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Background: Pulmonary hypertension (PH) is a chronic disease with a notable health burden; regular exercise may improve specific health outcome measures. Objective: The objective of this meta-analysis was to estimate the effectiveness of exercise training for PH patients. Data sources: PubMed, CINAHL, SportDiscuss and Google Scholar databases and reference lists of included studies were searched. Study selection: The selection criteria were randomized controlled trials (RCTs) employing an exercise training intervention. Data were extracted from the entered studies for analysis. The primary outcomes were peak oxygen uptake (VO2peak), anaerobic threshold (AT), 6-minute walk distance (6-MWD), and quality of life (QoL) measures (physical component score and mental component score). The analysis included 9 articles with a total of 302 participants: intervention (n = 154), and control (n = 148). Results: In the pooled analysis, improvements were seen in: VO2peak, mean difference (MD) 2.79 ml/kg/min (95% CI 2.00 to 3.59, p < 0.00001); AT, MD 107.83 ml/min (95% CI 39.64 to 176.00, p = 0.002); and 6-MWD, MD 46.67 meters (95% CI 32.39 to 60.96, p < 0.00001). Differences were found in the SF-36 physical component score MD 3.57 (95% CI 2.04 to 5.10, p < 0.00001) and the SF-36 mental component score MD 3.92 (95% CI 1.92 to 5.91, p = 0.001). Conclusion: This meta-analysis demonstrates exercise training has a beneficial effect on fitness, walking performance, and self-reported QoL in PH patients. [ABSTRACT FROM AUTHOR]

Background and aims: Poststroke shoulder pain is a common complication. We aimed to investigate the prevalence of poststroke shoulder pain, with attention to the neuropathic component, and the relationship between poststroke shoulder pain and upper limb improvement in motor function, strength, disability, and quality of life after upper limb rehabilitation. Methods: This is a secondary analysis of a multicenter randomized controlled trial to compare upper limb conventional or robotic rehabilitation on 224 patients enrolled in eight rehabilitation centers. We assessed poststroke shoulder pain (using the Numerical Rating Scale and the Douleur Neuropathique 4), and upper limb motor function, strength, disability, and quality of life at baseline (T0), after 30 rehabilitation sessions (T1), and three months after the end of rehabilitation (T2). Results: A moderate/severe poststroke shoulder pain was reported by 28.9% of patients, while 19.6% of them showed a neuropathic component. At T0, the intensity of pain was higher in women and in patients with neglect syndrome, positively correlated with the time since stroke and disability and negatively correlated with motor function, strength, and the physical aspects of the quality of life. Moderate/severe pain and neuropathic component significantly reduced after both treatments and this reduction was maintained at T2. Finally, the intensity of pain at baseline was negatively correlated with the improvement of upper limb motor function. Conclusions: Poststroke shoulder pain negatively impact on motor performance, strength, disability, and physical aspects of the quality of life as well as on upper limb motor recovery; however, it can be reduced after a robotic or a conventional rehabilitation. Therefore, we suggest considering poststroke shoulder pain when planning the rehabilitation intervention. [ABSTRACT FROM AUTHOR]

Background: The optimal blood pressure lowering target in the acute phase of severe stroke is uncertain. Our aim was to compare the efficacy and safety of individualized blood pressure lowering with standard blood pressure lowering in severe stroke. Methods: Five-hundred consecutive patients with acute severe stroke and elevated BP were recruited from 26 Chinese hospitals. Eligible patients were randomized into an individualized blood pressure lowering group (with 10–15% reduction in systolic blood pressure from admission level or standard blood pressure lowering group (with a target SBP of <200 mm Hg in acute ischemic stroke and <180 mm Hg in intracerebral hemorrhage). The primary outcome was the proportion of patients with a poor functional outcome at day 90 of enrolment. Results: Of 483 participants included in the analysis, 242 received individualized blood pressure lowering treatment and 241 received standard treatment. The primary outcome event was observed in 71.1% of the participants in the individualized treatment group and in 73.4% of the standard treatment group (odds ratio with individualized treatment for primary outcome, 0.75; 95% confidence interval, 0.47 to 1.19; p = 0.222). The rates of serious adverse events in the two groups were similar (27.7% vs. 28.2%). Conclusions: In patients with acute severe stoke, individualized blood pressure lowering treatment did not significantly reduce the rate of three-month death or dependence. Trial registration: Clinicaltrials.gov, NCT02982655. Registered in 5 December 2016, https://clinicaltrials.gov/ct2/show/NCT02982655 [ABSTRACT FROM AUTHOR]

Background: Awareness for the importance of psychological and spiritual needs in patients with terminal diseases has increased in recent years, but randomized trials on the effects of psychosocial interventions are still rare. Aim: To investigate the efficacy of the "Song of Life" music therapy intervention regarding the emotional and psycho-spiritual dimensions of quality of life. Design: Patients were randomly assigned to either "Song of Life" or a relaxation intervention. "Song of Life" is a novel three-session music therapy intervention working with a biographically meaningful song. Primary outcome was the improvement in psychological quality of life. Secondary outcomes included spiritual well-being, ego-integrity, momentary distress, and global quality of life and the explorative assessment of treatment satisfaction (patient and family member version). Intention-to-treat analysis was conducted including adjustment for multiple testing in secondary outcomes. Setting/participants: Between December 2018 and August 2020, 104 patients receiving specialized palliative care were recruited from two palliative care wards. Results: No significant differences were found regarding psychological and global quality of life, but "Song of Life" participants reported significantly higher spiritual well-being (p = 0.04) and ego-integrity (p < 0.01), as well as lower distress (p = 0.05) than patients in the control group. Both patients' and family members' treatment satisfaction was higher after "Song of Life" with large between-group effect sizes on items asking for meaningfulness (d = 0.96) and importance (d = 1.00). Conclusions: Our findings provide evidence that "Song of Life" is an effective and meaningful biographical music therapy intervention to facilitate psycho-spiritual integration in terminally ill patients. Trial Registration: German Clinical Trials Register (DRKS)—DRKS00015308 (date of registration: September 7th 2018). [ABSTRACT FROM AUTHOR]

Background: International oncology societies recommend early palliative care. Specific models to integrate early palliative care efficiently into clinical practice are debated. The authors designed a study to look at the quantitative and qualitative outcomes of an early palliative care intervention in oncological care to decrease stress and improve quality of life. Aims: To compare a single structured early palliative care intervention added to a usual oncology care in terms of distress and health-related quality of life at baseline compared to 6 months after enrollment. Design: This multicenter randomized controlled trial (NCT01983956) enrolled adult patients with advanced cancer. Participants were either randomly assigned to usual oncology care alone or usual care plus a structured early palliative care intervention. Setting/participants: One hundred fifty adult patients with a variety of advanced cancer diagnoses were randomized. Seventy-four participants were in the intervention and 76 participants in the control group. The primary outcome was the change in patient distress assessed by the National Comprehensive Cancer Network distress thermometer at 6 months. Health-related quality of life, the secondary outcome, was assessed by the Functional Assessment of Cancer Therapy–General Questionnaire. Results: The results showed no significant effect of the early palliative care intervention neither on patient distress nor on health-related quality of life. Conclusion: The addition of an early intervention to usual care for patients with advanced cancer did not improve distress or quality of life. Thus, patients may need more intensive early palliative care with continuous professional support to identify and address their palliative needs early. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the feasibility of a multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of early patient-directed rehabilitation versus standard rehabilitation following surgical repair of the rotator cuff of the shoulder. Design: Two-arm, multi-centre pilot and feasibility randomised controlled trial. Setting: Five National Health Service hospitals in England. Participants: Adults (n = 73) with non-traumatic rotator cuff tears scheduled for repair were recruited and randomly allocated remotely prior to surgery. Interventions: Early patient-directed rehabilitation (n = 37); advised to remove their sling as soon as able and move as symptoms allow. Standard rehabilitation (n = 36); sling immobilisation for four weeks. Measures: (1) Randomisation of 20% or more eligible patients. (2) Difference in time out of sling of 40% or more between groups. (3) Follow-up greater than 70%. Results: 73/185 (39%) potentially eligible patients were randomised. Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair. The between-group difference in proportions of participants who exceeded the cut-off of 222.6 hours out of the sling was 50% (80% CI = 29%, 72%), with the early patient-directed rehabilitation group reporting greater time out of sling. 52/73 (71%) and 52/53 (98%) participants were followed-up at 12 weeks when withdrawals were included and excluded respectively. Eighteen full-thickness re-tears were reported (early patient-directed rehabilitation = 7, standard rehabilitation = 11). Five serious adverse events were reported. Conclusion: A main randomised controlled trial is feasible but would require allocation of participants following surgery to counter the issue of withdrawal due to not receiving surgery. [ABSTRACT FROM AUTHOR]

Background: Fatigue is the most common symptom of MS and has no effective pharmacotherapy. Objective: To determine the tolerability, safety, and efficacy of low-dose ketamine infusion for MS-related fatigue. Methods: In this double-blind, randomized, active-placebo-controlled trial, 18 subjects with multiple sclerosis (MS) and reported fatigue received a single intravenous infusion of ketamine (0.5 mg/kg) or midazolam (0.05 mg/kg). The primary outcome was change in Daily Fatigue Severity (DFS) for 7 days following the infusion. Secondary outcomes included Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS) measured up to day 28 post-infusion. We analyzed changes in all outcomes using mixed-effect models. Results: In total, 18 participants were enrolled; 67% participants received ketamine. Side effects of ketamine were transient. No change in the DFS was observed after 7 days (−0.10 point; 95% confidence interval (CI): −0.32, 0.12; p = 0.40). We observed a trend in reduced FSS scores at 1 week (−5.2 points; 95% CI: −10.4, 0.14; p = 0.06) and a clinically and statistically significant reduction in MFIS score at day 28 (−13.5 point; 95% CI: −25.0, −1.98; p = 0.04). Conclusions: Ketamine infusions were safe and well-tolerated. While no change in DFS after 7 days was observed, secondary analyses suggest a benefit of ketamine infusion for reduction of longer term fatigue severity in people with MS. [ABSTRACT FROM AUTHOR]

Background: Enhancing detection of unrecognized atrial fibrillation among acute ischemic stroke patients is crucial for secondary stroke prevention. Aim: To evaluate whether the detection rate of new atrial fibrillation in acute ischemic stroke patients without known atrial fibrillation could be improved by doing serial 12-lead electrocardiograms once daily for five days, compared with conventional 24-h Holter monitoring (24-h Holter). Methods: We conducted a randomized clinical trial to compare the detection rates of paroxysmal atrial fibrillation between serial electrocardiograms versus 24-h Holter from October 2015 to October 2018 at six hospitals. Eligible participants were acute ischemic stroke patients with aged ≥65 years, with neither atrial fibrillation history nor any presence of atrial fibrillation on baseline electrocardiogram at admission. The primary outcome was newly detected electrocardiogram in the serial electrocardiograms and 24-h Holter group. Results: Among 826 patients, baseline characteristics were similar between both groups. In the intention-to-treat analysis, there was no statistical difference between serial electrocardiograms versus 24-Holter to detect atrial fibrillation (8.4% vs. 6.9%; adjusted odds ratio 1.17, 95% confidence interval 0.69–2.01). Stepwise multivariate logistic regression revealed age ≥80 years and history of heart failure were associated with detection of paroxysmal atrial fibrillation whereas patients with lacunar infarction had lower odds for detection of paroxysmal atrial fibrillation. Conclusions: Serial electrocardiograms had comparable detection rate of paroxysmal atrial fibrillation compared with 24-h Holter and might be a viable alternative to 24-h Holter as a first-line approach to survey for potential paroxysmal atrial fibrillation among elderly patients with acute ischemic stroke. Clinical Trial Registration: URL https://clinicaltrials.gov/ct2/show/NCT02578979 Unique Identifiers: NCT02578979 [ABSTRACT FROM AUTHOR]

Background: Previous observational studies have suggested poor results of arthroscopic surgery for the treatment of acetabular labral tears in patients older than 40 years. Purpose: To compare hip arthroscopy versus nonoperative management for symptomatic labral tears in patients older than 40 years who have limited radiographic osteoarthritis. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: In this single-surgeon, parallel randomized controlled trial, patients older than 40 years who had symptomatic, MRI-confirmed labral tears and limited radiographic osteoarthritis (Tönnis grades 0-2) were randomized 1:1 to arthroscopic surgery with postoperative physical therapy (SPT) or physical therapy alone (PTA) using an electronic randomization program. PTA patients who achieved unsatisfactory improvement were permitted to cross over to SPT after completing ≥14 weeks of physical therapy. The primary outcomes were International Hip Outcome Tool (iHOT-33) and modified Harris Hip Score (mHHS) at 12 months after randomization, and secondary outcomes included other patient-reported outcome measures and the visual analog scale. Outcomes were assessed at baseline and at 3, 6, and 12 months after randomization. Primary analysis was performed on an intention-to-treat basis using linear mixed-effect models. Sensitivity analyses included modified as-treated analysis and treatment-failure analysis. Due to infeasibility, patients and health care providers were both unblinded. Results: The study enrolled 90 patients (46 [51.1%] SPT; 44 [48.9%] PTA); of these, 81 patients (42 [51.9%] SPT; 39 (48.1%) PTA) completed 12-month follow-up. A total of 28 of the 44 PTA patients crossed over to SPT within the study period (63.6% crossover). Intention-to-treat analysis revealed significantly greater iHOT-33 scores (+12.11; P =.007) and mHHS scores (+6.99 points; P =.04) in the SPT group than the PTA group at 12 months. Modified as-treated analysis revealed that these differences exceeded the minimal clinically important difference of 10.0 points (SPT-PTA iHOT-33, +11.95) and 8.0 points (SPT-PTA mHHS, +9.76), respectively. Conclusion: In patients older than 40 years with limited osteoarthritis, arthroscopic acetabular labral repair with postoperative physical therapy led to better outcomes than physical therapy alone. Thus, age over 40 years should not be considered a contraindication to arthroscopic acetabular labral repair. Registration: NCT03909178 (ClinicalTrials.gov identifier) [ABSTRACT FROM AUTHOR]

Ascertainment bias is a well-recognized source of bias in research, but few studies have systematically analyzed sources of ascertainment bias in randomized trials in which blinding is not possible and endpoint assessment is not protocolized. In the current study, we sought to evaluate differences in the clinical practice patterns of trial investigators with respect to bias in the ascertainment of pre-revascularization patient risk and the incidence of secondary endpoints post-revascularization. We conducted a cross-sectional survey of active investigators (n = 936) from the Best Endovascular Versus Best Surgical Therapy for Patients with Critical Limb Ischemia (BEST-CLI) trial. The total survey response rate was 19.6% (183/936). Vascular surgeons were more likely than nonsurgical interventionalists to order tests for cardiac complications after both surgical bypass (p < 0.001) and endovascular revascularization (p = 0.038). Post-procedure, investigators were more likely to order additional testing for cardiac complications in open surgery versus endovascular cases (7% vs 16% never, 41% vs 65% rarely, 43% vs 17% sometimes, 9% vs 2% always, respectively; p < 0.0001). Significant variation in practice patterns exist in the pre- and post-procedure assessment of cardiac risk and events for patients with CLI undergoing revascularization. Variation in the ascertainment of risk and outcomes according to the type of revascularization procedure and physician specialty should be considered when interpreting the results of clinical studies, such as the BEST-CLI trial. ClinicalTrials.gov Identifier: NCT02060630 [ABSTRACT FROM AUTHOR]

For most interventions to reduce criminal recidivism, long-term effects are uncertain. Music therapy has shown effects on possible precursors of recidivism, but direct evidence on long-term effects is lacking. In an exploratory parallel randomized controlled trial, 66 inmates in a Norwegian prison were allocated to music therapy or standard care and followed up over a median of 6 years, using state registry data. Median time to relapse was 5 years, with no differences between the interventions. The imprisonment of most participants was too short to provide a sufficient number of therapy sessions. Sufficiently powered studies are needed to examine the long-term effects of appropriate doses of therapy. [ABSTRACT FROM AUTHOR]

Background: Needle aspiration of calcific deposits (NACD) is a frequently used treatment for rotator cuff calcific tendinitis (RCCT). However, a substantial number of patients experience recurrent or persisting shoulder symptoms after NACD. Purpose: To compare the effects of adjuvant application of platelet-rich plasma (PRP) after NACD (NACP+PRP) with those of conventional NACD with corticosteroids (NACD+corticosteroids) on pain, shoulder function, and quality of life (QoL). Study Design: Randomized controlled trial; Level of evidence, 1. Methods: In a single-center, double-blinded, randomized controlled trial, 80 adults with symptomatic RCCT were randomly allocated to receive NACD+corticosteroids or NACD+PRP. Pain, shoulder function, and QoL were assessed at baseline; 6 weeks; and 3, 6, 12, and 24 months after treatment using a numeric rating scale for pain (NRS); the Constant-Murley score (CMS); the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH); the Oxford Shoulder Score (OSS); and the EuroQol 5-dimension scale (EQ-5D). Additionally, resorption of calcific deposits and the integrity of rotator cuff tendons were assessed by using standard radiographs and ultrasound examination, respectively. The results were analyzed using noninferiority analysis for NRS scores and a mixed model for repeated measures. Results: Eighty patients were included (48 female; mean age, 49 ± 6 years; 41 patients in the NACD+PRP group). Both groups showed improvement of clinical scores at the 2-year follow-up (P <.001 for all clinical scores). NACD+PRP was found to be noninferior to NACD+corticosteroids with regard to the mean decrease of NRS scores (4.34 vs 3.56; P =.003). Mixed-model analysis showed a significant difference in favor of NACD+PRP (CMS, P <.001; DASH, P =.002; OSS, P =.010; EQ-5D, P <.001). However, clinically relevant differences in favor of NACD+PRP were only seen at the 6-month follow-up for NRS and CMS scores, whereas at the 6-week follow-up a clinically relevant difference in favor of NACD+corticosteroids was found for all clinical scores except for the NRS. Full resorption of calcific deposits was present in 84% of the NACD+PRP group compared with 66% in the NACD+corticosteroids group (P =.081). In the NACD+PRP group, 10 (24%) patients required a second NACD procedure compared with 19 (49%) patients in the NACD+corticosteroids group (P =.036). Six complications, of which 5 were frozen shoulders, occurred in the NACD+PRP group compared with 1 complication in the NACD+corticosteroids group (P =.11). Conclusion: NACD+PRP resulted in worse clinical scores at the 6-week follow-up but better clinical scores at the 6-month follow-up compared with NACD+corticosteroids. At the 1- and 2-year follow-ups, the results were comparable between groups. Furthermore, PRP seemed to reduce the need for additional treatments but was associated with more complications. In conclusion, NACD+corticosteroids had a favorable early effect on pain and function combined with low comorbidity. Thus, it remains the treatment of choice for patients with RCCT. Registration: NCT02173743 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Instructional interactions that occur between teachers and students around foundational mathematics topics are critical for supporting mathematical proficiency among students with mathematics learning disabilities (MLD). This study investigated whether the initial mathematics skill of 880 kindergarten students at risk of MLD predicted the quantity and quality of explicit instructional interactions (i.e., overt teacher modeling, student practice opportunities, and academic feedback) experienced during an empirically validated Tier 2 kindergarten mathematics intervention. It also examined whether the quantity and quality of such instructional interactions predicted gains in student mathematics achievement. Researchers conducted 740 direct observations of 255 intervention groups within a multiyear, randomized controlled trial. Results suggested that intervention groups with lower initial mathematics skill received higher rates of academic feedback and made more frequent errors. In addition, more frequent and higher quality academic feedback and group practice opportunities predicted increased mathematics achievement. Implications for investigating the active ingredients of mathematics interventions are discussed. [ABSTRACT FROM AUTHOR]

Background: Traumatic full-thickness rotator cuff tears are typically managed surgically, followed by rehabilitation, but the load progression to reach an optimal clinical outcome during postoperative rehabilitation is unknown. Purpose: To evaluate whether there was a superior effect of 12 weeks of progressive active exercise therapy on shoulder function, pain, and quality of life compared with usual care. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients with surgically repaired traumatic full-thickness rotator cuff tears were recruited from 2 orthopaedic departments and randomized to progressive active exercise therapy (PR) or limited passive exercise therapy (UC [usual care]). The primary outcome was the change in the Western Ontario Rotator Cuff Index (WORC) score between groups from before surgery to 12 weeks after surgery. Secondary outcomes included changes in the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire score, pain, range of motion, and strength. Adverse events were registered during the intervention period. Results: A total of 82 patients were randomized to the PR (n = 41) or UC (n = 41) group. All 82 patients (100%) participated in the 12-week assessment and 79 in the 1-year follow-up. At 12 weeks, there was no significant difference between the groups in the change in the WORC score from baseline adjusted for age, sex, and center (physical symptoms: P =.834; sports and recreation: P =.723; work: P =.541; lifestyle: P =.508; emotions: P =.568). Additionally, there was no between-group difference for the secondary outcomes including the WORC score at 1 year and the DASH score, pain, range of motion, and strength at 12 weeks and 1 year. Both groups showed significant improvements over time in all outcomes. In total, there were 13 retears (16%) at 1-year follow-up: 6 in the PR group and 7 in the UC group. Conclusion: PR did not result in superior patient-reported and objective outcomes compared with UC at either short- or long-term follow-up (12 weeks and 1 year). Registration: NCT02969135 (ClinicalTrials.gov identifier) [ABSTRACT FROM AUTHOR]

Objective: Assess the feasibility and acceptability of an Internet and telephone support and problem-solving intervention for stroke caregivers. Design: Randomized controlled pilot trial with four arms: four-week intervention (n = 13), eight-week intervention (n = 13), eight-week attention control (n = 13), and standard care (n = 14). Setting: Southeastern U.S. Veterans Health System. Participants: Informal caregivers of Veterans who suffered a stroke in the preceding 2.5 years were enrolled over an 18-month period. Interventions: Intervention participants received RESCUE, a support and problem-solving intervention delivered via telephone and Internet by registered nurses. Attention control participants received active listening with no advice delivered by nurses via telephone. Main Measures: Feasibility of a larger trial was assessed via recruitment and retention. Acceptability was assessed using an adapted enactment tool and qualitative interviews. Changes in caregiver depressive symptoms and burden were measured by the Center for Epidemiologic Studies Depression Scale and Zarit Burden Interview. The study was not powered for significance testing. Results: Of 340 eligible caregivers, 53 (16%) agreed to participate. Among those enrolled, 51 (96%) completed the study. Caregiver mean age was 60.3 (10.1), 49 (93%) were female and 36 (68%) were white. At baseline, 21 (39%) caregivers had high risk of depression and 18 (33%) had significant burden. Acceptability and enactment tool findings indicated positive participant responses to the intervention. Most rated the amount of sessions the "right amount". Qualitative analysis revealed the intervention was valued by and acceptable to caregivers. Conclusions: Findings indicate the RESCUE intervention is feasible and acceptable to caregivers and warrants further testing. [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]

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013-2014). Totally, 120 patients were randomly allocated into two groups of intervention (n = 60) and control (n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46-0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20-1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up. [ABSTRACT FROM AUTHOR]

Background: Femoroacetabular impingement (FAI) is a condition known to cause hip pain in young adults. Purpose: To evaluate the efficacy of the surgical correction of FAI via arthroscopic osteochondroplasty with or without labral repair compared with arthroscopic lavage of the hip joint with or without labral repair. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 220 male and female participants aged 18 to 50 years with nonarthritic FAI suitable for surgical treatment were recruited for the trial at 10 clinical centers in Canada, Finland, and Denmark between October 2012 and November 2017, of whom 214 were included in the final analysis. In the osteochondroplasty group, cam- and/or pincer-type lesions were resected using fluoroscopic guidance. In the lavage group, the joint was washed out with 3 L of normal saline. Surgeons were instructed to repair the labrum in both groups if it was mechanically unstable once probed, showing visible displacement or chondrolabral separation. The primary outcome was patient-reported pain (using the 100-point visual analog scale [VAS]) at 12 months. Secondary outcomes included hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool), physical and mental health (12-Item Short Form Health Survey), and health utility (EuroQol–5 Dimensions) at 12 months as well as any reoperations and other hip-related adverse events at 24 months. Results: At 12 months, there was no difference in pain (VAS) between the groups (mean difference [MD], 0.11 [95% CI, –7.22 to 7.45]; P =.98). Also, 88.3% (189/214) of participants had a labral tear, of which 60.3% were repaired. For the secondary outcomes, there were no significant differences between treatment groups, with the exception of the HOS activities of daily living domain in which lavage showed significant improvement compared with osteochondroplasty (MD, –5.03 [95% CI, −10.40 to −0.03]; P =.049). By 24 months, there were significantly fewer reoperations reported in the osteochondroplasty group (8/105) than the lavage group (19/104) (odds ratio, 0.37 [95% CI, 0.15-0.89]; P =.026). The primary reasons for a reoperation included hip pain (15/27; 55.6%) and a reinjury of the labrum (11/27; 40.7%). Conclusion: Both the osteochondroplasty and the lavage groups with or without labral repair for FAI had significantly improved pain or function significantly at 1 year. By 2 years, the reoperation rate was significantly lower in the osteochondroplasty group. Registration: NCT01623843 (ClinicalTrials.gov identifier) [ABSTRACT FROM AUTHOR]

Older adults with mild cognitive impairment (MCI) with no literacy are at increased risk of progression to dementia. Whether it is feasible to engage this population in visual art therapy (VAT) and yield effects on cognition and depression remained unclear. A pilot mixed-method single-blinded randomized controlled trial was conducted in a sample of community-dwelling older adults with MCI. The experimental group (n = 21) was assigned to 12 sessions of VAT over 6 weeks, and the control group (n = 18) was assigned to 6 weekly health education (HE) on nonbrain health topics. Participants were evaluated at baseline using Montreal Cognitive Assessment–5-minute protocol (MoCA-5-min) and Geriatric Depression Scale Short Form (GDS-SF). A focus group discussion (FGD) was also conducted to the experimental group to explore their experiences of participating in the VAT. Findings indicated that both VAT and HE groups had significant improvement in MoCA-5-min scores and depressed mood over time; however, the significant group × time interaction effect was noted only for the psychological outcome. Findings from the FGD indicated that participants had challenging experiences at the beginning of the therapy, but later, they were able to cope and found that the VAT was relevant and beneficial for their cognitive and psychosocial health. This pilot study provided initial evidence about the potential benefit of VAT in improving cognitive and psychological well-being of older adults with MCI and low literacy and provided insights on how to better engage them in this cognitive stimulating intervention. A full-scale trial is recommended for a stringent evaluation. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the state of evidence for the beneficial and harmful effects of Tai Chi on non-motor disorders in post-stroke patients. Design: Systematic review and meta-analysis of published studies. Subjects: Stroke survivors who received conventional rehabilitation therapy or Tai Chi training. Data sources: We searched seven electronic literature databases and one clinical registry platform to collect data from randomized controlled trials published up to July 26, 2020. Results: A total of 11 randomized controlled trials with 723 stroke survivors met the inclusion criteria, of which six were included in the meta-analysis. Among the 11 studies, one was assessed as "low", eight were assessed as "moderate", and only two were assessed as "high" for the assessment of methodologic quality. Compared to patients who received conventional rehabilitation therapy, those who received Tai Chi training showed greater improvement in scores of depression (standardized mean difference (SMD) [95% confidence interval (CI)] = 0.36 [0.10, 0.61], Grading of Recommendations Assessment, Development, and Evaluation [GRADE]: very low). There were no differences in the improvements in post-stroke global mental disorders (mean difference (MD [95% CI] = 6.15 [−3.05, 15.36], GRADE: moderate) or sleep disorders (MD [95% CI] = 0.33 [−1.51, 1.81], GRADE: low) between Tai Chi and control groups. Conclusion: Tai Chi may alleviate post-stroke depression in stroke survivors but has no clear effects on post-stroke cognitive and sleep disorders. [ABSTRACT FROM AUTHOR]

Background: Perinatal depression (PD) has important implications for maternal and infant well-being but largely goes undetected. There is a need to develop low-intensity psychosocial interventions applicable to obstetric health care facilities. Objective: To assess the effectiveness of a brief psychological intervention for mild to moderate PD delivered by a nurse as compared to treatment-as-usual (TAU). Methods: This study is a randomized, open-label, parallel-group, multicentric trial being conducted in four sites of India. A total of 816 pregnant women with mild to moderately severe depression (Patient Health Questionaire-9 score of 5–19) are being assessed for the effectiveness of the intervention. Participants are randomly allocated to two groups of trial intervention (psychological intervention given by nurse) and TAU. The primary outcome is to compare the proportion of women reporting improvement across both groups. Participants are serially followed-up in each trimester and at 6, 10, 14 weeks, and 6 months postpartum. Secondary outcomes include pregnancy outcomes, feeding practices, physical growth, and immunization status of the infants. Conclusion: It is a prospective pregnancy birth cohort with a robust design and long-term follow-up. This is one of the largest studies utilizing non-specialist health workers for the screening and management of PD. This study also holds promise to cast light on the course and outcome of depression during pregnancy in different parts of India. It is envisaged to help in developing a sound screening and referral-based protocol for obstetric settings. [ABSTRACT FROM AUTHOR]

Background: Persons with previous history of a suicide attempt are at increased future risk of death by suicide. These vulnerable individuals, however, do not seek receive or seek help from mental health services. Telephone-based psychosocial interventions are potential strategies in augmenting mental health care in such persons. Methods: We aim to compare the efficacy of telephone-based psychosocial interventions (TBPI) with routine telephone reminders in persons with recent suicide attempts using a multi-site, parallel group, rater-blind, two-arm randomized controlled trial design in 362 participants. In the first group, participants will receive three sessions of TBPI comprising of brief supportive interventions, problem-solving strategies, and reminders for adherence to prescribed mental health treatment at weekly intervals. In the second group, participants will receive three telephone reminders for adherence to prescribed mental health treatment at weekly intervals. We will follow up participants for 6 months. Primary outcomes are suicidal ideation scores on Beck's Scale for Suicide Ideation and number of repeat suicide attempts. Secondary outcomes are scores on Beck's Hopelessness Scale, Beck's Depression Inventory, Connor–Davidson Resilience Scale and Visual Analogue Rating Scales for acceptability of interventions. Outcomes will be assessed at 1, 3, and 6 months after receiving telephone interventions or reminders. Results: The trial is currently underway after prospective registration under Clinical Trials Registry of India and has recruited 260 participants till August 15, 2020. Conclusion: This study has potential to generate evidence on additional strategies for use along with standard mental health treatments in management of high-risk suicide behaviors. [ABSTRACT FROM AUTHOR]

Background: Suboptimal management of depression in type 2 diabetes mellitus (T2DM) often translates into poor glycemic control, medical complications, and impaired quality of life. Feasibility and effectiveness of collaborative care models of depression in diabetes in low- and middle-income countries (LMICs) remain unexplored. DIAbetes Mellitus ANd Depression (DIAMAND) study, a multicentric single-blind randomized controlled trial (SBRCT) comparing effectiveness of fluoxetine and mindfulness in primary care settings, addresses this gap in scientific literature. Methods: This trial conducted in diverse geographic settings of New Delhi, Bengaluru, and Bhubaneswar will comprise module-based training of primary care providers (PCPs) for screening, diagnosing, and managing depression in diabetes in phase I. Phase II will involve four-arm parallel group RCT on 350 participants with T2DM with comorbid depressive episode randomly allocated to receive fluoxetine, mindfulness therapy, fluoxetine plus mindfulness therapy, or treatment as usual at primary care settings. Interventions would include fluoxetine (up to 60 mg/day) and/or sessions of mindfulness for 16 weeks. Primary outcomes on standardized rating scales include depression scores (Hamilton Depression Rating Scale), treatment adherence (Adherence to Refill and Medication Scale), self-care (Diabetes Self-Management Questionnaire), diabetes-related distress (Diabetes Distress Scale), and glycemic control. Secondary outcomes include quality of life (World Health Organization Quality of Life Brief version [WHO-QOL BREF]) and mindfulness (Five Facets Mindfulness Questionnaire). Discussion: This RCT will investigate the effectiveness of module-based training of PCPs and feasibility of collaborative care model for managing depression in T2DM in primary care settings in LMICs and effectiveness of fluoxetine and/or mindfulness in improving diverse outcomes of T2DM with major depression. [ABSTRACT FROM AUTHOR]

One important issue in Bayesian estimation is the determination of an effective informative prior. In hierarchical Bayes models, the uncertainty of hyperparameters in a prior can be further modeled via their own priors, namely, hyper priors. This study introduces a framework to construct hyper priors for both the mean and the variance hyperparameters for estimating the treatment effect in a two-group randomized controlled trial. Assuming a random sample of treatment effect sizes is obtained from past studies, the hyper priors can be constructed based on the sampling distributions of the effect size mean and precision. The performance of the hierarchical Bayes approach was compared with the empirical Bayes approach (hyperparameters are fixed values or point estimates) and the ordinary least squares (OLS) method via simulation. The design factors for data generation included the sample treatment effect size, treatment/control group size ratio, and sample size. Each generated data set was analyzed using the hierarchical Bayes approach with three hyper priors, the empirical Bayes approach with twelve priors (including correct and inaccurate priors), and the OLS method. Results indicated that the proposed hierarchical Bayes approach generally outperformed the empirical Bayes approach and the OLS method, especially with small samples. When more sample effect sizes were available, the treatment effect was estimated more accurately regardless of the sample sizes. Practical implications and future research directions are discussed. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to report preplanned secondary analyses of the effects of a 12-month individualized active aging counseling intervention on six mobility and physical activity outcomes. Methods: A two-arm, single-blinded randomized controlled trial was conducted among 75- and 80-year-old community-dwelling people. The intervention group (IG, n = 101) received counseling aimed at increasing self-selected, primarily out-of-home activity. The control group (CG, n = 103) received general health information. Data were analyzed with generalized estimating equations. Results: Physical performance improved in the IG more than that in the CG (group by time p = .022), self-reported physical activity increased in both groups (time p = .012), and autonomy in outdoor mobility declined in the IG and was enhanced in the CG (group by time p = .011). No change was observed for life-space mobility, proportion of persons perceiving difficulty walking 2 km, or monitored physical activity. Discussion: Individualized counseling aiming at increasing self-selected out-of-home activity had nonsystematic effects on mobility and positively affected physical performance only. [ABSTRACT FROM AUTHOR]

This study examined the effects of cognitive behavioral treatment for insomnia. A randomized controlled trial was performed on 44 women. The intervention included one group session of sleep hygiene education and four individual sessions of counseling. The instruments included the Insomnia Severity Index, Pittsburgh Sleep Quality Index, the Center for Epidemiological Studies Depression Scale, and Menopausal quality of life. The data were analyzed using repeated measure MANOVA, followed by repeated measure ANOVA. Repeated measure MANOVA showed that time had a significant main effect on the anthropometric variables (body mass index, waist circumference, and blood pressures) and revealed significant main effects of the group and time on the psychosocial variables (sleep quality, insomnia, depressive symptoms, and quality of life) (p <.05). Repeated measure ANOVA results indicated a significant effect of the group on insomnia and sleep quality (p <.05). Overall, the intervention was effective in improving insomnia and poor sleep quality. [ABSTRACT FROM AUTHOR]

Previous research has demonstrated that college students who view TakeCARE, a video bystander program designed to encourage students to take action to prevent sexual and relationship violence (i.e., bystander behavior), display more bystander behavior relative to students who view a control video. The current study aimed to replicate and extend these findings by testing two different methods of administering TakeCARE and examining moderators of TakeCARE's effects on bystander behavior. Students at four universities (n = 557) were randomly assigned to one of three conditions: (a) view TakeCARE in a monitored computer lab, (b) view TakeCARE at their own convenience after receiving an email link to the video, or (c) view a video about study skills (control group). Participants completed measures of bystander behavior at baseline and at a 1-month follow-up. Participants in both TakeCARE conditions reported more bystander behavior at follow-up assessments, compared with participants in the control condition. The beneficial effect of TakeCARE did not differ significantly across administration methods. However, the effects of TakeCARE on bystander behavior were moderated by students' perceptions of campus responsiveness to sexual violence, with more potent effects when students perceived their institution as responsive to reports of sexual violence. [ABSTRACT FROM AUTHOR]

Objectives: Tinnitus is a common and distressing otologic symptom, with various probable pathophysiologic mechanisms, such as an imbalance between excitatory and inhibitory mechanisms. Acamprosate, generally used to treat alcoholism, is a glutaminergic antagonist and GABA agonist suggested for treating tinnitus. Thus, we aimed to evaluate the efficacy and safety of acamprosate in the treatment of tinnitus. Methods: The current randomized-controlled trial study included 20 subjects with chronic tinnitus. After performing psycho-acoustic, psychometric and electrophysiological evaluations, all studied tinnitus subjects were randomly divided into two groups of acamprosate and placebo. The first group received oral acamprosate (two tablets of 333 mg/d, three times a day), whereas the second group was given placebo treatment (two tablets, three times a day). After the first 30 days, all evaluations were repeated for the studied groups just in the same manner before the study. Subsequently, the final results of each evaluation were compared together with the baseline values. Results: Nine studied subjects randomly received acamprosate, whereas eleven others received a placebo. There was no significant improvement in the psycho-acoustic tests, except a decrease was observed in the pitch match of tinnitus (P =.039). For those subjects who were receiving acamprosate, a significant reduction was observed in tinnitus handicap inventory (P =.006), tinnitus questionnaire scores (P =.007), and the visual analog scores (P =.007) compared to the placebo group. There was a significant reduction in Action Potential latency (P =.048) as well as an increase in the amplitude of distortion product otoacoustic emissions at 4 kHz (P =.048). Conclusions: The study results indicated a subjective relief of tinnitus as well as some degree of the electrophysiological improvement at the level of the cochlear and the distal portion of the auditory nerve among the subjects who received the acamprosate. Clinical trial registration code: IRCT2013121115751N1 [ABSTRACT FROM AUTHOR]

Objective: Addiction comorbidity is an important clinical challenge in mood disorders, but the best way of pharmacologically treating people with mood disorders and addictions remains unclear. The aim of this study was to assess the efficacy of pharmacological treatments for mood and addiction symptoms in people with mood disorders and addiction comorbidity.Methods: A systematic search of placebo-controlled randomized controlled trials investigating the effects of pharmacological treatments in people with bipolar disorder (BD) or major depressive disorder (MDD), and comorbid addictions was performed. Treatment-related effects on mood and addiction measures were assessed in a meta-analysis, which also estimated risks of participant dropout and adverse effects.Results: A total of 32 studies met systematic review inclusion criteria. Pharmacological therapy was more effective than placebo for improving manic symptoms (standardized mean difference [SMD] = -0.15; 95% confidence interval [95% CI], -0.29 to -0.02; P = 0.03) but not BD depressive symptoms (SMD = -0.09; 95% CI, -0.22 to 0.03; P = 0.15). Quetiapine significantly improved manic symptoms (SMD = -0.23; 95% CI, -0.39 to -0.06; P = 0.008) but not BD depressive symptoms (SMD = -0.07; 95% CI, -0.23 to 0.10; P = 0.42). Pharmacological therapy was more effective than placebo for improving depressive symptoms in MDD (SMD = -0.16; 95% CI, -0.30 to -0.03; P = 0.02). Imipramine improved MDD depressive symptoms (SMD = -0.58; 95% CI, -1.03 to -0.13; P = 0.01) but Selective serotonin reuptake Inhibitors (SSRI)-based treatments had no effect (SMD = -0.06; 95% CI, -0.30 to 0.17; P = 0.60). Pharmacological treatment improved the odds of alcohol abstinence in MDD but had no effects on opiate abstinence.Conclusions: Pharmacological treatments were significantly better than placebo in improving manic symptoms, MDD depressive symptoms, and alcohol abstinence but were not better for bipolar depression symptoms. Importantly, quetiapine was not more effective than placebo in improving bipolar depression symptoms nor were SSRI's for the treatment of MDD depression. Our findings highlight the need for further high-quality clinical trials of treatments for mood disorders and comorbid addictions. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to evaluate the effectiveness of cognitive behavior therapy (CBT) on reducing self-stigma in Chinese people with depression. Methods: By adopting a randomized controlled trial design, 62 participants with clinical depression were randomly assigned to a 10-session CBT or treatment as usual. Standardized assessment tools were used to assess the self-stigma and depressive symptoms in the pre- and posttreatment periods by a research assistant who was blind to the group assignment of the participants. Results: The results of the 2 × 2 repeated measures of covariance (analysis of covariance) demonstrated that after completing the therapy, the treatment group had significantly lower self-stigma scores than the control group. Additionally, the reduction in self-stigmatizing beliefs predicted a reduction in depressive symptoms in participants. Conclusion: This study demonstrates the efficacy and effectiveness of a CBT group intervention in reducing self-stigma for people with clinical depression living in Chinese society. [ABSTRACT FROM AUTHOR]

Maintaining good oral hygiene in patients wearing fixed appliances is a challenge for orthodontics. Conventional education has been demonstrated to be insufficient for the promotion of good oral habits, while motivational interviewing has the potential to facilitate health behavior change. The present randomized controlled trial with 130 patients aimed to evaluate the effectiveness of a single session of motivational interviewing in enhancing oral hygiene in orthodontic patients compared with conventional education alone. Results revealed an immediate improvement in oral hygiene which remained stable throughout the 6-month follow-up. [ABSTRACT FROM AUTHOR]

The number needed to treat is often used to measure the efficacy of a binary outcome in randomized clinical trials. There are three different available measures of the number needed to treat. Two of these measures, Furukawa and Leucht's and Kraemer and Kupfer's, focus on converting Cohen's δ index into the number needed to treat, while Laupacis et al.'s measure deals primarily with the number needed to treat's estimation rather than with a reformulation. Mathematical and numerical analysis of numbers needed to treat and their estimators was conducted. Three novel number needed to treat estimators were introduced to supplement the numbers needed to treat introduced by Laupacis, Furukawa and Leucht, and Kraemer and Kupfer. The analysis showed that Laupacis et al.'s number needed to treat is intrinsically different from Kraemer and Kupfer's number needed to treat, and that Furukawa and Leucht's estimator is appropriate to use only for normally distributed outcomes with equal standard deviations. Based on the numerical analysis, the novel numbers needed to treat outperformed the existing ones under correct model specifications. Asymptotic analysis was used to test three different types of confidence intervals to supplement the numbers needed to treat. An R-package to calculate these numbers needed to treat and their confidence intervals has been developed and made available for users online. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effectiveness and safety of Baduanjin training on the cognitive function in stroke survivors with cognitive impairment. Design: A randomized, two-arm parallel controlled trial with allocation concealment and assessors blinding. Setting: Community centre of Fuzhou city, China. Subjects: A total of 48 participants were recruited and randomly allocated into the Baduanjin exercise intervention or control group. Interventions: The control group maintained original medication and rehabilitation treatment. The Baduanjin training group received 24-week Baduanjin training with a frequency of three days a week and 40 minutes a day based on original medication and rehabilitation treatment. Main outcome measures: The primary outcome was global cognitive function. Secondary outcome measures included the specific domains of cognition (i.e. memory, processing speed, execution, attention and visuospatial ability) and activities daily living. Results: In total, 41 (Baduanjin n = 22, control n = 19) participants completed 24-week treatment and data collection. Mean differences between groups at 24-week treatment were statistically significant for global cognitive function (MoCA: 2.54 (0.91 to 4.16)), execution (TMT-A: −42.4 (−75.0 to −9.8); TMT-B: −71.3 (−130.6 to −12.1)), memory (immediate recall: 2.11 (0.49 to 3.73); short-term delayed recognition: 2.47 (0.58 to 4.35) and long-term delayed recognition: 1.68(0.18 to 3.17)), attention (response time of alertness: −245.5 (−387 to −104)) and activities of daily living (modified Barthel Index). Conclusion: Regular Baduanjin training is associated with less loss of cognitive function in patients after stroke. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of a dialogue-based intervention targeting psychosocial well-being at 12 months post-stroke. Design: Multicenter, prospective, randomized, assessor-blinded, controlled trial with two parallel groups. Setting: Community. Subjects: Three-hundred and twenty-two adults (⩾18 years) with stroke within the last four weeks were randomly allocated into intervention group (n = 166) or control group (n = 156). Interventions: The intervention group received a dialogue-based intervention to promote psychosocial well-being, comprising eight individual 1–1½ hour sessions delivered during the first six months post-stroke. Main measures: The primary outcome measure was the General Health Questionnaire-28 (GHQ-28). Secondary outcome measures included the Stroke and Aphasia Quality of Life Scale-39g, the Sense of Coherence scale, and the Yale Brown single-item questionnaire. Results: The mean (SD) age of the participants was 66.8 (12.1) years in the intervention group and 65.7 (13.3) years in the control group. At 12 months post-stroke, the mean (SE) GHQ-28 score was 20.6 (0.84) in the intervention group and 19.9 (0.85) in the control group. There were no between-group differences in psychosocial well-being at 12 months post-stroke (mean difference: −0.74, 95% confidence interval (CI): −3.08, 1.60). The secondary outcomes showed no statistically significant between-group difference in health-related quality of life, sense of coherence, or depression at 12 months. Conclusion: The results of this trial did not demonstrate lower levels of emotional distress and anxiety or higher levels of health-related quality of life in the intervention group (dialogue-based intervention) as compared to the control group (usual care) at 12 months post-stroke. [ABSTRACT FROM AUTHOR]

Background: Anorexia nervosa (AN) is the psychiatric disorder with the highest mortality rate, with a standard mortality ratio of 5.86. Despite the large use of psychotropic drugs in the clinical setting, Food and Drug Administration has not approved any psychoactive treatment for AN.Aims: The aim of this study was to perform an updated systematic review and meta-analysis of published randomized controlled trials (RCTs) investigating psychopharmacological treatment in acute-phase AN.Methods: The present paper follows the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement. An extensive literature search was performed. All RCTs enrolling patients with acute-phase AN, comparing at least one psychotropic drug with another drug, placebo, treatment-as-usual or no treatment were included. The main outcome was the effect of psychoactive drugs on body mass index (BMI); data on psychopathological outcomes were also collected when available.Results: A total of 19 RCTs met all specified criteria. Of these, 11 were excluded from quantitative analyses. Of the eight studies included in the meta-analyses, five reported data on BMI, showing no significant difference between olanzapine and placebo for weight recovery. No significant result was found for AN psychopathology, depressive and anxious symptoms for any of the molecules studied.Conclusions: RCTs published in this field display methodological biases, low sample sizes and short follow-up periods. Further research efforts are needed in this field as no evidence has been demonstrated for the use of any psychotropic drug in acute-phase AN neither for weight recovery, nor for comorbid psychiatric symptoms. [ABSTRACT FROM AUTHOR]

Purpose: Develop and evaluate a mammography intervention that provides hope about cancer prevention and treatment.Design: Pilot randomized controlled trial.Setting: Two communities on the Navajo Nation.Participants: Navajo women and support persons.Intervention: Both groups received standard care: one home visit discussing mammography pros/cons and barriers. The treatment group received an intervention based on Navajo language via an additional home visit with health education materials (written and oral) in English and Navajo, including a Navajo Cancer Glossary with a new descriptive phrase for cancer.Analysis: Between control and intervention conditions, we compared baseline sociodemographics; changes from baseline to 3 months on mammography completion and breast cancer literacy scores.Measures: (1) intervention feasibility; (2) self- and clinic-reported mammography screening completion; (3) breast cancer literacy.Results: A total of 25 participants were randomly assigned (13 treatment, 12 control), with 7 support persons in each arm. Mean age was 53 years, 90% had a high school degree or higher, 86% spoke Navajo and English. At 3 months, 44% had a clinically verified mammogram. Mammography completion was 57% among those with a support person and 27% among those without (P = .14). Intervention women reported more breast cancer beliefs consistent with mammography (P = .015).Conclusions: Increases in breast cancer beliefs consistent with mammography show promise. Findings highlight a need to tailor education materials to Navajo culture/language and focus on enhancing support. [ABSTRACT FROM AUTHOR]

Objective: To compare the effectiveness of supervised physical therapy program versus non-supervised on pain, functionality, fear of movement and quality of life in patients with non-specific chronic low back pain. Design: A randomized double-blind clinical trial. Setting: Clinical outpatient unit; home. Subjects: A total of 64 participants with non-specific chronic low back pain were randomized into either supervised exercise group (n = 32) or non-supervised home exercise group (n = 32). Interventions: The supervised group was treated with therapy exercises (strengthen lumbopelvic musculature), while the non-supervised received an informative session of the exercises, which were performed un-supervised at home. Both groups received three weekly sessions for eight weeks. Main Measures: Pain, disability, fear of movement, quality of life, trunk muscle endurance and trunk anteflexion motion were assessed at baseline, two, and six months of follow-up. Results: Although analysis of variance (ANOVA) test showed statistically significant differences between groups for pain (P = 0.028; supervised: 2.5 ± 2.1; non-supervised: 3.5 ± 1.5) and disability for Roland–Morris Disability Questionnaire (P = 0.004; supervised: 3.1 ± 2.2; non-supervised: 5.1 ± 3.0) and for Oswestry Disability Index (P = 0.034; supervised: 14.5 ± 7.1; non-supervised: 19.2 ± 10.0) at 8 weeks immediately posttreatment, there were no differences between the groups in patient-rated pain, functionality, fear of movement and quality of life at six months of follow-up. Conclusion: Patients with chronic low back pain who received supervised exercise showed more improvement in both the short and long term in all patient-rated outcomes over the non-supervised group, but the differences were small and not clinically significant. [ABSTRACT FROM AUTHOR]

Objective: To estimate, among people with multiple sclerosis, the extent to which a personally tailored exercise programme (MSTEP©) resulted in greater improvements in exercise capacity and related outcomes over 12 months in comparison with general exercise guidelines. Design: Two-group randomized trial. Subjects: Ambulatory and sedentary. Interventions: MSTEP©, a personally adapted exercise regimen done on most days including two days of high intensity exercise; guidelines recommending 30 minutes of moderate intensity aerobic and strength training two times per week. Main measures: Primary outcome was peak oxygen consumption (VO2peak) at 12 months; secondary outcomes were composite measures of physical function, fatigue, and health-related quality of life. Results: In total, 137 people were randomized, 66 were lost over 12 months leaving 71 with outcome data, 34 in MSTEP© group, and 37 in the Guideline group. Exercise enjoyment and confidence and exercise-induced fatigue predicted retention. There were no differences between groups on the proportion making a 10% increase in VO2peak (27.1% MSTEP© vs 29.6% Guidelines; OR: 0.83; 95% CI: 0.23–3.08) by the 12 month assessment. The effect on fatigue was larger in the MSTEP© group than the Guideline groups (OR: 1.59; 95% CI: 0.93–2.74), the effect on physical function was more modest (OR: 1.35; 95% CI: 0.80–2.25), and null for health-related quality of life outcomes. Conclusions: The disappointing exercise retention suggests that people with multiple sclerosis may not consider exercise important to their brain health. Either type of exercise resulted in stable exercise capacity over 1 year in those sticking with the programme. [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]

Happier people are healthier, but does becoming happier lead to better health? In the current study, we deployed a comprehensive, 3-month positive psychological intervention as an experimental tool to examine the effects of increasing subjective well-being on physical health in a nonclinical population. In a 6-month randomized controlled trial with 155 community adults, we found effects of treatment on self-reported physical health—the number of days in the previous month that participants felt healthy or sick, as assessed by questions from the Centers for Disease Control and Prevention's Behavioral Risk Factor Surveillance System Questionnaire. In a subsample of 100 participants, we also found evidence that improvements in subjective well-being over the course of the program predicted subsequent decreases in the number of sick days. Combining experimental and longitudinal methodologies, this work provides some evidence for a causal effect of subjective well-being on self-reported physical health. [ABSTRACT FROM AUTHOR]

Background: Cap-assisted endoscopic sclerotherapy is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy. The proper length of the endoscopic injection needle is the core for performing cap-assisted endoscopic sclerotherapy well with more benefits and less complications. However, no data are currently available to guide endoscopists to consider the length of injection needle before cap-assisted endoscopic sclerotherapy. This study is designed to evaluate the efficacy and safety of cap-assisted endoscopic sclerotherapy with long or short injection needle in the treatment of internal hemorrhoids. Methods: This is a nationwide multi-center, prospective, single-blind and randomized controlled trial. Patients with grade I-II internal hemorrhoids who have failed to conservative treatments and grade III internal hemorrhoids who are not suitable for surgery or refuse surgery will be included. Participants will be randomized 1:1 into either long or short injection needle group. The primary outcome is the recurrence rate of internal hemorrhoids 24 weeks after cap-assisted endoscopic sclerotherapy. The secondary outcomes are as follows: (1) symptom severity score, (2) three-level EuroQoL five dimensions health scale scores, (3) occurrence of adverse events and severe adverse events, and (4) patients' attitudes toward cap-assisted endoscopic sclerotherapy. Data collection will be conducted before and during operation, the 1st day, 1st week, 2nd week, and 24th week after cap-assisted endoscopic sclerotherapy. Discussion: The outcome of this study is expected to provide a practical clinical protocol of cap-assisted endoscopic sclerotherapy for patients with internal hemorrhoids and promote the use of this new endoscopic technique. Trial registration: ClinicalTrials.gov, NCT03917056. Registered on 12 April 2019. [ABSTRACT FROM AUTHOR]

Objective: To analyze the effectiveness of an electrotherapy intervention with galvanic current on symptoms associated with Raynaud's phenomenon. Design: Single-blind randomized controlled trial, parallel design (1:1 ratio) and intention-to-treat analysis. Setting: Virgen de las Nieves Hospital, Granada, Spain. Subjects: Thirty-four participants with Raynaud's phenomenon, with a mean (SD) age of 43.43 (17.62) years. Interventions: The patients were randomly assigned to a control group with conservative treatment (anti-inflammatory, vasodilatory and analgesic drugs) or an intervention group that received conservative treatment and vasodilatory electrical stimulation during seven weeks, three times/week for a total of 20 sessions. Main measures: The primary outcome was the number of attacks. Secondary outcomes were pain, peripheral blow flow, oxygen saturation, upper limb disability, central sensitization, pain catastrophizing and temperature recovery. All outcomes were assessed at baseline, posttreatment and at two months of follow-up. Results: The galvanic current electrotherapy group showed significantly greater improvements in the number of attacks (mean difference = 26.3, 95% confidence interval (CI) = 14.4 to 38.3), pre-cold stress pain (95% CI = 0.6 to 2.4), radial artery blood flow (95% CI = −7.8 ⩾ x ⩽ 1.3), ulnar artery blood flow (95% CI = −8.63 to 0.60), oxygen saturation (95% CI = −1.7 ⩾ x ⩽ −0.29), upper limb disability (95% CI = 1.1 to 22.3), central sensitization (95% CI = 6.7 to 18.2) and temperature recovery (95% CI = −5.7 ⩾ x ⩽ −0.32) than the conservative treatment group. Conclusion: This study suggests that a complementary treatment with galvanic current in combination to conservative approach is superior to conservative applied as isolate, in reducing the clinical manifestations and disability in Raynaud's phenomenon. [ABSTRACT FROM AUTHOR]

Background: Patients with stroke-associated pneumonia experience poorer outcomes (increased hospital stays, costs, discharge dependency, and risk of death). High-quality, organized oral healthcare may reduce the incidence of stroke-associated pneumonia and improve oral health and quality of life. Aims: We piloted a pragmatic, stepped-wedge, cluster randomized controlled trial of clinical and cost effectiveness of enhanced versus usual oral healthcare for people in stroke rehabilitation settings. Methods: Scottish stroke rehabilitation wards were randomly allocated to stepped time-points for conversion from usual to enhanced oral healthcare. All admissions and nursing staff were eligible for inclusion. We piloted the viability of randomization, intervention, data collection, record linkage procedures, our sample size, screening, and recruitment estimates. The stepped-wedge trial design prevented full blinding of outcome assessors and staff. Predetermined criteria for progression included the validity of enhanced oral healthcare intervention (training, oral healthcare protocol, assessment, equipment), data collection, and stroke-associated pneumonia event rate and relationship between stroke-associated pneumonia and plaque. Results: We screened 1548/2613 (59%) admissions to four wards, recruiting n = 325 patients and n = 112 nurses. We observed marked between-site diversity in admissions, recruitment populations, stroke-associated pneumonia events (0% to 21%), training, and resource use. No adverse events were reported. Oral healthcare documentation was poor. We found no evidence of a difference in stroke-associated pneumonia between enhanced versus usual oral healthcare (P = 0.62, odds ratio = 0.61, confidence interval: 0.08 to 4.42). Conclusions: Our stepped-wedge cluster randomized control trial accommodated between-site diversity. The stroke-associated pneumonia event rate did not meet our predetermined progression criteria. We did not meet our predefined progression criteria including the SAP event rate and consequently were unable to establish whether there is a relationship between SAP and plaque. A wide confidence interval did not exclude the possibility that enhanced oral healthcare may result in a benefit or detrimental effect. Trial Registration: NCT01954212. [ABSTRACT FROM AUTHOR]

Background: Up to one in five women meet diagnostic criteria for an anxiety disorder during the perinatal period (i.e. pregnancy and up to 1 year postpartum). While psychotropic medications are effective, they are associated with risks for mothers and babies. There is a growing demand for evidence-based non-pharmacological treatments for perinatal anxiety. Objective: To evaluate the effectiveness of a cognitive behavioral group therapy protocol for perinatal anxiety. Methods: In total, 96 women were randomized to cognitive behavioral group therapy or waitlist at a clinic specializing in women's mental health. Participants were 22–41 years of age, pregnant or up to 6 months postpartum and had an anxiety disorder with or without comorbid depression. Results: Compared to waitlist, participants in cognitive behavioral group therapy reported significantly greater reductions in the primary outcome of anxiety (State-Trait Inventory of Cognitive and Somatic Anxiety, η2p =.19; Hamilton Anxiety Rating Scale, η2p =.16), as well as in secondary outcomes including worry (Penn State Worry Questionnaire, η2p =.29), perceived stress (Perceived Stress Scale, η2p =.33) and depressive symptoms (Edinburgh Postnatal Depression Scale, η2p =.27; Montgomery–Åsberg Depression Rating Scale, η2p =.11). Maternal status (pregnant, postpartum) and medication use were unrelated to treatment outcomes. All gains were maintained, or continued to improve, at 3-month follow-up. Conclusion: Cognitive behavioral group therapy was effective in improving anxiety and related symptoms among women with anxiety disorders in the perinatal period. [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]

Objectives: To compare the effects of continuous and pulsed therapeutic ultrasound combined with strengthening exercises. Design: This is a double-blind randomized controlled trial. Setting: Pontifical Catholic University. Subjects: One hundred participants with Grade 2–4 knee osteoarthritis and both genders were involved. Intervention: Participants were randomized into five groups: Group I (n = 20; in the first month, continuous ultrasound was applied), Group II (n = 20; in the first month, pulsed ultrasound was applied), Group III (n = 20; in the first and second months, continuous ultrasound was applied), Group IV (n = 20; in the first and second months, pulsed ultrasound was applied) and Group V (n = 20; patients received only exercise sessions for eight weeks). All patients in the groups that received ultrasound application performed exercises in the second month of treatment. The sessions occurred three times a week. Main measures: Pain was assessed using the visual analogical scale, functionality was assessed using the Lequesne questionnaire, range of motion was assessed using a universal goniometer, muscular strength was assessed using a dynamometer, mobility was assessed using the Timed Up and Go test and 8-meter walk test and the activity level was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Results: Statistically significant differences (P < 0.05) were presented by Group III in the variables pain during activities of daily living (ADLs) 5.89 (2.18), mobility assessed by 8-meter test 2.68 (2.56), in pain 10.65 (4.40), function 25.50 (10.87) and total 38.65 (15.29) of WOMAC and functionality 9.10 (5.15). Conclusion: Prolonged applications of continuous ultrasound combined with exercises are effective in providing pain, mobility, functionality and activity in subjects with knee osteoarthritis. [ABSTRACT FROM AUTHOR]

The use of a placebo is the gold standard for establishing the efficacy of new treatments in randomized controlled trials (RCTs). Placebo treatments are inert; this allows specific effects of the experimental treatment to be separated from nonspecific physiological, psychological, and social effects. The aim of this study was to scrutinize the workings of an audiobook (AB) placebo treatment, which was used in a placebo-controlled, investigator-blinded, RCT of the effect of guided imagery (GI) to improve pain and function in persons undergoing total knee replacement. A secondary analysis of quantitative and narrative data collected during the RCT was performed. The AB treatment provided attention control. Participants in the AB group identified benefits—pleasant get-away, new knowledge, quiet time-out, and inspiration; however, there was also evidence of resentful demoralization, especially in the postoperative period. The use of ABs as a placebo treatment in GI RCTs should be executed with caution. [ABSTRACT FROM AUTHOR]

This 6-month pilot randomized controlled trial examined the effectiveness of a Mobile Health (mHealth) intervention for hypertension self-monitoring and management in an underserved urban community. The four health outcomes measured included changes in systolic and diastolic blood pressure (BP), BP monitoring adherence, perceived medication adherence self-efficacy, and health-related quality of life. Thirty participants were randomly assigned to the mHealth group or a standard follow-up group; 25 participants completed the study. The mHealth group had statistically significant improvement in systolic BP decrease (p =.01). The mHealth group had better adherence to BP monitoring and improved perceived medication adherence self-efficacy at 6 months, compared with the standard follow-up group. The results suggest that an mHealth intervention has the potential to facilitate hypertension management in underserved urban communities. [ABSTRACT FROM AUTHOR]

Objectives: The main objective of this study is to determine the feasibility of recruiting and retaining patients recently diagnosed with thoracic cancer to a trial of short-term integrated rehabilitation; evaluate uptake of theoretically informed components targeting physical function, symptom self-management and participation; estimate sample size requirements for an efficacy trial. Design: Parallel group randomized controlled feasibility trial. Setting: Three U.K. hospitals. Participants: Patients ⩽eight weeks of thoracic cancer diagnosis, Eastern Cooperative Oncology Group Performance Status 0–3, any cancer stage and treatment plan. Interventions: Participants randomly allocated (1:1) to short-term integrated rehabilitation and standard care or standard care alone over 30 days. Main measures: Primary: participant recruitment and retention, targeting ⩾30% of eligible patients enrolling and ⩾50% of participants reporting outcomes at 30 days. Secondary: intervention fidelity; missing data and performance of outcome measures for self-efficacy, symptoms, physical activity and health-related quality of life. Results: Of 159 eligible patients approached, 54 (34%) were recruited. A total of 44 (82%) and 39 (72%) participants reported outcomes at 30 and 60 days, respectively. Intervention fidelity was high. Rehabilitation was delivered across 3 (1–3) sessions over 32 (22–45) days (median (range)). Changes in clinical outcomes were modest but most apparent at 60 days for health-related quality of life: Functional Assessment of Cancer Therapy Lung Cancer score median (interquartile range) change 9.7 (−12.0 to 16.0) rehabilitation versus 2.3 (−15.0 to 14.5) standard care. Conclusion: A trial to examine efficacy of short-term integrated rehabilitation for people newly diagnosed with thoracic cancer is feasible. A sample of 336 participants could detect a meaningful effect on health-related quality of life as the primary outcome. [ABSTRACT FROM AUTHOR]