumi; Nito, Takaharu; Kikuta, Shu; Sekimoto, Sotaro; Kondo, Kenji; Sakamoto, Takashi; Itoh, Kenji; Yamasoba, Tatsuya; Matsumoto, Sumio

2017-08-01

To evaluate the effect of a self-controlled vocal exercise in elderly people with glottal closure insufficiency. Parallel-arm, individual randomized controlled trial. Patients who visited one of 10 medical centers under the National Hospital Organization group in Japan for the first time, aged 60 years or older, complaining of aspiration or hoarseness, and endoscopically confirmed to have glottal closure insufficiency owing to vocal cord atrophy, were enrolled in this study. They were randomly assigned to an intervention or a control group. The patients of the intervention group were given guidance and a DVD about a self-controlled vocal exercise. The maximum phonation time which is a measure of glottal closure was evaluated, and the number of patients who developed pneumonia during the six months was compared between the two groups. Of the 543 patients enrolled in this trial, 259 were allocated into the intervention group and 284 into the control; 60 of the intervention group and 75 of the control were not able to continue the trial. A total of 199 patients (age 73.9 ±7.25 years) in the intervention group and 209 (73.3 ±6.68 years) in the control completed the six-month trial. Intervention of the self-controlled vocal exercise extended the maximum phonation time significantly ( p < 0.001). There were two hospitalizations for pneumonia in the intervention group and 18 in the control group, representing a significant difference ( p < 0.001). The self-controlled vocal exercise allowed patients to achieve vocal cord adduction and improve glottal closure insufficiency, which reduced the rate of hospitalization for pneumonia significantly. gov Identifier-UMIN000015567.

Treatment of Female Sexual Dysfunction Through Symbolic Modeling

ERIC Educational Resources Information Center

Nemetz, Georgia H.; And Others

1978-01-01

Clients (N=16) were randomly assigned to two groups receiving either individual or group treatment. Treatment consisted of relaxation training followed by viewing 45 videotaped vignettes depicting graduated sexual behaviors. Improvement remained stable through a one-year follow-up. Control clients showed no improvement and trends toward…

Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background We describe the rationale and protocol for a randomized controlled trial (RCT) to assess whether intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests the novel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlights considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Methods/Design Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of 12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention) or four weeks (recommended care) post abortion. Primary outcome measure is pregnancy rate at one year. Secondary outcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economic analyses comparing immediate and delayed insertion groups, and device retention rates, complication rates (infection, expulsion) and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires, clinical records and British Columbia linked health databases will be used to assess primary and secondary outcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and is expected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014. Discussion The RCT design combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry and hospital records, offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one through five years among enrolled women. We highlight considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Trial registration Current Controlled Trials ISRCTN19506752 PMID:21672213

Telephone-Based Adiposity Prevention for Families with Overweight Children (T.A.F.F.-Study): One Year Outcome of a Randomized, Controlled Trial

PubMed Central

Markert, Jana; Herget, Sabine; Petroff, David; Gausche, Ruth; Grimm, Andrea; Kiess, Wieland; Blüher, Susann

2014-01-01

The one-year outcome of the randomized controlled T.A.F.F. (Telephone based Adiposity prevention For Families) study is presented. Screening of overweight (BMI-SDS > 90th centile) children 3.5–17.4 years was performed via the German CrescNet database, and candidates were randomized to an intervention group (IG) and control group (CG). The intervention consisted of computer-aided telephone counselling for one year, supported by mailed newsletters. The primary endpoint was change in BMI-SDS; secondary endpoints were eating behavior, physical activity, media consumption, quality of life. Data from 289 families (145 IG (51% females); 144 CG (50% females)) were analyzed (Full Analysis Set: FAS; Per Protocol Set: PPS). Successful intervention was defined as decrease in BMI-SDS ≥ 0.2. In the FAS, 21% of the IG was successful as compared to 16% from the CG (95% CI for this difference: (−4, 14), p = 0.3, mean change in BMI-SDS: −0.02 for IG vs. 0.02 for CG; p = 0.4). According to the PPS, however, the success rate was 35% in the IG compared to 19% in the CG (mean change in BMI-SDS: −0.09 for IG vs. 0.02 for CG; p = 0.03). Scores for eating patterns (p = 0.01), media consumption (p = 0.007), physical activity (p = 9 × 10−9), quality of life (p = 5 × 10−8) decreased with age, independent of group or change in BMI-SDS. We conclude that a telephone-based obesity prevention program suffers from well-known high attrition rates so that its effectiveness could only be shown in those who adhered to completion. The connection between lifestyle and weight status is not simple and requires further research to better understand. PMID:25286167

Accelerometer-assessed sedentary work, leisure time and cardio-metabolic biomarkers during one year: Effectiveness of a cluster randomized controlled trial in parents with a sedentary occupation and young children.

PubMed

Pesola, Arto J; Laukkanen, Arto; Heikkinen, Risto; Sipilä, Sarianna; Sääkslahti, Arja; Finni, Taija

2017-01-01

It is unknown whether reducing sedentary time at work and during leisure time is possible and effective during one year. Office workers with young children were recruited for this one-year cluster-randomized controlled trial through kindergartens and primary schools from 7 clusters in the city of Jyväskylä, Finland. After a lecture, face-to-face tailored counseling was used to set contractually binding goals regarding reducing and breaking up sitting periods and increasing light intensity physical activity during work and leisure time. Primary outcomes of total, work and leisure sedentary time (<100 counts/min, cpm), light activity time (<2020 cpm), moderate-to-vigorous activity time (MVPA) and breaks/sedentary hour were assessed with a waist-worn Alive -accelerometer for 7 days, 5 times during the year. Anthropometrics (DXA), fasting biomarkers and self-reported diet were assessed as secondary outcomes. Data were collected between 2011-2013 and analyzed between 2013-2016 with a linear mixed-effects model fit by REML using likelihood ratio test and intention-to-treat-principle. Participants from intervention (N = 71) and control (N = 62) regions were assessed at baseline and 117 completed the study. Sedentary leisure time decreased [-21.2 (95% CI -37.3 to -5.1) min/8 hours, likelihood ratio P<0.001] and light activity time [13.4 (-2.2 to 29.0) min/8 hours, P = 0.008] and breaks per sedentary hour [1.0 (-0.2 to 2.2), P = 0.010] increased in the intervention group as compared to controls at 3 months. The decrease in sedentary leisure time was maintained throughout the year [-7.9 (-24.0 to 8.3) min/8 hours, P = 0.029]. Small decreases in the control group's work and leisure MVPA were observed mostly at 3 months. Small favorable intervention effects were observed for fasting plasma glucose at 3 months and for leg lean mass and apoB/apoA-1 ratio at 12 months, with no changes in other outcomes. Behavioral counseling induced a small decline in sedentary leisure time throughout one year in parents with a sedentary occupation and young children. Small concurrent changes in different biomarkers suggest that reducing sedentary leisure time during one year may be beneficial. ISRCTN28668090, registered 30 November 2011.

YAG laser peripheral iridotomy for the prevention of pigment dispersion glaucoma a prospective, randomized, controlled trial.

PubMed

Scott, Andrew; Kotecha, Aachal; Bunce, Catey; Balidis, Miltos; Garway-Heath, David F; Miller, Michael H; Wormald, Richard

2011-03-01

To test the hypothesis that neodymium:yttrium-aluminum-garnet (Nd:YAG) laser peripheral iridotomy (LPI) significantly reduces the incidence of conversion from pigment dispersion syndrome (PDS) with ocular hypertension (OHT) to pigmentary glaucoma (PG). Prospective, randomized, controlled 3-year trial. One hundred sixteen eyes of 116 patients with PDS and OHT. Patients were assigned randomly either to Nd:YAG LPI or to a control group (no laser). The primary outcome measure was conversion to PG within 3 years, based on full-threshold visual field (VF) analysis using the Ocular Hypertension Treatment Study criteria. Secondary outcome measures were whether eyes required topical antiglaucoma medications during the study period and the time to conversion or medication. Fifty-seven patients were randomized to undergo laser treatment and 59 were randomized to no laser (controls). Age, gender, spherical equivalent refraction, and intraocular pressure at baseline were similar between groups. Outcome data were available for 105 (90%) of recruited subjects, 52 in the laser treatment group and 53 in the no laser treatment group. Patients were followed up for a median of 35.9 months (range, 10-36 months) in the laser arm and 35.9 months (range, 1-36 months) in the control arm. Eight eyes (15%) in the laser group and 3 eyes (6%) in the control group converted to glaucoma in the study period. The proportion of eyes started on medical treatment was similar in the 2 groups: 8 eyes (15%) in the laser group and 9 eyes (17%) in the control group. Survival analyses showed no evidence of any difference in time to VF progression or commencement of topical therapy between the 2 groups. Cataract extraction was performed on 1 patient in the laser group and in 1 patient in the control group during the study period (laser eye at 18 months; control eye at 34 months). This study suggests that there was no benefit of Nd:YAG LPI in preventing progression from PDS with OHT to PG within 3 years of follow-up. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Neurofeedback to improve neurocognitive functioning of children treated for a brain tumor: design of a randomized controlled double-blind trial.

PubMed

de Ruiter, Marieke A; Schouten-Van Meeteren, Antoinette Y N; van Mourik, Rosa; Janssen, Tieme W P; Greidanus, Juliette E M; Oosterlaan, Jaap; Grootenhuis, Martha A

2012-12-06

Neurotoxicity caused by treatment for a brain tumor is a major cause of neurocognitive decline in survivors. Studies have shown that neurofeedback may enhance neurocognitive functioning. This paper describes the protocol of the PRISMA study, a randomized controlled trial to investigate the efficacy of neurofeedback to improve neurocognitive functioning in children treated for a brain tumor. Efficacy of neurofeedback will be compared to placebo training in a randomized controlled double-blind trial. A total of 70 brain tumor survivors in the age range of 8 to 18 years will be recruited. Inclusion also requires caregiver-reported neurocognitive problems and being off treatment for more than two years. A group of 35 healthy siblings will be included as the control group. On the basis of a qEEG patients will be assigned to one of three treatment protocols. Thereafter patients will be randomized to receive either neurofeedback training (n=35) or placebo training (n=35). Neurocognitive tests, and questionnaires administered to the patient, caregivers, and teacher, will be used to evaluate pre- and post-intervention functioning, as well as at 6-month follow-up. Siblings will be administered the same tests and questionnaires once. If neurofeedback proves to be effective for pediatric brain tumor survivors, this can be a valuable addition to the scarce interventions available to improve neurocognitive and psychosocial functioning. ClinicalTrials.gov NCT00961922.

One-Year Efficacy Testing of Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) Randomized Control Trial

ERIC Educational Resources Information Center

Knowlden, Adam; Sharma, Manoj

2016-01-01

Background: The purpose of this study was to evaluate the efficacy of the Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) intervention at 1-year, postintervention follow-up. Method: A mixed between-within subjects design was used to evaluate the trial. Independent variables included a…

The Effect of Text Messaging on 9- and 10-Year-Old Children's Reading, Spelling and Phonological Processing Skills

ERIC Educational Resources Information Center

Wood, C.; Jackson, E.; Hart, L.; Plester, B.; Wilde, L.

2011-01-01

This paper reports on an intervention study that considered the impact of text messaging on 9- to 10-year-old children's literacy skills. One hundred and fourteen children who had never owned a mobile phone before were recruited and randomly allocated to either the intervention or control conditions. All children were pre- and post-tested on a…

Training Preschoolers on First-Order False Belief Understanding: Transfer on Advanced ToM Skills and Metamemory

ERIC Educational Resources Information Center

Lecce, Serena; Bianco, Federica; Demicheli, Patrizia; Cavallini, Elena

2014-01-01

This study investigated the relation between theory of mind (ToM) and metamemory knowledge using a training methodology. Sixty-two 4- to 5-year-old children were recruited and randomly assigned to one of two training conditions: A first-order false belief (ToM) and a control condition. Intervention and control groups were equivalent at pretest for…

Comparing the effectiveness of the BPMAP (Blood Pressure Management Application) and usual care in self-management of primary hypertension and adherence to treatment in patients aged 30-60 years: study protocol for a randomized controlled trial.

PubMed

Ashoorkhani, Mahnaz; Bozorgi, Ali; Majdzadeh, Reza; Hosseini, Hamed; Yoonessi, Ali; Ramezankhani, Ali; Eftekhar, Hassan

2016-10-21

Hypertension is one of the most important and well-known risk factors for cardiovascular diseases. Unfortunately, in spite of effective treatments, adherence to the regular use of drugs and other nondrug treatments, such as lifestyle improvement, is often poor. This study evaluates the effectiveness of an educational, supportive intervention - in the form of a Blood Pressure Management Application (BPMAP) - on self-management in patients with primary hypertension on controlling the determinant factors of hypertension, and on adherence to treatment. A two-arm, parallel-design randomized controlled clinical trial will be conducted on 30 to 60 year-old patients with primary hypertension who are attending the Tehran Heart Center. One hundred and thirty-two (132) patients will be randomly assigned to the intervention and control (usual method) groups. The most important inclusion criteria are, having primary hypertension and being pharmacologically treated for it, and not having developed the complications of hypertension, such as myocardial infarction, cerebral stroke and cardiac insufficiency. The participants should be able to read Persian and be able to use the application. The most important outcomes of the study include adherence to treatment, weight control, and regular monitoring of blood pressure which are assessed in the primary assessment (baseline data questionnaire) and again at the 8 th and 24 th weeks. The intervention is a mobile application that has capabilities such as reminders and scientific and supportive information. This application has been programmed to reduce many of the nonadherence factors of hypertension treatment. Therefore, the findings may contribute to a rise in adherence to treatment. If proven to have an appropriate impact, it may be extended for use in the national hypertension control plan. This study was registered in the Iran Randomized Clinical Trial Center under the number IRCT2015111712211N2 on 1 January 2016.

A Randomized Controlled Trial to Evaluate if Computerized Cognitive Rehabilitation Improves Neurocognition in Ugandan Children with HIV.

PubMed

Boivin, Michael J; Nakasujja, Noeline; Sikorskii, Alla; Opoka, Robert O; Giordani, Bruno

2016-08-01

Clinically stable children with HIV can have neuromotor, attention, memory, visual-spatial, and executive function impairments. We evaluated neuropsychological and behavioral benefits of computerized cognitive rehabilitation training (CCRT) in Ugandan HIV children. One hundred fifty-nine rural Ugandan children with WHO Stage I or II HIV disease (6 to 12 years; 77 boys, 82 girls; M = 8.9, SD = 1.86 years) were randomized to one of three treatment arms over a 2-month period. The CCRT arm received 24 one-hour sessions over 2 months, using Captain's Log (BrainTrain Corporation) programmed for games targeting working memory, attention, and visual-spatial analysis. These games progressed in difficulty as the child's performance improved. The second arm was a "limited CCRT" with the same games rotated randomly from simple to moderate levels of training. The third arm was a passive control group receiving no training. All children were assessed at enrollment, 2 months (immediately following CCRT), and 3 months after CCRT completion. The CCRT group had significantly greater gains through 3 months of follow-up compared to passive controls on overall Kaufman Assessment Battery for Children-second edition (KABC-II) mental processing index (p < .01), planning (p = .04), and knowledge (p = .03). The limited CCRT group performed better than controls on learning (p = .05). Both CCRT arms had significant improvements on CogState Groton maze learning (p < .01); although not on CogState attention/memory, TOVA/impulsivity, or behavior rating inventory for executive function and child behavior checklist (psychiatric behavior/symptom problems) ratings by caregiver. CCRT intervention can be effective for neurocognitive rehabilitation in children with HIV in low-resource settings, especially in children who are clinically stable on ARV treatment.

Tissue angiotensin-converting enzyme inhibitors for the prevention of cardiovascular disease in patients with diabetes mellitus without left ventricular systolic dysfunction or clinical evidence of heart failure: a pooled meta-analysis of randomized placebo-controlled clinical trials.

PubMed

Saha, S A; Molnar, J; Arora, R R

2008-01-01

The aim of this study was to determine the role of tissue angiotensin-converting enzyme (ACE) inhibitors in the prevention of cardiovascular disease in patients with diabetes mellitus without left ventricular systolic dysfunction or clinical evidence of heart failure in randomized placebo-controlled clinical trials using pooled meta-analysis techniques. Randomized placebo-controlled clinical trials of at least 12 months duration in patients with diabetes mellitus without left ventricular systolic dysfunction or heart failure who had experienced a prior cardiovascular event or were at high cardiovascular risk were selected. A total of 10 328 patients (43 517 patient-years) from four selected trials were used for meta-analysis. Relative risk estimations were made using data pooled from the selected trials and statistical significance was determined using the Chi-squared test (two-sided alpha error <0.05). The number of patients needed to treat was also calculated. Tissue ACE inhibitors significantly reduced the risk of cardiovascular mortality by 14.9% (p = 0.022), myocardial infarction by 20.8% (p = 0.002) and the need for invasive coronary revascularization by 14% (p = 0.015) when compared to placebo. The risk of all-cause mortality also tended to be lower among patients randomized to tissue ACE inhibitors, whereas the risks of stroke and hospitalization for heart failure were not significantly affected. Treating about 65 patients with tissue ACE inhibitors for about 4.2 years would prevent one myocardial infarction, whereas treating about 85 patients would prevent one cardiovascular death. Pooled meta-analysis of randomized placebo-controlled trials suggests that tissue ACE inhibitors modestly reduce the risk of myocardial infarction and cardiovascular death and tend to reduce overall mortality in diabetic patients without left ventricular systolic dysfunction or heart failure.

Evaluation of a communication skills seminar for students in a Japanese medical school: a non-randomized controlled study.

PubMed

Mukohara, Kei; Kitamura, Kazuya; Wakabayashi, Hideki; Abe, Keiko; Sato, Juichi; Ban, Nobutaro

2004-11-18

Little data exist for the effectiveness of communication skills teaching for medical students in non-English speaking countries. We conducted a non-randomized controlled study to examine if a short intensive seminar for Japanese medical students had any impact on communication skills with patients. Throughout the academic year 2001-2002, a total of 105 fifth-year students (18 groups of 5 to 7 students) participated, one group at a time, in a two-day, small group seminar on medical interviewing. Half way through the year, a five-station objective structured clinical examination (OSCE) was conducted for all fifth-year students. We videotaped all the students' interaction with a standardized patient in one OSCE station that was focused on communication skills. Two independent observers rated the videotapes of 50 students who had attended the seminar and 47 who had not. Sixteen core communication skills were measured. Disagreements between raters were resolved by a third observer's rating. There was a statistically significant difference in proportions of students who were judged as 'acceptable' in one particular skill related to understanding patient's perspectives: asking how the illness or problems affected the patient's life, (53% in the experimental group and 30% in the control group, p = .02). No differences were observed in the other 15 core communication skills, although there was a trend for improvement in the skill for asking the patient's ideas about the illness or problems (60% vs. 40%, p = .054) and one of the relationship building skills; being attentive and empathic nonverbally (87% vs. 72%, p = .064). The results of this study suggest that a short, intensive small group seminar for Japanese medical students may have had a short-term impact on specific communication skills, pertaining to understanding patient's perspectives.

Health effects of cow's milk consumption in infants up to 3 years of age: a systematic review and meta-analysis.

PubMed

Griebler, Ursula; Bruckmüller, Melanie U; Kien, Christina; Dieminger, Birgit; Meidlinger, Bettina; Seper, Katrin; Hitthaller, Ariane; Emprechtinger, Robert; Wolf, Alexandra; Gartlehner, Gerald

2016-02-01

To summarize the best available evidence regarding the short- and long-term health effects of cow's milk intake in healthy, full-term infants up to 3 years of age. We conducted a systematic review and meta-analysis. We searched MEDLINE (via PubMed), EMBASE and the Cochrane Library between 1960 and July 2013 and manually reviewed reference lists of pertinent articles. Two researchers independently reviewed abstracts and full-text articles and extracted relevant data. We included (randomized/non-randomized) controlled trials and observational studies. We included data from twenty-three studies (one randomized controlled trial, four non-randomized controlled trials, eight case-control studies and ten cohort studies) for the evidence synthesis. Pooled results of four studies revealed a higher risk of Fe-deficiency anaemia for infants consuming cow's milk compared with those consuming follow-on formula (relative risk=3·76; 95 % CI 2·73, 5·19). For type 1 diabetes mellitus, six out of seven case-control studies did not show a difference in the risk of developing this disease based on the age of introduction of cow's milk. We did not find negative associations for other health effects. Cow's milk consumption in infancy is associated with an increased risk of developing Fe-deficiency anaemia. Limiting cow's milk consumption may be important to ensure an adequate Fe intake for infants and toddlers. High-quality patient information for caregivers is needed on how infants' Fe requirements can be met.

[Effects of egg and milk supplementation on growth and development among children in poor rural area].

PubMed

Lin, Shuang; Hu, Xiaoqi; Zhang, Fan; Ruan, Qing; Tang, Wen; Tao, Longxiang; Pan, Hui; Zhang, Qian

2015-08-01

To evaluate the effects of egg and milk supplementation on growth and development and body composition among children in poor rural area in Tianyang County of Guangxi province. Total four schools were randomly selected from four towns in Tianyang County of Guangxi province as intervention group in April, 2013. The intervention measures included that these students were given salty egg (net weight: 50 g) and ultra-high-temperature-sterilization school milk (net weight: 200 g) every school day and these schools were equipped with standard kitchens. Another four schools of familiar socio-economic level, teaching quality and size from the same town were randomly chosen as control group and none of the intervention measures were implemented. About 25 students were randomly selected and stratified by grades from grade one to grade five. The height, weight, and body composition of all students were measured in April, 2013 and one year after the intervention. A total of 978 students were measured at baseline from age 6 to 13, 552 students as intervention group and 426 as control group. t-test was used to compare the differences between groups and multivariate unconditional logistic regression was used to analyze the factors of malnutrition. After one year intervention, 892 students were measured randomly, with 515 students in intervention group and 377 in control one. The average weight of boys in intervention group increased (3.6 ± 1.7) kg compared with baseline. It was significantly higher than that of control group ((2.9 ± 1.5) kg) (t = 4.40, P < 0.001). The boy's lean body mass of intervention group increased (2.6 ± 1.4) kg, higher than the control group ((2.0 ± 1.2) kg) (t = 3.95, P < 0.001). The decrease of malnutrition rate of intervention schools (11.8%) was significantly higher than that of the control schools (4.7%, χ² = 16.90, P < 0.001), and the odds ratio was 0.37 (95% CI: 0.23-0.59). The risk difference of overweight and obesity was not statistically significant between the two groups (OR = 1.68, 95% CI: 0.57-4.94). After supplementing milk and egg, the nutritional status of the poor rural pupils was improved.

One-year postpartum outcomes following a weight management intervention in pregnant women with obesity

PubMed Central

Vesco, Kimberly K.; Leo, Michael C.; Karanja, Njeri; Gillman, Matthew W.; McEvoy, Cindy T.; King, Janet C.; Eckhardt, Cara L.; Smith, K. Sabina; Perrin, Nancy; Stevens, Victor J.

2016-01-01

Objective This analysis focuses on 1-year maternal and infant follow-up of a randomized trial that tested a weight management intervention conducted during pregnancy. Methods We randomly assigned 114 women with obesity (mean BMI 36.7 kg/m2) at a mean of 15 weeks’ gestation to a weight management intervention or usual care control condition. The intervention ended at delivery and resulted in less gestational weight gain and a lower proportion of large-for-gestational age newborns among intervention compared to control participants. The primary outcome at 12 months postpartum was maternal weight. Secondary outcomes included infant weight-for-age and weight-for-length z-scores. Results At 1 year, mothers in the intervention group weighed 96.3±18.6 kg, and in the control group, 99.7±19.2 kg. There was no significant difference between groups in change in weight from randomization to 1-year postpartum (b=-0.47, 95% CI [-4.03, 3.08]. There was a significant main effect of group for infant weight-for-age z-score (b=-0.40, 95% CI [-0.75,-0.05]) but not infant weight-for-length z-scores (b=-0.20, 95% CI [-0.59,0.20]. Conclusions A gestational weight management intervention did not influence maternal weight or infant weight-for-length at 1-year postpartum. Future studies may be warranted to determine if extending prenatal interventions into the postpartum period would be beneficial for maternal and infant outcomes. PMID:27670399

Effectiveness of a 12-week school-based educational preventive programme on weight and fasting blood glucose in "at-risk" adolescents of type 2 diabetes mellitus: Randomized controlled trial.

PubMed

Bani Salameh, Ayman; Al-Sheyab, Nihaya; El-Hneiti, Mamdouh; Shaheen, Abeer; Williams, Leonie M; Gallagher, Robyn

2017-06-01

To assess the effectiveness of a 12-week school-based educational preventive programme for type 2 diabetes by change in weight and fasting blood glucose level in Jordanian adolescents. Sixteen percent of Jordanian adults have obesity-related type 2 diabetes and 5.6% of obese adolescents examined, however one-third unexamined. Rates in Arabic countries will double in 20 years, but this can be prevented and reversed by controlling obesity. A single-blinded randomized controlled trial was conducted in 2 unisex high schools in Irbid, Jordan, in 2012. Intervention and control participants, aged 12 to 18 years, were visibly overweight/obese. They were randomly allocated to the intervention (n = 205) or control (n = 196) groups. At-risk students were assessed before and after the 12-week intervention, for change in weight and fasting blood glucose level following preventive instruction and parent-supported changes. Mean age of participants was 15.3 years with equal percentages of both males (49.4%) and females. Post intervention, the intervention group, demonstrated statistically significant reductions: mean difference of 3.3 kg in weight (P < .000) and 1.36 mg/dL (0.075 mmol/L) in fasting blood glucose (P < .000). School-based early prevention intervention effectively reduced weight and fasting blood glucose in Jordanian at-risk adolescents. © 2017 John Wiley & Sons Australia, Ltd.

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

PubMed

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

2009-08-01

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

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

PubMed Central

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

2009-01-01

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

The effectiveness of propolis on gingivitis: a randomized controlled trial.

PubMed

Bretz, Walter A; Paulino, Niraldo; Nör, Jacques E; Moreira, Alexandre

2014-12-01

A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days -14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). The 38 persons who completed the study (age 13-22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period.

ASPREE-NEURO study protocol: A randomized controlled trial to determine the effect of low-dose aspirin on cerebral microbleeds, white matter hyperintensities, cognition, and stroke in the healthy elderly.

PubMed

Ward, Stephanie A; Raniga, Parnesh; Ferris, Nicholas J; Woods, Robyn L; Storey, Elsdon; Bailey, Michael J; Brodtmann, Amy; Yates, Paul A; Donnan, Geoffrey A; Trevaks, Ruth E; Wolfe, Rory; Egan, Gary F; McNeil, John J

2017-01-01

Rationale Cerebral microbleeds seen on brain magnetic resonance imaging are markers of small vessel disease, linked to cognitive dysfunction and increased ischemic and hemorrhagic stroke risk. Observational studies suggest that aspirin use may induce cerebral microbleeds, and associated overt intracranial hemorrhage, but this has not been definitively resolved. Aims ASPREE-NEURO will determine the effect of aspirin on cerebral microbleed development over three years in healthy adults aged 70 years and over, participating in the larger 'ASPirin in Reducing Events in the Elderly (ASPREE)' primary prevention study of aspirin. Sample size Five hundred and fifty-nine participants provide 75% power (two-sided p value of 0.05) to determine an average difference of 0.5 cerebral microbleed per person after three years. Methods and design A multi-center, randomized placebo-controlled trial of 100 mg daily aspirin in participants who have brain magnetic resonance imaging at study entry, one and three years after randomization and who undergo cognitive testing at the same time points. Study outcomes The primary outcome is the number of new cerebral microbleeds on magnetic resonance imaging after three years. Secondary outcomes are the number of new cerebral microbleeds after one year, change in volume of white matter hyperintensity, cognitive function, and stroke. Discussion ASPREE-NEURO will resolve whether aspirin affects the presence and number of cerebral microbleeds, their relationship with cognitive performance, and indicate whether consideration of cerebral microbleeds alters the risk-benefit profile of aspirin in primary prevention for older people. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12613001313729.

Coaching to Augment Mentoring to Achieve Faculty Diversity: A Randomized Controlled Trial.

PubMed

Williams, Simon N; Thakore, Bhoomi K; McGee, Richard

2016-08-01

The Academy for Future Science Faculty (the Academy) is a novel coaching intervention for biomedical PhD students designed to address limitations in previous efforts to promote faculty diversity. Unlike traditional research mentoring, the Academy includes both group and individual coaching, coaches have no research or evaluation roles with the students, and it is based on social science theories. The authors present a qualitative case study of one of the coaching groups and provide statistical analyses indicating whether one year in the Academy effects students' perceptions of the achievability and desirability of an academic career. The authors tested (July 2012-July 2013), with Northwestern University ethical approval, the Academy via a longitudinal randomized controlled trial. Participants were 121 latter-stage biomedical PhD students. The authors collected data via questionnaires, interviews, and meeting recordings. The case study shows how group career coaching can effectively supplement traditional one-to-one research mentoring; provide new role models for underrepresented minority students; and provide theory-based lenses through which to engage in open conversations about race, gender, and science careers. Repeated-measures analysis of variance showed that perceived achievability increased in the Academy group from baseline to one-year follow-up (mean, 5.75 versus 6.39) but decreased in the control group (6.58 versus 5.81). Perceived desirability decreased significantly less (P < .05) in the Academy group (7.00 versus 6.36) than in the control group (7.83 versus 5.97). Early results suggest that an academic career coaching model can effectively supplement traditional research mentoring and promote persistence toward academic careers.

Preoperative pain neuroscience education for lumbar radiculopathy: a multicenter randomized controlled trial with 1-year follow-up.

PubMed

Louw, Adriaan; Diener, Ina; Landers, Merrill R; Puentedura, Emilio J

2014-08-15

Multicenter, randomized, controlled trial on preoperative pain neuroscience education (NE) for lumbar radiculopathy. To determine if the addition of NE to usual preoperative education would result in superior outcomes with regard to pain, function, surgical experience, and health care utilization postsurgery. One in 4 patients after lumbar surgery (LS) for radiculopathy experience persistent pain and disability, which is nonresponsive to perioperative treatments. NE focusing on the neurophysiology of pain has been shown to decrease pain and disability in populations with chronic low back pain. Eligible patients scheduled for LS for radiculopathy were randomized to receive either preoperative usual care (UC) or a combination of UC plus 1 session of NE delivered by a physical therapist (verbal one-on-one format) and a NE booklet. Sixty-seven patients completed the following outcomes prior to LS (baseline), and 1, 3, 6, and 12 months after LS: low back pain (numeric rating scale), leg pain (numeric rating scale), function (Oswestry Disability Index), various beliefs and experiences related to LS (10-item survey with Likert scale responses), and postoperative utilization of health care (utilization of health care questionnaire). At 1-year follow-up, there were no statistical differences between the experimental and control groups with regard to primary outcome measure of low back pain (P = 0.183), leg pain (P = 0.075), and function (P = 0.365). In a majority of the categories regarding surgical experience, the NE group scored significantly better: better prepared for LS (P = 0.001); preoperative session preparing them for LS (P < 0.001) and LS meeting their expectations (P = 0.021). Health care utilization post-LS also favored the NE group (P = 0.007) resulting in 45% less health care expenditure compared with the control group in the 1-year follow-up period. NE resulted in significant behavior change. Despite a similar pain and functional trajectory during the 1-year trial, patients with LS who received NE viewed their surgical experience more favorably and used less health care facility in the form of medical tests and treatments. 2.

Stanford GEMS phase 2 obesity prevention trial for low-income African-American girls: design and sample baseline characteristics.

PubMed

Robinson, Thomas N; Kraemer, Helena C; Matheson, Donna M; Obarzanek, Eva; Wilson, Darrell M; Haskell, William L; Pruitt, Leslie A; Thompson, Nikko S; Haydel, K Farish; Fujimoto, Michelle; Varady, Ann; McCarthy, Sally; Watanabe, Connie; Killen, Joel D

2008-01-01

African-American girls and women are at high risk of obesity and its associated morbidities. Few studies have tested obesity prevention strategies specifically designed for African-American girls. This report describes the design and baseline findings of the Stanford GEMS (Girls health Enrichment Multi-site Studies) trial to test the effect of a two-year community- and family-based intervention to reduce weight gain in low-income, pre-adolescent African-American girls. Randomized controlled trial with measurements scheduled in girls' homes at baseline, 6, 12, 18 and 24 month post-randomization. Low-income areas of Oakland, CA. Eight, nine and ten year old African-American girls and their parents/caregivers. Girls are randomized to a culturally-tailored after-school dance program and a home/family-based intervention to reduce screen media use versus an information-based community health education Active-Placebo Comparison intervention. Interventions last for 2 years for each participant. Change in body mass index over the two-year study. Recruitment and enrollment successfully produced a predominately low-socioeconomic status sample. Two-hundred sixty one (261) families were randomized. One girl per family is randomly chosen for the analysis sample. Randomization produced comparable experimental groups with only a few statistically significant differences. The sample had a mean body mass index (BMI) at the 74 th percentile on the 2000 CDC BMI reference, and one-third of the analysis sample had a BMI at the 95th percentile or above. Average fasting total cholesterol and LDL cholesterol were above NCEP thresholds for borderline high classifications. Girls averaged low levels of moderate to vigorous physical activity, more than 3 h per day of screen media use, and diets high in energy from fat. The Stanford GEMS trial is testing the benefits of culturally-tailored after-school dance and screen-time reduction interventions for obesity prevention in low-income, pre-adolescent African-American girls.

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

PubMed

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

2015-08-01

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

Fluoroscopic Caudal Epidural Injections in Managing Post Lumbar Surgery Syndrome: Two-Year Results of a Randomized, Double-Blind, Active-Control Trial

PubMed Central

Manchikanti, Laxmaiah; Singh, Vijay; Cash, Kimberly A.; Pampati, Vidyasagar; Datta, Sukdeb

2012-01-01

Study Design: A randomized, active control, double-blind trial. Objective: To evaluate the effectiveness of fluoroscopically directed caudal epidural injections with or without steroids in managing chronic low back and lower extremity pain secondary to post lumbar surgery syndrome. Summary of Background Data: There is a paucity of evidence concerning caudal epidural injections for managing chronic persistent low back pain with or without lower extremity pain caused by post lumbar surgery syndrome. Methods: This active control randomized study included 140 patients with 70 patients in each group. Group I received 0.5% lidocaine, 10 mL; Group II received 9 mL of 0.5% lidocaine mixed with 1 mL of 6 mg of nonparticulate betamethasone. The multiple outcome measures included the numeric rating scale, the Oswestry Disability Index 2.0, employment status, and opioid intake with assessments at 3, 6, 12, 18, and 24 months posttreatment. Primary outcome was defined as at least 50% improvement in pain and Oswestry Disability Index scores. Patients with a positive response to the first 2 procedures with at least 3 weeks of relief were considered to be successful. All others were considered as failures. Results: Overall in Group I, 53% and 47% of the patients and in Group II, 59% and 58% of the patients, showed significant improvement with reduction in pain scores and disability index at 12 months and 24 months. In contrast, in the successful groups, significant pain relief and improvement in function were observed in 70% and 62% of Group I at one and 2 years; in 75% and 69% of Group II at one and 2 years. The results in the successful group showed that at the end of the first year patients experienced approximately 38 weeks of relief and at the end of 2 years Group I had 62 weeks and Group II had 68 weeks of relief. Overall total relief for 2 years was 48 weeks in Group I and 54 weeks in Group II. The average procedures in the successful groups were at 4 in one year and 6 at the end of 2 years. Conclusion: Caudal epidural injections of local anesthetic with or without steroid might be effective in patients with chronic persistent low back and/or lower extremity pain in patients with post lumbar surgery syndrome. PMID:23028241

The healthy options for nutrition environments in schools (Healthy ONES) group randomized trial: using implementation models to change nutrition policy and environments in low income schools

PubMed Central

2012-01-01

Background The Healthy Options for Nutrition Environments in Schools (Healthy ONES) study was an evidence-based public health (EBPH) randomized group trial that adapted the Institute for Healthcare Improvement’s (IHI) rapid improvement process model to implement school nutrition policy and environmental change. Methods A low-income school district volunteered for participation in the study. All schools in the district agreed to participate (elementary = 6, middle school = 2) and were randomly assigned within school type to intervention (n = 4) and control (n =4) conditions following a baseline environmental audit year. Intervention goals were to 1) eliminate unhealthy foods and beverages on campus, 2) develop nutrition services as the main source on campus for healthful eating (HE), and 3) promote school staff modeling of HE. Schools were followed across a baseline year and two intervention years. Longitudinal assessment of height and weight was conducted with second, third, and sixth grade children. Behavioral observation of the nutrition environment was used to index the amount of outside foods and beverages on campuses. Observations were made monthly in each targeted school environment and findings were presented as items per child per week. Results From an eligible 827 second, third, and sixth grade students, baseline height and weight were collected for 444 second and third grade and 135 sixth grade students (51% reach). Data were available for 73% of these enrolled students at the end of three years. Intervention school outside food and beverage items per child per week decreased over time and control school outside food and beverage items increased over time. The effects were especially pronounced for unhealthy foods and beverage items. Changes in rates of obesity for intervention school (28% baseline, 27% year 1, 30% year 2) were similar to those seen for control school (22% baseline, 22% year 1, 25% year 2) children. Conclusions Healthy ONES adaptation of IHI’s rapid improvement process provided a promising model for implementing nutrition policy and environmental changes that can be used in a variety of school settings. This approach may be especially effective in assisting schools to implement the current federally-mandated wellness policies. PMID:22734945

Efficacy of a virtual assistance-based lifestyle intervention in reducing risk factors for Type 2 diabetes in young employees in the information technology industry in India: LIMIT, a randomized controlled trial.

PubMed

Limaye, T; Kumaran, K; Joglekar, C; Bhat, D; Kulkarni, R; Nanivadekar, A; Yajnik, C

2017-04-01

To investigate a virtual assistance-based lifestyle intervention to reduce risk factors for Type 2 diabetes in young employees in the information technology industry in India. LIMIT (Lifestyle Modification in Information Technology) was a parallel-group, partially blinded, randomized controlled trial. Employees in the information technology industry with ≥3 risk factors (family history of cardiometabolic disease, overweight/obesity, high blood pressure, impaired fasting glucose, hypertriglyceridaemia, high LDL cholesterol and low HDL cholesterol) from two industries were randomized to a control or an intervention (1:1) group. After initial lifestyle advice, the intervention group additionally received reinforcement through mobile phone messages (three per week) and e-mails (two per week) for 1 year. The primary outcome was change in prevalence of overweight/obesity, analysed by intention to treat. Of 437 employees screened (mean age 36.2 ± 9.3 years; 74.8% men), 265 (61.0%) were eligible and randomized into control (n=132) or intervention (n=133) group. After 1 year, the prevalence of overweight/obesity reduced by 6.0% in the intervention group and increased by 6.8% in the control group (risk difference 11.2%; 95% CI 1.2-21.1; P=0.042). There were also significant improvements in lifestyle measurements, waist circumference, and total and LDL cholesterol in the intervention group. The number-needed-to-treat to prevent one case of overweight/obesity in 1 year was 9 (95% CI 5-82), with an incremental cost of INR10665 (£112.30) per case treated/prevented. A total of 98% of participants found the intervention acceptable. A virtual assistance-based lifestyle intervention was effective, cost-effective and acceptable in reducing risk factors for diabetes in young employees in the information technology industry, and is potentially scalable. © 2016 Diabetes UK.

What's in a title? An assessment of whether randomized controlled trial in a title means that it is one.

PubMed

Koletsi, Despina; Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2012-06-01

In this study, we aimed to investigate whether studies published in orthodontic journals and titled as randomized clinical trials are truly randomized clinical trials. A second objective was to explore the association of journal type and other publication characteristics on correct classification. American Journal of Orthodontics and Dentofacial Orthopedics, European Journal of Orthodontics, Angle Orthodontist, Journal of Orthodontics, Orthodontics and Craniofacial Research, World Journal of Orthodontics, Australian Orthodontic Journal, and Journal of Orofacial Orthopedics were hand searched for clinical trials labeled in the title as randomized from 1979 to July 2011. The data were analyzed by using descriptive statistics, and univariable and multivariable examinations of statistical associations via ordinal logistic regression modeling (proportional odds model). One hundred twelve trials were identified. Of the included trials, 33 (29.5%) were randomized clinical trials, 52 (46.4%) had an unclear status, and 27 (24.1%) were not randomized clinical trials. In the multivariable analysis among the included journal types, year of publication, number of authors, multicenter trial, and involvement of statistician were significant predictors of correctly classifying a study as a randomized clinical trial vs unclear and not a randomized clinical trial. From 112 clinical trials in the orthodontic literature labeled as randomized clinical trials, only 29.5% were identified as randomized clinical trials based on clear descriptions of appropriate random number generation and allocation concealment. The type of journal, involvement of a statistician, multicenter trials, greater numbers of authors, and publication year were associated with correct clinical trial classification. This study indicates the need of clear and accurate reporting of clinical trials and the need for educating investigators on randomized clinical trial methodology. Copyright © 2012 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

A randomized trial of lifestyle intervention in primary healthcare for the modification of cardiovascular risk factors.

PubMed

Eriksson, K Margareta; Westborg, Carl-Johan; Eliasson, Mats C E

2006-01-01

To evaluate the effects of a lifestyle intervention programme in primary healthcare, targeted to patients with moderate to high risk of cardiovascular disease in terms of cardiovascular risk factors, physical activity, and quality of life. Randomized controlled trial with one-year follow-up, carried out in a primary healthcare centre in Northern Sweden. A total of 151 middle-aged men and women, with hypertension, dyslipidemia, type 2 diabetes, or obesity were enrolled. The subjects were randomized to either the intervention (n = 75) or the control group (n = 76). A total of 123 subjects completed the one-year follow-up. Exercise: supervised endurance and circuit training in groups three times a week for three months. Diet: five group sessions of diet counselling with a dietitian. Follow- up meetings with a physiotherapist were conducted monthly thereafter. Primary outcomes were changes in anthropometry, maximal oxygen uptake, health-related quality of life, and self-reported physical activity. The secondary outcomes were changes in blood pressure and metabolic variables. After one year the intervention group significantly increased maximal oxygen uptake, physical activity, and quality of life and significantly decreased body weight, waist and hip circumference, body mass index, waist-hip ratio, systolic and diastolic blood pressure, triglycerides, and glycosylated haemoglobin. There were significant differences between groups, mean changes (and their 95% confidence intervals, CI) in waist circumference -1.9 cm (-2.80 to -0.90; p<0.001), in waist-hip ratio -0.01 (-.02 to -0.004; p<0.01) and in diastolic blood pressure -2.3 mmHg (-4.04 to -0.51; p<0.05). A prevention programme in primary healthcare with a focus on physical activity and diet counselling followed by structured follow-up meetings can favourably influence several risk factors for cardiovascular diseases and quality of life in high-risk subjects for at least one year.

COACH trial: A randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: Rationale and design

PubMed Central

Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

2011-01-01

Background Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. Methods The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. Results A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. Conclusions This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. PMID:21241828

COACH trial: a randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: rationale and design.

PubMed

Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

2011-05-01

Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. Copyright © 2011 Elsevier Inc. All rights reserved.

Counseling African Americans to Control Hypertension (CAATCH) Trial: A Multi-level Intervention to Improve Blood Pressure Control in Hypertensive African Americans

PubMed Central

Ogedegbe, Gbenga; Tobin, Jonathan N.; Fernandez, Senaida; Gerin, William; Diaz-Gloster, Marleny; Cassells, Andrea; Khalida, Chamanara; Pickering, Thomas; Schoenthaler, Antoinette; Ravenell, Joseph

2009-01-01

Background Despite strong evidence of effective interventions targeted at blood pressure (BP) control, there is little evidence on the translation of these approaches to routine clinical practice in care of hypertensive African Americans. The goal of this study is to evaluate the effectiveness of a multi-level, multi-component, evidence-based intervention compared to usual care in improving BP control among hypertensive African Americans who receive care in Community Health Centers (CHCs). The primary outcomes are BP control rate at 12 months; and maintenance of intervention one year after the trial. The secondary outcomes are within-patient change in BP from baseline to 12 months and cost effectiveness of the intervention. Methods and Results Counseling African Americans to Control Hypertension (CAATCH) is a group randomized clinical trial with two conditions: Intervention Condition (IC) and Usual Care (UC). Thirty CHCs were randomly assigned equally to the IC group (N=15) or the UC group (N=15). The intervention is comprised of three components targeted at patients (interactive computerized hypertension education; home BP monitoring; and monthly behavioral counseling on lifestyle modification) and two components targeted at physicians (monthly case rounds based on JNC-7 guidelines; chart audit and provision of feedback on clinical performance and patients’ home BP readings). All outcomes are assessed at quarterly study visits for one year. Chart review is conducted at 24 months to evaluate maintenance of intervention effects and sustainability of the intervention. Conclusions Poor BP control is one of the major reasons for the mortality gap between African Americans and whites. Findings from this study, if successful, will provide salient information needed for translation and dissemination of evidence-based interventions targeted at BP control into clinical practice for this high-risk population. PMID:20031845

Laparoscopic extraperitoneal inguinal hernia repair versus open mesh repair: a prospective randomized controlled trial.

PubMed

Andersson, Bodil; Hallén, Magnus; Leveau, Per; Bergenfelz, Anders; Westerdahl, Johan

2003-05-01

This study was designed to compare an open tension-free technique (Lichtenstein repair) with a laparoscopic totally extraperitoneal hernia repair (TEP). One hundred sixty-eight men aged 30 to 65 years with primary or recurrent inguinal hernia were randomized to TEP or open mesh technique in the manner of Lichtenstein. Follow-up was after 1 and 6 weeks, and 1 year. Eighty-one patients were randomized to TEP, and 87 to open repair. For 1 patient in each group, the operation was converted to a different type of repair. No difference was seen in overall complications between the 2 groups. However, 1 patient in the TEP group underwent operation for small bowel obstruction after surgery. A higher frequency of postoperative hematomas was seen in the open group (P <.05). Patients in the TEP group consumed less analgesic after surgery (P <.001), returned to work earlier (P <.01), and had a shorter time to full recovery (P <.01). Two recurrences occurred in the TEP group 1 year after surgery. The TEP technique was associated with less postoperative pain, a shorter time to full recovery, and an earlier return to work compared with the open tension-free repair. No difference was seen in overall complications. However, 2 recurrences did occur after 1 year in the TEP group.

The addition of upper cervical manipulative therapy in the treatment of patients with fibromyalgia: a randomized controlled trial.

PubMed

Moustafa, Ibrahim M; Diab, Aliaa A

2015-07-01

The aim of this study was to investigate the immediate and long-term effects of a one-year multimodal program, with the addition of upper cervical manipulative therapy, on fibromyalgia management outcomes in addition to three-dimensional (3D) postural measures. This randomized clinical trial with one-year follow-up was completed at the research laboratory of our university. A total of 120 (52 female) patients with fibromyalgia syndrome (FMS) and definite C1-2 joint dysfunction were randomly assigned to the control or an experimental group. Both groups received a multimodal program; additionally, the experimental group received upper cervical manipulative therapy. Primary outcomes were the Fibromyalgia Impact Questionnaire (FIQ), whereas secondary outcomes included Pain Catastrophizing Scale (PCS), algometric score, Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and 3D postural measures. Measures were assessed at three time intervals: baseline, 12 weeks, and 1 year after the 12-week follow-up. The general linear model with repeated measures indicated a significant group × time effect in favor of the experimental group on the measures of 3D postural parameters (P < .0005), FIQ (P < .0005), PCS (P < .0005), algometric score (F = P < .0005), PSQI (P < .0005), BAI (P < .0005), and BDI (P < .0005). The addition of the upper cervical manipulative therapy to a multimodal program is beneficial in treating patients with FMS.

Running injuries in novice runners enrolled in different training interventions: a pilot randomized controlled trial.

PubMed

Baltich, J; Emery, C A; Whittaker, J L; Nigg, B M

2017-11-01

The purpose of this trial was to evaluate injury risk in novice runners participating in different strength training interventions. This was a pilot randomized controlled trial. Novice runners (n = 129, 18-60 years old, <2 years recent running experience) were block randomized to one of three groups: a "resistance" strength training group, a "functional" strength training group, or a stretching "control" group. The primary outcome was running related injury. The number of participants with complaints and the injury rate (IR = no. injuries/1000 running hours) were quantified for each intervention group. For the first 8 weeks, participants were instructed to complete their training intervention three to five times a week. The remaining 4 months was a maintenance period. NCT01900262. A total of 52 of the 129 (40%) novice runners experienced at least one running related injury: 21 in the functional strength training program, 16 in the resistance strength training program and 15 in the control stretching program. Injury rates did not differ between study groups [IR = 32.9 (95% CI 20.8, 49.3) in the functional group, IR = 31.6 (95% CI 18.4, 50.5) in the resistance group, and IR = 26.7 (95% CI 15.2, 43.2)] in the control group. Although this was a pilot assessment, home-based strength training did not appear to alter injury rates compared to stretching. Future studies should consider methods to minimize participant drop out to allow for the assessment of injury risk. Injury risk in novice runners based on this pilot study will inform the development of future larger studies investigating the impact of injury prevention interventions. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

rhBMP-2 for posterolateral instrumented lumbar fusion: a multicenter prospective randomized controlled trial.

PubMed

Hurlbert, R John; Alexander, David; Bailey, Stewart; Mahood, James; Abraham, Ed; McBroom, Robert; Jodoin, Alain; Fisher, Charles

2013-12-01

Multicenter randomized controlled trial. To evaluate the effect of recombinant human bone morphogenetic protein (rhBMP-2) on radiographical fusion rate and clinical outcome for surgical lumbar arthrodesis compared with iliac crest autograft. In many types of spinal surgery, radiographical fusion is a primary outcome equally important to clinical improvement, ensuring long-term stability and axial support. Biologic induction of bone growth has become a commonly used adjunct in obtaining this objective. We undertook this study to objectify the efficacy of rhBMP-2 compared with traditional iliac crest autograft in instrumented posterolateral lumbar fusion. Patients undergoing 1- or 2-level instrumented posterolateral lumbar fusion were randomized to receive either autograft or rhBMP-2 for their fusion construct. Clinical and radiographical outcome measures were followed for 2 to 4 years postoperatively. One hundred ninety seven patients were successfully randomized among the 8 participating institutions. Adverse events attributable to the study drug were not significantly different compared with controls. However, the control group experienced significantly more graft-site complications as might be expected. 36-Item Short Form Health Survey, Oswestry Disability Index, and leg/back pain scores were comparable between the 2 groups. After 4 years of follow-up, radiographical fusion rates remained significantly higher in patients treated with rhBMP-2 (94%) than those who received autograft (69%) (P = 0.007). The use of rhBMP-2 for instrumented posterolateral lumbar surgery significantly improves the chances of radiographical fusion compared with the use of autograft. However, there is no associated improvement in clinical outcome within a 4-year follow-up period. These results suggest that use of rhBMP-2 should be considered in cases where lumbar arthrodesis is of primary concern.

Placebo-controlled trial of lubiprostone for constipation associated with Parkinson disease.

PubMed

Ondo, W G; Kenney, C; Sullivan, K; Davidson, A; Hunter, C; Jahan, I; McCombs, A; Miller, A; Zesiewicz, T A

2012-05-22

To evaluate the efficacy and tolerability of lubiprostone (Amitiza) for constipation in Parkinson disease (PD) in a double-blind, randomized, controlled study. Patients with PD and clinically meaningful constipation (constipation rating scale score > 10 [range: 0-28]) were recruited from 2 academic movement disorder centers to participate in the study. After enrollment, patients were initially followed for 2 weeks and then were randomly assigned 1:1 to lubiprostone, and the dose was titrated up to 48 μg/day. They returned 4 weeks later for a final assessment. Data included stool diaries and global impressions (co-primary endpoints), demographics, Unified Parkinson's Disease Rating Scale scores, constipation scale scores, visual analog scale (VAS) scores, a stool diary, and adverse events. Fifty-four subjects (39 male, mean age 67.0 ± 10.1 years, and mean duration of PD 8.3 ± 5.4 years) were randomly assigned to lubiprostone or placebo. One patient in the drug group discontinued the study because of logistics, and one patient in the placebo group discontinued the study because of lack of efficacy. A marked or very marked clinical global improvement was reported by 16 of 25 (64.0%) subjects receiving drug vs 5 of 27 (18.5%) subjects receiving placebo (p = 0.001). The constipation rating scale (p < 0.05), VAS (p = 0.001), and stools per day in the diary (p < 0.001) all improved with drug compared with placebo. Adverse events with drug were mild, most commonly intermittent loose stools. In this randomized controlled trial, lubiprostone seemed to be well tolerated and effective for the short-term treatment of constipation in PD.

A 15-year randomized controlled study of a reduced shrinkage stress resin composite.

PubMed

van Dijken, Jan W V; Lindberg, Anders

2015-09-01

The aim of this randomized controlled study was to evaluate the long term effectiveness of a reduced shrinkage stress resin composite in Class II restorations. The material was compared intra-individually with a microhybrid resin composite. Each of 50 patients with at least one pair of two similar sized Class II cavities participated (22 female, 28 male, mean age 43 years, range 18-64). Each participant received in each pair, in a randomized way, one Class II restoration performed with a reduced shrinkage stress resin composite (InTen-S) and the other restoration with a microhybrid resin composite restoration (Point 4). Both restorations were placed with an etch-and-rinse bonding system and an oblique layering technique. A total of 106 restorations, 33 premolar and 73 molars, were placed. The restorations were evaluated blindly each year using modified USPHS criteria. The overall performance of the experimental restorations was tested after intra-individual comparison using the Friedmańs two-way analysis of variance test. The hypothesis was rejected at the 5% level. At 15 years, 91 restorations were evaluated. The drop out frequency was 15 restorations (5 male, 3 female participants; 2 premolar and 13 molar restorations). Except for 2 participants, who reported slight symptoms during a few weeks after placement, no post-operative sensitivity was observed at the recalls. The overall success rate at 15 years was 77%. Twenty-one non acceptable restorations were observed during the 15 years follow up, 10 InTen-S (21.7%) and 11 Point 4 (24.4%) restorations (p>0.05). Annual failure rates for the resin composites were 1.5% and 1.6%, respectively. The main reasons for failure were secondary caries (8) and resin composite fracture (7). The differences between premolar vs. molar restorations and between restorations in male vs. female participants were not significant. Significant differences were observed between 2-surface vs. 3-surface restorations. During the 15-year follow up, the reduced shrinkage stress resin composite showed a good clinical durability in Class II cavities, but not significantly better than the control microhybrid resin composite. Secondary caries and material fracture were the main reasons of failure. Copyright © 2015 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

A population-based dietary intervention trial in a high-risk area for stomach cancer and stroke: changes in intakes and related biomarkers.

PubMed

Takashashi, Yoshiko; Sasaki, Satoshi; Takahashi, Masako; Okubo, Shunji; Hayashi, Masato; Tsugane, Shoichiro

2003-11-01

Dietary intervention is one of the important fields in cancer and cardiovascular disease prevention. The Hiraka Dietary Intervention Study is a community-based randomized cross-over trial designed to develop an effective dietary modification tool and system in an area with high mortality of stomach cancer and stroke. The subjects were 550 healthy volunteers and were randomized into two groups with tailored dietary education to decrease sodium intake and to increase vitamin C and carotene intakes either in the first year (intervention group) or in the second year (control group). Dietary changes were assessed using a validated self-administered diet history questionnaire, fasting blood samples, and 48-hour urine samples, which were obtained before and after the one year period. During the first year, changes differed significantly between the intervention and control group for both dietary sodium intake (-384 and +255 mg/day, intervention and control respectively, p < 0.001) and urinary sodium excretion (-1003 and -84 mg/day, p < 0.001). Although favorable net changes were also observed in dietary carotene (+418 and +220 mug/day, p < 0.05) and vitamin C (+13 and +2 mg/day, p < 0.05), the serum level differences were modest (+13 and -25 mg/L, p = 0.09 for carotene, +0.1 and -0.5 mg/L, p = 0.07 for ascorbic acid). The present dietary intervention strategy effectively decreased sodium and increased carotene and vitamin C intakes, although the former was more distinct.

Connective Tissue Reflex Massage for Type 2 Diabetic Patients with Peripheral Arterial Disease: Randomized Controlled Trial

PubMed Central

Castro-Sánchez, Adelaida María; Moreno-Lorenzo, Carmen; Matarán-Peñarrocha, Guillermo A.; Feriche-Fernández-Castanys, Belen; Granados-Gámez, Genoveva; Quesada-Rubio, José Manuel

2011-01-01

The objective of this study was to evaluate the efficacy of connective tissue massage to improve blood circulation and intermittent claudication symptoms in type 2 diabetic patients. A randomized, placebo-controlled trial was undertaken. Ninety-eight type 2 diabetes patients with stage I or II-a peripheral arterial disease (PAD) (Leriche-Fontaine classification) were randomly assigned to a massage group or to a placebo group treated using disconnected magnetotherapy equipment. Peripheral arterial circulation was determined by measuring differential segmental arterial pressure, heart rate, skin temperature, oxygen saturation and skin blood flow. Measurements were taken before and at 30 min, 6 months and 1 year after the 15-week treatment. After the 15-week program, the groups differed (P < .05) in differential segmental arterial pressure in right lower limb (lower one-third of thigh, upper and lower one-third of leg) and left lower limb (lower one-third of thigh and upper and lower one-third of leg). A significant difference (P < .05) was also observed in skin blood flow in digits 1 and 4 of right foot and digits 2, 4 and 5 of left foot. ANOVA results were significant (P < .05) for right and left foot oxygen saturation but not for heart rate and temperature. At 6 months and 1 year, the groups differed in differential segmental arterial pressure in upper third of left and right legs. Connective tissue massage improves blood circulation in the lower limbs of type 2 diabetic patients at stage I or II-a and may be useful to slow the progression of PAD. PMID:19933770

Multicentre randomized controlled trial of structured transition on diabetes care management compared to standard diabetes care in adolescents and young adults with type 1 diabetes (Transition Trial).

PubMed

Spaic, Tamara; Mahon, Jeff L; Hramiak, Irene; Byers, Nicole; Evans, Keira; Robinson, Tracy; Lawson, Margaret L; Malcolm, Janine; Goldbloom, Ellen B; Clarson, Cheril L

2013-10-09

Transition from pediatric to adult diabetes care is a high risk period during which there is an increased rate of disengagement from care. Suboptimal transition has been associated with higher risks for acute and chronic diabetes-related complications. The period of emerging adulthood challenges current systems of healthcare delivery as many young adults with type 1 diabetes (T1D) default from diabetes care and are at risk for diabetes complications which are undetected and therefore untreated. Despite the importance of minimizing loss to follow-up there are no randomized control trials evaluating models of transition from pediatric to adult diabetes care. This is a multicentre randomized controlled trial. A minimum of 188 subjects with T1D aged between 17 and 20 years will be evaluated. Eligible subjects will be recruited from three pediatric care centres and randomly assigned in a 1:1 ratio to a structured transition program that will span 18 months or to receive standard diabetes care. The structured transition program is a multidisciplinary, complex intervention aiming to provide additional support in the transition period. A Transition Coordinator will provide transition support and will provide the link between pediatric and adult diabetes care. The Transition Coordinator is central to the intervention to facilitate ongoing contact with the medical system as well as education and clinical support where appropriate. Subjects will be seen in the pediatric care setting for 6 months and will then be transferred to the adult care setting where they will be seen for one year. There will then be a one-year follow-up period for outcome assessment. The primary outcome is the proportion of subjects who fail to attend at least one outpatient adult diabetes specialist visit during the second year after transition to adult diabetes care. Secondary outcome measures include A1C frequency measurement and levels, diabetes related emergency room visits and hospital admissions, frequency of complication screening, and subject perception and satisfaction with care. This trial will determine if the support of a Transition Coordinator improves health outcomes for this at-risk population of young adults. NCT01351857.

Effectiveness of a new health care organization model in primary care for chronic cardiovascular disease patients based on a multifactorial intervention: the PROPRESE randomized controlled trial.

PubMed

Orozco-Beltran, Domingo; Ruescas-Escolano, Esther; Navarro-Palazón, Ana Isabel; Cordero, Alberto; Gaubert-Tortosa, María; Navarro-Perez, Jorge; Carratalá-Munuera, Concepción; Pertusa-Martínez, Salvador; Soler-Bahilo, Enrique; Brotons-Muntó, Francisco; Bort-Cubero, Jose; Nuñez-Martinez, Miguel Angel; Bertomeu-Martinez, Vicente; Gil-Guillen, Vicente Francisco

2013-08-02

To evaluate the effectiveness of a new multifactorial intervention to improve health care for chronic ischemic heart disease patients in primary care. The strategy has two components: a) organizational for the patient/professional relationship and b) training for professionals. Experimental study. Randomized clinical trial. Follow-up period: one year. primary care, multicenter (15 health centers). For the intervention group 15 health centers are selected from those participating in ESCARVAL study. Once the center agreed to participate patients are randomly selected from the total amount of patients with ischemic heart disease registered in the electronic health records. For the control group a random sample of patients with ischemic heart disease is selected from all 72 health centers electronic records. This study aims to evaluate the efficacy of a multifactorial intervention strategy involving patients with ischemic heart disease for the improvement of the degree of control of the cardiovascular risk factors and of the quality of life, number of visits, and number of hospitalizations. NCT01826929.

Two-Year Follow-Up Results of Fluoroscopic Cervical Epidural Injections in Chronic Axial or Discogenic Neck Pain: A Randomized, Double-Blind, Controlled Trial

PubMed Central

Manchikanti, Laxmaiah; Cash, Kimberly A.; Pampati, Vidyasagar; Malla, Yogesh

2014-01-01

Study Design: A randomized, double-blind, active-controlled trial. Objective: To assess the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids for the management of axial or discogenic pain in patients without disc herniation, radiculitis, or facet joint pain. Summary of Background Data: Cervical discogenic pain without disc herniation is a common cause of suffering and disability in the adult population. Once conservative management has failed and facet joint pain has been excluded, cervical epidural injections may be considered as a management tool. Despite a paucity of evidence, cervical epidural injections are one of the most commonly performed nonsurgical interventions in the management of chronic axial or disc-related neck pain. Methods: One hundred and twenty patients without disc herniation or radiculitis and negative for facet joint pain as determined by means of controlled diagnostic medial branch blocks were randomly assigned to one of the 2 treatment groups. Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL), whereas Group II patients received 0.5% lidocaine, 4 mL, mixed with 1 mL or 6 mg of nonparticulate betamethasone. The primary outcome measure was ≥ 50% improvement in pain and function. Outcome assessments included numeric rating scale (NRS), Neck Disability Index (NDI), opioid intake, employment, and changes in weight. Results: Significant pain relief and functional improvement (≥ 50%) was present at the end of 2 years in 73% of patients receiving local anesthetic only and 70% receiving local anesthetic with steroids. In the successful group of patients, however, defined as consistent relief with 2 initial injections of at least 3 weeks, significant improvement was illustrated in 78% in the local anesthetic group and 75% in the local anesthetic with steroid group at the end of 2 years. The results reported at the one-year follow-up were sustained at the 2-year follow-up. Conclusions: Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and functioning in patients with chronic discogenic or axial pain that is function-limiting and not related to facet joint pain. PMID:24578607

Efficacy and safety of CP-945,598, a selective cannabinoid CB1 receptor antagonist, on weight loss and maintenance.

PubMed

Aronne, Louis J; Finer, Nick; Hollander, Priscilla A; England, Richard D; Klioze, Solomon S; Chew, Robert D; Fountaine, Robert J; Powell, Coralie M; Obourn, John D

2011-07-01

Three double-blind, placebo-controlled, three-parallel-group, multicenter phase 3 trials were conducted to assess the efficacy and safety of CP-945,598 for weight loss and weight-loss maintenance. Two trials were designed to be 2 years in duration (in obese and overweight patients) and one as a 1-year study (in obese and overweight patients with type 2 diabetes). However, the 2-year trials and the CP-945,598 development program were terminated before completion due to changing regulatory perspectives of CB1 receptor-related drugs. In total, 1,253 and 2,536 participants in the two 2-year multinational and North American studies were randomized to 10-mg CP-945,598 (n = 360; 718); 20-mg CP-945,598 (n = 534, 1,084) and placebo (n = 359, 734), respectively; and 975 participants were randomized to 10-mg CP-945,598 (n = 318); 20-mg CP-945,598 (n = 320); and placebo (n = 337) in the 1-year multinational diabetes trial. Baseline demographics were similar between treatment groups within each trial. One year of treatment with CP-945,598 resulted in a dose-related mean percentage reduction from baseline body-weight in all trials. A significant proportion of all participants also achieved 5% and 10% weight loss after 1 year. In participants with mainly well-controlled type 2 diabetes, the combination of lifestyle and CP-945,598 induced substantial improvements in glycemic control. The most frequent adverse events (AEs) for CP-945,598 were: diarrhea, nausea, nasopharyngitis, and headache. Self-reported experiences of anxiety and suicidal thoughts were higher with CP-945,598 than placebo, as were the incidence of depression and depressed mood. However, the reported increases in psychiatric symptoms were not consistently dose dependent.

Evidence for single-dose protection by the bivalent HPV vaccine-Review of the Costa Rica HPV vaccine trial and future research studies.

PubMed

Kreimer, Aimée R; Herrero, Rolando; Sampson, Joshua N; Porras, Carolina; Lowy, Douglas R; Schiller, John T; Schiffman, Mark; Rodriguez, Ana Cecilia; Chanock, Stephen; Jimenez, Silvia; Schussler, John; Gail, Mitchell H; Safaeian, Mahboobeh; Kemp, Troy J; Cortes, Bernal; Pinto, Ligia A; Hildesheim, Allan; Gonzalez, Paula

2018-01-20

The Costa Rica Vaccine Trial (CVT), a phase III randomized clinical trial, provided the initial data that one dose of the HPV vaccine could provide durable protection against HPV infection. Although the study design was to administer all participants three doses of HPV or control vaccine, 20% of women did not receive the three-dose regimens, mostly due to involuntary reasons unrelated to vaccination. In 2011, we reported that a single dose of the bivalent HPV vaccine could be as efficacious as three doses of the vaccine using the endpoint of persistent HPV infection accumulated over the first four years of the trial; findings independently confirmed in the GSK-sponsored PATRICIA trial. Antibody levels after one dose, although lower than levels elicited by three doses, were 9-times higher than levels elicited by natural infection. Importantly, levels remained essentially constant over at least seven years, suggesting that the observed protection provided by a single dose might be durable. Much work has been done to assure these non-randomized findings are valid. Yet, the group of recipients who received one dose of the bivalent HPV vaccine in the CVT and PATRICIA trials was small and not randomly selected nor blinded to the number of doses received. The next phase of research is to conduct a formal randomized, controlled trial to evaluate the protection afforded by a single dose of HPV vaccine. Complementary studies are in progress to bridge our findings to other populations, and to further document the long-term durability of antibody response following a single dose. Published by Elsevier Ltd.

MILD® Is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial.

PubMed

Benyamin, Ramsin M; Staats, Peter S; MiDAS Encore, Investigators

2016-05-01

Lumbar spinal stenosis (LSS) is a common degenerative condition of the spine, which is a major cause of pain and functional disability for the elderly. Neurogenic claudication symptoms are a hallmark of LSS, where patients develop low back or leg pain when walking or standing that is relieved by sitting or lumbar flexion. The treatment of LSS generally begins with conservative management such as physical therapy, home exercise programs, and oral analgesics. Once these therapies fail, patients commonly move forward with interventional pain treatment options such as epidural steroid injections (ESIs) or MILD® as the next step. To assess improvement of function and reduction in pain for Medicare beneficiaries following treatment with MILD (treatment group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy and to compare to a control group receiving ESIs. Prospective, multi-center, randomized controlled clinical trial. Twenty-six US interventional pain management centers. Patients in this trial were randomized one to one into 2 study arms. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. 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 ESI 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 is the 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. This report presents safety and efficacy results at 1-year follow-up. Outcomes at 2 years will be collected and reported for patients in the MILD group only. At 1-year follow-up, ODI, NPRS, and all 3 ZCQ domains (Symptom Severity, Physical Function and Patient Satisfaction) demonstrated statistically significant superiority of MILD versus the active control. For primary efficacy, the 58.0% ODI responder rate in the MILD group was higher than the 27.1% responder rate in the epidural steroid group (P < 0.001). The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). There was a 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 adjunctive pain therapy study restrictions. Study enrollment was not limited to patients that had never received ESI therapy. One-year results of this randomized controlled clinical trial demonstrate that MILD is statistically superior to ESIs in the treatment of LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. Primary and secondary efficacy outcome measures achieved statistical superiority in the MILD group compared to the control group. With 95% of patients in this study presenting with 5 or more LSS co-factors, it is important to note that patients with spinal co-morbidities also experienced statistically significant improved function that was durable through 1 year. MILD, minimally invasive lumbar decompression, interlaminar epidural steroid injections, ESI neurogenic claudication, ligamentum flavum, ENCORE, PILD, CED Study, LSS.

Changing friend selection in middle school: A social network analysis of a randomized intervention study designed to prevent adolescent problem behavior

PubMed Central

DeLay, Dawn; Ha, Thao; Van Ryzin, Mark; Winter, Charlotte; Dishion, Thomas J.

2015-01-01

Adolescent friendships that promote problem behavior are often chosen in middle school. The current study examines the unintended impact of a randomized school based intervention on the selection of friends in middle school, as well as on observations of deviant talk with friends five years later. Participants included 998 middle school students (526 boys and 472 girls) recruited at the onset of middle school (age 11-12 years) from three public middle schools participating in the Family Check-up model intervention. The current study focuses only on the effects of the SHAPe curriculum—one level of the Family Check-up model—on friendship choices. Participants nominated friends and completed measures of deviant peer affiliation. Approximately half of the sample (n=500) was randomly assigned to the intervention and the other half (n=498) comprised the control group within each school. The results indicate that the SHAPe curriculum affected friend selection within School 1, but not within Schools 2 or 3. The effects of friend selection in School 1 translated into reductions in observed deviancy training five years later (age 16-17 years). By coupling longitudinal social network analysis with a randomized intervention study the current findings provide initial evidence that a randomized public middle school intervention can disrupt the formation of deviant peer groups and diminish levels of adolescent deviance five years later. PMID:26377235

Design of a school-based randomized trial to reduce smoking among 13 to 15-year olds, the X:IT study.

PubMed

Andersen, Anette; Bast, Lotus Sofie; Ringgaard, Lene Winther; Wohllebe, Louise; Jensen, Poul Dengsøe; Svendsen, Maria; Dalum, Peter; Due, Pernille

2014-05-28

Adolescent smoking is still highly prevalent in Denmark. One in four 13-year olds indicates that they have tried to smoke, and one in four 15-year olds answer that they smoke regularly. Smoking is more prevalent in socioeconomically disadvantaged populations in Denmark as well as in most Western countries. Previous school-based programs to prevent smoking have shown contrasting results internationally. In Denmark, previous programs have shown limited or no effect. This indicates a need for developing a well-designed, comprehensive, and multi-component intervention aimed at Danish schools with careful implementation and thorough evaluation.This paper describes X:IT, a study including 1) the development of a 3-year school-based multi-component intervention and 2) the randomized trial investigating the effect of the intervention. The study aims at reducing the prevalence of smoking among 13 to 15-year olds by 25%. The X:IT study is based on the Theory of Triadic Influences. The theory organizes factors influencing adolescent smoking into three streams: cultural environment, social situation, and personal factors. We added a fourth stream, the community aspects. The X:IT program comprises three main components: 1) smoke-free school premises, 2) parental involvement including smoke-free dialogues and smoke-free contracts between students and parents, and 3) a curricular component. The study encompasses process- and effect-evaluations as well as health economic analyses. Ninety-four schools in 17 municipalities were randomly allocated to the intervention (51 schools) or control (43 schools) group. At baseline in September 2010, 4,468 year 7 students were eligible of which 4,167 answered the baseline questionnaire (response rate = 93.3%). The X:IT study is a large, randomized controlled trial evaluating the effect of an intervention, based on components proven to be efficient in other Nordic settings. The X:IT study directs students, their parents, and smoking prevention policies at the schools. These elements have proven to be effective tools in preventing smoking among adolescents. Program implementation is thoroughly evaluated to be able to add to the current knowledge of the importance of implementation. X:IT creates the basis for thorough effect and process evaluation, focusing on various social groups. Current Controlled Trials ISRCTN77415416.

Design of a school-based randomized trial to reduce smoking among 13 to 15-year olds, the X:IT study

PubMed Central

2014-01-01

Background Adolescent smoking is still highly prevalent in Denmark. One in four 13-year olds indicates that they have tried to smoke, and one in four 15-year olds answer that they smoke regularly. Smoking is more prevalent in socioeconomically disadvantaged populations in Denmark as well as in most Western countries. Previous school-based programs to prevent smoking have shown contrasting results internationally. In Denmark, previous programs have shown limited or no effect. This indicates a need for developing a well-designed, comprehensive, and multi-component intervention aimed at Danish schools with careful implementation and thorough evaluation. This paper describes X:IT, a study including 1) the development of a 3-year school-based multi-component intervention and 2) the randomized trial investigating the effect of the intervention. The study aims at reducing the prevalence of smoking among 13 to 15-year olds by 25%. Methods/Design The X:IT study is based on the Theory of Triadic Influences. The theory organizes factors influencing adolescent smoking into three streams: cultural environment, social situation, and personal factors. We added a fourth stream, the community aspects. The X:IT program comprises three main components: 1) smoke-free school premises, 2) parental involvement including smoke-free dialogues and smoke-free contracts between students and parents, and 3) a curricular component. The study encompasses process- and effect-evaluations as well as health economic analyses. Ninety-four schools in 17 municipalities were randomly allocated to the intervention (51 schools) or control (43 schools) group. At baseline in September 2010, 4,468 year 7 students were eligible of which 4,167 answered the baseline questionnaire (response rate = 93.3%). Discussion The X:IT study is a large, randomized controlled trial evaluating the effect of an intervention, based on components proven to be efficient in other Nordic settings. The X:IT study directs students, their parents, and smoking prevention policies at the schools. These elements have proven to be effective tools in preventing smoking among adolescents. Program implementation is thoroughly evaluated to be able to add to the current knowledge of the importance of implementation. X:IT creates the basis for thorough effect and process evaluation, focusing on various social groups. Trial registration Current Controlled Trials ISRCTN77415416. PMID:24886206

Glycemic control and macrovascular disease in types 1 and 2 diabetes mellitus: Meta-analysis of randomized trials.

PubMed

Stettler, Christoph; Allemann, Sabin; Jüni, Peter; Cull, Carole A; Holman, Rury R; Egger, Matthias; Krähenbühl, Stephan; Diem, Peter

2006-07-01

Uncertainty persists concerning the effect of improved long-term glycemic control on macrovascular disease in diabetes mellitus (DM). We performed a systematic review and meta-analysis of randomized controlled trials comparing interventions to improve glycemic control with conventional treatment in type 1 and type 2 diabetes. Outcomes included the incidence rate ratios for any macrovascular event, cardiac events, stroke, and peripheral arterial disease, and the number needed to treat intensively during 10 years to prevent one macrovascular event. The analysis was based on 8 randomized comparisons including 1800 patients with type 1 DM (134 macrovascular events, 40 cardiac events, 88 peripheral vascular events, 6 cerebrovascular events, 11293 person-years of follow-up) and 6 comparisons including 4472 patients with type 2 DM (1587 macrovascular events, 1197 cardiac events, 87 peripheral vascular events, 303 cerebrovascular events, 43607 person-years). Combined incidence rate ratios for any macrovascular event were 0.38 (95% CI 0.26-0.56) in type 1 and 0.81 (0.73-0.91) in type 2 DM. In type 1 DM, effect was mainly based on reduction of cardiac and peripheral vascular events and, in type 2 DM, due to reductions in stroke and peripheral vascular events. Effects appear to be particularly important in younger patients with shorter duration of diabetes. Our data suggest that attempts to improve glycemic control reduce the incidence of macrovascular events both in type 1 and type 2 DM. In absolute terms, benefits are comparable, although effects on specific manifestations of macrovascular disease differ.

Short- and long-term effects of a six-week clinical Pilates program in addition to physical therapy on postmenopausal women with chronic low back pain: a randomized controlled trial.

PubMed

Cruz-Díaz, David; Martínez-Amat, Antonio; Osuna-Pérez, M C; De la Torre-Cruz, M J; Hita-Contreras, Fidel

2016-01-01

To determine the short- and long-term effectiveness of the application of Clinical Pilates in addition to physical therapy versus a physical therapy treatment alone in a population of postmenopausal women with chronic low back pain (CLBP). A single-blind randomized controlled trial with repeated measures and a follow-up period. One hundred and one patients were randomly allocated to a Pilates + physical therapy (PPT) group or to a physical therapy (PT) only group for six weeks. Pain and disability were measured by visual analog scale (VAS) and the Oswestry disability index respectively preintervention, after 6 weeks of treatment and after 1-year follow-up. There were significant differences between groups in pain and disability after 6 weeks of treatment, with better results in the PPT group with an effect size of d = 3.14 and d = 2.33 for pain and disability. After 1-year follow-up, only PPT group showed better results compared with baseline with an effect size of d = 2.49 and d = 4.98 for pain and disability. The results suggest that using Clinical Pilates in addition to physical therapy provides improved results on pain management and functional status for postmenopausal woman with CLBP and that its benefits still linger after one year. Chronic Low Back Pain could benefit from the Pilates practice in postmenopausal women. Improvement in pain and disability derived from CLBP seem to be maintained over time due to Pilates practice. Pilates constitutes a safe tool to be applied in older population with CLBP due to its ability to be adapted to every performance and physical level.

Yoga based cardiac rehabilitation after coronary artery bypass surgery: One-year results on LVEF, lipid profile and psychological states – A randomized controlled study

PubMed Central

Raghuram, Nagarathna; Parachuri, Venkateshwara Rao; Swarnagowri, M.V.; Babu, Suresh; Chaku, Ritu; Kulkarni, Ravi; Bhuyan, Bhagavan; Bhargav, Hemant; Nagendra, Hongasandra Ramarao

2014-01-01

Objective To compare the long term effects of yoga based cardiac rehabilitation program with only physiotherapy based program as an add-on to conventional rehabilitation after coronary artery bypass grafting (CABG) on risk factors. Methods In this single blind prospective randomized parallel two armed active control study, 1026 patients posted for CABG at Narayana Hrudayalaya Institute of Cardiac Sciences, Bengaluru (India) were screened. Of these, 250 male participants (35–65 years) who satisfied the selection criteria and consented were randomized into two groups. Within and between group comparisons were done at three points of follow up (i.e. 6th week, 6th month, and 12th month) by using Wilcoxon's signed ranks test and Mann Whitney U test respectively. Results Yoga group had significantly (p = 0.001, Mann Whitney) better improvement in LVEF than control group in those with abnormal baseline EF (<53%) after 1 year. There was a better reduction in BMI in the yoga group (p = 0.038, between groups) in those with high baseline BMI (≥23) after 12 months. Yoga group showed significant (p = 0.008, Wilcoxon's) reduction in blood glucose at one year in those with high baseline FBS ≥110 mg/dl. There was significantly better improvement in yoga than the control group in HDL (p = 0.003), LDL (p = 0.01) and VLDL (p = 0.03) in those with abnormal baseline values. There was significantly better improvement (p = 0.02, between groups) in positive affect in yoga group. Within Yoga group, there was significant decrease in perceived stress (p = 0.001), anxiety (p = 0.001), depression (p = 0.001), and negative affect (p = 0.03) while in the control group there was reduction (p = 0.003) only in scores on anxiety. Conclusion Addition of yoga based relaxation to conventional post-CABG cardiac rehabilitation helps in better management of risk factors in those with abnormal baseline values and may help in preventing recurrence. PMID:25443601

The effects of blood pressure reduction in older patients: an overview of five randomized controlled trials in elderly hypertensives.

PubMed

MacMahon, S; Rodgers, A

1993-11-01

Direct evidence about the effects of antihypertensive treatment on vascular disease in older patients is available from five randomized trials conducted exclusively in patients over the age of 60 years. These trials involved a total of 12,483 individuals with systolic or diastolic hypertension (mean age = 72 years, mean entry blood pressure = 181/88 mmHg). Over an average follow-up period of 4.7 years, a 15/6 mmHg difference in blood pressure between study and control groups was achieved. Among those patients assigned active treatment, stroke incidence was reduced by 34% SD6 and coronary heart disease incidence was reduced by 19% SD7. These proportional reductions were of similar size to those observed in trials in predominantly younger patients. However, the absolute benefits observed in older patients were more than twice as great as those observed in younger patients. The results suggest that over 10 years, treatment would prevent at least one major vascular event among every 10 elderly patients at similar risk to those enrolled in the trials.

Lumbar spinous process splitting decompression provides equivalent outcomes to conventional midline decompression in degenerative lumbar canal stenosis: a prospective, randomized controlled study of 51 patients.

PubMed

Rajasekaran, S; Thomas, Ashok; Kanna, Rishi M; Prasad Shetty, Ajoy

2013-09-15

Prospective, randomized controlled study. To compare the functional outcomes and extent of paraspinal muscle damage between 2 decompressive techniques for lumbar canal stenosis. Lumbar spinous process splitting decompression (LSPSD) preserves the muscular and liga-mentous attachments of the posterior elements of the spine. It can potentially avoid problems such as paraspinal muscle atrophy and trunk extensor weakness that can occur after conventional midline decompression. However, large series prospective randomized controlled studies are lacking. Patients with lumbar canal stenosis were randomly allocated into 2 groups: LSPSD (28 patients) and conventional midline decompression (23 patients). The differences in operative time, blood loss, time to comfortable mobilization, and hospital stay were studied. Paraspinal muscle damage was assessed by postoperative rise in creatine phosphokinase and C-reactive protein levels. Functional outcome was evaluated at 1 year by Japanese Orthopaedic Association score, neurogenic claudication outcome score, and visual analogue scale for back pain and neurogenic claudication. Fifty-one patients of mean age 56 years were followed-up for a mean 14.2 ± 2.9 months. There were no significant differences in the operative time, blood loss, and hospital stay. Both the groups showed significant improvement in the functional outcome scores at 1 year. Between the 2 groups, the Japanese Orthopaedic Association score, neurogenic claudication outcome score improvement, visual analogue scale for back pain, neurogenic claudication visual analogue scale, and the postoperative changes in serum C-reactive protein and creatine phosphokinase levels did not show any statistically significant difference. On the basis of the Japanese Orthopaedic Association recovery rate, it was found that 73.9% of conventional midline decompression group had good outcomes compared with only 60.7% after LSPSD. The functional outcome scores, back pain, and claudication pain in the immediate period and at the end of 1 year are similar in both the techniques. More patients had better functional outcomes after conventional decompression than the LSPSD technique. On the basis of this study, the superiority of one technique compared with the other is not established, mandating the need for further long-term studies. 2.

A cluster randomized trial of sun protection at elementary schools. Results from year 2.

PubMed

Roetzheim, Richard G; Love-Jackson, Kymia M; Hunter, Seft G; Lee, Ji-Hyun; Chen, Ren; Abdulla, Rania; Wells, Kristen J

2011-12-01

Elementary schools are one potential venue for sun protection interventions that reduce childhood sun exposure. To assess Year-2 results from a cluster randomized trial promoting hat use at schools. Block randomization was used to assign intervention/control status to participating schools. Data were collected from 2006 to 2008 and analyzed in 2007-2010. Of the 24 schools in the School District of Hillsborough County, Florida enrolled, 4th-graders were targeted in the first year and followed through their 5th-grade year. Classroom sessions were conducted to improve sun protection knowledge, foster more positive attitudes about hat use, and change the subjective norm of wearing hats when at school. Year-2 outcomes assessed included hat use at school (measured by direct observation), hat use outside of school (measured by self-report) and skin pigmentation and nevi counts (measured for a subgroup of 439 students). The percentage of students observed wearing hats at control schools remained unchanged during the 2-year period (range 0%-2%) but increased significantly at intervention schools (2% at baseline, 41% at end of Year 1, 19% at end of Year 2; p<0.001 for intervention effect). Measures of skin pigmentation, nevi counts, and self-reported use of hats outside of school did not change during the study period. This intervention increased use of hats at school through Year 2 but had no measurable effect on skin pigmentation or nevi. Whether school-based interventions can ultimately prevent skin cancer is uncertain. Copyright © 2011 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

The Effectiveness of Propolis on Gingivitis: A Randomized Controlled Trial

PubMed Central

Paulino, Niraldo; Nör, Jacques E.; Moreira, Alexandre

2014-01-01

Abstract Background: A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Methods: Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days −14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). Results: The 38 persons who completed the study (age 13–22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Conclusions: Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period. PMID:25380344

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

PubMed

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

2014-12-06

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

General practitioners trained in motivational interviewing can positively affect the attitude to behaviour change in people with type 2 diabetes. One year follow-up of an RCT, ADDITION Denmark.

PubMed

Rubak, Sune; Sandbaek, Annelli; Lauritzen, Torsten; Borch-Johnsen, Knut; Christensen, Bo

2009-01-01

To examine whether training GPs in motivational interviewing (MI) can improve type 2 diabetic patients' (1) understanding of diabetes, (2) beliefs regarding prevention and treatment, and (3) motivation for behaviour change. A randomized controlled trial including 65 GPs and 265 type 2 diabetic patients. The GPs were randomized in two groups, one with and one without MI training. Both groups received training in target-driven intensive treatment of type 2 diabetic patients. The intervention was a 1(1/2)-day residential course in MI with (1/2)-day follow-up twice during the first year. The patient data stemmed from previously validated questionnaires. The Health Care Climates Questionnaire assesses the patient-doctor relationship and type of counselling. The Treatment Self-Regulation Questionnaire assesses the degree to which behaviour tends to be self-determined. The Diabetes Illness Representation Questionnaire assesses beliefs and understanding of type 2 diabetes. The Summary of Diabetes Self Care Activities assesses the extent of various self-care activities related to type 2 diabetes. The response rate to our questionnaires was 87%. Patients in the intervention group were significantly more autonomous and motivated in their inclination to change behaviour after one year compared with the patients from the control group. Patients in the intervention group were also significantly more conscious of the importance of controlling their diabetes, and had a significantly better understanding of the possibility of preventing complications. MI improved type 2 patients' understanding of diabetes, their beliefs regarding treatment aspects, their contemplation on and motivation for behaviour change. Whether our results can be sustained long term and are clinically relevant in terms of changes in risk profile advocates further research.

Effectiveness of balance training programme in reducing the frequency of falling in established osteoporotic women: a randomized controlled trial.

PubMed

Mikó, Ibolya; Szerb, Imre; Szerb, Anna; Poor, Gyula

2017-02-01

To investigate the effect of a 12-month sensomotor balance exercise programme on postural control and the frequency of falling in women with established osteoporosis. Randomized controlled trial where the intervention group was assigned the 12-month Balance Training Programme and the control group did not undertake any intervention beyond regular osteoporosis treatment. A total of 100 osteoporotic women - at least with one osteoporotic fracture - aged 65 years old and above. Balance was assessed in static and dynamic posture both with performance-based measures of balance, such as the Berg Balance Scale and the Timed Up and Go Test, and with a stabilometric computerized platform. Patients in the intervention group completed the 12-month sensomotor Balance Training Programme in an outpatient setting, guided by physical therapists, three times a week, for 30 minutes. The Berg Balance Scale and the Timed Up and Go Test showed a statistically significant improvement of balance in the intervention group ( p = 0.001 and p = 0.005, respectively). Balance tests using the stabilometer also showed a statistically significant improvement in static and dynamic postural balance for osteoporotic women after the completion of the Balance Training Programme. As a consequence, the one-year exercise programme significantly decreased the number of falls in the exercise group compared with the control group. The Balance Training Programme significantly improved the balance parameters and reduced the number of falls in postmenopausal women who have already had at least one fracture in the past.

A Randomized Trial to Compare Alternative Educational Interventions to Increase Colorectal Cancer Screening in a Hard-to-Reach Urban Minority Population with Health Insurance.

PubMed

Basch, Charles E; Zybert, Patricia; Wolf, Randi L; Basch, Corey H; Ullman, Ralph; Shmukler, Celia; King, Fionnuala; Neugut, Alfred I; Shea, Steven

2015-10-01

This randomized controlled trial assessed different educational approaches for increasing colorectal cancer screening uptake in a sample of primarily non-US born urban minority individuals, over aged 50, with health insurance, and out of compliance with screening guidelines. In one group, participants were mailed printed educational material (n = 180); in a second, participants' primary care physicians received academic detailing to improve screening referral and follow-up practices (n = 185); in a third, physicians received academic detailing and participants received tailored telephone education (n = 199). Overall, 21.5% of participants (n = 121) received appropriate screening within one year of randomization. There were no statistically significant pairwise differences between groups in screening rate. Among those 60 years of age or older, however, the detailing plus telephone education group had a higher screening rate than the print group (27.3 vs. 7.7%, p = .02). Different kinds of interventions will be required to increase colorectal cancer screening among the increasingly small population segment that remains unscreened. ClinicalTrials.gov Identifier: NCT02392143.

TakeCARE, a Video Bystander Program to Help Prevent Sexual Violence on College Campuses: Results of Two Randomized, Controlled Trials

PubMed Central

Jouriles, Ernest N.; McDonald, Renee; Rosenfield, David; Levy, Nicole; Sargent, Kelli; Caiozzo, Christina; Grych, John H.

2015-01-01

Objective The present research reports on two randomized controlled trials evaluating TakeCARE, a video bystander program designed to help prevent sexual violence on college campuses. Method In Study 1, students were recruited from psychology courses at two universities. In Study 2, first-year students were recruited from a required course at one university. In both studies, students were randomly assigned to view one of two videos: TakeCARE or a control video on study skills. Just before viewing the videos, students completed measures of bystander behavior toward friends and ratings of self-efficacy for performing such behaviors. The efficacy measure was administered again after the video, and both the bystander behavior measure and the efficacy measure were administered at either one (Study 1) or two (Study 2) months later. Results In both studies, students who viewed TakeCARE, compared to students who viewed the control video, reported engaging in more bystander behavior toward friends and greater feelings of efficacy for performing such behavior. In Study 1, feelings of efficacy mediated effects of TakeCARE on bystander behavior; this result did not emerge in Study 2. Conclusions This research demonstrates that TakeCARE, a video bystander program, can positively influence bystander behavior toward friends. Given its potential to be easily distributed to an entire campus community, TakeCARE might be an effective addition to campus efforts to prevent sexual violence. PMID:27867694

A randomized controlled trial to increase information, motivation, and behavioral skills in Ugandan adolescents

PubMed Central

Ybarra, Michele L.; Korchmaros, Josephine D.; Prescott, Tonya L.; Birungi, Ruth

2015-01-01

Background One in twenty-five Ugandan adolescents is HIV positive. Purpose Examine the impact of an Internet-based HIV prevention program on Information-Motivation-Behavior Skills Model-related constructs. Methods Three hundred and sixty-six sexually experienced and inexperienced students 12-18+ years-old in Mbarara, Uganda were randomly assigned to: the five-lesson CyberSenga program or treatment-as-usual. Half of the intervention participants were further randomized to a booster session. Assessments were collected at three and six months post-baseline. Results Participants’ HIV-related information improved over time at a greater rate for the intervention groups compared to the control group. Motivation for condom use changed to a greater degree over time for the intervention group – especially those in the intervention+booster group - compared to the control group. Behavioral skills for condom use, and motivation and behavioral skills for abstinence were statistically similar over time for both groups. Conclusions CyberSenga improves HIV preventive information and motivation to use condoms. PMID:25633626

One year follow-up after a randomized controlled trial of a 130 g/day low-carbohydrate diet in patients with type 2 diabetes mellitus and poor glycemic control

PubMed Central

Kanazawa, Akio; Hatae, Chie; Makita, Sumiko; Komiya, Koji; Shimizu, Tomoaki; Ikeda, Fuki; Tamura, Yoshifumi; Ogihara, Takeshi; Mita, Tomoya; Goto, Hiromasa; Uchida, Toyoyoshi; Miyatsuka, Takeshi; Ohmura, Chie; Watanabe, Takehito; Kobayashi, Kiyoe; Miura, Yoshiko; Iwaoka, Manami; Hirashima, Nao; Watada, Hirotaka

2017-01-01

Background & aims Recently, we conducted a prospective randomized controlled trial (RCT) showing that a 6-month 130g/day low-carbohydrate diet (LCD) reduced HbA1c and BMI more than a calorie restricted diet (CRD). [1] To assess whether the benefits of the LCD persisted after the intensive intervention, we compared HbA1c and BMI between the LCD and CRD groups at 1 year after the end of the 6-month RCT. Methods Following the end of the 6-month RCT, patients were allowed to manage their own diets with periodic outpatient visits. One year later, we analyzed clinical and nutrition data. Results Of the 66 participants in the original study, 27 in the CRD group and 22 in the LCD group completed this trial. One year after the end of the original RCT, the carbohydrate intake was comparable between the groups (215 [189–243]/day in the CRD group and 214 (176–262) g/day in the LCD group). Compared with the baseline data, HbA1c and BMI were decreased in both groups (CRD: HbA1c -0.4 [-0.9 to 0.3] % and BMI -0.63 [-1.20 to 0.18] kg/m2; LCD: HbA1c -0.35 [-1.0 to 0.35] % and BMI -0.77 [-1.15 to -0.12] kg/m2). There were no significant differences in HbA1c and BMI between the groups. Conclusions One year after the diet therapy intervention, the beneficial effect of the LCD on reduction of HbA1c and BMI did not persist in comparison with CRD. However, combining the data of both groups, significant improvements in HbA1c and BMI from baseline were observed. Although the superiority of the LCD disappeared 1 year after the intensive intervention, these data suggest that well-constructed nutrition therapy programs, both CRD and LCD, were equally effective in improving HbA1c for at least 1 year. Trial registration University Hospital Medical Information Network (UMIN) ID000010663 PMID:29206237

Varied overground walking-task practice versus body-weight-supported treadmill training in ambulatory adults within one year of stroke: a randomized controlled trial protocol.

PubMed

DePaul, Vincent G; Wishart, Laurie R; Richardson, Julie; Lee, Timothy D; Thabane, Lehana

2011-10-21

Although task-oriented training has been shown to improve walking outcomes after stroke, it is not yet clear whether one task-oriented approach is superior to another. The purpose of this study is to compare the effectiveness of the Motor Learning Walking Program (MLWP), a varied overground walking task program consistent with key motor learning principles, to body-weight-supported treadmill training (BWSTT) in community-dwelling, ambulatory, adults within 1 year of stroke. A parallel, randomized controlled trial with stratification by baseline gait speed will be conducted. Allocation will be controlled by a central randomization service and participants will be allocated to the two active intervention groups (1:1) using a permuted block randomization process. Seventy participants will be assigned to one of two 15-session training programs. In MLWP, one physiotherapist will supervise practice of various overground walking tasks. Instructions, feedback, and guidance will be provided in a manner that facilitates self-evaluation and problem solving. In BWSTT, training will emphasize repetition of the normal gait cycle while supported over a treadmill, assisted by up to three physiotherapists. Outcomes will be assessed by a blinded assessor at baseline, post-intervention and at 2-month follow-up. The primary outcome will be post-intervention comfortable gait speed. Secondary outcomes include fast gait speed, walking endurance, balance self-efficacy, participation in community mobility, health-related quality of life, and goal attainment. Groups will be compared using analysis of covariance with baseline gait speed strata as the single covariate. Intention-to-treat analysis will be used. In order to direct clinicians, patients, and other health decision-makers, there is a need for a head-to-head comparison of different approaches to active, task-related walking training after stroke. We hypothesize that outcomes will be optimized through the application of a task-related training program that is consistent with key motor learning principles related to practice, guidance and feedback. ClinicalTrials.gov # NCT00561405.

Varied overground walking-task practice versus body-weight-supported treadmill training in ambulatory adults within one year of stroke: a randomized controlled trial protocol

PubMed Central

2011-01-01

Background Although task-oriented training has been shown to improve walking outcomes after stroke, it is not yet clear whether one task-oriented approach is superior to another. The purpose of this study is to compare the effectiveness of the Motor Learning Walking Program (MLWP), a varied overground walking task program consistent with key motor learning principles, to body-weight-supported treadmill training (BWSTT) in community-dwelling, ambulatory, adults within 1 year of stroke. Methods/Design A parallel, randomized controlled trial with stratification by baseline gait speed will be conducted. Allocation will be controlled by a central randomization service and participants will be allocated to the two active intervention groups (1:1) using a permuted block randomization process. Seventy participants will be assigned to one of two 15-session training programs. In MLWP, one physiotherapist will supervise practice of various overground walking tasks. Instructions, feedback, and guidance will be provided in a manner that facilitates self-evaluation and problem solving. In BWSTT, training will emphasize repetition of the normal gait cycle while supported over a treadmill, assisted by up to three physiotherapists. Outcomes will be assessed by a blinded assessor at baseline, post-intervention and at 2-month follow-up. The primary outcome will be post-intervention comfortable gait speed. Secondary outcomes include fast gait speed, walking endurance, balance self-efficacy, participation in community mobility, health-related quality of life, and goal attainment. Groups will be compared using analysis of covariance with baseline gait speed strata as the single covariate. Intention-to-treat analysis will be used. Discussion In order to direct clinicians, patients, and other health decision-makers, there is a need for a head-to-head comparison of different approaches to active, task-related walking training after stroke. We hypothesize that outcomes will be optimized through the application of a task-related training program that is consistent with key motor learning principles related to practice, guidance and feedback. Trial Registration ClinicalTrials.gov # NCT00561405 PMID:22018267

Hospital-acquired complications in a randomized controlled clinical trial of a geriatric consultation team.

PubMed

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

1987-05-01

As part of a controlled clinical trial of a geriatric consultation team (GCT), we investigated whether a GCT could affect the incidence of hospital-acquired complications in elderly patients. One hundred eighty-five patients, aged 75 years and older, were randomized into an intervention (N = 92) and a control (N = 93) group. Members of the intervention group received a GCT consultation and were routinely followed up throughout their hospitalization. The incidence of hospital-acquired complications for the entire study population was 38%. The type and rate of hospital-acquired complications in the intervention and control groups were not significantly different. Functional status on admission and admission to the psychiatry service were predictive for the occurrence of a hospital-acquired complication. In a broadly selected population such as this, the intensity of care available through a GCT was unable to reduce the occurrence of hospital-acquired complications. However, since this is only one aspect of a GCT function, and others may be of great importance, such aspects, and more targeted populations, must be evaluated before final conclusions can be reached about GCT efficiency.

Taking Healthy Steps: rationale, design and baseline characteristics of a randomized trial of a pedometer-based internet-mediated walking program in veterans with chronic obstructive pulmonary disease

PubMed Central

2014-01-01

Background Low levels of physical activity are common in patients with chronic obstructive pulmonary disease (COPD), and a sedentary lifestyle is associated with poor outcomes including increased mortality, frequent hospitalizations, and poor health-related quality of life. Internet-mediated physical activity interventions may increase physical activity and improve health outcomes in persons with COPD. Methods/Design This manuscript describes the design and rationale of a randomized controlled trial that tests the effectiveness of Taking Healthy Steps, an Internet-mediated walking program for Veterans with COPD. Taking Healthy Steps includes an uploading pedometer, a website, and an online community. Eligible and consented patients wear a pedometer to obtain one week of baseline data and then are randomized on a 2:1 ratio to Taking Healthy Steps or to a wait list control. The intervention arm receives iterative step-count feedback; individualized step-count goals, motivational and informational messages, and access to an online community. Wait list controls are notified that they are enrolled, but that their intervention will start in one year; however, they keep the pedometer and have access to a static webpage. Discussion Participants include 239 Veterans (mean age 66.7 years, 93.7% male) with 155 randomized to Taking Healthy Steps and 84 to the wait list control arm; rural-living (45.2%); ever-smokers (93.3%); and current smokers (25.1%). Baseline mean St. George’s Respiratory Questionnaire Total Score was 46.0; 30.5% reported severe dyspnea; and the average number of comorbid conditions was 4.9. Mean baseline daily step counts was 3497 (+/- 2220). Veterans with COPD can be recruited to participate in an online walking program. We successfully recruited a cohort of older Veterans with a significant level of disability including Veterans who live in rural areas using a remote national recruitment strategy. Trial registration Clinical Trials.gov NCT01102777 PMID:24491137

The effect of massage therapy and/or exercise therapy on subacute or long-lasting neck pain--the Stockholm neck trial (STONE): study protocol for a randomized controlled trial.

PubMed

Skillgate, Eva; Bill, Anne-Sylvie; Côté, Pierre; Viklund, Peter; Peterson, Anna; Holm, Lena W

2015-09-16

Neck pain is a major health problem in populations worldwide and an economic burden in modern societies due to its high prevalence and costs in terms of health care expenditures and lost productivity. Massage and exercise therapy are widely used management options for neck pain. However, there is a lack of scientific evidence regarding their effectiveness for subacute and long-lasting neck pain. This study protocol describes a randomized controlled trial aiming to determine the effect of massage and/or exercise therapy on subacute and long-lasting neck pain over the course of 1 year. A randomized controlled trial in which at least 600 study participants with subacute or long-lasting nonspecific neck pain will be recruited and randomly allocated to one of four treatment arms: massage therapy (A), exercise therapy (B), exercise therapy plus massage therapy (C) and advice to stay active (D). The study has an E-health approach, and study participants are being recruited through advertising with a mix of traditional and online marketing channels. Web-based self-report questionnaires measure the main outcomes at 7, 12, 26 and 52 weeks after inclusion. The primary outcomes are a clinically important improvement in pain intensity and pain-related disability at follow-up, measured with a modified version of the Chronic Pain Questionnaire (CPQ). The secondary outcomes are global improvement, health-related quality of life (EQ-5D), sick leave, drug consumption and healthcare utilization. Adverse events are measured by questionnaires at return visits to the clinic, and automated text messages (SMSes) survey neck pain intensity and pain-related disability every week over one year. The results of this study will provide clinicians and stakeholders much needed knowledge to plan medical care for subacute and long-lasting neck pain disorders. Current Controlled Trials ISRCTN01453590. Date of registration: 3 July 2014.

A randomized, controlled study of a healthy corner store initiative on the purchases of urban, low-income youth

PubMed Central

Lent, Michelle R.; Veur, Stephanie S. Vander; McCoy, Tara A.; Wojtanowski, Alexis C.; Sandoval, Brianna; Sherman, Sandy; Komaroff, Eugene; Foster, Gary D.

2014-01-01

Objective Although many initiatives exist to improve the availability of healthy foods in corner stores, few randomized trials have assessed their effects. This study evaluated, in a randomized, controlled trial, the effects of a first-generation healthy corner store intervention on students’ food and beverage purchases over a two-year period. Design and Methods Participants (n=767) were 4th-6th grade students. Ten schools and their nearby corner stores (n=24) were randomly assigned to the healthy corner store intervention or an assessment-only control. Intercept surveys directly assessed the nutritional characteristics of students’ corner store purchases at baseline, 1 and 2 years. Students’ weight and heights were measured at baseline, 1 and 2 years. Results There were no differences in energy content per intercept purchased from control or intervention schools at year 1 (p=0.12) or 2 (p=0.58). There were no differences between control and intervention students in BMI-z score (year 1, p=0.83; year 2, p=0. 98) or obesity prevalence (year 1, p=0.96; year 2, p=0.58). Conclusions A healthy corner store initiative did not result in significant changes in the energy content of corner store purchases or in continuous or categorical measures of obesity. These data will help to inform future interventions. PMID:25311881

Children with Down Syndrome Improved in Motor Functioning and Muscle Tone Following Massage Therapy

ERIC Educational Resources Information Center

Hernandez-Reif, Maria; Field, Tiffany; Largie, Shay; Mora, Dana; Bornstein, Joan; Waldman, Ronnie

2006-01-01

Twenty-one moderate to high functioning young children (mean age, two years) with Down syndrome receiving early intervention (physical therapy, occupational therapy and speech therapy) were randomly assigned to additionally receive two 0.5-hour massage therapy or reading sessions (control group) per week for two months. On the first and last day…

A Mixed-Method Efficacy and Fidelity Study of Check and Connect

ERIC Educational Resources Information Center

Powers, Kristin; Hagans, Kristi; Linn, Megan

2017-01-01

The effectiveness of the Check and Connect dropout prevention program was examined, over the course of 2.5 years, with 54 middle school students from diverse backgrounds experiencing one or more conditions of risk for dropout. Participants were randomly assigned to receive the Check and Connect intervention or business as usual (i.e., control) in…

ANIMATED SERIAL SECTIONS, A TEACHING AID FOR ORAL HISTOLOGY AND EMBRYOLOGY.

ERIC Educational Resources Information Center

HAYDEN, JESS; AND OTHERS

THE RELATIVE EFFECTIVENESS OF TWO TYPES OF VISUAL MEDIA FOR THE DEVELOPMENT OF A THREE-DIMENSIONAL CONCEPT OF A GIVEN ANATOMICAL REGION WAS INVESTIGATED. EXPERIMENTAL AND CONTROL GROUPS WERE RANDOMLY SELECTED FROM 119 FIRST-YEAR MEDICAL AND DENTAL STUDENTS IN AN HISTOLOGY CLASS. BOTH GROUPS ATTENDED THE SAME ONE-HOUR LECTURE. FOLLOWING THE LECTURE…

Mediating Role of Parental Influence in Children's Response to Television Commercials: An Exploratory Study.

ERIC Educational Resources Information Center

Prasad, V. Kanti; And Others

This study investigated, in a laboratory experimental framework, the relative influences of television commercials and parental counter-commercial advocacy on children's consumption choice behavior. Sixty-four 8- to 10-year-old boys were randomly assigned to one of three treatment groups: (1) no counter commercial advocacy (control group), (2)…

Children's Executive Function and High-Calorie, Low-Nutrient Food Intake: Mediating Effects of Child-Perceived Adult Fast Food Intake

ERIC Educational Resources Information Center

Tate, Eleanor B.; Unger, Jennifer B.; Chou, Chih-Ping; Spruijt-Metz, Donna; Pentz, Mary Ann; Riggs, Nathaniel R.

2015-01-01

Objective: This study tested the relationships among child executive function (EF), child-perceived parent fast food intake, and child self-reported subsequent consumption of high-calorie, low-nutrient (HCLN) food. Design: One year and 6-month longitudinal observation from a larger randomized controlled trial. Setting. Southern California…

A randomized, comparative pilot trial of family-based interpersonal psychotherapy for reducing psychosocial symptoms, disordered-eating, and excess weight gain in at-risk preadolescents with loss-of-control-eating.

PubMed

Shomaker, Lauren B; Tanofsky-Kraff, Marian; Matherne, Camden E; Mehari, Rim D; Olsen, Cara H; Marwitz, Shannon E; Bakalar, Jennifer L; Ranzenhofer, Lisa M; Kelly, Nichole R; Schvey, Natasha A; Burke, Natasha L; Cassidy, Omni; Brady, Sheila M; Dietz, Laura J; Wilfley, Denise E; Yanovski, Susan Z; Yanovski, Jack A

2017-09-01

Preadolescent loss-of-control-eating (LOC-eating) is a risk factor for excess weight gain and binge-eating-disorder. We evaluated feasibility and acceptability of a preventive family-based interpersonal psychotherapy (FB-IPT) program. FB-IPT was compared to family-based health education (FB-HE) to evaluate changes in children's psychosocial functioning, LOC-eating, and body mass. A randomized, controlled pilot trial was conducted with 29 children, 8 to 13 years who had overweight/obesity and LOC-eating. Youth-parent dyads were randomized to 12-week FB-IPT (n = 15) or FB-HE (n = 14) and evaluated at post-treatment, six-months, and one-year. Changes in child psychosocial functioning, LOC-eating, BMI, and adiposity by dual-energy-X-ray-absorptiometry were assessed. Missing follow-up data were multiply imputed. FB-IPT feasibility and acceptability were indicated by good attendance (83%) and perceived benefits to social interactions and eating. Follow-up assessments were completed by 73% FB-IPT and 86% FB-HE at post-treatment, 60% and 64% at six-months, and 47% and 57% at one-year. At post-treatment, children in FB-IPT reported greater decreases in depression (95% CI -7.23, -2.01, Cohen's d = 1.23) and anxiety (95% CI -6.08, -0.70, Cohen's d = .79) and less odds of LOC-eating (95% CI -3.93, -0.03, Cohen's d = .38) than FB-HE. At six-months, children in FB-IPT had greater reductions in disordered-eating attitudes (95% CI -0.72, -0.05, Cohen's d = .66) and at one-year, tended to have greater decreases in depressive symptoms (95% CI -8.82, 0.44, Cohen's d = .69) than FB-HE. There was no difference in BMI gain between the groups. Family-based approaches that address interpersonal and emotional underpinnings of LOC-eating in preadolescents with overweight/obesity show preliminary promise, particularly for reducing internalizing symptoms. Whether observed psychological benefits translate into sustained prevention of disordered-eating or excess weight gain requires further study. © 2017 Wiley Periodicals, Inc.

[Effect of the ischemic post-conditioning on the prevention of the cardio-renal damage in patients with acute ST-segment elevation myocardial infarction after primary percutaneous coronary intervention].

PubMed

Wang, Y Y; Li, T; Liu, Y W; Liu, B J; Hu, X M; Wang, Y; Gao, W Q; Wu, P; Huang, L; Li, X; Peng, W J; Ning, M

2017-04-24

Objective: To evaluate the effect of the ischemic post-conditioning (IPC) on the prevention of the cardio-renal damage in patients with acute ST-segment elevation myocardial infarction (STEMI) after primary percutaneous coronary intervention (PPCI). Methods: A total of 251 consecutive STEMI patients underwent PPCI in the heart center of Tianjin Third Central Hospital from January 2012 to June 2014 were enrolled in this prospective, randomized, control, single-blinded, clinical registry study. Patients were randomly divided into IPC group (123 cases) and control group (128 cases) with random number table. Patients in IPC group underwent three times of inflation/deflation with low inflation pressure using a balloon catheter within one minute after culprit vessel blood recovery, and then treated by PPCI. Patients in control group received PPCI procedure directly. The basic clinical characteristics, incidence of reperfusion arrhythmia during the procedure, the rate of electrocardiogram ST-segment decline, peak value of myocardial necrosis markers, incidence of contrast induced acute kidney injury(CI-AKI), and one-year major adverse cardiovascular events(MACE) which including myocardial infarction again, malignant arrhythmia, rehospitalization for heart failure, repeat revascularization, stroke, and death after the procedure were analyzed between the two groups. Results: The age of IPC group and control group were comparable((61.2±12.6) vs. (64.2±12.1) years old, P =0.768). The incidence of reperfusion arrhythmia during the procedure was significantly lower in the IPC group than in the control group(42.28% (52/123) vs. 57.03% (73/128), P =0.023). The rate of electrocardiogram ST-segment decline immediately after the procedure was significantly higher in the IPC group than in the control group (77.24% (95/123) vs. 64.84% (83/128), P =0.037). The peak value of myocardial necrosis markers after the procedure were significantly lower in the IPC group than in the control group(creatine kinase: 1 257 (682, 2 202) U/L vs. 1 737(794, 2 816)U/L, P =0.029; creatine kinase-MB: 123(75, 218)U/L vs.165(95, 288)U/L, P =0.010). The rate of CI-AKI after the procedure was significantly lower in the IPC group than in the control group(5.69%(7/123) vs. 14.06%(18/128), P =0.034). The rate of the one-year MACE was significantly lower in the IPC group than in the control group(7.32%(9/123) vs. 15.63% (20/128), P =0.040). Conclusion: The IPC strategy performed eight before PPCI can reduce myocardial ischemia- reperfusion injury, decline the rates of CI-AKI and one-year MACE significantly in STEMI patients, thus has a significant protective effect on heart and kidney in STEMI patients. Clinical Trial Registration Chinese Clinical Trials Registry, ChiCTR-ICR-15006590.

Effects of unipedal standing balance exercise on the prevention of falls and hip fracture among clinically defined high-risk elderly individuals: a randomized controlled trial.

PubMed

Sakamoto, Keizo; Nakamura, Toshitaka; Hagino, Hiroshi; Endo, Naoto; Mori, Satoshi; Muto, Yoshiteru; Harada, Atsushi; Nakano, Tetsuo; Itoi, Eiji; Yoshimura, Mitsuo; Norimatsu, Hiromichi; Yamamoto, Hiroshi; Ochi, Takahiro

2006-10-01

The aim of this study was to assess the effectiveness of the unipedal standing balance exercise for 1 min to prevent falls and hip fractures in high-risk elderly individuals with a randomized controlled trial. This control study was designed as a 6-month intervention trial. Subjects included 553 clinically defined high-risk adults who were living in residences or in the community. They were randomized to an exercise group and a control group. Randomization to the subjects was performed by a table of random numbers. A unipedal standing balance exercise with open eyes was performed by standing on each leg for 1 min three times per day. As a rule, subjects of the exercise group stood on one leg without holding onto any support, but unstable subjects were permitted to hold onto a bar during the exercise time. Falls and hip fractures were reported by nurses, physical therapists, or facility staff with a survey sheet every month. This survey sheet was required every month for both groups. Registered subjects were 553 persons ranging in age from 37 to 102 years (average, 81.6 years of age). Twenty-six subjects dropped out. The number of falls and hip fractures for the 6-month period after the trial for 527 of the 553 subjects for whom related data were available were assessed. The exercise group comprised 315 subjects and the control group included 212 subjects. The cumulative number of falls of the exercise group, with 1 multiple faller omitted, was 118, and the control group recorded 121 falls. A significant intergroup difference was observed. However, the cumulative number of hip fractures was only 1 case in both groups. This difference was not statistically significant. The unipedal standing balance exercise is effective to prevent falls but was not shown to be statistically significant in the prevention of hip fracture in this study.

High Voltage Pulsed Radiofrequency for the Treatment of Refractory Neuralgia of the Infraorbital Nerve: A Prospective Double-Blinded Randomized Controlled Study.

PubMed

Luo, Fang; Wang, Tao; Shen, Ying; Meng, Lan; Lu, Jingjing; Ji, Nan

2017-05-01

A recent study showed that 50% of patients who suffered from refractory neuralgia of the infraorbital nerve obtained satisfactory efficacy after pulsed radiofrequency (PRF) treatment. A pilot study showed that increasing the output voltage of PRF significantly improved the efficacy for trigeminal neuralgia; however, whether increasing the output voltage of PRF can improve the treatment outcomes for neuralgia of the infraorbital nerve is unknown. To evaluate the efficacy and safety of high voltage PRF treatment in comparison with standard voltage PRF for neuralgia of the infraorbital nerve. Prospective, single-center, double-blinded, randomized, controlled trial. Beijing Tiantan Hospital, Capital Medical University. A total of 60 patients with refractory neuralgia of the infraorbital nerve were randomly divided into the high voltage PRF group and the standard voltage PRF group to treat their infraorbital nerves. Neither the patients, pain physicians, nor the follow-up evaluators knew the patient group assignments. The primary outcome measure was the one-year response rate. The secondary outcome measures included the time to take effect after PRF, the one-month, 3-month, and 6-month response rates, the relapse rate, and adverse reactions. The intent-to-treat analysis showed that the one-month, 3-month, 6-month, and one-year response rates were all 90% in the high voltage group, which were significantly higher than the rates in the standard voltage group (67% [P < 0.05], 67% [P < 0.05], 63% [P < 0.05], and 60% [P <0.01], respectively). Furthermore, 27% of the patients in the high-voltage group and 13% of the patients in the standard voltage group experienced minor transient (10 - 30 days) numbness in the innervation area after PRF; no other serious adverse reactions were observed in the 2 groups (P > 0.05). We did not investigate the dose-effect relationship between the output voltage and efficacy or the effect of a higher pulse dose on efficacy. This study was a single-center study, and multi-center, randomized, controlled studies are needed to obtain the highest level of empirical evidence. Additionally, the follow-up period lasted only one year in this study; thus, long-term efficacy needs to be further confirmed. The results showed that high voltage PRF was effective and safe for patients with refractory neuralgia of the infraorbital nerve and could become a treatment option in patients who do not respond to conservative treatment.

Addressing Younger Workers' Needs: The Promoting U through Safety and Health (PUSH) Trial Outcomes.

PubMed

Rohlman, Diane S; Parish, Megan; Elliot, Diane L; Hanson, Ginger; Perrin, Nancy

2016-08-10

Most younger workers, less than 25 years old, receive no training in worker safety. We report the feasibility and outcomes of a randomized controlled trial of an electronically delivered safety and health curriculum for younger workers entitled, PUSH (Promoting U through Safety and Health). All younger workers (14-24 years old) hired for summer work at a large parks and recreation organization were invited to participate in an evaluation of an online training and randomized into an intervention or control condition. Baseline and end-of-summer online instruments assessed acceptability, knowledge, and self-reported attitudes and behaviors. One-hundred and forty participants (mean age 17.9 years) completed the study. The innovative training was feasible and acceptable to participants and the organization. Durable increases in safety and health knowledge were achieved by intervention workers (p < 0.001, effect size (Cohen's d) 0.4). However, self-reported safety and health attitudes did not improve with this one-time training. These results indicate the potential utility of online training for younger workers and underscore the limitations of a single training interaction to change behaviors. Interventions may need to be delivered over a longer period of time and/or include environmental components to effectively alter behavior.

Addressing Younger Workers’ Needs: The Promoting U through Safety and Health (PUSH) Trial Outcomes

PubMed Central

Rohlman, Diane S.; Parish, Megan; Elliot, Diane L.; Hanson, Ginger; Perrin, Nancy

2016-01-01

Most younger workers, less than 25 years old, receive no training in worker safety. We report the feasibility and outcomes of a randomized controlled trial of an electronically delivered safety and health curriculum for younger workers entitled, PUSH (Promoting U through Safety and Health). All younger workers (14–24 years old) hired for summer work at a large parks and recreation organization were invited to participate in an evaluation of an online training and randomized into an intervention or control condition. Baseline and end-of-summer online instruments assessed acceptability, knowledge, and self-reported attitudes and behaviors. One-hundred and forty participants (mean age 17.9 years) completed the study. The innovative training was feasible and acceptable to participants and the organization. Durable increases in safety and health knowledge were achieved by intervention workers (p < 0.001, effect size (Cohen’s d) 0.4). However, self-reported safety and health attitudes did not improve with this one-time training. These results indicate the potential utility of online training for younger workers and underscore the limitations of a single training interaction to change behaviors. Interventions may need to be delivered over a longer period of time and/or include environmental components to effectively alter behavior. PMID:27517968

Increased 1-year continuation of DMPA among women randomized to self-administration: results from a randomized controlled trial at Planned Parenthood.

PubMed

Kohn, Julia E; Simons, Hannah R; Della Badia, Lisa; Draper, Elissa; Morfesis, Johanna; Talmont, Elizabeth; Beasley, Anitra; McDonald, Melanie; Westhoff, Carolyn L

2018-03-01

Self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA-sc) is feasible, acceptable, and effective. Our objective was to compare one-year continuation of DMPA-sc between women randomized to self-administration versus clinic administration. We randomized 401 females ages 15-44 requesting DMPA at clinics in Texas and New Jersey to self-administration or clinic administration in a 1:1 allocation. Clinic staff taught participants randomized to self-administration to self-inject and observed the first injection; participants received instructions, a sharps container, and three doses for home use. Participants randomized to clinic administration received usual care. All participants received DMPA-sc at no cost and injection reminders via text message or email. We conducted follow-up surveys at six and 12 months. Three hundred thirty-six participants (84%) completed the 12-month survey; 316 completed both follow-up surveys (an 80% response rate excluding eight withdrawals). Participants ranged in age from 16-44. One-year DMPA continuous use was 69% in the self-administration group and 54% in the clinic group (p=.005). There were three self-reported pregnancies during the study period, all occurred in the clinic group; all three women had discontinued DMPA and one reported her pregnancy as intended. Among the self-administration group, 97% reported that self-administration was very or somewhat easy; 87% would recommend self-administration of DMPA-sc to a friend. Among the clinic group, 52% reported interest in self-administration in the future. Satisfaction was similar between groups. No serious adverse events were reported. DMPA self-administration improves contraceptive continuation and is a feasible and acceptable option for women and adolescents. Self-administration of subcutaneous DMPA can improve contraceptive access, autonomy, and continuation, and is a feasible and acceptable option for women and adolescents. It should be made widely available as an option for women and adolescents. Copyright © 2017 Elsevier Inc. All rights reserved.

A Blinded Randomized Controlled Trial of Motivational Interviewing to Improve Adherence with Osteoporosis Medications: Design of the OPTIMA Trial

PubMed Central

Solomon, Daniel H.; Gleeson, Timothy; Iversen, Maura; Avorn, Jerome; Brookhart, M. Alan; Lii, Joyce; Losina, Elena; May, Frank; Patrick, Amanda; Shrank, William H.; Katz, Jeffrey N.

2010-01-01

Purpose While many effective treatments exist for osteoporosis, most people do not adhere to such treatments long-term. No proven interventions exist to improve osteoporosis medication adherence. We report here on the design and initial enrollment in an innovative randomized controlled trial aimed at improving adherence to osteoporosis treatments. Methods The trial represents a collaboration between academic researchers and a state-run pharmacy benefits program for low-income older adults. Beneficiaries beginning treatment with a medication for osteoporosis are targeted for recruitment. We randomize consenting individuals to receive 12-months of mailed education (control arm) or an intervention consisting of one-on-one telephone-based counseling and the mailed education. Motivational Interviewing forms the basis for the counseling program which is delivered by seven trained and supervised health counselors over ten telephone calls. The counseling sessions include scripted dialogue, open-ended questions about medication adherence and its barriers, as well as structured questions. The primary endpoint of the trial is medication adherence measured over the 12-month intervention period. Secondary endpoints include fractures, nursing home admissions, health care resource utilization, and mortality. Results During the first 7 months of recruitment, we have screened 3,638 potentially eligible subjects. After an initial mailing, 1,115 (30.6%) opted out of telephone recruitment and 1,019 (28.0%) could not be successfully contacted. Of the remaining, 879 (24.2%) consented to participate and were randomized. Women comprise over 90% of all groups, mean ages range from 77–80 years old, and the majority in all groups was white. The distribution of osteoporosis medications was comparable across groups and the median number of different prescription drugs used in the prior year was 8–10. Conclusions We have developed a novel intervention for improving osteoporosis medication adherence. The intervention is currently being tested in a large scale randomized controlled trial. If successful, the intervention may represent a useful model for improving adherence to other chronic treatments. PMID:19436935

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

PubMed

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

2009-09-01

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

The effects of two novel gratitude and mindfulness interventions on well-being.

PubMed

O'Leary, Karen; Dockray, Samantha

2015-04-01

To examine the efficacy of two dual-component interventions, one based on mindfulness and one based on gratitude, to reduce depression and stress and increase happiness levels. Randomized, controlled study with data collected at baseline, 3 weeks, and 5 weeks. Participants completed an online gratitude or mindfulness intervention at home. Self-report questionnaires were completed at home or at work. Sixty-five women aged 18-46 years (mean age±standard deviation, 28.35±6.65 years). Participants were randomly assigned to a wait-list control condition or to either a gratitude or a mindfulness intervention condition. The interventions were used four times a week for 3 weeks. The gratitude intervention involved a gratitude diary and grateful reflection. The mindfulness intervention involved a mindfulness diary and mindfulness meditation, the Body Scan. The outcome variables were depression, stress, and happiness measured by using the Edinburgh Depression Scale, the Perceived Stress Scale, and the Subjective Happiness Scale, respectively. All outcome variables improved over time in both interventions group but not in the wait-list control group. Efficacy of the interventions differed between the interventions. These short novel interventions seem to provide a useful way to enhance well-being. Further research in the area is warranted.

A Randomized Controlled Open-Label Pilot Study of Simvastatin Addition to Whole-Brain Radiation Therapy in Patients With Brain Metastases.

PubMed

El-Hamamsy, Manal; Elwakil, Hesham; Saad, Amr S; Shawki, May A

2016-10-27

Statins have been reported to have a potential radiosensitizing effect that has not been evaluated in clinical trials. The aim of this study was to evaluate the efficacy and safety of simvastatin in addition to whole-brain radiation therapy (WBRT) in patients with brain metastases (BM). A prospective randomized, controlled, open-label pilot study was conducted on 50 Egyptian patients with BM who were randomly assigned to receive 30-Gy WBRT (control group: 25 patients) or 30 Gy WBRT + simvastatin 80 mg/day for the WBRT period (simvastatin group: 25 patients). The primary outcome was radiological response at 4 weeks after WBRT. Secondary outcomes were 1-year progression-free survival (PFS), 1-year overall survival (OS), and health-related quality of life (HRQL) that was assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and its brain module (BN-20), at baseline, after WBRT, and 4 weeks after WBRT. The addition of simvastatin was tolerated. Twenty-one patients were not evaluated for radiological response because of death (n = 16), noncompliance to follow-up (n = 4), and clinical deterioration (n = 1). Response rates were 60% and 78.6% (p = 0.427), 1-year PFS rates were 5.2% and 17.7% (p = 0.392), and 1-year OS rates were 12% and 8% (p = 0.880) for the control group and simvastatin group, respectively. Nonsignificant differences were found between the two arms regarding HRQL scales. The addition of simvastatin 80 mg/day did not improve the clinical outcomes of patients with BM receiving WBRT.

Effectiveness of a group-based self-management program for people with chronic fatigue syndrome: a randomized controlled trial.

PubMed

Pinxsterhuis, Irma; Sandvik, Leiv; Strand, Elin Bolle; Bautz-Holter, Erik; Sveen, Unni

2017-01-01

To evaluate the effectiveness of a group-based self-management program for people with chronic fatigue syndrome. A randomized controlled trial. Four mid-sized towns in southern Norway and two suburbs of Oslo. A total of 137 adults with chronic fatigue syndrome. A self-management program including eight biweekly meetings of 2.5 hours duration. The control group received usual care. Primary outcome measure: Medical Outcomes Study-Short Form-36 physical functioning subscale. Fatigue severity scale, self-efficacy scale, physical and mental component summary of the Short Form-36, and the illness cognition questionnaire (acceptance subscale). Assessments were performed at baseline, and at six-month and one-year follow-ups. At the six-month follow-up, a significant difference between the two groups was found concerning fatigue severity ( p = 0.039) in favor of the control group, and concerning self-efficacy in favor of the intervention group ( p = 0.039). These significant differences were not sustained at the one-year follow-up. No significant differences were found between the groups concerning physical functioning, acceptance, and health status at any of the measure points. The drop-out rate was 13.9% and the median number of sessions attended was seven (out of eight). The evaluated self-management program did not have any sustained effect, as compared with receiving usual care.

The impact of vitamin D in pregnancy on extraskeletal health in children: a systematic review.

PubMed

Christesen, Henrik T; Elvander, Claes; Lamont, Ronald F; Jørgensen, Jan S

2012-12-01

The impact of maternal vitamin D status in pregnancy on the extraskeletal health of the offspring has become a "hot topic" with a potential for cost-beneficial prevention. The objective of this study was to systematically review the level I and II evidence. PubMed, Embase and Cochrane databases were searched using the MeSH terms "vitamin D" AND "pregnancy" until 1 January 2012. The search was limited to randomized controlled trials (evidence level I) and observational studies (evidence level II) in humans and in the English language. Papers reporting on vitamin D supplementation in combination with other supplements, or not reporting on 25OHD or outcomes of the offspring were excluded. Six randomized controlled trials and 24 observational studies were finally included. In randomized controlled studies, vitamin D supplementation resulted in increased birthweight in one study, but showed no effect in five other studies. In cohort and case-control studies, higher vitamin D intake, or higher 25OHD, was associated with increased birthweight in large studies only, and modified by vitamin D receptor polymorphisms and by race (U-shaped in Caucasians in one unconfirmed study). The risks of HIV mother-to-child transmission, rhinitis symptoms and eczema were lower. Data were conflicting on the effect on respiratory infections and wheezing, whereas U-shaped associations to inhalant allergen-specific IgE at five years and to schizophrenia were reported in unconfirmed studies. The risk of type 1 diabetes at 15 years was lower or unchanged. It is concluded that observational studies suggest an effect of vitamin D on several outcomes. U-Shaped associations warrant caution. © 2012 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2012 Nordic Federation of Societies of Obstetrics and Gynecology.

A randomized controlled trial of eicosapentaenoic acid and/or aspirin for colorectal adenoma prevention during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme (The seAFOod Polyp Prevention Trial): study protocol for a randomized controlled trial.

PubMed

Hull, Mark A; Sandell, Anna C; Montgomery, Alan A; Logan, Richard F A; Clifford, Gayle M; Rees, Colin J; Loadman, Paul M; Whitham, Diane

2013-07-29

The naturally-occurring omega (ω)-3 polyunsaturated fatty acid (PUFA) eicosapentaenoic acid (EPA) reduces colorectal adenoma (polyp) number and size in patients with familial adenomatous polyposis. The safety profile and potential cardiovascular benefits associated with ω-3 PUFAs make EPA a strong candidate for colorectal cancer (CRC) chemoprevention, alone or in combination with aspirin, which itself has recognized anti-CRC activity. Colorectal adenoma number and size are recognized as biomarkers of future CRC risk and are established as surrogate end-points in CRC chemoprevention trials. The seAFOod Polyp Prevention Trial is a randomized, double-blind, placebo-controlled, 2×2 factorial 'efficacy' study, which will determine whether EPA prevents colorectal adenomas, either alone or in combination with aspirin. Participants are 55-73 year-old patients, who have been identified as 'high risk' (detection of ≥5 small adenomas or ≥3 adenomas with at least one being ≥10 mm in diameter) at screening colonoscopy in the English Bowel Cancer Screening Programme (BCSP). Exclusion criteria include the need for more than one repeat endoscopy within the three-month BCSP screening period, malignant change in an adenoma, regular use of aspirin or non-aspirin non-steroidal anti-inflammatory drugs, regular use of fish oil supplements and concomitant warfarin or anti-platelet agent therapy. Patients are randomized to either EPA-free fatty acid 1 g twice daily or identical placebo AND aspirin 300 mg once daily or identical placebo, for approximately 12 months. The primary end-point is the number of participants with one or more adenomas detected at routine one-year BCSP surveillance colonoscopy. Secondary end-points include the number of adenomas (total and 'advanced') per patient, the location (left versus right colon) of colorectal adenomas and the number of participants re-classified as 'intermediate risk' for future surveillance. Exploratory end-points include levels of bioactive lipid mediators such as ω-3 PUFAs, resolvin E1 and PGE-M in plasma, urine, erythrocytes and rectal mucosa in order to gain insights into the mechanism(s) of action of EPA and aspirin, alone and in combination, as well as to discover predictive biomarkers of chemopreventive efficacy. The recruitment target is 904 patients. Current Controlled Trials ISRCTN05926847.

Clinical Efficacy and Safety of Pamidronate Therapy on Bone Mass Density in Early Post-Renal Transplant Period: A Meta-Analysis of Randomized Controlled Trials

PubMed Central

Wang, Zijie; Han, Zhijian; Tao, Jun; Lu, Pei; Liu, Xuzhong; Wang, Jun; Wu, Bian; Huang, Zhengkai; Yin, Changjun; Tan, Ruoyun; Gu, Min

2014-01-01

Introduction The overall effect of pamidronate on bone mass density (BMD) in the early renal transplant period varies considerably among studies. The effects of pamidronate on graft function have not been determined. Materials and Methods A comprehensive search was conducted in PubMed, the Cochrane Central Register of Controlled Trials (CENTRAL) and Embase independently by two authors. Randomized controlled trials of pamidronate evaluating bone loss in the first year of renal transplantation were included. Methods reported in the “Cochrane Handbook for Systematic Reviews of Interventions 5.0.2” were used to evaluate changes of lumbar spine and femoral neck BMD, and serum creatinine, calcium and intact parathyroid hormone (iPTH) levels. Fixed or random effect models were used as appropriate. Results Six randomized trials evaluating 281 patients were identified. One hundred forty-four were treated with pamidronate and 137 were control patients. Administration of pamidronate was associated with significant reduction of bone loss in the lumbar spine, compared to the control group (standardized mean difference (SMD)  = 24.62 [16.25, 32.99]). There was no difference between the pamidronate treated and control femoral neck BMD (SMD  = 3.53 [−1.84, 8.90]). A significant increase in the serum creatinine level of the intervention group was seen, compared to the control group. The serum calcium and iPTH of the pamidronate and control groups were not different after 1 year (serum creatinine: SMD  = −3.101 [−5.33, −0.89]; serum calcium: SMD  = 2.18 [−0.8, 5.16]; serum iPTH: SMD  = 0.06 [−0.19, 0.31]). Heterogeneity was low for serum calcium and iPTH and high for serum creatinine. Conclusions This meta-analysis demonstrated the beneficial clinical efficacy of pamidronate on BMD with no association with any alteration in graft function during the first year of renal transplantation. Significant heterogeneity precludes the conclusion of the relationship between serum creatinine and pamidronate. PMID:25265508

Two-year controlled effectiveness trial of a school-based intervention to prevent obesity in Chilean children.

PubMed

Kain, Juliana; Leyton, Barbara; Cerda, Ricardo; Vio, Fernando; Uauy, Ricardo

2009-09-01

Obesity prevalence among Chilean children is 19.4%. The present study aimed to assess the effectiveness of a school-based obesity prevention programme. Non-randomized controlled study. The intervention included activities in nutrition and physical activity, fully applied the first year and partially in the second one. Primary outcomes were BMI Z-score (BMIZ) and obesity prevalence; secondary outcomes were waist circumference and triceps skinfold thickness. Time effects were assessed by changes in BMI-related variables by gender and period (ANOVA and Tukey test), while intervention effects were determined by comparing changes in (i) obesity prevalence by gender and period (PROC GENMOD) and (ii) BMIZ according gender, age and period (PROC MIXED). Primary schools in the Chilean cities of Casablanca (intervention group) and Quillota (control group). One thousand seven hundred and fifty-nine children from three schools (intervention group) and 671 from one school (control group). Over the two years, obesity prevalence and BMIZ declined significantly in the intervention group; from 17.0% to 12.3% and 14.1% to 10.3% in boys and girls, respectively, and from 0.62 to 0.53 and 0.64 to 0.58, respectively. In the control group, obesity remained stable at about 21% and 15%, while BMIZ increased significantly in the second year. BMIZ declined in both genders and all age categories in the intervention group during the first year (significant only in younger boys). No changes occurred during the summer, while during the second year, BMIZ increased in boys and girls from both groups (significant only in the younger control boys). Obesity declined significantly only in boys during the first year. Effectiveness was greater in the first school year and more evident in younger boys.

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.

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

PubMed

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

2012-06-15

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

Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial.

PubMed

Norman, Wendy V; Kaczorowski, Janusz; Soon, Judith A; Brant, Rollin; Bryan, Stirling; Trouton, Konia J; Dicus, Lyda

2011-06-14

We describe the rationale and protocol for a randomized controlled trial (RCT) to assess whether intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests the novel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlights considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of 12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention) or four weeks (recommended care) post abortion. Primary outcome measure is pregnancy rate at one year. Secondary outcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economic analyses comparing immediate and delayed insertion groups, and device retention rates, complication rates (infection, expulsion) and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires, clinical records and British Columbia linked health databases will be used to assess primary and secondary outcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and is expected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014. The RCT design combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry and hospital records, offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one through five years among enrolled women. We highlight considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion.

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

PubMed

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

2009-07-02

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

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

PubMed Central

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

2009-01-01

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

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

PubMed

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

2013-08-16

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

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

PubMed Central

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

2015-01-01

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

A Randomized Controlled Trial to Evaluate if Computerized Cognitive Rehabilitation Improves Neurocognition in Ugandan Children with HIV

PubMed Central

Nakasujja, Noeline; Sikorskii, Alla; Opoka, Robert O.; Giordani, Bruno

2016-01-01

Abstract Objectives: Clinically stable children with HIV can have neuromotor, attention, memory, visual–spatial, and executive function impairments. We evaluated neuropsychological and behavioral benefits of computerized cognitive rehabilitation training (CCRT) in Ugandan HIV children. Design: One hundred fifty-nine rural Ugandan children with WHO Stage I or II HIV disease (6 to 12 years; 77 boys, 82 girls; M = 8.9, SD = 1.86 years) were randomized to one of three treatment arms over a 2-month period. Methods: The CCRT arm received 24 one-hour sessions over 2 months, using Captain's Log (BrainTrain Corporation) programmed for games targeting working memory, attention, and visual–spatial analysis. These games progressed in difficulty as the child's performance improved. The second arm was a “limited CCRT” with the same games rotated randomly from simple to moderate levels of training. The third arm was a passive control group receiving no training. All children were assessed at enrollment, 2 months (immediately following CCRT), and 3 months after CCRT completion. Results: The CCRT group had significantly greater gains through 3 months of follow-up compared to passive controls on overall Kaufman Assessment Battery for Children–second edition (KABC-II) mental processing index (p < .01), planning (p = .04), and knowledge (p = .03). The limited CCRT group performed better than controls on learning (p = .05). Both CCRT arms had significant improvements on CogState Groton maze learning (p < .01); although not on CogState attention/memory, TOVA/impulsivity, or behavior rating inventory for executive function and child behavior checklist (psychiatric behavior/symptom problems) ratings by caregiver. Conclusions: CCRT intervention can be effective for neurocognitive rehabilitation in children with HIV in low-resource settings, especially in children who are clinically stable on ARV treatment. PMID:27045714

Ankles back in randomized controlled trial (ABrCt): braces versus neuromuscular exercises for the secondary prevention of ankle sprains. Design of a randomised controlled trial.

PubMed

Janssen, Kasper W; van Mechelen, Willem; Verhagen, Evert Alm

2011-09-27

Ankle sprains are the most common sports and physical activity related injury. There is extensive evidence that there is a twofold increased risk for injury recurrence for at least one year post injury. In up to 50% of all cases recurrences result in disability and lead to chronic pain or instability, requiring prolonged medical care. Therefore ankle sprain recurrence prevention in athletes is essential. This RCT evaluates the effect of the combined use of braces and neuromuscular training (e.g. proprioceptive training/sensorimotor training/balance training) against the individual use of either braces or neuromuscular training alone on ankle sprain recurrences, when applied to individual athletes after usual care. This study was designed as three way randomized controlled trial with one year follow-up. Healthy individuals between 12 and 70 years of age, who were actively participating in sports and who had sustained a lateral ankle sprain in the two months prior to inclusion, were eligible for inclusion. After subjects had finished ankle sprain treatment by means of usual care, they were randomised to any of the three study groups. Subjects in group 1 received an eight week neuromuscular training program, subjects in group 2 received a sports brace to be worn during all sports activities for the duration of one year, and group 3 received a combination of the neuromuscular training program and a sports brace to be worn during all sports activities for the duration of eight weeks. Outcomes were assessed at baseline and every month for 12 months therafter. The primary outcome measure was incidence of ankle sprain recurrences. Secondary outcome measures included the direct and indirect costs of recurrent injury, the severity of recurrent injury, and the residual complaints during and after the intervention. The ABrCt is the first randomized controlled trial to directly compare the secondary preventive effect of the combined use of braces and neuromuscular training, against the use of either braces or neuromuscular training as separate secondary preventive measures. This study expects to identify the most effective and cost-efficient secondary preventive measure for ankle sprains. The study results could lead to changes in the clinical guidelines on the prevention of ankle sprains, and they will become available in 2012. Netherlands Trial Register (NTR): NTR2157.

Predictors of diagnosis of child psychiatric disorder in adult-infant social-communicative interaction at 12 months.

PubMed

Marwick, H; Doolin, O; Allely, C S; McConnachie, A; Johnson, P; Puckering, C; Golding, J; Gillberg, C; Wilson, P

2013-01-01

To establish which social interactive behaviours predict later psychiatric diagnosis, we examined 180 videos of a parent-infant interaction when children were aged one year, from within the Avon Longitudinal Study of Parents and Children (ALSPAC) cohort. Sixty of the videos involved infants who were later diagnosed with a psychiatric disorder at seven years, and 120 were a randomly selected sex-matched control group. Interactive behaviours for both the caregiver and the one year old infant were coded from the videos according to eight holistic categories of interpersonal engagement: Well-being, Contingent Responsiveness, Cooperativeness, Involvement, Activity, Playfulness, Fussiness, and Speech. Lower levels of adult activity and speech in interaction at one year significantly predicted overall diagnosis of child psychiatric disorder. Copyright © 2012 Elsevier Ltd. All rights reserved.

Evaluation of a randomized intervention to delay sexual initiation among fifth-graders followed through the sixth grade

PubMed Central

Koo, Helen P.; Rose, Allison; El-Khorazaty, M. Nabil; Yao, Qing; Jenkins, Renee R.; Anderson, Karen M.; Davis, Maurice; Walker, Leslie R.

2011-01-01

US adolescents initiate sex at increasingly younger ages, yet few pregnancy prevention interventions for children as young as 10–12 years old have been evaluated. Sixteen Washington, DC schools were randomly assigned to intervention versus control conditions. Beginning in 2001/02 with fifth-grade students and continuing during the sixth grade, students completed pre-intervention and post-intervention surveys each school year. Each year, the intervention included 10–13 classroom sessions related to delaying sexual initiation. Linear hierarchical models compared outcome changes between intervention and control groups by gender over time. Results show the intervention significantly decreased a rise over time in the anticipation of having sex in the next 12 months among intervention boys versus control boys, but it had no other outcome effects. Among girls, the intervention had no significant outcome effects. One exception is that for both genders, compared with control students, intervention students increased their pubertal knowledge. In conclusion, a school-based curriculum to delay sexual involvement among fifth-grade and sixth-grade high-risk youths had limited impact. Additional research is necessary to outline effective interventions, and more intensive, comprehensive interventions may be required to counteract adverse circumstances in students’ lives and pervasive influences toward early sex. ClinicalTrials. gov identifier: NCT00341471 PMID:21857793

A randomized controlled study comparing internet-based cognitive behavioral therapy and counselling by standard care for fear of birth - A study protocol.

PubMed

Ternström, Elin; Hildingsson, Ingegerd; Haines, Helen; Karlström, Annika; Sundin, Örjan; Ekdahl, Johanna; Segeblad, Birgitta; Larsson, Birgitta; Rondung, Elisabet; Rubertsson, Christine

2017-10-01

Fear of birth is a concern that requires evidence based treatment. The aim of this study is to present the protocol of a randomized controlled multi-center trial to compare internet-based cognitive therapy with counseling as standard care for pregnant women reporting fear of birth. Participants will be recruited in mid-pregnancy. Women who score 60 or above on the Fear of Birth Scale will be offered to participate in this study. Data will be collected by questionnaires including validated instruments at baseline and follow-ups at gestational weeks 30 and 36, two months and one year after birth. The primary outcome will be level of fear of birth measured with the Fear of Birth Scale at 36 weeks of gestation. Secondary outcome measures are level of fear of birth at two months and one year after giving birth, preferences for mode of birth, requests for elective cesarean section, compliance and satisfaction with treatment and birth outcomes. A power calculation based on a 20% reduction of fear implies that approximately 200 will be included in the trial. The study outlined in this protocol will be the first randomized controlled trial comparing internet-based cognitive therapy with counseling for women reporting fear of birth. An effective treatment may result in better overall health for women with fear of birth and a reduction in cesarean sections for non-medical reasons. Evidence regarding treatment options of fear of birth will also provide a greater choice for women. Copyright © 2017 Elsevier B.V. All rights reserved.

The role of adding metformin in insulin-resistant diabetic pregnant women: a randomized controlled trial.

PubMed

Ibrahim, Moustafa Ibrahim; Hamdy, Ahmed; Shafik, Adel; Taha, Salah; Anwar, Mohammed; Faris, Mohammed

2014-05-01

The aim of the present study is to assess the impact of adding oral metformin to insulin therapy in pregnant women with insulin-resistant diabetes mellitus. The current non-inferiority randomized controlled trial was conducted at Ain Shams University Maternity Hospital. The study included pregnant women with gestational or pre-existing diabetes mellitus at gestations between 20 and 34 weeks, who showed insulin resistance (defined as poor glycemic control at a daily dose of ≥1.12 units/kg). Recruited women were randomized into one of two groups: group I, including women who received oral metformin without increasing the insulin dose; and group II, including women who had their insulin dose increased. The primary outcome was maternal glycemic control. Secondary outcomes included maternal bouts of hypoglycemia, need for another hospital admission for uncontrolled diabetes during pregnancy, gestational age at delivery, mode of delivery, birth weight, birth trauma, congenital anomalies, 1- and 5-min Apgar score, neonatal hypoglycemia, need for neonatal intensive care unit (NICU) admission and adverse neonatal outcomes. A total number of 154 women with diabetes mellitus with pregnancy were approached; of them 90 women were eligible and were randomly allocated and included in the final analysis. The recruited 90 women were randomized into one of two groups: group I (metformin group) (n = 46), including women who received oral metformin in addition to the same initial insulin dose; and group II (control group) (n = 44), including women who had their insulin dose increased according to the standard protocol. The mean age of included women was 29.84 ± 5.37 years (range 20-42 years). The mean gestational age at recruitment was 28.7 ± 3.71 weeks (range 21-34 weeks). Among the 46 women of group I, 17 (36.9 %) women reached proper glycemic control at a daily metformin dose of 1,500 mg, 18 (39.2 %) at a daily dose of 2,000 mg, while 11 (23.9 %) received metformin at a daily dose of 2,000 mg without reaching proper glycemic control and needed raising the dose of insulin dose. Adding metformin to insulin therapy in women with insulin-resistant diabetes mellitus with pregnancy seems to be effective in proper glycemic control in a considerable proportion of women, along with benefits of reduced hospital stay, reduced frequency of maternal hypoglycemia as well as reduced frequency of neonatal hypoglycemia, NICU admission and neonatal respiratory distress syndrome.

Improvement in Depressive Symptoms Is Associated with Reduced Oxidative Damage and Inflammatory Response in Type 2 Diabetic Patients with Subsyndromal Depression: The Results of a Randomized Controlled Trial Comparing Psychoeducation, Physical Exercise, and Enhanced Treatment as Usual

PubMed Central

Vučić Lovrenčić, Marijana; Pibernik-Okanović, Mirjana; Šekerija, Mario; Prašek, Manja; Ajduković, Dea; Kos, Jadranka; Hermanns, Norbert

2015-01-01

Aims. To examine one-year changes in oxidative damage and inflammation level in type 2 diabetic patients undergoing behavioral treatment for subsyndromal depression. Materials and Methods. A randomized controlled comparison of psychoeducation (A), physical exercise (B), and enhanced treatment as usual (C) was performed in 209 eligible subjects in a tertiary diabetes care setting. Depressive symptoms (primary outcome) and selected biomarkers of oxidative damage and inflammation (secondary outcomes) were assessed at baseline and six- and twelve-month follow-up. Results. Out of the 74, 67, and 68 patients randomised into groups A, B, and C, respectively, 201 completed the interventions, and 179 were analysed. Participants in all three groups equally improved in depressive symptoms from baseline to one-year follow-up (repeated measures ANOVA; F = 12.51, p < 0.0001, η 2 = 0.07). Urinary 8-oxo-deoxyguanosine (u-8-oxodG) decreased (F = 10.66, p < 0.0001, η 2 = 0.06), as did sialic acid and leukocytes (F = 84.57, η 2 = 0.32 and F = 12.61, η 2 = 0.07, resp.; p < 0.0001), while uric acid increased (F = 12.53, p < 0.0001, η 2 = 0.07) in all subjects during one year. Improvement of depressive symptoms at 6 months significantly predicted one-year reduction in u-8-oxodG (β = 0.15, p = 0.044). Conclusion. Simple behavioral interventions are capable not only of alleviating depressive symptoms, but also of reducing the intensity of damaging oxidative/inflammatory processes in type 2 diabetic patients with subsyndromal depression. This trial is registered with ISRCTN05673017. PMID:26347775

Moderating Effects of Parental Characteristics on the Effectiveness of a Theory of Mind Training for Children with Autism: A Randomized Controlled Trial.

PubMed

de Veld, Danielle M J; Howlin, Patricia; Hoddenbach, Elske; Mulder, Fleur; Wolf, Imke; Koot, Hans M; Lindauer, Ramón; Begeer, Sander

2017-07-01

This RCT investigated whether the effect of a Theory of Mind (ToM) intervention for children with ASD was moderated by parental education level and employment, family structure, and parental ASD. Children with autism aged 8-13 years (n = 136) were randomized over a waitlist control or treatment condition. At posttest, children in the treatment condition had more ToM knowledge, showed fewer autistic features, and more ToM-related behavior than children in the control condition. Children who had one or two parents with at least a college degree, and children with parents not diagnosed with/suspected of having ASD themselves benefitted from the training. These findings provide valuable information about family variables that need to be taken into account in treatment design and implementation.

Coaching to Augment Mentoring to Achieve Faculty Diversity: A Randomized Controlled Trial

PubMed Central

Williams, Simon N.; Thakore, Bhoomi K.; McGee, Richard

2015-01-01

Purpose The Academy for Future Science Faculty (the Academy) is a novel coaching intervention for biomedical PhD students designed to address limitations in previous efforts to promote faculty diversity. Unlike traditional research mentoring, the Academy includes both group and individual coaching, coaches have no research or evaluation roles with the students, and it is based on social science theories. The authors present a qualitative case study of one of the coaching groups and provide statistical analyses indicating whether one year in the Academy effects students’ perceptions of the achievability and desirability of an academic career. Method The authors have tested (July 2012-July 2013), with Northwestern University ethical approval, the Academy via a longitudinal randomized controlled trial. Participants were 121 latter-stage biomedical PhD students. The authors collected data via questionnaires, interviews, and meeting recordings. Results The case study shows how group career coaching can effectively supplement traditional one-to-one research mentoring; provide new role models for underrepresented minority students; and provide theory-based lenses through which to engage in open conversations about race, gender, and science careers. Repeated-measures analysis of variances showed perceived achievability increased in the Academy group from baseline to 1-year follow-up (means, 5.75 vs. 6.39), but decreased in the control group (6.58 vs. 5.81). Perceived desirability decreased significantly less (P < 0.05) in the Academy group (7.00 vs. 6.36), than in the control group (7.83 vs. 5.97). Conclusions Early results suggest that an academic career-coaching model can effectively supplement traditional research mentoring and promote persistence towards academic careers. PMID:26675187

Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus.

PubMed

Petrak, Frank; Herpertz, Stephan; Albus, Christian; Hermanns, Norbert; Hiemke, Christoph; Hiller, Wolfgang; Kronfeld, Kai; Kruse, Johannes; Kulzer, Bernd; Ruckes, Christian; Müller, Matthias J

2013-08-06

Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes. This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50-200 mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12 weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary hypothesis we expect that CBT leads to significantly greater improvement of glycemic control in the one year follow-up in treatment responders of the short term phase. The DAD study is the first randomized controlled trial comparing antidepressants to a psychological treatment in diabetes patients with depression. Current controlled trials ISRCTN89333241.

Changing Friend Selection in Middle School: A Social Network Analysis of a Randomized Intervention Study Designed to Prevent Adolescent Problem Behavior.

PubMed

DeLay, Dawn; Ha, Thao; Van Ryzin, Mark; Winter, Charlotte; Dishion, Thomas J

2016-04-01

Adolescent friendships that promote problem behavior are often chosen in middle school. The current study examines the unintended impact of a randomized school-based intervention on the selection of friends in middle school, as well as on observations of deviant talk with friends 5 years later. Participants included 998 middle school students (526 boys and 472 girls) recruited at the onset of middle school (age 11-12 years) from three public middle schools participating in the Family Check-up model intervention. The current study focuses only on the effects of the SHAPe curriculum-one level of the Family Check-up model-on friendship choices. Participants nominated friends and completed measures of deviant peer affiliation. Approximately half of the sample (n = 500) was randomly assigned to the intervention, and the other half (n = 498) comprised the control group within each school. The results indicate that the SHAPe curriculum affected friend selection within school 1 but not within schools 2 or 3. The effects of friend selection in school 1 translated into reductions in observed deviancy training 5 years later (age 16-17 years). By coupling longitudinal social network analysis with a randomized intervention study, the current findings provide initial evidence that a randomized public middle school intervention can disrupt the formation of deviant peer groups and diminish levels of adolescent deviance 5 years later.

Assessing the effectiveness of a school-based oral health promotion programme in Yichang City, China.

PubMed

Tai, Bao-Jun; Jiang, Han; Du, Min-Quan; Peng, Bin

2009-10-01

To assess the outcome of oral health promotion in schoolchildren over a 3-year period in Yichang City, Hubei, China. In a cluster randomized controlled trial, the concept of the World Health Organization Health Promoting Schools Project was applied to primary schoolchildren. Seven intervention schools and eight control schools were randomly selected from one district by stratified cluster sampling. The study was conducted as a 3-year follow-up study. After 3 years, 661 children remained in the intervention group and 697 children in the control group. Data on dental caries, plaque accumulation, and sulcus bleeding were collected by clinical examination, while behavioural data were gathered by self-administered questionnaires. The 3-year net mean DMFS increment score was 0.22 in the intervention schools and 0.35 in the control schools (P < 0.013). A statistically significant difference in mean plaque (P < 0.013) and sulcus bleeding (P < 0.005) increment scores after 3 years was found between the two groups. Statistically significant higher scores were observed in restorations received and sealants placed, and a lower score in untreated dental caries, in children from the intervention group than the control group after 3 years (P < 0.01). In addition, more children in the intervention schools adopted regular oral health behavioural practices such as brushing their teeth at least twice a day, visiting the dentist within the past calendar year, and using fluoride toothpaste. The study suggests that the school-based oral health promotion was an effective way to reduce new caries incidence, improve oral hygiene and establish positive oral health behavioural practices in the targeted schoolchildren.

The Efficacy of Parent-Child Interaction Therapy with Chinese Families: Randomized Controlled Trial

ERIC Educational Resources Information Center

Leung, Cynthia; Tsang, Sandra; Sin, Tammy C. S.; Choi, Siu-yan

2015-01-01

Objective: This study aimed to examine the efficacy of the Parent-Child Interaction Therapy (PCIT) in Hong Kong Chinese families, using randomized controlled trial design. Methods: The participants included 111 Hong Kong Chinese parents with children aged 2--7 years old, who were randomized into the intervention group (n = 54) and control group (n…

Does adding mobilization to stretching improve outcomes for people with frozen shoulder? A randomized controlled clinical trial.

PubMed

Çelik, Derya; Kaya Mutlu, Ebru

2016-08-01

To assess the effectiveness of joint mobilization combined with stretching exercises in patients with frozen shoulder. A randomized controlled clinical pilot trial. Department of Orthopedics and Traumatology. Thirty patients with frozen shoulder. All participants were randomly assigned to one of two treatment groups: joint mobilization and stretching versus stretching exercises alone. Both groups performed a home exercise program and were treated for six weeks (18 sessions). The primary outcome measures for functional assessment were the Disabilities of the Arm, Shoulder and Hand score and the Constant score. The secondary outcome measures were pain level, as evaluated with a visual analog scale, and range of motion, as measured using a conventional goniometer. Patients were assessed before treatment, at the end of the treatment, and after one year as follow-up. Two-by-two repeated-measures ANOVA with Bonferroni corrections revealed significant increases in abduction (91.9° [CI: 86.1-96.7] to 172.8° [CI: 169.7-175.5]), external rotation (28.1° [CI: 22.2-34.2] to 77.7° [CI: 70.3-83.0]) and Constant score (39.1 [CI: 35.3-42.6] to 80.5 [75.3-86.6]) at the one-year follow-up in the joint mobilization combined with stretching exercise group, whereas the group performing stretching exercise alone did not show such changes. In the treatment of patients with frozen shoulder, joint mobilization combined with stretching exercises is better than stretching exercise alone in terms of external rotation, abduction range of motion and function score. © The Author(s) 2015.

Individual differences in the efficacy of a short theory of mind intervention for children with autism spectrum disorder: a randomized controlled trial.

PubMed

Hoddenbach, Elske; Koot, Hans M; Clifford, Pamela; Gevers, Carolien; Clauser, Cassandra; Boer, Frits; Begeer, Sander

2012-11-09

Having a 'theory of mind', or having the ability to attribute mental states to oneself or others, is considered one of the most central domains of impairment among children with an autism spectrum disorder (ASD). Many interventions focus on improving theory of mind skills in children with ASD. Nonetheless, the empirical evidence for the effect of these interventions is limited. The main goal of this study is to examine the effectiveness of a short theory of mind intervention for children with ASD. A second objective is to determine which subgroups within the autism spectrum profit most from the intervention. This study is a randomized controlled trial. One hundred children with ASD, aged 7 to 12 years will be randomly assigned to an intervention or a waiting list control group. Outcome measures include the completion of theory of mind and emotion understanding tasks, and parent and teacher questionnaires on children's social skills. Follow-up data for the intervention group will be collected 6 months after the interventions. This study evaluates the efficacy of a theory of mind intervention for children with ASD. Hypotheses, strengths, and limitations of the study are discussed. Netherlands Trial Register NTR2327.

Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial.

PubMed

Peterson, Arthur V; Marek, Patrick M; Kealey, Kathleen A; Bricker, Jonathan B; Ludman, Evette J; Heffner, Jaimee L

2016-01-01

The Hutchinson Study of High School Smoking was the first randomized trial to show effectiveness of a smoking cessation intervention on 6-months prolonged smoking abstinence at one year post-intervention in a large population-based sample of adolescent smokers. An important question remains: Do the positive effects from teen smoking cessation interventions seen at up to 12 months post-intervention endure into young adulthood? This study examines for the first time whether such positive early effects from teen smoking cessation intervention can endure into young adulthood in the absence of additional intervention. High school smokers (n = 2,151) were proactively recruited into the trial from fifty randomly selected Washington State high schools randomized to the experimental (Motivational Interviewing + Cognitive Behavioral Skills Training telephone counseling intervention) or control (no intervention) condition. These smokers were followed to 7 years post high school to ascertain rates of six-year prolonged smoking abstinence in young adulthood. All statistical tests are two-sided. No evidence of intervention impact at seven years post high school was observed for the main endpoint of six-year prolonged abstinence, neither among all smokers (14.2% in the experimental condition vs. 13.1% in the control condition, difference = +1.1%, 95% confidence interval (CI) = -3.4 to 5.8, p = .61), nor among the subgroups of daily smokers and less-than-daily smokers, nor among other a priori subgroups. But, observed among males was some evidence of an intervention impact on two endpoints related to progress towards quitting: reduction in number of days smoked in the past month, and increase in the length of the longest quit attempt in the past year. There was no evidence from this trial among adolescent smokers that positive effectiveness of the proactive telephone intervention for smoking abstinence, observed previously at one year post-intervention, was sustained for the long-term into young adulthood. In light of the positive short-term effectiveness consistently observed from this and other trials for teen smokers, together with the lack of evidence from this study that such short-term impact can endure into young adulthood, sustained interventions that continue into young adulthood should be developed and tested for long-term impact. ClinicalTrials.gov NCT00115882.

No Effect of Insecticide Treated Curtain Deployment on Aedes Infestation in a Cluster Randomized Trial in a Setting of Low Dengue Transmission in Guantanamo, Cuba

PubMed Central

Lambert, Isora; Montada, Domingo; Baly, Alberto; Van der Stuyft, Patrick

2015-01-01

Objective & Methodology The current study evaluated the effectiveness and cost-effectiveness of Insecticide Treated Curtain (ITC) deployment for reducing dengue vector infestation levels in the Cuban context with intensive routine control activities. A cluster randomized controlled trial took place in Guantanamo city, east Cuba. Twelve neighborhoods (about 500 households each) were selected among the ones with the highest Aedes infestation levels in the previous two years, and were randomly allocated to the intervention and control arms. Long lasting ITC (PermaNet) were distributed in the intervention clusters in March 2009. Routine control activities were continued in the whole study area. In both study arms, we monitored monthly pre- and post-intervention House Index (HI, number of houses with at least 1 container with Aedes immature stages/100 houses inspected), during 12 and 18 months respectively. We evaluated the effect of ITC deployment on HI by fitting a generalized linear regression model with a negative binomial link function to these data. Principal Findings At distribution, the ITC coverage (% of households using ≥1 ITC) reached 98.4%, with a median of 3 ITC distributed/household. After 18 months, the coverage remained 97.4%. The local Aedes species was susceptible to deltamethrin (mosquito mortality rate of 99.7%) and the residual deltamethrin activity in the ITC was within acceptable levels (mosquito mortality rate of 73.1%) after one year of curtain use. Over the 18 month observation period after ITC distribution, the adjusted HI rate ratio, intervention versus control clusters, was 1.15 (95% CI 0.57 to 2.34). The annualized cost per household of ITC implementation was 3.8 USD, against 16.8 USD for all routine ACP activities. Conclusion Deployment of ITC in a setting with already intensive routine Aedes control actions does not lead to reductions in Aedes infestation levels. PMID:25794192

Use of a multimedia module to aid the informed consent process in patients undergoing gynecologic laparoscopy for pelvic pain: randomized controlled trial.

PubMed

Ellett, Lenore; Villegas, Rocio; Beischer, Andrew; Ong, Nicole; Maher, Peter

2014-01-01

To determine whether providing additional information to the standard consent process, in the form of a multimedia module (MM), improves patient knowledge about operative laparoscopy without increasing anxiety. Randomized controlled trial (Canadian Task Force classification I). Two outpatient gynecologic clinics, one in a private hospital and the other in a public teaching hospital. Forty-one women aged 19 to 51 years (median, 35.6 years) requiring operative laparoscopy for investigation and treatment of pelvic pain. Following the standard informed consent process, patients were randomized to watch the MM (intervention group, n = 21) or not (control group, n = 20). The surgeon was blinded to the group assignments. All patients completed a knowledge questionnaire and the Spielberger short-form State-Trait Anxiety Inventory. Six weeks after recruitment, patients completed the knowledge questionnaire and the State-Trait Anxiety Inventory a second time to assess knowledge retention and anxiety scores. Patient knowledge of operative laparoscopy, anxiety level, and acceptance of the MM were recorded. The MM intervention group demonstrated superior knowledge scores. Mean (SE) score in the MM group was 11.3 (0.49), and in the control group was 7.9 (0.50) (p <.001) (maximum score, 14). This did not translate into improved knowledge scores 6 weeks later; the score in the MM group was 8.4 (0.53) vs. 7.8 (0.50) in the control group (p = .44). There was no difference in anxiety levels between the groups at intervention or after 6 weeks. Overall, patients found the MM acceptable, and 18 women (86%) in the intervention group and 12 (60%) in the control group stated they would prefer this style of informed consent in the future. Use of an MM enhances the informed consent process by improving patient knowledge, in the short term, without increasing anxiety. Copyright © 2014 AAGL. Published by Elsevier Inc. All rights reserved.

Randomized Controlled Trial of Adding Telephone Follow-Up to an Occupational Rehabilitation Program to Increase Work Participation.

PubMed

Hara, Karen Walseth; Bjørngaard, Johan Håkon; Brage, Søren; Borchgrevink, Petter Christian; Halsteinli, Vidar; Stiles, Tore Charles; Johnsen, Roar; Woodhouse, Astrid

2018-06-01

Purpose Transfer from on-site rehabilitation to the participant's daily environment is considered a weak link in the rehabilitation chain. The main objective of this study is to see if adding boosted telephone follow-up directly after completing an occupational rehabilitation program effects work participation. Methods A randomized controlled study included participants with chronic pain, chronic fatigue or common mental disorders on long-term sick leave. After completing 3½ weeks of acceptance and commitment therapy based occupational rehabilitation, participants were randomized to boosted follow-up or a control group before returning to their daily environment. The intervention was delivered over 6 months by on-site RTW coordinators mainly via telephone. Primary outcome was RTW categorized as participation in competitive work ≥1 day per week on average over 8 weeks. Results There were 213 participants of mean age 42 years old. Main diagnoses of sick leave certification were mental disorders (38%) and musculoskeletal disorders (30%). One year after discharge the intervention group had 87% increased odds (OR 1.87, 95% confidence interval 1.06-3.31, p = 0.031), of (re)entry to competitive work ≥1 day per week compared with the controls, with similar positive results for sensitivity analysis of participation half time (≥2.5 days per week). The cost of boosted follow-up was 390.5 EUR per participant. Conclusion Participants receiving boosted RTW follow-up had higher (re)entry to competitive work ≥1 day per week at 1 year when compared to the control group. Adding low-cost boosted follow-up by telephone after completing an occupational rehabilitation program augmented the effect on return-to-work.

Effectiveness of the bucco-lingual technique within a school-based supervised toothbrushing program on preventing caries: a randomized controlled trial

PubMed Central

2011-01-01

Background Supervised toothbrushing programs using fluoride dentifrice have reduced caries increment. However there is no information about the effectiveness of the professional cross-brushing technique within a community intervention. The aim was to assess if the bucco-lingual technique can increase the effectiveness of a school-based supervised toothbrushing program on preventing caries. Methods A randomized double-blinded controlled community intervention trial to be analyzed at an individual level was conducted in a Brazilian low-income fluoridated area. Six preschools were randomly assigned to the test and control groups and 284 five-year-old children presenting at least one permanent molar with emerged/sound occlusal surface participated. In control group, oral health education and dental plaque dying followed by toothbrushing with fluoride dentifrice supervised directly by a dental assistant, was developed four times per year. At the remaining school days the children brushed their teeth under indirect supervising of the teachers. In test group, children also underwent a professional cross-brushing on surfaces of first permanent molar rendered by a specially trained dental assistant five times per year. Enamel and dentin caries were recorded on buccal, occlusal and lingual surfaces of permanent molars during 18-month follow-up. Exposure time of surfaces was calculated and incidence density ratio was estimated using Poisson regression model. Results Difference of 21.6 lesions per 1,000 children between control and test groups was observed. Among boys whose caries risk was higher compared to girls, incidence density was 50% lower in test group (p = 0.016). Conclusion Modified program was effective among the boys. It is licit to project a relevant effect in a larger period suggesting in a broader population substantial reduction of dental care needs. Trial registration ISRCTN18548869. PMID:21426572

Manual therapy compared with physical therapy in patients with non-specific neck pain: a randomized controlled trial.

PubMed

Groeneweg, Ruud; van Assen, Luite; Kropman, Hans; Leopold, Huco; Mulder, Jan; Smits-Engelsman, Bouwien C M; Ostelo, Raymond W J G; Oostendorp, Rob A B; van Tulder, Maurits W

2017-01-01

Manual therapy according to the School of Manual Therapy Utrecht (MTU) is a specific type of passive manual joint mobilization. MTU has not yet been systematically compared to other manual therapies and physical therapy. In this study the effectiveness of MTU is compared to physical therapy, particularly active exercise therapy (PT) in patients with non-specific neck pain. Patients neck pain, aged between 18-70 years, were included in a pragmatic randomized controlled trial with a one-year follow-up. Primary outcome measures were global perceived effect and functioning (Neck Disability Index), the secondary outcome was pain intensity (Numeric Rating Scale for Pain). Outcomes were measured at 3, 7, 13, 26 and 52 weeks. Multilevel analyses (intention-to-treat) were the primary analyses for overall between-group differences. Additional to the primary and secondary outcomes the number of treatment sessions of the MTU group and PT group was analyzed. Data were collected from September 2008 to February 2011. A total of 181 patients were included. Multilevel analyses showed no statistically significant overall differences at one year between the MTU and PT groups on any of the primary and secondary outcomes. The MTU group showed significantly lower treatment sessions compared to the PT group (respectively 3.1 vs. 5.9 after 7 weeks; 6.1 vs. 10.0 after 52 weeks). Patients with neck pain improved in both groups without statistical significantly or clinically relevant differences between the MTU and PT groups during one-year follow-up. ClinicalTrials.gov Identifier: NCT00713843.

A randomized double-blind, placebo-controlled trial of minocycline in children and adolescents with fragile x syndrome.

PubMed

Leigh, Mary Jacena S; Nguyen, Danh V; Mu, Yi; Winarni, Tri I; Schneider, Andrea; Chechi, Tasleem; Polussa, Jonathan; Doucet, Paul; Tassone, Flora; Rivera, Susan M; Hessl, David; Hagerman, Randi J

2013-04-01

Minocycline rescued synaptic abnormalities and improved behavior in the fragile X mouse model. Previous open-label human studies demonstrated benefits in individuals with fragile X syndrome (FXS); however, its efficacy in patients with FXS has not been assessed in a controlled trial. Randomized, double-blind, placebo-controlled, crossover trial in individuals with FXS, aged 3.5 years to 16 years (n = 55, mean age 9.2 [SD, 3.6] years). Participants were randomized to minocycline or placebo for 3 months and then switched to the other treatment. Sixty-nine subjects were screened and 66 were randomized. Fifty-five subjects (83.3%) completed at least the first period and 48 (72.7%) completed the full trial. Intention-to-treat analysis demonstrated significantly greater improvements in one primary outcome, Clinical Global Impression Scale-Improvement after minocycline compared with placebo (2.49 ± 0.13 and 2.97 ± 0.13, respectively, p = .0173) and greater improvement in ad hoc analysis of anxiety and mood-related behaviors on the Visual Analog Scale (minocycline: 5.26 cm ± 0.46 cm, placebo: 4.05 cm ± 0.46 cm; p = .0488). Side effects were not significantly different during the minocycline and placebo treatments. No serious adverse events occurred on minocycline. Results may be potentially biased by study design weaknesses, including unblinding of subjects when they completed the study, drug-related side effects unblinding, and preliminary efficacy analysis results known to investigators. Minocycline treatment for 3 months in children with FXS resulted in greater global improvement than placebo. Treatment for 3 months appears safe; however, longer trials are indicated to further assess benefits, side effects, and factors associated with a clinical response to minocycline.

Zonisamide and renal calculi in patients with epilepsy: how big an issue?

PubMed

Wroe, Stephen

2007-08-01

To determine the prevalence of renal calculi in patients treated with zonisamide during randomized, controlled and open-label clinical trials, and from post-marketing surveillance data. Reports of renal calculi from four placebo-controlled double-blind trials of zonisamide, their long-term open-label treatment extension phases, and the US/European zonisamide clinical trial programme were reviewed. One double-blind study and its extension included routine ultrasound screening to identify asymptomatic calculi. Post-marketing surveillance data were also investigated, as was concomitant treatment with topiramate. No symptomatic renal calculi were reported during four randomized double-blind, placebo-controlled trials involving 848 subjects (including 498 zonisamide recipients) treated for up to 3 months. In long-term extension studies with treatment for up to 24 months, symptomatic renal calculi were reported in 9/626 (1.4%) patients. Pooled safety data from all US/European clinical trials identified 15/1296 (1.2%) patients with symptomatic renal calculi during treatment for up to 8.7 years. Post-marketing surveillance revealed nine cases from 59 667 patient-years of exposure in the USA, and 14 from 709 294 patient-years of exposure in Japan; only one case occurred during concomitant topiramate and zonisamide treatment. No imbalance in electrolyte levels was found from 35 patients receiving such co-treatment in clinical trials. The available data suggest that the risk of developing renal calculi during zonisamide treatment is low. Data are insufficient to determine whether concomitant treatment with topiramate increases the risk of renal stones.

Effect of Herbal and Fluoride Mouth Rinses on Streptococcus mutans and Dental Caries among 12–15-Year-Old School Children: A Randomized Controlled Trial

PubMed Central

Shenoy Panchmal, Ganesh; Kumar, Vijaya; Jodalli, Praveen S.; Sonde, Laxminarayan

2017-01-01

To assess and compare the effect of herbal and fluoride mouth rinses on Streptococcus mutans count and glucan synthesis by Streptococcus mutans and dental caries, a parallel group placebo controlled randomized trial was conducted among 240 schoolchildren (12–15 years old). Participants were randomly divided and allocated into Group I (0.2% fluoride group), Group II (herbal group), and Group III (placebo group). All received 10 ml of respective mouth rinses every fortnight for a period of one year. Intergroup and intragroup comparison were done for Streptococcus mutans count and glucan synthesis by Streptococcus mutans and dental caries. Streptococcus mutans count showed a statistically significant difference between Group I and Group III (p = 0.035) and also between Group II and Group III (p = 0.039). Glucan concentration levels showed a statistically significant difference (p = 0.024) between Group II and Group III at 12th month. Mean DMF scores showed no statistical difference between the three groups (p = 0.139). No difference in the level of significance was seen in the intention-to-treat and per-protocol analysis. The present study showed that both herbal and fluoride mouth rinses, when used fortnightly, were equally effective and could be recommended for use in school-based health education program to control dental caries. Trial registration number is CTRI/2015/08/006070. PMID:28352285

Effect of providing free glasses on children's educational outcomes in China: cluster randomized controlled trial.

PubMed

Ma, Xiaochen; Zhou, Zhongqiang; Yi, Hongmei; Pang, Xiaopeng; Shi, Yaojiang; Chen, Qianyun; Meltzer, Mirjam E; le Cessie, Saskia; He, Mingguang; Rozelle, Scott; Liu, Yizhi; Congdon, Nathan

2014-09-23

To assess the effect of provision of free glasses on academic performance in rural Chinese children with myopia. Cluster randomized, investigator masked, controlled trial. 252 primary schools in two prefectures in western China, 2012-13. 3177 of 19,934 children in fourth and fifth grades (mean age 10.5 years) with visual acuity <6/12 in either eye without glasses correctable to >6/12 with glasses. 3052 (96.0%) completed the study. Children were randomized by school (84 schools per arm) to one of three interventions at the beginning of the school year: prescription for glasses only (control group), vouchers for free glasses at a local facility, or free glasses provided in class. Spectacle wear at endline examination and end of year score on a specially designed mathematics test, adjusted for baseline score and expressed in standard deviations. Among 3177 eligible children, 1036 (32.6%) were randomized to control, 988 (31.1%) to vouchers, and 1153 (36.3%) to free glasses in class. All eligible children would benefit from glasses, but only 15% wore them at baseline. At closeout glasses wear was 41% (observed) and 68% (self reported) in the free glasses group, and 26% (observed) and 37% (self reported) in the controls. Effect on test score was 0.11 SD (95% confidence interval 0.01 to 0.21) when the free glasses group was compared with the control group. The adjusted effect of providing free glasses (0.10, 0.002 to 0.19) was greater than parental education (0.03, -0.04 to 0.09) or family wealth (0.01, -0.06 to 0.08). This difference between groups was significant, but was smaller than the prespecified 0.20 SD difference that the study was powered to detect. The provision of free glasses to Chinese children with myopia improves children's performance on mathematics testing to a statistically significant degree, despite imperfect compliance, although the observed difference between groups was smaller than the study was originally designed to detect. Myopia is common and rarely corrected in this setting.Trial Registration Current Controlled Trials ISRCTN03252665. © Ma et al 2014.

Child language interventions in public health: a systematic literature review.

PubMed

De Cesaro, Bruna Campos; Gurgel, Léia Gonçalves; Nunes, Gabriela Pisoni Canedo; Reppold, Caroline Tozzi

2013-01-01

Systematically review the literature on interventions in children's language in primary health care. One searched the electronic databases (January 1980 to March 2013) MEDLINE (accessed by PubMed), Scopus, Lilacs and Scielo. The search terms used were "child language", "primary health care", "randomized controlled trial" and "intervention studies" (in English, Portuguese and Spanish). There were included any randomized controlled trials that addressed the issues child language and primary health care. The analysis was based on the type of language intervention conducted in primary health care. Seven studies were included and used intervention strategies such as interactive video, guidance for parents and group therapy. Individuals of both genders were included in the seven studies. The age of the children participant in the samples of the articles included in this review ranged from zero to 11 years. These seven studies used approaches that included only parents, parents and children or just children. The mainly intervention in language on primary health care, used in randomized controlled trials, involved the use of interactional video. Several professionals, beyond speech and language therapist, been inserted in the language interventions on primary health care, demonstrating the importance of interdisciplinary work. None of the articles mentioned aspects related to hearing. There was scarcity of randomized controlled trials that address on language and public health, either in Brazil or internationally.

The Relationships of Color to the Attribution of Positive or Negative Affect.

ERIC Educational Resources Information Center

Sexton, Donna J.; And Others

The purpose of the study was to experimentally determine if the attribution of positive or negative social values is associated with particular colors. The subjects were 76 four-and five-year old females drawn from six privately owned kindergartens and nurseries. The children were randomly assigned to one of two groups. In the control group, color…

Strategies in Reading Comprehension: VIII. Pictures, Imagery, and Retarded Children's Story Recall. Working Paper No. 214.

ERIC Educational Resources Information Center

Bender, Bruce G.; Levin, Joel R.

Ninety-six educable mentally retarded individuals (10-16 years old) were randomly assigned to one of four experimental conditions to listen to a 20-sentence story. Picture Ss viewed illustrations of the story, Imagery Ss were instructed to generate mental pictures of the story, Repitition Control Ss heard each sentence of the story twice, and…

Long-term Effects of Two Levels of Caloric Restriction on Body Composition, and Diet Satisfaction in CALERIE, a One Year Randomized Controlled Trial

USDA-ARS?s Scientific Manuscript database

There is little information on whether the extent of dietary energy restriction in a weight loss program influences long-term weight change. We examined the effects of two levels of caloric restriction (CR) over 12 months on body weight and fat loss, total energy expenditure (TEE), resting metabolic...

Mitomycin C and the endoscopic treatment of laryngotracheal stenosis: are two applications better than one?

PubMed

Smith, Marshall E; Elstad, Mark

2009-02-01

Endoscopic treatment of laryngotracheal stenosis by airway dilation, despite short-term improvement, is often associated with long-term relapse. Mitomycin-C (MMC) inhibits fibroblast proliferation and synthesis of extracellular matrix proteins, and thereby modulates wound healing and scarring. MMC application at the time of endoscopic dilation and laser surgery has been suggested to improve outcomes, but this has not been studied in a rigorous manner. This study examines the hypothesis that two topical applications of MMC given 3-6 weeks apart will result in decreased scarring/restenosis of the airway, when compared to a single topical application. A randomized, prospective, double-blind, placebo-controlled clinical trial. Twenty-six patients with laryngotracheal stenosis due to idiopathic subglottic stenosis, postintubation stenosis, or Wegener's granulomatosis entered a protocol to receive three endoscopic CO(2) laser and dilation procedures over a 3-month interval. At the first procedure, after radial CO(2) laser incision and airway dilation, all patients received topical application of MMC (0.5 mg/mL) to the airway lesion. One month later, a second endoscopic incision and dilation was performed and the patients were randomized to either a second application of mitomycin-C or to application of saline placebo. A third dilation procedure was performed 2 months later, without MMC application. Patients were followed for up to 5 years for relapse of airway stenosis with clinical symptoms sufficient to require a subsequent procedure. The relapse rates at 1, 3, and 5 years were 7%, 36%, and 69% for patients treated with two applications of MMC compared to 33%, 58%, and 70% for patients treated with one application of MMC. The median interval to relapse was 3.8 years in the two-application group, compared with 2.4 years in the one-application group. This prospective randomized double-blind placebo-controlled trial suggests that, in the endoscopic management of laryngotracheal stenosis, two applications of MMC given 3-4 weeks apart after airway radial incision and dilation reduces the restenosis rate for 2 to 3 years after treatment when compared to a single application. However, restenosis and delayed symptom recurrence continues so that at 5 years the relapse rates are the same. Thus, MMC may postpone, but does not prevent, the recurrence of symptomatic stenosis in the majority of patients.

Four-year safety follow-up of the tetravalent dengue vaccine efficacy randomized controlled trials in Asia and Latin America.

PubMed

Arredondo-García, J L; Hadinegoro, S R; Reynales, H; Chua, M N; Rivera Medina, D M; Chotpitayasunondh, T; Tran, N H; Deseda, C C; Wirawan, D N; Cortés Supelano, M; Frago, C; Langevin, E; Coronel, D; Laot, T; Perroud, A P; Sanchez, L; Bonaparte, M; Limkittikul, K; Chansinghakul, D; Gailhardou, S; Noriega, F; Wartel, T A; Bouckenooghe, A; Zambrano, B

2018-02-08

Our objective was to describe the risk of hospital admission for virologically confirmed dengue (VCD) and the risk of clinically severe hospitalized VCD occurring up to 4 years after the first dose (years 1 to 4) in three randomized clinical trials comparing tetravalent dengue vaccine with placebo. The relative risks (RR) for hospitalized VCD from first dose to year 4 were estimated by year and age-group in individual and combined studies. Overall, from Year 1 to Year 4, 233 and 228 participants had at least one episode of hospitalized VCD in the vaccinated (n = 22 603) and placebo (n = 11 301) groups, respectively (RR = 0.511, 95% CI 0.42-0.62). Among these, 48 and 47 cases, respectively, were classified as clinically severe. In children aged ≥9 years, 88 and 136 participants had at least one episode of hospitalized VCD in the vaccinated (n = 17 629) and placebo (n = 8821) groups, respectively (RR = 0.324; 95% CI 0.24-0.43). In vaccinated participants aged <9 years, particularly in those aged 2-5 years, there were more hospitalized VCD cases compared with the control participants in Year 3 but not in Year 4. The overall RR in those aged <9 years for Year 1 to Year 4 was 0.786 (95% CI 0.60-1.03), with a higher protective effect in the 6-8 year olds than in the 2-5 year olds. The overall benefit-risk remained positive in those aged ≥9 years up to year 4, although the protective effect was lower in years 3 and 4 than in years 1 and 2. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Training Older Siblings to be Better Supervisors: An RCT Evaluating the "Safe Sibs" Program.

PubMed

Schell, Stacey L; Morrongiello, Barbara A; Pogrebtsova, Ekaterina

2015-09-01

This study evaluated a new online training program, Safe Sibs, aimed at improving supervision knowledge and behaviors of sibling supervisors. Participants included older children (7-11 years) and their younger siblings (2-5 years). A randomized controlled trial design was used, with older siblings randomly assigned to either an intervention or wait-list control group. Before and after either the intervention or wait-list period, older siblings completed measures of supervision knowledge and their supervision behaviors were unobtrusively observed when with their younger sibling. Compared with the control group, the intervention group showed significant improvements in supervision knowledge (child development, knowledge of effective supervision practices, injury beliefs, intervention-specific knowledge) and in some aspects of supervision behavior (frequency of proactive safety behaviors to prevent supervisee access to injury hazards). Although adult supervision is ideal, this new program can support older children to become more knowledgeable and improved supervisors of younger ones. © The Author 2015. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

One-Year Outcomes and Mediators of a Brief Intervention for Drug Abusing Adolescents

PubMed Central

Winters, Ken C.; Lee, Susanne; Botzet, Andria; Fahnhorst, Tamara; Nicholson, Ali

2014-01-01

Two manually-guided brief interventions were evaluated with a randomized controlled trial. Adolescents (aged 13-17 years) suspected of abusing alcohol and other drugs and their parent were randomly assigned to receive either a 2-session adolescent only (BI-A), 2-session adolescent and additional parent session (BI-AP), or assessment only control condition (CON). Adolescents were identified in a school setting and the intervention was delivered by trained counselors. Outcome analyses (N=284; 90% of those enrolled) of relative change (from intake to 12-months) and absolute status (at 12-months) revealed a general pattern of reductions in drug use behaviors, particularly with the cannabis outcome measures, in both active conditions (BI-A and BI-AP). Students in the control condition showed worse outcome compared to the BI-A and BI-AP groups. Among the four mediating variables measured at 6-months, use of additional services, motivation to change and parenting practices had significant influences on 12-month outcome; problem solving skills approached significance as a mediator. The potential value of a brief intervention for drug abusing adolescents is discussed. PMID:24955669

Teaching of evidence-based medicine to medical students in Mexico: a randomized controlled trial

PubMed Central

2012-01-01

Background Evidence-Based Medicine (EBM) is an important competency for the healthcare professional. Experimental evidence of EBM educational interventions from rigorous research studies is limited. The main objective of this study was to assess EBM learning (knowledge, attitudes and self-reported skills) in undergraduate medical students with a randomized controlled trial. Methods The educational intervention was a one-semester EBM course in the 5th year of a public medical school in Mexico. The study design was an experimental parallel group randomized controlled trial for the main outcome measures in the 5th year class (M5 EBM vs. M5 non-EBM groups), and quasi-experimental with static-groups comparisons for the 4th year (M4, not yet exposed) and 6th year (M6, exposed 6 months to a year earlier) groups. EBM attitudes, knowledge and self-reported skills were measured using Taylor’s questionnaire and a summative exam which comprised of a 100-item multiple-choice question (MCQ) test. Results 289 Medical students were assessed: M5 EBM=48, M5 non-EBM=47, M4=87, and M6=107. There was a higher reported use of the Cochrane Library and secondary journals in the intervention group (M5 vs. M5 non-EBM). Critical appraisal skills and attitude scores were higher in the intervention group (M5) and in the group of students exposed to EBM instruction during the previous year (M6). The knowledge level was higher after the intervention in the M5 EBM group compared to the M5 non-EBM group (p<0.001, Cohen's d=0.88 with Taylor's instrument and 3.54 with the 100-item MCQ test). M6 Students that received the intervention in the previous year had a knowledge score higher than the M4 and M5 non-EBM groups, but lower than the M5 EBM group. Conclusions Formal medical student training in EBM produced higher scores in attitudes, knowledge and self-reported critical appraisal skills compared with a randomized control group. Data from the concurrent groups add validity evidence to the study, but rigorous follow-up needs to be done to document retention of EBM abilities. PMID:23131115

Web-Based Cognitive Behavioral Therapy Intervention for the Prevention of Suicidal Ideation in Medical Interns: A Randomized Controlled Trial

PubMed Central

Guille, Constance; Zhao, Zhuo; Krystal, John; Nichols, Breck; Brady, Kathleen; Sen, Srijan

2016-01-01

Importance In the United States, approximately one physician dies by suicide every day. Training physicians are at particularly high risk, with suicidal ideation increasing over four-fold during the first three months of internship year. Despite this dramatic increase, very few efforts have been made to prevent the escalation of suicidal thoughts among training physicians. Objective To assess the effectiveness of a Web-based Cognitive Behavioral Therapy (wCBT) program delivered prior to the start of internship year in the prevention of suicidal ideation in medical interns. Design, Setting and Participants A randomized controlled trial conducted at two university hospitals with 199 interns from multiple specialties during academic years 2009-10 or 2011-12. Interventions Interns were randomly assigned to study groups (wCBT, n=100; attention-control group (ACG), n=99), and completed study activities lasting 30-minutes each week for four weeks prior to starting internship year. Subjects assigned to wCBT completed online-CBT modules and subjects assigned to ACG received emails with general information about depression, suicidal thinking and local mental health providers. Main Outcome Measure The Patient Health Questionnaire (PHQ-9) was employed to assess suicidal ideation (i.e., “thoughts that you would be better off dead, or hurting yourself in some way”) prior to the start of intern year and at 3-month intervals throughout the year. Results 62.2% (199/320) of individuals agreed to take part in the study. During at least one time point over the course of internship year 12% (12/100) of interns assigned to wCBT endorsed suicidal ideation, compared to 21%(21/99) of interns assigned to ACG. After adjusting for covariates identified a priori that have previously shown to increase the risk for suicidal ideation, interns assigned to wCBT were 60% less likely to endorse suicidal ideation during internship year (RR: 0.40, 95% CI 0.17-0.91; p=0.03), compared to those assigned to ACG. Conclusion This study demonstrates that a free, easily accessible, brief wCBT program can help reduce the development of suicidal ideation among medical interns. Prevention programs with these characteristics could be easily disseminated to medical training program across the country. PMID:26535958

Is Reducing Uncertain Control the Key to Successful Test Anxiety Intervention for Secondary School Students? Findings from a Randomized Control Trial

ERIC Educational Resources Information Center

Putwain, David W.; Pescod, Marc

2018-01-01

The aim of the study was to conduct a randomized control trial of a targeted, facilitated, test anxiety intervention for a group of adolescent students, and to examine the mediating role of uncertain control. Fifty-six participants (male = 19, white = 21, mean age = 14.7 years) were randomly allocated to an early intervention or wait-list control…

A pilot study on the randomization of inferior vena cava filter placement for venous thromboembolism prophylaxis in high-risk trauma patients.

PubMed

Rajasekhar, Anita; Lottenberg, Lawrence; Lottenberg, Richard; Feezor, Robert J; Armen, Scott B; Liu, Huazhi; Efron, Philip A; Crowther, Mark; Ang, Darwin

2011-08-01

Placement of prophylactic inferior vena cava filters (pIVCFs) for the prevention of pulmonary embolism (PE) in high-risk trauma patients (HRTPs) are widely practiced despite the lack of Level I data supporting this use. We report the 2-year interim analysis of the Filters in Trauma pilot study. This is a single institution, prospective randomized controlled pilot feasibility study in a Level I trauma center. HRTPs were identified for pIVCF placement by the Eastern Association for the Surgery of Trauma guidelines. From November 2008 to November 2010, HRTPs were enrolled and randomized to either pIVCF or no pIVCF. All patients received pharmacologic prophylaxis when safe. Primary outcomes included feasibility objectives and secondary outcomes were incidence of PE, deep vein thrombosis (DVT), and death. Thirty-four of 38 enrolled patients were eligible for analysis. The baseline sociodemographic characteristics were balanced between the both groups. Results of the feasibility objectives included: time from admission to enrollment (mean, 47.4 hours ± 22.0 hours), time from enrollment to randomization (mean, 4.8 hours ± 9.1 hours), time from randomization to IVCF placement (mean, 16.9 hours ± 9.2 hours), adherence to weekly compression ultrasound within first month (IVCF group = 44.4%; non-IVCF group = 62.5%), and 1-month clinical follow-up (IVCF group = 83.3%; non-IVCF group = 100%). At 6-month follow-up, one PE in the nonfilter group and one DVT in the filter group had occurred. One non-PE-related death occurred in the filter group. Barriers to enrollment included inability to obtain informed consent due to patient refusal or no next of kin identified and delayed notification of eligibility status. Our pilot study demonstrates for the first time that a randomized controlled trial evaluating the efficacy of pIVCFs in trauma patients is feasible. This pilot data will be used to inform the design of a multicenter randomized controlled trial to determine the incidence of PE and DVT in HRTPs receiving pIVCFs versus no pIVCF.

Effect of Cranberry Capsules on Bacteriuria Plus Pyuria among Older Women in Nursing Homes: A Randomized Clinical Trial

PubMed Central

Juthani-Mehta, Manisha; Van Ness, Peter H.; Bianco, Luann; Rink, Andrea; Rubeck, Sabina; Ginter, Sandra; Argraves, Stephanie; Charpentier, Peter; Acampora, Denise; Trentalange, Mark; Quagliarello, Vincent; Peduzzi, Peter

2017-01-01

Importance Bacteriuria plus pyuria is highly prevalent among older women living in nursing homes. Cranberry capsules are an understudied, non-antimicrobial, prevention strategy used in this population. Objective To test the effect of two oral cranberry capsules once per day on presence of bacteriuria plus pyuria among women residing in nursing homes Design, Setting, and Participants This study was a double-blind, randomized, placebo-controlled efficacy trial with stratification by nursing home and surveillance of one year. 21 nursing homes with at least 90 beds and within 50 miles of New Haven, CT participated. 185 English-speaking, female, nursing home residents, age 65 or older, with or without bacteriuria and pyuria at baseline, were randomized. The study was conducted from 8/24/12-10/26/15. Intervention Two oral cranberry capsules, each capsule containing 36mg of the active ingredient proanthocyanidin (i.e., 72mg total, equivalent to 20 ounces of cranberry juice), versus placebo administered once per day in 92 treatment and 93 control group participants. Main Outcomes and Measures The primary outcome was the presence of bacteriuria (i.e., at least 105 cfu/mL of one or two microorganisms on urine culture) plus pyuria (i.e., any number of white blood cells on urinalysis) assessed every two months for a total of six assessments over the one year of surveillance; any positive finding was considered to meet the primary outcome. Secondary outcomes were symptomatic urinary tract infection (UTI), all-cause death, all-cause hospitalization, all multi-drug antibiotic resistant organisms, antibiotics administered for suspected UTI, and total antimicrobial administration. Results Among 185 women who were randomized (mean age 86.4 years [± 8.2], 90.3% white, 31.4% with bacteriuria plus pyuria at baseline), 147 completed the study. Overall adherence to capsule administration was 80.1%. Unadjusted results showed the presence of bacteriuria plus pyuria in 25.5% (95% CI 18.6, 33.9) of the treatment group and 29.5% (95% CI 22.2, 37.9) of the control group overall over 1 year. The adjusted GEE model that accounted for missing data and covariates showed no significant difference in the presence of bacteriuria plus pyuria between the treatment and control groups (29.1% vs. 29.0%; OR 1.01, 95% CI 0.61,1.66; p=0.984). There were no significant differences in number of symptomatic UTIs (10 vs. 12 episodes), rates of death (17 vs. 16, 20.4 vs. 19.1 deaths/100 person-years, Rate Ratio [RR] 1.07, 95% CI 0.54, 2.12), hospitalization (33 vs. 50 episodes, 39.7 vs. 59.6 hospitalizations/100 person-years, RR 0.67, 95% CI 0.32, 1.40), bacteriuria associated with multi-drug resistant gram-negative bacilli (9 vs. 24 episodes, 10.8 vs. 28.6 episodes/100 person-years, RR 0.38, 0.10, 1.46), antibiotics administered for suspected UTI (692 vs. 909 antibiotic days, 8.3 vs. 10.8 antibiotic days/person-year, RR 0.77, 95% CI 0.44, 1.33), or total antimicrobial utilization (1415 vs. 1883 antimicrobial days, 17.0 vs. 22.4 antimicrobial days/person-year, RR 0.76, 95% CI 0.46, 1.25). Conclusions and Relevance Among older women residing in nursing homes, administration of cranberry capsules, compared with placebo, resulted in no significant difference in presence of bacteriuria plus pyuria over 1 year. PMID:27787564

Randomized controlled GH trial: effects on anthropometry, body composition and body proportions in a large group of children with Prader-Willi syndrome.

PubMed

Festen, Dederieke A M; de Lind van Wijngaarden, Roderick; van Eekelen, Marielle; Otten, Barto J; Wit, Jan M; Duivenvoorden, Hugo J; Hokken-Koelega, Anita C S

2008-09-01

Prader-Willi syndrome (PWS) children have impaired growth, and abnormal body composition. Previous 1-year controlled studies showed improvement of height and body composition during GH-treatment. To evaluate growth, body composition and body proportions during GH-treatment in a large group of PWS children. We performed a randomized controlled GH trial in 91 prepubertal PWS children (42 infants, 49 children, aged 3-14 years). After stratification for age, infants were randomized to GH-treatment (GH-group; 1 mg/m(2)/day; n = 20), or no treatment (control group; n = 22) for 1 year. In the second year all infants were treated with GH. After stratification for BMI, children > 3 years of age were randomized to GH-treatment (GH-group; 1 mg/m(2)/day; n = 27) or no treatment (control group; n = 22) for 2 years. Anthropometric parameters were assessed once in every 3 months. Body composition was measured by Dual Energy X-ray Absorptiometry. Median (interquartile range, iqr) height SDS increased during 2 years of GH in infants from -2.3 (-2.8 to -0.7) to -0.4 (-1.1-0.0) and in prepubertal children from -2.0 (-3.1 to -1.7) to -0.6 (-1.1 to -0.1). In non-GH-treated children height SDS did not increase. Head circumference completely normalized during 1 and 2 years of GH in infants and children, respectively. Body fat percentage and body proportions improved in GH-treated children, but did not completely normalize. Lean body mass SDS improved compared to the control group. Serum IGF-I increased to levels above the normal range in most GH-treated children. Our randomized study shows that GH-treatment in PWS children significantly improves height, BMI, head circumference, body composition and body proportions. PWS children are highly sensitive to GH, suggesting that monitoring of serum IGF-I is indicated.

Surgery for post-vitrectomy cataract

PubMed Central

Do, Diana V; Gichuhi, Stephen; Vedula, Satyanarayana S; Hawkins, Barbara S

2014-01-01

Background Cataract formation or acceleration can occur after intraocular surgery, especially following vitrectomy, a surgical technique for removing the vitreous which is used in the treatment of disorders that affect the posterior segment of the eye. The underlying problem that led to vitrectomy may limit the benefit from cataract surgery. Objectives The objective of this review was to evaluate the effectiveness and safety of surgery for post-vitrectomy cataract with respect to visual acuity, quality of life, and other outcomes. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 4), Ovid MEDLINE, Ovid MEDLINE in-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily Update, Ovid OLDMED-LINE (January 1946 to May 2013), EMBASE (January 1980 to May 2013, Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to May 2013), PubMed (January 1946 to May 2013), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrial.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 22 May 2013. Selection criteria We planned to include randomized and quasi-randomized controlled trials comparing cataract surgery with no surgery in adult patients who developed cataract following vitrectomy. Data collection and analysis Two authors screened the search results independently according to the standard methodological procedures expected by The Cochrane Collaboration. Main results We found no randomized or quasi-randomized controlled trials comparing cataract surgery with no cataract surgery for patients who developed cataracts following vitrectomy surgery. Authors' conclusions There is no evidence from randomized or quasi-randomized controlled trials on which to base clinical recommendations for surgery for post-vitrectomy cataract. There is a clear need for randomized controlled trials to address this evidence gap. Such trials should stratify participants by their age, the retinal disorder leading to vitrectomy, and the status of the underlying disease process in the contralateral eye. Outcomes assessed in such trials may include gain of vision on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale, quality of life, and adverse events such as posterior capsular rupture. Both short-term (six-month) and long-term (one-year or two-year) outcomes should be examined. PMID:24357418

Porous titanium construct cup compared to porous coated titanium cup in total hip arthroplasty. A randomised controlled trial.

PubMed

Salemyr, Mats; Muren, Olle; Eisler, Thomas; Bodén, Henrik; Chammout, Ghazi; Stark, André; Sköldenberg, Olof

2015-05-01

The purpose of this study was to determine if a new titanium cup with increased porosity resulted in different periacetabular bone loss and migration compared to a porous coated cup. Fifty-one patients with primary hip osteoarthritis were randomized to either a cup with porous titanium construct backside (porous titanium group, n = 25) or a conventional porous coated titanium cup (control group, n = 26). The primary outcome variable was change in periacetabular bone mineral density two years after surgery measured with dual energy X-ray absorptiometry (DXA). Secondary outcomes were implant fixation measured with radiostereometry (RSA) and clinical outcome scores. The pattern of bone remodelling was similar in the two groups with almost complete restoration to baseline values. BMD diminished in the two proximal zones and increased in the two distal zones. After minimal migration up to six months all implants in both groups became stable. We found no difference between the two groups in clinical outcome scores. In this prospective, randomized, controlled trial on a new porous titanium cup we found, compared to the control group, no clinically relevant differences regarding periacetabular bone preservation, implant fixation or clinical outcome up to two years postoperatively.

Randomized Trial of a Broad Preventive Intervention for Mexican American Adolescents

PubMed Central

Gonzales, N.A.; Dumka, L.E.; Millsap, R.E.; Gottschall, A.; McClain, D.B.; Wong, J.J.; Germán, M.; Mauricio, A.M.; Wheeler, L.; Carpentier, F.D.; Kim, S.Y.

2012-01-01

Objective This randomized trial of a family-focused preventive intervention for Mexican American (MA) adolescents evaluated intervention effects on adolescent substance use, internalizing and externalizing symptoms, and school discipline and grade records in 8th grade, one year after completion of the intervention. The study also examined hypothesized mediators and moderators of intervention effects. Method Stratified by language of program delivery (English vs. Spanish), the trial included a sample of 516 MA adolescents (50.8% female; M =12.3 years, SD=.54) and at least one caregiver that were randomized to receive a low dosage control group workshop or the 9-week group intervention that included parenting, adolescent coping, and conjoint family sessions. Results Positive program effects were found on all five outcomes at one-year posttest, but varied depending on whether adolescents, parents, or teachers reported on the outcome. Intervention effects were mediated by posttest changes in effective parenting, adolescent coping efficacy, adolescent school engagement, and family cohesion. The majority of direct and mediated effects were moderated by language, with a larger number of significant effects for families that participated in Spanish. Intervention effects also were moderated by baseline levels of mediators and outcomes, with the majority showing stronger effects for families with poorer functioning at baseline. Conclusion Findings support the efficacy of the intervention to decrease multiple problem outcomes for MA adolescents, but also demonstrate differential effects for parents and adolescents receiving the intervention in Spanish vs. English, and depending on their baseline levels of functioning. PMID:22103956

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

PubMed

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

2012-12-01

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

Clinical and radiological outcome of conservative vs. surgical treatment of atraumatic degenerative rotator cuff rupture: design of a randomized controlled trial.

PubMed

Lambers Heerspink, Frederik O; Hoogeslag, Roy Ag; Diercks, Ron L; van Eerden, Pepijn Jm; van den Akker-Scheek, Inge; van Raay, Jos Jam

2011-01-26

Subacromial impingement syndrome is a frequently observed disorder in orthopedic practice. Lasting symptoms and impairment may occur when a subsequent atraumatic rotator cuff rupture is also present. However, degenerative ruptures of the rotator cuff can also be observed in asymptomatic elderly individuals. Treatment of these symptomatic degenerative ruptures may be conservative or surgical. Acceptable results are reported for both treatment modalities. No evidence-based level-1 studies have been conducted so far to compare these treatment modalities. The objective of this study is to determine whether there is a difference in outcome between surgical reconstruction and conservative treatment of a degenerative atraumatic rotator cuff tendon rupture. A randomized controlled trial will be conducted. Patients aged between 45 and 75 with a symptomatic atraumatic rotator cuff rupture as diagnosed by MRI will be included. Exclusion criteria are traumatic rotator cuff rupture, frozen shoulder and diabetes mellitus. Patients will be randomized into two groups. Conservative treatment includes physical therapy according to a standardized protocol, NSAIDs and, if indicated, subacromial infiltration with a local anesthetic and corticosteroids. Surgical reconstruction is performed under general anesthesia in combination with an interscalenus plexus block. An acromioplasty with reconstruction of the rotator cuff tendon is performed, as described by Rockwood et al. Measurements take place preoperatively and 6 weeks, 3 months, 6 months and 1 year postoperatively. The primary outcome measure is the Constant score. Secondary measures include both disease-specific and generic outcome measures, and an economic evaluation. Additionally, one year after inclusion a second MRI will be taken of all patients in order to determine whether extent and localization of the rupture as well as the amount of fatty degeneration are prognostic factors. Both surgical as conservative treatment of a symptomatic atraumatic rotator cuff tendon rupture is used in current practice. There is a lack of level-1 studies comparing surgical vs. conservative treatment. This randomized controlled trial has been designed to determine whether the surgical treatment of a degenerative atraumatic rotator cuff tendon rupture may lead to a better functional and radiological outcome than conservative treatment after one year of follow-up. Netherlands Trial Register (NTR): NTRTC2343.

Te Ira Tangata: a Zelen randomised controlled trial of a culturally informed treatment compared to treatment as usual in Māori who present to hospital after self-harm.

PubMed

Hatcher, Simon; Coupe, Nicole; Wikiriwhi, Karen; Durie, Sir Mason; Pillai, Avinesh

2016-06-01

Indigenous people have high rates of suicide and self-harm compared to other population groups. The aim of this trial was to see if a package of interventions delivered in a culturally appropriate way improved outcomes at one year in Maori who presented with intentional self-harm to emergency departments. Participants were Maori who presented with intentional self-harm to emergency departments in New Zealand. The study design was a double consent Zelen randomised controlled trial. The intervention included regular postcards, problem solving therapy, patient support, risk management, improved access to primary care and cultural assessment in addition to usual care. The control group received usual care. The main outcome measure was the self-rated change in scores on the Beck Hopelessness Scale at one year. 182 people were randomized to the intervention group 95 of whom consented to take part in the study. 183 people were randomized to the control group 72 of whom consented to take part in the study. For those who consented comparing the intervention group with the control group there was a statistically significant greater change in hopelessness scores at 3 months (difference -1.7 95 % CI -3.4 to -0.01, p = 0.05) but not at one year (difference -1.6 95 % CI -3.4 to 0.3, p = 0.11). Maori who consented and received the intervention were also significantly less likely to present to hospital for non-self-harm reasons in the year after the index episode (44.2 vs. 61.1 %, p = 0.03). Those participants randomised to the intervention were less likely to re-present with self-harm at 3 months (10.4 vs. 18 %, p = 0.04) but not at 12 months compared to the control group. In Maori who presented to hospital with intentional self-harm a culturally informed intervention had an effect on hopelessness and re-presentation with self-harm in the short term but not at 12 months. There was a significant decrease in hospital presentations for non-self harm over the next year. Australian and New Zealand Clinical Trials Registry ACTRN12609000952246.

Long-term effectiveness of patient-centered training in cultural competence: what is retained? What is lost?

PubMed

Ho, Ming-Jung; Yao, Grace; Lee, Keng-Lin; Hwang, Tzung-Jeng; Beach, Mary Catherine

2010-04-01

To determine whether the effects of a patient-centered cultural competence curriculum could be sustained for one year. In 2006, 57 fifth-year medical students at National Taiwan University were randomly assigned either to a group that received training in patient-centered cross-cultural communication skills or one that received no training. Students' scores on objective structured clinical exams (OSCEs) were compared in the realms of exploring (1) patient perspectives and (2) social factors related to illness, immediately after training (OSCE1) and one year after training (OSCE2). Regarding students' exploration of patient perspectives, the intervention group scored significantly higher than the control group at OSCE1, but there was a significant decrease from OSCE1 to OSCE2 in the intervention group and no significant difference between the intervention and control group at OSCE2. Regarding students' exploration of social factors related to illness, the intervention group scored significantly higher than the control group at OSCE1, with a nonsignificant decrease from OSCE1 to OSCE2 in the two groups, such that the intervention group again scored higher than the control group in OSCE2. The effect of a patient-centered cultural competence training curriculum on students' exploration of social factors related to illness was sustained to a significant degree after one year, whereas the effects on students' exploration of patient perspectives were not. Further research is needed to determine the extent to which additional training can prevent the loss of student skills.

Motivational impairment predicts functional remission in first-episode psychosis: 3-Year follow-up of the randomized controlled trial on extended early intervention.

PubMed

Chang, Wing Chung; Kwong, Vivian Wing Yan; Or Chi Fai, Philip; Lau, Emily Sin Kei; Chan, Gloria Hoi Kei; Jim, Olivia Tsz Ting; Hui, Christy Lai Ming; Chan, Sherry Kit Wa; Lee, Edwin Ho Ming; Chen, Eric Yu Hai

2018-02-01

Functional remission represents an intermediate functional milestone toward recovery. Differential relationships of negative symptom sub-domains with functional remission in first-episode psychosis are understudied. We aimed to examine rate and predictors of functional remission in people with first-episode psychosis in the context of a 3-year follow-up of a randomized controlled trial comparing 1-year extension of early intervention (i.e. 3-year early intervention) with step-down psychiatric care (i.e. 2-year early intervention). A total of 160 participants were recruited upon completion of a 2-year specialized early intervention program for first-episode psychosis in Hong Kong and underwent a 1-year randomized controlled trial comparing 1-year extended early intervention with step-down care. Participants were followed up and reassessed 3 years after inclusion to the trial (i.e. 3-year follow-up). Functional remission was operationalized as simultaneous fulfillment of attaining adequate functioning (measured by Social and Occupational Functioning Scale and Role Functioning Scale) at 3-year follow-up and sustained employment in the last 6 months of 3-year study period. Negative symptom measure was delineated into amotivation (i.e. motivational impairment) and diminished expression (i.e. reduced affect and speech output). Data analysis was based on 143 participants who completed follow-up functional assessments. A total of 31 (21.7%) participants achieved functional remission status at 3-year follow-up. Multivariate regression analysis showed that lower levels of amotivation ( p = 0.010) and better functioning at study intake ( p = 0.004) independently predicted functional remission (Final model: Nagelkerke R 2  = 0.40, χ 2  = 42.9, p < 0.001). Extended early intervention, duration of untreated psychosis and diminished expression did not predict functional remission. Only approximately one-fifths of early psychosis patients were found to achieve functional remission. Functional impairment remains an unmet treatment need in the early stage of psychotic illness. Our results further suggest that amotivation may represent a critical therapeutic target for functional remission attainment in early psychosis.

Impact of Targeted Preoperative Optimization on Clinical Outcome in Emergency Abdominal Surgeries: A Prospective Randomized Trial.

PubMed

Sethi, Ashish; Debbarma, Miltan; Narang, Neeraj; Saxena, Anudeep; Mahobia, Mamta; Tomar, Gaurav Singh

2018-01-01

Perforation peritonitis continues to be one of the most common surgical emergencies that need a surgical intervention most of the times. Anesthesiologists are invariably involved in managing such cases efficiently in perioperative period. The assessment and evaluation of Acute Physiology and Chronic Health Evaluation II (APACHE II) score at presentation and 24 h after goal-directed optimization, administration of empirical broad-spectrum antibiotics, and definitive source control postoperatively. Outcome assessment in terms of duration of hospital stay and mortality in with or without optimization was also measured. It is a prospective, randomized, double-blind controlled study in hospital setting. One hundred and one patients aged ≥18 years, of the American Society of Anesthesiologists physical Status I and II (E) with clinical diagnosis of perforation peritonitis posted for surgery were enrolled. Enrolled patients were randomly divided into two groups. Group A is optimized by goal-directed optimization protocol in the preoperative holding room by anesthesiology residents whereas in Group S, managed by surgery residents in the surgical wards without any fixed algorithm. The assessment of APACHE II score was done as a first step on admission and 24 h postoperatively. Duration of hospital stay and mortality in both the groups were also measured and compared. Categorical data are presented as frequency counts (percent) and compared using the Chi-square or Fisher's exact test. The statistical significance for categorical variables was determined by Chi-square analysis. For continuous variables, a two-sample t -test was applied. The mean APACHE II score on admission in case and control groups was comparable. Significant lowering of serial scores in case group was observed as compared to control group ( P = 0.02). There was a significant lowering of mean duration of hospital stay seen in case group (9.8 ± 1.7 days) as compared to control group ( P = 0.007). Furthermore, a significant decline in death rate was noted in case group as compared to control group ( P = 0.03). Goal-directed optimized patients with perforation peritonitis were discharged early as compared to control group with significantly lesser mortality as compared with randomly optimized patients in the perioperative period.

Delivery of iron-fortified yoghurt, through a dairy value chain program, increases hemoglobin concentration among children 24 to 59 months old in Northern Senegal: A cluster-randomized control trial.

PubMed

Le Port, Agnes; Bernard, Tanguy; Hidrobo, Melissa; Birba, Ousmane; Rawat, Rahul; Ruel, Marie T

2017-01-01

Innovative strategies are needed to enhance the nutritional impact of agriculture. Value chain approaches, which use supply chains to add value (usually economic) to products as they move from producers to consumers, can be used to increase access to nutritious foods and improve nutritional status. This study tested whether a dairy value chain could be used to distribute a micronutrient-fortified yoghurt (MNFY) (conditional upon the producer supplying a minimum amount of cow milk/day) to improve hemoglobin and reduce anemia among preschool children in a remote area in Northern Senegal. A cluster randomized control trial was used to compare 204 children (24 to 59 months of age at baseline) from households who received the MNFY coupled to a behavior change communication (BCC) campaign focusing on anemia prevention to 245 children from a control group (receiving BCC only) after one year. Randomization was done at the level of the family concession (households from the same family) (n = 321). Eligible households had a child of the target age and were willing to deliver milk to the dairy factory. Changes in anemia and hemoglobin between groups were assessed using mixed regression models. Anemia prevalence was very high at baseline (80%) and dropped to close to 60% at endline, with no differences between intervention groups. Hemoglobin increased by 0.55 g/dL, 95%CI (0.27; 0.84) more in the intervention compared to the control group after one year, in models that controlled for potentially confounding factors. The impact was greater (0.72 g/dL, 95%CI (0.34; 1.12)) for boys, compared to girls (0.38 g/dL, 95%CI (-0.03; 0.80)). The dairy value chain was a successful strategy to distribute MNFY among pastoralists in Northern Senegal, and increase Hb concentrations among their children. This study is one of the first proofs of concept showing that a nutrition-sensitive agriculture value chain approach can contribute to improved child nutrition in a remote pastoralist population. ClinicalTrials.gov NCT02079961.

Delivery of iron-fortified yoghurt, through a dairy value chain program, increases hemoglobin concentration among children 24 to 59 months old in Northern Senegal: A cluster-randomized control trial

PubMed Central

Le Port, Agnes; Bernard, Tanguy; Hidrobo, Melissa; Birba, Ousmane; Rawat, Rahul; Ruel, Marie T.

2017-01-01

Background Innovative strategies are needed to enhance the nutritional impact of agriculture. Value chain approaches, which use supply chains to add value (usually economic) to products as they move from producers to consumers, can be used to increase access to nutritious foods and improve nutritional status. This study tested whether a dairy value chain could be used to distribute a micronutrient-fortified yoghurt (MNFY) (conditional upon the producer supplying a minimum amount of cow milk/day) to improve hemoglobin and reduce anemia among preschool children in a remote area in Northern Senegal. Methods A cluster randomized control trial was used to compare 204 children (24 to 59 months of age at baseline) from households who received the MNFY coupled to a behavior change communication (BCC) campaign focusing on anemia prevention to 245 children from a control group (receiving BCC only) after one year. Randomization was done at the level of the family concession (households from the same family) (n = 321). Eligible households had a child of the target age and were willing to deliver milk to the dairy factory. Changes in anemia and hemoglobin between groups were assessed using mixed regression models. Key findings Anemia prevalence was very high at baseline (80%) and dropped to close to 60% at endline, with no differences between intervention groups. Hemoglobin increased by 0.55 g/dL, 95%CI (0.27; 0.84) more in the intervention compared to the control group after one year, in models that controlled for potentially confounding factors. The impact was greater (0.72 g/dL, 95%CI (0.34; 1.12)) for boys, compared to girls (0.38 g/dL, 95%CI (-0.03; 0.80)). Conclusion The dairy value chain was a successful strategy to distribute MNFY among pastoralists in Northern Senegal, and increase Hb concentrations among their children. This study is one of the first proofs of concept showing that a nutrition-sensitive agriculture value chain approach can contribute to improved child nutrition in a remote pastoralist population. Trial registration ClinicalTrials.gov NCT02079961 PMID:28245227

An intervention to improve program implementation: findings from a two-year cluster randomized trial of Assets-Getting To Outcomes

PubMed Central

2013-01-01

Background Studies have shown that communities have not always been able to implement evidence-based prevention programs with quality and achieve outcomes demonstrated by prevention science. Implementation support interventions are needed to bridge this gap between science and practice. The purpose of this article is to present two-year outcomes from an evaluation of the Assets Getting To Outcomes (AGTO) intervention in 12 Maine communities engaged in promoting Developmental Assets, a positive youth development approach to prevention. AGTO is an implementation support intervention that consists of: a manual of text and tools; face-to-face training, and onsite technical assistance, focused on activities shown to be associated with obtaining positive results across any prevention program. Methods This study uses a nested and cross-sectional, cluster randomized controlled design. Participants were coalition members and program staff from 12 communities in Maine. Each coalition nominated up to five prevention programs to participate. At random, six coalitions and their respective 30 programs received the two-year AGTO intervention and the other six maintained routine operations. The study assessed prevention practitioner capacity (efficacy and behaviors), practitioner exposure to and use of AGTO, practitioner perceptions of AGTO, and prevention program performance. Capacity of coalition members and performance of their programs were compared between the two groups across the baseline, one-, and two-year time points. Results We found no significant differences between AGTO and control group’s prevention capacity. However, within the AGTO group, significant differences were found between those with greater exposure to and use of AGTO. Programs that received the highest number of technical assistance hours showed the most program improvement. Conclusions This study is the first of its kind to show that use of an implementation support intervention-AGTO -yielded improvements in practitioner capacity and consequently in program performance on a large sample of practitioners and programs using a randomized controlled design. ClinicalTrials.gov identifier NCT00780338 PMID:23924279

The Marriage Checkup: A Randomized Controlled Trial of Annual Relationship Health Checkups

PubMed Central

Cordova, James V.; Fleming, C.J. Eubanks; Morrill, Melinda Ippolito; Hawrilenko, Matt; Sollenberger, Julia W.; Harp, Amanda G.; Gray, Tatiana D.; Darling, Ellen V.; Blair, Jonathan M.; Meade, Amy E.; Wachs, Karen

2014-01-01

Objective This study assessed the efficacy of the Marriage Checkup for improving relationship health and intimacy. Method Cohabiting married couples (N=215, Mage women=44.5 years, men=47 years, 93.1% Caucasian) recruited from a northeastern U.S. metropolitan area through print and electronic media were randomly assigned to MC treatment or wait-list control. Treatment but not control couples participated in assessment and feedback visits, at the beginning of the study and again one year later. All couples completed nine sets of questionnaires over two years. Outcome measures included the Quality of Marriage Index, the Global Distress subscale of the Marital Satisfaction Inventory-Revised, the Intimate Safety Questionnaire, and the Relational Acceptance Questionnaire. Results A latent growth curve model indicated significant between group differences in intimacy at every measurement point after baseline (d ranged from .20 to .55, Md = .37), significant between group differences in women’s felt acceptance for every measurement point after baseline (d ranged from .17 to .47, Md = .34), significant between group differences in men’s felt acceptance through the 1-year-2 week follow-up (d across follow-up ranged from .11 to .40, Md = .25), and significant between group differences in relationship distress through 1-year 6-month follow-up (d across follow-up ranged from .11 to .39, Md = .23). Conclusions Longitudinal analysis of the MC supports the hypothesis that the MC significantly improves intimacy, acceptance, and satisfaction. Implications for dissemination are discussed. PMID:24932565

Transobturator TVT-O versus retropubic TVT: results of a multicenter randomized controlled trial at 24 months follow-up.

PubMed

Deffieux, Xavier; Daher, Nagib; Mansoor, Aslam; Debodinance, Philippe; Muhlstein, Joël; Fernandez, Hervé

2010-11-01

The purpose of this study is to compare the retropubic tension-free vaginal tape (TVT) procedure with the inside-out transobturator approach (TVT-O). Multicenter randomized controlled trial. One hundred forty-nine patients were randomly allocated to either TVT (n = 75) or TVT-O (n = 74). Interview, medical examination, pain scores, success rates, and quality of life assessment were recorded pre-operatively, and 2, 6, 12, and 24 months post-operatively. One hundred forty-nine patients underwent surgery, and 132 completed a 24-month follow-up. Bladder injury rate was 5% (4/75) in the TVT group and 2% (2/74) in the TVT-O group (p = 0.68). There was no significant difference between the two groups, concerning overall cure rate and the patients' satisfaction rate at 24 months follow-up. The range of mean pain scores was significantly higher after the TVT-O procedure post-operatively but not at 24 months follow-up. TVT and TVT-O procedures both have an outcome associated with an increase in quality of life with no significant differences in satisfaction rates at 2 years follow-up.

The Hi Five study: design of a school-based randomized trial to reduce infections and improve hygiene and well-being among 6-15 year olds in Denmark.

PubMed

Johansen, Anette; Denbæk, Anne Maj; Bonnesen, Camilla Thørring; Due, Pernille

2015-03-01

Infectious illnesses such as influenza and diarrhea are leading causes of absenteeism among Danish school children. Interventions in school settings addressing hand hygiene have shown to reduce the number of infectious illnesses. However, most of these studies include small populations and almost none of them are conducted as randomized controlled trials. The overall aim of the Hi Five study was to develop, implement and evaluate a multi-component school-based intervention to improve hand hygiene and well-being and to reduce the prevalence of infections among school children in intervention schools by 20% compared to control schools. This paper describes the development and the evaluation design of Hi Five. The Hi Five study was designed as a tree-armed cluster-randomized controlled trial. A national random sample of schools (n = 44) was randomized to one of two intervention groups (n = 29) or to a control group with no intervention (n = 15). A total of 8,438 six to fifteen-year-old school children were enrolled in the study. The Hi Five intervention consisted of three components: 1) a curriculum component 2) mandatory daily hand washing before lunch 3) extra cleaning of school toilets during the school day. Baseline data was collected from December 2011 to April 2012. The intervention period was August 2012 to June 2013. The follow-up data was collected from December 2012 to April 2013. The Hi Five study fills a gap in international research. This large randomized multi-component school-based hand hygiene intervention is the first to include education on healthy and appropriate toilet behavior as part of the curriculum. No previous studies have involved supplementary cleaning at the school toilets as an intervention component. The study will have the added value of providing new knowledge about usability of short message service (SMS, text message) for collecting data on infectious illness and absenteeism in large study populations. Current Controlled Trials ISRCTN19287682 , 21 December 2012.

Are Fourth-Year Medical Students Effective Teachers of the Physical Examination to First-Year Medical Students?

PubMed Central

Haist, Steven A; Wilson, John F; Fosson, Sue E; Brigham, Nancy L

1997-01-01

OBJECTIVE To determine if fourth-year medical students are as effective as faculty in teaching the physical examination to first-year medical students. DESIGN Stratified randomization of the first-year students. SETTING A public medical school. PARTICIPANTS All 100 first-year medical students in one medical school class were randomly assigned (controlling for gender) to either a faculty or a fourth-year student preceptor for the Physical Examination Module. MAIN RESULTS The first-year students of faculty preceptors scored no differently on the written examination than the students of the fourth-year medical student preceptors (82.8% vs 80.3%, p = .09) and no differently on a standardized patient practical examination (95.5% vs 95.4%, p = .92). Also, the first-year students rated the two groups of preceptors similarly on an evaluation form, with faculty rated higher on six items and the student preceptors rated higher on six items (all p > .10). The fourth-year student preceptors rated the experience favorably. CONCLUSIONS Fourth-year medical students were as successful as faculty in teaching first-year medical students the physical examination as measured by first-year student’s performances on objective measures and ratings of teaching effectiveness.

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

PubMed

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

2008-04-01

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

Comparison of range of commercial or primary care led weight reduction programmes with minimal intervention control for weight loss in obesity: lighten Up randomised controlled trial.

PubMed

Jolly, Kate; Lewis, Amanda; Beach, Jane; Denley, John; Adab, Peymane; Deeks, Jonathan J; Daley, Amanda; Aveyard, Paul

2011-11-03

To assess the effectiveness of a range of weight management programmes in terms of weight loss. Eight arm randomised controlled trial. Primary care trust in Birmingham, England. 740 obese or overweight men and women with a comorbid disorder identified from general practice records. Weight loss programmes of 12 weeks' duration: Weight Watchers; Slimming World; Rosemary Conley; group based, dietetics led programme; general practice one to one counselling; pharmacy led one to one counselling; choice of any of the six programmes. The comparator group was provided with 12 vouchers enabling free entrance to a local leisure (fitness) centre. The primary outcome was weight loss at programme end (12 weeks). Secondary outcomes were weight loss at one year, self reported physical activity, and percentage weight loss at programme end and one year. Follow-up data were available for 658 (88.9%) participants at programme end and 522 (70.5%) at one year. All programmes achieved significant weight loss from baseline to programme end (range 1.37 kg (general practice) to 4.43 kg (Weight Watchers)), and all except general practice and pharmacy provision resulted in significant weight loss at one year. At one year, only the Weight Watchers group had significantly greater weight loss than did the comparator group (2.5 (95% confidence interval 0.8 to 4.2) kg greater loss,). The commercial programmes achieved significantly greater weight loss than did the primary care programmes at programme end (mean difference 2.3 (1.3 to 3.4) kg). The primary care programmes were the most costly to provide. Participants allocated to the choice arm did not have better outcomes than those randomly allocated to a programme. Commercially provided weight management services are more effective and cheaper than primary care based services led by specially trained staff, which are ineffective. Trial registration Current Controlled Trials ISRCTN25072883.

ORCHIDS: an observational randomized controlled trial on childhood differential susceptibility.

PubMed

Chhangur, Rabia R; Weeland, Joyce; Overbeek, Geertjan; Matthys, Walterchj; Orobio de Castro, Bram

2012-10-29

A central tenet in developmental psychopathology is that childhood rearing experiences have a major impact on children's development. Recently, candidate genes have been identified that may cause children to be differentially susceptible to these experiences (i.e., susceptibility genes). However, our understanding of the differential impact of parenting is limited at best. Specifically, more experimental research is needed. The ORCHIDS study will investigate gene-(gene-)environment interactions to obtain more insight into a) moderating effects of polymorphisms on the link between parenting and child behavior, and b) behavioral mechanisms that underlie these gene-(gene-)environment interactions in an experimental design. The ORCHIDS study is a randomized controlled trial, in which the environment will be manipulated with an intervention (i.e., Incredible Years parent training). In a screening, families with children aged 4-8 who show mild to (sub)clinical behavior problems will be targeted through community records via two Dutch regional healthcare organizations. Assessments in both the intervention and control condition will be conducted at baseline (i.e., pretest), after 6 months (i.e., posttest), and after 10 months (i.e., follow-up). This study protocol describes the design of a randomized controlled trial that investigates gene-(gene-)environment interactions in the development of child behavior. Two hypotheses will be tested. First, we expect that children in the intervention condition who carry one or more susceptibility genes will show significantly lower levels of problem behavior and higher levels of prosocial behavior after their parent(s) received the Incredible Years training, compared to children without these genes, or children in the control group. Second, we expect that children carrying one or more susceptibility genes will show a heightened sensitivity to changes in parenting behaviors, and will manifest higher emotional synchronization in dyadic interchanges with their parents. This may lead to either more prosocial behavior or antisocial behavior depending on their parents' behavior. Dutch Trial Register (NTR3594).

Differential Effect of Taekwondo Training on Knee Muscle Strength and Reactive and Static Balance Control in Children with Developmental Coordination Disorder: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Fong, Shirley S. M.; Chung, Joanne W. Y.; Chow, Lina P. Y.; Ma, Ada W. W.; Tsang, William W. N.

2013-01-01

This randomized controlled trial aimed to investigate the effect of short-term intensive TKD training on the isokinetic knee muscle strength and reactive and static balance control of children with developmental coordination disorder (DCD). Among the 44 children with DCD (mean age: 7.6 plus or minus 1.3 years) recruited, 21 were randomly assigned…

A Randomized Trial of Genetic and Environmental Risk Assessment (GERA) for Colorectal Cancer Risk in Primary Care: Trial Design and Baseline Findings

PubMed Central

Myers, Ronald E.; Manne, Sharon L.; Wilfond, Benjamin; Sifri, Randa; Ziring, Barry; Wolf, Thomas A.; Cocroft, James; Ueland, Amy; Petrich, Anett; Swan, Heidi; DiCarlo, Melissa; Weinberg, David S.

2010-01-01

Purpose This paper describes an ongoing randomized controlled trial designed to assess the impact of genetic and environmental risk assessment (GERA) on colorectal cancer (CRC) screening. Methods The trial includes asymptomatic patients who are 50-79 years and are not up-to-date with CRC screening guidelines. Patients who responded to a baseline telephone survey are randomized to a GERA or Control group. GERA Group participants meet with a nurse, decide whether to have a GERA blood test (a combination of genetic polymorphism and folate), and, if tested, receive GERA feedback. Follow-up telephone surveys are conducted at one and six months. A chart audit is performed at six months. Results Of 2,223 eligible patients, 562 (25%) have enrolled. Patients who enrolled in the study were significantly younger than those who did not (p<0.001). Participants tended to be 50-59 years (64%), female (58%), white (52%), married (51%), and have more than a high school education (67%). At baseline, most participants had some knowledge of CRC screening and GERA, viewed CRC screening favorably, and reported that they had decided to do screening. Almost half had worries and concerns about CRC. Conclusions One in four eligible primary care patients enrolled in the study. Age was negatively associated with enrollment. Prospective analyses using data for all participants will provide more definitive information on GERA uptake and the impact of GERA feedback. PMID:20828635

Age-Related Corresponding Relationships of Controlled Force Exertion Measured by a Computer-Generated Sinusoidal and Quasi-Random Display

ERIC Educational Resources Information Center

Nagasawa, Yoshinori; Demura, Shinichi

2011-01-01

This study examined age-group corresponding relationships of the controlled force exertion based on sinusoidal and quasi-random waveforms in 175 right-handed male adults aged 20 to 86 years. The subjects were divided into 3 groups based on age-level: 53 young (mean age 24.6, SD = 3.3 years), 71 middle aged (mean age 44.3, SD = 8.7 years), and 51…

Efficacy of a new device to optimize positive pressure ventilation via face mask in edentulous patients: a randomized trial.

PubMed

Niño, Maria C; Pauwels, Andres; Raffan, Fernando; Arango, Enrique; Romero, David J; Benitez, Daniel

2017-04-01

Mask ventilation is routinely performed during anesthesia. Under some circumstances, it might be difficult to perform, such as in edentulous patients, due to inadequate mask seal. We developed a new device called NIPARA and studied its use For ventilation optimization in edentulous patients. This randomized controlled trial included edentulous adults who had no other predictors of difficult airway, scheduled to undergo general anesthesia. Patients were assigned either to the NIPARA device group or to the control group (oral airway only). The primary outcomes were peak inspiratory pressure and tidal volume values of the first 14 breaths. The secondary outcome was the incidence of complications. Data from 37 patients were collected during a one-year period (twenty in the NIPARA device group and 17 in the control group). The difference in mean PIP was not statistically significant. The tidal volume was 1.5 times greater in the NIPARA group than in the control group. One patient from the intervention group had minimal oral trauma. In the administration of face mask ventilation, NIPARA is an effective device that significantly improves the tidal volume administered in edentulous patients.

A cluster-randomized controlled trial evaluating the effects of delaying onset of adolescent substance abuse on cognitive development and addiction following a selective, personality-targeted intervention programme: the Co-Venture trial.

PubMed

O'Leary-Barrett, Maeve; Mâsse, Benoit; Pihl, Robert O; Stewart, Sherry H; Séguin, Jean R; Conrod, Patricia J

2017-10-01

Substance use and binge drinking during early adolescence are associated with neurocognitive abnormalities, mental health problems and an increased risk for future addiction. The trial aims to evaluate the protective effects of an evidence-based substance use prevention programme on the onset of alcohol and drug use in adolescence, as well as on cognitive, mental health and addiction outcomes over 5 years. Thirty-eight high schools will be recruited, with a final sample of 31 schools assigned to intervention or control conditions (3826 youth). Brief personality-targeted interventions will be delivered to high-risk youth attending intervention schools during the first year of the trial. Control school participants will receive no intervention above what is offered to them in the regular curriculum by their respective schools. Public/private French and English high schools in Montreal (Canada). All grade 7 students (12-13 years old) will be invited to participate. High-risk youth will be identified as those scoring one standard deviation or more above the school mean on one of the four personality subscales of the Substance Use Risk Profile Scale (40-45% youth). Self-reported substance use and mental health symptoms and cognitive functioning measured annually throughout 5 years. Primary outcomes are the onset of substance use disorders at 4 years post-intervention (year 5). Secondary intermediate outcomes are the onset of alcohol and substance use 2 years post-intervention and neuropsychological functions; namely, the protective effects of substance use prevention on cognitive functions generally, and executive functions and reward sensitivity specifically. This longitudinal, cluster-randomized controlled trial will investigate the impact of a brief personality-targeted intervention program on reducing the onset of addiction 4 years-post intervention. Results will tease apart the developmental sequences of uptake and growth in substance use and cognitive development in adolescence using developmentally sensitive neuropsychological measures. © 2017 Society for the Study of Addiction.

Multidisciplinary intensive functional restoration versus outpatient active physiotherapy in chronic low back pain: a randomized controlled trial.

PubMed

Roche-Leboucher, Ghislaine; Petit-Lemanac'h, Audrey; Bontoux, Luc; Dubus-Bausière, Valérie; Parot-Shinkel, Elsa; Fanello, Serge; Penneau-Fontbonne, Dominique; Fouquet, Natacha; Legrand, Erick; Roquelaure, Yves; Richard, Isabelle

2011-12-15

Randomized parallel group comparative trial with a 1-year follow-up period. To compare in a population of patients with chronic low back pain, the effectiveness of a functional restoration program (FRP), including intensive physical training and a multidisciplinary approach, with an outpatient active physiotherapy program at 1-year follow-up. Controlled studies conducted in the United States and in Northern Europe showed a benefit of FRPs, especially on return to work. Randomized studies have compared these programs with standard care. A previously reported study presented the effectiveness at 6 months of both functional restoration and active physiotherapy, with a significantly greater reduction of sick-leave days for functional restoration. A total of 132 patients with low back pain were randomized to either FRP (68 patients) or active individual therapy (64 patients). One patient did not complete the FRP; 19 patients were lost to follow-up (4 in the FRP group and 15 in the active individual treatment group). The number of sick-leave days in 2 years before the program was similar in both groups (180 ± 135.1 days in active individual treatment vs. 185 ± 149.8 days in FRP, P = 0.847). In both groups, at 1-year follow-up, intensity of pain, flexibility, trunk muscle endurance, Dallas daily activities and work and leisure scores, and number of sick-leave days were significantly improved compared with baseline. The number of sick-leave days was significantly lower in the FRP group. Both programs are efficient in reducing disability and sick-leave days. The FRP is significantly more effective in reducing sick-leave days. Further analysis is required to determine if this overweighs the difference in costs of both programs.

Exercise rehabilitation on home-dwelling patients with Alzheimer's disease--a randomized, controlled trial. Study protocol.

PubMed

Pitkala, Kaisu H; Raivio, Minna M; Laakkonen, Marja-Liisa; Tilvis, Reijo S; Kautiainen, Hannu; Strandberg, Timo E

2010-10-06

Besides cognitive decline, Alzheimer's disease (AD) leads to physical disability, need for help and permanent institutional care. The trials investigating effects of exercise rehabilitation on physical functioning of home-dwelling older dementia patients are still scarce. The aim of this study is to investigate the effectiveness of intensive exercise rehabilitation lasting for one year on mobility and physical functioning of home-dwelling patients with AD. During years 2008-2010, patients with AD (n = 210) living with their spousal caregiver in community are recruited using central AD registers in Finland, and they are offered exercise rehabilitation lasting for one year. The patients are randomized into three arms: 1) tailored home-based exercise twice weekly 2) group-based exercise twice weekly in rehabilitation center 3) control group with usual care and information of exercise and nutrition. Main outcome measures will be Guralnik's mobility and balance tests and FIM-test to assess physical functioning. Secondary measures will be cognition, neuropsychiatric symptoms according to the Neuropsychiatric Inventory, caregivers' burden, depression and health-related quality of life (RAND-36). Data concerning admissions to institutional care and the use and costs of health and social services will be collected during a two year follow-up. To our knowledge this is the first large scale trial exploring whether home-dwelling patients with AD will benefit from intense and long-lasting exercise rehabilitation in respect to their mobility and physical functioning. It will also provide data on cost-effectiveness of the intervention. ACTRN12608000037303.

A Randomized Controlled Trial Evaluation of an After-School Prosocial Behavior Program in an Area of Socioeconomic Disadvantage

ERIC Educational Resources Information Center

O'Hare, Liam; Biggart, Andy; Kerr, Karen; Connolly, Paul

2015-01-01

A randomized controlled trial was used to evaluate the effects of a prosocial behavior after-school program called Mate-Tricks for 9- and 10-year-old children and their parents living in an area of significant socioeconomic disadvantage. The children were randomly assigned to an intervention (n = 220) or a control group (n = 198). Children were…

One year soy protein supplementation has positive effects on bone formation markers but not bone density in postmenopausal women.

PubMed

Arjmandi, Bahram H; Lucas, Edralin A; Khalil, Dania A; Devareddy, Latha; Smith, Brenda J; McDonald, Jennifer; Arquitt, Andrea B; Payton, Mark E; Mason, Claudia

2005-02-23

Although soy protein and its isoflavones have been reported to reduce the risk of osteoporosis in peri- and post-menopausal women, most of these studies are of short duration (i.e. six months). The objective of this study was to examine if one year consumption of soy-containing foods (providing 25 g protein and 60 mg isoflavones) exerts beneficial effects on bone in postmenopausal women. Eighty-seven eligible postmenopausal women were randomly assigned to consume soy or control foods daily for one year. Bone mineral density (BMD) and bone mineral content (BMC) of the whole body, lumbar (L1-L4), and total hip were measured using dual energy x-ray absorptiometry at baseline and after one year. Blood and urine markers of bone metabolism were also assessed. Sixty-two subjects completed the one-year long study. Whole body and lumbar BMD and BMC were significantly decreased in both the soy and control groups. However, there were no significant changes in total hip BMD and BMC irrespective of treatment. Both treatments positively affected markers of bone formation as indicated by increased serum bone-specific alkaline phosphatase (BSAP) activity, insulin-like growth factor-I (IGF-I), and osteocalcin (BSAP: 27.8 and 25.8%, IGF-I: 12.8 and 26.3%, osteocalcin: 95.2 and 103.4% for control and soy groups, respectively). Neither of the protein supplements had any effect on urinary deoxypyridinoline excretion, a marker of bone resorption. Our findings suggest that although one year supplementation of 25 g protein per se positively modulated markers of bone formation, this amount of protein was unable to prevent lumbar and whole body bone loss in postmenopausal women.

Twelve-year follow-up of a randomized controlled trial of comprehensive physiotherapy following disc herniation operation.

PubMed

Ebenbichler, Gerold R; Inschlag, Silke; Pflüger, Verena; Stemberger, Regina; Wiesinger, Günther; Novak, Klaus; Christoph, Krall; Resch, Karl L

2015-06-01

To evaluate the long-term effects of postoperative comprehensive physiotherapy starting one week after lumbar disc surgery. Twelve-year follow-up of a three-armed, randomized, controlled, single-blinded clinical trial. Department of Physical Medicine & Rehabilitation. Of 111 patients following first-time, uncomplicated lumbar disc surgery who participated in the original study and completed the treatment originally allocated, 74 ((67%; 29 (73%) physiotherapy, 22 (58%) sham therapy, 23 (68%) no therapy) completed a 12-year follow-up examination. In the original study, patients had been randomly assigned to comprehensive physiotherapy, sham intervention (neck massage), or no therapy. Low Back Pain Rating Scale; best score 0, worst score 130 points). At 12 years after surgery, the group participating in comprehensive physiotherapy had significantly better functional outcomes, as rated on the Low Back Pain Rating Score, than the untreated group (mean difference: -13.2 (95% CI: (-25.4; -1.0)). Equally, there was a clinically relevant, non-significant difference between the sham therapy and no therapy (mean difference: -12.5 (95%CI: -26.1; 1.1)). Consequently, the Low Back Pain Rating Score outcome did not differ between physiotherapy and sham therapy (mean difference: -0.7 (95%CI: -14.2; 12.8)). Participating in a comprehensive physiotherapy program following lumbar disc surgery may be associated with better long-term health benefits over no intervention, but may not be superior to sham therapy. © The Author(s) 2014.

Fall risk and incidence reduction in high risk individuals with multiple sclerosis: a pilot randomized control trial.

PubMed

Sosnoff, Jacob J; Moon, Yaejin; Wajda, Douglas A; Finlayson, Marcia L; McAuley, Edward; Peterson, Elizabeth W; Morrison, Steve; Motl, Robert W

2015-10-01

To determine the feasibility of three fall prevention programs delivered over 12 weeks among individuals with multiple sclerosis: (A) a home-based exercise program targeting physiological risk factors; (B) an educational program targeting behavioral risk factors; and (C) a combined exercise-and-education program targeting both factors. Randomized controlled trial. Home-based training with assessments at research laboratory. A total of 103 individuals inquired about the investigation. After screening, 37 individuals with multiple sclerosis who had fallen in the last year and ranged in age from 45-75 years volunteered for the investigation. A total of 34 participants completed postassessment following the 12-week intervention. Participants were randomly assigned into one of four conditions: (1) wait-list control (n = 9); (2) home-based exercise (n = 11); (3) education (n = 9); or (4) a combined exercise and education (n = 8) group. Before and after the 12-week interventions, participants underwent a fall risk assessment as determined by the physiological profile assessment and provided information on their fall prevention behaviors as indexed by the Falls Prevention Strategy Survey. Participants completed falls diaries during the three-months postintervention. A total of 34 participants completed postintervention testing. Procedures and processes were found to be feasible. Overall, fall risk scores were lower in the exercise groups (1.15 SD 1.31) compared with the non-exercise groups (2.04 SD 1.04) following the intervention (p < 0.01). There was no group difference in fall prevention behaviors (p > 0.05). Further examination of home-based exercise/education programs for reducing falls in individuals with multiple sclerosis is warranted. A total of 108 participants would be needed in a larger randomized controlled trial.ClinicalTrials.org #NCT01956227. © The Author(s) 2014.

A brief history of placebos and clinical trials in psychiatry.

PubMed

Shorter, Edward

2011-04-01

The history of placebos in psychiatry can be understood only in the context of randomized controlled trials (RCTs). Placebo treatments are as old as medicine itself, and are particularly effective in dealing with psychosomatic symptoms. In psychiatry, placebos have mainly been featured in clinical drug trials. The earliest controlled trial in psychiatry (not involving drugs) occurred in 1922, followed by the first crossover studies during the 1930s. Meanwhile the concept of randomization was developed during the interwar years by British statistician Ronald A Fisher, and introduced in 3 trials of tuberculosis drugs between 1947 and 1951. These classic studies established the RCT as the gold standard in pharmaceutical trials, and its status was cemented during the mid-1950s. Nevertheless, while the placebo became established as a standard measure of drug action, placebo treatments became stigmatized as unethical. This is unfortunate, as they constitute one of the most powerful therapies in psychiatry. In recent years, moreover, the dogma of the placebo-controlled trial as the only acceptable data for drug licensing is also being increasingly discredited. This backlash has had 2 sources: one is the recognition that the US Food and Drug Administration has been too lax in permitting trials controlled with placebos alone, rather than also using an active agent as a test of comparative efficacy. In addition, there is evidence that in the hands of the pharmaceutical industry, the scientific integrity of RCTs themselves has been degraded into a marketing device. The once-powerful placebo is thus threatened with extinction.

Randomized Controlled Field Trial to Assess the Immunogenicity and Safety of Rift Valley Fever Clone 13 Vaccine in Livestock

PubMed Central

Njenga, M. Kariuki; Njagi, Leonard; Thumbi, S. Mwangi; Kahariri, Samuel; Githinji, Jane; Omondi, Eunice; Baden, Amy; Murithi, Mbabu; Paweska, Janusz; Ithondeka, Peter M.; Ngeiywa, Kisa J.; Dungu, Baptiste; Donadeu, Meritxell; Munyua, Peninah M.

2015-01-01

Background Although livestock vaccination is effective in preventing Rift Valley fever (RVF) epidemics, there are concerns about safety and effectiveness of the only commercially available RVF Smithburn vaccine. We conducted a randomized controlled field trial to evaluate the immunogenicity and safety of the new RVF Clone 13 vaccine, recently registered in South Africa. Methods In a blinded randomized controlled field trial, 404 animals (85 cattle, 168 sheep, and 151 goats) in three farms in Kenya were divided into three groups. Group A included males and non-pregnant females that were randomized and assigned to two groups; one vaccinated with RVF Clone 13 and the other given placebo. Groups B included animals in 1st half of pregnancy, and group C animals in 2nd half of pregnancy, which were also randomized and either vaccinated and given placebo. Animals were monitored for one year and virus antibodies titers assessed on days 14, 28, 56, 183 and 365. Results In vaccinated goats (N = 72), 72% developed anti-RVF virus IgM antibodies and 97% neutralizing IgG antibodies. In vaccinated sheep (N = 77), 84% developed IgM and 91% neutralizing IgG antibodies. Vaccinated cattle (N = 42) did not develop IgM antibodies but 67% developed neutralizing IgG antibodies. At day 14 post-vaccination, the odds of being seropositive for IgG in the vaccine group was 3.6 (95% CI, 1.5 – 9.2) in cattle, 90.0 (95% CI, 25.1 – 579.2) in goats, and 40.0 (95% CI, 16.5 – 110.5) in sheep. Abortion was observed in one vaccinated goat but histopathologic analysis did not indicate RVF virus infection. There was no evidence of teratogenicity in vaccinated or placebo animals. Conclusions The results suggest RVF Clone 13 vaccine is safe to use and has high (>90%) immunogenicity in sheep and goats but moderate (> 65%) immunogenicity in cattle. PMID:25756501

Death Is Certain, Strategy Isn't: Assessing the Robert Wood Johnson Foundation's End-of-Life Grant Making

ERIC Educational Resources Information Center

Patrizi, Patricia A.

2010-01-01

The author discusses an assessment of the Robert Wood Johnson Foundation's work over a 20-year period to improve end-of-life care in America. The case illustrates the evolution of the strategy from one focused on a multiyear randomized control trial of a series of hospital-based interventions that produced findings of "no effects" into several…

One session of high-intensity interval training (HIIT) every 5 days, improves muscle power but not static balance in lifelong sedentary ageing men: A randomized controlled trial.

PubMed

Sculthorpe, Nicholas F; Herbert, Peter; Grace, Fergal

2017-02-01

Declining muscle power during advancing age predicts falls and loss of independence. High-intensity interval training (HIIT) may improve muscle power, but remains largely unstudied in ageing participants. This randomized controlled trial (RCT) investigated the efficacy of a low-frequency HIIT (LfHIIT) intervention on peak muscle power (peak power output [PPO]), body composition, and balance in lifelong sedentary but otherwise healthy males. Thirty-three lifelong sedentary ageing men were randomly assigned to either intervention (INT; n = 22, age 62.3 ± 4.1 years) or control (n = 11, age 61.6 ± 5.0 years) who were both assessed at 3 distinct measurement points (phase A), after 6 weeks of conditioning exercise (phase B), and after 6 weeks of HIIT once every 5 days in INT (phase C), where control remained inactive throughout the study. Static balance remained unaffected, and both absolute and relative PPO were not different between groups at phases A or B, but increased significantly in INT after LfHIIT (P < 0.01). Lean body mass displayed a significant interaction (P < 0.01) due to an increase in INT between phases B and C (P < 0.05). 6 weeks of LfHIIT exercise feasible and effective method to induce clinically relevant improvements in absolute and relative PPO, but does not improve static balance in sedentary ageing men.

An Intervention to Reduce Bicycle Injuries among Middle School Students in Rural China

PubMed Central

Ye, Yanru; Lu, Yaogui; Li, Liping; Gao, Yang

2017-01-01

This study aimed to evaluate the effectiveness of an intervention to reduce bicycle injuries among rural middle school students in China. A one-year cluster-randomized controlled trial was conducted with seventh grade students from six middle schools in two towns in rural Chaoshan, China. The two towns were randomly assigned to either the intervention or control group. Road safety education materials, two lectures on road safety, and a series of health education activities were delivered to 1312 students in the intervention group over one year, and the content of the intervention included traffic safety knowledge, methods of preventing bicycle injury and management of bicycle injuries. Questionnaires weere administered to the two groups before and after the intervention to measure the incidence, cognitions, and behaviors related to bicycle injuries. The pre-intervention incidence of bicycle injuries exhibited no significant difference between the two groups, while the difference reached significance after the intervention (χ2 = 13.409, p < 0.001). In the intervention group, the incidence decreased significantly after the intervention (χ2 = 8.137, p = 0.004), while no significant change was observed in the control group. Publicity and education intervention measures have certain short-term effects on the prevention of bicycle injuries among rural middle school students; we should approach intervention measures according to the characteristics of traffic injuries in different areas. PMID:28672854

Cluster-randomized controlled trial of the effects of free glasses on purchase of children's glasses in China: The PRICE (Potentiating Rural Investment in Children's Eyecare) study.

PubMed

Wang, Xiuqin; Congdon, Nathan; Ma, Yue; Hu, Min; Zhou, Yuan; Liao, Weiqi; Jin, Ling; Xiao, Baixiang; Wu, Xiaoyi; Ni, Ming; Yi, Hongmei; Huang, Yiwen; Varga, Beatrice; Zhang, Hong; Cun, Yongkang; Li, Xianshun; Yang, Luhua; Liang, Chaoguang; Huang, Wan; Rozelle, Scott; Ma, Xiaochen

2017-01-01

Offering free glasses can be important to increase children's wear. We sought to assess whether "Upgrade glasses" could avoid reduced glasses sales when offering free glasses to children in China. In this cluster-randomized, controlled trial, children with uncorrected visual acuity (VA)< = 6/12 in either eye correctable to >6/12 in both eyes at 138 randomly-selected primary schools in 9 counties in Guangdong and Yunnan provinces, China, were randomized by school to one of four groups: glasses prescription only (Control); Free Glasses; Free Glasses + offer of $15 Upgrade Glasses; Free Glasses + offer of $30 Upgrade Glasses. Spectacle purchase (main outcome) was assessed 6 months after randomization. Among 10,234 children screened, 882 (8.62%, mean age 10.6 years, 45.5% boys) were eligible and randomized: 257 (29.1%) at 37 schools to Control; 253 (28.7%) at 32 schools to Free Glasses; 187 (21.2%) at 31 schools to Free Glasses + $15 Upgrade; and 185 (21.0%) at 27 schools to Free Glasses +$30 Upgrade. Baseline ownership among these children needing glasses was 11.8% (104/882), and 867 (98.3%) children completed follow-up. Glasses purchase was significantly less likely when free glasses were given: Control: 59/250 = 23.6%; Free glasses: 32/252 = 12.7%, P = 0.010. Offering Upgrade Glasses eliminated this difference: Free + $15 Upgrade: 39/183 = 21.3%, multiple regression relative risk (RR) 0.90 (0.56-1.43), P = 0.65; Free + $30 Upgrade: 38/182 = 20.9%, RR 0.91 (0.59, 1.42), P = 0.69. Upgrade glasses can prevent reductions in glasses purchase when free spectacles are provided, providing important program income. ClinicalTrials.gov Identifier: NCT02231606. Registered on 31 August 2014.

One-year weight losses in the Tianjin Gestational Diabetes Mellitus Prevention Programme: A randomized clinical trial.

PubMed

Liu, Huikun; Wang, Leishen; Zhang, Shuang; Leng, Junhong; Li, Nan; Li, Weiqin; Wang, Jing; Tian, Huiguang; Qi, Lu; Yang, Xilin; Yu, Zhijie; Tuomilehto, Jaakko; Hu, Gang

2018-05-01

To report the weight loss findings after the first year of a lifestyle intervention trial among women with gestational diabetes mellitus (GDM). A total of 1180 women with GDM were randomly assigned (1:1) to receive a 4-year lifestyle intervention (intervention group, n = 586) or standard care (control group, n = 594) between August 2009 and July 2011. Major elements of the intervention included 6 face-to-face sessions with study dieticians and two telephone calls in the first year, and two individual sessions and two telephone calls in each subsequent year. Among 79% of participants who completed the year 1 trial, mean weight loss was 0.82 kg (1.12% of initial weight) in the intervention group and 0.09 kg (0.03% of initial weight) in the control group (P = .001). In a prespecified subgroup analysis of people who completed the trial, weight loss was more pronounced in women who were overweight (body mass index ≥24 kg/m 2 ) at baseline: mean weight loss 2.01 kg (2.87% of initial weight) in the intervention group and 0.44 kg (0.52% of initial weight) in the control group (P < .001). Compared with those in the control group, women in the intervention group had a greater decrease in waist circumference (1.76 cm vs 0.73 cm; P = .003) and body fat (0.50% vs 0.05% increase; P = .001). The 1-year lifestyle intervention led to significant weight losses after delivery in women who had GDM, and the effect was more pronounced in women who were overweight at baseline. © 2018 John Wiley & Sons Ltd.

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

PubMed Central

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

2015-01-01

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

Effects of cholecalciferol supplementation and optimized calcium intakes on vitamin D status, muscle strength and bone health: a one-year pilot randomized controlled trial in adults with severe burns.

PubMed

Rousseau, Anne-Françoise; Foidart-Desalle, Marguerite; Ledoux, Didier; Remy, Christophe; Croisier, Jean-Louis; Damas, Pierre; Cavalier, Etienne

2015-03-01

Burn patients are at risk of hypovitaminosis D and osteopenia or sarcopenia. Vitamin D pleiotropic effects may influence bone and muscle health. The aim of this pilot study was to assess effects of a cholecalciferol (VD3) supplementation and an optimized calcium (Ca) regimen on vitamin D (VD) status, bone and muscle health during sequelar stage of burn injury. Monocentric randomized controlled trial. Fifteen adults with thermal burns dating from 2 to 5 years were randomized into two groups. For 12 months, they either received a quarterly IM injection of 200,000IU VD3 and daily oral Ca (Group D) or placebo (Group P). VD status and bone remodeling markers were assessed every 3 months. Knee muscle strength and bone mineral density were, respectively, assessed using isokinetic dynamometry and dual X-ray absorptiometry at initiation (M0) and completion (M12) of the protocol. Of all the patients, 66% presented with VD deficiency and 53% (with 3 men <40y) were considered osteopenic at inclusion. After one year, calcidiol levels significantly increased in Group D to reach 40 (37-61)ng/ml. No significant change in bone health was observed in both groups while Group D significantly improved quadriceps strength when tested at high velocity. This VD3 supplementation was safe and efficient to correct hypovitaminosis D in burn adults. When combined with optimized Ca intakes, it demonstrated positive effects on muscle health but not on bone health. A high prevalence of hypovitaminosis D and osteopenia in these patients, as well as their wide range of muscle performances, seem to be worrying when considering rehabilitation and quality of life. Copyright © 2014 Elsevier Ltd and ISBI. All rights reserved.

Outcomes from a randomized controlled trial of a multi-component alcohol use preventive intervention for urban youth: project northland Chicago.

PubMed

Komro, Kelli A; Perry, Cheryl L; Veblen-Mortenson, Sara; Farbakhsh, Kian; Toomey, Traci L; Stigler, Melissa H; Jones-Webb, Rhonda; Kugler, Kari C; Pasch, Keryn E; Williams, Carolyn L

2008-04-01

The goal of this group-randomized trial was to test the effectiveness of an adapted alcohol use preventive intervention for urban, low-income and multi-ethnic settings. Sixty-one public schools in Chicago were recruited to participate, were grouped into neighborhood study units and assigned randomly to intervention or 'delayed program' control condition. The study sample (n = 5812 students) was primarily African American, Hispanic and low-income. Students, beginning in sixth grade (age 12 years), received 3 years of intervention strategies (curricula, family interventions, youth-led community service projects, community organizing). Students participated in yearly classroom-based surveys to measure their alcohol use and related risk and protective factors. Additional evaluation components included a parent survey, a community leader survey and alcohol purchase attempts. Overall, the intervention, compared with a control condition receiving 'prevention as usual', was not effective in reducing alcohol use, drug use or any hypothesized mediating variables (i.e. related risk and protective factors). There was a non-significant trend (P = 0.066) that suggested the ability to purchase alcohol by young-appearing buyers was reduced in the intervention communities compared to the control communities, but this could be due to chance. Secondary outcome analyses to assess the effects of each intervention component indicated that the home-based programs were associated with reduced alcohol, marijuana and tobacco use combined (P = 0.01), with alcohol use alone approaching statistical significance (P = 0.06). Study results indicate the importance of conducting evaluations of previously validated programs in contexts that differ from the original study sample. Also, the findings highlight the need for further research with urban, low-income adolescents from different ethnic backgrounds to identify effective methods to prevent and reduce alcohol use.

Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol.

PubMed

Pérula-de-Torres, Luis Á; Martínez-Adell, Miguel Á; González-Blanco, Virginia; Baena-Díez, José M; Martín-Rioboó, Enrique; Parras-Rejano, Juan M; González-Lama, Jesús; Martín-Alvarez, Remedios; Ruiz-Moral, Roger; Fernández-García, José Á; Pérez-Díaz, Modesto; Ruiz-de-Castroviejo, Joaquin; Pérula-de-Torres, Carlos; Valero-Martín, Antonio; Roldán-Villalobos, Ana; Criado-Larumbe, Margarita; Burdoy-Joaquín, Emili; Coma-Solé, Montserrat; Cervera-León, Mercè; Cuixart-Costa, Lluís

2012-10-30

Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group). As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group). Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis). If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. The study is registered as NCT01291953 (ClinicalTrials.gob).

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

PubMed

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

1999-03-01

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

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

ERIC Educational Resources Information Center

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

2016-01-01

Mental abacus (MA) is a technique of performing fast, accurate arithmetic using a mental image of an abacus; experts exhibit astonishing calculation abilities. Over 3 years, 204 elementary school students (age range at outset: 5-7 years old) participated in a randomized, controlled trial to test whether MA expertise (a) can be acquired in standard…

The Impact of Achieve3000 on Elementary Literacy Outcomes: Evidence from a Two-Year Randomized Control Trial

ERIC Educational Resources Information Center

Hill, Darryl V.; Lenard, Matthew A.; Page, Lindsay Coleman

2016-01-01

School districts are increasingly adopting technology-based resources in an attempt to improve student achievement. This paper reports the two-year results from randomized control trial of Achieve3000 in the Wake County Public School System (WCPSS) in Raleigh, North Carolina. Achieve3000 is an early literacy program that differentiates non-fiction…

Fibrin sealant for mesh fixation in laparoscopic umbilical hernia repair: 1-year results of a randomized controlled double-blinded study.

PubMed

Eriksen, J R; Bisgaard, T; Assaadzadeh, S; Jorgensen, L N; Rosenberg, J

2013-08-01

Fibrin sealant for mesh fixation has significant positive effects on early outcome after laparoscopic ventral hernia repair (LVHR) compared with titanium tacks. Whether fibrin sealant fixation also results in better long-term outcome is unknown. We performed a randomized controlled trial including patients with umbilical hernia defects from 1.5 to 5 cm at three Danish hernia centres. We used a 12 cm circular mesh. Participants were randomized to fibrin sealant or titanium tack fixation. Patients were seen in the outpatient clinic at 1 and 12 months follow-up. Forty patients were included of whom 34 were available for intention to treat analysis after 1 year. There were no significant differences in pain, discomfort, fatigue, satisfaction or quality of life between the two groups at the 1-year follow-up. Five patients (26 %) in the fibrin sealant group and one (6 %) in the tack group were diagnosed with a recurrence at the 1-year follow-up (p = 0.182) (overall recurrence rate 17 %). Hernia defects in patients with recurrence were significantly larger than in those without recurrence (median 4.0 vs. 2.8 cm, p = 0.009). Patients with larger hernia defects and fibrin sealant mesh fixation had higher recurrence rates than expected, although the study was not powered for assessment of recurrence. There was no significant difference between groups in any parameters after the 1-year follow-up. The beneficial effects of mesh fixation with fibrin sealant on early outcome warrant further studies on optimization of the surgical technique to prevent recurrence.

The influence of empathic concern on prosocial behavior in children.

PubMed

Williams, Amanda; O'Driscoll, Kelly; Moore, Chris

2014-01-01

This research explored the influence of empathic distress on prosocial behavior in a resource allocation task with children. Children were randomly assigned to one of two conditions before engaging in a sticker sharing task; watching either a video of a girl upset that her dog had gone missing (emotion induction condition), or a video of the same girl preparing for a yard sale (control condition). In study one, 5-6 year old children in the emotion induction condition rated the emotional state of both the protagonist and the self more negatively, and also exhibited more prosocial behavior; sharing more in advantageous inequity (AI) trials, and less often withholding a benefit in disadvantageous inequity trials, than the control group. Prosocial behavior was significantly correlated with ratings of the emotional state of the protagonist but not with own emotional state, suggesting that empathic concern rather than personal distress was the primary influence on prosocial behavior. In study two, 3-year-olds were tested on AI trials alone, and like the 5 and 6-year-olds, showed more prosocial behavior in the emotion induction condition than the control.

The influence of empathic concern on prosocial behavior in children

PubMed Central

Williams, Amanda; O’Driscoll, Kelly; Moore, Chris

2014-01-01

This research explored the influence of empathic distress on prosocial behavior in a resource allocation task with children. Children were randomly assigned to one of two conditions before engaging in a sticker sharing task; watching either a video of a girl upset that her dog had gone missing (emotion induction condition), or a video of the same girl preparing for a yard sale (control condition). In study one, 5–6 year old children in the emotion induction condition rated the emotional state of both the protagonist and the self more negatively, and also exhibited more prosocial behavior; sharing more in advantageous inequity (AI) trials, and less often withholding a benefit in disadvantageous inequity trials, than the control group. Prosocial behavior was significantly correlated with ratings of the emotional state of the protagonist but not with own emotional state, suggesting that empathic concern rather than personal distress was the primary influence on prosocial behavior. In study two, 3-year-olds were tested on AI trials alone, and like the 5 and 6-year-olds, showed more prosocial behavior in the emotion induction condition than the control. PMID:24860537

Ongoing positive effect of platelet-rich plasma versus corticosteroid injection in lateral epicondylitis: a double-blind randomized controlled trial with 2-year follow-up.

PubMed

Gosens, Taco; Peerbooms, Joost C; van Laar, Wilbert; den Oudsten, Brenda L

2011-06-01

Platelet-rich plasma (PRP) has been shown to be a general stimulation for repair and 1-year results showed promising success percentages. This trial was undertaken to determine the effectiveness of PRP compared with corticosteroid injections in patients with chronic lateral epicondylitis with a 2-year follow-up. Randomized controlled trial; Level of evidence, 1. The trial was conducted in 2 Dutch teaching hospitals. One hundred patients with chronic lateral epicondylitis were randomly assigned to a leukocyte-enriched PRP group (n = 51) or the corticosteroid group (n = 49). Randomization and allocation to the trial group were carried out by a central computer system. Patients received either a corticosteroid injection or an autologous platelet concentrate injection through a peppering needling technique. The primary analysis included visual analog scale (VAS) pain scores and Disabilities of the Arm, Shoulder and Hand (DASH) outcome scores. The PRP group was more often successfully treated than the corticosteroid group (P < .0001). Success was defined as a reduction of 25% on VAS or DASH scores without a reintervention after 2 years. When baseline VAS and DASH scores were compared with the scores at 2-year follow-up, both groups significantly improved across time (intention-to-treat principle). However, the DASH scores of the corticosteroid group returned to baseline levels, while those of the PRP group significantly improved (as-treated principle). There were no complications related to the use of PRP. Treatment of patients with chronic lateral epicondylitis with PRP reduces pain and increases function significantly, exceeding the effect of corticosteroid injection even after a follow-up of 2 years. Future decisions for application of PRP for lateral epicondylitis should be confirmed by further follow-up from this trial and should take into account possible costs and harms as well as benefits.

Weight Gain Prevention among Midlife Women: A Randomized Controlled Trial to Address Needs Related to the Physical and Social Environment.

PubMed

Perry, Courtney D; Degeneffe, Dennis; Davey, Cynthia; Kollannoor-Samuel, Grace; Reicks, Marla

2016-05-25

Women tend to gain weight at midlife (40-60 years) increasing risk of obesity-related chronic diseases. Within specific eating occasions, needs related to the physical and social environment may result in less healthy eating behavior, which can lead to weight gain over time. The purpose of this study was to determine if a dietitian-delivered nutrition counseling intervention tailored to eating occasion needs could improve diet and prevent weight gain among midlife women over two years. A randomized controlled trial was conducted with healthy midlife women (n = 354) in one U.S. metropolitan area. The intervention group (n = 185) received ten hours of individual nutrition counseling from dietitians over six months, while women in a control group (n = 169) received no counseling. Measured height, weight and waist circumference, and dietary intakes were collected at baseline and every six months over two years. Mixed linear models were used to test for intervention effect on change in outcome variables over time. Dietary intakes of fruit, reduced/low-fat dairy foods and refined grains were significantly improved over time in the intervention compared to control group. However, the intervention had no effect on weight over time (p = 0.48). Nutrition counseling tailored to address eating occasion needs improved self-reported diet but did not significantly affect weight change.

Hip Abductor Strengthening Improves Physical Function Following Total Knee Replacement: One-Year Follow-Up of a Randomized Pilot Study.

PubMed

Harikesavan, Karvannan; Chakravarty, Raj D; Maiya, Arun G; Hegde, Sanjay P; Y Shivanna, Shivakumar

2017-01-01

Total knee replacement (TKR) is the commonest surgical procedure for patients with severe pain and impaired physical function following end stage knee osteoarthritis. The hip abductors are well renowned in stabilization of the trunk and hip during walking, maintaining the lower limb position, and transferring the forces from the lower limbs to the pelvis. To assess the efficacy of hip abductor strengthening exercise on functional outcome using performance based outcome measures following total knee replacement. An observer blinded randomized pilot trial design was conducted at Manipal hospital, Bangalore, India. Participants designated for elective TKR were randomized to experimental group hip abductor strengthening along with standard rehabilitation (n=10) or control group standard rehabilitation alone (n=10). Participants followed for one year to assess physical function using performance based outcomes, such as timed up and go test, single leg stance test, six minute walk test, knee extensor strength and hip abductor strength. Eighteen participants with a mean age of 63.1 ± 5.5 years (8 Males and 10 Females) completed the study. Improvement in hip abduction strength, single leg stand test was superior in hip abductor strengthening group at 3 months and 1 year when compared to standard rehabilitation alone. Hip abductor strengthening showed superior improvements in single leg stance test and six minute walk test. Hip abductor strengthening exercises has the potential to improve physical function following total knee replacement.

Hip Abductor Strengthening Improves Physical Function Following Total Knee Replacement: One-Year Follow-Up of a Randomized Pilot Study

PubMed Central

Harikesavan, Karvannan; Chakravarty, Raj D.; Maiya, Arun G; Hegde, Sanjay P.; Y. Shivanna, Shivakumar

2017-01-01

Background: Total knee replacement (TKR) is the commonest surgical procedure for patients with severe pain and impaired physical function following end stage knee osteoarthritis. The hip abductors are well renowned in stabilization of the trunk and hip during walking, maintaining the lower limb position, and transferring the forces from the lower limbs to the pelvis. Objective: To assess the efficacy of hip abductor strengthening exercise on functional outcome using performance based outcome measures following total knee replacement. Methods: An observer blinded randomized pilot trial design was conducted at Manipal hospital, Bangalore, India. Participants designated for elective TKR were randomized to experimental group hip abductor strengthening along with standard rehabilitation (n=10) or control group standard rehabilitation alone (n=10). Participants followed for one year to assess physical function using performance based outcomes, such as timed up and go test, single leg stance test, six minute walk test, knee extensor strength and hip abductor strength. Result: Eighteen participants with a mean age of 63.1 ± 5.5 years (8 Males and 10 Females) completed the study. Improvement in hip abduction strength, single leg stand test was superior in hip abductor strengthening group at 3 months and 1 year when compared to standard rehabilitation alone. Conclusion: Hip abductor strengthening showed superior improvements in single leg stance test and six minute walk test. Hip abductor strengthening exercises has the potential to improve physical function following total knee replacement. PMID:28567148

Motivating first-time, group O blood donors to return: Rationale and design of a randomized controlled trial of a post-donation telephone interview

PubMed Central

France, Janis L.; France, Christopher R.; Carlson, Bruce W.; Kessler, Debra A.; Rebosa, Mark; Shaz, Beth H.; Madden, Katrala; Carey, Patricia M.

2015-01-01

First-time blood donors are essential to the US donor pool, providing nearly a third of all donations. Unfortunately, there are a wide variety of obstacles to repeat donation and new donors are extremely difficult to retain. Because each donor experiences a unique set of deterrents, we developed a post-donation interview based on motivational interview principles in order to flexibly address individual barriers. The primary aim of this randomized clinical trial is to examine retention of first-time, group O blood donors who are randomly assigned to receive either a telephone-delivered interview with motivational and action planning components or a standard-of-care control call approximately six weeks after their donation. Measures of donation attitude, perceived behavioral control, intention, and motivational autonomy will be measured before and after the telephone contact using online surveys, and donation attempts will be tracked for one year using blood center donor databases. We hypothesize that, compared to controls, donors who receive the telephone interview will be more likely to make a donation attempt over the following year. In addition, we will examine possible mechanisms of action of the interview using key predictors of donation behavior as described by Self Determination Theory (i.e., motivational autonomy) and the Theory of Planned Behavior (i.e., attitude, perceived behavioral control, and intention). Results of this intervention may help to support a novel strategy to enhance retention of selected blood donors in an effort to better meet the nation’s blood supply needs. PMID:26247570

The efficacy of early initiated, supervised, progressive resistance training compared to unsupervised, home-based exercise after unicompartmental knee arthroplasty: a single-blinded randomized controlled trial.

PubMed

Jørgensen, Peter B; Bogh, Søren B; Kierkegaard, Signe; Sørensen, Henrik; Odgaard, Anders; Søballe, Kjeld; Mechlenburg, Inger

2017-01-01

To examine if supervised progressive resistance training was superior to home-based exercise in rehabilitation after unicompartmental knee arthroplasty. Single blinded, randomized clinical trial. Surgery, progressive resistance training and testing was carried out at Aarhus University Hospital and home-based exercise was carried out in the home of the patient. Fifty five patients were randomized to either progressive resistance training or home-based exercise. Patients were randomized to either progressive resistance training (home based exercise five days/week and progressive resistance training two days/week) or control group (home based exercise seven days/week). Preoperative assessment, 10-week (primary endpoint) and one-year follow-up were performed for leg extension power, spatiotemporal gait parameters and knee injury and osteoarthritis outcome score (KOOS). Forty patients (73%) completed 1-year follow-up. Patients in the progressive resistance training group participated in average 11 of 16 training sessions. Leg extension power increased from baseline to 10-week follow-up in progressive resistance training group (progressive resistance training: 0.28 W/kg, P= 0.01, control group: 0.01 W/kg, P=0.93) with no between-group difference. Walking speed and KOOS scores increased from baseline to 10-week follow-up in both groups with no between-group difference (six minutes walk test P=0.63, KOOS P>0.29). Progressive resistance training two days/week combined with home based exercise five days/week was not superior to home based exercise seven days/week in improving leg extension power of the operated leg.

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

PubMed

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

2013-02-01

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

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

PubMed Central

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

2013-01-01

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

Predictors of short- and long-term adherence with a Mediterranean-type diet intervention: the PREDIMED randomized trial.

PubMed

Downer, Mary Kathryn; Gea, Alfredo; Stampfer, Meir; Sánchez-Tainta, Ana; Corella, Dolores; Salas-Salvadó, Jordi; Ros, Emilio; Estruch, Ramón; Fitó, Montserrat; Gómez-Gracia, Enrique; Arós, Fernando; Fiol, Miquel; De-la-Corte, Francisco Jose Garcia; Serra-Majem, Lluís; Pinto, Xavier; Basora, Josep; Sorlí, José V; Vinyoles, Ernest; Zazpe, Itziar; Martínez-González, Miguel-Ángel

2016-06-14

Dietary intervention success requires strong participant adherence, but very few studies have examined factors related to both short-term and long-term adherence. A better understanding of predictors of adherence is necessary to improve the design and execution of dietary intervention trials. This study was designed to identify participant characteristics at baseline and study features that predict short-term and long-term adherence with interventions promoting the Mediterranean-type diet (MedDiet) in the PREvención con DIeta MEDiterránea (PREDIMED) randomized trial. Analyses included men and women living in Spain aged 55-80 at high risk for cardiovascular disease. Participants were randomized to the MedDiet supplemented with either complementary extra-virgin olive oil (EVOO) or tree nuts. The control group and participants with insufficient information on adherence were excluded. PREDIMED began in 2003 and ended in 2010. Investigators assessed covariates at baseline and dietary information was updated yearly throughout follow-up. Adherence was measured with a validated 14-point Mediterranean-type diet adherence score. Logistic regression was used to examine associations between baseline characteristics and adherence at one and four years of follow-up. Participants were randomized to the MedDiet supplemented with EVOO (n = 2,543; 1,962 after exclusions) or tree nuts (n = 2,454; 2,236 after exclusions). A higher number of cardiovascular risk factors, larger waist circumference, lower physical activity levels, lower total energy intake, poorer baseline adherence to the 14-point adherence score, and allocation to MedDiet + EVOO each independently predicted poorer adherence. Participants from PREDIMED recruiting centers with a higher total workload (measured as total number of persons-years of follow-up) achieved better adherence. No adverse events or side effects were reported. To maximize dietary adherence in dietary interventions, additional efforts to promote adherence should be used for participants with lower baseline adherence to the intended diet and poorer health status. The design of multicenter nutrition trials should prioritize few large centers with more participants in each, rather than many small centers. This study was registered at controlled-trials.com (http://www.controlled-trials. com/ISRCTN35739639). International Standard Randomized Controlled Trial Number (ISRCTN): 35739639. Registration date: 5 October 2005. parallel randomized trial.

Childhood obesity prevention and control in city recreation centres and family homes: the MOVE/me Muevo Project.

PubMed

Elder, J P; Crespo, N C; Corder, K; Ayala, G X; Slymen, D J; Lopez, N V; Moody, J S; McKenzie, T L

2014-06-01

Interventions to prevent and control childhood obesity have shown mixed results in terms of short- and long-term changes. 'MOVE/me Muevo' was a 2-year family- and recreation centre-based randomized controlled trial to promote healthy eating and physical activity among 5- to 8-year-old children. It was hypothesized that children in the intervention group would demonstrate lower post-intervention body mass index (BMI) values and improved obesity-related behaviours compared with the control group children. Thirty recreation centres in San Diego County, California, were randomized to an intervention or control condition. Five hundred forty-one families were enrolled and children's BMI, diet, physical activity and other health indicators were tracked from baseline to 2 years post-baseline. Analyses followed an intent-to-treat approach using mixed-effects models. No significant intervention effects were observed for the primary outcomes of child's or parent's BMI and child's waist circumference. Moderator analyses, however, showed that girls (but not boys) in the intervention condition reduced their BMI. At the 2-year follow-up, intervention condition parents reported that their children were consuming fewer high-fat foods and sugary beverages. Favourable implementation fidelity and high retention rates support the feasibility of this intervention in a large metropolitan area; however, interventions of greater intensity may be needed to achieve effects on child's BMI. Also, further research is needed to develop gender-specific intervention strategies so that both genders may benefit from such efforts. © 2013 The Authors. Pediatric Obesity © 2013 International Association for the Study of Obesity.

Immunogenicity and safety of tetravalent dengue vaccine in 2-11 year-olds previously vaccinated against yellow fever: randomized, controlled, phase II study in Piura, Peru.

PubMed

Lanata, Claudio F; Andrade, Teresa; Gil, Ana I; Terrones, Cynthia; Valladolid, Omar; Zambrano, Betzana; Saville, Melanie; Crevat, Denis

2012-09-07

In a randomized, placebo-controlled, monocenter, observer blinded study conducted in an area where dengue is endemic, we assessed the safety and immunogenicity of a recombinant, live, attenuated, tetravalent dengue vaccine candidate (CYD-TDV) in 2-11 year-olds with varying levels of pre-existing yellow-fever immunity due to vaccination 1-7 years previously. 199 children received 3 injections of CYD-TDV (months 0, 6 and 12) and 99 received placebo (months 0 and 6) or pneumococcal polysaccharide vaccine (month 12). One month after the third dengue vaccination, serotype specific neutralizing antibody GMTs were in the range of 178-190 (1/dil) (versus 16.7-38.1 in the control group), a 10-20 fold-increase from baseline, and 94% of vaccines were seropositive to all four serotypes (versus 39% in the control group). There were no vaccine-related SAEs. The observed reactogenicity profile was consistent with phase I studies, with severity grade 1-2 injection site pain, headache, malaise and fever most frequently reported and no increase after subsequent vaccinations. Virologically confirmed dengue cases were seen after completion of the 3 doses: 1 in the CYD-TDV group (N=199), and 3 in the control group (N=99). A 3-dose regimen of CYD-TDV had a good safety profile in 2-11 year olds with a history of YF vaccination and elicited robust antibody responses that were balanced against the four serotypes. Copyright © 2012 Elsevier Ltd. All rights reserved.

Childhood obesity prevention and control in city recreation centers and family homes: the MOVE/me Muevo Project

PubMed Central

Elder, John P.; Crespo, Noe C.; Corder, Kirsten; Ayala, Guadalupe X.; Slymen, Donald J.; Lopez, Nanette V.; Moody, Jamie S.; McKenzie, Thomas L.

2013-01-01

Background Interventions to prevent and control childhood obesity have shown mixed results in terms of short- and long-term changes. Objectives “MOVE/me Muevo” was a two-year family- and recreation center-based randomized controlled trial to promote healthy eating and physical activity among 5-8 year old children. It was hypothesized that children in the intervention group would demonstrate lower post-intervention BMI values and improve obesity-related behaviors compared to control group children. Methods Thirty recreation centers in San Diego County, California were randomized to an intervention or control condition. Five hundred and forty-one families were enrolled and children’s body mass index (BMI), diet, physical activity and other health indicators were tracked from baseline to two years post-baseline. Analyses followed an intent-to-treat approach using mixed effects models. Results No significant intervention effects were observed for the primary outcomes of child or parent BMI and child waist circumference. Moderator analyses however showed girls (but not boys) in the intervention condition reduced their BMI. At the two-year follow-up, intervention condition parents reported that their children were consuming fewer high-fat foods and sugary beverages. Conclusions Favorable implementation fidelity and high retention rates support the feasibility of this intervention in a large metropolitan area; however, interventions of greater intensity may be needed to achieve effects on child’s BMI. Also, further research is needed to develop gender-specific intervention strategies so that both genders may benefit from such efforts. PMID:23754782

Dry needling in a manual physiotherapy and therapeutic exercise protocol for patients with chronic mechanical shoulder pain of unspecific origin: a protocol for a randomized control trial.

PubMed

Tejera-Falcón, Emma; Toledo-Martel, Nuria Del Carmen; Sosa-Medina, Francisco Manuel; Santana-González, Fátima; Quintana-de la Fe, Miriam Del Pino; Gallego-Izquierdo, Tomás; Pecos-Martín, Daniel

2017-09-18

Shoulder pain of musculoskeletal origin is the main cause of upper limb pain of non-traumatic origin. Despite being one of the most common reasons for consultation, there is no established protocol for treatment due to the complexity of its etiology. However, it has been shown that the presence of myofascial trigger points on the shoulder muscles is a common condition associated with patients suffering from shoulder pain. This protocol has been created which describes the design of a randomized controlled trial to evaluate the effectiveness of the inclusion of dry needling (DN) within a protocol of manual physiotherapy and therapeutic exercise in the treatment of chronic shoulder pain of unspecific origin. Thirty-six participants aged 18-65 years will be recruited having mechanical chronic shoulder pain on unspecific origin and meeting the inclusion criteria. These will be randomized to one of two interventions, (i) DN, manual physiotherapy and therapeutic exercise or (ii) sham DN, manual physiotherapy and therapeutic exercise. The protocol will cover 6 weeks of treatment, with a 6-month follow-up. Our main outcome measure will be the Visual Analogue Scale for pain. This is the first study to combine the use of DN, manual physiotherapy and an exercise program with a 6-month follow-up, thus becoming a new contribution to the treatment of chronic shoulder pain, while new lines of research may be established to help determine the effects of DN on chronic shoulder pain and the frequency and proper dosage. International Standard Randomized Controlled Trial Number Register: ISRCTN30604244 ( http://www.controlled-trials.com ) 29 June 2016.

The risks and benefits of switching patients with schizophrenia or schizoaffective disorder from two to one antipsychotic medication: a randomized controlled trial.

PubMed

Constantine, Robert J; Andel, Ross; McPherson, Marie; Tandon, Rajiv

2015-08-01

Despite little evidence to support its use and practice guidelines discouraging the practice, antipsychotic polypharmacy is widely prevalent in schizophrenia. This randomized controlled trial studied the effects of switching patients stable on two antipsychotic medications to one antipsychotic medication. 104 adult outpatients with schizophrenia from 7 community mental health centers clinically stable on concurrent treatment with 2 antipsychotics were randomly assigned to stay on polypharmacy or to switch to antipsychotic monotherapy. Participants were followed for 1-year with assessments of symptoms and side effects occurring every 60days (7 total assessments). We examined differences in time trajectories in symptoms (PANSS, CGI) and side effects (EPS, metabolic, other) as a function of group assignment (switch vs. stay) and time, using intention-to-treat analysis. Participants who switched to antipsychotic monotherapy experienced greater increases in symptoms than stay patients. These differences emerged in the second 6months of the trial. All-cause discontinuation rates over the 1-year trial were higher in the switch-to-monotherapy group than in the stay-on-polypharmacy group (42% vs. 13%; p<0.01). There were no differences in change over time in any of the side effect measures, except that stay patients experienced a greater decrease in Simpson Angus total scores than switch patients. Clinicians should be cautious in switching patients with chronic schizophrenia who are stable on 2 antipsychotics to one antipsychotic. Given the challenges in discontinuing antipsychotic polypharmacy, adequate trials of evidence-based treatments such as clozapine and long-acting injectable antipsychotics should be undertaken in inadequately responsive schizophrenia patients before moving to antipsychotic polypharmacy. Copyright © 2015 Elsevier B.V. All rights reserved.

One year treatment effects of the eruption guidance appliance in 7- to 8-year-old children: a randomized clinical trial.

PubMed

Myrlund, Rita; Dubland, Mari; Keski-Nisula, Katri; Kerosuo, Heidi

2015-04-01

The eruption guidance appliance (EGA) aims to correct sagittal and vertical occlusal relations concomitantly with alignment of the incisors. Few reports have been published on treatment effects with the EGA but no randomized studies have been available. The aim was to find out if 1 year active treatment time with EGA was sufficient for achieving normal occlusal relationships and dental alignment in 7- to 8-year-old children. Eligibility criteria for participants were: fully erupted upper central incisors, and Angle's Class I or Class II molar relationship combined with any of the following traits: deep bite, increased overjet ≥5mm, moderate anterior crowding with overjet ≥4mm. After screening of 148 children, 48 7- to 8-year-old children were recruited in the study. The participants were randomly assigned into a treatment group (N = 25) and a control group (N = 23). Children in the treatment group received treatment with the EGA for 1 year. The controls had no orthodontic treatment. Changes in overjet, overbite, Angle's Class, and crowding were used as primary outcome measures. Occlusal assessments were performed on dental casts obtained from all subjects at start of the study (T1) and after 1 year (T2). Lateral cephalograms were obtained from all subjects at T1 and from the treatment group at T2. All measurements on dental casts and cephalograms were carried out blinded. Forty-six children completed the study. Mean overjet and overbite decreased significantly in the treated subjects during 1 year, in contrast to a slight increase in the controls. Class II molar relationship decreased from 46 to 4 per cent in the treatment group, with no significant change in the control group. Mandibular anterior crowding decreased significantly in the treated subjects, while the controls showed a slight increase. In short term, the EGA seems to be effective in correcting increased overjet and overbite, Class II malocclusion, and lower anterior crowding in the early mixed dentition. Follow-up data are needed to assess long-term effects of this treatment. This study was not registered. © The Author 2014. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Motivational characteristics and resistance training in older adults: a randomized controlled trial and 1-year follow-up.

PubMed

Kekäläinen, Tiia; Kokko, Katja; Tammelin, Tuija; Sipilä, Sarianna; Walker, Simon

2018-06-07

The aim of this study was to investigate the effects of a nine-month supervised resistance training intervention on motivational and volitional characteristics related to exercise, and whether the absolute level and/or intervention-induced change in these characteristics predict self-directed continuation of resistance training one year after the intervention. Community-dwelling older adults aged 65-75, who did not fulfill physical activity recommendations, were randomized into resistance training intervention groups: training once- (n=26), twice- (n=27), three-times-a-week (n=28) or non-training control group (n=25). Training groups participated in supervised resistance training for nine months: during months 1-3 all groups trained twice-a-week and then with allocated frequencies during months 4-9. Exercise-related motivation, self-efficacy and planning were measured with questionnaires at baseline, month-3 and month-9. The continuance of resistance training was determined by interviews six and twelve months after the end of the intervention. The intervention improved action and coping planning as well as intrinsic motivation (group×time p<.05). During one-year follow-up, 54% of participants did not continue self-directed regular resistance training, 22% continued regular resistance training once-a-week and 24% twice-a-week. Increases in exercise self-efficacy and intrinsic motivation related to training during the intervention predicted continuation of resistance training twice-a-week. Resistance training improved exercise-related motivational and volitional characteristics in older adults. These improvements were linked to continuing resistance training one year after the supervised intervention. The role of these characteristics should be taken into account when promoting long-term resistance training participation among older adults. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Impact of a Behavioral Weight Loss Intervention on Comorbidities in Overweight and Obese Breast Cancer Survivors

PubMed Central

Sedjo, Rebecca L.; Flatt, Shirley W.; Byers, Tim; Colditz, Graham A.; Demark-Wahnefried, Wendy; Ganz, Patricia A.; Wolin, Kathleen Y.; Elias, Anthony; Krontiras, Helen; Liu, Jingxia; Naughton, Michael; Pakiz, Bilgé; Parker, Barbara A.; Wyatt, Holly; Rock, Cheryl L.

2017-01-01

Purpose Comorbid medical conditions are common among breast cancer survivors, contribute to poorer long-term survival and increased overall mortality, and may be ameliorated by weight loss. This secondary analysis evaluated the impact of a weight loss intervention on comorbid medical conditions immediately following an intervention (12-months) and one-year post-intervention (24-month) using data from the Exercise and Nutrition to Enhance Recovery and Good health for You (ENERGY) trial – a phase III trial which was aimed at and successfully promoted weight loss. Methods ENERGY randomized 692 overweight/obese women who had completed treatment for early stage breast cancer to either a one-year group-based behavioral intervention designed to achieve and maintain weight loss or to a less intensive control intervention. Minimal support was provided post-intervention. New medical conditions, medical conditions in which non-cancer medications were prescribed, hospitalizations, and emergency room visits were compared at baseline, year 1 and 2. Changes over time were analyzed using chi-squared tests, Kaplan-Meier and logistic regression analyses. Results At 12 months, women randomized to the intervention had fewer new medical conditions compared to the control group (19.6% vs. 32.2%, p<0.001); however, by 24 months, there was no longer a significant difference. No difference was observed in each of four conditions for which non-cancer medications were prescribed, hospital visits, or emergency visits at either 12 or 24 months. Conclusions These results support a short-term benefit of modest weight loss on the likelihood of comorbid conditions; however, recidivism and weight regain likely explain no benefit at one-year post-intervention follow-up. PMID:26945570

How Important Is ‘Accuracy’ of Surrogate Decision-Making for Research Participation?

PubMed Central

Kim, Scott Y. H.; Kim, H. Myra; Ryan, Kerry A.; Appelbaum, Paul S.; Knopman, David S.; Damschroder, Laura; De Vries, Raymond

2013-01-01

Background There is a longstanding concern about the accuracy of surrogate consent in representing the health care and research preferences of those who lose their ability to decide for themselves. We sought informed, deliberative views of the older general public (≥50 years old) regarding their willingness to participate in dementia research and to grant leeway to future surrogates to choose an option contrary to their stated wishes. Methodology/Principal Findings 503 persons aged 50+ recruited by random digit dialing were randomly assigned to one of three groups: deliberation, education, or control. The deliberation group attended an all-day education/peer deliberation session; the education group received written information only. Participants were surveyed at baseline, after the deliberation session (or equivalent time), and one month after the session, regarding their willingness to participate in dementia research and to give leeway to surrogates, regarding studies of varying risk-benefit profiles (a lumbar puncture study, a drug randomized controlled trial, a vaccine randomized controlled trial, and an early phase gene transfer trial). At baseline, 48% (gene transfer scenario) to 92% (drug RCT) were willing to participate in future dementia research. A majority of respondents (57–71% depending on scenario) were willing to give leeway to future surrogate decision-makers. Democratic deliberation increased willingness to participate in all scenarios, to grant leeway in 3 of 4 scenarios (lumbar puncture, vaccine, and gene transfer), and to enroll loved ones in research in all scenarios. On average, respondents were more willing to volunteer themselves for research than to enroll their loved ones. Conclusions/Significance Most people were willing to grant leeway to their surrogates, and this willingness was either sustained or increased after democratic deliberation, suggesting that the attitude toward leeway is a reliable opinion. Eliciting a person’s current preferences about future research participation should also involve eliciting his or her leeway preferences. PMID:23382969

Percutaneous coronary intervention vs coronary artery bypass grafting for left main coronary artery disease? A systematic review and meta-analysis of randomized controlled trials.

PubMed

Sharma, Sharan P; Dahal, Khagendra; Khatra, Jaspreet; Rosenfeld, Alan; Lee, Juyong

2017-06-01

It is not clear whether percutaneous coronary intervention (PCI) is as effective and safe as coronary artery bypass grafting (CABG) for left main coronary artery disease. We aimed to perform a systematic review and meta-analysis of all randomized controlled trials (RCTs) that compared PCI and CABG in left main coronary disease. We searched PubMed, EMBASE, Cochrane, Scopus and relevant references for RCTs (inception through, November 20, 2016 without language restrictions) and performed meta-analysis using random-effects model. All-cause mortality, myocardial infarction, revascularization rate, stroke, and major adverse cardiac and cerebrovascular events (MACCE) were the measured outcomes. Six RCTs with a total population of 4700 were analyzed. There was no difference in all-cause mortality at 30-day, one-year, and five-year (1.8% vs 1.1%; OR 0.60; 95% CI: 0.26-1.39; P=.23; I 2 =9%) follow-up between PCI and CABG. CABG group had less myocardial infarction (MI) at five-year follow-up than PCI (5% vs 2.5%; OR 2.04; CI: 1.30-3.19; P=.002; I 2 =1%). Revascularization rate favored CABG in one-year (8.6% vs 4.5%; OR 2; CI: 1.46-2.73; P<.0001; I 2 =45%) and five-year (15.9% vs 9.9%; OR 1.73; CI: 1.36-2.20; P<.0001; I 2 =0%) follow-up. Although stroke rate was lower in PCI group at 1 year, there was no difference in longer follow-up. MACCE at 5 years favored CABG (24% vs 18%; OR 1.45; CI: 1.19-1.76; P=.0001; I 2 =0%). On subgroup analysis, MACCE were not different between two groups in low-to-intermediate SYNTAX group while it was higher for PCI group with high SYNTAX group. Percutaneous coronary intervention could be as safe and effective as CABG in a select group of left main coronary artery disease patients. © 2017 John Wiley & Sons Ltd.

A Randomized, Comparative Pilot Trial of Family-Based Interpersonal Psychotherapy for Reducing Psychosocial Symptoms, Disordered-eating, and Excess Weight Gain in At-Risk Preadolescents with Loss-of-control-eating

PubMed Central

Shomaker, Lauren B.; Tanofsky-Kraff, Marian; Matherne, Camden E.; Mehari, Rim D.; Olsen, Cara H.; Marwitz, Shannon E.; Bakalar, Jennifer L.; Ranzenhofer, Lisa M.; Kelly, Nichole R.; Schvey, Natasha A.; Burke, Natasha L.; Cassidy, Omni; Brady, Sheila M.; Dietz, Laura J.; Wilfley, Denise E.; Yanovski, Susan Z.; Yanovski, Jack A.

2018-01-01

Objective Preadolescent loss-of-control-eating (LOC-eating) is a risk factor for excess weight gain and binge-eating-disorder. We evaluated feasibility and acceptability of a preventive family-based interpersonal psychotherapy (FB-IPT) program. FB-IPT was compared to family-based health education (FB-HE) to evaluate changes in children’s psychosocial functioning, LOC-eating, and body mass. Method A randomized, controlled pilot trial was conducted with 29 children, 8 to 13 years who had overweight/obesity and LOC-eating. Youth-parent dyads were randomized to 12-week FB-IPT (n=15) or FB-HE (n=14) and evaluated at post-treatment, six-months, and one-year. Changes in child psychosocial functioning, LOC-eating, BMI, and adiposity by dual-energy-X-ray-absorptiometry were assessed. Missing follow-up data were multiply imputed. Results FB-IPT feasibility and acceptability were indicated by good attendance (83%) and perceived benefits to social interactions and eating. Follow-up assessments were completed by 73% FB-IPT and 86% FB-HE at post-treatment, 60% and 64% at six-months, and 47% and 57% at one-year. At post-treatment, children in FB-IPT reported greater decreases in depression (95% CI −7.23, −2.01, Cohen’s d=1.23) and anxiety (95% CI −6.08, −0.70, Cohen’s d=.79) and less odds of LOC-eating (95% CI −3.93, −0.03, Cohen’s d=.38) than FB-HE. At six-months, children in FB-IPT had greater reductions in disordered-eating attitudes (95% CI −0.72, −0.05, Cohen’s d=.66) and at one-year, tended to have greater decreases in depressive symptoms (95% CI −8.82, 0.44, Cohen’s d=.69) than FB-HE. There was no difference in BMI gain between the groups. Discussion Family-based approaches that address interpersonal and emotional underpinnings of LOC-eating in preadolescents with overweight/obesity show preliminary promise, particularly for reducing internalizing symptoms. Whether observed psychological benefits translate into sustained prevention of disordered-eating or excess weight gain requires further study. PMID:28714097

Daily corticosteroids reduce infection-associated relapses in frequently relapsing nephrotic syndrome: a randomized controlled trial.

PubMed

Gulati, Ashima; Sinha, Aditi; Sreenivas, Vishnubhatla; Math, Aparna; Hari, Pankaj; Bagga, Arvind

2011-01-01

Relapses of nephrotic syndrome often follow minor infections, commonly of the upper respiratory tract. Daily administration of maintenance prednisolone during intercurrent infections was examined to determine whether the treatment reduces relapse rates in children with frequently relapsing nephrotic syndrome. In a randomized controlled trial (nonblind, parallel group, tertiary-care hospital), 100 patients with idiopathic, frequently relapsing nephrotic syndrome eligible for therapy with prolonged low-dose, alternate-day prednisolone with or without levamisole were randomized to either receive their usual dose of alternate-day prednisolone daily for 7 days during intercurrent infections (intervention group) or continue alternate-day prednisolone (controls). Primary outcome was assessed by comparing the rates of infection-associated relapses at 12-month follow-up. Secondary outcomes were the frequency of infections and the cumulative amount of prednisolone received in both groups. Patients in the intervention group showed significantly lower infection-associated (rate difference, 0.7 episodes/patient per year; 95% confidence intervals [CI] 0.3, 1.1) and lower total relapse rates (0.9 episodes/patient per year, 95% CI 0.4, 1.4) without increase in steroid toxicity. Poisson regression, adjusted for occurrence of infections, showed that daily administration of prednisolone during infections independently resulted in 59% reduction in frequency of relapses (rate ratio, 0.41; 95% CI 0.3, 0.6). For every six patients receiving this intervention, one showed a reduction of relapse frequency to less than three per year. Daily administration of maintenance doses of prednisolone, during intercurrent infections, significantly reduces relapse rates and the proportion of children with frequently relapsing nephrotic syndrome.

Effect of transcranial direct-current stimulation combined with treadmill training on balance and functional performance in children with cerebral palsy: a double-blind randomized controlled trial.

PubMed

Duarte, Natália de Almeida Carvalho; Grecco, Luanda André Collange; Galli, Manuela; Fregni, Felipe; Oliveira, Cláudia Santos

2014-01-01

Cerebral palsy refers to permanent, mutable motor development disorders stemming from a primary brain lesion, causing secondary musculoskeletal problems and limitations in activities of daily living. The aim of the present study was to determine the effects of gait training combined with transcranial direct-current stimulation over the primary motor cortex on balance and functional performance in children with cerebral palsy. A double-blind randomized controlled study was carried out with 24 children aged five to 12 years with cerebral palsy randomly allocated to two intervention groups (blocks of six and stratified based on GMFCS level (levels I-II or level III).The experimental group (12 children) was submitted to treadmill training and anodal stimulation of the primary motor cortex. The control group (12 children) was submitted to treadmill training and placebo transcranial direct-current stimulation. Training was performed in five weekly sessions for 2 weeks. Evaluations consisted of stabilometric analysis as well as the administration of the Pediatric Balance Scale and Pediatric Evaluation of Disability Inventory one week before the intervention, one week after the completion of the intervention and one month after the completion of the intervention. All patients and two examiners were blinded to the allocation of the children to the different groups. The experimental group exhibited better results in comparison to the control group with regard to anteroposterior sway (eyes open and closed; p<0.05), mediolateral sway (eyes closed; p<0.05) and the Pediatric Balance Scale both one week and one month after the completion of the protocol. Gait training on a treadmill combined with anodal stimulation of the primary motor cortex led to improvements in static balance and functional performance in children with cerebral palsy. Ensaiosclinicos.gov.br/RBR-9B5DH7.

[Effects of daily physical exercise at school on cardiovascular risk--results of a 2-year cluster-randomized study].

PubMed

Walther, C; Mende, M; Gaede, L; Müller, U; Machalica, K; Schuler, G

2011-11-01

It was the aim of this study to measure the effects over two years of daily sport activity during the school-day on their physical fitness (primary endpoint), motor coordination and blood pressure (secondary endpoints). A total of 232 children from eleven different 6 (th) grade classes were enrolled after informed parental consent. Their mean age was 11.1  ±  0.6 years. Six classes were randomly assigned for intervention (n=141), five as control (n=91). Those of the intervention cohort undertook, for five days weekly during the school year one hour of regulated sport exercise, including 15 min of endurance training. The pupils of the control group undertook customary sport activity (two hours a week). Anthropometric data were recorded and maximal oxygen uptake measured in each pupil, as well as blood pressure and motor coordination at the beginning and at the end of each of the two years of the study. The data were analyzed using the cluster randomization method. Maximal oxygen uptake (VO (2)max) had improved among the intervention group after two years, compared with the controls (3.12 m/kg/min, 95% confindence interval [CI] 0.06-6.19), while improvement in motor coordination just failed to reach statistical significance (3.06, 95% CI -0.17-6.29). There was no significant difference in systolic and diastolic blood pressure, but a downward trend in the prevalence of overweight and obesity from 12.1% to 7.8% in the intervention group. The results indicate that daily physical exercise during school hours should be given greater importance. But it will require a long-term trial to determine whether promotion of increased physical activity at school influences the prevalence of cardiovascular risk factors when the pupils reach adulthood. © Georg Thieme Verlag KG Stuttgart · New York.

Coping with stress in medical students: results of a randomized controlled trial using a mindfulness-based stress prevention training (MediMind) in Germany.

PubMed

Kuhlmann, S M; Huss, M; Bürger, A; Hammerle, F

2016-12-28

High prevalence rates of psychological distress in medical training and later professional life indicate a need for prevention. Different types of intervention were shown to have good effects, but little is known about the relative efficacy of different types of stress management interventions, and methodological limitations have been reported. In order to overcome some of these limitations, the present study aimed at evaluating the effect of a specifically developed mindfulness-based stress prevention training for medical students (MediMind) on measures of distress, coping and psychological morbidity. We report on a prospective randomized controlled trial with three study conditions: experimental treatment (MediMind), standard treatment (Autogenic Training) and a control group without treatment. The sample consisted of medical or dental students in the second or eighth semester. They completed self-report questionnaires at baseline, after the training and at one year follow-up. Distress (Trier Inventory for the Assessment of Chronic Stress, TICS) was assessed as the primary outcome and coping (Brief COPE) as a co-primary outcome. Effects on the psychological morbidity (Brief Symptom Inventory, BSI) as a secondary outcome were expected one year after the trainings. Initially, N = 183 students were randomly allocated to the study groups. At one year follow-up N = 80 could be included into the per-protocol analysis: MediMind (n =31), Autogenic Training (n = 32) and control group (n = 17). A selective drop-out for students who suffered more often from psychological symptoms was detected (p = .020). MANCOVA's on TICS and Brief COPE revealed no significant interaction effects. On the BSI, a significant overall interaction effect became apparent (p = .002, η2partial = .382), but post hoc analyses were not significant. Means of the Global Severity Index (BSI) indicated that MediMind may contribute to a decrease in psychological morbidity. Due to the high and selective dropout rates, the results cannot be generalized and further research is necessary. Since the participation rate of the trainings was high, a need for further prevention programs is indicated. The study gives important suggestions on further implementation and evaluation of stress prevention in medical schools. This trial is recorded at German Clinical Trials Register under the number DRKS00005354 (08.11.2013).

Randomized Trial of ConquerFear: A Novel, Theoretically Based Psychosocial Intervention for Fear of Cancer Recurrence.

PubMed

Butow, Phyllis N; Turner, Jane; Gilchrist, Jemma; Sharpe, Louise; Smith, Allan Ben; Fardell, Joanna E; Tesson, Stephanie; O'Connell, Rachel; Girgis, Afaf; Gebski, Val J; Asher, Rebecca; Mihalopoulos, Cathrine; Bell, Melanie L; Zola, Karina Grunewald; Beith, Jane; Thewes, Belinda

2017-12-20

Purpose Fear of cancer recurrence (FCR) is prevalent, distressing, and long lasting. This study evaluated the impact of a theoretically/empirically based intervention (ConquerFear) on FCR. Methods Eligible survivors had curable breast or colorectal cancer or melanoma, had completed treatment (not including endocrine therapy) 2 months to 5 years previously, were age > 18 years, and had scores above the clinical cutoff on the FCR Inventory (FCRI) severity subscale at screening. Participants were randomly assigned at a one-to-one ratio to either five face-to-face sessions of ConquerFear (attention training, metacognitions, acceptance/mindfulness, screening behavior, and values-based goal setting) or an attention control (Taking-it-Easy relaxation therapy). Participants completed questionnaires at baseline (T0), immediately post-therapy (T1), and 3 (T2) and 6 months (T3) later. The primary outcome was FCRI total score. Results Of 704 potentially eligible survivors from 17 sites and two online databases, 533 were contactable, of whom 222 (42%) consented; 121 were randomly assigned to intervention and 101 to control. Study arms were equivalent at baseline on all measured characteristics. ConquerFear participants had clinically and statistically greater improvements than control participants from T0 to T1 on FCRI total ( P < .001) and severity subscale scores ( P = .001), which were maintained at T2 ( P = .017 and P = .023, respectively) and, for FCRI total only, at T3 ( P = .018), and from T0 to T1 on three FCRI subscales (coping, psychological distress, and triggers) as well as in general anxiety, cancer-specific distress (total), and mental quality of life and metacognitions (total). Differences in FCRI psychological distress and cancer-specific distress (total) remained significantly different at T3. Conclusion This randomized trial demonstrated efficacy of ConquerFear compared with attention control (Taking-it-Easy) in reduction of FCRI total scores immediately post-therapy and 3 and 6 months later and in many secondary outcomes immediately post-therapy. Cancer-specific distress (total) remained more improved at 3- and 6-month follow-up.

A Randomized, Controlled Trial of Immersive Virtual Reality Analgesia during Physical Therapy for Pediatric Burn Injuries

PubMed Central

Schmitt, Yuko S.; Hoffman, Hunter G.; Blough, David K.; Patterson, David R.; Jensen, Mark P.; Soltani, Maryam; Carrougher, Gretchen J.; Nakamura, Dana; Sharar, Sam R.

2010-01-01

This randomized, controlled, within-subjects (crossover design) study examined the effects of immersive virtual reality as an adjunctive analgesic technique for hospitalized pediatric burn inpatients undergoing painful physical therapy. Fifty-four subjects (6–19 years old) performed range-of-motion exercises under a therapist’s direction for one to five days. During each session, subjects spent equivalent time in both the virtual reality and the control conditions (treatment order randomized and counterbalanced). Graphic rating scale scores assessing the sensory, affective, and cognitive components of pain were obtained for each treatment condition. Secondary outcomes assessed subjects’ perception of the virtual reality experience and maximum range-of-motion. Results showed that on study day one, subjects reported significant decreases (27–44%) in pain ratings during virtual reality. They also reported improved affect (“fun”) during virtual reality. The analgesia and affect improvements were maintained with repeated virtual reality use over multiple therapy sessions. Maximum range-of-motion was not different between treatment conditions, but was significantly greater after the second treatment condition (regardless of treatment order). These results suggest that immersive virtual reality is an effective nonpharmacologic, adjunctive pain reduction technique in the pediatric burn population undergoing painful rehabilitation therapy. The magnitude of the analgesic effect is clinically meaningful and is maintained with repeated use. PMID:20692769

Genetic differential susceptibility in literacy-delayed children: a randomized controlled trial on emergent literacy in kindergarten.

PubMed

Plak, Rachel D; Kegel, Cornelia A T; Bus, Adriana G

2015-02-01

In this randomized controlled trial, 508 5-year-old kindergarten children participated, of whom 257 were delayed in literacy skills because they belonged to the lowest quartile of a national standard literacy test. We tested the hypothesis that some children are more susceptible to school-entry educational interventions than their peers due to their genetic makeup, and thus whether the dopamine receptor D4 gene moderated intervention effects. Children were randomly assigned to a control condition or one of two interventions involving computer programs tailored to the literacy needs of delayed pupils: Living Letters for alphabetic knowledge and Living Books for text comprehension. Effects of Living Books met the criteria of differential susceptibility. For carriers of the dopamine receptor D4 gene seven-repeat allele (about one-third of the delayed group), the Living Books program was an important addition to the common core curriculum in kindergarten (effect size d = 0.56), whereas the program did not affect the other children (d = -0.09). The same seven-repeat carriers benefited more from Living Letters than did the noncarriers, as reflected in effect sizes of 0.63 and 0.34, respectively, although such differences did not fulfill the statistical criteria for differential susceptibility. The implications of differential susceptibility for education and regarding the crucial question "what works for whom?" are discussed.

A randomized controlled trial of eicosapentaenoic acid and/or aspirin for colorectal adenoma prevention during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme (The seAFOod Polyp Prevention Trial): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background The naturally-occurring omega (ω)-3 polyunsaturated fatty acid (PUFA) eicosapentaenoic acid (EPA) reduces colorectal adenoma (polyp) number and size in patients with familial adenomatous polyposis. The safety profile and potential cardiovascular benefits associated with ω-3 PUFAs make EPA a strong candidate for colorectal cancer (CRC) chemoprevention, alone or in combination with aspirin, which itself has recognized anti-CRC activity. Colorectal adenoma number and size are recognized as biomarkers of future CRC risk and are established as surrogate end-points in CRC chemoprevention trials. Design The seAFOod Polyp Prevention Trial is a randomized, double-blind, placebo-controlled, 2 × 2 factorial ‘efficacy’ study, which will determine whether EPA prevents colorectal adenomas, either alone or in combination with aspirin. Participants are 55–73 year-old patients, who have been identified as ‘high risk’ (detection of ≥5 small adenomas or ≥3 adenomas with at least one being ≥10 mm in diameter) at screening colonoscopy in the English Bowel Cancer Screening Programme (BCSP). Exclusion criteria include the need for more than one repeat endoscopy within the three-month BCSP screening period, malignant change in an adenoma, regular use of aspirin or non-aspirin non-steroidal anti-inflammatory drugs, regular use of fish oil supplements and concomitant warfarin or anti-platelet agent therapy. Patients are randomized to either EPA-free fatty acid 1 g twice daily or identical placebo AND aspirin 300 mg once daily or identical placebo, for approximately 12 months. The primary end-point is the number of participants with one or more adenomas detected at routine one-year BCSP surveillance colonoscopy. Secondary end-points include the number of adenomas (total and ‘advanced’) per patient, the location (left versus right colon) of colorectal adenomas and the number of participants re-classified as ‘intermediate risk’ for future surveillance. Exploratory end-points include levels of bioactive lipid mediators such as ω-3 PUFAs, resolvin E1 and PGE-M in plasma, urine, erythrocytes and rectal mucosa in order to gain insights into the mechanism(s) of action of EPA and aspirin, alone and in combination, as well as to discover predictive biomarkers of chemopreventive efficacy. The recruitment target is 904 patients. Trial Registration Current Controlled Trials ISRCTN05926847 PMID:23895505

A cluster randomized control field trial of the ABRACADABRA web-based reading technology: replication and extension of basic findings

PubMed Central

Piquette, Noella A.; Savage, Robert S.; Abrami, Philip C.

2014-01-01

The present paper reports a cluster randomized control trial evaluation of teaching using ABRACADABRA (ABRA), an evidence-based and web-based literacy intervention (http://abralite.concordia.ca) with 107 kindergarten and 96 grade 1 children in 24 classes (12 intervention 12 control classes) from all 12 elementary schools in one school district in Canada. Children in the intervention condition received 10–12 h of whole class instruction using ABRA between pre- and post-test. Hierarchical linear modeling of post-test results showed significant gains in letter-sound knowledge for intervention classrooms over control classrooms. In addition, medium effect sizes were evident for three of five outcome measures favoring the intervention: letter-sound knowledge (d= +0.66), phonological blending (d = +0.52), and word reading (d = +0.52), over effect sizes for regular teaching. It is concluded that regular teaching with ABRA technology adds significantly to literacy in the early elementary years. PMID:25538663

Reducing diarrhea through the use of household-based ceramic water filters: a randomized, controlled trial in rural Bolivia.

PubMed

Clasen, Thomas F; Brown, Joseph; Collin, Simon; Suntura, Oscar; Cairncross, Sandy

2004-06-01

Ceramic water filters have been identified as one of the most promising and accessible technologies for treating water at the household level. In a six-month trial, water filters were distributed randomly to half of the 50 participating households in a rural community in Bolivia; the remaining households continued to use customary water handling practices and served as controls. In four rounds of sampling following distribution of the filters, 100% of the 96 water samples from the filter households were free of thermotolerant coliforms compared with 15.5% of the control household samples. Diarrheal disease risk for individuals in intervention households was 70% lower than for controls (95% confidence interval [CI] = 53-80%; P < 0.001). For children less than five years old, the reduction in risk was 83% (95% CI = 51-94%; P < 0.001). These results show that affordable ceramic water filters enable low-income households to treat and maintain the microbiologic quality of their drinking water.

A Phase II, Randomized, Safety and Immunogenicity Trial of a Re-Derived, Live-Attenuated Dengue Virus Vaccine in Healthy Children and Adults Living in Puerto Rico.

PubMed

Bauer, Kristen; Esquilin, Ines O; Cornier, Alberto Santiago; Thomas, Stephen J; Quintero Del Rio, Ana I; Bertran-Pasarell, Jorge; Morales Ramirez, Javier O; Diaz, Clemente; Carlo, Simon; Eckels, Kenneth H; Tournay, Elodie; Toussaint, Jean-Francois; De La Barrera, Rafael; Fernandez, Stefan; Lyons, Arthur; Sun, Wellington; Innis, Bruce L

2015-09-01

This was a double-blind, randomized, controlled, phase II clinical trial, two dose study of re-derived, live-attenuated, tetravalent dengue virus (TDEN) vaccine (two formulations) or placebo in subjects 1-50 years of age. Among the 636 subjects enrolled, 331 (52%) were primed, that is, baseline seropositive to at least one dengue virus (DENV) type. Baseline seropositivity prevalence increased with age (10% [< 2 years], 26% [2-4 years], 60% [5-20 years], and 93% [21-50 years]). Safety profiles of TDEN vaccines were similar to placebo regardless of priming status. No vaccine-related serious adverse events (SAEs) were reported. Among unprimed subjects, immunogenicity (geometric mean antibody titers [GMT] and seropositivity rates) for each DENV increased substantially in both TDEN vaccine groups with at least 74.6% seropositive for four DENV types. The TDEN vaccine candidate showed an acceptable safety and immunogenicity profile in children and adults ranging from 1 to 50 years of age, regardless of priming status. ClinicalTrials.gov: NCT00468858. © The American Society of Tropical Medicine and Hygiene.

Role of exercise training in polycystic ovary syndrome: a systematic review and meta-analysis.

PubMed

Benham, J L; Yamamoto, J M; Friedenreich, C M; Rabi, D M; Sigal, R J

2018-06-12

Preliminary evidence suggests exercise in polycystic ovary syndrome (PCOS) may improve reproductive and cardiometabolic parameters. Our primary aim was to determine the impact of exercise training on reproductive health in women with PCOS. Our secondary aim was to determine the effect of exercise training on cardiometabolic indices. A systematic review of published literature was conducted using MEDLINE and EMBASE based on a pre-published protocol (PROSPERO CRD42017065324). The search was not limited by year. Randomized controlled trials, non-randomized controlled trials and uncontrolled trials that evaluated an exercise intervention in women with PCOS and reported reproductive outcomes were included. Reproductive outcomes were analysed semi-quantitatively and a meta-analysis was conducted for reported cardiometabolic outcomes. Of 517 screened abstracts, 14 studies involving 617 women with PCOS were included: seven randomized controlled trials, one non-randomized controlled trial and six uncontrolled trials. There were insufficient published data to describe the effect of exercise interventions on ovulation quantitatively, but semi-quantitative analysis suggested that exercise interventions may improve menstrual regularity, pregnancy and ovulation rates. Our meta-analysis found that exercise improved lipid profiles and decreased waist circumference, systolic blood pressure and fasting insulin. The impact of exercise interventions on reproductive function remains unclear. However, our meta-analysis suggests that exercise interventions may improve cardiometabolic profiles in women with PCOS. © 2018 World Obesity Federation.

Effect of decision aid for breast cancer prevention on decisional conflict in women with a BRCA1 or BRCA2 mutation: a multisite, randomized, controlled trial.

PubMed

Metcalfe, Kelly A; Dennis, Cindy-Lee; Poll, Aletta; Armel, Susan; Demsky, Rochelle; Carlsson, Lindsay; Nanda, Sonia; Kiss, Alexander; Narod, Steven A

2017-03-01

Women with a BRCA1 or BRCA2 mutation are at high risk for breast cancer and must make important decisions about breast cancer prevention and screening. In the current study, we report a multisite, randomized, controlled trial evaluating the effectiveness of a decision aid for breast cancer prevention in women with a BRCA mutation with no previous diagnosis of cancer. Within 1 month of receiving a positive BRCA result, women were randomized to receive either usual care (control group) or decision aid (intervention group). Participants were followed at 3, 6, and 12 months; were asked about preventive measures; and completed standardized questionnaires assessing decision making and psychosocial functioning. One hundred fifty women were randomized. Mean cancer-related distress scores were significantly lower in the intervention group compared with the control group at 6 months (P = 0.01) and at 12 months postrandomization (P = 0.05). Decisional conflict scores declined over time for both groups and at no time were there statistical differences between the two groups. The decision aid for breast cancer prevention in women with a BRCA1 or BRCA2 mutation is effective in significantly decreasing cancer-related distress within the year following receipt of positive genetic test results.Genet Med 19 3, 330-336.

A Pilot Randomized Controlled Trial of an Intervention to Promote Psychological Well-Being in Critically Ill Children: Soothing Through Touch, Reading, and Music.

PubMed

Rennick, Janet E; Stremler, Robyn; Horwood, Linda; Aita, Marilyn; Lavoie, Tanya; Majnemer, Annette; Antonacci, Marie; Knox, Alyssa; Constantin, Evelyn

2018-04-13

To examine the feasibility and acceptability of a PICU Soothing intervention using touch, reading, and music. Nonblinded, pilot randomized controlled trial. The PICU and medical-surgical wards of one Canadian pediatric hospital. Twenty PICU patients age 2-14 years old and their parents, randomized to an intervention group (n = 10) or control group (n = 10). PICU Soothing consisted of: 1) parental comforting (touch and reading), followed by 2) a quiet period with music via soft headbands, administered once daily throughout hospitalization. Acceptability and feasibility of the intervention and methods were assessed via participation rates, observation, measurement completion rates, semistructured interviews, and telephone calls. Psychological well-being was assessed using measures of distress, sleep, and child and parent anxiety in the PICU, on the wards and 3 months post discharge. Forty-four percent of parents agreed to participate. Seventy percent and 100% of intervention group parents responded positively to comforting and music, respectively. Most intervention group parents (70%) and all nurses felt children responded positively. All nurses found the intervention acceptable and feasible. Measurement completion rates ranged from 70% to 100%. Pilot data suggested lower intervention group child and parent anxiety after transfer to hospital wards. PICU Soothing is acceptable and feasible to conduct. Results support the implementation of a full-scale randomized controlled trial to evaluate intervention effectiveness.

A randomized controlled trial of cognitive-behavioral therapy versus treatment as usual for adolescents with autism spectrum disorders and comorbid anxiety.

PubMed

Storch, Eric A; Lewin, Adam B; Collier, Amanda B; Arnold, Elysse; De Nadai, Alessandro S; Dane, Brittney F; Nadeau, Joshua M; Mutch, P Jane; Murphy, Tanya K

2015-03-01

Examine the efficacy of a personalized, modular cognitive-behavioral therapy (CBT) protocol among early adolescents with high-functioning autism spectrum disorders (ASDs) and co-occurring anxiety relative to treatment as usual (TAU). Thirty-one children (11-16 years) with ASD and clinically significant anxiety were randomly assigned to receive 16 weekly CBT sessions or an equivalent duration of TAU. Participants were assessed by blinded raters at screening, posttreatment, and 1-month follow-up. Youth randomized to CBT demonstrated superior improvement across primary outcomes relative to those receiving TAU. Eleven of 16 adolescents randomized to CBT were treatment responders, versus 4 of 15 in the TAU condition. Gains were maintained at 1-month follow-up for CBT responders. These data extend findings of the promising effects of CBT in anxious youth with ASD to early adolescents. © 2014 Wiley Periodicals, Inc.

The C-seal trial: colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler, a multi-center randomized controlled trial

PubMed Central

2012-01-01

Background Anastomotic leakage is a major complication in colorectal surgery and with an incidence of 11% the most common cause of morbidity and mortality. In order to reduce the incidence of anastomotic leakage the C-seal is developed. This intraluminal biodegradable drain is stapled to the anastomosis with a circular stapler and prevents extravasation of intracolonic content in case of an anastomotic dehiscence. The aim of this study is to evaluate the efficacy of the C-seal in reducing anastomotic leakage in stapled colorectal anastomoses, as assessed by anastomotic leakage leading to invasive treatment within 30 days postoperative. Methods The C-seal trial is a prospective multi-center randomized controlled trial with primary endpoint, anastomotic leakage leading to re-intervention within 30 days after operation. In this trial 616 patients will be randomized to the C-seal or control group (1:1), stratified by center, anastomotic height (proximal or distal of peritoneal reflection) and the intention to create a temporary deviating ostomy. Interim analyses are planned after 50% and 75% of patient inclusion. Eligible patients are at least 18 years of age, have any colorectal disease requiring a colorectal anastomosis to be made with a circular stapler in an elective setting, with an ASA-classification < 4. Oral mechanical bowel preparation is mandatory and patients with signs of peritonitis are excluded. The C-seal student team will perform the randomization procedure, supports the operating surgeon during the C-seal application and achieves the monitoring of the trial. Patients are followed for one year after randomization en will be analyzed on an intention to treat basis. Discussion This Randomized Clinical trial is designed to evaluate the effectiveness of the C-seal in preventing clinical anastomotic leakage. Trial registration NTR3080 PMID:23153188

Design, conduct, and analyses of Breast International Group (BIG) 1-98: a randomized, double-blind, phase-III study comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive, early breast cancer.

PubMed

Giobbie-Hurder, Anita; Price, Karen N; Gelber, Richard D

2009-06-01

Aromatase inhibitors provide superior disease control when compared with tamoxifen as adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer. To present the design, history, and analytic challenges of the Breast International Group (BIG) 1-98 trial: an international, multicenter, randomized, double-blind, phase-III study comparing the aromatase inhibitor letrozole with tamoxifen in this clinical setting. From 1998-2003, BIG 1-98 enrolled 8028 women to receive monotherapy with either tamoxifen or letrozole for 5 years, or sequential therapy of 2 years of one agent followed by 3 years of the other. Randomization to one of four treatment groups permitted two complementary analyses to be conducted several years apart. The first, reported in 2005, provided a head-to-head comparison of letrozole versus tamoxifen. Statistical power was increased by an enriched design, which included patients who were assigned sequential treatments until the time of the treatment switch. The second, reported in late 2008, used a conditional landmark approach to test the hypothesis that switching endocrine agents at approximately 2 years from randomization for patients who are disease-free is superior to continuing with the original agent. The 2005 analysis showed the superiority of letrozole compared with tamoxifen. The patients who were assigned tamoxifen alone were unblinded and offered the opportunity to switch to letrozole. Results from other trials increased the clinical relevance about whether or not to start treatment with letrozole or tamoxifen, and analysis plans were expanded to evaluate sequential versus single-agent strategies from randomization. Due to the unblinding of patients assigned tamoxifen alone, analysis of updated data will require ascertainment of the influence of selective crossover from tamoxifen to letrozole. BIG 1-98 is an example of an enriched design, involving complementary analyses addressing different questions several years apart, and subject to evolving analytic plans influenced by new data that emerge over time.

A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation

ERIC Educational Resources Information Center

Acosta, Joie D.; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S.

2016-01-01

Restorative practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this article describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI)…

Effects of Cognitive Enhancement Therapy on Employment Outcomes in Early Schizophrenia: Results from a 2-Year Randomized Trial

ERIC Educational Resources Information Center

Eack, Shaun M.; Hogarty, Gerard E.; Greenwald, Deborah P.; Hogarty, Susan S.; Keshavan, Matcheri S.

2011-01-01

Objective: To examine the effects of psychosocial cognitive rehabilitation on employment outcomes in a randomized controlled trial for individuals with early course schizophrenia. Method: Early course schizophrenia outpatients (N = 58) were randomly assigned to cognitive enhancement therapy (CET) or an enriched supportive therapy (EST) control and…

Interventions to reduce sexual risk behaviors among youth in alternative schools: a randomized controlled trial.

PubMed

Coyle, Karin K; Glassman, Jill R; Franks, Heather M; Campe, Shannon M; Denner, Jill; Lepore, Gina M

2013-07-01

This paper presents results from a randomized controlled trial that assessed the short- and longer-term impact of a skills-based HIV/STI/pregnancy prevention curriculum, service learning, and the combination. The study featured a four-arm experimental design involving 47 classrooms (765 youth) from continuation high schools. Classrooms were randomly assigned to one of four conditions: (1) HIV/STI/pregnancy prevention curriculum only; (2) service learning only; (3) HIV/STI/pregnancy prevention curriculum plus service learning; or (4) an attention control curriculum. Students completed 3 surveys over 18 months. Multi-level analysis was used to adjust for the correlation among students within the same classroom and school, and the correlation of repeated measurements. Participants were 53% male (mean age: 16.2 years). The majority of youth reported being Hispanic/Latino or African-American (37.9% and 22.3%, respectively). Students in the HIV/STI/pregnancy prevention curriculum condition were less likely to have vaginal intercourse without a condom in the 3 months prior to the survey [odds ratio (OR) = .58, p = .04]; these effects diminished by final follow-up. The program also significantly reduced students' exposure to risky situations. These changes were not significant in the service learning only or combined intervention conditions relative to control. This study is one of a few controlled studies of HIV/STI and pregnancy prevention programs in continuation settings, and suggests the curriculum was effective in changing selected risk behaviors in the short term. Copyright © 2013 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Methods of pushing during vaginal delivery and pelvic floor and perineal outcomes: a review.

PubMed

de Tayrac, Renaud; Letouzey, Vincent

2016-12-01

Over the past 20 years, several randomized studies have compared Valsalva and spontaneous pushing techniques during vaginal delivery. This review summarizes current medical knowledge concerning their maternal and fetal consequences, focusing on pelvic and perineal outcomes. We selected nine randomized controlled trials comparing Valsalva and spontaneous pushing, and a secondary analysis of a randomized controlled trial comparing different methods of perineal protection. Two trials showed that spontaneous pushing reduces the risk of perineal tears, but no firm conclusions can be drawn given the heterogeneity and inconsistent results of these studies. Conflicting results have been reported regarding the duration of the second stage of labor. Pushing technique does not seem to affect episiotomy, instrumental delivery or cesarean rates. Maternal satisfaction seems to be better after spontaneous pushing. Spontaneous pushing appears to have no adverse effects on neonatal well being, and one study showed a significant improvement in prenatal fetal parameters during the expulsive phase. Valsalva and spontaneous pushing techniques currently appear comparable in terms of duration, pelvic floor, perineal, and neonatal outcomes. In the absence of strong evidence in favor of either technique, the decision should be guided by patient preference and the clinical situation. Additional, well-designed randomized controlled trials are required.

Comparative Effectiveness of Medication versus Cognitive-Behavioral Therapy in a Randomized Controlled Trial of Low-Income Young Minority Women with Depression

ERIC Educational Resources Information Center

Siddique, Juned; Chung, Joyce Y.; Brown, C. Hendricks; Miranda, Jeanne

2012-01-01

Objective: To examine whether there are latent trajectory classes in response to treatment and whether they moderate the effects of medication versus psychotherapy. Method: Data come from a 1-year randomized controlled trial of 267 low-income, young (M = 29 years), minority (44% Black, 50% Latina, 6% White) women with current major depression…

A Randomized Controlled Trial Evaluation of "Time to Read", a Volunteer Tutoring Program for 8- to 9-Year-Olds

ERIC Educational Resources Information Center

Miller, Sarah; Connolly, Paul

2013-01-01

Tutoring is commonly employed to prevent early reading failure, and evidence suggests that it can have a positive effect. This article presents findings from a large-scale ("n" = 734) randomized controlled trial evaluation of the effect of "Time to Read"--a volunteer tutoring program aimed at children aged 8 to 9 years--on…

High School Students with Reading Comprehension Difficulties: Results of a Randomized Control Trial of a Two-Year Reading Intervention

ERIC Educational Resources Information Center

Vaughn, Sharon; Roberts, Greg; Wexler, Jade; Vaughn, Michael G.; Fall, Anna-Mária; Schnakenberg, Jennifer B.

2015-01-01

A 2-year, randomized control trial with 9th to 10th grade students with significant reading problems was provided for 50 minutes a day in small groups. Comparison students were provided an elective class and treatment students the reading intervention. Students were identified as demonstrating reading difficulties through failure on their state…

Cervical epidural injections in chronic discogenic neck pain without disc herniation or radiculitis: preliminary results of a randomized, double-blind, controlled trial.

PubMed

Manchikanti, Laxmaiah; Cash, Kimberly A; Pampati, Vidyasagar; Wargo, Bradley W; Malla, Yogesh

2010-01-01

Chronic neck pain is a common problem in the adult population with a typical 12-month prevalence of 30% to 50%. However, there is a lack of consensus regarding the causes and treatments of chronic neck pain. Despite limited evidence, cervical epidural injections are one of the commonly performed non-surgical interventions in the management of chronic neck pain. A randomized, double-blind, active control trial. An interventional pain management practice, a specialty referral center, a private practice setting in the United States. To evaluate the effectiveness of cervical interlaminar epidural injections with local anesthetic with or without steroids in the management of chronic neck pain with or without upper extremity pain in patients without disc herniation or radiculitis or facet joint pain. Patients without disc herniation or radiculitis and negative for facet joint pain by means of controlled diagnostic medial branch blocks were randomly assigned to one of 2 groups: injection of local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Seventy patients were included in this analysis. Randomization was performed by computer-generated random allocation sequence by simple randomization. Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake with assessment at 3, 6, and 12 months post-treatment. Significant pain relief or functional status was defined as a 50% or more reduction. Significant pain relief (> or = 50%) was demonstrated in 80% of patients in both groups and functional status improvement (> or = 50%) in 69% of Group I and 80% of Group II. The overall average procedures per year were 3.9 +/- 1.01 in Group I and 3.9 +/- 0.8 in Group II with an average total relief per year of 40.3 +/- 14.1 weeks in Group I and 42.1 +/- 9.9 weeks in Group II over a period of 52 weeks in the successful group. The results of this study are limited by the lack of a placebo group and a preliminary report of 70 patients, with 35 patients in each group. Cervical interlaminar epidural injections with local anesthetic with or without steroids may be effective in patients with chronic function-limiting discogenic.

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.

Prescribing by general practitioners after an osteoporotic fracture.

PubMed

Torgerson, D J; Dolan, P

1998-06-01

Osteoporosis is a major cause of morbidity and cost. Patients sustaining one osteoporotic fracture are at increased risk of having another fracture. The objective of this study was to examine the use of "bone drugs" for the prevention of further osteoporotic fractures among patients who have had a "typical" osteoporotic fracture. This study took a random sample of 300 women aged 50 and over who had sustained either a vertebral, hip or Colles fracture in 1995 from the General Practice Research Database (GPRD) and compared their use of bone drugs with 300 age and practice matched controls. Compared with age and practice matched control patients only vertebral fracture patients showed a statistically significant increase in the use of bone drugs in the year after fracture (39% and 2% for cases and controls respectively; 95% CI of difference 27% to 47%). Etidronate was the most commonly used compound. The majority of patients sustaining an osteoporotic fracture are not prescribed any pharmaceutical agents for the secondary prevention of fracture one year after a primary fracture.

School-based programmes for preventing smoking.

PubMed

Thomas, R; Perera, R

2006-07-19

Smoking rates in adolescents are rising in some countries. Helping young people to avoid starting smoking is a widely endorsed goal of public health, but there is uncertainty about how to do this. Schools provide a route for communicating with a large proportion of young people, and school-based programmes for smoking prevention have been widely developed and evaluated. To review all randomized controlled trials of behavioural interventions in schools to prevent children (aged 5 to12) and adolescents (aged 13 to18) starting smoking. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Tobacco Addiction Group's Specialized Register, MEDLINE, EMBASE, PsyclNFO, ERIC, CINAHL, Health Star, Dissertation Abstracts and studies identified in the bibliographies of articles. Individual MEDLINE searches were made for 133 authors who had undertaken randomized controlled trials in this area. Types of studies: those in which individual students, classes, schools, or school districts were randomized to the intervention or control groups and followed for at least six months. Children (aged 5 to12) or adolescents (aged 13 to18) in school settings. Types of interventions: Classroom programmes or curricula, including those with associated family and community interventions, intended to deter use of tobacco. We included programmes or curricula that provided information, those that used social influences approaches, those that taught generic social competence, and those that included interventions beyond the school into the community. We included programmes with a drug or alcohol focus if outcomes for tobacco use were reported. Types of outcome measures: Prevalence of non-smoking at follow up among those not smoking at baseline. We did not require biochemical validation of self-reported tobacco use for study inclusion. We assessed whether identified citations were randomized controlled trials. We assessed the quality of design and execution, and abstracted outcome data. Because of the marked heterogeneity of design and outcomes, we computed pooled estimates only for those trials that could be analyzed together and for which statistical data were available. We predominantly synthesized the data using narrative systematic review. We grouped studies by intervention method (information; social competence; social influences; combined social influences/social competence; multi-modal programmes). Within each group, we placed them into three categories (low, medium and high risk of bias) according to validity using quality criteria for reported study design. Of the 94 randomized controlled trials identified, we classified 23 as category one (most valid). There was one category one study of information-giving and two of teaching social comeptence. There were thirteen category one studies of social influences interventions. Of these, nine found some positive effect of intervention on smoking prevalence, and four failed to detect an effect on smoking prevalence. The largest and most rigorous study, the Hutchinson Smoking Prevention Project, found no long-term effect of an intensive eight-year programme on smoking behaviour. There were three category one RCTs of combined social influences and social competence interventions: one provided significant results and one only for instruction by health educators compared to self-instruction. There was a lack of high quality evidence about the effectiveness of combinations of social influences and social competence approaches. There was one category one study providing data on social influences compared with information giving. There were four category one studies of multi-modal approaches but they provided limited evidence about the effectiveness of multi-modal approaches including community initiatives. There is one rigorous test of the effects of information-giving about smoking. There are well-conducted randomized controlled trials to test the effects of social influences interventions: in half of the group of best quality studies those in the intervention group smoke less than those in the control, but many studies failed to detect an effect of the intervention. There are only three high quality RCTs which test the effectiveness of combinations of social influences and social competence interventions, and four which test multi-modal interventions; half showed significant positive results.

The effects of an 8-week computerized cognitive training program in older adults: a study protocol for a randomized controlled trial.

PubMed

Ten Brinke, Lisanne F; Best, John R; Crockett, Rachel A; Liu-Ambrose, Teresa

2018-01-30

Given the world's aging population, it is important to identify strategies that promote healthy cognitive aging and minimize cognitive decline. Currently, no curative pharmaceutical therapy exists for cognitive impairment and dementia. As a result, there is much interest in lifestyle approaches. Specifically, complex mental activity, such as cognitive training, may be a promising method to combat cognitive decline in older adults. As such, the industry of commercial computerized cognitive training (CCT) applications has rapidly grown in the last decade. However, the efficacy of these commercial products is largely not established. Moreover, exercise is a recognized strategy for promoting cognitive outcomes in older adults and may augment the efficacy of computerized cognitive training applications. Therefore, we propose a proof-of-concept randomized controlled trial (RCT) to examine the effect of a commercial CCT program in community-dwelling older adults. An 8-week RCT to examine the effect of a commercial CCT program, alone and preceded by a 15-min brisk walk, on cognitive function and explore the underlying neural mechanisms in adults aged 65-85 years old. Participants will be randomized to one of three intervention groups: 1) Computerized cognitive training (FBT); 2) A 15-min brisk walk followed by computerized cognitive training (Ex-FBT); or 3) A combination of educational classes, sham cognitive training, and balanced and tone exercises (active control, BAT). Participants in all intervention groups will attend three one-hour classes per week over the course of the intervention. Participants will be assessed at baseline, trial completion, and 1-year post study completion (1-year follow-up). If results from this study show benefits for cognition at trial completion, CCT programs, alone or in combination with walking, might be a strategy to promote healthy cognitive aging in older adults. In addition, results from the 1-year follow-up measurement could provide important information regarding the long-term benefits of these CCT programs. ClinicalTrials.gov Protocol Registration System: NCT02564809; registered September 1, 2015.

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

PubMed Central

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

2016-01-01

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

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.

Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Over the years, there has been a strong consensus in dentistry that at least two implants are required to retain a complete mandibular denture. It has been shown in several clinical trials that one single median implant can retain a mandibular overdenture sufficiently well for up to 5 years without implant failures, when delayed loading was used. However, other trials have reported conflicting results with in part considerable failure rates when immediate loading was applied. Therefore it is the purpose of the current randomized clinical trial to test the hypothesis that immediate loading of a single mandibular midline implant with an overdenture will result in a comparable clinical outcome as using the standard protocol of delayed loading. Methods/design This prospective nine-center randomized controlled clinical trial is still ongoing. The final patient will complete the trial in 2016. In total, 180 edentulous patients between 60 and 89 years with sufficient complete dentures will receive one median implant in the edentulous mandible, which will retain the existing complete denture using a ball attachment. Loading of the median implant is either immediately after implant placement (experimental group) or delayed by 3 months of submerged healing at second-stage surgery (control group). Follow-up of patients will be performed for 24 months after implant loading. The primary outcome measure is non-inferiority of implant success rate of the experimental group compared to the control group. The secondary outcome measures encompass clinical, technical and subjective variables. The study was funded by the Deutsche Forschungsgemeinschaft (German research foundation, KE 477/8-1). Discussion This multi-center clinical trial will give information on the ability of a single median implant to retain a complete mandibular denture when immediately loaded. If viable, this treatment option will strongly improve everyday dental practice. Trial registration The trial has been registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: DRKS00003730 since 23 August 2012. (http://www.germanctr.de). PMID:24884848

Influence of a Mediterranean Dietary Pattern on Body Fat Distribution: Results of the PREDIMED-Canarias Intervention Randomized Trial.

PubMed

Álvarez-Pérez, Jacqueline; Sánchez-Villegas, Almudena; Díaz-Benítez, Elena María; Ruano-Rodríguez, Cristina; Corella, Dolores; Martínez-González, Míguel Ángel; Estruch, Ramón; Salas-Salvadó, Jordi; Serra-Majem, Lluís

2016-08-01

To assess the influence of a Mediterranean dietary pattern (MeDiet) on anthropometric and body composition parameters in one of the centers of the PREDIMED randomized dietary trial. 351 Canarian free-living subjects aged 55 to 80 years, with type 2 diabetes or ≥3 cardiovascular risk factors. Participants were randomly assigned to one of 3 different dietary interventions: MeDiet + extra-virgin olive oil (EVOO), MeDiet + nuts (walnuts, almonds, and hazelnuts), or a control low-fat diet. Total energy intake was ad libitum. Measures included changes in anthropometric measures (weight, body mass index [BMI] and waist circumference [WC]), body fat distribution, energy, and nutrient intake after 1 year. Body composition (percentage of total body fat [%TBF], total fat mass [TFM], free fat mass [FFM], percentage of truncal fat [%TrF], truncal fat mass [TrFM]) and total body water (TBW) were estimated by octapolar electrical impedance analysis. Paired t tests were conducted to assess within-group changes. Analyses of variance (ANOVAs) were used to assess the effect of the dietary intervention on the percentage change in anthropometric variables, body composition, and dietary intake profile. All pairwise comparisons that were statistically significant in ANOVA were subsequently adjusted using the Benjamini-Hochberg test, which penalizes for multiple comparisons. After 1 year of intervention, significant within-group reductions in all anthropometric variables were observed for the MeDiet + EVOO and the control group. The MeDiet + nuts group exhibited a significant reduction in WC and TBW. The control group showed a significant increase in %TBF and a reduction in TBW. The control group showed a significant increase in the percentage of total body fat and a reduction in TBW. However, we did not find any between-group significant difference in anthropometric or body composition changes. Mediterranean diets enriched with EVOO or specific mixed nuts (walnuts, almonds, hazelnuts) that contain approximately 40% total fat can be alternative options to low-fat diets for weight maintenance regimes in older overweight or obese adults.

Advising people to take more exercise is ineffective: a randomized controlled trial of physical activity promotion in primary care.

PubMed

Hillsdon, Melvyn; Thorogood, Margaret; White, Ian; Foster, Charlie

2002-08-01

Over the last 10 years 'exercise referral schemes' have been popular even though the evidence for effectiveness of any one-to-one intervention in primary care is deficient. We report the results of a primary care based one-to-one intervention that compared the effect of two communication styles with a no-intervention control group on self-reported physical activity at 12 months. In all, 1658 middle-aged men and women were randomly assigned to 30 minutes of brief negotiation or direct advice in primary care or a no-intervention control group. The main outcome was self-reported physical activity at 12 months. Secondary outcome measures included change in blood pressure and body mass index. Intention-to-treat analysis revealed no significant differences in physical activity between groups. Brief negotiation group participants who completed the study increased their physical activity significantly more than controls. There was no change in body mass index in any group. The brief negotiation group produced a greater reduction in diastolic blood pressure than direct advice. If patients whose health may benefit from increased physical activity seek advice in primary care, 20-30 minutes of brief negotiation to increase physical activity is probably more effective than similar attempts to persuade or coerce. However, blanket physical activity promotion in primary care is not effective. The most effective way of increasing physical activity in primary care has yet to be determined.

Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus

PubMed Central

2013-01-01

Background Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes. Methods/Design This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50–200 mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12 weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary hypothesis we expect that CBT leads to significantly greater improvement of glycemic control in the one year follow-up in treatment responders of the short term phase. Discussion The DAD study is the first randomized controlled trial comparing antidepressants to a psychological treatment in diabetes patients with depression. The study is investigator initiated and was supported by the ‘Förderprogramm Klinische Studien (Clinical Trials)’ and the ‘Competence Network for Diabetes mellitus’ funded by the Federal Ministry of Education and Research (FKZ 01KG0505). Trial registration Current controlled trials ISRCTN89333241. PMID:23915015

Social adjustment and competence 35 years after onset of childhood epilepsy: a prospective controlled study.

PubMed

Jalava, M; Sillanpää, M; Camfield, C; Camfield, P

1997-06-01

To study the effect of childhood-onset epilepsy without other neurologic deficit on adult social adjustment and competence. Social competence was studied in a prospective, population-based cohort of childhood-onset epilepsy after a mean follow-up of 35 years. One hundred patients (60% of the total cohort) had no other neurologic problems ("epilepsy only"), and for each patient, two matched controls, a "random" control and an "employee" control were chosen. Good social outcome was significantly reduced in the "epilepsy only" cohort compared with random controls: education [cumulative odds ratio (COR), 2.4; 95% confidence interval (CI), 1.4-4.1]; employability (COR, 7.3; 95% CI, 2.7-20.0); and marriage rate (COR, 3.7; 95% CI, 1.9-7.3). The patients with epilepsy rated their own ability to control their lives as "poor or missing" four times more frequently than the employee controls. Patients receiving antiepileptic polytherapy, but not monotherapy, were significantly less satisfied with their present life (OR, 6.7; 95% CI, 1.9-24.1) and felt their general health was significantly poorer (OR, 5.1; 95% CI, 1.2-21.3) than did the employee controls. Furthermore, patients with continuing seizures were significantly less satisfied with their present life (OR, 4.1; 95% CI, 1.1-15.1) than were employee controls. Many patients with "epilepsy only" beginning in childhood have persistent and significant social-adjustment and competence problems in adulthood.

Obesity/Overweight in Persons With Early and Chronic SCI: A Randomized, Multicenter, Controlled Lifestyle Intervention

DTIC Science & Technology

2014-10-01

A.J. Mendez, S.L. Groah, J. Kressler. Fasting plasma glucose values may significantly underestimate prevalence of dysfunctional glycemic regulation in...taken corrective actions without undertaking additional protocol changes. There have been no screening issues since protocol amendments were approved...extending approval for the project through September 9, 2015. Enclosed is the dated/stamped Informed Consent Form, approved for one additional year until

One-year follow-up results from AUGMENT-HF: a multicentre randomized controlled clinical trial of the efficacy of left ventricular augmentation with Algisyl in the treatment of heart failure.

PubMed

Mann, Douglas L; Lee, Randall J; Coats, Andrew J S; Neagoe, Gheorghe; Dragomir, Dinu; Pusineri, Enrico; Piredda, Massimo; Bettari, Luca; Kirwan, Bridget-Anne; Dowling, Robert; Volterrani, Maurizio; Solomon, Scott D; Sabbah, Hani N; Hinson, Andy; Anker, Stefan D

2016-03-01

AUGMENT-HF was an international, multicentre, prospective, open-label, randomized, controlled evaluation testing the hypothesis that Algisyl (injectable calcium alginate hydrogel) is superior to standard medical therapy (SMT) for improving functional capacity and clinical outcomes in patients with advanced heart failure (HF). We previously reported results following 6 months of follow-up. This report presents the results from 1 year of extended follow up for this clinical trial. We enrolled 78 patients with advanced HF, randomized (1:1), to Algisyl with SMT or SMT alone as previously reported. Patient inclusion criteria were LVEF ≤35%, peak VO2 of 9.0-14.5 mL/min/kg and LV end-diastolic diameter (LVEDD) index 30-40 mm/m(2) (LVEDD/body surface area). Patients must have been on stable, evidence-based therapy for HF. A total of 58 patients, mean age 62.3 ± 9.6 years, with ischaemic (57.7%) or non-ischaemic (42.3%) HF completed 12 months of follow-up. Treatment with Algisyl was associated with improved peak VO2 at 12 months; treatment effect vs. control of +2.10 mL/kg/min (95% confidence interval 0.96-3.24, P < 0.001). Statistically significant improvements were observed for VO2 at anaerobic threshold, 6-min walk test distance, and NYHA functional class (all P < 0.001). Through 12 months of follow-up there were 4 (10.5%) deaths in the control group and 9 (22.5%) deaths in the Algisyl group. Algisyl in addition to SMT was more effective than SMT alone for providing sustained 1-year benefits in exercise capacity, symptoms, and clinical status for patients with advanced HF. These data support larger clinical evaluations of this novel therapy. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.

Randomized trial of balneotherapy associated with patient education in patients with advanced chronic venous insufficiency.

PubMed

Carpentier, Patrick H; Satger, Bernadette

2009-01-01

Except for compression therapy, physical therapy has scarcely been evaluated in the treatment of chronic venous disorders (CVD). Spa treatment is a popular way to administer physical therapy for CVD in France, but its efficacy has not been evaluated yet. This study aimed to assess the efficacy of balneotherapy associated with patient education, as performed in the spa resort of La Léchère, in patients with advanced chronic venous insufficiency (CEAP clinical classes C4/C5). The study was a randomized controlled trial, spa therapy being administered on top of the usual medical care. Evaluation was by a blinded independent investigator. Subjects were patients with primary or post-thrombotic CVD with skin changes but no active ulcer (C4a, C4b, or C5), living in Grenoble area, and willing to undergo a spa treatment course in La Léchère. The treated group had the three week spa treatment course in La Léchère, soon after randomization; the control group also had a spa treatment, but starting at day 365. The treatment consisted of four balneology sessions per day, six days a week during three weeks, and three educational workshops. An independent follow-up was performed in Grenoble hospital every three months for 15 months. The main outcome criterion was the severity of the skin changes, as evaluated by means of malleolar chromametry. Quality of life, as measured by the Chronic Venous Insufficiency Questionnaire 2 scale, a visual analog scale (VAS) for leg symptoms, and the occurrence of leg ulcers were used as secondary criteria. The year after spa treatment in the treated group was compared with the year before spa treatment in the control group. Fifty-nine subjects were enrolled (29 in the treatment group and 30 in the control group). No statistically significant difference between groups was found at study onset regarding age, sex, etiology, CEAP "C" class, and the outcome variables. After treatment, chromametry showed significantly decreased pigmentation and erythema in the treatment group compared with the controls (P < .01). Quality of life (P < .01) and symptoms (P < .001) also improved significantly. These differences remained significant after one year follow-up. The control patients improved similarly after their own spa treatment (day 450). This study shows that spa therapy, associating balneotherapy and patient education, is able to improve significantly the skin trophic changes of the CVD patients and their CVD related quality of life and symptoms. This effect is of large magnitude and remains significant one year after the treatment course.

[Natural history of breast cancer: a systematic review of worldwide randomized controlled trials of mammography screening].

PubMed

Yue, X P; Shi, J F; Mao, A Y; Wang, L; Ma, H M; Chen, L L; Zhu, J; Cheng, X; Dai, M

2017-02-23

Objective: To parameterize the 1-year transition probabilities between different health status of the natural history of breast cancer based on the data of randomized controlled trial of X-ray mammography screening worldwide. Methods: Based on the breast cancer screening randomized controlled trials defined by a mammography screening review from the Cochrane 2013 and the International Agency for Research on Cancer, a systematic review was initiated in PubMed by searching names of the key investigators of the trials, combined with the diseases, screening intervention and outcome indicators. If applicable, all the original cumulative incidence rates were converted into one-year transition rate, using the life-table approach considering time length of follow-up. Results: A total of 23 reports from 9 RCTs were included. The data on transition rate between the healthy status to precancerous lesions was absent. The 1-year transition rate from health to carcinoma in situ was 17.78 to 50.21 per 100 000 persons in the intervention group and 9.16 to 26.84 per 100 000 persons in the control group. Correspondingly, the 1-year transition rate from health to breast cancer (including carcinoma in situ and invasive cancer) were estimated as 143.75 to 316.97 per 100 000 persons in the intervention group, and 141.45 to 288.84 per 100 000 persons in the control group. Furthermore, the transition rate from the healthy status to invasive breast cancer was 159.79 to 264.60 per 100 000 persons in intervention group and 170.12 to 255.33 per 100 000 persons in control group. The transition rate from carcinoma in situ to invasive breast cancer varied among different pathological types. Conclusions: The most common natural history states of reported by the included trials involved the full healthy status, carcinoma in situ and invasive breast cancer. The findings of transition rates between different health statuses will be informative for future model development of natural history studies of breast cancer. Information in relation to breast precancerous lesions still limited and needs to be further addressed.

E-Rehabilitation - an Internet and mobile phone based tailored intervention to enhance self-management of cardiovascular disease: study protocol for a randomized controlled trial.

PubMed

Antypas, Konstantinos; Wangberg, Silje C

2012-07-09

Cardiac rehabilitation is very important for the recovery and the secondary prevention of cardiovascular disease, and one of its main strategies is to increase the level of physical activity. Internet and mobile phone based interventions have been successfully used to help people to achieve this. One of the components that are related to the efficacy of these interventions is tailoring of content to the individual. This trial is studying the effect of a longitudinally tailored Internet and mobile phone based intervention that is based on models of health behaviour, on the level of physical activity and the adherence to the intervention, as an extension of a face-to-face cardiac rehabilitation stay. A parallel group, cluster randomized controlled trial. The study population is adult participants of a cardiac rehabilitation programme in Norway with home Internet access and mobile phone, who in monthly clusters are randomized to the control or the intervention condition. Participants have access to a website with information regarding cardiac rehabilitation, an online discussion forum and an online activity calendar. Those randomized to the intervention condition, receive in addition tailored content based on models of health behaviour, through the website and mobile text messages. The objective is to assess the effect of the intervention on maintenance of self-management behaviours after the rehabilitation stay. Main outcome is the level of physical activity one month, three months and one year after the end of the cardiac rehabilitation programme. The randomization of clusters is based on a true random number online service, and participants, investigators and outcome assessor are blinded to the condition of the clusters. The study suggests a theory-based intervention that combines models of health behaviour in an innovative way, in order to tailor the delivered content. The users have been actively involved in its design, and because of the use of Open-Source software, the intervention can easily and at low-cost be reproduced and expanded by others. Challenges are the recruitment in the elderly population and the possible underrepresentation of women in the study sample. Funding by Northern Norway Regional Health Authority. Trial registry http://www.clinicaltrials.gov: NCT01223170.

Assessing the Effectiveness of Case-Based Collaborative Learning via Randomized Controlled Trial.

PubMed

Krupat, Edward; Richards, Jeremy B; Sullivan, Amy M; Fleenor, Thomas J; Schwartzstein, Richard M

2016-05-01

Case-based collaborative learning (CBCL) is a novel small-group approach that borrows from team-based learning principles and incorporates elements of problem-based learning (PBL) and case-based learning. CBCL includes a preclass readiness assurance process and case-based in-class activities in which students respond to focused, open-ended questions individually, discuss their answers in groups of 4, and then reach consensus in larger groups of 16. This study introduces CBCL and assesses its effectiveness in one course at Harvard Medical School. In a 2013 randomized controlled trial, 64 medical and dental student volunteers were assigned randomly to one of four 8-person PBL tutorial groups (control; n = 32) or one of two 16-person CBCL tutorial groups (experimental condition; n = 32) as part of a required first-year physiology course. Outcomes for the PBL and CBCL groups were compared using final exam scores, student responses to a postcourse survey, and behavioral coding of portions of video-recorded class sessions. Overall, the course final exam scores for CBCL and PBL students were not significantly different. However, CBCL students whose mean exam performance in prior courses was below the participant median scored significantly higher than their PBL counterparts on the physiology course final exam. The most common adjectives students used to describe CBCL were "engaging," "fun," and "thought-provoking." Coding of observed behaviors indicated that individual affect was significantly higher in the CBCL groups than in the PBL groups. CBCL is a viable, engaging, active learning method. It may particularly benefit students with lower academic performance.

Impact of a social-emotional and character development program on school-level indicators of academic achievement, absenteeism, and disciplinary outcomes: A matched-pair, cluster randomized, controlled trial.

PubMed

Snyder, Frank; Flay, Brian; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac; Beets, Michael; Li, Kin-Kit

2010-01-01

This paper reports the effects of a comprehensive elementary school-based social-emotional and character education program on school-level achievement, absenteeism, and disciplinary outcomes utilizing a matched-pair, cluster randomized, controlled design. The Positive Action Hawai'i trial included 20 racially/ethnically diverse schools (mean enrollment = 544) and was conducted from the 2002-03 through the 2005-06 academic years. Using school-level archival data, analyses comparing change from baseline (2002) to one-year post trial (2007) revealed that intervention schools scored 9.8% better on the TerraNova (2 nd ed.) test for reading and 8.8% on math; 20.7% better in Hawai'i Content and Performance Standards scores for reading and 51.4% better in math; and that intervention schools reported 15.2% lower absenteeism and fewer suspensions (72.6%) and retentions (72.7%). Overall, effect sizes were moderate to large (range 0.5-1.1) for all of the examined outcomes. Sensitivity analyses using permutation models and random-intercept growth curve models substantiated results. The results provide evidence that a comprehensive school-based program, specifically developed to target student behavior and character, can positively influence school-level achievement, attendance, and disciplinary outcomes concurrently.

Failure to preserve beta-cell function with mycophenolate mofetil and daclizumab combined therapy in patients with new- onset type 1 diabetes.

PubMed

Gottlieb, Peter A; Quinlan, Scott; Krause-Steinrauf, Heidi; Greenbaum, Carla J; Wilson, Darrell M; Rodriguez, Henry; Schatz, Desmond A; Moran, Antoinette M; Lachin, John M; Skyler, Jay S

2010-04-01

This trial tested whether mycophenolate mofetil (MMF) alone or with daclizumab (DZB) could arrest the loss of insulin-producing beta-cells in subjects with new-onset type 1 diabetes. A multi-center, randomized, placebo-controlled, double-masked trial was initiated by Type 1 Diabetes TrialNet at 13 sites in North America and Europe. Subjects diagnosed with type 1 diabetes and with sufficient C-peptide within 3 months of diagnosis were randomized to either MMF alone, MMF plus DZB, or placebo, and then followed for 2 years. The primary outcome was the geometric mean area under the curve (AUC) C-peptide from the 2-h mixed meal tolerance test. One hundred and twenty-six subjects were randomized and treated during the trial. The geometric mean C-peptide AUC at 2 years was unaffected by MMF alone or MMF plus DZB versus placebo. Adverse events were more frequent in the active therapy groups relative to the control group, but not significantly. Neither MMF alone nor MMF in combination with DZB had an effect on the loss of C-peptide in subjects with new-onset type 1 diabetes. Higher doses or more targeted immunotherapies may be needed to affect the autoimmune process.

Failure to Preserve β-Cell Function With Mycophenolate Mofetil and Daclizumab Combined Therapy in Patients With New- Onset Type 1 Diabetes

PubMed Central

Gottlieb, Peter A.; Quinlan, Scott; Krause-Steinrauf, Heidi; Greenbaum, Carla J.; Wilson, Darrell M.; Rodriguez, Henry; Schatz, Desmond A.; Moran, Antoinette M.; Lachin, John M.; Skyler, Jay S.

2010-01-01

OBJECTIVE This trial tested whether mycophenolate mofetil (MMF) alone or with daclizumab (DZB) could arrest the loss of insulin-producing β-cells in subjects with new-onset type 1 diabetes. RESEARCH DESIGN AND METHODS A multi-center, randomized, placebo-controlled, double-masked trial was initiated by Type 1 Diabetes TrialNet at 13 sites in North America and Europe. Subjects diagnosed with type 1 diabetes and with sufficient C-peptide within 3 months of diagnosis were randomized to either MMF alone, MMF plus DZB, or placebo, and then followed for 2 years. The primary outcome was the geometric mean area under the curve (AUC) C-peptide from the 2-h mixed meal tolerance test. RESULTS One hundred and twenty-six subjects were randomized and treated during the trial. The geometric mean C-peptide AUC at 2 years was unaffected by MMF alone or MMF plus DZB versus placebo. Adverse events were more frequent in the active therapy groups relative to the control group, but not significantly. CONCLUSIONS Neither MMF alone nor MMF in combination with DZB had an effect on the loss of C-peptide in subjects with new-onset type 1 diabetes. Higher doses or more targeted immunotherapies may be needed to affect the autoimmune process. PMID:20067954

Group physiotherapy compared to individual physiotherapy to treat urinary incontinence in aging women: study protocol for a randomized controlled trial.

PubMed

Dumoulin, Chantale; Morin, Mélanie; Mayrand, Marie-Hélène; Tousignant, Michel; Abrahamowicz, Michal

2017-11-16

Urinary incontinence (UI), one of the most prevalent health concerns confronting women aged over 60 years, affects up to 55% of older community-dwelling women-20-25% with severe symptoms. Clinical practice guidelines recommend individualized pelvic floor muscle training (PFMT) as a first-line treatment for stress or mixed UI in women, although lack of human and financial resources limits delivery of this first-line treatment. Preliminary data suggest that group-based treatments may provide the answer. To date, no adequately powered trials have evaluated the effectiveness or cost-effectiveness of group compared to individual PFMT for UI in older women. Given demographic projections, high prevalence of UI in older women, costly barriers, and group PFMT promising results, there is a clear need to rigorously compare the short- and long-term effectiveness and cost-effectiveness of group vs individual PFMT. The study is designed as a non-inferiority randomized controlled trial, conducted in two facilities (Montreal and Sherbrooke) in the Canadian province of Quebec. Participants include 364 ambulatory, community-dwelling women, aged 60 years and older, with stress or mixed UI. Randomly assigned participants will follow a 12-week PFMT, either in one-on-one sessions or as part of a group, under the supervision of a physiotherapist. Blinded assessments at baseline, immediately post intervention, and at one year will include the seven-day bladder diary, the 24-h pad test, symptoms and quality of life questionnaires, adherence and self-efficacy questionnaire, pelvic floor muscle function, and cost assessments. Primary analysis will test our main hypothesis that group-based treatment is not inferior to individualized treatment with respect to the primary outcome: relative (%) reduction in the number of leakages. Should this study find that a group-based approach is not less effective than individual PFMT, and more cost-effective, this trial will impact positively continence-care accessibility and warrant a change in clinical practice. ClinicalTrials.gov, NCT02039830 . Registered on 12 December 2013; Study protocol version 2; 21 November 2013.

Family planning to promote physical activity: a randomized controlled trial protocol.

PubMed

Quinlan, Alison; Rhodes, Ryan E; Blanchard, Chris M; Naylor, Patti-Jean; Warburton, Darren E R

2015-10-05

Physical activity is associated with the reduction of several chronic conditions in adults. Additionally, physical activity is extremely important for children for their development and cognitive functioning and also to create a physically active lifestyle that continues into adulthood. Despite the known benefits of physical activity, only one in five adults are achieving the public health recommendations of 150 minutes of moderate-to-vigorous physical activity per week and only 13 % of boys and 6 % of girls between the ages of 5 and 17 years are meeting the guidelines of 60 minutes per day. This study aims to evaluate whether a planning condition improves adherence to regular physical activity compared to an education-only control condition among families. Families are eligible if there is at least one child between the ages of 6 and 12 years who is not meeting the Canadian Physical Activity Guidelines. A six-month longitudinal randomized controlled trial will be used to compare the two conditions. Materials will be delivered at baseline with 'booster' sessions at six weeks and three months. Participants will be assessed at baseline and at six months with a fitness test, as well as questionnaires and accelerometery at baseline, six weeks, three months and six months. A total of 137 families have been recruited thus far from Greater Victoria. This study is ongoing and recruitment will continue until December 2015 with the target goal of reaching 160 families. This protocol describes the implementation of a randomized controlled trial that utilizes planning strategies to try and increase physical activity among families. Research findings could be useful in public health in providing effective strategies to families to help decrease sedentary lifestyles. Additionally, findings may help to inform future interventions aimed at increasing physical activity among families. This trial was registered on June 5, 2012 with the Clinical Trials Registry maintained by the National Library of Medicine at the National Institutes of Health. The registration ID is NCT01882192.

Home exercise improves the quality of sleep and daytime sleepiness of elderlies: a randomized controlled trial.

PubMed

Brandão, Glauber Sá; Gomes, Glaucia Sá Brandão Freitas; Brandão, Glaudson Sá; Callou Sampaio, Antônia A; Donner, Claudio F; Oliveira, Luis V F; Camelier, Aquiles Assunção

2018-01-01

Aging causes physiological changes which affect the quality of sleep. Supervised physical exercise is an important therapeutic resource to improve the sleep of the elderlies, however there is a low adherence to those type of programs, so it is necessary to implement an exercise program which is feasible and effective. The study aimed to test the hypothesis that a semi-supervised home exercise program, improves sleep quality and daytime sleepiness of elderlies of the community who present poor sleep quality. This was a randomized controlled trial study, conducted from May to September 2017, in Northeastern Brazil, with elderlies of the community aging 60 years old or older, sedentary, with lower scores or equal to 5 at the Pittsburgh Sleep Quality Index (PSQI) and without cognitive decline. From one hundred ninety-one potential participants twenty-eight refused to participate, therefore, one hundred thirty-one (mean age 68 ± 7 years), and 88% female, were randomly assigned to an intervention group - IG (home exercise and sleep hygiene, n  = 65) and a control group - CG (sleep hygiene only, n  = 66). Sleep assessment tools were used: PSQI, Epworth sleepiness scale (ESS) and clinical questionnaire of Berlin. The level of physical activity has been assessed by means of International Physical Activity Questionnaire adapted for the elderly (IPAQ) and Mini-Mental State Examination for cognitive decline. All participants were assessed before and after the 12-week intervention period and, also, the assessors were blind. The IG showed significant improvement in quality of sleep with a mean reduction of 4.9 ± 2.7 points in the overall PSQI ( p  < 0.01) and in all its 7 components of evaluation ( p  < 0.05), and improvement of secondary endpoint, daytime sleepiness, a decline of 2.8 ± 2.2 points in the ESS (p < 0.01). Our results suggest that semi-supervised home exercise is effective in improving the quality of sleep and self-referred daytime sleepiness of sedentary elderlies of the community who presented sleep disorders. Ensaiosclinicos.gov.br process number: RBR-3cqzfy.

Effect of providing free glasses on children’s educational outcomes in China: cluster randomized controlled trial

PubMed Central

Yi, Hongmei; Pang, Xiaopeng; Shi, Yaojiang; Chen, Qianyun; Meltzer, Mirjam E; le Cessie, Saskia; He, Mingguang; Rozelle, Scott; Liu, Yizhi

2014-01-01

Objective To assess the effect of provision of free glasses on academic performance in rural Chinese children with myopia. Design Cluster randomized, investigator masked, controlled trial. Setting 252 primary schools in two prefectures in western China, 2012-13. Participants 3177 of 19 934 children in fourth and fifth grades (mean age 10.5 years) with visual acuity <6/12 in either eye without glasses correctable to >6/12 with glasses. 3052 (96.0%) completed the study. Interventions Children were randomized by school (84 schools per arm) to one of three interventions at the beginning of the school year: prescription for glasses only (control group), vouchers for free glasses at a local facility, or free glasses provided in class. Main outcome measures Spectacle wear at endline examination and end of year score on a specially designed mathematics test, adjusted for baseline score and expressed in standard deviations. Results Among 3177 eligible children, 1036 (32.6%) were randomized to control, 988 (31.1%) to vouchers, and 1153 (36.3%) to free glasses in class. All eligible children would benefit from glasses, but only 15% wore them at baseline. At closeout glasses wear was 41% (observed) and 68% (self reported) in the free glasses group, and 26% (observed) and 37% (self reported) in the controls. Effect on test score was 0.11 SD (95% confidence interval 0.01 to 0.21) when the free glasses group was compared with the control group. The adjusted effect of providing free glasses (0.10, 0.002 to 0.19) was greater than parental education (0.03, −0.04 to 0.09) or family wealth (0.01, −0.06 to 0.08). This difference between groups was significant, but was smaller than the prespecified 0.20 SD difference that the study was powered to detect. Conclusions The provision of free glasses to Chinese children with myopia improves children’s performance on mathematics testing to a statistically significant degree, despite imperfect compliance, although the observed difference between groups was smaller than the study was originally designed to detect. Myopia is common and rarely corrected in this setting. Trial Registration Current Controlled Trials ISRCTN03252665. PMID:25249453

Healthy Moms, a randomized trial to promote and evaluate weight maintenance among obese pregnant women: study design and rationale

PubMed Central

Vesco, Kimberly K.; Karanja, Njeri; King, Janet C.; Gillman, Matthew W.; Perrin, Nancy; McEvoy, Cindy; Eckhardt, Cara; Smith, K. Sabina; Stevens, Victor J.

2012-01-01

Background Obesity and excessive weight gain during pregnancy are associated with adverse pregnancy outcomes. Observational studies suggest that minimal or no gestational weight gain (GWG) may minimize the risk of adverse pregnancy outcomes for obese women. Objective This report describes the design of Healthy Moms, a randomized trial testing a weekly, group-based, weight management intervention designed to help limit GWG to 3% of weight (measured at the time of randomization) among obese pregnant women (BMI ≥30 kg/m2). Participants are randomized at 10–20 weeks gestation to either the intervention or a single dietary advice control condition. Primary Outcomes The study is powered for the primary outcome of total GWG, yielding a target sample size of 160 women. Additional secondary outcomes include weight change between randomization and one-year postpartum and proportion of infants with birth weight > 90th percentile for gestational age. Statistical analyses will be based on intention-to-treat. Methods Following randomization, all participants receive a 45-minute dietary consultation. They are encouraged to follow the Dietary Approaches to Stop Hypertension diet without sodium restriction. Intervention group participants receive an individualized calorie intake goal, a second individual counseling session and attend weekly group meetings until they give birth. Research staff assess all participants at 34-weeks gestation and at 2-weeks and one-year postpartum with their infants. Summary The Healthy Moms study is testing weight management techniques that have been used with non-pregnant adults. We aim to help obese women limit GWG to improve their long-term health and the health of their offspring. PMID:22465256

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

PubMed

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

2009-12-01

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

A Facility Specialist Model for Improving Retention of Nursing Home Staff: Results from a Randomized, Controlled Study

ERIC Educational Resources Information Center

Pillemer, Karl; Meador, Rhoda; Henderson, Charles, Jr.; Robison, Julie; Hegeman, Carol; Graham, Edwin; Schultz, Leslie

2008-01-01

Purpose: This article reports on a randomized, controlled intervention study designed to reduce employee turnover by creating a retention specialist position in nursing homes. Design and Methods: We collected data three times over a 1-year period in 30 nursing homes, sampled in stratified random manner from facilities in New York State and…

Cognitive behavioral therapy program for cannabis use cessation in first-episode psychosis patients: study protocol for a randomized controlled trial.

PubMed

González-Ortega, Itxaso; Echeburúa, Enrique; García-Alocén, Adriana; Vega, Patricia; González-Pinto, Ana

2016-07-29

The high rate of cannabis use among patients with first-episode psychosis (FEP), as well as the associated negative impact on illness course and treatment outcomes, underlines the need for effective interventions in these populations. However, to date, there have been few clinical treatment trials (of pharmacological or psychological interventions) that have specifically focused on addressing comorbid cannabis use among these patients. The aim of this paper is to describe the design of a study protocol for a randomized controlled trial in which the objective is to assess the efficacy of a specific cognitive behavioral therapy program for cannabis cessation in patients with FEP compared to standard treatment (psychoeducation). This is a single-blind randomized study with 1 year of follow-up. Patients are to be randomly assigned to one of two treatments: (1) specific cognitive behavioral therapy for cannabis cessation composed of 1-hour sessions once a week for 16 weeks, in addition to pharmacological treatment scheduled by the psychiatrist, or (2) a control group (psychoeducation + pharmacological treatment) following the same format as the experimental group. Participants in both groups will be evaluated at baseline (pre-treatment), at 16 weeks (post-treatment), and at 3 and 6 months and 1 year of follow-up. The primary outcome will be that patients in the experimental group will have greater cannabis cessation than patients in the control group at post-treatment. The secondary outcome will be that the experimental group will have better clinical and functional outcomes than the control group. This study provides the description of a clinical trial design based on specific cognitive behavioral therapy for cannabis cessation in FEP patients, aiming to improve clinical and functional outcome, as well as tackling the addictive disorder. NCT02319746 ClinicalTrials.gov Identifier. ClinicalTrials.gov Protocol and Results Registration System (PRS) Receipt Release Date: 15 December 2014.

Randomized clinical trial of two resin-modified glass ionomer materials: 1-year results.

PubMed

Perdigão, J; Dutra-Corrêa, M; Saraceni, S H C; Ciaramicoli, M T; Kiyan, V H

2012-01-01

With institutional review board approval, 33 patients who needed restoration of noncarious cervical lesions (NCCL) were enrolled in this study. A total of 92 NCCL were selected and randomly assigned to three groups: (1) Ambar (FGM), a two-step etch-and-rinse adhesive (control), combined with the nanofilled composite resin Filtek Supreme Plus (FSP; 3M ESPE); (2) Fuji II LC (GC America), a traditional resin-modified glass ionomer (RMGIC) restorative material; (3) Ketac Nano (3M ESPE), a nanofilled RMGIC restorative material. Restorations were evaluated at six months and one year using modified United States Public Health Service parameters. At six months after initial placement, 84 restorations (a 91.3% recall rate) were evaluated. At one year, 78 restorations (a 84.8% recall rate) were available for evaluation. The six month and one year overall retention rates were 93.1% and 92.6%, respectively, for Ambar/FSP; 100% and 100%, respectively, for Fuji II LC; and 100% and 100%, respectively, for Ketac Nano with no statistical difference between any pair of groups at each recall. Sensitivity to air decreased for all three adhesive materials from the preoperative to the postoperative stage, but the difference was not statistically significant. For Ambar/FSP, there were no statistical differences for any of the parameters from baseline to six months and from baseline to one year. For Fuji II LC, surface texture worsened significantly from baseline to six months and from baseline to one year. For Ketac Nano, enamel marginal staining increased significantly from baseline to one year and from six months to one year. Marginal adaptation was statistically worse at one year compared with baseline only for Ketac Nano. When parameters were compared for materials at each recall, Ketac Nano resulted in significantly worse color match than any of the other two materials at any evaluation period. At one year, Ketac Nano resulted in significantly worse marginal adaptation than the other two materials and worse marginal staining than Fuji II LC. Surface texture was statistically worse for Fuji II LC compared with the other two materials at all evaluation periods. The one-year retention rate was statistically similar for the three adhesive materials. Nevertheless, enamel marginal deficiencies and color mismatch were more prevalent for Ketac Nano. Surface texture of Fuji II LC restorations deteriorated quickly.

A community-wide campaign to promote physical activity in middle-aged and elderly people: a cluster randomized controlled trial

PubMed Central

2013-01-01

Background We aimed to evaluate the effectiveness of a community-wide campaign (CWC) for promoting physical activity in middle-aged and elderly people. Methods A cluster randomized controlled trial (RCT) with a community as the unit of randomization was performed using a population-based random-sampled evaluation by self-administered questionnaires in the city of Unnan, Shimane Prefecture, Japan. The evaluation sample included 6000 residents aged 40 to 79 years. We randomly allocated nine communities to the intervention group and three to the control group. The intervention was a CWC from 2009 to 2010 to promote physical activity, and it comprised information, education, and support delivery. The primary outcome was a change in engaging in regular aerobic, flexibility, and/or muscle-strengthening activities evaluated at the individual level. Results In total, 4414 residents aged 40–79 years responded to a self-administered questionnaire (73.6% response rate). Awareness of the CWC was 79% in the intervention group. Awareness and knowledge were significantly different between the intervention and control groups, although there were no significant differences in belief and intention. The 1-year CWC did not significantly promote the recommended level of physical activity (adjusted odds ratio: 0.97; 95% confidence interval: 0.84–1.14). Conclusions This cluster RCT showed that the CWC did not promote physical activity in 1 year. Significant differences were observed in awareness and knowledge between intervention and control groups as short-term impacts of the campaign. Trial registration UMIN-CTR UMIN000002683 PMID:23570536

A randomized controlled clinical trial of a HEMA-free all-in-one adhesive in non-carious cervical lesions at 1 year.

PubMed

Van Landuyt, K L; Peumans, M; Fieuws, S; De Munck, J; Cardoso, M V; Ermis, R B; Lambrechts, P; Van Meerbeek, B

2008-10-01

One-step self-etch adhesives are the most recent generation of adhesives introduced onto the market. The objective of this randomized controlled clinical trial was to test the hypothesis that a one-step self-etch adhesive performs equally well as a conventional three-step etch&rinse adhesive (gold standard). Fifty-two patients had 267 non-carious cervical lesions restored with Gradia Direct Anterior (GC). These composite restorations were bonded either with the 'all-in-one' adhesive G-Bond (GC) or with the three-step etch&rinse adhesive Optibond FL (Kerr). The restorations were evaluated after 6 and 12 months clinical service regarding their retention, marginal integrity and discoloration, caries occurrence, preservation of tooth vitality and post-operative sensitivity. Retention loss, severe marginal defects and/or discoloration that needed intervention (repair or replacement) and the occurrence of caries were considered as clinical failures. A logistic regression analysis with generalized estimating equations was used to account for the clustered data (multiple restorations per patient). The recall rate at 1 year was 98%. The statistical analysis revealed a relatively low patient factor, indicating that supplementary information could be obtained from the additional restorations placed per patient. The retention rate for G-Bond was 98.5% compared to 99.3% for Optibond FL, due to the retention loss of two and one restorations, respectively. There were no significant differences between the two adhesives regarding the evaluated parameters except for the presence of small enamel marginal defects with G-Bond. After 12 months, the simplified one-step G-Bond and the three-step Optibond FL were clinically equally successful, even though both adhesives were characterized by progressive degradation of marginal adaptation, and G-Bond exhibited more small enamel marginal defects.

Randomized Control Trial of a CBT Trauma Recovery Program in Palestinian Schools

ERIC Educational Resources Information Center

Barron, Ian G.; Abdallah, Ghassan; Smith, Patrick

2013-01-01

The current study aimed to assess the Teaching Recovery Techniques (TRT) trauma recovery program within the context of ongoing violence. Utilizing a randomized controlled trial, 11-14-year-old students in Nablus, Palestine, were allocated by class to intervention or wait-list control conditions. Standardized measures assessed trauma exposure,…

Hierarchical model analysis of the Atlantic Flyway Breeding Waterfowl Survey

USGS Publications Warehouse

Sauer, John R.; Zimmerman, Guthrie S.; Klimstra, Jon D.; Link, William A.

2014-01-01

We used log-linear hierarchical models to analyze data from the Atlantic Flyway Breeding Waterfowl Survey. The survey has been conducted by state biologists each year since 1989 in the northeastern United States from Virginia north to New Hampshire and Vermont. Although yearly population estimates from the survey are used by the United States Fish and Wildlife Service for estimating regional waterfowl population status for mallards (Anas platyrhynchos), black ducks (Anas rubripes), wood ducks (Aix sponsa), and Canada geese (Branta canadensis), they are not routinely adjusted to control for time of day effects and other survey design issues. The hierarchical model analysis permits estimation of year effects and population change while accommodating the repeated sampling of plots and controlling for time of day effects in counting. We compared population estimates from the current stratified random sample analysis to population estimates from hierarchical models with alternative model structures that describe year to year changes as random year effects, a trend with random year effects, or year effects modeled as 1-year differences. Patterns of population change from the hierarchical model results generally were similar to the patterns described by stratified random sample estimates, but significant visibility differences occurred between twilight to midday counts in all species. Controlling for the effects of time of day resulted in larger population estimates for all species in the hierarchical model analysis relative to the stratified random sample analysis. The hierarchical models also provided a convenient means of estimating population trend as derived statistics from the analysis. We detected significant declines in mallard and American black ducks and significant increases in wood ducks and Canada geese, a trend that had not been significant for 3 of these 4 species in the prior analysis. We recommend using hierarchical models for analysis of the Atlantic Flyway Breeding Waterfowl Survey.

Colorectal adenoma recurrence rates among post-polypectomy patients in the placebo-controlled groups of randomized clinical trials: a meta-analysis

PubMed Central

Shi, Xin; Yang, Zhiping; Wu, Qiong; Fan, Daiming

2017-01-01

Background Evidence regarding the benefit of therapy to prevent the post-polypectomy recurrence of colorectal adenoma is limited. Endoscopic recurrence is the main outcome according to an evaluation of trials involving recurrence prevention. Aim To estimate the recurrence rates of post-polypectomy colorectal adenoma in placebo-controlled arms of randomized clinical trials and to identify the prognostic factors influencing these rates. Methods We combined data from all randomized controlled trials evaluating therapies for colorectal adenoma using placebo from 1988 to 2016. The data were combined in a random-effects model. Primary outcomes were endoscopic adenoma and advanced adenoma recurrence of colorectal adenoma. Results The pooled estimates of the adenoma recurrence rates were 37% (95% confidence interval [CI], 33%-41%; range, 33%-52%) at 1 year, 47% (95% CI, 41%-54%; range, 46%-51%) at 2 years, 41% (95% CI, 33%-48%; range, 20%-61%) at 3 years, 48% (95% CI, 38%-57%; range, 37%-53%) at 4 years, and 60% (95% CI, 52%-68%; range, 48%-68%) at 5 years. The pooled estimates of the advanced adenoma recurrence rates were 10% (95% CI, 6%-15%; range, 7%-13%) at 1 year, 12% (95% CI, 8%-16%; range, 3%-19%) at 3 years, 14% (95% CI, 10%-18%; range, 13%-16%) at 4 years, and 14% (95% CI, 10%-19%; range, 9%-21%) at 5 years. Significant heterogeneity among the randomized clinical trials (P < 0.001) was observed for each recurrence rate. Conclusions This meta-analysis confirms the heterogeneity of recurrence rates among post-polypectomy colorectal adenoma patients who received placebo. No single design variable was identified that might explain the heterogeneity. PMID:28977952

The 40-Something randomized controlled trial to prevent weight gain in mid-age women.

PubMed

Williams, Lauren T; Hollis, Jenna L; Collins, Clare E; Morgan, Philip J

2013-10-25

Obesity prevention is a major public health priority. Despite the health risks associated with weight gain, there has been a distinct lack of research into effective interventions to prevent, rather than treat, obesity particularly at high risk life stages such as menopause in women. This paper describes the rationale for and design of a 2-year randomized controlled trial (RCT) (the 40-Something Study) aimed at testing the feasibility and efficacy of a relatively low intensity intervention designed to achieve weight control in non-obese women about to enter the menopause transition. The study is a parallel-group RCT consisting of 12 months of intervention (Phase 1) and 12 months of monitoring (Phase 2). Non-obese pre-menopausal healthy females 44-50 years of age were screened, stratified according to Body Mass Index (BMI) category (18.5-24.9 and 25-29.9 kg/m²) and randomly assigned to one of two groups: motivational interviewing (MI) intervention (n = 28), or a self-directed intervention (SDI) (control) (n = 26). The MI intervention consisted of five consultations with health professionals (four with a Dietitian and one with an Exercise Physiologist) who applied components of MI counselling to consultations with the women over a 12 month period. The SDI was developed as a control and these participants received print materials only. Outcome measures were collected at baseline, three, 12, 18 and 24 months and included weight (primary outcome), waist circumference, body composition, blood pressure, plasma markers of metabolic syndrome risk, dietary intake, physical activity and quality of life. Analysis of covariance will be used to investigate outcomes according to intervention type and duration (comparing baseline, 12 and 24 months). The 40-Something study is the first RCT aimed at preventing menopausal weight gain in Australian women. Importantly, this paper describes the methods used to evaluate whether a relatively low intensity, health professional led intervention will achieve better weight control in pre-menopausal women than a self-directed intervention. The results will add to the scant body of literature on obesity prevention methods at an under-researched high-risk life stage, and inform the development of population-based interventions. ACTRN12611000064909.

CHAMP: Cognitive behaviour therapy for health anxiety in medical patients, a randomised controlled trial

PubMed Central

2011-01-01

Background Abnormal health anxiety, also called hypochondriasis, has been successfully treated by cognitive behaviour therapy (CBT) in patients recruited from primary care, but only one pilot trial has been carried out among those attending secondary medical clinics where health anxiety is likely to be more common and have a greater impact on services. The CHAMP study extends this work to examine both the clinical and cost effectiveness of CBT in this population. Method/Design The study is a randomized controlled trial with two parallel arms and equal randomization of 466 eligible patients (assuming a 20% drop-out) to an active treatment group of 5-10 sessions of cognitive behaviour therapy and to a control group. The aim at baseline, after completion of all assessments but before randomization, was to give a standard simple explanation of the nature of health anxiety for all participants. Subsequently the control group was to receive whatever care might usually be available in the clinics, which is normally a combination of clinical assessment, appropriate tests and reassurance. Those allocated to the active treatment group were planned to receive between 5 and 10 sessions of an adapted form of cognitive behaviour therapy based on the Salkovskis/Warwick model, in which a set of treatment strategies are chosen aimed at helping patients understand the factors that drive and maintain health anxiety. The therapy was planned to be given by graduate research workers, nurses or other health professionals trained for this intervention whom would also have their competence assessed independently during the course of treatment. The primary outcome is reduction in health anxiety symptoms after one year and the main secondary outcome is the cost of care after two years. Discussion This represents the first trial of adapted cognitive behaviour therapy in health anxiety that is large enough to test not only the clinical benefits of treatment but also whether the cost of treatment is offset by savings from reduced use of other health services in comparison to the control group. Cognitive behaviour therapy for Health Anxiety in Medical Patients (CHAMP) Trial registration Current Controlled Trials ISRCTN14565822 PMID:21672205

Percutaneous Ventricular Assist Devices: A Health Technology Assessment.

PubMed

2017-01-01

Percutaneous coronary intervention (PCI)-using a catheter to place a stent to keep blood vessels open-is increasingly used for high-risk patients who cannot undergo surgery. Cardiogenic shock (when the heart suddenly cannot pump enough blood) is associated with a high mortality rate. The percutaneous ventricular assist device can help control blood pressure and increase blood flow in these high-risk conditions. This health technology assessment examined the benefits, harms, and budget impact of the Impella percutaneous ventricular assist device in high-risk PCI and cardiogenic shock. We also analyzed cost-effectiveness of the Impella device in high-risk PCI. We performed a systematic search of the literature for studies examining the effects of the Impella percutaneous ventricular assist device in high-risk PCI and cardiogenic shock, and appraised the evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria, focusing on hemodynamic stability, mortality, major adverse cardiac events, bleeding, and vascular complications. We developed a Markov decision-analytical model to assess the cost- effectiveness of Impella devices versus intra-aortic balloon pumps (IABPs), calculated incremental cost-effectiveness ratios (ICERs) using a 10-year time horizon, and conducted sensitivity analyses to examine the robustness of the estimates. The economic model was conducted from the perspective of the Ontario Ministry of Health and Long-Term Care. Eighteen studies (one randomized controlled trial and 10 observational studies for high-risk PCI, and one randomized controlled trial and six observational studies for cardiogenic shock) were included in the clinical review. Compared with IABPs, Impella 2.5, one model of the device, improved hemodynamic parameters (GRADE low-very low) but showed no significant difference in mortality (GRADE low), major adverse cardiac events (GRADE low), bleeding (GRADE low), or vascular complications (GRADE low) in high-risk PCI and cardiogenic shock. No randomized controlled trials or prospective observational studies with a control group have studied Impella CP and Impella 5.0 (other models of the device) in patients undergoing high-risk PCI or patients with cardiogenic shock. The economic model predicted that treatment with the Impella device would have fewer quality-adjusted life-years (QALYs) and higher costs than IABP in high-risk PCI patients. These observations were consistent even when uncertainty in model inputs and parameters was considered. We estimated that adopting Impella would increase costs by $2.9 to $11.5 million per year. On the basis of evidence of low to very low quality, Impella 2.5 devices were associated with improved hemodynamic stability, but had mortality rates and safety profile similar to IABPs in high-risk PCI and cardiogenic shock. Our cost-effectiveness analysis indicated that Impella 2.5 is likely associated with greater costs and fewer quality-adjusted life years than IABP.

Pulsed electromagnetic fields after arthroscopic treatment for osteochondral defects of the talus: double-blind randomized controlled multicenter trial

PubMed Central

van Bergen, Christiaan JA; Blankevoort, Leendert; de Haan, Rob J; Sierevelt, Inger N; Meuffels, Duncan E; d'Hooghe, Pieter RN; Krips, Rover; van Damme, Geert; van Dijk, C Niek

2009-01-01

Background Osteochondral talar defects usually affect athletic patients. The primary surgical treatment consists of arthroscopic debridement and microfracturing. Although this is mostly successful, early sport resumption is difficult to achieve, and it can take up to one year to obtain clinical improvement. Pulsed electromagnetic fields (PEMFs) may be effective for talar defects after arthroscopic treatment by promoting tissue healing, suppressing inflammation, and relieving pain. We hypothesize that PEMF-treatment compared to sham-treatment after arthroscopy will lead to earlier resumption of sports, and aim at 25% increase in patients that resume sports. Methods/Design A prospective, double-blind, randomized, placebo-controlled trial (RCT) will be conducted in five centers throughout the Netherlands and Belgium. 68 patients will be randomized to either active PEMF-treatment or sham-treatment for 60 days, four hours daily. They will be followed-up for one year. The combined primary outcome measures are (a) the percentage of patients that resume and maintain sports, and (b) the time to resumption of sports, defined by the Ankle Activity Score. Secondary outcome measures include resumption of work, subjective and objective scoring systems (American Orthopaedic Foot and Ankle Society – Ankle-Hindfoot Scale, Foot Ankle Outcome Score, Numeric Rating Scales of pain and satisfaction, EuroQol-5D), and computed tomography. Time to resumption of sports will be analyzed using Kaplan-Meier curves and log-rank tests. Discussion This trial will provide level-1 evidence on the effectiveness of PEMFs in the management of osteochondral ankle lesions after arthroscopy. Trial registration Netherlands Trial Register (NTR1636) PMID:19591674

A randomized nutrition counseling intervention in pediatric leukemia patients receiving steroids results in reduced caloric intake.

PubMed

Li, Rhea; Donnella, Hayley; Knouse, Phillip; Raber, Margaret; Crawford, Karla; Swartz, Maria C; Wu, Jimin; Liu, Diane; Chandra, Joya

2017-02-01

Quality of life in survivors of pediatric acute lymphocytic leukemia (ALL) can be compromised by chronic diseases including increased risk of second cancers, cardiovascular disease, and diabetes. Overweight or obesity further increases these risks. Steroids are a component of chemotherapy for ALL, and weight gain is a common side effect. To impact behaviors associated with weight gain, we conducted a randomized nutrition counseling intervention in ALL patients on treatment. ALL patients on a steroid-based treatment regimen at the MD Anderson Children's Cancer Hospital were recruited and randomized into control or intervention groups. The control group received standard care and nutrition education materials. The intervention group received monthly one-on-one nutrition counseling sessions, consisting of a baseline and 12 follow-up visits. Anthropometrics, dietary intake (3-day 24-hr dietary recalls) and oxidative stress measures were collected at baseline, 6 months, and postintervention. Dietary recall data were analyzed using the Nutrition Data System for Research. Twenty-two patients (median age 11.5 years), all in the maintenance phase of treatment, were recruited. The intervention group (n = 12) reported significantly lower calorie intake from baseline to 12-month follow-up and significant changes in glutamic acid and selenium intake (P < 0.05). Waist circumference was significantly associated with calorie, vitamin E, glutamic acid, and selenium intake. A year-long dietary intervention was effective at reducing caloric intake in pediatric ALL patients receiving steroid-based chemotherapy, indicating that this is a modality that can be built upon for obesity prevention and management. © 2016 Wiley Periodicals, Inc.

Comparison of two different rehabilitation programmes for thrust plate prosthesis: a randomized controlled study.

PubMed

Unver, Bayram; Karatosun, Vasfi; Gunal, Izge; Angin, Salih

2004-02-01

Weight bearing after total hip arthroplasty is postponed in order to prevent early loosening, but this negatively affects the rehabilitation programme. For the force transfer characteristics of thrust plate prosthesis (TPP), a new type of hip prosthesis used without cement is similar to the normal hip. We evaluated the possibilities of early weight bearing after TPP by comparing early partial with early full weight bearing. Randomized controlled study. Department of orthopaedics and traumatology in a university hospital. Sixty hips of 51 patients who underwent total hip arthroplasty with TPP were randomly assigned into two groups. Both groups received accelerated rehabilitation programmes: group 1 with early partial weight bearing and group 2 with early full weight bearing. Patients were evaluated by a blind observer preoperatively, at three months after surgery by clinical (measurement of range of hip motion (universal goniometry), muscle strength (Manual Muscle Test), functional test (6-minute walk test), hip function (Harris Hip Scoring System)) and radiographical parameters and one year after surgery by clinical (Harris Hip Scoring System) and radiographical parameters. Group 2 performed transfer activities earlier, had more walking distance at the time of discharge and shorter hospital stay than group 1. At three months, Harris Hip Score, muscle strength, 6-minute walk test, and duration of crutch use were significantly (p < 0.05) in favour of group 2. None of the patients in either group showed signs of loosening one year after the operation. These results suggest that patients with TPP can tolerate an accelerated rehabilitation programme with early weight bearing and will gain the goals of rehabilitation earlier.

Action seniors! - secondary falls prevention in community-dwelling senior fallers: study protocol for a randomized controlled trial.

PubMed

Liu-Ambrose, Teresa; Davis, Jennifer C; Hsu, Chun Liang; Gomez, Caitlin; Vertes, Kelly; Marra, Carlo; Brasher, Penelope M; Dao, Elizabeth; Khan, Karim M; Cook, Wendy; Donaldson, Meghan G; Rhodes, Ryan; Dian, Larry

2015-04-10

Falls are a 'geriatric giant' and are the third leading cause of chronic disability worldwide. About 30% of community-dwellers over the age of 65 experience one or more falls every year leading to significant risk for hospitalization, institutionalization, and even death. As the proportion of older adults increases, falls will place an increasing demand and cost on the health care system. Exercise can effectively and efficiently reduce falls. Specifically, the Otago Exercise Program has demonstrated benefit and cost-effectiveness for the primary prevention of falls in four randomized trials of community-dwelling seniors. Although evidence is mounting, few studies have evaluated exercise for secondary falls prevention (that is, preventing falls among those with a significant history of falls). Hence, we propose a randomized controlled trial powered for falls that will, for the first time, assess the efficacy and efficiency of the Otago Exercise Program for secondary falls prevention. A randomized controlled trial among 344 community-dwelling seniors aged 70 years and older who attend a falls prevention clinic to assess the efficacy and the cost-effectiveness of a 12-month Otago Exercise Program intervention as a secondary falls prevention strategy. Participants randomized to the control group will continue to behave as they did prior to study enrolment. The economic evaluation will examine the incremental costs and benefits generated by using the Otago Exercise Program intervention versus the control. The burden of falls is significant. The challenge is to make a difference - to discover effective, ideally cost-effective, interventions that prevent injurious falls that can be readily translated to the population. Our proposal is very practical - the exercise program requires minimal equipment, the physical therapist expertise is widely available, and seniors in Canada and elsewhere have adopted the program and complied with it. Our innovation includes applying the intervention to a targeted high-risk population, aiming to provide the best value for money. Given society's limited financial resources and the known and increasing burden of falls, there is an urgent need to test this feasible intervention which would be eminently ready for roll out. ClinicalTrials.gov Protocol Registration System: NCT01029171; registered 7 December 2009.

Effectiveness of Facebook-Delivered Lifestyle Counselling and Physical Activity Self-Monitoring on Physical Activity and Body Mass Index in Overweight and Obese Adolescents: A Randomized Controlled Trial.

PubMed

Ruotsalainen, Heidi; Kyngäs, Helvi; Tammelin, Tuija; Heikkinen, Hanna; Kääriäinen, Maria

2015-01-01

Background. The aim was to evaluate the effects of a 12-week, Facebook-delivered lifestyle counselling intervention, with or without physical activity self-monitoring, on physical activity and body mass index (BMI) in overweight and obese 13-16-year-old adolescents. Methods. Three-arm randomized controlled trial. Participants (n = 46) were randomly assigned to intervention and control groups: one group received Facebook-delivered lifestyle counselling and monitoring of their physical activity (Fb + Act, n = 15), whereas a second experimental group received the same Facebook-delivered lifestyle counselling without self-monitoring (Fb, n = 16) and a third group served as the control group (n = 15). Objective and self-reported physical activity assessment were used. Nonparametric statistical tests were used. Results. There were no significant intervention effects in terms of changes in physical activity levels or BMI from baseline to the 12-week postintervention measurements between the intervention and control groups. The Fb + Act group had lower sedentary time on weekdays compared to the control group during postintervention measurements (p = 0.021), but there was no interaction between time and group. Conclusions. Interventions were not effective at increasing physical activity in overweight and obese adolescents. Before implementing such interventions, more evaluations on their effectiveness are needed. This trial is registered with ClinicalTrials.gov identifier NCT02295761 (2014-11-17).

Effectiveness of the addition of citicoline to patching in the treatment of amblyopia around visual maturity: A randomized controlled trial

PubMed Central

Pawar, Prachee Vasant; Mumbare, Sachin S; Patil, Mrunal Suresh; Ramakrishnan, Seema

2014-01-01

Aim: To study the effectiveness of the addition of citicoline to patching in the treatment of amblyopia in the age group of 4-13 years. Materials and Methods: A randomized controlled trial, which included patients who were randomly divided into two groups. Both the groups received patching therapy till plateau was achieved in phase 1 of the study. Then in phase 2, group I received citicoline plus patching and group II continued to receive only patching. Outcome Measures: Outcome was measured by the visual acuity in logMAR every month in phase 1 till plateau was achieved and then for 12 months in phase 2. Results: No significant difference was found in the mean visual acuities in these two groups in phase 1 till plateau was reached. In phase 2, for the initial four months, there was no significant difference in the visual acuities in these two groups, at the respective intervals. However, five months onward, up to 12 months, there was a significant difference in the visual acuities in these groups. The result was the same in younger patients (< seven years of age) as well as in older patients (> seven years of age). In phase 2, the mean proportional improvement in group I was significantly more than that in group II, at two months and onward, at the respective intervals. Conclusion: The improvement in visual acuity with citicoline plus patching was significantly more than that with patching alone, in one year of treatment. PMID:24618483

Postural insoles on gait in children with cerebral palsy: Randomized controlled double-blind clinical trial.

PubMed

Pasin Neto, Hugo; Grecco, Luanda André Collange; Ferreira, Luis Alfredo Braun; Duarte, Natália Almeida Carvalho; Galli, Manuela; Oliveira, Claudia Santos

2017-10-01

The aim of the present study was to assess the effect of postural insoles on gait performance in children with Cerebral Palsy (CP). Twenty four children between four and 12 years of age were randomly allocated either the control group (n = 12) or experimental group (n = 12). The control group used placebo insoles and the experimental group used postural insoles. Three-dimensional gait analysis was performed under three conditions: barefoot, in shoes and in shoes with insoles. Three evaluations were carried out: 1)immediately following placement of the insoles; 2)after three months of insole use; and 3)one month after suspending insole use. Regarding the immediate effects and after three months use of insole, significant improvements in gait velocity and cadence were found in the experimental group, along with an increase in foot dorsiflexion, a reduction in knee flexion and a reduction in internal rotation. Conversely, these changes were not maintained in the third assessment, one month after withdrawal of the insoles. The use of postural insoles led to improvements in gait performance in children with CP. Copyright © 2017 Elsevier Ltd. All rights reserved.

Effectiveness of a Chlorhexidine Digluconate 0.12% and Cetylpyridinium Chloride 0.05% Solution in eliminating Candida albicans Colonizing Dentures: A Randomized Clinical in vivo Study.

PubMed

Aoun, Georges; Cassia, Antoine; Berberi, Antoine

2015-06-01

Effective denture hygiene is important for patients suffering from denture stomatitis (DS). This study aimed to evaluate the efficacy of a solution containing 0.12% chlorhexidine (CHX) digluconate and 0.05% cetylpyridinium chloride (CPC) in eliminating Candida albicans colonizing dentures. Forty denture wearers (11 men, 29 women; age range 40 to 80 years) with clinical evidence of DS were randomly divided into two groups, one test and one control. The dentures of the test group were treated by immersion in a solution of 0.12% CHX and 0.05% CPC while those of the control group were immersed in distilled water. Swabs were collected from the fitting surfaces of the upper dentures prior and post cleaner use and examined mycologically. Reduction in the number of colony-forming units (CFU) of Candida albicans after immersion of the dentures in a solution of 0.12% CHX and 0.05% CPC was significantly greater than that of the control group. A solution of 0.12% CHX and 0.05% CPC tested as a product of disinfection of the acrylic dentures showed significant results after immersion of 8 night hours for 4 days.

A randomized control trial of interventions in school-aged children with auditory processing disorders.

PubMed

Sharma, Mridula; Purdy, Suzanne C; Kelly, Andrea S

2012-07-01

The primary purpose of the study was to compare intervention approaches for children with auditory processing disorder (APD): bottom-up training including activities focused on auditory perception, discrimination, and phonological awareness, and top-down training including a range of language activities. Another purpose was to determine the benefits of personal FM systems. The study is a randomized control trial where participants were allocated to groups receiving one of the two interventions, with and without personal FM, or to the no intervention group. The six-week intervention included weekly one-hour sessions with a therapist in the clinic, plus 1-2 hours per week of parent-directed homework. 55 children (7 to 13 years) with APD participated in the study. Intervention outcomes included reading, language, and auditory processing. Positive outcomes were observed for both training approaches and personal FM systems on several measures. Pre-intervention nonverbal IQ, age, and severity of APD did not influence outcomes. Performance of control group participants did not change when retested after the intervention period. Both intervention approaches were beneficial and there were additional benefits with the use of personal FM. Positive results were not limited to the areas specifically targeted by the interventions.

10-year results of a new low-monomer cement: follow-up of a randomized RSA study.

PubMed

Söderlund, Per; Dahl, Jon; Röhrl, Stephan; Nivbrant, Bo; Nilsson, Kjell G

2012-12-01

The properties and performance of a new low-monomer cement were examined in this prospective randomized, controlled RSA study. 5-year data have already been published, showing no statistically significant differences compared to controls. In the present paper we present the 10-year results. 44 patients were originally randomized to receive total hip replacement with a Lubinus SPII titanium-aluminum-vanadium stem cemented either with the new Cemex Rx bone cement or with control bone cement, Palacos R. Patients were examined using RSA, Harris hip score, and conventional radiographs. At 10 years, 33 hips could be evaluated clinically and 30 hips could be evaluated with RSA (16 Cemex and 14 Palacos). 9 patients had died and 4 patients were too old or infirm to be investigated. Except for 1 hip that was revised for infection after less than 5 years, no further hips were revised before the 10-year follow-up. There were no statistically significant clinical differences between the groups. The Cemex cement had magnitudes of migration similar to or sometimes lower than those of Palacos cement. In both groups, most hips showed extensive radiolucent lines, probably due to the use of titanium alloy stems. At 10 years, the Cemex bone cement tested performed just as well as the control (Palacos bone cement).

Progesterone increases resistance of ophthalmic and central retinal arteries in climacteric women.

PubMed

Souza, M A M De; Souza, B M De; Geber, S

2013-04-01

To evaluate the effect of a synthetic progestin on the vascular resistance of the ophthalmic and central retinal arteries in climacteric women, compared to placebo, using transorbital ultrasound with Doppler velocimetry. We performed a prospective, randomized, double-blinded, placebo-controlled study with 216 climacteric women. Subjects were randomly allocated to one of two groups: either the group receiving placebo (one pill/day for 30 days) (n = 108) or the group receiving progestin (5 mg medroxyprogesterone acetate/day for 30 days) (n = 108). Transorbital Doppler velocimetric ultrasound was performed, before and after treatment; we measured the pulsatility index, resistance index and systole/diastole ratio. The mean ages of the participants in the study group and the control group were 54 ± 6.2 years (range 48-59 years) and 55 ± 6.8 years (range 46-60 years), respectively. When we compared the effect of the progestin on the central retinal artery before and after treatment, we observed a significant increase after the treatment in all Doppler indices. The same was observed when we compared the effect of the progestin on the ophthalmic artery. In the group of women receiving placebo, the Doppler indices were similar before and after treatment. Our results demonstrate the existence of a progestogenic vasoconstrictive effect in the ophthalmic and central retinal arteries. As this study provides new data, the observed effect needs further investigations to better elucidate its extent. Moreover, our findings may be particularly useful to others interested in understanding the vascular dynamics of the cerebral vessels and to researchers running clinical trials related to hormone replacement therapy.

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

PubMed

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

2011-04-14

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

Comparison of clinical efficacy and safety of thermotherapy versus cryotherapy in treatment of skin warts: A randomized controlled trial.

PubMed

Izadi Firouzabadi, Leila; Khamesipour, Ali; Ghandi, Narges; Hosseini, Hamed; Teymourpour, Amir; Firooz, Alireza

2018-01-01

The effect of thermotherapy in the treatment of skin warts in comparison to cryotherapy, as the standard conventional method, has remained uncertain. This study aimed to assess the clinical efficacy and safety of thermotherapy and cryotherapy in removing skin warts. This randomized controlled trial was conducted on 52 patients aged 18 years and over with ≤ 10 skin warts. The participants were randomly assigned into two groups to receive cryotherapy (every 2 to 3 weeks up to six sessions if required) or thermotherapy (one session). The patients in both groups were followed every 2 to 3 weeks for the first three months, and then three months after the last treatment session. The clearance rate was 79.2% in the thermotherapy group and 58.3% in the cryotherapy group with no significant difference (p = 0.212). The rate of scarring in the thermotherapy group was 20% (p = .018). A higher clearance rate was achieved in the thermotherapy group. However, this result was not statistically significant. There were some minimal post-treatment complications. Patients needed only one session of thermotherapy. Due to the risk of scarring, we suggest thermotherapy only as a suitable treatment method for palmoplantar warts. © 2017 Wiley Periodicals, Inc.

Clinical outcomes of immediate/early loading of dental implants. A literature review of recent controlled prospective clinical studies.

PubMed

Sennerby, L; Gottlow, J

2008-06-01

Two previous reviews have evaluated the clinical outcomes of immediate/early loading of dental implants based on studies published until 2005.(1,2) The aim of the present paper was to review controlled clinical studies on the subject published since 2005 including at least 10 patients in each group followed for at least one year in function. Six comparative studies were found and none of these showed any differences in survival rates or marginal bone loss after one to five years. Most authors used specified inclusion criteria to avoid known risk factors such as soft bone, short implants and bruxism. Data from one randomized study in the edentulous maxilla showed no differences between early and delayed loading in consecutive clinical routine cases including short implants and soft bone. Three additional studies comparing different surfaces or implant designs under immediate loading were reviewed. No differences between implants with a moderately rough or smooth surface topography were observed. The data add to the previous bulk of evidence that various designs of implants can be loaded shortly after their placement in both the mandible and the maxilla. However, one study reported on marginal bone loss around a novel one-piece implant design leading to implant failure which was not seen for control two-piece implants.(3).

A Controlled Study of Funding for Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome as Resource Capacity Building in the Health System in Rwanda

PubMed Central

Shepard, Donald S.; Zeng, Wu; Amico, Peter; Rwiyereka, Angelique K.; Avila-Figueroa, Carlos

2012-01-01

Because human inmmunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) receives more donor funding globally than that for all other diseases combined, some critics allege this support undermines general health care. This empirical study evaluates the impact of HIV/AIDS funding on the primary health care system in Rwanda. Using a quasi-experimental design, we randomly selected 25 rural health centers (HCs) that started comprehensive HIV/AIDS services from 2002 through 2006 as the intervention group. Matched HCs with no HIV/AIDS services formed the control group. The analysis compared growth in inputs and services between intervention and control HCs with a difference-in-difference analysis in a random-effects model. Intervention HCs performed better than control HCs in most services (seven of nine), although only one of these improvements (Bacille Calmette-Guérin vaccination) reached or approached statistical significance. In conclusion, this six-year controlled study found no adverse effects of the expansion of HIV/AIDS services on non-HIV services among rural health centers in Rwanda. PMID:22556094

A controlled study of funding for human immunodeficiency virus/acquired immunodeficiency syndrome as resource capacity building in the health system in Rwanda.

PubMed

Shepard, Donald S; Zeng, Wu; Amico, Peter; Rwiyereka, Angelique K; Avila-Figueroa, Carlos

2012-05-01

Because human inmmunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) receives more donor funding globally than that for all other diseases combined, some critics allege this support undermines general health care. This empirical study evaluates the impact of HIV/AIDS funding on the primary health care system in Rwanda. Using a quasi-experimental design, we randomly selected 25 rural health centers (HCs) that started comprehensive HIV/AIDS services from 2002 through 2006 as the intervention group. Matched HCs with no HIV/AIDS services formed the control group. The analysis compared growth in inputs and services between intervention and control HCs with a difference-in-difference analysis in a random-effects model. Intervention HCs performed better than control HCs in most services (seven of nine), although only one of these improvements (Bacille Calmette-Guérin vaccination) reached or approached statistical significance. In conclusion, this six-year controlled study found no adverse effects of the expansion of HIV/AIDS services on non-HIV services among rural health centers in Rwanda.

A Randomized Trial of Soft Multifocal Contact Lenses for Myopia Control: Baseline Data and Methods.

PubMed

Walline, Jeffrey J; Gaume Giannoni, Amber; Sinnott, Loraine T; Chandler, Moriah A; Huang, Juan; Mutti, Donald O; Jones-Jordan, Lisa A; Berntsen, David A

2017-09-01

The Bifocal Lenses In Nearsighted Kids (BLINK) study is the first soft multifocal contact lens myopia control study to compare add powers and measure peripheral refractive error in the vertical meridian, so it will provide important information about the potential mechanism of myopia control. The BLINK study is a National Eye Institute-sponsored, double-masked, randomized clinical trial to investigate the effects of soft multifocal contact lenses on myopia progression. This article describes the subjects' baseline characteristics and study methods. Subjects were 7 to 11 years old, had -0.75 to -5.00 spherical component and less than 1.00 diopter (D) astigmatism, and had 20/25 or better logMAR distance visual acuity with manifest refraction in each eye and with +2.50-D add soft bifocal contact lenses on both eyes. Children were randomly assigned to wear Biofinity single-vision, Biofinity Multifocal "D" with a +1.50-D add power, or Biofinity Multifocal "D" with a +2.50-D add power contact lenses. We examined 443 subjects at the baseline visits, and 294 (66.4%) subjects were enrolled. Of the enrolled subjects, 177 (60.2%) were female, and 200 (68%) were white. The mean (± SD) age was 10.3 ± 1.2 years, and 117 (39.8%) of the eligible subjects were younger than 10 years. The mean spherical equivalent refractive error, measured by cycloplegic autorefraction was -2.39 ± 1.00 D. The best-corrected binocular logMAR visual acuity with glasses was +0.01 ± 0.06 (20/21) at distance and -0.03 ± 0.08 (20/18) at near. The BLINK study subjects are similar to patients who would routinely be eligible for myopia control in practice, so the results will provide clinical information about soft bifocal contact lens myopia control as well as information about the mechanism of the treatment effect, if one occurs.

Glutamate in Pediatric Obsessive-Compulsive Disorder and Response to Cognitive-Behavioral Therapy: Randomized Clinical Trial.

PubMed

O'Neill, Joseph; Piacentini, John; Chang, Susanna; Ly, Ronald; Lai, Tsz M; Armstrong, Casey C; Bergman, Lindsey; Rozenman, Michelle; Peris, Tara; Vreeland, Allison; Mudgway, Ross; Levitt, Jennifer G; Salamon, Noriko; Posse, Stefan; Hellemann, Gerhard S; Alger, Jeffry R; McCracken, James T; Nurmi, Erika L

2017-11-01

Cognitive-behavioral therapy (CBT) is effective for pediatric obsessive-compulsive disorder (OCD), but non-response is common. Brain glutamate (Glu) signaling may contribute to OCD pathophysiology and moderate CBT outcomes. We assessed whether Glu measured with magnetic resonance spectroscopy (MRS) was associated with OCD and/or CBT response. Youths aged 7-17 years with DSM-IV OCD and typically developing controls underwent 3 T proton echo-planar spectroscopic imaging (PEPSI) MRS scans of pregenual anterior cingulate cortex (pACC) and ventral posterior cingulate cortex (vPCC)-regions possibly affected by OCD-at baseline. Controls returned for re-scan after 8 weeks. OCD youth-in a randomized rater-blinded trial-were re-scanned after 12-14 weeks of CBT or after 8 weeks of minimal-contact waitlist; waitlist participants underwent a third scan after crossover to 12-14 weeks of CBT. Forty-nine children with OCD (mean age 12.2±2.9 years) and 29 controls (13.2±2.2 years) provided at least one MRS scan. At baseline, Glu did not differ significantly between OCD and controls in pACC or vPCC. Within controls, Glu was stable from scan-to-scan. Within OCD subjects, a treatment-by-scan interaction (p=0.034) was observed, driven by pACC Glu dropping 19.5% from scan-to-scan for patients randomized to CBT, with minor increases (3.8%) for waitlist participants. The combined OCD participants (CBT-only plus waitlist-CBT) also showed a 16.2% (p=0.004) post-CBT decrease in pACC Glu. In the combined OCD group, within vPCC, lower pre-CBT Glu predicted greater post-CBT improvement in symptoms (CY-BOCS; r=0.81, p=0.00025). Glu may be involved in the pathophysiology of OCD and may moderate response to CBT.

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

A Brief History of Placebos and Clinical Trials in Psychiatry

PubMed Central

Shorter, Edward

2013-01-01

The history of placebos in psychiatry can be understood only in the context of randomized controlled trials (RCTs). Placebo treatments are as old as medicine itself, and are particularly effective in dealing with psychosomatic symptoms. In psychiatry, placebos have mainly been featured in clinical drug trials. The earliest controlled trial in psychiatry (not involving drugs) occurred in 1922, followed by the first crossover studies during the 1930s. Meanwhile the concept of randomization was developed during the interwar years by British statistician Ronald A Fisher, and introduced in 3 trials of tuberculosis drugs between 1947 and 1951. These classic studies established the RCT as the gold standard in pharmaceutical trials, and its status was cemented during the mid-1950s. Nevertheless, while the placebo became established as a standard measure of drug action, placebo treatments became stigmatized as unethical. This is unfortunate, as they constitute one of the most powerful therapies in psychiatry. In recent years, moreover, the dogma of the placebo-controlled trial as the only acceptable data for drug licensing is also being increasingly discredited. This backlash has had 2 sources: one is the recognition that the US Food and Drug Administration has been too lax in permitting trials controlled with placebos alone, rather than also using an active agent as a test of comparative efficacy. In addition, there is evidence that in the hands of the pharmaceutical industry, the scientific integrity of RCTs themselves has been degraded into a marketing device. The once-powerful placebo is thus threatened with extinction. PMID:21507275

PARot – assessing platelet-rich plasma plus arthroscopic subacromial decompression in the treatment of rotator cuff tendinopathy: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Platelet-rich plasma (PRP) is an autologous platelet concentrate. It is prepared by separating the platelet fraction of whole blood from patients and mixing it with an agent to activate the platelets. In a clinical setting, PRP may be reapplied to the patient to improve and hasten the healing of tissue. The therapeutic effect is based on the presence of growth factors stored in the platelets. Current evidence in orthopedics shows that PRP applications can be used to accelerate bone and soft tissue regeneration following tendon injuries and arthroplasty. Outcomes include decreased inflammation, reduced blood loss and post-treatment pain relief. Recent shoulder research indicates there is poor vascularization present in the area around tendinopathies and this possibly prevents full healing capacity post surgery (Am J Sports Med36(6):1171–1178, 2008). Although it is becoming popular in other areas of orthopedics there is little evidence regarding the use of PRP for shoulder pathologies. The application of PRP may help to revascularize the area and consequently promote tendon healing. Such evidence highlights an opportunity to explore the efficacy of PRP use during arthroscopic shoulder surgery for rotator cuff pathologies. Methods/Design PARot is a single center, blinded superiority-type randomized controlled trial assessing the clinical outcomes of PRP applications in patients who undergo shoulder surgery for rotator cuff disease. Patients will be randomized to one of the following treatment groups: arthroscopic subacromial decompression surgery or arthroscopic subacromial decompression surgery with application of PRP. The study will run for 3 years and aims to randomize 40 patients. Recruitment will be for 24 months with final follow-up at 1 year post surgery. The third year will also involve collation and analysis of the data. This study will be funded through the NIHR Biomedical Research Unit at the Oxford University Hospitals NHS Trust. Trial registration Current Controlled Trials: ISRCTN10464365 PMID:23758981

Registry-based randomized controlled trials merged the strength of randomized controlled trails and observational studies and give rise to more pragmatic trials.

PubMed

Mathes, Tim; Buehn, Stefanie; Prengel, Peggy; Pieper, Dawid

2018-01-01

The objective of this study was to analyze the features of registry-based randomized trials (rRCTs). We systematically searched PubMed for rRCTs. Study selection was performed independently by two reviewers. We extracted all data in standardized tables and prepared descriptive summary statistics. The search resulted in 1,202 hits. We included 71 rRCTs. Most rRCTs were from Denmark and Sweden. Chronic conditions were considered in 82.2%. A preventive intervention was examined in 45.1%. The median of included patients was 2,000 (range: 69-246,079). Definition of the study population was mostly broad. Study procedures were regularly little standardized. The number of included and analyzed patients was the same in 82.1%. In half of the rRCTs, more than one registry was utilized. Various linkage techniques were used. In median, two outcomes were collected from the registry/ies. The median follow-up of the rRCTs was 5.3 years (range: 6 weeks to 27 years). Information on quality of registry data was reported in 11.3%. rRCTs can provide valid (randomization, low lost-to-follow-up rates, generalizable) patient important long-term comparative-effectiveness data for relative little effort. Researchers planning an RCT should always check whether existing registries can be used for data collection. Reporting on data quality must be improved for use in evidence synthesis. Copyright © 2017 Elsevier Inc. All rights reserved.

Intake of low sodium salt substitute for 3years attenuates the increase in blood pressure in a rural population of North China - A randomized controlled trial.

PubMed

Zhou, Bo; Webster, Jacqui; Fu, Ling-Yu; Wang, Hai-Long; Wu, Xiao-Mei; Wang, Wen-Li; Shi, Jing-Pu

2016-07-15

Lowering salt intake is one of the successful and cost-effective methods to reduce blood pressure (BP). In this randomized controlled study, we investigated the effects of a 3-year substitution of table salt with a low-sodium salt substitute in a rural population of North China. Subjects from 200 families residing in five villages in Liaoning, North China were registered in this study and randomly divided into two groups: normal salt (100% sodium chloride) and low salt substitute (65% NaCl, 25% KCl, 10% MgSO4). We compared the effects of the low-sodium salt substitute and normal salt on differences in BP from baseline to various follow-up time points during this 3-year study period. We also examined several factors that may affect the long-term changes in BP. Hypertension was defined per World Health Organization guidelines as BP≥140/90mmHg. The low sodium substitute significantly reduced the increase in both systolic and diastolic BP compared with the regular salt (P=0.000). Also, the population aged 40-70years showed most beneficial response to the salt substitute compared with those aged <40 or >70years. The low salt substitute had similar beneficial effects in both males and females. In addition, the salt type consumed and body mass index significantly affected the change in BP. Use of the salt substitute significantly reduces the increase in BP over a long term, and thus, the salt substitute can be used as a replacement for regular salt in the daily diet to prevent/diminish the incidence of hypertension. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

A Mobile Health Intervention for Self-Management and Lifestyle Change for Persons With Type 2 Diabetes, Part 2: One-Year Results From the Norwegian Randomized Controlled Trial RENEWING HEALTH

PubMed Central

Torbjørnsen, Astrid; Wahl, Astrid Klopstad; Jenum, Anne Karen; Småstuen, Milada Cvancarova; Årsand, Eirik; Ribu, Lis

2014-01-01

Background Self-management is crucial in the daily management of type 2 diabetes. It has been suggested that mHealth may be an important method for enhancing self-management when delivered in combination with health counseling. Objective The objective of this study was to test whether the use of a mobile phone–based self-management system used for 1 year, with or without telephone health counseling by a diabetes specialist nurse for the first 4 months, could improve glycated hemoglobin A1c (HbA1c) level, self-management, and health-related quality of life compared with usual care. Methods We conducted a 3-arm prospective randomized controlled trial involving 2 intervention groups and 1 control group. Eligible participants were persons with type 2 diabetes with an HbA1c level ≥7.1% (≥54.1 mmol/mol) and aged ≥18 years. Both intervention groups received the mobile phone–based self-management system Few Touch Application (FTA). The FTA consisted of a blood glucose–measuring system with automatic wireless data transfer, diet manual, physical activity registration, and management of personal goals, all recorded and operated using a diabetes diary app on the mobile phone. In addition, one intervention group received health counseling based on behavior change theory and delivered by a diabetes specialist nurse for the first 4 months after randomization. All groups received usual care by their general practitioner. The primary outcome was HbA1c level. Secondary outcomes were self-management (heiQ), health-related quality of life (SF-36), depressive symptoms (CES-D), and lifestyle changes (dietary habits and physical activity). Data were analyzed using univariate methods (t test, ANOVA) and multivariate linear and logistic regression. Results A total of 151 participants were randomized: 51 to the FTA group, 50 to the FTA-health counseling (FTA-HC) group, and 50 to the control group. Follow-up data after 1 year were available for 120 participants (79%). HbA1c level decreased in all groups, but did not differ between groups after 1 year. The mean change in the heiQ domain skills and technique acquisition was significantly greater in the FTA-HC group after adjusting for age, gender, and education (P=.04). Other secondary outcomes did not differ between groups after 1 year. In the FTA group, 39% were substantial users of the app; 34% of the FTA-HC group were substantial users. Those aged ≥63 years used the app more than their younger counterparts did (OR 2.7; 95% CI 1.02-7.12; P=.045). Conclusions The change in HbA1c level did not differ between groups after the 1-year intervention. Secondary outcomes did not differ between groups except for an increase in the self-management domain of skill and technique acquisition in the FTA-HC group. Older participants used the app more than the younger participants did. PMID:25499872

Valeriana officinalis L. for conscious sedation of patients submitted to impacted lower third molar surgery: A randomized, double-blind, placebo-controlled split-mouth study.

PubMed

Pinheiro, Marcos Luciano Pimenta; Alcântara, Carlos Eduardo Pinto; de Moraes, Márcio; de Andrade, Eduardo Dias

2014-04-01

Anxiety is one of the components of patient stress in the dental office and is recognized as one of the main factors that negatively affect treatment. The control of anxiety can be performed through conscious sedation, for which benzodiazepine is the drug of choice in dental practice, however present side-effects. The objective of the following study is to evaluate the efficacy of Valeriana officinalis L. (Valerian) for control of anxiety during the third molar surgery. A single oral dose of either Valerian (100 mg) or placebo was randomly administered 1 h before each surgical procedure to 20 volunteers between 17 and 31 years of age. Anxiety level was assessed by physiological parameters (blood pressure and heart rate [HR]) and the observation of signs. Descriptive analysis, Chi-square test, Friedman test, Wilcoxon test and effect size test were performed (P < 0.05). According to the researcher's (80%) and surgeon's (75%) evaluations, the patients treated with Valerian were calmer and more relaxed during surgery. Valerian had a greater effect on the maintenance of systolic blood pressure and HR after surgery. Valerian was more effective at controlling anxiety than a placebo when used for the conscious sedation of adult patients submitted to impacted lower third molar surgery.

The impact of incentives on intrinsic and extrinsic motives for fitness-center attendance in college first-year students.

PubMed

Pope, Lizzy; Harvey, Jean

2015-01-01

A criticism of incentives for health behaviors is that incentives undermine intrinsic motivation. The objective of this study was to determine the impact of monetary incentive provision on participation motives for exercise in first-year college students at a northeastern public university. Randomized-controlled trial. Public university in the Northeastern United States. One hundred seventeen first-year college students. Participants were randomized to one of three conditions: a control condition receiving no incentives for meeting fitness-center attendance goals; a discontinued-incentive condition receiving weekly incentives during fall semester 2011, and no incentives during spring semester 2012; or a continued-incentive condition receiving weekly incentives during fall semester, and incentives on a variable-interval schedule during spring semester. The Exercise Motivation Inventory 2 measured exercise participation motives at baseline, end of fall semester, and end of spring semester. Fitness-center attendance was monitored by using ID-card check-in/check-out records. Repeated-measures analyses using linear mixed models with first-order autoregressive covariance structures were run to compare motive changes in the three conditions. Participation motives of Enjoyment and Revitalization associated with intrinsic motivation did not decrease significantly over time in any of the conditions, F(4, 218) = 2.25, p = .065 and F(4, 220) = 1.67, p = .16, respectively. Intrinsically associated participation motives for exercise did not decrease with incentive provision. Therefore, incentives may encourage fitness-center attendance without negatively impacting participation motives for exercise.

Conventional box model training improves laparoscopic skills during salpingectomy on LapSim: a randomized trial.

PubMed

Akdemir, Ali; Ergenoğlu, Ahmet Mete; Yeniel, Ahmet Özgür; Sendağ, Fatih

2013-01-01

Box model trainers have been used for many years to facilitate the improvement of laparoscopic skills. However, there are limited data available on box trainers and their impact on skill acquisition, assessed by virtual reality systems. Twenty-two Postgraduate Year 1 gynecology residents with no laparoscopic experience were randomly divided into one group that received structured box model training and a control group. All residents performed a salpingectomy on LapSim before and after the training. Performances before and after the training were assessed using LapSim and were recorded using objective parameters, registered by a computer system (time, damage, and economy of motion scores). There were initially no differences between the two groups. The box trainer group showed significantly greater improvement in time (p=0.01) and economy of motion scores (p=0.001) compared with the control group post-training. The present study confirmed the positive effect of low cost box model training on laparoscopic skill acquisition as assessed using LapSim. Novice surgeons should obtain practice on box trainers and teaching centers should make efforts to establish training laboratories.

Longitudinal follow-up comparison of educational interventions: multimedia textbook, traditional lecture, and printed textbook.

PubMed

D'Alessandro, D M; Kreiter, C D; Erkonen, W E; Winter, R J; Knapp, H R

1997-11-01

The goal of this prospective, interinstitutional study was to compare the long-term instructional effectiveness of a pediatric multimedia textbook (MMTB) to that of a standard lecture and a printed textbook. A randomized cohort of 89 3rd-year medical students from two institutions were initially evaluated from June 1992 to June 1993 and reevaluated in May 1994. Students were randomly assigned to one of four instructional groups: computer-aided instruction by means of MMTBs (n = 21), traditional lecture (n = 23), printed textbook (n = 19), and a control group (n = 26). After instruction, all groups were tested by means of a multiple choice test at the end of their pediatric clerkship; they were given this same test 11-22 months later. The long-term instructional effectiveness of the MMTB, printed textbook, and lecture were the same as that in the control group, as determined by analysis of variance of mean test scores. The educational advantage of MMTBs observed immediately after instruction was not detected 1 year later. Because attrition reduced statistical power, further research is necessary to determine how educational fading affects these instructional formats.

Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): Study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Laparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients can lead to significant morbidity and mortality. Percutaneous cholecystostomy may be an alternative treatment option but the current literature does not provide the surgical community with evidence based advice. Methods/Design The CHOCOLATE trial is a randomised controlled, parallel-group, superiority multicenter trial. High risk patients, defined as APACHE-II score 7-14, with acute calculous cholecystitis will be randomised to laparoscopic cholecystectomy or percutaneous cholecystostomy. During a two year period 284 patients will be enrolled from 30 high volume teaching hospitals. The primary endpoint is a composite endpoint of major complications within three months following randomization and need for re-intervention and mortality during the follow-up period of one year. Secondary endpoints include all other complications, duration of hospital admission, difficulty of procedures and total costs. Discussion The CHOCOLATE trial is designed to provide the surgical community with an evidence based guideline in the treatment of acute calculous cholecystitis in high risk patients. Trial Registration Netherlands Trial Register (NTR): NTR2666 PMID:22236534

Effect of self-consistency group intervention for adolescents with schizophrenia: An inpatient randomized controlled trial.

PubMed

She, Pan; Zeng, Hongling; Yang, Bingxiang

2016-02-01

The aim of the study was to explore the efficacy of structural group therapy on the self-consistency and congruence of inpatient adolescents with a diagnosis of schizophrenia. Sixty inpatient adolescents with schizophrenia were randomly assigned to an intervention group (n = 30) and a control group (n = 30). The intervention group was provided with a 12-session structural group therapy program for six weeks (1 h, two times per week), while the control group participated in a handicraft group. All patients were assessed with the Self-Consistency and Congruence Scale (SCCS) and the Positive and Negative Syndrome Scale (PANSS) at pretest, posttest, three-month and one-year follow-up. The results were analyzed using t-test and repeated measures ANOVA. The two groups had no significant difference at the pre-test of outcome measures (p > 0.05). Significant differences existed between the two groups in ego-dystonic, self-flexibility, SCCS scores, positive syndrome, general psychopathology and PANSS scores after the intervention (p < 0.05). At the three-month follow-up, ego-dystonic, self-flexibility and PANSS scores were also found to be significantly different between the two groups (p < 0.05). But the outcome measures were not significantly different between the two groups at the one-year follow-up. Structural group therapy in a mental health setting had a positive effect on improving self-consistency and congruence, positive symptoms and general psychopathology of inpatient adolescents with a diagnosis of schizophrenia. Copyright © 2015 Elsevier Ltd. All rights reserved.

PlanYourLifeSpan.org - an intervention to help seniors make choices for their fourth quarter of life: Results from the randomized clinical trial.

PubMed

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

2017-11-01

Few older adults contemplate their home support and health needs that may be required for aging-in-place. We sought to assess the efficacy of PlanYourLifespan.org (PYL), in influencing seniors' planning behaviors, perception of the importance of planning, and confidence accessing services. Randomized controlled trial, of adults, age ≥65 years in urban, suburban, rural areas of Texas, Illinois, Indiana. Among 385 participants, mean age was 71.9 years, 79.5% female. Between baseline and one-month follow-up, average planning behavior score increased 0.22 points in the PYL arm when compared to the attention control (AC) arm. After controlling for baseline, mean one-month planning behavior score was significantly higher in the PYL arm than in the AC arm (1.25 points, CI 0.37-2.12, p=0.005). Secondary analyses via longitudinal linear mixed modelling suggested a study arm-by-time interaction effect for both planning behavior (p=0.047 and perception of importance (p=0.05). Significant baseline covariates included self-efficacy, education, perceived social support, power of attorney, and history of stroke. PlanYourLifespan.org demonstrated efficacy in helping seniors plan for and communicate their health support needs. This free, nationally available tool may help individuals understand, plan, and communicate their options for their future support needs. Copyright © 2017 Elsevier B.V. All rights reserved.

[METHODS OF EVALUATION OF MUSCLE MASS: A SYSTEMATIC REVIEW OF RANDOMIZED CONTROLLED TRIALS].

PubMed

Moreira, Osvaldo Costa; de Oliveira, Cláudia Eliza Patrocínio; Candia-Luján, Ramón; Romero-Pérez, Ena Monserrat; de Paz Fernandez, José Antonio

2015-09-01

in recent years, research about muscle mass has gained popularity for their relationship to health. Thus precise measurement of muscle mass may have clinical application once may interfere with the diagnosis and prescription drug or drug treatment. to conduct a systematic review of the methods most used for evaluation of muscle mass in randomized controlled trials, with its advantages and disadvantages. we conducted a search of the data bases Pub- Med, Web of Science and Scopus, with words "muscle mass", "measurement", "assessment" and "evaluation", combined in this way: "muscle mass" AND (assessment OR measurement OR evaluation). 23 studies were recovered and analyzed, all in English. 69.56% only used a method for quantification of muscle mass; 69.57% used dual X-ray absorptiometry (DXA); in 45.46% the type of measure used was the body lean mass; and 51.61% chose the whole body as a site of measurement. in the randomized controlled trials analyzed the majority used just one method of assessment, with the DXA being the method most used, the body lean mass the measurement type most used and total body the most common site of measure. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Design, methods, and baseline characteristics of the Kids' Health Insurance by Educating Lots of Parents (Kids' HELP) trial: a randomized, controlled trial of the effectiveness of parent mentors in insuring uninsured minority children.

PubMed

Flores, Glenn; Walker, Candy; Lin, Hua; Lee, Michael; Fierro, Marco; Henry, Monica; Massey, Kenneth; Portillo, Alberto

2015-01-01

Six million US children have no health insurance, and substantial racial/ethnic disparities exist. The design, methods, and baseline characteristics are described for Kids' Health Insurance by Educating Lots of Parents (Kids' HELP), the first randomized, clinical trial of the effectiveness of Parent Mentors (PMs) in insuring uninsured minority children. Latino and African-American children eligible for but not enrolled in Medicaid/CHIP were randomized to PMs, or a control group receiving traditional Medicaid/CHIP outreach. PMs are experienced parents with ≥1 Medicaid/CHIP-covered children. PMs received two days of training, and provide intervention families with information on Medicaid/CHIP eligibility, assistance with application submission, and help maintaining coverage. Primary outcomes include obtaining health insurance, time interval to obtain coverage, and parental satisfaction. A blinded assessor contacts subjects monthly for one year to monitor outcomes. Of 49,361 candidates screened, 329 fulfilled eligibility criteria and were randomized. The mean age is seven years for children and 32 years for caregivers; 2/3 are Latino, 1/3 are African-American, and the mean annual family income is $21,857. Half of caregivers were unaware that their uninsured child is Medicaid/CHIP eligible, and 95% of uninsured children had prior insurance. Fifteen PMs completed two-day training sessions. All PMs are female and minority, 60% are unemployed, and the mean annual family income is $20,913. Post-PM-training, overall knowledge/skills test scores significantly increased, and 100% reported being very satisfied/satisfied with the training. Kids' HELP successfully reached target populations, met participant enrollment goals, and recruited and trained PMs. Copyright © 2014 Elsevier Inc. All rights reserved.

Design, methods, and baseline characteristics of the Kids’ Health Insurance by Educating Lots of Parents (Kids’ HELP) trial: A randomized, controlled trial of the effectiveness of parent mentors in insuring uninsured minority children✰

PubMed Central

Flores, Glenn; Walker, Candy; Lin, Hua; Lee, Michael; Fierro, Marco; Henry, Monica; Massey, Kenneth; Portillo, Alberto

2014-01-01

Background & objectives Six million US children have no health insurance, and substantial racial/ethnic disparities exist. The design, methods, and baseline characteristics are described for Kids’ Health Insurance by Educating Lots of Parents (Kids’ HELP), the first randomized, clinical trial of the effectiveness of Parent Mentors (PMs) in insuring uninsured minority children. Methods & research design Latino and African-American children eligible for but not enrolled in Medicaid/CHIP were randomized to PMs, or a control group receiving traditional Medicaid/CHIP outreach. PMs are experienced parents with ≥ 1 Medicaid/CHIP-covered children. PMs received two days of training, and provide intervention families with information on Medicaid/CHIP eligibility, assistance with application submission, and help maintaining coverage. Primary outcomes include obtaining health insurance, time interval to obtain coverage, and parental satisfaction. A blinded assessor contacts subjects monthly for one year to monitor outcomes. Results Of 49,361 candidates screened, 329 fulfilled eligibility criteria and were randomized. The mean age is seven years for children and 32 years for caregivers; 2/3 are Latino, 1/3 are African-American, and the mean annual family income is $21,857. Half of caregivers were unaware that their uninsured child is Medicaid/CHIP eligible, and 95% of uninsured children had prior insurance. Fifteen PMs completed two-day training sessions. All PMs are female and minority, 60% are unemployed, and the mean annual family income is $20,913. Post-PM-training, overall knowledge/skills test scores significantly increased, and 100% reported being very satisfied/satisfied with the training. Conclusions Kids’ HELP successfully reached target populations, met participant enrollment goals, and recruited and trained PMs. PMID:25476583

Effects of inspiratory muscle training on pulmonary function, respiratory muscle strength and functional capacity in patients with atrial fibrillation: a randomized controlled trial.

PubMed

Zeren, Melih; Demir, Rengin; Yigit, Zerrin; Gurses, Hulya N

2016-12-01

To investigate the effects of inspiratory muscle training on pulmonary function, respiratory muscle strength and functional capacity in patients with atrial fibrillation. Prospective randomized controlled single-blind study. Cardiology department of a university hospital. A total of 38 patients with permanent atrial fibrillation were randomly allocated to either a treatment group (n = 19; age 66.2 years (8.8)) or a control group (n = 19; age 67.1 years (6.4)). The training group received inspiratory muscle training at 30% of maximal inspiratory pressure for 15 minutes twice a day, 7 days a week, for 12 weeks alongside the standard medical treatment. The control group received standard medical treatment only. Spirometry, maximal inspiratory and expiratory pressures and 6-minute walking distance was measured at the beginning and end of the study. There was a significant increase in maximal inspiratory pressure (27.94 cmH 2 O (8.90)), maximal expiratory pressure (24.53 cmH 2 O (10.34)), forced vital capacity (10.29% (8.18) predicted), forced expiratory volume in one second (13.88% (13.42) predicted), forced expiratory flow 25%-75% (14.82% (12.44) predicted), peak expiratory flow (19.82% (15.62) predicted) and 6-minute walking distance (55.53 m (14.13)) in the training group (p < 0.01). No significant changes occurred in the control group (p > 0.05). Inspiratory muscle training can improve pulmonary function, respiratory muscle strength and functional capacity in patients with atrial fibrillation. © The Author(s) 2016.

Healthy Homes/Healthy Kids: A Randomized Trial of a Pediatric Primary Care Based Obesity Prevention Intervention for At-Risk 5-10 Year Olds

PubMed Central

Sherwood, Nancy E.; Levy, Rona L.; Langer, Shelby L.; Senso, Meghan M.; Crain, A. Lauren; Hayes, Marcia G.; Anderson, Julie D.; Seburg, Elisabeth M.; Jeffery, Robert W.

2014-01-01

Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to families in the pediatric primary care setting, overcome barriers to implementation in busy practice settings, and facilitate sustained involvement of parents is an important public health priority. The goal of the Healthy Homes/Healthy Kids (HHHK 5-10) randomized controlled trial is to evaluate the efficacy of a relatively low-cost primary care-based obesity prevention intervention aimed at 5 to 10 year old children who are at risk for obesity. Four hundred twenty one parent/child dyads were recruited and randomized to either the obesity prevention arm or a contact control condition that focuses on safety and injury prevention. The HHHK 5-10 obesity prevention intervention combines brief counseling with a pediatric primary care provider during routine well-child visits and follow-up telephone coaching that supports parents in making home environmental changes to support healthful eating, activity patterns, and body weight. The contact control condition combines the same provider counseling with telephone coaching focused on safety and injury prevention messages. This manuscript describes the study design and baseline characteristics of participants enrolled in the HHHK 5-10 trial. PMID:23816490

A Randomized Double-Blind, Placebo-Controlled Trial of Minocycline in Children and Adolescents with Fragile X Syndrome

PubMed Central

Leigh, Mary Jacena S.; Nguyen, Danh V.; Mu, Yi; Winarni, Tri I.; Schneider, Andrea; Chechi, Tasleem; Polussa, Jonathan; Doucet, Paul; Tassone, Flora; Rivera, Susan M.; Hessl, David; Hagerman, Randi J.

2013-01-01

Objective Minocycline rescued synaptic abnormalities and improved behavior in the fragile X mouse model. Prior open-label human studies demonstrated benefits in individuals with fragile X syndrome (FXS); however, its efficacy in patients with FXS has not been assessed in a controlled trial. Method Randomized, double-blind, placebo-controlled, crossover trial in individuals with FXS, ages 3.5-16 years (n=55, mean age 9.2 (SD 3.6 years)). Participants were randomized to minocycline or placebo for three months, then switched to the other treatment. Results Sixty-nine subjects were screened and 66 were randomized. Fifty-five subjects (83.3%) completed at least the first period and 48 (72.7%) completed the full trial. Intention-to-treat analysis demonstrated significantly greater improvements in one primary outcome, Clinical Global Impression Scale-Improvement after minocycline compared to placebo (2.49 ±0.13, 2.97 ±0.13, respectively, p 0.0173) and greater improvement in ad hoc analysis of anxiety and mood-related behaviors on the Visual Analoge Scale (minocycline 5.26 cm ±0.46 cm, placebo 4.05 cm±0.46cm; p 0.0488). Side effects were not significantly different during the minocycline and placebo treatments. No serious adverse events occurred on minocycline. Results may be potentially biased by study design weaknesses, including unblinding of subjects when they completed the study, drug-related side effects unblinding and preliminary efficacy analysis results known to investigators. Conclusion Minocycline treatment for three months in children with FXS resulted in greater global improvement than placebo. Treatment for three months appears safe; however, longer trials are indicated to further assess benefits, side effects, and factors associated with a clinical response to minocycline. PMID:23572165

The preliminary effect of a parenting program for Korean American mothers: a randomized controlled experimental study.

PubMed

Kim, Eunjung; Cain, Kevin C; Webster-Stratton, Carolyn

2008-09-01

Traditional Korean American discipline is characterized by a lack of expression of affection and use of harsh discipline. The purpose of this study was to pilot test the effect of the Incredible Years Parenting Program among Korean American mothers. A randomized controlled experimental study design was used; 29 first-generation Korean American mothers of young children (3-8 years old) were randomly assigned to intervention (n=20) and control (n=9) groups. Intervention group mothers received a 12-week parenting program. Control group mothers did not receive the intervention. Mothers reported on discipline styles (positive, appropriate, and harsh), level of acculturation, and their child's outcomes (behavioral problems and social competence) at pre-, post-, and 1-year follow-up intervals. After completing the program, intervention group mothers significantly increased use of positive discipline as compared to control group mothers. Among intervention group mothers, high-acculturated mothers significantly increased appropriate discipline whereas low-acculturated mothers significantly decreased harsh discipline. In the 1-year follow-up, intervention group mothers maintained the significant effect for positive discipline. Providing this program appears to be a promising way of promoting positive discipline among Korean American mothers.

Exercise frequency and calcium intake predict 4-year bone changes in postmenopausal women.

PubMed

Cussler, Ellen C; Going, Scott B; Houtkooper, Linda B; Stanford, Vanessa A; Blew, Robert M; Flint-Wagner, Hilary G; Metcalfe, Lauve L; Choi, Ji-Eun; Lohman, Timothy G

2005-12-01

The aim of this study was to examine the association of exercise frequency and calcium intake (CI) with change in regional and total bone mineral density (BMD) in a group of postmenopausal women completing 4 years of progressive strength training. One hundred sixty-seven calcium-supplemented (800 mg/day) sedentary women (56.1+/-4.5 years) randomized to a progressive strength training exercise program or to control were followed for 4 years. Fifty-four percent of the women were using hormone therapy (HT) at baseline. At 1 year, controls were permitted to begin the exercise program (crossovers). The final sample included 23 controls, 55 crossovers, and 89 randomized exercisers. Exercisers were instructed to complete two sets of six to eight repetitions of exercises at 70-80% of one repetition maximum, three times weekly. BMD was measured at baseline and thereafter annually using dual-energy X-ray absorptiometry. Four-year percentage exercise frequency (ExFreq) averaged 26.8%+/-20.1% for crossovers (including the first year at 0%), and 50.4%+/-26.7% for exercisers. Four-year total CI averaged 1,635+/-367 mg/day and supplemental calcium intake, 711+/-174 mg/day. In adjusted multiple linear regression models, ExFreq was positively and significantly related to changes in femur trochanter (FT) and neck (FN), lumbar spine (LS), and total body (TB) BMD. Among HT users, FT BMD increased 1.5%, and FN and LS BMD, 1.2% (p<0.01) for each standard deviation (SD) of percentage ExFreq (29.5% or 0.9 days/week). HT non-users gained 1.9% and 2.3% BMD at FT and FN, respectively, (p<0.05) for every SD of CI. The significant, positive, association between BMD change and ExFreq supports the long-term usefulness of strength training exercise for the prevention of osteoporosis in postmenopausal women, especially HT users. The positive relationship of CI to change in BMD among postmenopausal women not using HT has clinical implications in light of recent evidence of an increased health risk associated with HT.

Maxillary Three-Implant Overdentures Opposing Mandibular Two-Implant Overdentures: 10-Year Surgical Outcomes of a Randomized Controlled Trial.

PubMed

Ma, Sunyoung; Tawse-Smith, Andrew; De Silva, Rohana K; Atieh, Momen A; Alsabeeha, Nabeel H M; Payne, Alan G T

2016-06-01

The surgical placement of four maxillary implants for overdentures may not be obligatory when opposing mandibular two-implant overdentures. To determine 10-year surgical outcomes and implant success of three narrow diameter implants in edentulous maxillae with conventional loading. Forty participants with mandibular two-implant overdentures were randomly allocated for surgery for maxillary overdentures. Using osteotomes, three implants of similar systems were placed with a one-stage procedure and 12-week loading with splinted and unsplinted prosthodontic designs. Marginal bone and stability measurements were done at surgery, 12 weeks, 1-, 2-, 5-, 7-, 10 years. One hundred seventeen implants were placed in 39 participants, with 35 being seen at 1 year; 29 at 2 years; 28 at 5 years; 26 at 7 years; and 23 (59%) at 10 years. Marginal bone loss was 1.35 mm between surgery and 12 weeks; 0.36 mm between 12 weeks and 1 year; 0.48 mm between 1 and 5 years; and 0.22 mm between 5 and 10 years. Implant stability quotients were 56.05, 57.54, 60.88, 58.80, 61.17 at surgery, 12 weeks, 1 year, 5 years, and 10 years. Four-field tables by implant showed success rates of 82% at 1 year; 69.2% at 2 years; 66.7% at 5 years; 61.5% at 7 years; 51.3% at 10 years. Data showed no differences between surgical technique, systems, or prosthodontic designs. Surgical placement with osteotomes of three narrow diameter implants for maxillary overdentures, opposing mandibular two-implant overdentures, is an acceptable approach, subject to strict patient selection. Implant success is independent of prosthodontic design. © 2015 Wiley Periodicals, Inc.

Restorations in abrasion/erosion cervical lesions: 8-year results of a triple blind randomized controlled trial.

PubMed

Dall'Orologio, Giovanni Dondi; Lorenzi, Roberta

2014-10-01

An equivalence randomized controlled trial within the subject was organized to evaluate the clinical long-term success of a new 2-step etch & rinse adhesive and a new nano-filled ormocer. 50 subjects, 21 males and 29 females aged between 21 and 65, were randomized to receive 150 restorations, 100 with the new restorative material, 50 with the composite as control, placed in non-carious cervical lesions with the same bonding system. The main outcome measure was the cause of failure at 8 years. Randomization was number table-generated, with allocation concealment by opaque sequentially numbered sealed and stapled envelopes. Subjects, examiner, and analyst were blinded to group assignment. Two interim analyses were performed. Data were analyzed by ANOVA and Cox test (P < 0.05). After 8 years, 40 subjects and 120 teeth were included in the analysis of the primary outcome. There were eight failures in the experimental group and four failures in the control group. The cumulative loss rate was 7% for both restorative materials, with the annual failure lower than 1%, without any statistically significant difference. There were two key elements of failure: the presence of sclerotic dentin and the relationship between lesion and gingival margin.

Randomized Clinical Trial of the Effectiveness of a Home-Based Advanced Practice Psychiatric Nurse Intervention: Outcomes for Individuals with Serious Mental Illness and HIV

PubMed Central

Hanrahan, Nancy P.; Wu, Evan; Kelly, Deena; Aiken, Linda H.; Blank, Michael B.

2011-01-01

Individuals with serious mental illness have greater risk for contracting HIV, multiple morbidities, and die 25 years younger than the general population. This high need and high cost subgroup face unique barriers to accessing required health care in the current health care system. The effectiveness of an advanced practice nurse model of care management was assessed in a four-year random controlled trial. Results are reported in this paper. In a four-year random controlled trial, a total of 238 community-dwelling individuals with HIV and serious mental illness (SMI) were randomly assigned to an intervention group (n=128) or to a control group (n=110). Over 12 months, the intervention group received care management from advanced practice psychiatric nurse, and the control group received usual care. The intervention group showed significant improvement in depression (P=.012) and the physical component of health-related quality of life (P=.03) from baseline to 12 months. The advanced practice psychiatric nurse intervention is a model of care that holds promise for a higher quality of care and outcomes for this vulnerable population. PMID:21935499

Impact of written information on control and adherence in type 2 diabetes.

PubMed

Caetano, Inês Rosendo Carvalho E Silva; Santiago, Luiz Miguel; Marques, Margarida

2018-02-01

Diabetes therapeutic education and information by leaflets is important. This study aimed to understand the effectiveness of written information to diabetic patients, after six months, in the control of diabetes and medication adherence. Non-pharmacological clinical trial. Randomized sample of diabetic patients of 65 volunteer doctors, distributed among the five health regions in Portugal. At the first appointment, patients were randomized in four groups (three intervention with validated leaflets and one control), leaflet reading being reinforced at the follow-up appointments in a 6-months period. Variables collected: HbA1c, home blood glucose, weight, waist circumference, blood pressure, cigarettes smoked, physical activity level, adherence to medication, medication, height, diabetes progression, age, sex and educational background. Descriptive and inferential statistics. From the 709 patients recruited, 702 were studied in this 6-months period with no statistical differences in the baseline variables studied. After six months of intervention, the adherence to medication improved in the leaflet group (p=0.034). This was noticed in those under 65 years of age (p=0.027), with diabetes for ≤ 5 years (p=0.010), with educational background up to 4 years (p=0.030) and 9 years (p=0.006) and with HbA1c ≥ 7% at the beginning of the study. Interventions with leaflets handed in primary healthcare to people with diabetes type 2 can bring benefits in what concerns adherence to therapeutics, namely in younger people with a less studies.

Environmental Modifications and 2-Year Measured and Self-reported Stair-Use: A Worksite Randomized Trial

PubMed Central

Linde, Jennifer A.; Cousins, Julie M.; Jeffery, Robert W.

2014-01-01

Environmental modifications have been shown to increase short-term stair use, longer-term success is unclear. This study assessed the 2-year effectiveness of an environmental intervention promoting worksite stair use. We assessed stair use at work by means of self-reports and infrared beam counters (which send a safe and invisible beam of infrared light from one side of a stairwell to a reflector on the other side; when an individual uses the stairs, the infrared beam is disrupted and an instance of stair use is recorded) at six worksites (three intervention, three control) in a group randomized, controlled worksite weight-gain prevention trial in Minneapolis/St. Paul, MN. Intervention modifications were signs encouraging stair use, music, and art posters in stairwells. We collected data before environmental modifications (2006–2007) and at the end of the 2-year intervention (2008–2009). The intervention had a significant positive effect on stair use measured both objectively and via self-report, with greatest increases reported among those participants who used the stairs least at baseline. Following 2-years of continuously-maintained stairwell modifications, increases in both objectively-measured and self-reported stair use were significantly larger at intervention than control worksites. Study findings suggest that the positive impact of environmental modifications on stair use persist over a longer time period than has been previously demonstrated. Results also indicate that infrequent stair users may be most amenable to the behavior changes encouraged by these environmental enhancements. PMID:23979097

Current Evidence on Auricular Therapy for Chemotherapy-Induced Nausea and Vomiting in Cancer Patients: A Systematic Review of Randomized Controlled Trials

PubMed Central

Molassiotis, Alexander; Wang, Tao; Suen, Lorna K. P.

2014-01-01

Auricular therapy (AT) has been historically viewed as a convenient approach adjunct to pharmacological therapy for cancer patients with chemotherapy-induced nausea and vomiting (CINV). The aim of this study was to assess the evidence of the therapeutic effect of AT for CINV management in cancer patients. Relevant randomized controlled trials were retrieved from 12 electronic databases without language restrictions. Meanwhile, manual search was conducted for Chinese journals on complementary medicine published within the last five years, and the reference lists of included studies were also checked to identify any possible eligible studies. Twenty-one studies with 1713 participants were included. The effect rate of AT for managing acute CINV ranged from 44.44% to 93.33% in the intervention groups and 15% to 91.67% in the control groups. For delayed CINV, it was 62.96% to 100% and 25% to 100%, respectively. AT seems to be a promising approach in managing CINV. However, the level of evidence was low and the definite effect cannot be concluded as there were significant methodological flaws identified in the analyzed studies. The implications drawn from the 21 studies put some clues for future practice in this area including the need to conduct more rigorously designed randomized controlled trials. PMID:25525445

Comparative Effectiveness of PCI Education's "PCI Reading Program": Phase 2--A Report of a Comparison Group Study in Brevard Public Schools and Miami-Dade County Public Schools. Research Summary

ERIC Educational Resources Information Center

Empirical Education Inc., 2010

2010-01-01

PCI Education sought scientifically based evidence on the comparative effectiveness of the "PCI Reading Program" through a five-year longitudinal study. Phase 1 of the study consisted of a randomized control trial studying the efficacy of the "PCI Reading Program-Level One" that was conducted in the 2007-2008 in Miami-Dade…

Exploring Interactive Writing as an Effective Practice for Increasing Head Start Students' Alphabet Knowledge Skills

ERIC Educational Resources Information Center

Hall, Anna H.; Toland, Michael D.; Grisham-Brown, Jennifer; Graham, Steve

2014-01-01

The current study used a pretest-posttest randomized control group design with 73 Head Start students, ages 3-5 years. The researcher served as the interactive writing teacher for the treatment group, rotating to five different classrooms in one Head Start center 3-4 days a week for 13 weeks. Children in the treatment group received a 10-15 min…

A cluster-randomized controlled trial to reduce sedentary behavior and promote physical activity and health of 8-9 year olds: the Transform-Us! study.

PubMed

Salmon, Jo; Arundell, Lauren; Hume, Clare; Brown, Helen; Hesketh, Kylie; Dunstan, David W; Daly, Robin M; Pearson, Natalie; Cerin, Ester; Moodie, Marj; Sheppard, Lauren; Ball, Kylie; Bagley, Sarah; Paw, Mai Chin A; Crawford, David

2011-10-04

Physical activity (PA) is associated with positive cardio-metabolic health and emerging evidence suggests sedentary behavior (SB) may be detrimental to children's health independent of PA. The primary aim of the Transform-Us! study is to determine whether an 18-month, behavioral and environmental intervention in the school and family settings results in higher levels of PA and lower rates of SB among 8-9 year old children compared with usual practice (post-intervention and 12-months follow-up). The secondary aims are to determine the independent and combined effects of PA and SB on children's cardio-metabolic health risk factors; identify the factors that mediate the success of the intervention; and determine whether the intervention is cost-effective. A four-arm cluster-randomized controlled trial (RCT) with a 2 × 2 factorial design, with schools as the unit of randomization. Twenty schools will be allocated to one of four intervention groups, sedentary behavior (SB-I), physical activity (PA-I), combined SB and PA (SB+PA-I) or current practice control (C), which will be evaluated among approximately 600 children aged 8-9 years in school year 3 living in Melbourne, Australia. All children in year 3 at intervention schools in 2010 (8-9 years) will receive the intervention over an 18-month period with a maintenance 'booster' delivered in 2012 and children at all schools will be invited to participate in the evaluation assessments. To maximize the sample and to capture new students arriving at intervention and control schools, recruitment will be on-going up to the post-intervention time point. Primary outcomes are time spent sitting and in PA assessed via accelerometers and inclinometers and survey. To our knowledge, Transform-Us! is the first RCT to examine the effectiveness of intervention strategies for reducing children's overall sedentary time, promoting PA and optimizing health outcomes. The integration of consistent strategies and messages to children from teachers and parents in both school and family settings is a critical component of this study, and if shown to be effective, may have a significant impact on educational policies as well as on pedagogical and parenting practices. ACTRN12609000715279; Current Controlled Trials ISRCTN83725066.

The Effects of a Pedometer-Based Intervention on First-Year University Students: A Randomized Control Trial

ERIC Educational Resources Information Center

Sharp, Paul; Caperchione, Cristina

2016-01-01

Objectives: To assess the effects of a 12-week pedometer-based intervention on the physical activity behavior, health-related quality of life (HRQOL), and psychological well-being of first-year university students. Participants: First-year university students (N = 184) were recruited during September 2012 and randomly assigned to an intervention…

Cognitive Behavioral Therapy for 4- to 7-Year-Old Children with Anxiety Disorders: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Hirshfeld-Becker, Dina R.; Masek, Bruce; Henin, Aude; Blakely, Lauren Raezer; Pollock-Wurman, Rachel A.; McQuade, Julia; DePetrillo, Lillian; Briesch, Jacquelyn; Ollendick, Thomas H.; Rosenbaum, Jerrold F.; Biederman, Joseph

2010-01-01

Objective: To examine the efficacy of a developmentally appropriate parent-child cognitive behavioral therapy (CBT) protocol for anxiety disorders in children ages 4-7 years. Method: Design: Randomized wait-list controlled trial. Conduct: Sixty-four children (53% female, mean age 5.4 years, 80% European American) with anxiety disorders were…

Changes in sexual behavior of HIV-infected older adults enrolled in a clinical trial of standalone group psychotherapies targeting depression.

PubMed

Lovejoy, Travis I; Heckman, Timothy G; Sikkema, Kathleen J; Hansen, Nathan B; Kochman, Arlene

2015-01-01

By 2015, one-half of all HIV-positive persons in the U.S. will be 50-plus years of age, and as many as 30 % of older adults living with HIV/AIDS continue to engage in unprotected sexual intercourse. Contemporary positive prevention models often include mental health treatment as a key component of HIV prevention interventions. This secondary data analysis characterized longitudinal patterns of sexual behavior in HIV-positive older adults enrolled in a randomized controlled trial of group mental health interventions and assessed the efficacy of psychosocial treatments that targeted depression to reduce sexual risk behavior. Participants were 295 HIV-positive adults ≥50 years of age experiencing mild to severe depressive symptoms, randomized to one of three study conditions: a 12-session coping improvement group intervention, a 12-session interpersonal support group intervention, or individual therapy upon request. Approximately one-fifth of participants reported one or more occasions of unprotected anal or vaginal intercourse with HIV-negative sexual partners or persons of unknown HIV serostatus over the study period. Changes in sexual behavior did not vary by intervention condition, indicating that standalone treatments that target and reduce depression may be insufficient to reduce sexual risk behavior in depressed HIV-positive older adults.

Changes in sexual behavior of HIV-infected older adults enrolled in a clinical trial of standalone group psychotherapies targeting depression

PubMed Central

Lovejoy, Travis I.; Heckman, Timothy G.; Sikkema, Kathleen J.; Hansen, Nathan B.; Kochman, Arlene

2014-01-01

By 2015, one-half of all HIV-positive persons in the U.S. will be 50-plus years of age, and as many as 30% of older adults living with HIV/AIDS continue to engage in unprotected sexual intercourse. Contemporary positive prevention models often include mental health treatment as a key component of HIV prevention interventions. This secondary data analysis characterized longitudinal patterns of sexual behavior in HIV-positive older adults enrolled in a randomized controlled trial of group mental health interventions and assessed the efficacy of psychosocial treatments that targeted depression to reduce sexual risk behavior. Participants were 295 HIV-positive adults ≥ 50 years of age experiencing mild to severe depressive symptoms, randomized to one of three study conditions: a 12-session coping improvement group intervention, a 12-session interpersonal support group intervention, or individual therapy upon request. Approximately one-fifth of participants reported one or more occasions of unprotected anal or vaginal intercourse with HIV-negative sexual partners or persons of unknown HIV serostatus over the study period. Changes in sexual behavior did not vary by intervention condition, indicating that standalone treatments that target and reduce depression may be insufficient to reduce sexual risk behavior in depressed HIV-positive older adults. PMID:24668254

Diet and lifestyle intervention among patients with colorectal adenomas: rationale and design of a Malaysian study.

PubMed

Kandiah, Mirnalini; Ramadas, Amutha; Shariff, Zalilah Mohd; Yusof, Rokiah Mohd; Gul, Yunus Gul Alif

2005-01-01

Comprehensive evaluation of the large body of consistent evidence from laboratory, epidemiologic and clinical studies has led to the conclusion that modification of the dietary and lifestyle patterns of populations has considerable potential for reducing cancer risk. This paper describes a randomized-controlled trial involving a diet and lifestyle intervention for patients with history of colorectal adenomas. The primary aim of this trial is to evaluate the effectiveness of the intervention with reference to recurrence of adenomatous polyps over a two year period--the first year being the intervention period and the second year of the study allowing for post-intervention follow-up. Subjects found to fit the inclusion criteria are recruited and randomized to two groups: the intervention group and the control group. The intervention group subjects will attend a monthly lecture-discussion session for 10 months and small group counseling on modification of lifestyle behavior and diet as well as receive educational materials which were adapted from the WCRF Diet and Health Recommendations for Cancer Prevention. Control subjects will be provided with the usual care given to such patients. One hundred and sixteen patients who were diagnosed with colorectal adenomatous polyps in the previous twelve months at the Hospital Kuala Lumpur have already been enrolled in this trial. Baseline data collection is on-going.

Determining the effect of vein visualization technology on donation success, vasovagal symptoms, anxiety and intention to re-donate in whole blood donors aged 18-30 years: A randomized controlled trial.

PubMed

Waller, D; Mondy, P; Brama, T; Fisher, J; King, A; Malkov, K; Wall-Smith, D; Ryan, L; Irving, D O

2016-08-01

Vein visualization technology (VVT) devices use near-infrared light to assist location of peripheral veins. The current study investigated the impact of VVT on donor experience and collection success for young blood donors at the Australian Red Cross Blood Service. The study in donors aged 18 to 30 years used a two intervention to one control randomized trial design with 285 new and 587 returning donors recruited at two sites. Donors reported presyncopal symptoms, phlebotomy pain, anxiety and intentions to redonate along with other measures. Participating phlebotomists rated usefulness of the technology. Flow rates, collection volumes and other donation information were taken from routine data. No significant differences were found between control and intervention groups on presyncopal symptoms, phlebotomy pain, anxiety, intentions to redonate, flow rates, collection volumes or vasovagal reactions (all P's > 0·05). Phlebotomist ratings of VVT were significantly more positive when they had less than 5 years of experience (P < 0·01) or when the vein was not visible to the naked eye (P < 0·01). Results suggest that VVT does not improve the donation experience for younger blood donors. Staff reports indicate that VVT may have some utility for assisting with difficult phlebotomies. © 2016 International Society of Blood Transfusion.

N-Acetylcysteine in the Treatment of Pediatric Tourette Syndrome: Randomized, Double-Blind, Placebo-Controlled Add-On Trial.

PubMed

Bloch, Michael H; Panza, Kaitlyn E; Yaffa, Alisa; Alvarenga, Pedro G; Jakubovski, Ewgeni; Mulqueen, Jilian M; Landeros-Weisenberger, Angeli; Leckman, James F

2016-05-01

Current pharmacological treatments for Tourette Syndrome (TS), such as antipsychotic agents and α-2 agonists, are moderately effective in the treatment of tics, but have substantial side effects that limit their use. N-acetylcysteine (NAC) modulates glutamatergic systems, and has been used safely as an antioxidant agent with minimal side effects for decades. NAC has been increasingly studied for the treatment of other obsessive-compulsive spectrum disorders. We aim to examine the efficacy of NAC for the treatment of pediatric TS in a double-blind, placebo-controlled, add-on study. Thirty-one children and adolescents 8-17 years of age with TS were randomly assigned to receive NAC or matching placebo for 12 weeks. Our primary outcome was change in severity of tics as measured by the Yale Global Tic Severity Scale (YGTSS), Total tic score. Secondary measures assessed comorbid obsessive-compulsive disorder (OCD), depression, anxiety, and attention-deficit/hyperactivity disorder (ADHD). Linear mixed models in SAS were used to examine differences between NAC and placebo. Of 31 randomized subjects, 14 were assigned to placebo (two females; 11.5 + 2.8 years) and 17 to active NAC (five females; 12.4 + 1.4 years) treatment. No significant difference between NAC and placebo was found in reducing tic severity or any secondary outcomes. We found no evidence for efficacy of NAC in treating tic symptoms. Our findings stand in contrast to studies suggesting benefits of NAC in the treatment of other obsessive-compulsive spectrum disorders in adults, including OCD and trichotillomania, but are similar to a recent placebo-controlled trial of pediatric trichotillomania that found no benefit of NAC.

A randomized intervention of reminder letter for human papillomavirus vaccine series completion.

PubMed

Chao, Chun; Preciado, Melissa; Slezak, Jeff; Xu, Lanfang

2015-01-01

Completion rate for the three-dose series of the human papillomavirus (HPV) vaccine has generally been low. This study evaluated the effectiveness of a reminder letter intervention on HPV vaccine three-dose series completion. Female members of Kaiser Permanente Southern California Health Plan who received at least one dose, but not more than two doses, of the HPV vaccine by February 13, 2013, and who were between ages 9 and 26 years at the time of first HPV vaccination were included. Eighty percent of these females were randomized to receive the reminder letter, and 20% were randomized to receive standard of care (control). The reminder letters were mailed quarterly to those who had not completed the series. The proportion of series completion at the end of the 12-month evaluation period was compared using chi-square test. A total of 9,760 females were included in the intervention group and 2,445 in the control group. HPV vaccine series completion was 56.4% in the intervention group and 46.6% in the control groups (p < .001). The effect of the intervention appeared to be stronger in girls aged 9-17 years compared with young women aged 18-26 years at the first dose and in blacks compared with whites. Reminder letters scheduled quarterly were effective to enhance HPV vaccine series completion among those who initiated the vaccine. However, a large gap in series completion remained despite the intervention. Future studies should address other barriers to series completion, including those at the providers and the health care system level. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Early Colorectal Cancer Detected by Machine Learning Model Using Gender, Age, and Complete Blood Count Data.

PubMed

Hornbrook, Mark C; Goshen, Ran; Choman, Eran; O'Keeffe-Rosetti, Maureen; Kinar, Yaron; Liles, Elizabeth G; Rust, Kristal C

2017-10-01

Machine learning tools identify patients with blood counts indicating greater likelihood of colorectal cancer and warranting colonoscopy referral. To validate a machine learning colorectal cancer detection model on a US community-based insured adult population. Eligible colorectal cancer cases (439 females, 461 males) with complete blood counts before diagnosis were identified from Kaiser Permanente Northwest Region's Tumor Registry. Control patients (n = 9108) were randomly selected from KPNW's population who had no cancers, received at ≥1 blood count, had continuous enrollment from 180 days prior to the blood count through 24 months after the count, and were aged 40-89. For each control, one blood count was randomly selected as the pseudo-colorectal cancer diagnosis date for matching to cases, and assigned a "calendar year" based on the count date. For each calendar year, 18 controls were randomly selected to match the general enrollment's 10-year age groups and lengths of continuous enrollment. Prediction performance was evaluated by area under the curve, specificity, and odds ratios. Area under the receiver operating characteristics curve for detecting colorectal cancer was 0.80 ± 0.01. At 99% specificity, the odds ratio for association of a high-risk detection score with colorectal cancer was 34.7 (95% CI 28.9-40.4). The detection model had the highest accuracy in identifying right-sided colorectal cancers. ColonFlag ® identifies individuals with tenfold higher risk of undiagnosed colorectal cancer at curable stages (0/I/II), flags colorectal tumors 180-360 days prior to usual clinical diagnosis, and is more accurate at identifying right-sided (compared to left-sided) colorectal cancers.

No difference in joint awareness after mobile- and fixed-bearing total knee arthroplasty: 3-year follow-up of a randomized controlled trial.

PubMed

Schotanus, M G M; Pilot, P; Vos, R; Kort, N P

2017-12-01

To compare the patients ability to forget the artificial knee joint in everyday life who were randomized to be operated for mobile- or fixed-bearing total knee arthroplasty (TKA). This single-center randomized controlled trial evaluated the 3-year follow-up of the cemented mobile- and fixed-bearing TKA from the same brand in a series of 41 patients. Clinical examination was during the pre-, 6-week, 6-month, 1-, 2- and 3-year follow-up containing multiple patient-reported outcome measures (PROMs) including the 12-item Forgotten Joint Score (FJS-12) at 3 years. Effect size was calculated for each PROM at 3-year follow-up to quantify the size of the difference between both bearings. At 3-year follow-up, general linear mixed model analysis showed that there were no significant or clinically relevant differences between the two groups for all outcome measures. Calculated effect sizes were small (<0.3) for all the PROMs except for the FJS-12; these were moderate (0.5). The results of this study demonstrate that joint awareness was slightly lower in patients operated with the MB TKA with comparable improved clinical outcome and PROMs at 3-year follow-up. Measuring joint awareness with the FJS-12 is useful and provides more stringent information at 3-year follow-up compared to other PROMs and should be the PROM of choice at each follow-up after TKA. Level I, randomized controlled trial.

A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial.

PubMed

Ngandu, Tiia; Lehtisalo, Jenni; Solomon, Alina; Levälahti, Esko; Ahtiluoto, Satu; Antikainen, Riitta; Bäckman, Lars; Hänninen, Tuomo; Jula, Antti; Laatikainen, Tiina; Lindström, Jaana; Mangialasche, Francesca; Paajanen, Teemu; Pajala, Satu; Peltonen, Markku; Rauramaa, Rainer; Stigsdotter-Neely, Anna; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia

2015-06-06

Modifiable vascular and lifestyle-related risk factors have been associated with dementia risk in observational studies. In the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), a proof-of-concept randomised controlled trial, we aimed to assess a multidomain approach to prevent cognitive decline in at-risk elderly people from the general population. In a double-blind randomised controlled trial we enrolled individuals aged 60-77 years recruited from previous national surveys. Inclusion criteria were CAIDE (Cardiovascular Risk Factors, Aging and Dementia) Dementia Risk Score of at least 6 points and cognition at mean level or slightly lower than expected for age. We randomly assigned participants in a 1:1 ratio to a 2 year multidomain intervention (diet, exercise, cognitive training, vascular risk monitoring), or a control group (general health advice). Computer-generated allocation was done in blocks of four (two individuals randomly allocated to each group) at each site. Group allocation was not actively disclosed to participants and outcome assessors were masked to group allocation. The primary outcome was change in cognition as measured through comprehensive neuropsychological test battery (NTB) Z score. Analysis was by modified intention to treat (all participants with at least one post-baseline observation). This trial is registered at ClinicalTrials.gov, number NCT01041989. Between Sept 7, 2009, and Nov 24, 2011, we screened 2654 individuals and randomly assigned 1260 to the intervention group (n=631) or control group (n=629). 591 (94%) participants in the intervention group and 599 (95%) in the control group had at least one post-baseline assessment and were included in the modified intention-to-treat analysis. Estimated mean change in NTB total Z score at 2 years was 0·20 (SE 0·02, SD 0·51) in the intervention group and 0·16 (0·01, 0·51) in the control group. Between-group difference in the change of NTB total score per year was 0·022 (95% CI 0·002-0·042, p=0·030). 153 (12%) individuals dropped out overall. Adverse events occurred in 46 (7%) participants in the intervention group compared with six (1%) participants in the control group; the most common adverse event was musculoskeletal pain (32 [5%] individuals for intervention vs no individuals for control). Findings from this large, long-term, randomised controlled trial suggest that a multidomain intervention could improve or maintain cognitive functioning in at-risk elderly people from the general population. Academy of Finland, La Carita Foundation, Alzheimer Association, Alzheimer's Research and Prevention Foundation, Juho Vainio Foundation, Novo Nordisk Foundation, Finnish Social Insurance Institution, Ministry of Education and Culture, Salama bint Hamdan Al Nahyan Foundation, Axa Research Fund, EVO funding for University Hospitals of Kuopio, Oulu, and Turku and for Seinäjoki Central Hospital and Oulu City Hospital, Swedish Research Council, Swedish Research Council for Health, Working Life and Welfare, and af Jochnick Foundation. Copyright © 2015 Elsevier Ltd. All rights reserved.

Group-based multimodal exercises integrated with cognitive-behavioural therapy improve disability, pain and quality of life of subjects with chronic neck pain: a randomized controlled trial with one-year follow-up.

PubMed

Monticone, Marco; Ambrosini, Emilia; Rocca, Barbara; Cazzaniga, Daniele; Liquori, Valentina; Pedrocchi, Alessandra; Vernon, Howard

2017-06-01

To evaluate the effect of a group-based multidisciplinary rehabilitation programme on disability, pain and quality of life in subjects with chronic neck pain. Randomized controlled trial. Specialized rehabilitation centre. A total of 170 patients (mean age of 53 years (13); 121 females). The multidisciplinary group underwent a multidisciplinary rehabilitation programme combining multimodal exercises with psychologist-lead cognitive-behavioural therapy sessions. The general exercise group underwent general physiotherapy. Both groups followed group-based programmes once a week for ten weeks. Additionally, the multidisciplinary group met with the psychologist once a week for a 60-minute session. The Neck Disability Index (primary outcome), the Tampa Scale for Kinesiophobia, the Pain Catastrophizing Scale, a pain numerical rating scale and the Short-Form Health Survey. The participants were evaluated before, after training and after 12 months. A linear mixed model for repeated measures was used for each outcome measure. Significant effects ( p-value <0.001) were found over time and between groups for all outcome measures. After training, significant improvements were found for both groups for all outcome measures except kinesiophobia and catastrophizing, which did not change in the control group; however, the improvements were significantly greater for the multidisciplinary group. At 12-month follow-up a clinically meaningful between-group difference of 12.4 Neck Disability Index points was found for disability. A group-based multidisciplinary rehabilitation programme including cognitive-behavioural therapy was superior to group-based general physiotherapy in improving disability, pain and quality of life of subjects with chronic neck pain. The effects lasted for at least one year.

Health and agricultural productivity: Evidence from Zambia.

PubMed

Fink, Günther; Masiye, Felix

2015-07-01

We evaluate the productivity effects of investment in preventive health technology through a randomized controlled trial in rural Zambia. In the experiment, access to subsidized bed nets was randomly assigned at the community level; 516 farmers were followed over a one-year farming period. We find large positive effects of preventative health investment on productivity: among farmers provided with access to free nets, harvest value increased by US$ 76, corresponding to about 14.7% of the average output value. While only limited information was collected on farming inputs, shifts in the extensive and the intensive margins of labor supply appear to be the most likely mechanism underlying the productivity improvements observed. Copyright © 2015 Elsevier B.V. All rights reserved.

Treatment of chronic antibody mediated rejection with intravenous immunoglobulins and rituximab: A multicenter, prospective, randomized, double-blind clinical trial.

PubMed

Moreso, Francesc; Crespo, Marta; Ruiz, Juan C; Torres, Armando; Gutierrez-Dalmau, Alex; Osuna, Antonio; Perelló, Manel; Pascual, Julio; Torres, Irina B; Redondo-Pachón, Dolores; Rodrigo, Emilio; Lopez-Hoyos, Marcos; Seron, Daniel

2018-04-01

There are no approved treatments for chronic antibody mediated rejection (ABMR). We conducted a multicenter, prospective, randomized, placebo-controlled, double-blind clinical trial to evaluate efficacy and safety of intravenous immunoglobulins (IVIG) combined with rituximab (RTX) (EudraCT 2010-023746-67). Patients with transplant glomerulopathy and anti-HLA donor-specific antibodies (DSA) were eligible. Patients with estimated glomerular filtration rate (eGFR) <20 mL/min per 1.73m 2 and/or severe interstitial fibrosis/tubular atrophy were excluded. Patients were randomized to receive IVIG (4 doses of 0.5 g/kg) and RTX (375 mg/m 2 ) or a wrapped isovolumetric saline infusion. Primary efficacy variable was the decline of eGFR at one year. Secondary efficacy variables included evolution of proteinuria, renal lesions, and DSA at 1 year. The planned sample size was 25 patients per group. During 2012-2015, 25 patients were randomized (13 to the treatment and 12 to the placebo group). The planned patient enrollment was not achieved because of budgetary constraints and slow patient recruitment. There were no differences between the treatment and placebo groups in eGFR decline (-4.2 ± 14.4 vs. -6.6 ± 12.0 mL/min per 1.73 m 2 , P-value = .475), increase of proteinuria (+0.9 ± 2.1 vs. +0.9 ± 2.1 g/day, P-value = .378), Banff scores at one year and MFI of the immunodominant DSA. Safety was similar between groups. These data suggest that the combination of IVIG and RTX is not useful in patients displaying transplant glomerulopathy and DSA. © 2017 The American Society of Transplantation and the American Society of Transplant Surgeons.

Design, randomization and methodology of the TriAtiva Program to reduce obesity in school children in Southern Brazil.

PubMed

Friedrich, Roberta R; Caetano, Lisandrea C; Schiffner, Mariana D; Wagner, Mário B; Schuch, Ilaine

2015-04-11

The prevalence of child obesity in Brazil has increased rapidly in recent decades. There is, therefore, an urgent need to develop effective strategies to prevent and control child obesity. In light of these considerations, an intervention program with a focus on nutrition education and physical activity was developed for to prevent and control obesity in schools. The intervention was called the TriAtiva Program: Education, Nutrition and Physical Activity. This article describes the design, randomization and method used to evaluate the TriAtiva program. This randomized controlled cluster trial was performed in 12 municipal schools in the city of Porto Alegre/RS (six schools in the intervention group and six control schools) which offered first- through fourth grade, during one school year. The TriAtiva Program was implemented through educational activities related to healthy eating and physical activity, creating an environment which promoted student health while involving the school community and student families. The primary outcome of the present study was body mass, while its secondary outcomes were waist circumference, percent body fat, blood pressure and behavioural variables such as eating habits and physical activity levels, as well as the prevalence, incidence and remission rates of obesity. The intervention was developed based on a comprehensive review of controlled trials of similar design. The TriAtiva Program: Education, Nutrition and Physical Activity was the first study in Southern Brazil to use a randomized controlled design to evaluate an intervention involving both nutrition education and physical activity in schools. Our results will contribute to the development of future interventions aimed at preventing and controlling child obesity in schools, especially in Brazil. Brazilian Clinical Trials Registry (REBEC) number RBR2xx2z4.

Long-term effectiveness of bee venom acupuncture and physiotherapy in the treatment of adhesive capsulitis: a one-year follow-up analysis of a previous randomized controlled trial.

PubMed

Park, Yeon Cheol; Koh, Pil Seong; Seo, Byung Kwan; Lee, Jung Woo; Cho, Nam Su; Park, Hyung Soon; Park, Dong Suk; Baek, Yong Hyeon

2014-12-01

An earlier randomized controlled trial (RCT) study showed that bee venom acupuncture (BVA) in combination with physiotherapy can be more effective in functional improvement and pain reduction in patients with adhesive capsulitis (AC). The objective of the current study was to examine the long-term effect of BVA in combination with physiotherapy on AC of the shoulder. Retrospective 1-year follow-up analysis of a previous RCT using a telephone interview method. Outpatient joint center at the Gang Dong Kyung Hee University Hospital of Seoul, Republic of Korea. A total of 192 patients had been enrolled in the previous study, and 124 of these were excluded from the current study. Sixty-eight patients who had been treated with combined BVA and physiotherapy for AC of the shoulder for 2 months were interviewed at approximately 1 year after treatment by telephone. Sixty of 68 patients were included in the follow-up analysis. Twenty received BV 1 treatment (1:10,000 concentration BVA plus physiotherapy), 22 received BV 2 treatment (1:30,000 concentration BVA plus physiotherapy), and 18 received control treatment (normal saline injection plus physiotherapy). The primary outcome measure was Shoulder Pain And Disability Index (SPADI) score. Secondary outcome measure was score on verbal rating scale for pain and patient satisfaction. Baseline characteristics of the groups did not significantly differ. SPADI scores at 1 year significantly differed between the BV 1 group and the control group (p=0.043). No significant differences were found in pain verbal rating scores after 1 year. Treatment satisfaction with therapy was also assessed, and the BV 1 and BV 2 groups showed significantly greater satisfaction compared with the control group. BVA combined with physiotherapy remains clinically effective 1 year after treatment and may help improve long-term quality of life in patients with AC of the shoulder.

Treatment of Focal Articular Cartilage Defects in the Knee

PubMed Central

Magnussen, Robert A.; Dunn, Warren R.; Carey, James L.

2008-01-01

We asked whether autologous chondrocyte implantation or osteochondral autograft transfer yields better clinical outcomes compared with one another or with traditional abrasive techniques for treatment of isolated articular cartilage defects and whether lesion size influences this clinical outcome. We performed a literature search and identified five randomized, controlled trials and one prospective comparative trial evaluating these treatment techniques in 421 patients. The operative procedures included autologous chondrocyte implantation, osteochondral autograft transfer, matrix-induced autologous chondrocyte implantation, and microfracture. Minimum followup was 1 year (mean, 1.7 years; range, 1–3 years). All studies documented greater than 95% followup for clinical outcome measures. No technique consistently had superior results compared with the others. Outcomes for microfracture tended to be worse in larger lesions. All studies reported improvement in clinical outcome measures in all treatment groups when compared with preoperative assessment; however, no control (nonoperative) groups were used in any of the studies. A large prospective trial investigating these techniques with the addition of a control group would be the best way to definitively address the clinical questions. Level of Evidence: Level II, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence. PMID:18196358

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

PubMed

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

2012-04-01

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

Physical activity and adolescents: an exploratory randomized controlled trial investigating the influence of affective and instrumental text messages.

PubMed

Sirriyeh, Reema; Lawton, Rebecca; Ward, Jane

2010-11-01

The present study attempts to develop and pilot the feasibility and efficacy of a novel intervention using affective messages as a strategy to increase physical activity (PA) levels in adolescents. Design An exploratory pilot randomized control trial was used to compare behaviour change over 2 weeks. A modified form of the International Physical Activity Questionnaire was used to assess PA behaviour. A total of 120 adolescents (16-19 years) from 4 sixth forms in West Yorkshire completed the field-based study. Participants were randomly assigned to one of three experimental conditions, or the control condition (N=28). Participants in experimental conditions received 1 short messaging service (SMS) text message per day over the 2 weeks, which included manipulations of either affective beliefs (enjoyable/unenjoyable; N=31), instrumental beliefs (beneficial/harmful; N=30), or a combination of these (N=31). Control participants received one SMS text message per week. Outcomes were measured at baseline and at the end of the 2 week intervention. PA levels increased by the equivalent of 31.5  minutes of moderate (four metabolic equivalent) activity per week during the study. Main effects of condition (p=.049), and current physical activity level (p=.002) were identified, along with a significant interaction between condition and current activity level (p=.006). However, when the sample was split at baseline into active and inactive participants, a main effect of condition remained for inactive participants only (p=.001). Post hoc analysis revealed that inactive participants who received messages targeting affective beliefs increased their activity levels significantly more than the instrumental (p=.012), combined (p=.002), and control groups (p=.018). Strategies based on affective associations may be more effective for increasing PA levels in inactive individuals.

A Patient Navigator Intervention to Reduce Hospital Readmissions among High-Risk Safety-Net Patients: A Randomized Controlled Trial.

PubMed

Balaban, Richard B; Galbraith, Alison A; Burns, Marguerite E; Vialle-Valentin, Catherine E; Larochelle, Marc R; Ross-Degnan, Dennis

2015-07-01

Evidence-based interventions to reduce hospital readmissions may not generalize to resource-constrained safety-net hospitals. To determine if an intervention by patient navigators (PNs), hospital-based Community Health Workers, reduces readmissions among high risk, low socioeconomic status patients. Randomized controlled trial. General medicine inpatients having at least one of the following readmission risk factors: (1) age ≥60 years, (2) any in-network inpatient admission within the past 6 months, (3) length of stay ≥3 days, (4) admission diagnosis of heart failure, or (5) chronic obstructive pulmonary disease. The analytic sample included 585 intervention patients and 925 controls. PNs provided coaching and assistance in navigating the transition from hospital to home through hospital visits and weekly telephone outreach, supporting patients for 30 days post-discharge with discharge preparation, medication management, scheduling of follow-up appointments, communication with primary care, and symptom management. The primary outcome was in-network 30-day hospital readmissions. Secondary outcomes included rates of outpatient follow-up. We evaluated outcomes for the entire cohort and stratified by patient age >60 years (425 intervention/584 controls) and ≤60 years (160 intervention/341 controls). Overall, 30-day readmission rates did not differ between intervention and control patients. However, the two age groups demonstrated marked differences. Intervention patients >60 years showed a statistically significant adjusted absolute 4.1% decrease [95% CI: -8.0%, -0.2%] in readmission with an increase in 30-day outpatient follow-up. Intervention patients ≤60 years showed a statistically significant adjusted absolute 11.8% increase [95% CI: 4.4%, 19.0%] in readmission with no change in 30-day outpatient follow-up. A patient navigator intervention among high risk, safety-net patients decreased readmission among older patients while increasing readmissions among younger patients. Care transition strategies should be evaluated among diverse populations, and younger high risk patients may require novel strategies.

A public health evaluation of 13-valent pneumococcal conjugate vaccine impact on adult disease outcomes from a randomized clinical trial in the Netherlands.

PubMed

Gessner, Bradford D; Jiang, Qin; Van Werkhoven, Cornelis H; Sings, Heather L; Webber, Chris; Scott, Daniel; Neuzil, Kathleen M; O'Brien, Katherine L; Wunderink, Richard G; Grobbee, Diederick E; Bonten, Marc J M; Jodar, Luis

2018-05-31

We conducted a post-hoc analysis of a double blind, randomized, placebo-controlled trial of 13-valent pneumococcal conjugate vaccine (PCV13) among adults aged 65 years or older to assess public health impact. For all outcomes, we included all randomized subjects, using a modified intention-to-treat (mITT) approach to determine vaccine efficacy (VE), vaccine preventable disease incidence (VPDI) defined as control minus vaccinated group incidence, and numbers needed to vaccinate (NNV) (based on a five-year duration of protection). Results are reported for, in order, clinical, adjudicated (clinical plus radiologic infiltrate determined by committee), pneumococcal, and vaccine-type pneumococcal (VT-Sp) community-acquired pneumonia; invasive pneumococcal disease (IPD) and VT-IPD. VEs (95% CI) for all hospital episodes were 8.1% (-0.6%, 16.1%), 6.7% (-4.1%, 16.3%), 22.2% (2.0%, 38.3%), 37.5% (14.3%, 54.5%), 49.3% (23.2%, 66.5%), and 75.8% (47.6%, 88.8%). VPDIs per 100,000 person-years of observation (PYOs) were 72, 37, 25, 25, 20, and 15 with NNVs of 277, 535, 816, 798, 1016, and 1342. For clinical CAP, PCV13 was associated with a reduction of 909 (-115, 2013) hospital days per 100,000 PYOs translating to a reduction over 5 years of one hospital day for every 22 people vaccinated. When comparing at-risk persons (defined by self-report of diabetes, chronic lung disease, or other underlying conditions) to not at-risk persons, VEs were similar or lower, but because baseline incidences were higher the VPDIs were approximately 2-10 times higher and NNVs 50-90% lower. A public health analysis of pneumonia and IPD outcomes in a randomized controlled trial found substantial burden reduction following adult PCV13 immunization implemented in a setting with an ongoing infant PCV7-PCV10 program. VPDIs were higher among at-risk adults. The original study and the current analysis were funded by Pfizer. Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.

The MOSAIC study - comparison of the Maudsley Model of Treatment for Adults with Anorexia Nervosa (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with anorexia nervosa or eating disorder not otherwise specified, anorexia nervosa type: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Anorexia nervosa (AN) is a biologically based serious mental disorder with high levels of mortality and disability, physical and psychological morbidity and impaired quality of life. AN is one of the leading causes of disease burden in terms of years of life lost through death or disability in young women. Psychotherapeutic interventions are the treatment of choice for AN, but the results of psychotherapy depend critically on the stage of the illness. The treatment response in adults with a chronic form of the illness is poor and drop-out from treatment is high. Despite the seriousness of the disorder the evidence-base for psychological treatment of adults with AN is extremely limited and there is no leading treatment. There is therefore an urgent need to develop more effective treatments for adults with AN. The aim of the Maudsley Outpatient Study of Treatments for Anorexia Nervosa and Related Conditions (MOSAIC) is to evaluate the efficacy and cost effectiveness of two outpatient treatments for adults with AN, Specialist Supportive Clinical Management (SSCM) and the Maudsley Model of Treatment for Adults with Anorexia Nervosa (MANTRA). Methods/Design 138 patients meeting the inclusion criteria are randomly assigned to one of the two treatment groups (MANTRA or SSCM). All participants receive 20 once-weekly individual therapy sessions (with 10 extra weekly sessions for those who are severely ill) and four follow-up sessions with monthly spacing thereafter. There is also optional access to a dietician and extra sessions involving a family member or a close other. Body weight, eating disorder- related symptoms, neurocognitive and psychosocial measures, and service use data are measured during the course of treatment and across a one year follow up period. The primary outcome measure is body mass index (BMI) taken at twelve months after randomization. Discussion This multi-center study provides a large sample size, broad inclusion criteria and a follow-up period. However, the study has to contend with difficulties directly related to running a large multi-center randomized controlled trial and the psychopathology of AN. These issues are discussed. Trial Registration Current Controlled Trials ISRCTN67720902 - A Maudsley outpatient study of treatments for anorexia nervosa and related conditions. PMID:23721562

A randomized clinical trial on the effects of remote intercessory prayer in the adverse outcomes of pregnancies.

PubMed

da Rosa, Maria Inês; Silva, Fabio Rosa; Silva, Bruno Rosa; Costa, Luciana Carvalho; Bergamo, Angela Mendes; Silva, Napoleão Chiaramonte; Medeiros, Lidia Rosi de Freitas; Battisti, Iara Denise Endruweit; Azevedo, Rafael

2013-08-01

The scope of this article was to investigate whether intercessory prayer (IP) influences the adverse outcomes of pregnancies. A double-blind, randomized clinical trial was conducted with 564 pregnant women attending a prenatal public health care service. The women were randomly assigned to an IP group or to a control group (n = 289 per group). They were simultaneously and randomly assigned to practice prayer off-site or not. The following parameters were evaluated: Apgar scores, type of delivery and birth weight. The mean age of the women was 25.1 years of age (± 7.4), and the average gestational age was 23.4 weeks (± 8.1). The average number of years of schooling for the women was 8.1 years (± 3.1). The women in the IP and control groups presented a similar number of adverse medical events with non-significant p. No significant differences were detected in the frequency of adverse outcomes in pregnant women who practiced IP and those in the control group.

A randomized, controlled trial to increase discussion of breast cancer in primary care.

PubMed

Kaplan, Celia P; Livaudais-Toman, Jennifer; Tice, Jeffrey A; Kerlikowske, Karla; Gregorich, Steven E; Pérez-Stable, Eliseo J; Pasick, Rena J; Chen, Alice; Quinn, Jessica; Karliner, Leah S

2014-07-01

Assessment and discussion of individual risk for breast cancer within the primary care setting are crucial to discussion of risk reduction and timely referral. We conducted a randomized controlled trial of a multiethnic, multilingual sample of women ages 40 to 74 years from two primary care practices (one academic, one safety net) to test a breast cancer risk assessment and education intervention. Patients were randomly assigned to control or intervention group. All patients completed a baseline telephone survey and risk assessment (via telephone for controls, via tablet computer in clinic waiting room before visit for intervention). Intervention (BreastCARE) patients and their physicians received an individualized risk report to discuss during the visit. One-week follow-up telephone surveys with all patients assessed patient-physician discussion of family cancer history, personal breast cancer risk, high-risk clinics, and genetic counseling/testing. A total of 655 control and 580 intervention women completed the risk assessment and follow-up interview; 25% were high-risk by family history, Gail, or Breast Cancer Surveillance Consortium risk models. BreastCARE increased discussions of family cancer history [OR, 1.54; 95% confidence interval (CI), 1.25-1.91], personal breast cancer risk (OR, 4.15; 95% CI, 3.02-5.70), high-risk clinics (OR, 3.84; 95% CI, 2.13-6.95), and genetic counseling/testing (OR, 2.22; 95% CI, 1.34-3.68). Among high-risk women, all intervention effects were stronger. An intervention combining an easy-to-use, quick risk assessment tool with patient-centered risk reports at the point of care can successfully promote discussion of breast cancer risk reduction between patients and primary care physicians, particularly for high-risk women. Next steps include scaling and dissemination of BreastCARE with integration into electronic medical record systems. ©2014 American Association for Cancer Research.

A Randomized, Controlled Trial to Increase Discussion of Breast Cancer in Primary Care

PubMed Central

Kaplan, Celia P.; Livaudais-Toman, Jennifer; Tice, Jeffrey A.; Kerlikowske, Karla; Gregorich, Steven E.; Pérez-Stable, Eliseo J.; Pasick, Rena J.; Chen, Alice; Quinn, Jessica; Karliner, Leah S.

2014-01-01

Background Assessment and discussion of individual risk for breast cancer within the primary care setting are crucial to discussion of risk reduction and timely referral. Methods We conducted a randomized controlled trial of a multiethnic, multilingual sample of women ages 40 to 74 years from two primary care practices (one academic, one safety net) to test a breast cancer risk assessment and education intervention. Patients were randomly assigned to control or intervention group. All patients completed a baseline telephone survey and risk assessment (via telephone for controls, via tablet computer in clinic waiting room before visit for intervention). Intervention (BreastCARE) patients and their physicians received an individualized risk report to discuss during the visit. One-week follow-up telephone surveys with all patients assessed patient–physician discussion of family cancer history, personal breast cancer risk, high-risk clinics, and genetic counseling/testing. Results A total of 655 control and 580 intervention women completed the risk assessment and follow-up interview; 25% were high-risk by family history, Gail, or Breast Cancer Surveillance Consortium risk models. BreastCARE increased discussions of family cancer history [OR, 1.54; 95% confidence interval (CI), 1.25–1.91], personal breast cancer risk (OR, 4.15; 95% CI, 3.02–5.70), high-risk clinics (OR, 3.84; 95% CI, 2.13–6.95), and genetic counseling/testing (OR, 2.22; 95% CI, 1.34–3.68). Among high-risk women, all intervention effects were stronger. Conclusions An intervention combining an easy-to-use, quick risk assessment tool with patient-centered risk reports at the point of care can successfully promote discussion of breast cancer risk reduction between patients and primary care physicians, particularly for high-risk women. Impact Next steps include scaling and dissemination of BreastCARE with integration into electronic medical record systems. PMID:24762560

Protocol for Fit Bodies, Fine Minds: a randomized controlled trial on the affect of exercise and cognitive training on cognitive functioning in older adults

PubMed Central

O'Dwyer, Siobhan T; Burton, Nicola W; Pachana, Nancy A; Brown, Wendy J

2007-01-01

Background Declines in cognitive functioning are a normal part of aging that can affect daily functioning and quality of life. This study will examine the impact of an exercise training program, and a combined exercise and cognitive training program, on the cognitive and physical functioning of older adults. Methods/Design Fit Bodies, Fine Minds is a randomized, controlled trial. Community-dwelling adults, aged between 65 and 75 years, are randomly allocated to one of three groups for 16 weeks. The exercise-only group do three 60-minute exercise sessions per week. The exercise and cognitive training group do two 60-minute exercise sessions and one 60-minute cognitive training session per week. A no-training control group is contacted every 4 weeks. Measures of cognitive functioning, physical fitness and psychological well-being are taken at baseline (0 weeks), post-test (16 weeks) and 6-month follop (40 weeks). Qualitative responses to the program are taken at post-test. Discussion With an increasingly aged population, interventions to improve the functioning and quality of life of older adults are particularly important. Exercise training, either alone or in combination with cognitive training, may be an effective means of optimizing cognitive functioning in older adults. This study will add to the growing evidence base on the effectiveness of these interventions. Trial Registration Australian Clinical Trials Register: ACTRN012607000151437 PMID:17915035

Intensive multifactorial treatment modifies the effect of family history of diabetes on glycaemic control in people with Type 2 diabetes: a post hoc analysis of the ADDITION-Denmark randomized controlled trial.

PubMed

Eliraqi, G M; Vistisen, D; Lauritzen, T; Sandbaek, A; Jørgensen, M E; Faerch, K

2015-08-01

To investigate whether intensive multifactorial treatment can reverse the predisposed adverse phenotype of people with Type 2 diabetes who have a family history of diabetes. Data from the randomized controlled trial ADDITION-Denmark were used. A total of 1441 newly diagnosed patients with diabetes (598 with family history of diabetes) were randomized to intensive treatment or routine care. Family history of diabetes was defined as having one parent and/or sibling with diabetes. Linear mixed-effects models were used to assess the changes in risk factors (BMI, waist circumference, blood pressure, lipids and HbA1c ) after 5 years of follow-up in participants with and without a family history of diabetes. An interaction term between family history of diabetes and treatment group was included in the models to test for a modifying effect of the intervention. All analyses were adjusted for age, sex, baseline value of the risk factor and general practice (random effect). At baseline, participants with a family history of diabetes were younger and had a 1.1 mmol/mol (0.1%) higher HbA1c concentration at the time of diagnosis than those without a family history of diabetes. Family history of diabetes modified the effect of the intervention on changes in HbA1c levels. In the group receiving routine care, participants with a family history of diabetes experienced an improvement in HbA1c concentration that was 3.3 mmol/mol (0.3%) lower than the improvement found in those without a family history of diabetes after 5 years of follow-up. In the intensive treatment group, however, there was no difference in HbA1c concentrations between participants with and without a family history of diabetes after 5 years of treatment. Intensive treatment of diabetes may partly remove the adverse effects of family history of diabetes on glycaemic control. The effect of this improvement on long-term diabetic complications warrants further investigation. © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

Antimicrobial drugs for persistent diarrhoea of unknown or non-specific cause in children under six in low and middle income countries: systematic review of randomized controlled trials

PubMed Central

2009-01-01

Background A high proportion of children with persistent diarrhoea in middle and low income countries die. The best treatment is not clear. We conducted a systematic review to evaluate the effectiveness of antimicrobial drug treatment for persistent diarrhoea of unknown or non-specific cause. Methods We included randomized comparisons of antimicrobial drugs for the treatment of persistent diarrhoea of unknown or non-specific cause in children under the age of six years in low and middle income countries. We searched the electronic databases MEDLINE, EMBASE, LILACS, WEB OF SCIENCE, and the Cochrane Central Register of Controlled Trials (CENTRAL) to May 2008 for relevant randomized or quasi randomized controlled trials. We summarised the characteristics of the eligible trials, assessed their quality using standard criteria, and extracted relevant outcomes data. Where appropriate, we combined the results of different trials. Results Three trials from South East Asia and one from Guatemala were included, all were small, and three had adequate allocation concealment. Two were in patients with diarrhoea of unknown cause, and two were in patients in whom known bacterial or parasitological causes of diarrhoea had been excluded. No difference was demonstrated for oral gentamicin compared with placebo (presence of diarrhoea at 6 or 7 days; 2 trials, n = 151); and for metronidazole compared with placebo (presence of diarrhoea at 3, 5 and 7 days; 1 trial, n = 99). In one small trial, sulphamethoxazole-trimethoprim appeared better than placebo in relation to diarrhoea at seven days and total stool volume (n = 55). Conclusion There is little evidence as to whether or not antimicrobials help treat persistent diarrhoea in young children in low and middle income countries. PMID:19257885

Randomized controlled trial of REbeL: A peer education program to promote positive body image, healthy eating behavior, and empowerment in teens.

PubMed

Eickman, Laura; Betts, Jessica; Pollack, Lauren; Bozsik, Frances; Beauchamp, Marshall; Lundgren, Jennifer

2018-01-01

Short-term outcomes associated with participation in REbeL, a peer-led dissonance-based eating disorder prevention program for high school students, were evaluated. Seventy-one students across the three high schools were enrolled in the study (REbeL N = 48; Control N = 23) and were assessed on measures of eating attitudes and behaviors, body image, weight bias, self-esteem, empowerment, and mood at the beginning of the school year; 37 REbeL students and 20 control students completed assessments at the end of the school year. Mixed effects GLM compared groups on outcomes at the end of the academic year. When controlling for baseline scores, students in both REbeL schools, compared to control school students, demonstrated statistically significantly lower scores at post-test on the EDE-Q Global score, the EDE-Q Restraint, Eating Concern, Shape Concern and Weight Concern subscales, and the Body Checking Questionnaire (all ps < .05). This study provides preliminary empirical support for the REbeL program.

A randomized controlled trial of two primary school intervention strategies to prevent early onset tobacco smoking.

PubMed

Storr, Carla L; Ialongo, Nicholas S; Kellam, Sheppard G; Anthony, James C

2002-03-01

In this article, we examine the impact of two universal, grade 1 preventive interventions on the onset of tobacco smoking as assessed in early adolescence. The classroom-centered (CC) intervention was designed to reduce the risk for tobacco smoking by enhancing teachers' behavior management skills in first grade and, thereby, reducing child attention problems and aggressive and shy behavior-known risk behaviors for later substance use. The family-school partnership (FSP) intervention targeted these early risk behaviors via improvements in parent-teacher communication and parents' child behavior management strategies. A cohort of 678 urban, predominately African-American, public school students were randomly assigned to one of three Grade 1 classrooms at entrance to primary school (age 6). One classroom featured the CC intervention, a second the FSP intervention, and the third served as a control classroom. Six years later, 81% of the students completed audio computer-assisted self-interviews. Relative to controls, a modest attenuation in the risk of smoking initiation was found for students who had been assigned to either the CC or FSP intervention classrooms (26% versus 33%) (adjusted relative risk for CC/control contrast=0.57, 95% confidence interval (CI), 0.34-0.96; adjusted relative risk for FSP/control contrast=0.69, 95% CI, 0.50-0.97). Results lend support to targeting the early antecedent risk behaviors for tobacco smoking.

[A multicenter randomized controlled study of Saccharomyces boulardii in the prevention of antibiotic-associated diarrhea in infants and young children].

PubMed

Wan, C M; Yu, H; Liu, G; Xu, H M; Mao, Z Q; Xu, Y; Jin, Y; Luo, R P; Wang, W J; Fang, F

2017-05-04

Objective: To evaluate the efficacy and safety of Saccharomyces boulardii in the prevention of antibiotic-associated diarrhea (AAD) in infants and young children. Method: From November 2012 to September 2013, ten research units of large teaching hospitals or children's hospitals participated in this multicenter randomized controlled clinical trial. Hospitalized young children aged between 1 month and 3 years (nongastrointestinal infection and antibiotic therapy required)were involved in our study. The children were randomly divided into control group and prevention group by means of block random allocation method. The control group received antibiotic therapy and other conventional treatment. The prevention group was given additional Saccharomyces boulardii (250 mg/d) orally. Diarrhea rates of two groups were compared both during the usage of antibiotics and within 14 days after the antibiotics withdrawal. The adverse reactions of Saccharomyces boulardii were observed all through this study. The results were analyzed by χ(2) test or Kruskal-Wallis test or t test. Result: Totally 408 cases (213 cases in prevention group and 195 cases in control group) were enrolled. The age ranged from 1 month to 3 years, with an average age of 1.14 years. The basic diseases were parenteral infections: 368 cases with different kinds of respiratory tract infections or pneumonia, 10 cases of bacterial meningitis, 9 cases with septicemia or sepsis, 6 cases with pertussis or pertussis like syndrome, 5 cases with urinary infection, 5 cases with skin or subcutaneous tissue infections, 3 cases of Kawasaki disease, one with scarlet fever and one with congenital syphilis. During the administration of antibiotics, the incidence of AAD in prevention group was 10.3% (22 cases), which was significantly lower than that of control group (57 cases, 29.2%, χ(2)=23.296, P <0.05). Within 14 days after the discontinuation of antibiotics, the percent of new diarrhea cases in prevention group (2.4%, 5/213) was also significantly lower than that in control group (16.4%, 32/195, χ(2)=23.4, P <0.05). Further analysis revealed that the rate of AAD in children less than or equal to 1 year old (25.1%, 52/207) was significantly higher than that of over 1 year old (13.4%, 27/201, χ(2)=8.922, P <0.05). The incidence of AAD in children treated with antibiotics for more than 5 days was 22.2%(60/270), which was significantly higher than that of less than or equal to 5 days (13.8%, 19/138, χ(2)=4.180, P <0.05). Although no significant difference was observed, the AAD rate of patients with combined use of two antibiotics was higher than that of using one. During the antibiotic therapy, compared with the control group, the risk of AAD in children under 1 year old was reduced by 52% (χ(2)=9.217, P <0.05), and 91% (χ(2)=20.35, P <0.05) in the children over 1 year old in prevention group. The risk of AAD of prevention group decreased by 66% (χ(2)=13.67, P <0.05) in patients treated with one antibiotics, and 65% in children with combined use of antibiotics (χ(2)=10.57, P <0.05). In patients treated with antibiotics for less than or equal to 5 days, the risk of AAD decreased by 74% in prevention group (χ(2)=7.38, P <0.05); and 63% if the course lasted for over 5 days (χ(2)=16.87, P <0.05). Within 14 days after the withdrawal of antibiotics, compared with the control group, the risk of diarrhea in the prevention group decreased by 82% (χ(2)=13.35, P <0.05) in infants (≤1 year old) and 93% (χ(2)=12.00, P <0.05) in children (>1 year old); the risk of diarrhea was reduced by 86% (χ(2)=9.57, P <0.05) and 87% (χ(2)=17.71, P <0.05) respectively in prevention group with single and combined use of antibiotics. In patients treated with antibiotics for more than 5 days, the risk of diarrhea in prevention group was reduced by 63% (χ(2)=22.79, P <0.05), while there was no significant difference if the antibiotics course was less than or equal to 5 days (χ(2)=2.97, P >0.05). No adverse effects related with Saccharomyces boulardii were observed in our study. Conclusion: Saccharomyces boulardii is effective and safe to prevent AAD of infants and young children both during the usage of antibiotics and up to 14 days after drug discontinuance. It can be one of the drugs of for choice prevention of AAD in infants and young children. Trial registration Chinese Clinical Trial Tegister, ChiECRCT-2012-25.

Prospective randomized clinical trial of aggressive rehabilitation after acute Achilles tendon ruptures repaired with Dresden technique.

PubMed

De la Fuente, Carlos; Peña y Lillo, Roberto; Carreño, Gabriel; Marambio, Hugo

2016-03-01

Rupture of the Achilles tendon is a common injury during working years. Aggressive rehabilitation may provide better outcomes, but also a greater chance of re-rupture. To determine if aggressive rehabilitation has better clinical outcomes for Achilles tendon function, Triceps surae function, one-leg heel rise capacity and lower complication rate during twelve weeks after percutaneous Achilles tendon repair compared to conventional rehabilitation. Randomized controlled trial. Thirty-nine patients were prospectively randomized. The aggressive group (n=20, 41.4 ± 8.3 years) received rehabilitation from the first day after surgery. The conventional group (n=19, 41.7 ± 10.7 years) rested for 28 days, before rehabilitation started. The statistical parameters were the Achilles tendon rupture score (ATRS), verbal pain scale, time to return to work, pain medication consumption, Achilles tendon strength, dorsiflexion range of motion (RoM), injured-leg calf circumference, calf circumference difference, one-leg heel rise repetition and difference, re-rupture rate, strength deficit rate, and other complication rates. Mixed-ANOVA and Bonferroni's post hoc test were performed for multiple comparisons. Student's t-test was performed for parameters measured on the 12th week. The aggressive group with respect to the conventional group had a higher ATRS; lower verbal pain score; lower pain medication consumption; early return to work; higher Achilles tendon strength; higher one-leg heel rise repetitions; and lower one-leg heel rise difference. The re-rupture rate was 5% and 5%, the strength deficit rate was 42% and 5%, and other complications rate was 11% and 15% in the conventional and aggressive group, respectively. Patients with Dresden repair and aggressive rehabilitation have better clinical outcomes, Achilles tendon function and one-leg heel rise capacity without increasing the postoperative complications rate after 12 weeks compared to rehabilitation with immobilization and non-weight-bearing during the first 28 days after surgery. Copyright © 2015 Elsevier Ltd. All rights reserved.

A randomized controlled study into the efficacy and toxicity of pegylated liposome encapsulated doxorubicin as an adjuvant therapy in dogs with splenic haemangiosarcoma.

PubMed

Teske, E; Rutteman, G R; Kirpenstein, J; Hirschberger, J

2011-12-01

Safety and efficacy of pegylated liposome encapsulated doxorubicin (PL-DOX) was compared with free doxorubicin as an adjuvant monotherapy in dogs with splenic haemangiosarcoma after splenectomy in a randomized prospective clinical trial. A total of 17 dogs in each group were treated. No significant difference in survival between the two treatments was found. The calculated median overall survival time for the 34 dogs was 166 days [95% confidence interval (CI) 148-184]. The ½ year and one-year survival was 41.2% (95% CI 24.8-56.9) and 22.7% (95% CI 9.9-37.4), respectively. In dogs treated with PL-DOX, a desquamating dermatitis like palmar-plantar erythrodysesthesia (PPES) was seen in two dogs, while three other dogs showed anaphylactic reactions. Cardiotoxicity was not seen in either treatment groups. © 2011 Blackwell Publishing Ltd.

Teacher consultation and coaching within mental health practice: classroom and child effects in urban elementary schools.

PubMed

Cappella, Elise; Hamre, Bridget K; Kim, Ha Yeon; Henry, David B; Frazier, Stacy L; Atkins, Marc S; Schoenwald, Sonja K

2012-08-01

To examine effects of a teacher consultation and coaching program delivered by school and community mental health professionals on change in observed classroom interactions and child functioning across one school year. Thirty-six classrooms within 5 urban elementary schools (87% Latino, 11% Black) were randomly assigned to intervention (training + consultation/coaching) and control (training only) conditions. Classroom and child outcomes (n = 364; 43% girls) were assessed in the fall and spring. Random effects regression models showed main effects of intervention on teacher-student relationship closeness, academic self-concept, and peer victimization. Results of multiple regression models showed levels of observed teacher emotional support in the fall moderated intervention impact on emotional support at the end of the school year. Results suggest teacher consultation and coaching can be integrated within existing mental health activities in urban schools and impact classroom effectiveness and child adaptation across multiple domains. © 2012 American Psychological Association

Study protocol of a randomized clinical trial evaluating the effectiveness of a primary care intervention using the Nintendo™ Wii console to improve balance and decrease falls in the elderly.

PubMed

Montero-Alía, Pilar; Muñoz-Ortiz, Laura; Jiménez-González, Mercè; Benedicto-Pañell, Carla; Altimir-Losada, Salvador; López-Colomer, Yolanda; Prat-Rovira, Josep; Amargant-Rubio, Joan Francesc; Jastes, Sheila Mendes; Moreno-Buitrago, Ana; Rodríguez-Pérez, M Carmen; Teixidó-Vargas, Cristina; Albarrán-Sánchez, José Luís; Candel-Gil, Anna; Serra-Serra, Domènec; Martí-Cervantes, Juan José; Sánchez-Pérez, Carlos Andrés; Sañudo-Blanco, Lidia; Dolader-Olivé, Sònia; Torán-Monserrat, Pere

2016-01-12

Balance alteration is a risk factor for falls in elderly individuals that has physical, psychological and economic consequences. The objectives of this study are to evaluate the usefulness of an intervention utilizing the Nintendo™ Wii console in order to improve balance, thereby decreasing both the fear of falling as well as the number of falls, and to evaluate the correlation between balance as determined by the console and the value obtained in the Tinetti tests and the one foot stationary test. This is a controlled, randomized clinical trial of individual assignment, carried out on patients over 70 years in age, from five primary care centers in the city of Mataró (Barcelona). 380 patients were necessary for the intervention group that carried out the balance board exercises in 2 sessions per week for a 3 month period, and 380 patients in the control group who carried out their usual habits. Balance was evaluated using the Tinetti test, the one foot stationary test and with the console, at the start of the study, at the end of the intervention (3 months) and one year later. Quarterly telephone follow-up was also conducted to keep track of falls and their consequences. The study aimed to connect the community with a technology that may be an easy and fun way to assist the elderly in improving their balance without the need to leave home or join rehabilitation groups, offering greater comfort for this population and decreasing healthcare costs since there is no need for specialized personnel. Current Control Trial NCT02570178.

Vehicle year and the risk of car crash injury

PubMed Central

Blows, S; Ivers, R; Woodward, M; Connor, J; Ameratunga, S; Norton, R

2003-01-01

Objective: To quantify the association between vehicle age and risk of car crash injury. Design and setting: Data from a population based case-control study conducted in the Auckland region in 1998/99 was used to examine the adjusted risk of car crash injury or death due to vehicle age, after controlling for a range of known confounders. Cases were all cars involved in crashes in which at least one occupant was hospitalized or killed anywhere in the Auckland region, and controls were randomly selected cars on Auckland roads. The drivers of the 571 case vehicles and 588 control vehicles completed a structured interview. Main outcome measure: Hospitalisation or death of a vehicle occupant due to car crash injury. Results: Vehicles constructed before 1984 had significantly greater chance of being involved in an injury crash than those constructed after 1994 (odds ratio 2.88, 95% confidence interval (CI) 1.20 to 6.91), after adjustment for potential confounders. There was also a trend for increasing crash risk with each one year increase in vehicle age after adjustment for potential confounders (odds ratio 1.05, 95% CI 0.99 to 1.11; p = 0.09). Conclusion: This study quantifies the increased risk of car crash injury associated with older vehicle year and confirms this as an important public health issue. PMID:14693899

Vehicle year and the risk of car crash injury.

PubMed

Blows, S; Ivers, R Q; Woodward, M; Connor, J; Ameratunga, S; Norton, R

2003-12-01

To quantify the association between vehicle age and risk of car crash injury. Data from a population based case-control study conducted in the Auckland region in 1998/99 was used to examine the adjusted risk of car crash injury or death due to vehicle age, after controlling for a range of known confounders. Cases were all cars involved in crashes in which at least one occupant was hospitalized or killed anywhere in the Auckland region, and controls were randomly selected cars on Auckland roads. The drivers of the 571 case vehicles and 588 control vehicles completed a structured interview. Hospitalisation or death of a vehicle occupant due to car crash injury. Vehicles constructed before 1984 had significantly greater chance of being involved in an injury crash than those constructed after 1994 (odds ratio 2.88, 95% confidence interval (CI) 1.20 to 6.91), after adjustment for potential confounders. There was also a trend for increasing crash risk with each one year increase in vehicle age after adjustment for potential confounders (odds ratio 1.05, 95% CI 0.99 to 1.11; p = 0.09). This study quantifies the increased risk of car crash injury associated with older vehicle year and confirms this as an important public health issue.

Variation in the oxytocin receptor gene moderates the protective effects of a family-based prevention program on telomere length.

PubMed

Smearman, Erica L; Yu, Tianyi; Brody, Gene H

2016-02-01

Parent-child relationships with high conflict and low warmth and support are associated with later adverse behavioral and physiological child outcomes. These outcomes include shorter telomere lengths, the repetitive sequences at the ends of chromosomes that have been utilized as a biomarker for chronic stress. Our research group furthered this by exploring telomere length outcomes following a family-based prevention program and identified reduced telomere shortening 5 years post intervention among those originally exposed to nonsupportive parenting and randomized to the intervention condition. However, not all individuals respond equally, and a growing literature suggests genetic sensitivity to one's environment, with variations in the oxytocin receptor gene (OXTR) potentially influencing this sensitivity. We utilized data from African American youths (mean age 17) randomized to intervention (n = 100) or control condition (n = 91) with baseline assessments of genetic status and nonsupportive parenting, and 5-year follow-up assessments of telomere length. We found a significant three-way interaction between nonsupportive parenting, intervention condition, and OXTR rs53576 genotype. OXTR GG individuals, who are suggested to be more sensitive to their social environment, exhibited significantly more variability, evidencing the shortest telomeres when exposed to nonsupportive parenting and randomized to the control condition, and similar telomere lengths to non at-risk groups when randomized to the intervention. In contrast, those with the A allele showed no statistical difference in telomere lengths across parental and intervention conditions. Subsequent analyses suggest that these findings may be mediated through chronic anger, whereby GG individuals exposed to nonsupportive parenting and randomized to the control condition had a greater increase in chronic anger by study follow-up, compared to those in the intervention, and this change associated with greater telomere shortening. These findings highlight the importance of individual differences and potential role of genetic status in moderating the relationship between environmental contexts and biological outcomes.

Randomized controlled trial of mailed Nicotine Replacement Therapy to Canadian smokers: study protocol.

PubMed

Cunningham, John A; Leatherdale, Scott T; Selby, Peter L; Tyndale, Rachel F; Zawertailo, Laurie; Kushnir, Vladyslav

2011-09-28

Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population. From 1985 to 2005, smoking rates among adults decreased from 35% to 19%, however, since that time, the prevalence has plateaued at around 18-19%. To continue to reduce the number of smokers at the population level, one option has been to translate interventions that have demonstrated clinical efficacy into population level initiatives. Nicotine Replacement Therapy (NRT) has a considerable clinical research base demonstrating its efficacy and safety and thus public health initiatives in Canada and other countries are distributing NRT widely through the mail. However, one important question remains unanswered--do smoking cessation programs that involve mailed distribution of free NRT work? To answer this question, a randomized controlled trial is required. A single blinded, panel survey design with random assignment to an experimental and a control condition will be used in this study. A two-stage recruitment process will be employed, in the context of a general population survey with two follow-ups (8 weeks and 6 months). Random digit dialing of Canadian home telephone numbers will identify households with adult smokers (aged 18+ years) who are willing to take part in a smoking study that involves three interviews, with saliva collection for 3-HC/cotinine ratio measurement at baseline and saliva cotinine verification at 8-week and 6-month follow-ups (N = 3,000). Eligible subjects interested in free NRT will be determined at baseline (N = 1,000) and subsequently randomized into experimental and control conditions to receive versus not receive nicotine patches. The primary hypothesis is that subjects who receive nicotine patches will display significantly higher quit rates (as assessed by 30 day point prevalence of abstinence from tobacco) at 6-month follow-up as compared to subjects who do not receive nicotine patches at baseline. The findings from the proposed trial are timely and highly relevant as mailed distribution of NRT require considerable resources and there are limited public health dollars available to combat this substantial health concern. In addition, findings from this randomized controlled trial will inform the development of models to engage smokers to quit, incorporating proactive recruitment and the offer of evidence based treatment. ClinicalTrials.gov: NCT01429129.

Mobile App for Treatment of Stress Urinary Incontinence: A Cost-Effectiveness Analysis.

PubMed

Sjöström, Malin; Lindholm, Lars; Samuelsson, Eva

2017-05-08

Mobile apps can increase access to care, facilitate self-management, and improve adherence to treatment. Stress urinary incontinence (SUI) affects 10-35% of women and, currently, an app with instructions for pelvic floor muscle training (PFMT) is available as first-line treatment. A previous randomized controlled study demonstrated that the app benefitted symptom severity and quality of life (QoL); in this study we investigate the cost-effectiveness of the app. The objective of this study was to evaluate the health economy of the app for treating SUI. This deterministic cost-utility analysis, with a 1-year societal perspective, compared the app treatment with no treatment. Health economic data were collected alongside a randomized controlled trial performed in Sweden from March 2013 to October 2014. This study included 123 community-dwelling women participants of 18 years and above, with stress urinary incontinence ≥1 time per week. Participants were self-assessed with validated questionnaires and 2-day leakage diaries, and then randomized to 3 months of treatment (app group, n=62) or no treatment (controls, n=61). The app focused on pelvic floor muscle training, prescribed 3 times daily. We continuously registered treatment delivery costs. Data were collected on each participant's training time, incontinence aids, and laundry at baseline and at a 3-month follow-up. We measured quality of life with the International Consultation on Incontinence Modular Questionnaire on Lower Urinary Tract Symptoms and Quality of Life, and calculated the quality-adjusted life years (QALYs) gained. Data from the 3-month follow-up were extrapolated to 1 year for the calculations. Our main outcome was the incremental cost-effectiveness ratios compared between app and control groups. One-way and multiway sensitivity analyses were performed. The mean age of participants was 44.7 years (SD 9.4). Annual costs were €547.0 for the app group and €482.4 for the control group. Annual gains in quality-adjusted life years for app and control groups were 0.0101 and 0.0016, respectively. Compared with controls, the extra cost per quality-adjusted life year for the app group ranged from -€2425.7 to €14,870.6, which indicated greater gains in quality-adjusted life years at similar or slightly higher cost. The app for treating stress urinary incontinence is a new, cost-effective, first-line treatment with potential for increasing access to care in a sustainable way for this patient group. ©Malin Sjöström, Lars Lindholm, Eva Samuelsson. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 08.05.2017.

Clinical hypnosis versus cognitive behavioral training for pain management with pediatric cancer patients undergoing bone marrow aspirations.

PubMed

Liossi, C; Hatira, P

1999-04-01

A randomized controlled trial was conducted to compare the efficacy of clinical hypnosis versus cognitive behavioral (CB) coping skills training in alleviating the pain and distress of 30 pediatric cancer patients (age 5 to 15 years) undergoing bone marrow aspirations. Patients were randomized to one of three groups: hypnosis, a package of CB coping skills, and no intervention. Patients who received either hypnosis or CB reported less pain and pain-related anxiety than did control patients and less pain and anxiety than at their own baseline. Hypnosis and CB were similarly effective in the relief of pain. Results also indicated that children reported more anxiety and exhibited more behavioral distress in the CB group than in the hypnosis group. It is concluded that hypnosis and CB coping skills are effective in preparing pediatric oncology patients for bone marrow aspiration.

The effects of Bifidobacterium animalis ssp. lactis B94 on gastrointestinal wellness in adults with Prader-Willi syndrome: study protocol for a randomized controlled trial.

PubMed

Alyousif, Zainab; Miller, Jennifer L; Sandoval, Mariana Y; MacPherson, Chad W; Nagulesapillai, Varuni; Dahl, Wendy J

2018-04-27

Constipation is a frequent problem in adults with Prader-Willi syndrome. Certain probiotics have been shown to improve transit and gastrointestinal symptoms of adults with functional constipation. The aim of this study is to determine the effect of daily consumption of Bifidobacterium animalis ssp. lactis B94 (B. lactis B94) on stool frequency, stool form, and gastrointestinal symptoms in adults with Prader-Willi syndrome. Adults with Prader-Willi syndrome (18-75 years old, n = 36) will be recruited and enrolled in a 20-week, randomized, double-blind, placebo-controlled, crossover study. Study subjects will be randomized to B. lactis B94 or placebo each for a 4-week period, preceded by a 4-week baseline and followed by 4-week washouts. Subjects will complete daily records of stool frequency and stool form (a proxy of transit time). Dietary intake data also will be collected. Stools, one in each period, will be collected for exploratory microbiota analyses. To our knowledge, this is the first randomized controlled trial evaluating the effectiveness of B. lactis in adults with Prader-Willi syndrome. The results of this study will provide evidence of efficacy for future clinical trials in patient populations with constipation. ClinicalTrials.gov ( NCT03277157 ). Registered on 08 September 2017.

Use of a low-literacy patient education tool to enhance pneumococcal vaccination rates. A randomized controlled trial.

PubMed

Jacobson, T A; Thomas, D M; Morton, F J; Offutt, G; Shevlin, J; Ray, S

1999-08-18

Pneumococcal immunization rates for elderly and high-risk patients are only one third to one half the target rate of 60% established by the US Public Health Service. Limited or marginal literacy, which affects nearly 100 million Americans, especially the elderly, may contribute to these low rates of immunization. To determine whether the use of a simple, low-literacy educational tool enhances patient-physician dialogue about pneumococcal vaccination and increases rates of immunization. A randomized controlled trial conducted between May and June of 1998. Ambulatory care clinic of a 900-bed public teaching hospital serving a predominantly indigent, low-literate, African American, inner-city population. Of 433 patients who presented for routine primary care, had vaccine indications (age > or =65 years or chronic disease), and had not been previously vaccinated, 221 were randomly assigned to the intervention group and 212 to the control group. Of the total patient population (mean age, 63 years), 280 (64.7%) had less than a high school education, 401 (92.6%) were African American, and 300 (69.3%) were female. One-page, low-literacy (below fifth-grade level) educational handout encouraging patients to "ask your doctor about the pneumonia shot" vs a control group (1 -page, low-literacy educational handout conveying information about nutrition). Vaccination rates (documented by chart audit) of patients who received pneumococcal vaccination and rates of patients who self-reported having discussed vaccination with their physicians. Patients in the intervention group were 4 times more likely to have discussed the pneumococcal vaccine with their physicians than patients in the control group (87/221 [39.4%] vs 21/212 [9.9%]; relative risk [RR], 3.97 [95% confidence interval [CI], 2.71-5.83]), and were more than 5 times as likely to have received the pneumococcal vaccine than the control group (44/221 [19.9%] vs 8/212 [3.8%]; RR, 5.28 [95% CI, 2.80-9.93]). In a multivariate analysis controlling for race, sex, education, insurance status, age, level of physician training, health status, and vaccine indication, only assignment to the intervention group was statistically significantly related to the probability of being immunized or discussing the issue with their physicians (P<.001 for both trends). A simple, low-literacy educational tool increased pneumococcal vaccination rates and patient-physician discussions about the vaccine in an elderly, low-literate, indigent, minority population.

Insulin and oral agents for managing cystic fibrosis-related diabetes.

PubMed

Onady, Gary M; Stolfi, Adrienne

2016-04-18

The Cystic Fibrosis Foundation recommends both short-term and long-acting insulin therapy when cystic fibrosis-related diabetes has been diagnosed. Diagnosis is based on: an elevated fasting blood glucose level greater than 6.94 mmol/liter (125 mg/deciliter); or oral glucose tolerance tests greater than 11.11 mmol/liter (200 mg/deciliter) at two hours; or symptomatic diabetes for random glucose levels greater than 11.11 mmol/liter (200 mg/deciliter); or glycated hemoglobin levels of at least 6.5%. To establish the effectiveness of insulin and oral agents for managing diabetes in people with cystic fibrosis in relation to blood sugar levels, lung function and weight management. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also handsearched abstracts from pulmonary symposia and the North American Cystic Fibrosis Conferences.Date of the most recent search of the Group's Cystic Fibrosis Trials Register: 18 February 2016. Randomized controlled trials comparing all methods of diabetes therapy in people with diagnosed cystic fibrosis-related diabetes. Two authors independently extracted data and assessed the risk of bias in the included studies. The searches identified 22 trials (34 references). Four trials (200 participants) are included: one short-term single-center trial (n = 7) comparing insulin with oral repaglinide and no medication in people with cystic fibrosis-related diabetes and normal fasting glucose; one long-term multicenter trial (n = 100, 74 of whom had cystic fibrosis-related diabetes) comparing insulin with oral repaglinide and placebo; one long-term multicenter trial (n = 73) comparing insulin with oral repaglinide; and one 12-week single-center trial (n = 20) comparing the long-acting insulin glargine to short-term neutral protamine Hagedorn insulin.Two trials with data for the comparison of insulin to placebo did not report any significant differences between groups for the primary outcomes of blood glucose levels, lung function and nutritional status. This was also true for the single trial with data for the comparison of repaglinide to placebo. Two trials (one lasting one year and one lasting two years) contributed data for the comparison of insulin versus repaglinide. There were no significant differences for the primary outcomes at any time point, except at one year (in the two-year trial) when the insulin group had significant improvement in z score for body mass index compared to the repaglinide group. The single trial comparing glargine to neutral protamine Hagedorn insulin also did not report any significant differences in the review's primary outcomes. A few cases of hypoglycemia were seen in three out of the four trials (none in the longest trial), but these events resolved without further treatment.There was an unclear risk of bias from randomization and allocation concealment in two of the four included trials as the authors did not report any details; in the remaining two studies details for randomization led to a low risk of bias, but only one had sufficient details on allocation concealment to allow a low risk judgement, the second was unclear. There was a high risk from blinding for all trials (except for the comparison of oral repaglinide versus placebo) due to the nature of the interventions. Complete data for all outcomes were not available from any trial leading to a high risk of reporting bias. The amounts of insulin and repaglinide administered were not comparable and this may lead to bias in the results. None of the included trials were powered to show a significant improvement in lung function. This review has not found any significant conclusive evidence that long-acting insulins, short-acting insulins or oral hypoglycemic agents have a distinct advantage over one another in controlling hyperglycemia or clinical outcomes associated with cystic fibrosis-related diabetes. While some cystic fibrosis centers use oral medications to help control diabetes, the Cystic Fibrosis Foundation (USA) clinical practice guidelines support the use of insulin therapy and this remains the most widely-used treatment method. Randomized controlled trials specifically related to controlling diabetes with this impact on the course of pulmonary disease process in cystic fibrosis continue to be a high priority.There is no demonstrated advantage yet established for using oral hypoglycemic agents over insulin, and further trials need to be evaluated to establish whether there is clear benefit for using hypoglycemic agents. Agents that potentiate insulin action, especially agents with additional anti-inflammatory potential should be further investigated to see if there may be a clinical advantage to adding these medications to insulin as adjuvant therapy.

Cost-Effectiveness of a Long-Term Internet-Delivered Worksite Health Promotion Programme on Physical Activity and Nutrition: A Cluster Randomized Controlled Trial

ERIC Educational Resources Information Center

Robroek, Suzan J. W.; Polinder, Suzanne; Bredt, Folef J.; Burdorf, Alex

2012-01-01

This study aims to evaluate the cost-effectiveness of a long-term workplace health promotion programme on physical activity (PA) and nutrition. In total, 924 participants enrolled in a 2-year cluster randomized controlled trial, with departments (n = 74) within companies (n = 6) as the unit of randomization. The intervention was compared with a…

The effect of Valerian on the severity and frequency of hot flashes: A triple-blind randomized clinical trial.

PubMed

Jenabi, Ensiyeh; Shobeiri, Fatemeh; Hazavehei, Seyyed Mohammad Mahdi; Roshanaei, Ghodratollah

2018-03-01

Valerian is one of the most widely used herbal supplements and a phytoestrogenic herb. The aim of this study was to determine the effect of Valerian on the severity and frequency of hot flashes. This triple-blind, randomized, controlled clinical trial was conducted during a three-month period in Hamadan, Iran, in 60 postmenopausal women aged 45-55 years. Participants were randomly assigned to one of two groups- either placebo or Valerian. An oral Valerian 530 mg capsule was given twice per day for two months. An oral placebo 530 mg capsule (starch) was similarly administered. The severity and frequency of hot flashes were determined by the Kupperman index, before the intervention, one month after, and two months after initiation of the intervention. The severity of hot flashes in the Valerian group was significantly lower than that in the placebo group at one (p = .048) and two months (p = .020) after initiation of the intervention. Compared with the placebo group, the mean frequency of hot flashes was significantly reduced two months after initiating the use of Valerian (p = .033). Health-care providers should consider Valerian to be effective for menopausal women with hot flashes.

Cluster-randomized controlled trial of the effects of free glasses on purchase of children's glasses in China: The PRICE (Potentiating Rural Investment in Children's Eyecare) study

PubMed Central

Wang, Xiuqin; Ma, Yue; Hu, Min; Zhou, Yuan; Liao, Weiqi; Jin, Ling; Xiao, Baixiang; Wu, Xiaoyi; Ni, Ming; Yi, Hongmei; Huang, Yiwen; Varga, Beatrice; Zhang, Hong; Cun, Yongkang; Li, Xianshun; Yang, Luhua; Liang, Chaoguang; Huang, Wan; Rozelle, Scott; Ma, Xiaochen

2017-01-01

Background Offering free glasses can be important to increase children’s wear. We sought to assess whether “Upgrade glasses” could avoid reduced glasses sales when offering free glasses to children in China. Methods In this cluster-randomized, controlled trial, children with uncorrected visual acuity (VA)< = 6/12 in either eye correctable to >6/12 in both eyes at 138 randomly-selected primary schools in 9 counties in Guangdong and Yunnan provinces, China, were randomized by school to one of four groups: glasses prescription only (Control); Free Glasses; Free Glasses + offer of $15 Upgrade Glasses; Free Glasses + offer of $30 Upgrade Glasses. Spectacle purchase (main outcome) was assessed 6 months after randomization. Results Among 10,234 children screened, 882 (8.62%, mean age 10.6 years, 45.5% boys) were eligible and randomized: 257 (29.1%) at 37 schools to Control; 253 (28.7%) at 32 schools to Free Glasses; 187 (21.2%) at 31 schools to Free Glasses + $15 Upgrade; and 185 (21.0%) at 27 schools to Free Glasses +$30 Upgrade. Baseline ownership among these children needing glasses was 11.8% (104/882), and 867 (98.3%) children completed follow-up. Glasses purchase was significantly less likely when free glasses were given: Control: 59/250 = 23.6%; Free glasses: 32/252 = 12.7%, P = 0.010. Offering Upgrade Glasses eliminated this difference: Free + $15 Upgrade: 39/183 = 21.3%, multiple regression relative risk (RR) 0.90 (0.56–1.43), P = 0.65; Free + $30 Upgrade: 38/182 = 20.9%, RR 0.91 (0.59, 1.42), P = 0.69. Conclusions Upgrade glasses can prevent reductions in glasses purchase when free spectacles are provided, providing important program income. Trial registration ClinicalTrials.gov Identifier: NCT02231606. Registered on 31 August 2014. PMID:29161286

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

PubMed

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

2014-08-30

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

A RCT comparing 7-year clinical outcomes of one level symptomatic cervical disc disease (SCDD) following ProDisc-C total disc arthroplasty (TDA) versus anterior cervical discectomy and fusion (ACDF).

PubMed

Loumeau, Thomas P; Darden, Bruce V; Kesman, Thomas J; Odum, Susan M; Van Doren, Bryce A; Laxer, Eric B; Murrey, Daniel B

2016-07-01

The objective of this trial was to compare the safety and efficacy of TDA using the ProDisc-C implant to ACDF in patients with single-level SCDD between C3 and C7. We report on the single-site results from a larger multicenter trial of 13 sites using an approved US Food and Drug Administration protocol (prospective, randomized controlled non-inferiority design). Patients were randomized one-to-one to either the ProDisc-C device or ACDF. All enrollees were evaluated pre- and post-operatively at regular intervals through month 84. Visual Analog Scale (VAS) for neck and arm pain/intensity, Neck Disability Index (NDI), Short-Form 36 (SF-36), and satisfaction were assessed. Twenty-two patients were randomized to each arm of the study. Nineteen additional patients received the ProDisc-C via continued access. NDI improved with the ProDisc-C more than with ACDF. Total range of motion was maintained with the ProDisc-C, but diminished with ACDF. Neck and arm pain improved more in the ProDisc-C than ACDF group. Patient satisfaction remained higher in the ProDisc-C group at 7 years. SF-36 scores were higher in the TDA group than ACDF group at 7 years; the difference was not clinically significant. Six additional operations (two at the same level; four at an adjacent level) were performed in the ACDF, but none in the ProDisc-C group. The ProDisc-C implant appears to be safe and effective for the treatment of SCDD. Patients with the implant retained motion at the involved segment and had a lower reoperation rate than those with an ACDF.

Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial.

PubMed

Williams, Joni S; Lynch, Cheryl P; Knapp, Rebecca G; Egede, Leonard E

2014-11-25

Compared to American Whites, African Americans have a higher prevalence of type 2 diabetes mellitus (T2DM), experiencing poorer metabolic control and greater risks for complications and death. Patient-level factors, such as diabetes knowledge, self-management skills, empowerment, and perceived control, account for >90% of the variance observed in outcomes between these racial groups. There is strong evidence that self-management interventions that include telephone-delivered diabetes education and skills training are effective at improving metabolic control in diabetes. Web-based home telemonitoring systems in conjunction with active care management are also effective ways to lower glycosylated hemoglobin A1c values when compared to standard care, and provide feedback to patients; however, there are no studies in African Americans with poorly controlled T2DM that examine the use of technology-based feedback to tailor or augment diabetes education and skills training. This study provides a unique opportunity to address this gap in the literature. We describe an ongoing 4-year randomized clinical trial, which will test the efficacy of a technology-intensified diabetes education and skills training (TIDES) intervention in African Americans with poorly controlled T2DM. Two hundred male and female AfricanAmerican participants, 21 years of age or older and with a glycosylated hemoglobin A1c level ≥ 8%, will be randomized into one of two groups for 12 weeks of telephone interventions: (1) TIDES intervention group or (2) a usual-care group. Participants will be followed for 12 months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that, among African Americans with poorly controlled T2DM, patients randomized to the TIDES intervention will have significantly greater reduction in glycosylated hemoglobin A1c at 12 months of follow-up compared to the usual-care group. Results from this study will add to the current literature examining how best to deliver diabetes education and skills training and provide important insight into effective strategies to improve metabolic control and hence reduce diabetes complications and mortality rates in African Americans with poorly controlled T2DM. This study was registered with the National Institutes of Health Clinical Trials Registry on 13 March 2014 (ClinicalTrials.gov identifier# NCT02088658).

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.

A comparison between two lingual orthodontic brackets in terms of speech performance and patients' acceptance in correcting Class II, Division 1 malocclusion: a randomized controlled trial

PubMed Central

Haj-Younis, Samiha; Khattab, Tarek Z.; Hajeer, Mohammad Y.; Farah, Hassan

2016-01-01

ABSTRACT Objective: To compare speech performance and levels of oral impairment between two types of lingual brackets. Methods: A parallel-group randomized controlled trial was carried out on patients with Class II, Division 1 malocclusion treated at the University of Hama School of Dentistry in Hama, Syria. A total of 46 participants (mean age: 22.3 ± 2.3 years) with maxillary dentoalveolar protrusion were randomly distributed into two groups with 23 patients each (1:1 allocation ratio). Either STb (Ormco) or 7th Generation (Ormco) lingual brackets were applied. Fricative sound/s/ spectrograms were analyzed directly before intervention (T0), one week following premolar extraction prior to bracket placement (T1), within 24 hours of bracket bonding (T2), one month after (T3), and three months after (T4) bracket placement. Patients′ acceptance was assessed by means of standardized questionnaires. Results: After bracket placement, significant deterioration in articulation was recorded at all assessment times in the 7th Generation group, and up to T3 in the STb group. Significant intergroup differences were detected at T2 and T3. No statistically significant differences were found between the two groups in reported tongue irritation levels, whereas chewing difficulty was significantly higher in the 7th Generation group one month after bracket placement. Conclusions: 7th Generation brackets have more interaction with sound production than STb ones. Although patients in both groups complained of some degree of oral impairment, STb appliances appeared to be more comfortable than the 7th Generation ones, particularly within the first month of treatment. PMID:27653268

A comparison between two lingual orthodontic brackets in terms of speech performance and patients' acceptance in correcting Class II, Division 1 malocclusion: a randomized controlled trial.

PubMed

Haj-Younis, Samiha; Khattab, Tarek Z; Hajeer, Mohammad Y; Farah, Hassan

2016-01-01

To compare speech performance and levels of oral impairment between two types of lingual brackets. A parallel-group randomized controlled trial was carried out on patients with Class II, Division 1 malocclusion treated at the University of Hama School of Dentistry in Hama, Syria. A total of 46 participants (mean age: 22.3 ± 2.3 years) with maxillary dentoalveolar protrusion were randomly distributed into two groups with 23 patients each (1:1 allocation ratio). Either STb (Ormco) or 7th Generation (Ormco) lingual brackets were applied. Fricative sound/s/ spectrograms were analyzed directly before intervention (T0), one week following premolar extraction prior to bracket placement (T1), within 24 hours of bracket bonding (T2), one month after (T3), and three months after (T4) bracket placement. Patients' acceptance was assessed by means of standardized questionnaires. After bracket placement, significant deterioration in articulation was recorded at all assessment times in the 7th Generation group, and up to T3 in the STb group. Significant intergroup differences were detected at T2 and T3. No statistically significant differences were found between the two groups in reported tongue irritation levels, whereas chewing difficulty was significantly higher in the 7th Generation group one month after bracket placement. 7th Generation brackets have more interaction with sound production than STb ones. Although patients in both groups complained of some degree of oral impairment, STb appliances appeared to be more comfortable than the 7th Generation ones, particularly within the first month of treatment.

A cluster-randomized trial to reduce major perinatal morbidity among women with one prior cesarean delivery in Québec (PRISMA trial): study protocol for a randomized controlled trial.

PubMed

Chaillet, N; Bujold, E; Masse, B; Grobman, W A; Rozenberg, P; Pasquier, J C; Shorten, A; Johri, M; Beaudoin, F; Abenhaim, H; Demers, S; Fraser, W; Dugas, M; Blouin, S; Dubé, E; Gauthier, R

2017-09-20

Rates of cesarean delivery are continuously increasing in industrialized countries, with repeated cesarean accounting for about a third of all cesareans. Women who have undergone a first cesarean are facing a difficult choice for their next pregnancy, i.e.: (1) to plan for a second cesarean delivery, associated with higher risk of maternal complications than vaginal delivery; or (b) to have a trial of labor (TOL) with the aim to achieve a vaginal birth after cesarean (VBAC) and to accept a significant, but rare, risk of uterine rupture and its related maternal and neonatal complications. The objective of this trial is to assess whether a multifaceted intervention would reduce the rate of major perinatal morbidity among women with one prior cesarean. The study is a stratified, non-blinded, cluster-randomized, parallel-group trial of a multifaceted intervention. Hospitals in Quebec are the units of randomization and women are the units of analysis. As depicted in Figure 1, the study includes a 1-year pre-intervention period (baseline), a 5-month implementation period, and a 2-year intervention period. At the end of the baseline period, 20 hospitals will be allocated to the intervention group and 20 to the control group, using a randomization stratified by level of care. Medical records will be used to collect data before and during the intervention period. Primary outcome is the rate of a composite of major perinatal morbidities measured during the intervention period. Secondary outcomes include major and minor maternal morbidity; minor perinatal morbidity; and TOL and VBAC rate. The effect of the intervention will be assessed using the multivariable generalized-estimating-equations extension of logistic regression. The evaluation will include subgroup analyses for preterm and term birth, and a cost-effectiveness analysis. The intervention is designed to facilitate: (1) women's decision-making process, using a decision analysis tool (DAT), (2) an estimate of uterine rupture risk during TOL using ultrasound evaluation of low-uterine segment thickness, (3) an estimate of chance of TOL success, using a validated prediction tool, and (4) the implementation of best practices for intrapartum management. Current Controlled Trials, ID: ISRCTN15346559 . Registered on 20 August 2015.

Healthy Children, Strong Families 2: a randomized controlled trial of a healthy lifestyle intervention for American Indian families designed using community-based approaches

PubMed Central

Tomayko, Emily J; Prince, Ronald J; Cronin, Kate A; Parker, Tassy; Kim, KyungMann; Grant, Vernon M; Sheche, Judith N; Adams, Alexandra K

2017-01-01

Background/Aims Few obesity prevention trials have focused on young children and their families in the home environment, particularly in underserved communities. Healthy Children, Strong Families 2 (HCSF2) is a randomized controlled trial of a healthy lifestyle intervention for American Indian children and their families, a group at very high risk of obesity. The study design resulted from our long-standing engagement with American Indian communities, and few collaborations of this type resulting in the development and implementation of an RCT have been described. Methods HCSF2 is a lifestyle intervention targeting increased fruit and vegetable intake, decreased sugar intake, increased physical activity, decreased TV/screen time, and two lesser-studied risk factors: stress and sleep. Families with young children from five American Indian communities nationwide were randomly assigned to a healthy lifestyles intervention (Wellness Journey) augmented with social support (Facebook and text messaging) or a child safety control group (Safety Journey) for one year. After Year 1, families in the Safety Journey receive the Wellness Journey, and families in the Wellness Journey start the Safety Journey with continued wellness-focused social support based on communities’ request that all families receive the intervention. Primary (adult body mass index and child body mass index z-score) and secondary (health behaviors) outcomes are assessed after Year 1 with additional analyses planned after Year 2. Results To date, 450 adult/child dyads have been enrolled (100% target enrollment). Statistical analyses await trial completion in 2017. Lessons Learned Conducting a community-partnered randomized controlled trial requires significant formative work, relationship building, and ongoing flexibility. At the communities’ request, the study involved minimal exclusion criteria, focused on wellness rather than obesity, and included an active control group and a design allowing all families to receive the intervention. This collective effort took additional time but was critical to secure community engagement. Hiring and retaining qualified local site coordinators was a challenge but was strongly related to successful recruitment and retention of study families. Local infrastructure has also been critical to project success. Other challenges included geographic dispersion of study communities and providing appropriate incentives to retain families in a two-year study. Conclusions This multi-site intervention addresses key gaps regarding family/home-based approaches for obesity prevention in American Indian communities. HCSF2’s innovative aspects include substantial community input, inclusion of both traditional (diet/activity) and lesser-studied obesity risk factors (stress/sleep), measurement of both adult and child outcomes, social networking support for geographically dispersed households, and a community selected active control group. Our data will address a literature gap regarding multiple risk factors and their relationship to health outcomes in American Indian families. PMID:28064525

A randomized controlled trial of an internet-based mentoring program for type 1 diabetes patients with inadequate glycemic control.

PubMed

Suh, Sunghwan; Jean, Cheol; Koo, Mihyun; Lee, Sun Young; Cho, Min Ja; Sim, Kang-Hee; Jin, Sang-Man; Bae, Ji Cheol; Kim, Jae Hyeon

2014-04-01

To determine whether an internet-based mentoring program can improve glycemic control in subjects with type 1 diabetes mellitus (T1DM). Subjects with T1DM on intensive insulin therapy and with hemoglobin A1c (HbA1c) ≥8.0% were randomized to mentored (glucometer transmission with feedback from mentors) or control (glucometer transmission without feedback) groups and were examined for 12 weeks. Five mentors were interviewed and selected, of which two were T1DM patients themselves and three were parents with at least one child diagnosed with T1DM since more than 5 years ago. A total of 57 T1DM adult subjects with a mean duration after being diagnosed with diabetes of 7.4 years were recruited from Samsung Medical Center. Unfortunately, the mentored group failed to show significant improvements in HbA1c levels or other outcomes, including the quality of life, after completion of the study. However, the mentored group monitored their blood glucose (1.41 vs. 0.30) and logged into our website (http://ubisens.co.kr/) more frequently (20.59 times vs. 5.07 times) than the control group. A 12-week internet-based mentoring program for T1DM patients with inadequate glycemic control did not prove to be superior to the usual follow-up. However, the noted increase in the subjects' frequency of blood glucose monitoring may lead to clinical benefits.

A Randomized Controlled Trial of an Internet-Based Mentoring Program for Type 1 Diabetes Patients with Inadequate Glycemic Control

PubMed Central

Suh, Sunghwan; Jean, Cheol; Koo, Mihyun; Lee, Sun Young; Cho, Min Ja; Sim, Kang-Hee; Jin, Sang-Man; Bae, Ji Cheol

2014-01-01

Background To determine whether an internet-based mentoring program can improve glycemic control in subjects with type 1 diabetes mellitus (T1DM). Methods Subjects with T1DM on intensive insulin therapy and with hemoglobin A1c (HbA1c) ≥8.0% were randomized to mentored (glucometer transmission with feedback from mentors) or control (glucometer transmission without feedback) groups and were examined for 12 weeks. Five mentors were interviewed and selected, of which two were T1DM patients themselves and three were parents with at least one child diagnosed with T1DM since more than 5 years ago. Results A total of 57 T1DM adult subjects with a mean duration after being diagnosed with diabetes of 7.4 years were recruited from Samsung Medical Center. Unfortunately, the mentored group failed to show significant improvements in HbA1c levels or other outcomes, including the quality of life, after completion of the study. However, the mentored group monitored their blood glucose (1.41 vs. 0.30) and logged into our website (http://ubisens.co.kr/) more frequently (20.59 times vs. 5.07 times) than the control group. Conclusion A 12-week internet-based mentoring program for T1DM patients with inadequate glycemic control did not prove to be superior to the usual follow-up. However, the noted increase in the subjects' frequency of blood glucose monitoring may lead to clinical benefits. PMID:24851207

Effect of Aerobics Exercise on Self-Esteem in Iranian Female Adolescents Covered by Welfare Organization

PubMed Central

Tabatabaei, Mansooreh; Alavi, Mousa; Zolaktaf, Vahid

2014-01-01

Introduction. Deprivation of parents might decrease self-esteem (SE) and result in affective and social incompatibility. In this randomized control trial, we examined the effect of aerobics exercise on SE among female adolescents living with no natural family. Materials and Methods. The sample consisted of all female adolescents aged 13 to 19 years (n: 72) who were covered by Isfahan Welfare organization. Participants were assigned into intervention and control groups by matched random sampling. Intervention included 8 weeks of aerobics exercise. Coppersmith SE inventory was administered before and after intervention as well as after one month follow-up. Results. No significant difference was seen between pre-SE scores of intervention (32.7 ± 8.4) and control (33.0 ± 6.7) groups (t = .16, P = .87). A significant difference was obtained in post-SE scores (40.2 ± 5.7 versus 34.7 ± 6.8, t = 3.58, P = .001) and in one month follow-up scores (36.4 ± 5.2 versus 33.0 ± 5.2, t = 2.25, P = .03). Discussion. The results demonstrated a low level of pre-SE in both groups. However, a significant improvement was seen in posttest of intervention group which persisted even one month after intervention. It supports the use of aerobics for female adolescents deprived from family life. PMID:25610905

Dissemination of evidence-based cancer control interventions among Catholic faith-based organizations: results from the CRUZA randomized trial.

PubMed

Allen, Jennifer D; Torres, Maria Idalí; Tom, Laura S; Leyva, Bryan; Galeas, Ana V; Ospino, Hosffman

2016-05-18

The CRUZA randomized trial tested the efficacy of an organizational-level intervention to increase the capacity of Catholic faith-based organizations (FBOs) serving Latinos to implement evidence-based strategies (EBS) for cancer control. Thirty-one Catholic parishes were enrolled. Twenty were randomized to a "capacity enhancement" (CE) intervention and 11 to a "standard dissemination" (SD) condition. Each received a Program Implementation Manual and Toolkit of materials culturally adapted for FBOs with Latino audiences for five types of EBS recommended by the US Preventive Services Community Guide. CE parishes were offered a menu of capacity-building activities over a 3-month period, while SD parishes were provided a one-time consultation by an Intervention Specialist. Baseline and follow-up surveys compared the number and types of EBS offered. At baseline, only one parish had offered any cancer-related program in the prior year, yet a third (36 %) had offered some other type of health program or service. At post-intervention follow-up, all parishes offered a greater number of EBS. The only statistically significant difference between CE and SD groups was the number of parishes offering small media interventions (90 % in CE, 64 % in SD; p < 0.05). All parishes increased the number of cancer control activities offered to their members. These findings suggest that Catholic parishes may already have capacity to implement EBS if they are appropriately adapted and packaged and may only require low levels of support to carry out programming. Further research is needed to examine the extent to which program offerings continued after the period of grant funding. Clinicaltrials.gov NCT01740219 .

DYNAMIC OSCILLATORY STRETCHING EFFICACY ON HAMSTRING EXTENSIBILITY AND STRETCH TOLERANCE: A RANDOMIZED CONTROLLED TRIAL

PubMed Central

Tee, Jason Cameron; Stewart, Aimee

2017-01-01

Background While static stretch (SS), proprioceptive neuromuscular facilitation (PNF) and oscillatory physiological mobilization techniques are documented to have positive effects on a range of motion (ROM), there are no reports on the effect of dynamic oscillatory stretching (DOS), a technique that combines these three techniques, on hamstring extensibility. Purpose To determine whether DOS improves hamstring extensibility and stretch tolerance to a greater degree than SS in asymptomatic young participants. Study Design Randomized Controlled Trial. Methods Sixty participants (47 females, 13 males, mean age 22 ± 1 years, height 166 ± 6 centimeters, body mass 67.6 ± 9.7 kg) completed a passive straight leg (SLR) to establish hamstring extensibility and stretch tolerance as perceived by participants, using a visual analogue scale (VAS). Participants were randomly assigned to one of two treatment groups (SS or DOS) or a placebo control (20 per group). Tests were repeated immediately following and one hour after each intervention. Data were assessed using a two-way repeated measure analysis of variance (ANOVA) and Tukey's post hoc test. Results Immediately post-intervention, there was a significant improvement in the hamstring extensibility as measured by the SLR in both the SS and DOS groups, with the DOS group exhibiting a significantly greater increase than the SS group (Control 73 ± 12°, SS 86 ± 8°, DOS 94 ± 11°, p < 0.001). One hour post-intervention, hamstring extensibility in the DOS group remained elevated, while the SS group no longer differed from the control group (Control 73 ± 12°, SS 80 ± 8°, DOS 89 ± 12°, p = 0.001). Furthermore, the stretch tolerance remained significantly elevated for the SS group, but there was no difference between the control and DOS groups, (Control 4.6 ± 1.3, SS 5.9 ± 0.8, DOS 4.3 ± 1.0 AU, p < 0.001). Conclusion DOS was more effective than SS at achieving an immediate increase in hamstring extensibility, and DOS demonstrated an increased stretch tolerance one-hour post-intervention. Level of evidence 2C PMID:28593083

A randomized controlled trial of culturally tailored dance and reducing screen time to prevent weight gain in low-income African American girls: Stanford GEMS.

PubMed

Robinson, Thomas N; Matheson, Donna M; Kraemer, Helena C; Wilson, Darrell M; Obarzanek, Eva; Thompson, Nikko S; Alhassan, Sofiya; Spencer, Tirzah R; Haydel, K Farish; Fujimoto, Michelle; Varady, Ann; Killen, Joel D

2010-11-01

To test a 2-year community- and family-based obesity prevention program for low-income African American girls: Stanford GEMS (Girls' health Enrichment Multi-site Studies). Randomized controlled trial with follow-up measures scheduled at 6, 12, 18, and 24 months. Low-income areas of Oakland, California. African American girls aged 8 to 10 years (N=261) and their parents or guardians. Families were randomized to one of two 2-year, culturally tailored interventions: (1) after-school hip-hop, African, and step dance classes and a home/family-based intervention to reduce screen media use or (2) information-based health education. Changes in body mass index (BMI). Changes in BMI did not differ between groups (adjusted mean difference [95% confidence interval] = 0.04 [-0.18 to 0.27] per year). Among secondary outcomes, fasting total cholesterol level (adjusted mean difference, -3.49 [95% confidence interval, -5.28 to -1.70] mg/dL per year), low-density lipoprotein cholesterol level (-3.02 [-4.74 to -1.31] mg/dL per year), incidence of hyperinsulinemia (relative risk, 0.35 [0.13 to 0.93]), and depressive symptoms (-0.21 [-0.42 to -0.001] per year) decreased more among girls in the dance and screen time reduction intervention. In exploratory moderator analysis, the dance and screen time reduction intervention slowed BMI gain more than health education among girls who watched more television at baseline (P = .02) and/or those whose parents or guardians were unmarried (P = .01). A culturally tailored after-school dance and screen time reduction intervention for low-income, preadolescent African American girls did not significantly reduce BMI gain compared with health education but did produce potentially clinically important reductions in lipid levels, hyperinsulinemia, and depressive symptoms. There was also evidence for greater effectiveness in high-risk subgroups of girls.

Long-term effects of high-intensity interval training in heart transplant recipients: A 5-year follow-up study of a randomized controlled trial.

PubMed

Yardley, Marianne; Gullestad, Lars; Bendz, Bjørn; Bjørkelund, Elisabeth; Rolid, Katrine; Arora, Satish; Nytrøen, Kari

2017-01-01

Previous studies have demonstrated that high-intensity interval training (HIT) is superior to moderate-continuous exercise in general and in cardiovascular diseases. Recently, we also found HIT safe and efficient after heart transplantation (HTx). This study reports the 5-year long-term effects. Forty-one HTx patients who had completed the previous 12-month randomized controlled trial, comparing HIT intervention with usual care, were eligible. In particular, we measured VO 2peak , muscular capacity, intravascular ultrasound, and questionnaires measuring physical and mental health. The baseline mean±SD values were as follows: age; 49.1±16.5 years, men; 68%, time since HTx: 4.1±2.2 years. Within the HIT group, initial VO 2peak increased significantly from 27.7±5.7 to 31.2±5.3 mL/kg/min. However, during the next 4 years, VO 2peak decreased to 26.0±6.2 mL/kg/min. The control group showed slightly decreasing VO 2peak values during the entire 5-year period. The HIT group reported significantly less anxiety symptoms, but there were no long-term differences in VO 2peak , muscular capacity, or cardiac allograft vasculopathy between the groups. The similar VO 2peak values correspond to our findings of similar everyday activity. Our findings suggest that intermittent periods of HIT may be necessary to maintain the initial benefits gained from the intervention. However, HIT probably reduces the burden of anxiety, which is a frequent health issue following HTx. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Comparison of topical ropivacaine with and without ketamine on post-surgical pain in children undergoing tonsillectomy: a randomized controlled double-blind study.

PubMed

Hong, Boohwi; Lim, Chae Seong; Kim, Yoon-Hee; Lee, Jung Un; Kim, Yong Min; Jung, Choonho; Jo, Yumin

2017-08-01

Tonsillectomy in pediatric patients may cause severe postoperative pain. Topical local anesthetics are an easy and safe way to control post-tonsillectomy pain, but there is no benefit during the early postoperative stage. Topical ketamine shows a good effect on early stage postoperative pain. We compared the effect of topical ropivacaine with and without ketamine on post-tonsillectomy pain. Patients aged 3-7 years undergoing tonsillectomy were selected to participate in the study. Our study was performed in a randomized, placebo-controlled, double-blind manner. Patients were randomly assigned to one of two groups using computer-generated random numbers. The researchers who assessed the pain score, the caregivers, and the patient were blinded to group assignment. One group received topical ropivacaine with saline (RS group) and the other group received topical ropivacaine with 20 mg ketamine (RK group) on the tonsillar bed. Pain scores using the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS) at 15 min and 30 min, and at 1, 2, 4, 8, 16 and 24 h were recorded. Rescue analgesic requirement and complications were also recorded. A total of 66 patients were randomly assigned to the RS group (n = 33) and the RK group (n = 33). The mCHEOPS scores were significantly lower in the RK group at 15 min (P = 0.046). The mCHEOPS scores of the two groups decreased with time, but there was no intergroup interaction. The RS group received more analgesics until 1 h after surgery and the RK group received more analgesics during 1-24 h after surgery. There were no differences in adverse outcomes. Topical ropivacaine with ketamine can reduce immediate postoperative pain and analgesic requirement better than ropivacaine alone.

Decreased flexion contracture after total knee arthroplasty using Botulinum toxin A: a randomized controlled trial.

PubMed

Smith, Eric B; Shafi, Karim A; Greis, Ari C; Maltenfort, Mitchell G; Chen, Antonia F

2016-10-01

Flexion contracture after total knee arthroplasty (TKA) can cause significant dissatisfaction. Botulinum toxin A has shown improved extension in patients with spastic flexion contractures after TKA. The purpose of this study was to evaluate whether Botulinum toxin A improves knee extension for any patient with flexion contractures following TKA. A prospective, double-blinded, randomized controlled trial was conducted. Fourteen patients (15 knees), with a flexion contracture (≥10°) one month postoperatively, were randomized to receive either Botulinum toxin A or saline placebo to the affected hamstrings. The subject, surgeon, and administering physiatrist were blinded to the treatment group throughout the study. Subject range of motion (ROM) was evaluated at 1, 6, and 12 months following injection. Differences were tested using mixed-effects regression to control for multiple measurements. The initial post-operative flexion contracture averaged 19° ± 6° in the Botulinum toxin A group and 13° ± 3° in the saline group. Injections were performed 53 and 57 days after TKA in the Botulinum toxin A and saline groups, respectively. Post-injection extension improved to an average of 8, 5, and 1 degrees for BTX and 4, 2, and 1 degrees for SAL, at 1, 6, and 12 months, respectively, compared to pre-injection extension (p < 0.0001). Improvement in knee extension at 1 year improved 18° ± 7.5° for Botulinum toxin A and 12° ± 2° for saline (p = 0.04). No complications resulted from either injection. Patients who received Botulinum toxin A or placebo were able to achieve near full extension one year after surgery. There was a statistically significant improvement in the amount of extension achieved at 1 year with Botulinum toxin A, but this may be of little clinical significance. Since achieving full extension is important for patient function and satisfaction, novel techniques to address this issue deserve special attention. I.

The treatment of systemic lupus proliferative nephritis.

PubMed

Punaro, Marilynn G

2013-11-01

Lupus nephritis is one of the most common and serious complications of systemic lupus erythematosus (SLE) in childhood affecting more than 80% of patients. Treatment of this complication has undergone significant evolution in recent years. A series of randomized controlled trials has clarified the role of a variety of immunomodulating regimens including some novel biologic medications. This review touches on the major trials that have influenced practice and shaped current thinking about the treatment of proliferative lupus glomerulonephritis.

Randomized controlled trial of a 12-month computerized mindfulness-based intervention for obese patients with binge eating disorder: The MindOb study protocol.

PubMed

Ruffault, Alexis; Carette, Claire; Lurbe I Puerto, Kàtia; Juge, Nicolas; Beauchet, Alain; Benoliel, Jean-Jacques; Lacorte, Jean-Marc; Fournier, Jean F; Czernichow, Sébastien; Flahault, Cécile

2016-07-01

Mindfulness-based interventions for healthy behaviors such as exercise and dietary modifications have aroused growing interest. This study aims to test the effectiveness of a mindfulness-based intervention for the reduction of impulsive eating and the improvement of motivation to exercise among obese individuals. One-hundred and twenty obese outpatients, aged 18 to 65years, diagnosed with a binge eating disorder, will be randomly assigned to one of the three following groups: mindfulness practice, sham meditation, or treatment as usual control. The tested intervention consists of a 1-year computerized mindfulness-based program. Mindfulness sessions are audio recordings that the patients are asked to listen to, 10min every day. Self-reported questionnaires measuring impulsive eating, motivation to exercise, physical activity level, mood, and mindfulness skills are filled in at baseline, 1, 6, and 12months. Physical activity, calories consumption, and biomarkers are measured with more objective measurement tools at baseline, 6months and 12months. Mindfulness, as both a de-automation element and as a moderator of motivation to exercise, can lead to the reduction of impulsive eating and also to an increase in levels of physical activity. These effects could cause weight loss in obese patients suffering from binge eating disorder. clinicaltrials.gov: NCT02571387. Copyright © 2016 Elsevier Inc. All rights reserved.

Rigid versus semi-rigid orthotic use following TMC arthroplasty: a randomized controlled trial.

PubMed

Prosser, Rosemary; Hancock, Mark J; Nicholson, Leslie; Merry, Cathy; Thorley, Felicity; Wheen, Douglass

2014-01-01

The trapeziometacarpal (TMC) joint of the human thumb is the second most common joint in the hand affected by osteoarthritis. TMC arthroplasty is a common procedure used to alleviate symptoms. No randomized controlled trials have been published on the efficacy of different post-operative orthotic regimes. Fifty six participants who underwent TMC arthroplasty were allocated to either rigid orthotic or semi-rigid orthotic groups. Both groups started an identical exercise program at two weeks following surgery. Outcome measures were assessed by an assessor blinded to group allocation. The primary outcome was the Patient Rated Wrist and Hand Evaluation (PRWHE) and secondary outcomes included the Michigan Hand Questionnaire (MHQ), thumb palmar abduction, first metacarpophalangeal extension and three point pinch grip. Measures were taken pre-operatively, at six weeks, three months and one year post-operatively. Between-group differences were analyzed with linear regression. Both groups performed equally well. There was no significant between-group difference for PRWHE scores (0.47, CI -11.5 to 12.4), including subscales for pain and function, or for any of the secondary outcomes at one year follow-up. We found no difference in outcomes between using a rigid or semi-rigid orthosis after TMC arthroplasty. Patient comfort, cost and availability may determine choice between orthoses in clinical practice. 1b RCT. Copyright © 2014 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Effect of whole-body vibration on neuromuscular performance and body composition for females 65 years and older: a randomized-controlled trial.

PubMed

von Stengel, S; Kemmler, W; Engelke, K; Kalender, W A

2012-02-01

We examined whether the effect of multipurpose exercise can be enhanced by whole-body vibration (WBV). One hundred and fifty-one post-menopausal women (68.5 ± 3.1 years) were randomly assigned to three groups: (1) a training group (TG); (2) training including vibration (VTG); and (3) a wellness control group (CG). TG and VTG performed the same training program twice weekly (60 min), consisting of aerobic and strength exercises, with the only difference that leg strength exercises (15 min) were performed with (VTG) or without (TG) vibration. CG performed a low-intensity "wellness" program. At baseline and after 18 months, body composition was determined using dual-X-ray-absorptiometry. Maximum isometric strength was determined for the legs and the trunk region. Leg power was measured by countermovement jumps using a force-measuring plate. In the TG lean body mass, total body fat, and abdominal fat were favorably affected, but no additive effects were generated by the vibration stimulus. However, concerning muscle strength and power, there was a tendency in favor of the VTG. Only vibration training resulted in a significant increase of leg and trunk flexion strength compared with CG. In summary, WBV embedded in a multipurpose exercise program showed minor additive effects on body composition and neuromuscular performance. © 2010 John Wiley & Sons A/S.

Brief counselling after home-based HIV counselling and testing strongly increases linkage to care: a cluster-randomized trial in Uganda.

PubMed

Ruzagira, Eugene; Grosskurth, Heiner; Kamali, Anatoli; Baisley, Kathy

2017-10-01

The aim of this study was to determine whether counselling provided subsequent to HIV testing and referral for care increases linkage to care among HIV-positive persons identified through home-based HIV counselling and testing (HBHCT) in Masaka, Uganda. The study was an open-label cluster-randomized trial. 28 rural communities were randomly allocated (1:1) to intervention (HBHCT, referral and counselling at one and two months) or control (HBHCT and referral only). HIV-positive care-naïve adults (≥18 years) were enrolled. To conceal participants' HIV status, one HIV-negative person was recruited for every three HIV-positive participants. Primary outcomes were linkage to care (clinic-verified registration for care) status at six months, and time to linkage. Primary analyses were intention-to-treat using random effects logistic regression or Cox regression with shared frailty, as appropriate. Three hundred and two(intervention, n = 149; control, n = 153) HIV-positive participants were enrolled. Except for travel time to the nearest HIV clinic, baseline participant characteristics were generally balanced between trial arms. Retention was similar across trial arms (92% overall). One hundred and twenty-seven (42.1%) participants linked to care: 76 (51.0%) in the intervention arm versus 51 (33.3%) in the control arm [odds ratio = 2.18, 95% confidence interval (CI) = 1.26-3.78; p = 0.008)]. There was evidence of interaction between trial arm and follow-up time (p = 0.009). The probability of linkage to care, did not differ between arms in the first two months of follow-up, but was subsequently higher in the intervention arm versus the control arm [hazard ratio = 4.87, 95% CI = 1.79-13.27, p = 0.002]. Counselling substantially increases linkage to care among HIV-positive adults identified through HBHCT and may enhance efforts to increase antiretroviral therapy coverage in sub-Saharan Africa. © 2017 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of the International AIDS Society.

Can peer support be cost saving? An economic evaluation of RAPSID: a randomized controlled trial of peer support in diabetes compared to usual care alone in East of England communities.

PubMed

Wingate, La'Marcus; Graffy, Jonathan; Holman, Daniel; Simmons, David

2017-01-01

Diabetes peer support, where one person with diabetes helps others, may improve diabetes management. The objective of this study was to perform a cost analysis of peer support strategies used in RAndomized controlled trial of Peer Support in type 2 Diabetes. We performed a 2×2 factorial randomized cluster controlled trial in England. People with type 2 diabetes were invited to participate as either 'peer' or 'peer support facilitator' (PSF) through postal invitation predominantly from general practice. Clusters, based on local communities, were each randomly assigned to one arm of group, 1:1, both group and 1:1 or control interventions. The intervention was delivered over 8-12 months by trained PSFs, supported by monthly meetings with a diabetes nurse. Out-of-pocket expenses/service utilization were self-reported at baseline, midpoint and on trial completion. Intervention costs were collated. Non-hospital costs used National Health Service (NHS) reference costs. Hospital payments were obtained from one local commissioning group and mean payments calculated. The analysis employed a societal perspective. Costs were evaluated at the conclusion of the trial. Participants (n=1299) were recruited across 130 clusters. The four arms were well balanced and matched (60% male, mean diabetes duration 9.5 years, mean glycated haemoglobin (HbA1c) 7.4+/-1.3%, 17% insulin treated). Implementation costs at 2013 rates were £13.84/participant/annum, participant out-of-pocket expenses for any intervention were £11.41/participant/annum and the NHS-incurred costs were reduced by £138.38/participant/annum. Savings for the 1:1, group and any intervention were £233.65, £90.52 and £113.13/participant/annum, respectively. We conclude that both 1:1 and group diabetes peer support over 8-12 months are cost saving in this setting, although much of the benefit is largely derived by differences in self-reported healthcare utilization. Long-term benefits should be investigated. ISRCTN66963621.

Increasing weight-bearing physical activity and calcium-rich foods to promote bone mass gains among 9–11 year old girls: outcomes of the Cal-Girls study

PubMed Central

French, Simone A; Story, Mary; Fulkerson, Jayne A; Himes, John H; Hannan, Peter; Neumark-Sztainer, Dianne; Ensrud, Kristine

2005-01-01

Background A two-year, community-based, group-randomized trial to promote bone mass gains among 9–11 year-old girls through increased intake of calcium-rich foods and weight-bearing physical activity was evaluated. Methods Following baseline data collection, 30 5th-grade Girl Scout troops were randomized to a two-year behavioral intervention program or to a no-treatment control group. Evaluations were conducted at baseline, one year, and two years. Measures included bone mineral content, density, and area (measured by DXA), dietary calcium intake (24-hour recall), and weight-bearing physical activity (physical activity checklist interview). Mixed-model regression was used to evaluate treatment-related changes in bone mineral content (g) for the total body, lumbar spine (L1-L4), proximal femur, one-third distal radius, and femoral neck. Changes in eating and physical activity behavioral outcomes were examined. Results Although the intervention was implemented with high fidelity, no significant intervention effects were observed for total bone mineral content or any specific bone sites. Significant intervention effects were observed for increases in dietary calcium. No significant intervention effects were observed for increases in weight-bearing physical activity. Conclusion Future research needs to identify the optimal dosage of weight-bearing physical activity and calcium-rich dietary behavior change required to maximize bone mass gains in pre-adolescent and adolescent girls. PMID:16029507

Effect of rater training on reliability and accuracy of mini-CEX scores: a randomized, controlled trial.

PubMed

Cook, David A; Dupras, Denise M; Beckman, Thomas J; Thomas, Kris G; Pankratz, V Shane

2009-01-01

Mini-CEX scores assess resident competence. Rater training might improve mini-CEX score interrater reliability, but evidence is lacking. Evaluate a rater training workshop using interrater reliability and accuracy. Randomized trial (immediate versus delayed workshop) and single-group pre/post study (randomized groups combined). Academic medical center. Fifty-two internal medicine clinic preceptors (31 randomized and 21 additional workshop attendees). The workshop included rater error training, performance dimension training, behavioral observation training, and frame of reference training using lecture, video, and facilitated discussion. Delayed group received no intervention until after posttest. Mini-CEX ratings at baseline (just before workshop for workshop group), and four weeks later using videotaped resident-patient encounters; mini-CEX ratings of live resident-patient encounters one year preceding and one year following the workshop; rater confidence using mini-CEX. Among 31 randomized participants, interrater reliabilities in the delayed group (baseline intraclass correlation coefficient [ICC] 0.43, follow-up 0.53) and workshop group (baseline 0.40, follow-up 0.43) were not significantly different (p = 0.19). Mean ratings were similar at baseline (delayed 4.9 [95% confidence interval 4.6-5.2], workshop 4.8 [4.5-5.1]) and follow-up (delayed 5.4 [5.0-5.7], workshop 5.3 [5.0-5.6]; p = 0.88 for interaction). For the entire cohort, rater confidence (1 = not confident, 6 = very confident) improved from mean (SD) 3.8 (1.4) to 4.4 (1.0), p = 0.018. Interrater reliability for ratings of live encounters (entire cohort) was higher after the workshop (ICC 0.34) than before (ICC 0.18) but the standard error of measurement was similar for both periods. Rater training did not improve interrater reliability or accuracy of mini-CEX scores. clinicaltrials.gov identifier NCT00667940

Randomized, Phase II Study of the Insulin-Like Growth Factor-1 Receptor Inhibitor IMC-A12, With or Without Cetuximab, in Patients With Cetuximab- or Panitumumab-Refractory Metastatic Colorectal Cancer

PubMed Central

Reidy, Diane Lauren; Vakiani, Efsevia; Fakih, Marwan G.; Saif, Muhammad Wasif; Hecht, Joel Randolph; Goodman-Davis, Noah; Hollywood, Ellen; Shia, Jinru; Schwartz, Jonathan; Chandrawansa, Kumari; Dontabhaktuni, Aruna; Youssoufian, Hagop; Solit, David B.; Saltz, Leonard B.

2010-01-01

Purpose To evaluate the safety and efficacy of IMC-A12, a human monoclonal antibody (mAb) that blocks insulin-like growth factor receptor-1 (IGF-1R), as monotherapy or in combination with cetuximab in patients with metastatic refractory anti–epidermal growth factor receptor (EGFR) mAb colorectal cancer. Methods A randomized, phase II study was performed in which patients in arm A received IMC-A12 10 mg/kg intravenously (IV) every 2 weeks, while patients in arm B received this same dose of IMC-A12 plus cetuximab 500 mg/m2 IV every 2 weeks. Subsequently, arm C (same combination treatment as arm B) was added to include patients who had disease control on a prior anti-EGFR mAb and wild-type KRAS tumors. Archived pretreatment tumor tissue was obtained when possible for KRAS, PIK3CA, and BRAF genotyping, and immunohistochemistry was obtained for pAKT as well as IGF-1R. Results Overall, 64 patients were treated (median age, 61 years; range, 40 to 84 years): 23 patients in arm A, 21 in arm B, and 20 in arm C. No antitumor activity was seen in the 23 patients treated with IMC-A12 monotherapy. Of the 21 patients randomly assigned to IMC-A12 plus cetuximab, one patient (with KRAS wild type) achieved a partial response, with disease control lasting 6.5 months. Arm C (all patients with KRAS wild type), however, showed no additional antitumor activity. Serious adverse events thought possibly related to IMC-A12 included a grade 2 infusion-related reaction (2%; one of 64 patients), thrombocytopenia (2%; one of 64 patients), grade 3 hyperglycemia (2%; one of 64 patients), and grade 1 pyrexia (2%, one of 64 patients). Conclusion IMC-A12 alone or in combination with cetuximab was insufficient to warrant additional study in patients with colorectal cancer refractory to EGFR inhibitors. PMID:20713879

Systematic review: an evaluation of major commercial weight loss programs in the United States.

PubMed

Tsai, Adam Gilden; Wadden, Thomas A

2005-01-04

Each year millions of Americans enroll in commercial and self-help weight loss programs. Health care providers and their obese patients know little about these programs because of the absence of systematic reviews. To describe the components, costs, and efficacy of the major commercial and organized self-help weight loss programs in the United States that provide structured in-person or online counseling. Review of company Web sites, telephone discussion with company representatives, and search of the MEDLINE database. Randomized trials at least 12 weeks in duration that enrolled only adults and assessed interventions as they are usually provided to the public, or case series that met these criteria, stated the number of enrollees, and included a follow-up evaluation that lasted 1 year or longer. Data were extracted on study design, attrition, weight loss, duration of follow-up, and maintenance of weight loss. We found studies of eDiets.com, Health Management Resources, Take Off Pounds Sensibly, OPTIFAST, and Weight Watchers. Of 3 randomized, controlled trials of Weight Watchers, the largest reported a loss of 3.2% of initial weight at 2 years. One randomized trial and several case series of medically supervised very-low-calorie diet programs found that patients who completed treatment lost approximately 15% to 25% of initial weight. These programs were associated with high costs, high attrition rates, and a high probability of regaining 50% or more of lost weight in 1 to 2 years. Commercial interventions available over the Internet and organized self-help programs produced minimal weight loss. Because many studies did not control for high attrition rates, the reported results are probably a best-case scenario. With the exception of 1 trial of Weight Watchers, the evidence to support the use of the major commercial and self-help weight loss programs is suboptimal. Controlled trials are needed to assess the efficacy and cost-effectiveness of these interventions.

Corrective shoes and inserts as treatment for flexible flatfoot in infants and children.

PubMed

Wenger, D R; Mauldin, D; Speck, G; Morgan, D; Lieber, R L

1989-07-01

We performed a prospective study to determine whether flexible flatfoot in children can be influenced by treatment. One hundred and twenty-nine children who had been referred by pediatricians, and for whom the radiographic findings met the criteria for flatfoot, were randomly assigned to one of four groups: Group I, controls; Group II, treatment with corrective orthopaedic shoes; Group III, treatment with a Helfet heel-cup; or Group IV, treatment with a custom-molded plastic insert. All of the patients in Groups II, III, and IV had a minimum of three years of treatment, and ninety-eight patients whose compliance with the protocol was documented completed the study. Analysis of radiographs before treatment and at the most recent follow-up demonstrated a significant improvement in all groups (p less than 0.01), including the controls, and no significant difference between the controls and the treated patients (p greater than 0.4). We concluded that wearing corrective shoes or inserts for three years does not influence the course of flexible flatfoot in children.

[Benefits of an educational intervention on diet and anthropometric profile of women with one cardiovascular risk factor].

PubMed

Soto Rodríguez, Anxela; García Soidán, José Luís; de Toro Santos, Manuel; Lagoa Labrador, Fiz; Failde Garrido, José M; Pérez Fernández, María Reyes

2016-05-20

To assess whether an educational intervention in perimenopausal women with hypertension, diabetes mellitus and/or dyslipidaemia would improve adherence to a Mediterranean diet pattern and achieve changes in anthropometric parameters. Randomized clinical trial of parallel groups: 320 women (45-60 years) in 2 urban primary care services. hip and waist circumference, body mass index (BMI), total, visceral and trunk fat (bioimpedance measures) and adherence to Mediterranean diet (MEDAS-14 questionnaire). Intervention group: 3 interactive workshops on prevention of cardiovascular disease, and control group: information by post. Two hundred and thirty women completed the study (113 control group and 117 intervention group). The differences between groups were significant in all parameters one year later. In the intragroup comparison, the intervention group maintained their BMI and improved adherence to the Mediterranean diet. The control group increased their BMI, abdominal and hip circumference and fat parameters (total, visceral and trunk fat). A simple educational intervention in perimenopausal women with cardiovascular risk can improve their healthy habits. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

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

PubMed

Pitchford, Nicola J

2015-01-01

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

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

PubMed Central

Pitchford, Nicola J.

2015-01-01

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

Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol

PubMed Central

2012-01-01

Background Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. Methods/design An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group). As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group). Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis). Discussion If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. Trial registration The study is registered as NCT01291953 (ClinicalTrials.gob) PMID:23130754

Three doses of vitamin D, bone mineral density, and geometry in older women during modest weight control in a 1-year randomized controlled trial.

PubMed

Pop, L C; Sukumar, D; Schneider, S H; Schlussel, Y; Stahl, T; Gordon, C; Wang, X; Papathomas, T V; Shapses, S A

2017-01-01

The effects of higher than recommended vitamin D doses on bone mineral density (BMD) and quality are not known. In this study, higher intakes, in postmenopausal women undergoing weight control over 1 year, had no effect on areal or volumetric BMD but prevented the deterioration in cortical bone geometry. Studies examining how bone responds to a standard dose of vitamin D supplementation have been inconsistent. In addition, the effects of higher doses on BMD and quality are not known. Postmenopausal women undergoing weight control to improve health outcomes are particularly at risk for bone loss and might benefit from supplemental vitamin D intake above the recommended allowance. This 1-year-long, randomized, double-blind controlled study addresses whether vitamin D supplementation, in healthy overweight/obese older women, affects BMD and bone structural parameters. In addition, bone turnover and serum total, free, and bioavailable 25-hydroxyvitamin D (25OHD) responses to one of three daily levels of vitamin D 3 (600, 2000, 4000 IU) with 1.2 Ca g/day during weight control were examined. Fifty-eight women (age, 58 ± 6 years; body mass index, 30.2 ± 3.8 kg/m 2 , serum 25OHD, 27.3 ± 4.4 ng/mL) were randomized to treatment. After 1 year, serum 25OHD concentrations increased to 26.5 ± 4.4, 35.9 ± 4.5, and 41.5 ± 6.9 ng/mL, in groups 600, 2000, and 4000 IU, respectively, and differed between groups (p < 0.01). Weight change was similar between groups (-3.0 ± 4.1 %). Cortical (Ct) thickness of the tibia changed by -1.5 ± 5.1 %, +0.6 ± 3.2 %, and +2.0 ± 4.5 % in groups 600, 2000, and 4000 IU, respectively, and each group was significantly different from each other (p < 0.05). The decline in Ct thickness was prevented with higher vitamin D 3 supplementation, but there were no other significant changes due to treatment over 1 year. Whether these findings translate to changes in biomechanical properties leading to reduced fracture risk should be addressed in future studies.

Effect of prophylactic percutaneous endoscopic gastrostomy tube on swallowing in advanced head and neck cancer: A randomized controlled study.

PubMed

Axelsson, Lars; Silander, Ewa; Nyman, Jan; Bove, Mogens; Johansson, Leif; Hammerlid, Eva

2017-05-01

Dysphagia is common in head and neck cancer. A percutaneous endoscopic gastrostomy (PEG) tube is used to facilitate nutrition; however, some retrospective studies have indicated that the PEG tube causes dysphagia. A randomized study of patients with head and neck cancer was conducted with up to 10 years of follow-up. Patients were randomized to either the prophylactic PEG tube group (study group) or the common clinical nutritional support group (control group). At each follow-up, a dietician assessed the oral intake, noted the patients' weight, and if the patients used a PEG tube. Dysphagia was also assessed by the quality of life questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Head and Neck 35-questions (EORTC-QLQ-H&N35). One hundred thirty-four patients were included in this study. There was no significant difference in swallowing function between the groups after 12 months, 24 months, and 8 years based on the EORTC-QLQ-H&N35, the oral intake scale, tube dependence, esophageal intervention, weight, body mass index (BMI), and overall survival. A prophylactic PEG tube can be used without an increased risk of long-term dysphagia in patients with head and neck cancer. © 2017 Wiley Periodicals, Inc. Head Neck 39: 908-915, 2017. © 2017 Wiley Periodicals, Inc.

Effects of pumpkin seed in men with lower urinary tract symptoms due to benign prostatic hyperplasia in the one-year, randomized, placebo-controlled GRANU study.

PubMed

Vahlensieck, Winfried; Theurer, Christoph; Pfitzer, Edith; Patz, Brigitte; Banik, Norbert; Engelmann, Udo

2015-01-01

The German Research Activities on Natural Urologicals (GRANU) study was a randomized, partially blinded, placebo-controlled, parallel-group trial that investigated the efficacy of pumpkin seed in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH/LUTS). A total of 1,431 men (50-80 years) with BPH/LUTS were randomly assigned to either pumpkin seed (5 g b.i.d.), capsules with pumpkin seed extract (500 mg b.i.d.) or matching placebo. The primary response criterion was a decrease in International Prostate Symptom Score (IPSS) of ≥5 points from baseline after 12 months. Secondary outcome measures included IPSS-related quality of life, IPSS single items and diary-recorded nocturia. After 12 months, the response rate (intention-to-treat/last-observation-carried-forward approach) did not differ between pumpkin seed extract and placebo. In the case of pumpkin seed (responders: 58.5%), the difference compared with placebo (responders: 47.3%) was descriptively significant. The study products were well tolerated. Overall, in men with BPH, 12 months of treatment with pumpkin seed led to a clinically relevant reduction in IPSS compared with placebo. In order to fully justify a recommendation for the use of pumpkin seed to treat moderate LUTS, these findings need to be substantiated in a confirmatory study or systematic review. 2014 S. Karger AG, Basel

Randomized controlled trial of nettle sting for treatment of base-of-thumb pain.

PubMed Central

Randall, C; Randall, H; Dobbs, F; Hutton, C; Sanders, H

2000-01-01

There are numerous published references to use of nettle sting for arthritis pain but no randomized controlled trials have been reported. We conducted a randomized controlled double-blind crossover study in 27 patients with osteoarthritic pain at the base of the thumb or index finger. Patients applied stinging nettle leaf (Urtica dioica) daily for one week to the painful area. The effect of this treatment was compared with that of placebo, white deadnettle leaf (Lamium album), for one week after a five-week washout period. Observations of pain and disability were recorded for the twelve weeks of the study. After one week's treatment with nettle sting, score reductions on both visual analogue scale (pain) and health assessment questionnaire (disability) were significantly greater than with placebo (P = 0.026 and P = 0.0027). PMID:10911825

Impact of village-based health education of tobacco control on the current smoking rate in Chinese rural areas.

PubMed

Wang, Jian-miao; Xiong, Wei-ning; Xie, Jun-gang; Liu, Xian-sheng; Zhao, Jian-ping; Zhang, Zhen-xiang; Xu, Yong-jian

2016-02-01

The number of smokers in Chinese rural areas is more than 200 million, which is twice that in cities. It is very significant to carry out tobacco control interventions in rural areas. We performed this community intervention study to evaluate the efficacy of village-based health education of tobacco control on the male current smoking rate in rural areas. The population of this study was the males above 15 years old from 6 villages in rural areas. The villages were randomly assigned to intervention group or control group (3 villages in each group). Self-designed smoking questionnaire was applied. The intervention group received the village-based health education of tobacco control for one year. The primary outcome measurement was the male current smoking rate. In the baseline investigation, completed surveys were returned by 814 male residents from the control group and 831 male residents from the intervention group. The male current smoking rate in the control group and the intervention group was 61.2% and 58.5%, respectively, before intervention. There was no significant difference between these two groups (P>0.05). After one-year intervention, the current smoking rate in the intervention group (51.2%) was significantly lower than that in the control group (62.8%) (P<0.001). Our study suggested that the village-based health education of tobacco control was effective in lowering the male current smoking rate in rural areas, which could be a suitable and feasible way for tobacco control in the Chinese rural areas.

Retention of Moisture-tolerant and Conventional Resin-based Sealant in Six- to Nine-year-old Children.

PubMed

Khatri, Sachin G; Samuel, Srinivasan Raj; Acharya, Shashidhar; Patil, Snehal; Madan, Kavita

2015-01-01

The purpose of this study was to evaluate and compare the retention rates and development of caries in permanent molars in children sealed with moisture-tolerant, resin-based (Embrace WetBond), and conventional resin-based (Helioseal) sealant over a period of one year. This was a double blind, split-mouth, randomized controlled trial among six- to nine-year-olds. Sixty-eight permanent mandibular first molars in 34 children were randomly assigned to be sealed with Embrace WetBond or Helioseal sealant. The final sample was 32 children with 64 teeth. At 12 months, 23 of 32 (72 percent) sealants were completely retained in Embrace WetBond, whereas only 16 of 32 (50 percent) were retained in the Helioseal group. There was a statistically significant difference in retention rates of Embrace WetBond and Helioseal sealants at 12 months (P<.05). At 12 months follow-up, only two teeth developed caries in Embrace WetBond; in the Helioseal group, five teeth developed caries (two initial and three enamel caries). Embrace WetBond was superior to Helioseal sealant, as Embrace exhibited higher retention and lower caries scores. Embrace WetBond can be preferred over conventional resin-based sealants for community and outreach sealant programs where use of rubber dam for moisture control is difficult to practice.

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.

Large femoral heads decrease the incidence of dislocation after total hip arthroplasty: a randomized controlled trial.

PubMed

Howie, Donald W; Holubowycz, Oksana T; Middleton, Robert

2012-06-20

The use of larger femoral heads has been proposed to reduce the risk of dislocation after total hip arthroplasty, but there is a lack of evidence to support this proposal. The aim of this multicenter randomized controlled trial was to determine whether the incidence of dislocation one year after total hip arthroplasty is significantly lower in association with the use of a 36-mm femoral head articulation as compared with a 28-mm articulation. Six hundred and forty-four middle-aged and elderly patients undergoing primary or revision arthroplasty were randomized intraoperatively to receive either a 36 or 28-mm metal femoral head on highly cross-linked polyethylene. Patients who were at high risk of dislocation (including those with dementia and neuromuscular disease) and those undergoing revision for the treatment of recurrent hip dislocation or infection were excluded. Patients were stratified according to other potential risk factors for dislocation, including diagnosis and age. Diagnosis of hip dislocation required confirmation by a physician and radiographic evidence of a dislocation. Overall, at one year of follow-up, hips with a 36-mm femoral head articulation had a significantly lower incidence of dislocation than did those with a 28-mm articulation (1.3% [four of 299] compared with 5.4% [seventeen of 316]; difference, 4.1% [95% confidence interval, 1.2% to 7.2%]) when controlling for the type of procedure (primary or revision) (p = 0.012). The incidence of dislocation following primary arthroplasty was also significantly lower for hips with a 36-mm femoral head articulation than for those with a 28-mm articulation (0.8% [two of 258] compared with 4.4% [twelve of 275]; difference, 3.6% [95% confidence interval, 0.9% to 6.8%]) (p = 0.024). The incidence of dislocation following revision arthroplasty was 4.9% (two of forty-one) for hips with a 36-mm articulation and 12.2% (five of forty-one) for hips with a 28-mm articulation; this difference was not significant with the relatively small sample size of the revision group (difference, 7.3% [95% confidence interval, -5.9% to 21.1%]) (p = 0.273). Compared with a 28-mm femoral head articulation, a larger 36-mm articulation resulted in a significantly decreased incidence of dislocation in the first year following primary total hip arthroplasty. However, before a 36-mm metal-on-highly cross-linked polyethylene articulation is widely recommended, the incidence of late dislocation, wear, periprosthetic osteolysis, and liner fracture should be established.

Can Chronic Disease Management Programs for Patients with Type 2 Diabetes Reduce Productivity-Related Indirect Costs of the Disease? Evidence from a Randomized Controlled Trial

PubMed Central

Bolin, Jane N.; Ohsfeldt, Robert L.; Phillips, Charles D.; Zhao, Hongwei; Ory, Marcia G.; Forjuoh, Samuel N.

2014-01-01

Abstract The objective was to assess the impacts of diabetes self-management programs on productivity-related indirect costs of the disease. Using an employer's perspective, this study estimated the productivity losses associated with: (1) employee absence on the job, (2) diabetes-related disability, (3) employee presence on the job, and (4) early mortality. Data were obtained from electronic medical records and survey responses of 376 adults aged ≥18 years who were enrolled in a randomized controlled trial of type 2 diabetes self-management programs. All study participants had uncontrolled diabetes and were randomized into one of 4 study arms: personal digital assistant (PDA), chronic disease self-management program (CDSMP), combined PDA and CDSMP, and usual care (UC). The human-capital approach was used to estimate lost productivity resulting from 1, 2, 3, and 4 above, which are summed to obtain total productivity loss. Using robust regression, total productivity loss was modeled as a function of the diabetes self-management programs and other identified demographic and clinical characteristics. Compared to subjects in the UC arm, there were no statistically significant differences in productivity losses among persons undergoing any of the 3 diabetes management interventions. Males were associated with higher productivity losses (+$708/year; P<0.001) and persons with greater than high school education were associated with additional productivity losses (+$758/year; P<0.001). Persons with more than 1 comorbid condition were marginally associated with lower productivity losses (-$326/year; P=0.055). No evidence was found that the chronic disease management programs examined in this trial affect indirect productivity losses. (Population Health Management 2014;17:112–120) PMID:24152055

Gait mechanics and tibiofemoral loading in men of the ACL-SPORTS randomized control trial.

PubMed

Capin, Jacob J; Khandha, Ashutosh; Zarzycki, Ryan; Arundale, Amelia J H; Ziegler, Melissa L; Manal, Kurt; Buchanan, Thomas S; Snyder-Mackler, Lynn

2018-03-25

The risk for post-traumatic osteoarthritis is elevated after anterior cruciate ligament reconstruction (ACLR), and may be especially high among individuals with aberrant walking mechanics, such as medial tibiofemoral joint underloading 6 months postoperatively. Rehabilitation training programs have been proposed as one strategy to address aberrant gait mechanics. We developed the anterior cruciate ligament specialized post-operative return-to-sports (ACL-SPORTS) randomized control trial to test the effect of 10 post-operative training sessions consisting of strength, agility, plyometric, and secondary prevention exercises (SAPP) or SAPP plus perturbation (SAPP + PERT) training on gait mechanics after ACLR. A total of 40 male athletes (age 23 ± 7 years) after primary ACLR were randomized to SAPP or SAPP + PERT training and tested at three distinct, post-operative time points: 1) after impairment resolution (Pre-training); 2) following 10 training sessions (Post-training); and 3) 2 years after ACLR. Knee kinematic and kinetic variables as well as muscle and joint contact forces were calculated via inverse dynamics and a validated electromyography-informed musculoskeletal model. There were no significant improvements from Pre-training to Post-training in either intervention group. Smaller peak knee flexion angles, extension moments, extensor muscle forces, medial compartment contact forces, and tibiofemoral contact forces were present across group and time, however the magnitude of interlimb differences were generally smaller and likely not meaningful 2 years postoperatively. Neither SAPP nor SAPP + PERT training appears effective at altering gait mechanics in men in the short-term; however, meaningful gait asymmetries mostly resolved between post-training and 2 years after ACLR regardless of intervention group. © 2018 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res. © 2018 Orthopaedic Research Society. Published by Wiley Periodicals, Inc.

Oral Ondansetron in Management of Dehydrating Diarrhea with Vomiting in Children Aged 3 Months to 5 Years: A Randomized Controlled Trial.

PubMed

Danewa, Arun Singh; Shah, Dheeraj; Batra, Prerna; Bhattacharya, Swapan Kumar; Gupta, Piyush

2016-02-01

To evaluate the role of oral ondansetron in facilitating successful rehydration of under-5-year-old children suffering from acute diarrhea with vomiting and some dehydration. Children (n = 170) aged 3 months to 5 years with acute diarrhea with vomiting and some dehydration were enrolled in this double blind, randomized, placebo-controlled trial. The participants were randomized to receive either single dose of oral ondansetron (n = 85) or placebo (n = 85) in addition to standard management of dehydration according to World Health Organization guidelines. Failure of oral rehydration therapy (ORT), administration of unscheduled intravenous fluids, and amount of oral rehydration solution intake in 4 hours were the primary outcomes. Secondary outcome measures included duration of dehydration correction, number of vomiting episodes, adverse effects, and caregiver satisfaction. Failure of ORT was significantly less in children receiving ondansetron compared with those receiving placebo (31% vs 62%; P < .001; relative risk 0.50, 95% CI 0.35-0.72). Almost one-half of the children in the ondansetron group received intravenous fluids compared with those in the placebo group, but it was not statistically significant (P = .074; relative risk 0.56, 95% CI 0.30-1.07). The oral rehydration solution consumption was significantly more in the ondansetron group (645 mL vs 554 mL; mean difference 91 mL; 95% CI: 35-148 mL). Patients in the ondansetron group also showed faster rehydration, lesser number of vomiting episodes, and better caregiver satisfaction. A single oral dose of ondansetron, given before starting ORT to children <5 years of age with acute diarrhea and vomiting results in better oral rehydration. Clinical Trial Registry of India: CTRI-2011/07/001916. Copyright © 2016 Elsevier Inc. All rights reserved.

Can chronic disease management programs for patients with type 2 diabetes reduce productivity-related indirect costs of the disease? Evidence from a randomized controlled trial.

PubMed

Adepoju, Omolola E; Bolin, Jane N; Ohsfeldt, Robert L; Phillips, Charles D; Zhao, Hongwei; Ory, Marcia G; Forjuoh, Samuel N

2014-04-01

The objective was to assess the impacts of diabetes self-management programs on productivity-related indirect costs of the disease. Using an employer's perspective, this study estimated the productivity losses associated with: (1) employee absence on the job, (2) diabetes-related disability, (3) employee presence on the job, and (4) early mortality. Data were obtained from electronic medical records and survey responses of 376 adults aged ≥18 years who were enrolled in a randomized controlled trial of type 2 diabetes self-management programs. All study participants had uncontrolled diabetes and were randomized into one of 4 study arms: personal digital assistant (PDA), chronic disease self-management program (CDSMP), combined PDA and CDSMP, and usual care (UC). The human-capital approach was used to estimate lost productivity resulting from 1, 2, 3, and 4 above, which are summed to obtain total productivity loss. Using robust regression, total productivity loss was modeled as a function of the diabetes self-management programs and other identified demographic and clinical characteristics. Compared to subjects in the UC arm, there were no statistically significant differences in productivity losses among persons undergoing any of the 3 diabetes management interventions. Males were associated with higher productivity losses (+$708/year; P<0.001) and persons with greater than high school education were associated with additional productivity losses (+$758/year; P<0.001). Persons with more than 1 comorbid condition were marginally associated with lower productivity losses (-$326/year; P=0.055). No evidence was found that the chronic disease management programs examined in this trial affect indirect productivity losses.

Feasibility and effectiveness of a combined individual and psychoeducational group intervention in psychiatric residential facilities: A controlled, non-randomized study.

PubMed

Magliano, Lorenza; Puviani, Marta; Rega, Sonia; Marchesini, Nadia; Rossetti, Marisa; Starace, Fabrizio

2016-01-30

This controlled, non-randomized study explored the feasibility of introducing a Combined Individual and Group Intervention (CIGI) for users with mental disorders in residential facilities, and tested whether users who received the CIGI had better functioning than users who received the Treatment-As-Usual (TAU), at two-year follow up. In the CIGI, a structured cognitivebehavioral approach called VADO (in English, Skills Assessment and Definition of Goals) was used to set specific goals with each user, while Falloon's psychoeducational treatment was applied with the users as a group. Thirty-one professionals attended a training course in CIGI, open to users' voluntary participation, and applied it for two years with all users living in 8 residential facilities of the Mental Health Department of Modena, Italy. In the same department, 5 other residential facilities providing TAU were used as controls. ANOVA for repeated measures showed a significant interaction effect between users' functioning at baseline and follow up assessments, and the intervention. In particular, change in global functioning was higher in the 55 CIGI users than in the 44 TAU users. These results suggest that CIGI can be successfully introduced in residential facilities and may be useful to improve functioning in users with severe mental disorders. Copyright © 2016. Published by Elsevier Ireland Ltd.

Intermittent levosimendan infusions in advanced heart failure: favourable effects on left ventricular function, neurohormonal balance, and one-year survival.

PubMed

Malfatto, Gabriella; Della Rosa, Francesco; Villani, Alessandra; Rella, Valeria; Branzi, Giovanna; Facchini, Mario; Parati, Gianfranco

2012-11-01

The role of repeated infusions of Levosimendan (LEVO) in patients with chronic advanced heart failure is still unclear. Thirty-three patients with chronic heart failure presenting clinical deterioration were randomized 2:1 to receive monthly infusions of LEVO (n = 22) or Furosemide (Controls, n = 11). At the first drug's administration, noninvasive hemodynamic evaluation was performed; before and after each infusion, we assessed NYHA class, systolic and diastolic function, functional mitral regurgitation, and brain natriuretic peptide (BNP) levels. Noninvasive hemodynamic in the LEVO group showed vasodilation and decrease in thoracic conductance (index of pulmonary congestion), whereas in Controls, only a reduced thoracic conductance was observed. In the LEVO group, systolic and diastolic function, ventricular volumes, severity of mitral regurgitation, and BNP levels improved over time from baseline and persisted 4 weeks after the last infusion (P < 0.01). In Controls, no change developed over time in cardiac function and BNP levels. In LEVO-treated patients, 1-year mortality tended to be lower than in those treated with Furosemide. In conclusion, serial LEVO infusions in advanced heart failure improved ventricular performance and favorably modulated neurohormonal activation. Multicenter randomized studies are warranted to test the effect of LEVO on long-term outcome.

The effect of Early Head Start on child welfare system involvement: A first look at longitudinal child maltreatment outcomes☆

PubMed Central

Green, Beth L.; Ayoub, Catherine; Bartlett, Jessica Dym; Von Ende, Adam; Furrer, Carrie; Chazan-Cohen, Rachel; Vallotton, Claire; Klevens, Joanne

2015-01-01

The high societal and personal costs of child maltreatment make identification of effective early prevention programs a high research priority. Early Head Start (EHS), a dual generational program serving low-income families with children prenatally through age three years, is one of the largest federally funded programs for infants and toddlers in the United States. A national randomized trial found EHS to be effective in improving parent and child outcomes, but its effectiveness in reducing child maltreatment was not assessed. The current study used administrative data from state child welfare agencies to examine the impact of EHS on documented abuse and neglect among children from seven of the original seventeen programs in the national EHS randomized controlled trial. Results indicated that children in EHS had significantly fewer child welfare encounters between the ages of five and nine years than did children in the control group, and that EHS slowed the rate of subsequent encounters. Additionally, compared to children in the control group, children in EHS were less likely to have a substantiated report of physical or sexual abuse, but more likely to have a substantiated report of neglect. These findings suggest that EHS may be effective in reducing child maltreatment among low-income children, in particular, physical and sexual abuse. PMID:26744550

Effects of periodontal treatment on lung function and exacerbation frequency in patients with chronic obstructive pulmonary disease and chronic periodontitis: a 2-year pilot randomized controlled trial.

PubMed

Zhou, Xuan; Han, Jing; Liu, Zhiqiang; Song, Yiqing; Wang, Zuomin; Sun, Zheng

2014-06-01

To evaluate the direct effects of periodontal therapy in Chronic Obstructive Pulmonary Disease (COPD) patients with chronic periodontitis (CP). In a pilot randomized controlled trial, 60 COPD patients with CP were randomly assigned to receive scaling and root planing (SRP) treatment, supragingival scaling treatment, or oral hygiene instructions only with no periodontal treatment. We evaluated their periodontal indexes, respiratory function, and COPD exacerbations at baseline, 6 months, 1, and 2 years. Compared with the control group, measurements of periodontal indexes were significantly improved in patients in two treatment groups at 6-month, 1-year, and 2-year follow-up (all p < 0.05). Overall, the means of forced expiratory volume in the first second/forced vital capacity (FEV1/FVC) and FEV1 were significantly higher in the two therapy groups compared with the control group during the follow-up (p < 0.05). In addition, the frequencies of COPD exacerbation were significantly lower in the two therapy groups than in the control group at 2-year follow-up (p < 0.05). Our preliminary results from this pilot trial suggest that periodontal therapy in COPD patients with CP may improve lung function and decrease the frequency of COPD exacerbation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Randomized clinical trial of laparoscopic anterior 180° partial versus 360° Nissen fundoplication: 5-year results.

PubMed

Cao, Z; Cai, W; Qin, M; Zhao, H; Yue, P; Li, Y

2012-02-01

Anterior partial fundoplication (AF) has been popularized by a lower risk of mechanical side effects. The question then emerges whether anterior partial wrap has a similar antireflux effect with Nissen fundoplication (NF). We therefore conducted a randomized study to compare the long-term outcome of anterior fundoplication with NF. One hundred patients who enrolled in the trial from May 2003 to March 2005 were randomized to laparoscopic AF or laparoscopic NF. Endoscopy, pH monitoring, manometry, a detailed questionnaire, and a visual analog symptom score were completed preoperative at 6, 12, 24, and 60 months after surgical procedures. The postoperative adverse effects such as dysphagia and flatulence were compared between the two groups. Revision surgery or maintenance proton pump inhibitor therapy was defined as failure. Fifty procedures were performed in each group. The outcome at 5 years follow-up was determined for 96 patients (96%; 49 patients in the AF group and 47 in the NF group). Three patients (3%) died of unrelated causes during follow-up, and one patient changed address. Both fundoplications were found to provide good control of reflux-related symptoms in most of the patients. For 96 patients followed up more than 5 years, gastroesophageal reflux symptoms were well controlled in 81 patients (84.38%); the mean DeMeester scores in the AF group decreased from 106.89 ± 14.12 to 12.67 ± 3.14 and in the NF group from 109.51 ± 17.98 to 10.81 ± 2.65, and the esophagitis was ameliorated visibly. Moreover, there were significantly fewer patients in the AF group who complained of flatulence. Compared with NF, anterior 180° partial fundoplication is an effective treatment of gastroesophageal reflux and associates with fewer postoperative adverse effects. © 2011 Copyright the Authors. Journal compilation © 2011, Wiley Periodicals, Inc. and the International Society for Diseases of the Esophagus.

Improving diets and nutrition through an integrated poultry value chain and nutrition intervention (SELEVER) in Burkina Faso: study protocol for a randomized trial.

PubMed

Gelli, Aulo; Becquey, Elodie; Ganaba, Rasmane; Headey, Derek; Hidrobo, Melissa; Huybregts, Lieven; Verhoef, Hans; Kenfack, Romain; Zongouri, Sita; Guedenet, Hannah

2017-09-06

The SELEVER study is designed to evaluate the impact of an integrated agriculture-nutrition package of interventions (including poultry value chain development, women's empowerment activities, and a behavior change communications strategy to promote improved diets and feeding, care, and hygiene practices) on the diets, health, and nutritional status of women and children in Burkina Faso. This paper presents the rationale and study design. The impact evaluation involves a cluster randomized controlled trial design that will be implemented in 120 rural communities/villages within 60 communes supported by SELEVER in the Boucle de Mouhoun, Centre-Ouest, and Haut-Bassins regions of Burkina Faso. Communities will be randomly assigned to one of three treatment arms, including: (1) SELEVER intervention group; (2) SELEVER with an intensive WASH component; and (3) control group without intervention. Primary outcomes include the mean probability of adequacy of diets for women and children (aged 2-4 years at baseline), infant and young child feeding practices of caregivers of children aged 0-2 years, and household poultry production and sales. Intermediate outcomes along the agriculture and nutrition pathways will also be measured, including child nutrition status and development. The evaluation will follow a mixed-methods approach, including a panel of child-, household-, community-, and market-level surveys, and data collection points during post-harvest and lean seasons, as well as one year after implementation completion to examine sustainability. To our knowledge, this study is the first to rigorously examine from a food systems perspective, the simultaneous impact of scaling-up nutrition-specific and nutrition-sensitive interventions through a livestock value-chain and community-intervention platform, across nutrition, health, and agriculture domains. The findings of this evaluation will provide evidence to support the design of market-based nutrition-sensitive interventions. ISRCTN registry, ISRCTN16686478 . Registered on 2 December 2016.