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Introduction: Pilot studies are meritorious for determining the feasibility of a definitive clinical trial in terms of conduct and potential for efficacy, but their possible applications for planning a future trial are not always fully realized. The purpose of this review was to estimate the extent to which pilot/feasibility studies: (i) addressed needed objectives; (ii) led to definitive trials; and (iii) whether the subsequent undertaking of a definitive trial was influenced by the strength of the evidence of outcome improvement. Methods: Trials published in the journal Clinical Rehabilitation, since its inception, were eligible if the word 'pilot' or 'feasibility' was specified somewhere in the article. A total of 191 studies were reviewed, results were summarized descriptively, and between-group effect sizes were computed. Results: The specific purposes of piloting were stated in only 58% (n = 110) of the studies. The most frequent purpose was to estimate the potential for efficacy (85%), followed by testing the feasibility of the intervention (60%). Only 12% of the studies were followed by a definitive trial; <4% of studies had a main study underway or a published study protocol. There was no relationship between observed effect size and follow-up of pilot studies, although the confidence intervals were very wide owing to small number of trials that followed on. Discussion: Labelling and reporting of pilot studies needs to be improved to be concordant with the recently issued CONSORT guidelines. Feasibility needs to be fully tested and demonstrated prior to committing considerable human and monetary resources. [ABSTRACT FROM AUTHOR]

The controversies surrounding the effectiveness of cognitive behavioural therapy and graded exercise therapy for chronic fatigue syndrome are explained using Cohen’s d effect sizes rather than arbitrary thresholds for ‘success’. This article shows that the treatment effects vanish when switching to objective outcomes. The preference for subjective outcomes by the PACE trial team leads to false hope. This article provides a more realistic view, which will help patients and their doctors to evaluate the pros and cons. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the effect of a self-controlled vocal exercise in elderly people with glottal closure insufficiency. Design: Parallel-arm, individual randomized controlled trial. Methods: 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. Results: 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). Conclusion: 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. Clinical Trial.gov Identifier-UMIN000015567 [ABSTRACT FROM AUTHOR]

Tele-pulmonary rehabilitation is increasingly advocated but cannot completely substitute for in-person services for chronic conditions. Adherence to Pulmonary rehabilitation (PR) remains low in chronic obstructive pulmonary disease (COPD) patients. Shared decision-making (SDM) promotes patients' participation in PR decisions and helps patients and healthcare providers to jointly make decisions that patients are informed and aligned with patient preferences and values, which are critical for patient adherence to PR.This study aimed to develop a hybrid in-person and virtual model of home-based PR services for older COPD patients and study the effectiveness of the patient decision aid (PDA)-supported recurring SDM intervention on patient adherence to PR, rehabilitation outcomes, and decision-related outcomes, as well as to explore the mechanisms of the intervention on PR adherence.A total of 78 older COPD patients were randomly assigned to the PR group (n = 39) or PDA-PR group (n = 39). Both groups were conducted hybrid in-person and virtual PR intervention for 3 months. The primary outcomes were patients’ quality of life and PR adherence. The secondary outcomes were dyspnea symptoms, exercise self-efficacy, knowledge, and decision-related outcomes.A total of 72 participants completed the 3-month PR program. There were statistically significant differences in PR adherence (p = 0.033), COPD assessment test (CAT) scores (p = 0.016), PR knowledge (p < 0.001), decision self-efficacy (p < 0.001), decision conflict (p < 0.001), and decision regret scores (p = 0.027) between the two groups. The modified Medical Research Council Dyspnoea scale (mMRC) score was significantly decreased only in PDA-PR group (p = 0.011). No statistically significant differences were observed in St George’s Respiratory Questionnaire (SGRQ) score (p = 0.078), Exercise Self-Regulatory Efficacy Scale (Ex-SRES) score (p = 0.29) and COPD knowledge (p = 0.086) between the two groups. PR value score had a significant effect on adherence to PR (p = 0.007) and CAT score (p = 0.028).PDA supported recurring SDM intervention was helpful in maintaining older COPD patients’ PR adherence and had advantages in improving quality of life, enhancing PR knowledge, decision self-efficacy, and reducing decision conflict and decision regret, but did not improve SGRQ and Ex-SRES. PR value score influenced patients’ rehabilitation adherence and quality of life.Chinese Clinical Trial Registry (ChiCTR): ChiCTR1900028563; http://apps.who.int/trialsearch/default.aspx. [ABSTRACT FROM AUTHOR]

Despite proven benefits, patients with coronary heart disease (CHD) typically fail to participate in sufficient physical activity (PA). Effective interventions should be implemented to help patients maintain a healthy lifestyle and modify their present behavior. Gamification is the use of game design features (such as points, leaderboards, and progress bars) to improve motivation and engagement. It shows the potential for encouraging patients to engage in PA. However, empirical evidence on the efficacy of such interventions among patients with CHD is still emerging.The aim of the study is to explore whether a smartphone-based gamification intervention could increase PA participation and other physical and psychological outcomes in CHD patients.Participants with CHD were randomly assigned to three groups (control group, individual group, and team group). The individual and team groups received gamified behavior intervention based on behavioral economics. The team group combined gamified intervention with social interaction. The intervention lasted for 12 weeks, and the follow-up was12 weeks. The primary outcomes included the change in daily steps and the proportion of patient days that step goals were achieved. The secondary outcomes included competence, autonomy, relatedness, and autonomous motivation.For the individual group, smartphone-based gamification intervention significantly increased PA among CHD patients over the 12-week period (step count difference 988; 95% CI 259−1717; p < 0.01) and had a good maintenance effect during the follow-up period (step count difference 819; 95% CI 24−1613; p < 0.01). There are also significant differences in competence, autonomous motivation, body mass index (BMI), and waist circumference in 12 weeks between the control group and individual group. For the team group, gamification intervention with collaboration didn't result in significant increases in PA. But patients in this group had a significant increase in competence, relatedness, and autonomous motivation.A smartphone-based gamification intervention was proven to be an effective way to increase motivation and PA engagement, with a substantial maintenance impact (Chinese Clinical Trial Registry Identifier: ChiCTR2100044879). [ABSTRACT FROM AUTHOR]

This study was a randomized controlled trial that examined the impact of meditation practice on the mental health outcomes of female trauma survivors of interpersonal violence who have co-occurring disorders. Sixty-three female trauma survivors were randomly assigned to the meditation condition and the control condition. Treatment conditions consisted of a 6-week meditation curriculum that was influenced by Tibetan meditation tradition and focused on breathing, loving kindness, and compassion meditation. Clients in the meditation condition made significant changes in mental health symptoms (t = 5.252, df = 31, p = .000) and trauma symptoms (t = 6.009, df = 31, p = .000) from pre-treatment to post-treatment, whereas non-significant changes were observed among the control condition clients. There were significant group differences between clients in the meditation condition and in the control condition on their mental health symptoms, F(1, 54) = 13.438, p = .001, and trauma symptoms, F(1, 54) = 13.395, p = .001, with a generally large effect size of eta squared .127 and .146, respectively. In addition, significantly more clients in the meditation condition achieved reliable change in mental health symptoms (35.5% vs. 8.3%) and trauma symptoms (42.3% vs. 4.8%) than clients in the control condition. Significance of the study is discussed with respect to the empirical evidence of meditation practice as a complementary behavioral intervention for treating female trauma survivors of interpersonal violence who have co-occurring disorders. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness and safety of Chinese massage therapy (Tui Na) for patients with post-stroke spasticity. Design: A prospective, multicenter, blinded, randomized, placebo-controlled intervention trial. Subject: A total of 90 patients with post-stroke spasticity were randomly assigned to the experimental (Tui Na therapy) group (n = 45) or control (placebo Tui Na therapy) group (n = 45). Intervention: Participants in the experimental group received Tui Na therapy, while those in the control group received placebo-Tai Na (gentle rubbing) for 20-25 minutes per limb, once per day, five days per week for a total of four weeks. All participants in both groups received conventional rehabilitation. Main measure: The Modified Ashworth Scale, the Fugl-Meyer Assessment and the Modified Barthel Index were used to assess the severity of spasticity, motor function of limbs and activities of daily living, respectively. Assessments were performed at baseline, at four weeks and at three months. Results: Tui Na group had a significantly greater reduction in Modified Ashworth Scale in only four muscle groups than the control did (elbow flexors, P = 0.026; wrist flexors, P = 0.005; knee flexors, P = 0.023; knee extensors, P = 0.017). Improvements were sustained at three months follow-up. There was no significant difference between the two groups in Fugl-Meyer Assessment (P = 0.503) and Modified Barthel Index (P = 0.544). No adverse reaction was recorded in any of the cases mentioned at all study sites. Conclusions: Tui Na might be a safe and effective treatment to reduce post-stroke spasticity of several muscle groups. [ABSTRACT FROM AUTHOR]

Objective: To determine feasibility of a randomised controlled trial (RCT) of home-based Reach-to- Grasp training after stroke. Design: single-blind parallel group RCT. Participants: Residual arm deficit less than I2 months post-stroke. Interventions: Reach-to-Grasp training in I4 one-hour therapist's visits over 6 weeks, plus one hour self-practice per day (total 56 hours). Control: Usual care. Main Measures: Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), pre- randomisation, 7, 12, 24 weeks post-randomisation. Results: Forty-seven participants (Reach-to-Grasp=24, usual care=23) were randomised over I7 months. Reach-to-Grasp participants received a median (IQR) 14 (13,14) visits, and performed 157 (96,211) repetitions per visit; plus 30 minutes (22,45) self-practice per day. Usual care participants received I0.5 (5,14) therapist visits, comprising 38.6 (30,45) minutes of arm therapy with 16 (6,24) repetitions of functional tasks per visit. Median ARAT scores in the reach-to-grasp group were 8.5 (3.0,24.0) at baseline and 14.5 (3.5,26.0) at 24 weeks compared to median of 4 at both time points (IQR: baseline (3.0,14.0), 24 weeks (3.0,30.0)) in the usual-care group. Median WMFT tasks completed at baseline and 24 weeks were 6 (3.0,11.5) and 8.5 (4.5,13.5) respectively in the reach-to-grasp group and 4 (3.0,10.0), 6 (3.0,14.0) in the usual care group. Incidence of arm pain was similar between groups. The study was stopped before II patients reached the 24 weeks assessment. Conclusions: An RCT of home-based Reach-to-Grasp training after stroke is feasible and safe. With ARAT being our preferred measure it is estimated that 240 participants will be needed for a future two armed trial. [ABSTRACT FROM AUTHOR]

Introduction Self-help computer-based programs are easily accessible and cost-effective interventions with a great recruitment potential. However, each program is different and results of meta-analyses may not apply to each new program; therefore, evaluations of new programs are warranted. The aim of this study was to assess the marginal efficacy of a computer-based, individually tailored program (the Coach) over and above the use of a comprehensive Internet smoking cessation website. Methods A two-group randomized controlled trial was conducted. The control group only accessed the website, whereas the intervention group received the Coach in addition. Follow-up was conducted by e-mail after three and six months (self-administrated questionnaires). Of 1120 participants, 579 (51.7%) responded after three months and 436 (38.9%) after six months. The primary outcome was self-reported smoking abstinence over four weeks. Results Counting dropouts as smokers, there were no statistically significant differences between intervention and control groups in smoking cessation rates after three months (20.2% vs. 17.5%, p = 0.25, odds ratio (OR) = 1.20) and six months (17% vs. 15.5%, p = 0.52, OR = 1.12). Excluding dropouts from the analysis, there were statistically significant differences after three months (42% vs. 31.6%, p = 0.01, OR = 1.57), but not after six months (46.1% vs. 37.8%, p = 0.081, OR = 1.41). The program also significantly increased motivation to quit after three months and self-efficacy after three and six months. Discussion An individually tailored program delivered via the Internet and by e-mail in addition to a smoking cessation website did not significantly increase smoking cessation rates, but it increased motivation to quit and self-efficacy. [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]

We report the secondary outcomes and longevity of efficacy from a randomized controlled trial that evaluated a novel sexual assault resistance program designed for first-year women university students. Participants (N = 893) were randomly assigned to receive the Enhanced Assess, Acknowledge, Act (EAAA) program or a selection of brochures (control). Perception of personal risk, self-defense self-efficacy, and rape myth acceptance was assessed at baseline; 1-week postintervention; and 6-, 12-, 18-, and 24-month postrandomization. Risk detection was assessed at 1 week, 6 months, and 12 months. Sexual assault experience and knowledge of effective resistance strategies were assessed at all follow-ups. The EAAA program produced significant increases in women's perception of personal risk, self-defense self-efficacy, and knowledge of effective (forceful verbal and physical) resistance strategies; the program also produced decreases in general rape myth acceptance and woman blaming over the entire 24-month follow-up period. Risk detection was significantly improved for the intervention group at post-test. The program significantly reduced the risk of completed and attempted rape, attempted coercion, and nonconsensual sexual contact over the entire follow-up period, yielding reductions between 30% and 64% at 2 years. The EAAA program produces long-lasting changes in secondary outcomes and in the incidence of sexual assault experienced by women students. Universities can reduce the harm and the negative health consequences that young women experience as a result of campus sexual assault by implementing this program. Online slides for instructors who want to use this article for teaching are available on PWQ's website at http://journals.sagepub.com/page/pwq/suppl/index. [ABSTRACT FROM AUTHOR]

Objective: (1) To study the effects of providing ankle-foot orthoses in subjects with (sub)acute stroke; and (2) to study whether the point in time at which an ankle-foot orthosis is provided post-stroke (early or delayed) influences these effects. Design: Randomized controlled trial. Setting: Rehabilitation centre. Subjects: Unilateral hemiparetic stroke subjects with indication for use of an ankle-foot orthosis and maximal six weeks post-stroke. Interventions: Subjects were randomly assigned to: early provision (at inclusion; Week 1) or delayed provision (eight weeks later; Week 9). Outcome measures: 10-metre walk test, 6-minute walk test, Timed Up and Go Test, stairs test, Functional Ambulation Categories, Berg Balance Scale, Rivermead Mobility Index and Barthel Index; assessed in Weeks 1, 3, 9 and 11. Results: A total of 33 subjects were randomized (16 early, 17 delayed). Positive effects of ankle-foot orthoses were found two weeks after provision, both when provided early (significant effects on all outcomes) or delayed (Berg Balance Scale p = 0.011, Functional Ambulation Categories p = 0.008, 6-minute walk test p = 0.005, Timed Up and Go Test p = 0.028). Comparing effects after early and delayed provision showed that early provision resulted in increased levels of improvement on Berg Balance Scale (+5.1 points, p = 0.002), Barthel Index (+1.9 points, p = 0.002) and non-significant improvements on 10-metre walk test (+0.14 m/s, p = 0.093) and Timed Up and Go Test (–5.4 seconds, p = 0.087), compared with delayed provision. Conclusions: We found positive effects of providing ankle-foot orthoses in (sub)acute stroke subjects that had not used these orthoses before. [ABSTRACT FROM AUTHOR]

Objective: To systematically review randomized controlled trials of botulinum neurotoxin for limb spasticity to determine whether different injection techniques affect spasticity outcomes. Methods: MEDLINE, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials electronic databases were searched for English language human randomized controlled trials from 1990 to 13 May 2016. Studies were assessed in duplicate for data extraction and risk of bias using the Physiotherapy Evidence Database scale and graded according to Sackett’s levels of evidence. Results: Nine of 347 studies screened met selection criteria. Four categories of botulinum neurotoxin injection techniques were identified: (1) injection localization technique; (2) injection site selection; (3) injectate volume; (4) injection volume and site selection. There is level 1 evidence that: ultrasound, electromyography, and electrostimulation are superior to manual needle placement; endplate injections improve outcomes vs. multisite quadrant injections; motor point injections are equivalent to multisite injections; high volume injections are similar to low volume injections; and high volume injections distant from the endplate are more efficacious than low volumes closer to the endplate. Conclusion: Level 1 evidence exists for differences in treatment outcomes using specific botulinum neurotoxin injection techniques. Findings are based on single studies that require independent replication and further study. [ABSTRACT FROM AUTHOR]

Objective: To compare efficacy of a web-based multimodal training programme, ‘Move it to improve it’ (MitiiTM), to usual care on gross motor capacity and performance for children with an acquired brain injury. Design: Randomized waitlist controlled trial. Setting: Home environment. Participants: A total of 60 independently ambulant children (30 in each group), minimum 12 months post-acquired brain injury were recruited and randomly allocated to receive either 20 weeks of MitiiTM training (30 minutes/day, six days/week, total 60 hours) immediately, or waitlisted (usual care control group) for 20 weeks. A total of 58 children completed baseline assessments (32 males; age 11 years 11 months ± 2 years 6 months; Gross Motor Function Classification System equivalent I = 29, II = 29). Intervention: The MitiiTM program comprised of gross motor, upper limb and visual perception/cognitive activities. Main measures: The primary outcome was 30-second, repetition maximum functional strength tests for the lower limb (sit-to-stand, step-ups, half-kneel to stand). Secondary outcomes were the 6-minute walk test, High-level Mobility Assessment Tool, Timed Up and Go Test and habitual physical activity as captured by four-day accelerometry. Results: Groups were equivalent at baseline on demographic and clinical measures. The MitiiTM group demonstrated significantly greater improvements on combined score of functional strength tests (mean difference 10.19 repetitions; 95% confidence interval, 3.26–17.11; p = 0.006) compared with the control group. There were no other between-group differences on secondary outcomes. Conclusion: Although the MitiiTM programme demonstrated statistically significant improvements in the functional strength tests of the lower limb, results did not exceed the minimum detectable change and cannot be considered clinically relevant for children with an acquired brain injury. Clinical Trial Registration: Australian New Zealand Clinical Trials Registration Number, ANZCTR12613000403730. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of a group-based multidisciplinary rehabilitation programme on disability, pain and quality of life in subjects with chronic neck pain. Design: Randomized controlled trial. Setting: Specialized rehabilitation centre. Subjects: A total of 170 patients (mean age of 53 years (13); 121 females). Interventions: 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. Main measures: 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. Results: 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. Conclusions: 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. [ABSTRACT FROM AUTHOR]

Most randomized controlled trials with a time-to-event outcome are designed and analyzed assuming proportional hazards of the treatment effect. The sample-size calculation is based on a log-rank test or the equivalent Cox test. Nonproportional hazards are seen increasingly in trials and are recognized as a potential threat to the power of the log-rank test. To address the issue, Royston and Parmar (2016, BMC Medical Research Methodology 16: 16) devised a new "combined test" of the global null hypothesis of identical survival curves in each trial arm. The test, which combines the conventional Cox test with a new formulation, is based on the maximal standardized difference in restricted mean survival time (RMST) between the arms. The test statistic is based on evaluations of RMST over several preselected time points. The combined test involves the minimum p-value across the Cox and RMST-based tests, appropriately standardized to have the correct null distribution. In this article, I outline the combined test and introduce a command, stctest, that implements the combined test. I point the way to additional tools currently under development for power and sample-size calculation for the combined test. [ABSTRACT FROM AUTHOR]

Background: Several risk factors are associated with multiple sclerosis (MS) progression and may be amenable to intervention. Objective: To systematically review the evidence for interventions targeting risk factors for MS progression. Methods: We searched six databases and existing reviews till March 2015 and consulted with experts to identify randomized controlled trials (RCTs) of interventions targeting MS risk factors (PROSPERO 2015:CRD42015016461). Results: In total, 37 RCTs met inclusion criteria. Expanded Disability Status Scale (EDSS) scores after exercise interventions did not differ compared with untreated controls (standardized mean differences (SMDs): 0.02; confidence interval (CI): -0.40, 0.44; I2: 0%; seven RCTs; very low quality of evidence (QoE)). Dietary interventions did not show a statistically significant effect on the relative risk (RR) of progression (RR: 0.86; CI: 0.67, 1.05; I2: 0%; four RCTs; moderate QoE) compared to placebo. EDSS scores after vitamin D supplementation were not significantly different from placebo (SMD: -0.15; CI: -0.33, 0.02; I2: 0%; five RCTs; very low QoE). Conclusion: We did not identify any risk factor interventions with significant effects on MS progression, but the overall QoE was limited. More adequately powered trials are needed on vitamin D supplementation, long-term exercise, and smoking cessation. [ABSTRACT FROM AUTHOR]

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

This study examined the effectiveness of an active play intervention on fundamental movement skills of 3- to 5-year-old children from deprived communities. In a cluster randomized controlled trial design, six preschools received a resource pack and a 6-week local authority program involving staff training with help implementing 60- minute weekly sessions and postprogram support. Six comparison preschools received a resource pack only. Twelve skills were assessed at baseline, postintervention, and at a 6-month follow-up using the Children's Activity and Movement in Preschool Study Motor Skills Protocol. One hundred and sixty-two children (Mean Age=4.64±0.58 years; 53.1% boys) were included in the final analyses. There were no significant differences between groups for total fundamental movement skill, object-control skill or locomotor skill scores, indicating a need for program modification to facilitate greater skill improvements. [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]

Objective To analyze the age- and trial-specific effects of the breast cancer screening trials with mammography in Malmö, Stockholm, and Göteborg. Methods The original trial files were linked to the Swedish Cancer and Cause of Death Registers to obtain date of breast cancer diagnosis and date and cause of death. Relative risks and 95% confidence intervals were calculated using the evaluation model (only breast cancers diagnosed between date of randomization and date when the first screening round of the control group was completed were included in the analysis). Results Women aged 40–70 at randomization in the Malmö I and II, Stockholm, and Göteborg trials were followed-up for an average of 30, 22, 25, and 24 years, respectively. The overview of all trials resulted in a significant decrease of 15% in breast cancer mortality. The variation by consecutive 10-year age group at randomization was small—from 21% in the age group 40–49 to 11% in the age group 50–59. After adjustment for age, there was a significant reduction in breast cancer mortality in the Göteborg trial (26%), and a non-significant reduction in the Malmö I and II and Stockholm trials (12%, 15%, and 5.8%, respectively). Conclusions The overview showed a 15% significant relative reduction in breast cancer mortality due to invitation to mammography screening. Heterogeneity in age, trial time, attendance rates, and length of screening intervals may have contributed to the variation in effect between the trials. [ABSTRACT FROM AUTHOR]

Improving early detection and treatment of atrial fibrillation (AF) is critical because untreated AF is a major contributor to stroke and heart failure. We sought to generate knowledge about the feasibility of conducting a randomized controlled trial to test the effect of the Alert for AFib intervention on knowledge, attitudes, and beliefs about treatment-seeking for signs and symptoms of AF. Adults ≥65 years old (96% White) at risk for developing AF were randomized to receive the Alert for AFib intervention (n = 40) or an attention control session (n = 40). Feasibility goals for recruitment, participant retention, adherence, perceived satisfaction and burden, and intervention fidelity were met. From baseline to study completion, knowledge (p = .005) and attitudes (p < .001) about treatment-seeking improved more in the intervention group compared with the control group. Results support testing the effectiveness of the Alert for AFib intervention in a large trial. [ABSTRACT FROM AUTHOR]

The purpose of this study was to evaluate the ability of two concurrent randomized controlled interventions based on social cognitive theory to increase walking. A second purpose was to compare the efficacy of the intervention between two distinct groups: dog owners and non-dog owners. Adult dog owners (n = 40) and non-dog owners (n = 65) were randomized into control or intervention groups. Intervention groups received bi-weekly emails for first 4 weeks and then weekly email for the next 8 weeks targeting self-efficacy, social support, goal setting, and benefits/barriers to walking. Dog owner messages focused on dog walking while non-dog owners received general walking messages. Control groups received a 1-time email reviewing current physical activity guidelines. At 6 months, both intervention groups reported greater increases in walking and maintained these increases at 12 months. The greatest increases were seen in the dog owner intervention group. In conclusion, dog owners accumulated more walking, which may be attributed to the dog-owner relationship. [ABSTRACT FROM AUTHOR]

Objective: The Trial of Wii™ in Stroke investigated the efficacy of using the Nintendo Wii Sports™ (Wii™) to improve affected arm function after stroke. Design: Multicentre, pragmatic, parallel group, randomized controlled trial. Setting: Home-based rehabilitation. Subjects: A total of 240 participants aged 24-90 years with arm weakness following a stroke within the previous six months. Intervention: Participants were randomly assigned to exercise daily for six weeks using the Wii™ or arm exercises at home. Main measures: Primary outcome was change in the affected arm function at six weeks follow-up using the Action Research Arm Test. Secondary outcomes included occupational performance, quality of life, arm function at six months and a cost effectiveness analysis. Results: The study was completed by 209 participants (87.1%). There was no significant difference in the primary outcome of affected arm function at six weeks follow-up (mean difference -1.7, 95% CI -3.9 to 0.5, p = 0.12) and no significant difference in secondary outcomes, including occupational performance, quality of life or arm function at six months, between the two groups. No serious adverse events related to the study treatment were reported. The cost effectiveness analysis showed that the Wii™ was more expensive than arm exercises £1106 (SD 1656) vs. £730 (SD 829) (probability 0.866). Conclusion: The trial showed that the Wii™ was not superior to arm exercises in home-based rehabilitation for stroke survivors with arm weakness. The Wii™ was well tolerated but more expensive than arm exercises. [ABSTRACT FROM AUTHOR]

Background: The Phase IIIb, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Alteplase in Patients With Mild Stroke: Rapidly Improving Symptoms and Minor Neurologic Deficits (PRISMS) trial will assess r-tPA in ischemic stroke patients who present with mild deficits (i.e. mild stroke). Aims: To assess PRISMS's societal value in clarifying the optimal care for patients with mild ischemic stroke. Methods: A value of information (VOI) decision model was developed to compare the outcomes of mild stroke patients treated vs. not treated with r-tPA. Model inputs were derived from a subset of Third International Stroke Trial patients, a recent meta-analysis of r-tPA trials, expert opinion, and other published sources. VOI analyses were also used to assess the expected US societal value of the PRISMS trial and the expected value of reducing uncertainty in key trial estimates. Results: The expected net societal value of the PRISMS trial was approximately $210 million ($160 m-$260 m), representing a six-fold return on investment. The value of reducing uncertainty in r-tPA efficacy was approximately $150 million ($100 m-$200 m), while reducing uncertainty in r-tPA safety (increased risk for symptomatic intracranial hemorrhage) did not add additional value in comparison. Conclusions: Developing a better understanding of the outcomes of r-tPA treatment in patients with mild ischemic stroke will provide tremendous societal value by clarifying current uncertainty around treatment effectiveness. Enrollment in the PRISMS trial for patients presenting with mild ischemic stroke within 0-3 h of symptom onset should be highly encouraged. [ABSTRACT FROM AUTHOR]

Objective: To assess the feasibility of Wii.n.Walk for improving walking capacity in older adults with lower limb amputation. Design: A parallel, evaluator-blind randomized controlled feasibility trial. Setting: Community-living. Participants: Individuals who were ⩾50 years old with a unilateral lower limb amputation. Intervention: Wii.n.Walk consisted of Wii Fit training, 3x/week (40 minute sessions), for 4 weeks. Training started in the clinic in groups of 3 and graduated to unsupervised home training. Control group were trained using cognitive games. Main Measures: Feasibility indicators: trial process (recruitment, retention, participants’ perceived benefit from the Wii.n.Walk intervention measured by exit questionnaire), resources (adherence), management (participant processing, blinding), and treatment (adverse event, and Cohen’s d effect size and variance). Primary clinical outcome: walking capacity measured using the 2 Minute Walk Test at baseline, end of treatment, and 3-week retention. Results: Of 28 randomized participants, 24 completed the trial (12/arm). Median (range) age was 62.0 (50-78) years. Mean (SD) score for perceived benefit from the Wii.n.Walk intervention was 38.9/45 (6.8). Adherence was 83.4%. The effect sizes for the 2 Minute Walk Test were 0.5 (end of treatment) and 0.6 (3-week retention) based on intention to treat with imputed data; and 0.9 (end of treatment) and 1.2 (3-week retention) based on per protocol analysis. The required sample size for a future larger RCT was deemed to be 72 (36 per arm). Conclusions: The results suggested the feasibility of the Wii.n.Walk with a medium effect size for improving walking capacity. Future larger randomized controlled trials investigating efficacy are warranted. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of a group-based self-management program for people with chronic fatigue syndrome. Design: A randomized controlled trial. Setting: Four mid-sized towns in southern Norway and two suburbs of Oslo. Subjects: A total of 137 adults with chronic fatigue syndrome. Intervention: A self-management program including eight biweekly meetings of 2.5 hours duration. The control group received usual care. Main measures: Primary outcome measure: Medical Outcomes Study-Short Form-36 physical functioning subscale. Secondary outcome measures: 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. Results: 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). Conclusions: The evaluated self-management program did not have any sustained effect, as compared with receiving usual care. [ABSTRACT FROM AUTHOR]

This multisite randomized block experiment examines the efficacy of the seamless system of care for probationers (an integrated probation model combined with substance abuse treatment intervention onsite at a probation office). The sample consists of 251 drug-involved probationers randomized into probation with referral to community treatment or the seamless system of care. Key outcomes are examined over a 1-year period by recidivism risk level. When compared with probationers in the control group, the findings are that those in the seamless system of care group had fewer drug use days overall, less alcohol consumption, improved treatment initiation and adherence, but a higher number of days incarcerated. Low-risk seamless system participants had the most favorable outcomes compared with other study conditions. This study demonstrates the importance of tailoring interventions to the risk level of the probationer, and that the seamless system works better for lower risk offenders with substance use disorders. [ABSTRACT FROM AUTHOR]

Efficient eye movements provide a physical foundation for proficient reading skills. We investigated the effect of in-school saccadic training on reading performance. In this cross-over design, study participants (n = 327, 165 males; mean age [SD]: 7 y 6 mo [1y 1 mo]) were randomized into treatment and control groups, who then underwent eighteen 20-minute training sessions over 5 weeks using King-Devick Reading Acceleration Program Software. Pre- and posttreatment reading assessments included fluency, comprehension, and rapid number naming performance. The treatment group had significantly greater improvement than the control group in fluency (6.2% vs 3.6%, P = .0277) and comprehension (7.5% vs 1.5%, P = .0002). The high-needs student group significantly improved in fluency (P < .001) and comprehension (P < .001). We hypothesize these improvements to be attributed to the repetitive practice of reading-related eye movements, shifting visuospatial attention, and visual processing. Consideration should be given to teaching the physical act of reading within the early education curriculum. [ABSTRACT FROM AUTHOR]

Objective: To modify a published group intervention for adjustment to multiple sclerosis (MS) to suit an individual format, and to assess the feasibility of a randomised controlled trial (RCT) to compare individual and group intervention for people with multiple sclerosis and low mood. Design: Feasibility randomised controlled trial. Setting: Participants were recruited through healthcare professionals at a hospital-based multiple sclerosis service and the MS Society. Subjects: People with multiple sclerosis. Interventions: Adjustment to multiple sclerosis in individual or group delivery format. Main measures: Participants completed mood and quality of life assessments at baseline and at four-month follow-up. Measures of feasibility included: recruitment rate, acceptability of randomisation and the intervention (content and format), and whether the intervention could be adapted for individual delivery. Participants were screened for inclusion using the General Health Questionnaire-12 and Hospital Anxiety and Depression Scale, and were randomly allocated to receive either individual or group intervention, with the same content. Results: Twenty-one participants were recruited (mean age 48.5 years, SD 10.5) and were randomly allocated to individual (n=11) or group (n=10) intervention. Of those offered individual treatment, nine (82%) completed all six sessions. Of those allocated to group intervention, two (20%) attended all six sessions and three (30%) attended five sessions. There were no statistically significant differences between the groups on the outcome measures of mood and quality of life. Conclusions: The intervention could be provided on an individual basis and the trial design was feasible. There were lower attendance rates at group sessions compared to individual sessions. [ABSTRACT FROM AUTHOR]

This study evaluated the effects of Group Triple P with Chinese parents on parenting and child outcomes as well as outcomes relating to child academic learning in Mainland China. Participants were 81 Chinese parents and their children in Shanghai, who were randomly allocated to an intervention group or wait-list control group. Parents in the intervention condition received Group Triple P training, and parents and children were assessed at three/two time points. Compared with the control group, parents in the intervention group reported significant improvements in child adjustment problems, parenting practices, parental adjustment, and parenting self-efficacy at post-assessment. Moreover, there was a significant increase in parents’ satisfaction with children’s academic achievement and a reduction in children’s academic problem behaviors at post-intervention. All these effects were maintained at 6-month follow-up. There was also a significant increase in the child report of positive parenting at post-intervention. [ABSTRACT FROM AUTHOR]

Objective: To investigate if motivational interviewing improved physical activity, self-efficacy, quality of life, mobility and mental health in people living in the community after hip fracture. Design: Single-blind randomized controlled trial. Setting: Community. Participants: A total of 30 adults after hip fracture who had been discharged from rehabilitation to independent living in the community and allocated to a control group (n = 14) or an intervention group (n = 16). Intervention: All participants received usual care. The intervention group also received eight weekly sessions of motivational interviewing as additional input, with the control group having no additional matching input. Main outcomes: The primary outcome was physical activity levels as measured by an accelerometer (steps taken per day, time spent walking per day, and time spent sitting or lying each day). Secondary outcomes included self-efficacy (confidence about walking and not falling), health-related quality of life, mobility and mental health. Results: Relative to usual care, the motivational interviewing group took significantly more steps per day (mean = 1237 steps, 95% confidence interval (CI) 12 to 2463), walked for longer per day (mean = 14.4 minutes, 95% CI 0.6 to 28.8), had improved self-efficacy evidenced by being more confident about walking (mean = 1.6 units out of 10, 95% CI 0.3 to 2.9) and not falling (mean = 1.1 units out of 10, 95% CI 0.3 to 1.9) and improved health-related quality of life and mental health. Conclusion: This study provides preliminary evidence that motivational interviewing can result in clinically meaningful improvements in physical activity and psychosocial outcomes for people recovering from hip fracture. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the feasibility of Pilates exercise in older people to decrease falls risk and inform a larger trial. Design: Pilot Randomized controlled trial. Setting: Community physiotherapy clinic. Participants: A total of 53 community-dwelling people aged ⩾60 years (mean age, 69.3 years; age range, 61–84). Interventions: A 60-minute Pilates class incorporating best practice guidelines for exercise to prevent falls, performed twice weekly for 12 weeks. All participants received a letter to their general practitioner with falls risk information, fall and fracture prevention education and home exercises. Main outcome measure(s): Indicators of feasibility included: acceptability (recruitment, retention, intervention adherence and participant experience survey); safety (adverse events); and potential effectiveness (fall, fall injury and injurious fall rates; standing balance; lower limb strength; and flexibility) measured at 12 and 24 weeks. Results: Recruitment was achievable but control group drop-outs were high (23%). Of the 20 participants who completed the intervention, 19 (95%) attended ⩾75% of the classes and reported classes were enjoyable and would recommend them to others. The rate of fall injuries at 24 weeks was 42% lower and injurious fall rates 64% lower in the Pilates group, however, was not statistically significant (P = 0.347 and P = 0.136). Standing balance, lower-limb strength and flexibility improved in the Pilates group relative to the control group (P < 0.05). Estimates suggest a future definitive study would require 804 participants to detect a difference in fall injury rates. Conclusion: A definitive randomized controlled trial analysing the effect of Pilates in older people would be feasible and is warranted given the acceptability and potential positive effects of Pilates on fall injuries and fall risk factors. Trial Registration: The protocol for this study is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN1262000224820). [ABSTRACT FROM AUTHOR]

Objective: To explore the feasibility of implementing and evaluating the Guide to Action Care Home fall prevention intervention. Design: Two-centre, cluster feasibility randomized controlled trial and process evaluation. Setting: Purposive sample of six diverse old age/learning disability, long stay care homes in Nottinghamshire, UK. Subjects: Residents aged over 50 years, who had fallen at least once in the past year, not bed-bound, hoist-dependent or terminally ill. Interventions: Intervention homes (n = 3) received Guide to Action Care Home fall prevention intervention training and support. Control homes (n = 3) received usual care. Outcomes: Recruitment, attrition, baseline and six-month outcome completion, contamination and intervention fidelity, compliance, tolerability, acceptance and impact. Results: A total of 81 of 145 (56%) care homes expressed participatory interest. Six of 22 letter respondent homes (27%) participated. The expected resident recruitment target was achieved by 76% (52/68). Ten (19%) residents did not complete follow-up (seven died, three moved). In intervention homes 36/114 (32%) staff attended training. Two of three (75%) care homes received protocol compliant training. Staff valued the training, but advised greater management involvement to improve intervention implementation. Fall risks were assessed, actioned and recorded in care records. Of 115 recorded falls, 533/570 (93%) of details were complete. Six-month resident fall rates were 1.9 and 4.0 per year for intervention and control homes, respectively. Conclusions: The Guide to Action Care Home is implementable under trial conditions. Recruitment and follow-up rates indicate that a definitive trial can be completed. Falls (primary outcome) can be ascertained reliably from care records. [ABSTRACT FROM AUTHOR]

Chronic pain is a critical public health problem that affects over 100 million Americans. Medical pain treatments carry undesirable side effects, whereas low-risk psychosocial treatments offer notable benefits, in combination or in isolation. This report presents the protocol for the Learning About My Pain study, one of the first comparative-effectiveness trials funded by the Patient-Centered Outcomes Research Institute. Adhering to published standards for clinical trials (e.g. Standard Protocol Items: Recommendations for Intervention Trials), it provides an overview of the trial (n = 294), comparing cognitive-behavioral and education pain interventions to usual care, and a detailed description of how its methodology reduces the risks from bias. [ABSTRACT FROM AUTHOR]

Background: The Canadian Network for Mood and Anxiety Treatments (CANMAT) conducted a revision of the 2009 guidelines by updating the evidence and recommendations. The scope of the 2016 guidelines remains the management of major depressive disorder (MDD) in adults, with a target audience of psychiatrists and other mental health professionals.Methods: Using the question-answer format, we conducted a systematic literature search focusing on systematic reviews and meta-analyses. Evidence was graded using CANMAT-defined criteria for level of evidence. Recommendations for lines of treatment were based on the quality of evidence and clinical expert consensus. "Pharmacological Treatments" is the third of six sections of the 2016 guidelines. With little new information on older medications, treatment recommendations focus on second-generation antidepressants.Results: Evidence-informed responses are given for 21 questions under 4 broad categories: 1) principles of pharmacological management, including individualized assessment of patient and medication factors for antidepressant selection, regular and frequent monitoring, and assessing clinical and functional outcomes with measurement-based care; 2) comparative aspects of antidepressant medications based on efficacy, tolerability, and safety, including summaries of newly approved drugs since 2009; 3) practical approaches to pharmacological management, including drug-drug interactions and maintenance recommendations; and 4) managing inadequate response and treatment resistance, with a focus on switching antidepressants, applying adjunctive treatments, and new and emerging agents.Conclusions: Evidence-based pharmacological treatments are available for first-line treatment of MDD and for management of inadequate response. However, given the limitations of the evidence base, pharmacological management of MDD still depends on tailoring treatments to the patient. [ABSTRACT FROM AUTHOR]

As police departments across the United States equip officers with body worn cameras (BWCs), research has focused on the technology’s impact on police interactions with citizens, officer misconduct, officer use of force, and false allegations against police. Given the large number of police agencies implementing BWCs across the country (numbering in the thousands), there will be a growing number of opportunities for BWC evaluations and expectations that these programs will be evaluated. Studying the implementation of BWCs presents a number of challenges to both researchers and police agencies, particularly when large police organizations are involved. Drawing on our experiences involving a BWC experiment with the Las Vegas Metropolitan Police Department, this article discusses the programmatic challenges of implementing a BWC program in a large agency (technical, political, and administrative) while simultaneously evaluating the program using a randomized controlled trial design. [ABSTRACT FROM AUTHOR]

Objective: To determine whether publically funded ‘reablement services’ have any effect on patient health or use of services. Design: Systematic review of randomized controlled trials and non-randomized studies in which reablement interventions were compared with no care or usual care in people referred to public-funded personal care services. Data sources included: Cochrane Central Register of Controlled Trials, EPOC register of studies, trials registers, Medline, EMBASE, and CINHAL. Searches were from 2000 up to end February 2015. Setting: Not applicable. Participants: Investigators’ definition of the target population for reablement interventions. Main outcome measures: Use of publically funded personal care services and dependence in personal activities of daily living. Results: We found no studies fulfilling our inclusion criteria that assessed the effectiveness of reablement interventions. We did note the lack of an agreed understanding of the nature of reablement. Conclusions: Reablement is an ill-defined intervention targeted towards an ill-defined and potentially highly heterogeneous population/patient group. There is no evidence to suggest it is effective at either of its goals; increasing personal independence or reducing use of personal care services. [ABSTRACT FROM AUTHOR]

Background: Achilles tendinopathy (AT) is a common and difficult to treat musculoskeletal disorder. Purpose: To examine whether 1 injection of platelet-rich plasma (PRP) would improve outcomes more effectively than placebo (saline) after 3 months in patients with AT. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 24 patients with chronic AT (median disease duration, 33 months) were randomized (1:1) to receive either a blinded injection of PRP (n = 12) or saline (n = 12). The primary endpoint was improvement in Victorian Institute of Sports Assessment–Achilles (VISA-A) score at 3 months. Secondary outcomes were pain at rest, pain while walking, pain when tendon was squeezed, ultrasonographic changes in tendon thickness, and color Doppler activity. Patients were informed that they could drop out after 3 months if they were dissatisfied with the treatment. Results: After 3 months, all 24 patients were reassessed (no dropouts). No difference between the PRP and the saline group could be observed with regard to the primary outcome (VISA-A score: mean difference [MD], –1.3; 95% CI, −17.8 to 15.2; P = .868). Secondary outcomes were pain at rest (MD, 1.6; 95% CI, −0.5 to 3.7; P = .137), pain while walking (MD, 0.8; 95% CI, −1.8 to 3.3; P = .544), pain when tendon was squeezed (MD, 0.3; 95% CI, −0.2 to 0.9; P = .208), color Doppler activity (MD, 0.3; 95% CI, −0.2 to 0.8; P = .260), and tendon thickness (MD, 0.8 mm; 95% CI, 0.1 to 1.6 mm; P = .030). After the 3-month follow-up, a large dropout was observed: 75% of patients in the PRP group and 33% in the saline group. Conclusion: PRP injection did not result in an improved VISA-A score over a 3-month period in patients with chronic AT compared with placebo. The only secondary outcome demonstrating a statistically significant difference between the groups was change in tendon thickness; this difference indicates that a PRP injection could increase tendon thickness compared with saline injection. The conclusions are limited to the 3 months after treatment owing to the large dropout rate. [ABSTRACT FROM AUTHOR]

Many students are not aware that research design can be simultaneously described in many different ways; for example, a drug trial may be described as being prospective, longitudinal, randomized, double-blind, and placebo-controlled, all at the same time. This article provides examples to explain how studies can be simultaneously prospective and cross-sectional, prospective and longitudinal, retrospective and cross-sectional, and retrospective and longitudinal. The term prospective indicates that the study data are newly collected, whereas the term retrospective indicates that the study data already exist in records and merely need to be extracted for study. The term cross-sectional indicates that the study subjects are studied on a single occasion; that is, at a single point in time. The term longitudinal indicates that the study subjects are followed up and that there is almost always more than one time point at which the subjects are assessed. This article also describes unusual designs, such as cross-sectional randomized controlled trials and retrospective studies with prospective data ascertainment. [ABSTRACT FROM AUTHOR]

Objective: To compare the efficacy of intensive daily applied progressive group therapy task training with equally dosed individual progressive task training on self-reported mobility for patients with moderate to severe stroke during inpatient rehabilitation. Design: Randomized controlled clinical trial. Setting: In-patient rehabilitation center. Subjects: A total of 73 subacute patients with stroke who were not able to walk without physical assistance at randomisation. Interventions: Patients were allocated to group therapy task training (GT) or individual task training (IT). Both interventions were intended to improve walking competency and comprised 30 sessions of 90 minutes over six weeks. Main measures: Primary outcome was the mobility domain of the Stroke Impact Scale (SIS-3.0). Secondary outcomes were the other domains of SIS-3.0, standing balance, gait speed, walking distance, stair climbing, fatigue, anxiety and depression. Results: No adverse events were reported in either arm of the trial. There were no significant differences between groups for the SIS mobility domain at the end of the intervention (Z= −0.26, P = 0.79). No significant differences between groups were found in gait speed improvements (GT:0.38 ±0.23; IT:0.26±0.35), any other gait related parameters, or in non-physical outcomes such as depression and fatigue. Conclusion: Inpatient group therapy task training for patients with moderate to severe stroke is safe and equally effective as a dose-matched individual task training therapy. Group therapy task training may be delivered as an alternative to individual therapy or as valuable adjunct to increase time spent in gait-related activities. [ABSTRACT FROM AUTHOR]

We evaluated a cognitive behaviour therapy–based programme to improve glycaemic control and psychosocial wellbeing in adolescents with type 1 diabetes. A total of 147 adolescents aged 13–16 years were randomized to the intervention (n = 73) or standard care (n = 74). The primary outcome was glycaemic control at 3 and 12 months post randomization, and secondary measures were stress, self-efficacy and quality of life. Mixed-effects regression models were used to assess differences in means between groups at each time point. There was little evidence of differences in glycaemic control between groups. However, psychosocial wellbeing improved in the intervention group compared to the control group. Recommendations for future programmes are discussed. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12608000368336). [ABSTRACT FROM AUTHOR]

Post-stroke dysphagia (a difficulty in swallowing after a stroke) is a common and expensive complication of acute stroke and is associated with increased mortality, morbidity, and institutionalization due in part to aspiration, pneumonia, and malnutrition. Although most patients recover swallowing spontaneously, a significant minority still have dysphagia at six months. Although multiple advances have been made in the hyperacute treatment of stroke and secondary prevention, the management of dysphagia post-stroke remains a neglected area of research, and its optimal management, including diagnosis, investigation and treatment, have still to be defined. [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]

Background: The aim of this prospective randomized study was to compare the outcomes of the anatomic double-bundle (DB) and anatomic single-bundle (SB) techniques 5 years after anterior cruciate ligament (ACL) reconstruction. Since more effective restoration of rotational laxity is considered the main advantage of the DB technique, the pivot-shift test was the primary outcome variable of the study. Hypothesis: Double-bundle ACL reconstruction will result in a better outcome in terms of the pivot-shift test. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 105 patients (33 women, 72 men; median age, 27 years; range, 18-52 years) were randomized and underwent ACL reconstruction (DB group, n = 53; SB group, n = 52). All reconstructions were performed anatomically by identifying the ACL footprints, using the anteromedial portal for the femoral tunnel drilling, and utilizing interference screw for tibial and femoral fixation. A single blinded observer examined the patients preoperatively and at follow-up (median, 64 months; range, 55-75 months). Multiple subjective and objective clinical evaluation tests and radiographic assessments of osteoarthritis (OA) were performed using the Ahlbäck, Kellgren-Lawrence, and Fairbank grading systems at 6 weeks postoperatively and at the final follow-up evaluation. Results: Preoperatively, no differences were found between the study groups, apart from the preinjury Tegner activity level, which was lower in the DB group (SB: mean, 7.8 [range, 3-9]; DB: mean, 7.3 [range, 0-9]; P = .02). Eighty-seven patients (83%) were available for examination at the 5-year follow-up. Statistical differences could not be found between the groups in terms of the pivot-shift test, KT-1000 arthrometer laxity measurements, manual Lachman test, single-legged-hop test, square-hop test, range of motion, Lysholm knee scoring scale, Tegner activity scale, or Knee injury and Osteoarthritis Outcome Score. Correspondingly, no differences were found between the groups regarding the presence of OA at follow-up. However, a significant increase of OA was found within the DB group at the 5-year follow-up. Both groups improved at follow-up compared with the preoperative assessment in terms of the laxity tests, hop tests, and scoring scales. Conclusion: At the 5-year follow-up of an unselected group of patients, anatomic DB reconstruction was not superior to anatomic SB reconstruction in terms of the pivot-shift test. [ABSTRACT FROM AUTHOR]

Objectives: To explore long-term effects of treatment and prognostic relevance of variables assessed at baseline and during the European secondary progressive multiple sclerosis (SPMS) trial of interferon beta 1b (IFNB-1b). Methods: We assessed 362 patients (60% female; median age 41 years; Expanded Disability Status Scale (EDSS): 5.5; 51% randomized to IFNB-1b) for their EDSS and treatment history after 10 years. Non-parametric analysis of covariance (ANCOVA) and multivariate linear regression models were applied. Results: Median EDSS was 6.0 at the end of the randomized controlled trial (RCT), in the IFNB-1b and placebo groups, and 7.0 in long-term follow-up patients (those receiving IFNB-1b in the RCT were 6.5 and those receiving placebo in the RCT were 7.0; p = 0.086). 24 patients (6.6%) were deceased. The EDSS at baseline and the EDSS change during the RCT were the most important predictors of the EDSS 10 years later (partial R2: 0.47). The ability to predict changes in EDSS 10 years after the RCT was limited (R2: 0.12). Magnetic resonance imaging (MRI) measures remained in the predictive models, but explained < 5% of the variability. Conclusions: The results from this analysis did not provide convincing evidence to support a favorable long-term outcome in those patients allocated IFNB-1b during the RCT, in our SPMS cohort. The progressive stage of the disease remains largely unpredictable by clinical and conventional MRI measures, so better prognostic markers are needed. [ABSTRACT FROM AUTHOR]

Objective: To test the feasibility of a randomised controlled trial comparing face to face and remotely delivered word finding therapy for people with aphasia. Design: A quasi-randomised controlled feasibility study comparing remote therapy delivered from a University lab, remote therapy delivered from a clinical site, face to face therapy and an attention control condition. Setting: A University lab and NHS outpatient service. Participants: Twenty-one people with aphasia following left hemisphere stroke. Interventions: Eight sessions of word finding therapy, delivered either face to face or remotely, were compared to an attention control condition comprising eight sessions of remotely delivered supported conversation. The remote conditions used mainstream video conferencing technology. Outcome measures: Feasibility was assessed by recruitment and attrition rates, participant observations and interviews, and treatment fidelity checking. Effects of therapy on word retrieval were assessed by tests of picture naming and naming in conversation. Results: Twenty-one participants were recruited over 17 months, with one lost at baseline. Compliance and satisfaction with the intervention was good. Treatment fidelity was high for both remote and face to face delivery (1251/1421 therapist behaviours were compliant with the protocol). Participants who received therapy improved on picture naming significantly more than controls (mean numerical gains: 20.2 (remote from University); 41 (remote from clinical site); 30.8 (face to face); 5.8 (attention control); P <.001). There were no significant differences between groups in the assessment of conversation. Conclusions: Word finding therapy can be delivered via mainstream internet video conferencing. Therapy improved picture naming, but not naming in conversation. [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]

There are few high-quality studies using randomized controlled trials (RCTs) in the adventure and wilderness therapy literature. Thus, a unison call is heard for more such studies to be carried out. This article presents a Norwegian wilderness therapy research project that planned to incorporate this “gold standard” that is regarded as the most scientific and rigorous approach available. We did not succeed. Mounting challenges led us to discard the RCT altogether and select other methodologies. Here, we account for the ethical, health outcome, practical, and empirical obstacles that we encountered when attempting to randomize at-risk adolescents into experiment and control groups. Our conclusion is that although RCTs may be superior in some aspects, they hold the potential to become bad science when the interventions are as complex and multi-faceted as adventure and wilderness therapy programs. [ABSTRACT FROM AUTHOR]

Objective: To test the efficacy of the Alexander Technique, local heat and guided imagery on pain and quality of life in patients with chronic non-specific neck pain. Design: A randomized controlled trial with 3 parallel groups was conducted. Setting: Outpatient clinic, Department of Internal and Integrative Medicine. Subjects: A total of 72 patients (65 females, 40.7±7.9 years) with chronic non-specific neck pain. Interventions: Patients received 5 sessions of the Alexander Technique - an educational method which aims to modify dysfunctional posture, movement and thinking patterns associated with musculoskeletal disorders. Control groups were treated with local heat application or guided imagery. All interventions were conducted once a week for 45 minutes each. Main measures: The primary outcome measure at week 5 was neck pain intensity on a 100-mm visual analogue scale; secondary outcomes included neck disability, quality of life, satisfaction and safety. Statistics: Analyses of covariance were applied; testing ordered hypotheses. Results: No group difference was found for pain intensity for the Alexander Technique compared to local heat (difference 4.5mm; 95%CI:-8.1;17.1;p=0.48), but exploratory analysis revealed the superiority of the Alexander Technique over guided imagery (difference -12.9mm; 95%CI:-22.6;-3.1,p=0.01). Significant group differences in favor of the Alexander Technique were also found for physical quality of life (P<0.05). Adverse events mainly included slightly increased pain and muscle soreness. Conclusion: The Alexander Technique was not superior to local heat application in treating chronic non-specific neck pain. It cannot be recommended as routine intervention at this time. Further trials are warranted for conclusive judgment. [ABSTRACT FROM AUTHOR]