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Introduction: Telerehabilitation may be effective on average but is not equally effective among all people with multiple sclerosis (MS). Thus, the purpose of this secondary analysis of a randomized controlled trial was to explore whether baseline characteristics of participants with MS influence fatigue and physical activity outcomes of three telerehabilitation interventions.Methods: Participants were randomized to contact-control intervention (CC), physical activity-only intervention (PA-only), and physical activity plus fatigue self-management intervention (FM+). The 12-week interventions were delivered over the phone. Sociodemographic (age and income), clinical (comorbidities, mental function and physical function), psychosocial (self-efficacy, outcome expectations and goal-setting), and behavioural baseline characteristics (step count and fatigue self-management behaviors) were used in a moderated regression analysis and a responder analysis to examine their influence on the Fatigue Impact Scale (FIS) and Godin Leisure-Time Exercise Questionnaire (GLTEQ) at post-test (i.e. immediately post-interventions).Results: No interactions terms were statistically significant in the moderation analysis. However, the responder analysis showed that baseline psychosocial characteristics and mental function were significantly different (p < 0.05) between responders and non-responders. Specifically, non-responders on the FIS at post-test in the PA-only intervention had significantly lower baseline scores in goal setting for engaging in fatigue self-management behaviours. Also, non-responders on the GLTEQ at post-test in the FM+ intervention had significantly worse baseline scores in mental function.Discussion: Further research is needed to understand the complex relationship among baseline characteristics, telerehabilitation and response heterogeneity. We discuss how research on examining response heterogeneity may be advanced by conducting mega-clinical trials, secondary analyses of big data, meta-analyses and employing non-traditional research designs.Trial Registration: Clinicaltrials.gov (NCT01572714). [ABSTRACT FROM AUTHOR]

Objective: Increasing meaning in life (MiL) among people experiencing disease or adversity may improve coping and resilience. The purpose of this review is to characterize the effects of MiL interventions.Data Source: A systematic search of PubMed, PsycInfo, and Google Scholar was conducted encompassing the following parameters: meaning in life, purpose in life, or sense of purpose with randomized controlled trials.Study Inclusion& Exclusion Criteria: Randomized controlled trials (RCTs) of interventions with at least one outcome that measured improvement in MiL and were published in English between January 2000 and January 2020.Data Extraction& Synthesis: 33 randomized controlled trials (k = 35) were identified. Data were coded by authors and a research assistant for intervention type, control group type, and risk of bias. The random effects model of Review Manager 5.3 was used to produce SMD and evaluate heterogeneity.Results: The effect size for studies with a passive control group was SMD = 0.85 (95% CI 0.54 to 1.17) and for studies with an active control group was SMD = .032 (95% CI 0.09 to 0.55). Mindfulness programs produced the largest effect size (1.57) compared to passive controls, while narrative programs produced the largest effect relative to active controls (0.61). There was considerable heterogeneity in most estimates.Conclusion: Several interventions increase MiL, including some that are relatively brief and do not require licensed professionals. [ABSTRACT FROM AUTHOR]

Objective: ADHD has been associated with persistent problems of working memory. This study investigated the efficacy of an intensive and adaptive computerized working memory treatment (CWMT) at behavioral and neural levels. Method: College students (n = 89; 40 females) with ADHD were randomized into a standard-length CWMT (45 min/session, 25 sessions, n = 29), shortened-length CWMT (15 min/session, 25 sessions, n = 32), and a waitlist group (n = 28). Both CWMT groups received treatment for 5 days a week for 5 weeks. Lab sessions before and after CWMT assessed electroencephalography (EEG) indicators of working memory, behavioral indicators of working memory performance, and ADHD symptomatology. Results: No evidence was found for neural or any other behavioral transfer effects of improvement for the CWMT treatment groups over the active control or waitlist group. Conclusion: Our study does not provide evidence for the benefits of CWMT at neural or behavioral levels. [ABSTRACT FROM AUTHOR]

The National Institutes of Health estimated that $3–$4 billion is spent supporting clinical trials annually, yet an average of 17 years is required for research evidence to be implemented into practice. Study designs that balance external and internal validity, based on the goals of the study and relative to the state of the science, may accelerate knowledge translation. The purpose of this case study was to evaluate two randomized control trials on the effectiveness-efficacy continuum using the PRagmatic Explanatory Continuum Indicator Summary and the Research Effectiveness Adoption Implementation Maintenance model. Findings provided insight into strategies that may lead to more balanced approaches to research design. Incorporating tools such as PRECIS-2 and RE-AIM when designing and implementing research interventions may accelerate knowledge translation to close the gap between scientific knowledge and clinical practice. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of acceptance and commitment therapy (ACT) on depressive symptoms in physically disabled persons. Design: Randomized controlled trial. Setting: State welfare organization in Kamyaran, Kurdistan, Iran. Participants: Fifty-two physically disabled participants with a primary diagnosis of depression were randomly assigned to either ACT or control groups. Interventions: Participants in the ACT group (n = 23) received eight weekly 90-minute group sessions based on standard ACT protocol for depression. Participants in the control group (n = 29) received psychoeducation regarding depression. Main measures: Measures were recorded at baseline, eight weeks (end of treatment), and 16 weeks (follow-up). The outcomes were the change in the depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively. Results: After eight weeks, significant changes in depressive symptoms was observed in the experimental group (ACT –10.39 ± 0.79 vs control 0.66 ± 0.68, P < 0.001). Compared to the control group, the experimental group also showed significant improvement in psychological flexibility (ACT 8.13 ± 0.52 vs control –0.03 ± 0.51, P < 0.001), adaptive emotion regulation strategies (ACT 10.74 ± 0.62 vs control 0.03 ± 1.03, P < 0.001), and psychological well-being (ACT 66.95 ± 4.01 vs control –1.90 ± 1.04, P < 0.001). Conclusion: Compared with control group, ACT significantly reduced the participants' depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability. [ABSTRACT FROM AUTHOR]

Objective: To evaluate a group-based music intervention in patients with Parkinson's disease. Design: Parallel group randomized controlled trial with qualitative triangulation. Setting: Neurorehabilitation in primary care. Subjects: Forty-six patients with Parkinson's disease were randomized into intervention group (n = 26), which received training with the music-based intervention, and control group (n = 20) without training. Interventions: The intervention was delivered twice weekly for 12 weeks. Main measures: Primary outcome was Timed-Up-and-Go subtracting serial 7's (dual-task ability). Secondary outcomes were cognition, balance, concerns about falling, freezing of gait, and quality of life. All outcomes were evaluated at baseline, post-intervention, and three months post-intervention. Focus groups and individual interviews were conducted with the intervention group and with the delivering physiotherapists. Results: No between-group differences were observed for dual-task ability. Between-group differences were observed for Falls Efficacy Scale (mean difference (MD) = 6.5 points; 95% confidence interval (CI) = 3.0 to 10.0, P = 0.001) and for Parkinson Disease Questionnaire-39 items (MD = 8.3; 95% CI = 2.7 to 13.8, P = 0.005) when compared to the control group post-intervention, but these were not maintained at three months post-intervention. Three themes were derived from the interviews: Expectations versus Results, Perspectives on Treatment Contents, and Key Factors for Success. Conclusion: Patient-reported outcomes and interviews suggest that the group-based music intervention adds value to mood, alertness, and quality of life in patients with Parkinson's disease. The study does not support the efficacy in producing immediate or lasting gains in dual-tasking, cognition, balance, or freezing of gait. [ABSTRACT FROM AUTHOR]

Objective: The aim of the study is to investigate the feasibility of a family-based mindfulness intervention in improving children with inattention and hyperactivity symptoms. Method: A total of 100 children aged 5 to 7 years with ADHD symptoms and their parents were randomly assigned to a family-based mindfulness intervention (n = 50) or a wait-list control group (n = 50). Results: Families from intervention group had greater improvements in children's ADHD symptoms, with medium effect sizes of -0.60 for inattention and -0.59 for hyperactivity; overall behaviors; and parenting stress and well-being than those in wait-list control group. Conclusion: The positive results on the child primary outcome measures have provided initial evidence of the family-based mindfulness intervention as a treatment option to ADHD. The reduction of parental stress and increase in psychological well-being has demonstrated the value of mindfulness in enhancing parent's self-management. [ABSTRACT FROM AUTHOR]

Objective: This study evaluated the efficacy of an Integrated Brain, Body, and Social (IBBS) intervention for children with ADHD. Treatment consisted of computerized cognitive remediation training, physical exercises, and a behavior management strategy. Method: Ninety-two children aged 5 to 9 years with ADHD were randomly assigned to 15 weeks of IBBS or to treatment-as-usual. Primary outcome measures included blinded clinician ratings of ADHD symptoms and global clinical functioning. Secondary outcome measures consisted of parent and teacher ratings of ADHD and neurocognitive tests. Results: No significant treatment effects were found on any of our primary outcome measures. In terms of secondary outcome measures, the IBBS group showed significant improvement on a verbal working memory task; however, this result did not survive correction for multiple group comparisons. Conclusion: These results suggest that expanding cognitive training to multiple domains by means of two training modalities does not lead to generalized improvement of ADHD symptomatology. [ABSTRACT FROM AUTHOR]

Objective: Psychoeducation forms part of the current practice for ADHD; however, its efficacy is yet to be established. Method: Sixty-nine children/adolescents with ADHD were randomly assigned for their families to receive either a well-structured psychoeducation program (n = 35), or belong to a control group (treatment-as-usual, n = 34). Results: One-way analyses of variance showed a statistically significant Treatment × Time interaction, for ADHD total symptoms, inattention/cognition, and hyperactivity/impulsivity subdomains according to the parents, the first two with medium-large effect sizes. The effects of the intervention on the ADHD total and the inattention/cognition domain persisted after 6 months follow-up. No significant differences in teacher ratings were found; however, an improvement in clinical functioning as measured by clinicians was observed. Conclusion: This psychoeducation program has shown effectiveness in reducing ADHD symptoms when compared with treatment as usual. Psychoeducation needs to be considered as a valid and additional approach in ADHD. [ABSTRACT FROM AUTHOR]

Objective: To determine the feasibility of conducting a trial of a pre-surgical psychological intervention on pain, function, and mood in people with knee osteoarthritis listed for total knee arthroplasty. Design: Multi-centre, mixed-methods feasibility randomized controlled trial of intervention plus usual care versus usual care. Setting: Participants’ homes or hospital. Participants: Patients with knee osteoarthritis listed for total knee arthroplasty and score >7 on either subscales of Hospital Anxiety and Depression Scale. Intervention: Up-to 10 sessions of psychological intervention (based on cognitive behavioural therapy). Main measures: Feasibility outcomes (recruitment and retention rates, acceptability of trial procedures and intervention, completion of outcome measures), and standardized questionnaires assessing pain, function, and mood at baseline, and four and six months post-randomisation. Results: Of 222 people screened, 81 did not meet inclusion criteria, 64 did not wish to participate, 26 were excluded for other reasons, and 51 were randomized. A total of 30 completed 4-month outcomes and 25 completed 6-month outcomes. Modal number of intervention sessions completed was three (range 2–8). At 6-month follow-up, mood, pain, and physical function scores were consistent with clinically important benefits from intervention, with effect sizes ranging from small (d = 0.005) to moderate (d = 0.74), and significant differences in physical function between intervention and usual care groups (d = 1.16). Feedback interviews suggested that participants understood the rationale for the study, found the information provided adequate, the measures comprehensive, and the intervention acceptable. Conclusion: A definitive trial is feasible, with a total sample size of 444 people. Pain is a suitable primary outcome, but best assessed 6 and 12 months post-surgery. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate whether exposure to MyFamilyPlan-a web-based preconception health education module-changes the proportion of women discussing reproductive health with providers at well-woman visits.Design: Cluster randomized controlled trial. One hundred thirty participants per arm distributed among 34 clusters (physicians) required to detect a 20% change in the primary outcome.Setting: Urban academic medical center (California).Participants: Eligible women were 18 to 45 years old, were English speaking, were nonpregnant, were able to access the Internet, and had an upcoming well-woman visit. E-mail and phone recruitment between September 2015 and May 2016; 292 enrollees randomized.Intervention: Intervention participants completed the MyFamilyPlan module online 7 to 10 days before a scheduled well-woman visit; control participants reviewed standard online preconception health education materials.Measures: The primary outcome was self-reported discussion of reproductive health with the physician at the well-woman visit. Self-reported secondary outcomes were folic acid use, contraceptive method initiation/change, and self-efficacy score.Analysis: Multilevel multivariate logistic regression.Results: After adjusting for covariates and cluster, exposure to MyFamilyPlan was the only variable significantly associated with an increase in the proportion of women discussing reproductive health with providers (odds ratio: 1.97, 95% confidence interval: 1.22-3.19). Prespecified secondary outcomes were unaffected.Conclusion: MyFamilyPlan exposure was associated with a significant increase in the proportion of women who reported discussing reproductive health with providers and may promote preconception health awareness; more work is needed to affect associated behaviors. [ABSTRACT FROM AUTHOR]

Background Clinical observations and results from recent studies support the use of non-invasive vagus nerve stimulation (nVNS) for treating cluster headache (CH) attacks. This study compared nVNS with a sham device for acute treatment in patients with episodic or chronic CH (eCH, cCH). Methods After completing a 1-week run-in period, subjects were randomly assigned (1:1) to receive nVNS or sham therapy during a 2-week double-blind period. The primary efficacy endpoint was the proportion of all treated attacks that achieved pain-free status within 15 minutes after treatment initiation, without rescue treatment. Results The Full Analysis Set comprised 48 nVNS-treated (14 eCH, 34 cCH) and 44 sham-treated (13 eCH, 31 cCH) subjects. For the primary endpoint, nVNS (14%) and sham (12%) treatments were not significantly different for the total cohort. In the eCH subgroup, nVNS (48%) was superior to sham (6%; p < 0.01). No significant differences between nVNS (5%) and sham (13%) were seen in the cCH subgroup. Conclusions Combing both eCH and cCH patients, nVNS was no different to sham. For the treatment of CH attacks, nVNS was superior to sham therapy in eCH but not in cCH. These results confirm and extend previous findings regarding the efficacy, safety, and tolerability of nVNS for the acute treatment of eCH. [ABSTRACT FROM AUTHOR]

Purpose: To examine the effects of a free-living, sedentary-inducing intervention on cognitive function.Design: Randomized controlled, parallel group intervention.Setting: University campus.Participants: Thirty-three young adults (n = 23 intervention; n = 10 control).Measures: The intervention group was asked to eliminate all exercise and minimize steps to ≤5000 steps/day for 1 week, whereas the control group was asked to continue normal physical activity (PA) levels for 1 week. Both groups completed a series of 8 cognitive function assessments (assessing multiple parameters of cognition) preintervention and immediately postintervention. The intervention group was asked to resume normal PA levels for 1 week postintervention and completed the cognitive assessments for a third time at 2 weeks postintervention.Analysis: Split-plot repeated-measures analysis of variance.Results: The results of our statistical analyses showed that the group × time interaction effect was not significant ( P > .05) for any of the evaluated cognitive parameters.Conclusion: These findings demonstrate the need for future experimental investigations of sedentary behavior to better understand its effects on cognitive function. However, although previous work has demonstrated favorable effects of acute and chronic PA on cognitive function, our findings suggest that a 1-week period of reduced PA does not detrimentally affect cognitive function, which may have encouraging implications for individuals going through a temporary relapse in PA. [ABSTRACT FROM AUTHOR]

Purpose: To assess the safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) for the treatment of de novo and native artery restenotic lesions in the superficial femoral and proximal popliteal arteries vs percutaneous transluminal angioplasty (PTA) with an uncoated balloon in a Japanese cohort.Methods: MDT-2113 SFA Japan ( ClinicalTrials.gov identifier NCT01947478) is an independently adjudicated, prospective, randomized, single-blinded trial that randomized (2:1) 100 patients (mean age 73.6±7.0 years; 76 men) from 11 Japanese centers to treatment with DCB (n=68) or PTA (n=32). Baseline characteristics were similar between the groups, including mean lesion length (9.15±5.85 and 8.89±6.01 cm for the DCB and PTA groups, respectively). The primary effectiveness outcome was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasonography. The safety endpoint was a composite of 30-day device- and procedure-related death and target limb major amputation and clinically-driven target vessel revascularization within 12 months.Results: Patients treated with DCBs exhibited superior 12-month primary patency (89%) compared to patients treated with PTA (48%, p<0.001). The 12-month CD-TLR rate was 3% for DCB vs 19% for PTA (p=0.012). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Quality-of-life measures showed sustained improvement from baseline to 12 months in both groups.Conclusion: Results from the MDT-2113 SFA Japan trial showed superior treatment effect for DCB vs PTA, with excellent patency and low CD-TLR rates. These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and effectiveness of this DCB for the treatment of femoropopliteal lesions in this Japanese cohort. [ABSTRACT FROM AUTHOR]

Emerging evidence suggests that design flaws of randomized controlled trials can result in over- or underestimation of the treatment effect size (ES). The objective of this study was to examine associations between treatment ES estimates and adequacy of sequence generation, allocation concealment, and baseline comparability among a sample of oral health randomized controlled trials. For our analysis, we selected all meta-analyses that included a minimum of 5 oral health randomized controlled trials and used continuous outcomes. We extracted data, in duplicate, related to items of selection bias (sequence generation, allocation concealment, and baseline comparability) in the Cochrane Risk of Bias tool. Using a 2-level meta-meta-analytic approach with a random effects model to allow for intra- and inter-meta-analysis heterogeneity, we quantified the impact of selection bias on the magnitude of ES estimates. We identified 64 meta-analyses, including 540 randomized controlled trials analyzing 137,957 patients. Sequence generation was judged to be adequate (at low risk of bias) in 32% ( n = 173) of trials, and baseline comparability was judged to be adequate in 77.8% of trials. Allocation concealment was unclear in the majority of trials ( n = 458, 84.8%). We identified significantly larger treatment ES estimates in trials that had inadequate/unknown sequence generation (difference in ES = 0.13; 95% CI: 0.01 to 0.25) and inadequate/unknown allocation concealment (difference in ES = 0.15; 95% CI: 0.02 to 0.27). In contrast, baseline imbalance (difference in ES = 0.01, 95% CI: -0.09 to 0.12) was not associated with inflated or underestimated ES. In conclusion, treatment ES estimates were 0.13 and 0.15 larger in trials with inadequate/unknown sequence generation and inadequate/unknown allocation concealment, respectively. Therefore, authors of systematic reviews using oral health randomized controlled trials should perform sensitivity analyses based on the adequacy of sequence generation and allocation concealment. [ABSTRACT FROM AUTHOR]

Objective: To test the effectiveness of Houvast: a strengths-based intervention for homeless young adults. Method: A cluster randomized controlled trial was conducted with 10 Dutch shelter facilities randomly allocated to an intervention and a control group. Homeless young adults were interviewed when entering the facility and when care ended. Repeated-measures analyses and logistic regression analyses were conducted by the principle of intention-to-treat framework (N = 251). Results: Improvements were demonstrated on quality of life; satisfaction with family relations, finances, and health; employed or in school; depression; care needs; autonomy; competence, and resilience in both conditions. A higher proportion of homeless young adults who received care according to Houvast were still receiving care at follow-up and successfully completed the trajectory compared to those who received care as usual. Conclusion: Homeless young adults seem to benefit from service provision in general. Further research on the effectiveness of Houvast is needed after sufficient model fidelity has been achieved. [ABSTRACT FROM AUTHOR]

Introduction The goal of the study was to determinate if there was added value in the use of videoconferencing (VCF) in outpatient care for people with severe mental illness (SMI). Methods A VCF-group was compared to a control group (care as usual) over a period of 18 months. Block randomization was used to assign patients to one of the two groups. The video communication was available to the patients on a 24/7 basis, so that emergency calls could also be made via VCF. The primary outcome was patient satisfaction, other outcomes were: quality of life, loneliness, daily functioning (psychologically and socially), and the fulfilment of needs of care. Eventually, 93 patients signed their informed consent and participated. Results For the primary outcome a statistically significant time by treatment interaction effect was found, where higher degree of satisfaction was associated with the patients in the VCF-group. The secondary outcomes revealed no differences between the two groups. Despite the participants not using the VCF units extensively during the project, they were reasonably satisfied with VCF; on average, they rated the service with a 7.5 grade (on a scale from 1-10). Discussion Although the study showed a positive result for patient satisfaction, overall the VCF seemed to have limited impact. So VCF might not offer much added value to care as usual. However, statistical power in this study dropped somewhat due to dropout. Furthermore, VCF usage was lower than expected. Assuming that VCF will be most effective if it is actually used, it seems likely that the actual effect-size reached in this study has been significantly lower than the anticipated effect-size. Finally, this study shows that VCF is a tool that can be used in the care for people with severe mental illness. [ABSTRACT FROM AUTHOR]

Purpose The purpose of this article is to investigate possible differences in effect between three types of masks in the acute treatment of cluster headache (CH). Patients and methods Fifty-seven CH patients according to ICHD-II-criteria participated in a single-blinded, semi-randomized, placebo-controlled, crossover inpatient study, and 102 CH attacks were treated with 100% oxygen delivered by demand valve oxygen (DVO), O2ptimask or simple mask (15 liters/min) or placebo delivered by DVO for 15 minutes. Primary endpoint: Two-point decrease of pain on a five-point rating scale within 15 minutes. Results Only 10 CH patients had multiple attacks and reached the point of placebo. There were no significant differences between masks in the primary endpoints ( p = 0.412). After 15 minutes 48% had a two-point decrease using the DVO compared to 45% with placebo ( p = 0.867). After 30 minutes 68% were pain free or had pain relief using DVO and 45% by placebo ( p = 0.061). The DVO was preferred by 62% compared to 5% and 33% for simple mask ( p < 0.0001) and O2ptimask ( p = 0.061). In the first attack the DVO was significantly better at achieving pain relief at 15 minutes ( p = 0.018). Treatment with DVO or O2ptimask reduced the need for rescue medication compared to the simple mask (23%, 19%, 50%, respectively). No treatment-related adverse events were observed. Conclusion The primary endpoint with pain relief at 15 minutes was non-significant; however, a post hoc analysis of the first attack significantly favored DVO. Further, therapy by O2ptimask and DVO resulted in a decreased need for rescue medication. We recommend that CH patients be offered DVO or O2ptimask before oxygen therapy is abandoned. [ABSTRACT FROM AUTHOR]

Background: Evidence from preclinical and human studies indicates the presence of reduced dopamine-1 receptor (D1R) signaling in the cortex, where D1Rs predominate, in patients with schizophrenia (SCZ), which may contribute to their cognitive deficits. Furthermore, studies in nonhuman primates (NHP) have suggested that intermittent administration of low doses of D1R agonists produce long-lasting reversals in cognitive deficits. The purpose of this trial was to test whether a similar design, involving subacute intermittent administration of low doses of a full, selective agonist at D1Rs, DAR-0100A, would improve cognitive deficits in SCZ.Methods: We randomized 49 clinically stable individuals with SCZ to three weeks of intermittent treatment with 0.5 mg or 15 mg of DAR-0100A, or placebo (normal saline). Functional magnetic resonance imaging (fMRI) BOLD was used to evaluate the effects of drug administration on brain activity during a working memory (WM) task. Effects on cognition were also assessed using the MATRICS and the N-back task as primary endpoints. The CogState battery was used as a secondary endpoint.Results: There were no observed treatment effects on either the BOLD fMRI signal during WM tasks or the WM domains of the MATRICS. Moderate improvement was detected on the CogState battery and on the attention domain of the MATRICS.Conclusion: These results suggest that low doses of D1 agonists that do not result in measureable occupancy of the D1R do not reliably improve cognition in SCZ, unlike the observations in NHP. As this drug is limited by its pharmacokinetic profile, better D1R agonists that can achieve adequate levels of D1R occupancy are needed to test the efficacy of this mechanism for cognitive enhancement in SCZ. [ABSTRACT FROM AUTHOR]

Purpose: To examine if employee health literacy (HL) status moderated reach, retention, and weight outcomes in a worksite weight loss program.Design: The study was a two-group cluster randomized controlled weight loss trial.Setting: The study was conducted in 28 worksites.Subjects: Subjects comprised 1460 employees with a body mass index >25 kg/m(2).Interventions: Two 12-month weight loss interventions targeted diet and physical activity behaviors: incentaHEALTH (INCENT; incentivized individually targeted Internet-based intervention) and Livin' My Weigh (LMW; less-intense quarterly newsletters).Measures: A validated three-item HL screening measure was self-completed at baseline. Weight was objectively assessed with the Health Spot scale at baseline and 12-month follow-up.Analysis: The impact of HL on program effectiveness was assessed through fixed-effect parametric models that controlled for individual (i.e., age, gender, race, ethnicity, income, education) and worksite random effects.Results: Enrolled employees had significantly higher HL status [13.54 (1.68)] as compared to unenrolled [13.04 (2.17)] (p < .001). This finding was consistent in both interventions. Also, HL moderated weight loss effects (beta = .66; SE = 027; p = .014) and losing >5% weight (beta = -1.53; SE = .77; p < .047). For those with lower baseline HL, the INCENT intervention produced greater weight loss outcomes compared to LMW. The HL level of employees retained was not significantly different from those lost to follow-up.Conclusion: HL influences reach and moderates weight effects. These findings underscore the need to integrate recruitment strategies and further evaluate programmatic approaches that attend to the needs of low-HL audiences. [ABSTRACT FROM AUTHOR]

Objective: The objective of the current study was to examine the feasibility of telemedicine vs. telephone for the delivery of a multidisciplinary weekly family-based behavioural group intervention to treat paediatric obesity delivered to families living in rural areas using a randomized controlled trial methodology.Methods: 103 rural children and their families were recruited. Feasibility measures included participant satisfaction, session attendance and retention. Treatment outcome measures included child Body Mass Index z-score (BMIz), parent BMI, 24-hour dietary recalls, accelerometer data, the child behavior checklist and the behavioral pediatrics feeding assessment scale.Results: Participants were highly satisfied with the intervention both via telemedicine and via telephone. Completion rates were much higher than for other paediatric obesity intervention programmes, and both methodologies were highly feasible. There were no differences in telemedicine and telephone groups on primary outcomes.Conclusion: Both telemedicine and telephone intervention appear to be feasible and acceptable methods of delivering paediatric obesity treatment to rural children. [ABSTRACT FROM AUTHOR]

The role of cholinergic abnormalities in autism was recently evidenced and there is a growing interest in cholinergic modulation, emerging for targeting autistic symptoms. Galantamine is an acetylcholinesterase inhibitor and an allosteric potentiator of nicotinic receptors. This study aimed to evaluate the possible effects of galantamine as an augmentative therapy to risperidone, in autistic children. In this randomized, double-blind, placebo-controlled, parallel-group study, 40 outpatients aged 4–12 years whom had a diagnosis of autism (DSM IV-TR) and a score of 12 or higher on the Aberrant Behavior Checklist-Community (ABC-C) Irritability subscale were equally randomized to receive either galantamine (up to 24 mg/day) or placebo, in addition to risperidone (up to 2 mg/day), for 10 weeks. We rated participants by ABC-C and a side effects checklist, at baseline and at weeks 5 and 10. By the study endpoint, the galantamine-treated patients showed significantly greater improvement in the Irritability (P = 0.017) and Lethargy/Social Withdrawal (P = 0.005) subscales than the placebo group. The difference between the two groups in the frequency of side effects was not significant. In conclusion, galantamine augmentation was shown to be a relatively effective and safe augmentative strategy for alleviating some of the autism-related symptoms. [ABSTRACT FROM PUBLISHER]

Social and psychological interventions are often complex. Understanding randomized controlled trials (RCTs) of these complex interventions requires a detailed description of the interventions tested and the methods used to evaluate them; however, RCT reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. In this article, we explain how reporting guidelines have improved the quality of reports in medicine and describe the ongoing development of a new reporting guideline for RCTs: Consolidated Standards of Reporting Trials-SPI (an extension for social and psychological interventions). We invite readers to participate in the project by visiting our website, in order to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/CONSORT-study). [ABSTRACT FROM AUTHOR]

The article discusses study that aimed to gain a deeper understanding of participants' perspectives of the intervention and palliative care trial participation and compares their benefits and burdens. It also discusses design and analysis of data followed standard procedures of descriptive thematic analysis. Results were drawn and it was concluded that the benefits of the intervention and the positive aspects of trial participation outweighed the burdens.

The article discusses a randomized controlled feasibility study which shows the impact of occupational therapy in Parkinson's disease. Parkinson's disease is a neurodegenerative disease which affects motor and non-motor brain systems and lead to impairments in balance, coordination of hand and functioning of memory. Occupational therapy improves patient's functional ability. The study concludes that adaptation in training is required to use Canadian Occupational Performance Measure (COPM).

Therapies in current use for episodic tension-type headache (ETTH) are often unsatisfactory. Few trials have been conducted to demonstrate efficacy of any of them. This multicenter placebo-controlled randomized parallel-groups study compared the analgesic efficacy of single oral doses of ketoprofen 25 mg and acetaminophen 1000 mg as outpatient treatment of 1 attack of ETTH. Efficacy was assessed by patients as pain relief on a diary-entered 7-point categorical scale. A total of 457 patients treated 348 attacks, 330 of which were evaluable. There were no serious adverse events (AEs); gastrointestinal AEs were most common on all treatments. Total relief from pain after 2 h was recorded by 16% of patients on placebo, 28% on ketoprofen, and 22% on acetaminophen. Worthwhile effect or total relief (all other responses were regarded as treatment failures) were recorded by 36% on placebo, 70% on ketoprofen (p < 0.001), 61% on acetaminophen (p < 0.001). The difference between ketoprofen and acetaminophen was not significant (p = 0.24). Various secondary efficacy measures confirmed superiority of both active treatments over placebo, with some trends for slightly better outcome on ketoprofen that on acetaminophen. This study demonstrates that ketoprofen is an effective alternative to standard therapy in ETTH. [ABSTRACT FROM AUTHOR]