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The article discusses the approaches for gluteal tendinopathy which includes education plus exercise and corticosteroid injection.

Objectives: The aim of this study was to assess the measurement equivalence of individual response scale types by using a patient reported outcome measure (PROM) collected on paper and migrated into electronic format for use on the subject's own mobile device (BYOD) and on a provisioned device (site device).Methods: Subjects suffering from chronic health conditions causing daily pain or discomfort were invited to participate in this single-site, single visit, three-way crossover study. Association between individual item and instrument subscale scores was assessed by using the intraclass correlation coefficient (ICC) and its CI. Participant attitudes toward the use of BYOD in a clinical trial were assessed through use of a questionnaire.Results: In this study, 155 subjects (females 83 [54%]; males 72 [46%]) ages 19 to 69 years (mean ± SD: 48.6 ± 13.1) were recruited. High association between the modes of administration (paper, BYOD, site device) was shown with analysis of ICCs (0.79-0.98) for each response scale type, including visual analogue scale, numeric rating scale, verbal response scale, and Likert scale. Of the subjects, 94% (146 of 155) stated that they would definitely or probably be willing to download an app onto their own mobile device for a forthcoming clinical trial. Forty-five percent of subjects felt BYOD would be more convenient compared with 15% preferring a provisioned device (40% had no preference).Conclusions: This study provides strong evidence supporting the use of BYOD for PROM collection in terms of the conservation of instrument measurement equivalence across the most widely used response scale types, and high patient acceptance of the approach. [ABSTRACT FROM AUTHOR]

Background: Little is known about the influence of practice schedules on motor learning and skills transfer in children with and without developmental coordination disorder (DCD). Understanding how practice schedules affect motor learning is necessary for motor skills development and rehabilitation.Aims: The study investigated whether active video games (exergames) training delivered under variable practice led to better learning and transfer than repetitive practice.Methods and Procedures: 111 children aged 6-10 years (M=8.0, SD=1.0) with no active exergaming experience were randomized to receive exergames training delivered under variable (Variable Game Group (VGG), n=56) or repetitive practice schedule (Repetitive Game Group (RGG), n=55). Half the participants were identified as DCD using the DSM-5 criteria, while the rest were typically developing (TD), age-matched children. Both groups participated in two 20min sessions per week for 5 weeks.Outcomes and Results: Both participant groups (TD and DCD) improved equally well on game performance. There was no significant difference in positive transfer to balance tasks between practice schedules (Repetitive and Variable) and participant groups (TD and DCD).Conclusions and Implications: Children with and without DCD learn balance skills quite well when exposed to exergames. Gains in learning and transfer are similar regardless of the form of practice schedule employed.What This Paper Adds: This is the first paper to compare the effect of practice schedules on learning in children with DCD and those with typical development. No differences in motor learning were found between repetitive and variable practice schedules. When children with and without DCD spend the same amount of time on exergames, they do not show any differences in acquisition of motor skills. Transfer of motor skills is similar in children with and without DCD regardless of differences in practice schedules. [ABSTRACT FROM AUTHOR]

Background: Medication dispensing errors are common in clinical trials, and have a significant impact on the quality and validity of a trial. Therefore, the definition, calculation and evaluation of such errors are important for supporting a trial's conclusions. A variety of medication dispensing errors can occur. In this paper, we focus on errors in trials where the intervention includes multiple therapies that must be given in a pre-specified order that varies across treatment arms and varies in duration.Methods: The Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial was a Phase III multi-site, randomized trial to compare the effectiveness and safety of 1:1:1 transfusion ratios of plasma and platelets to red blood cells with a 1:1:2 ratio. In this trial, these three types of blood products were to be transfused in a pre-defined order that differed by treatment arm. In this paper, we present approaches from the PROPPR trial that we used to define and calculate the occurrence of out of order blood transfusion errors. We applied the proposed method to calculate protocol adherence to the specified order of transfusion in each treatment arm.Results: Using our proposed method, protocol adherence was greater in the 1:1:1 group than in the 1:1:2 group (96% vs 93%) (p<0.0001), although out of order transfusion errors in both groups were low. Final transfusion ratios of plasma to platelets to red blood cells for the 1:1:1 ratio group was 0.93:1.32:1, while the transfusion ratio for the 1:1:2 ratio group was 0.48:0.48:1.Conclusions: Overall, PROPPR adherence to blood transfusion order pre-specified in the protocol was high, and the required order of transfusions for the 1:1:2 group was more difficult to achieve. The approaches proposed in this manuscript were useful in evaluating the PROPPR adherence and are potentially useful for other trials where a specific treatment orders with varying durations must be maintained. [ABSTRACT FROM AUTHOR]

Introduction: Brief (≤4 sessions) behavioral treatment for insomnia (BBTi) improves insomnia symptoms in older adults. Findings for BBTi-related improvements in objective cognition are mixed, with our recent trial reporting no effects. Metacognition (appraisal of one's own performance) has not been examined. This study examined the effects of BBTi on metacognition in older adults with insomnia.Methods: Older adults with insomnia [N = 62, Mage = 69.45 (SD = 7.71)] were randomized to 4-weeks of BBTi (n = 32; psychoeducation, sleep hygiene, stimulus control, sleep restriction, relaxation, review/maintenance) or self-monitoring control (SMC; n = 30; social conversations). Throughout the study (2 week baseline, 4 week treatment, 2 week post-treament, 2 week 3-month followup), participants completed daily paper/pencil cognitive tasks (measuring verbal memory, attention, processing speed and reasoning) and provided daily metacognition ratings of their performance in four areas: quality, satisfaction, compared to same age peers, compared to own ability. Two-week averages of metacognitive ratings were calculated for baseline, treatment-first half, treatment-second half, post-treatment, and 3-month follow-up. Multilevel Modeling examined treatment effects (BBTi/SMC) over time on metacognition, controlling for age and sex.Results: A significant group by time interaction (p = 0.05) revealed consistent improvements over time in better metacognitive ratings relative to same age peers for BBTi. Specifically, baseline ratings [mean (M) = 51.21, standard error (SE) = 3.15] improved at first half of treatment (M = 56.65, SE = 3.15, p < 0.001), maintained improvement at second-half of treatment (p = 0.18), showed additional improvement at post-treatment (M = 60.79, SE = 3.15, p = 0.02), and maintained improvement at follow-up (M = 62.30, SE = 3.15; p = 0.02). SMC prompted inconsistent and smaller improvements between baseline (M = 53.24, SE = 3.29) and first-half of treatment (M = 56.62, SE = 3.28; p = 0.004), with additional improvement at second-half of treatment (M = 59.39, SE = 3.28; p = 0.02) that was maintained at post-treatment (p = 0.73) and returned to levels observed at first-half of treatment (M = 57.78, SE = 3.21; p = 0.55). Significant main effects of time (all ps < 0.001) for other metacognition variables (Quality, Satisfaction, Compared to own ability) indicated general improvements over time for both groups.Discussion: Metacognition generally improved over time regardless of treatment. BBTi selectively improved ratings of performance relative to same age peers. Repeated objective testing alone may improve metacognition in older adults with insomnia. Better understanding of metacognition and how to improve it has important implications for older adults as metacognitive complaints have been associated with mild cognitive impairment. [ABSTRACT FROM AUTHOR]

Objective: The study aimed to determine the effect of motivational interviewing on the change of breast cancer screening behaviors among rural Iranian women.Methods: This Randomized controlled trial (RCT) was performed on 120 Iranian rural women selected through cluster random sampling method. Out of all 20 rural health centers of Abish Ahmad District, in the northwest of Iran, about one third (six clusters) were randomly selected; out of which three were randomly assigned to the control group and three to the intervention group. A list of women aged 40-69 years in the selective health centers was prepared and 60 participants were selected for each group through the convenience sampling method based on the inclusion and exclusion criteria. Then, six group sessions (two educational and four motivational interviewing sessions) were held for the intervention group. The data were collected using demographic and obstetric questionnaire, paper-based health records, and the stages of change checklist and analyzed in SPSS 24. The groups were compared through the chi square test, homogeneity test, and the sequential logistic regression with generalized estimating equations.Results: Two months after the intervention, a significant difference was found between the two groups in terms of the stages of change for clinical breast examination and mammography by taking into account the pre-intervention stages (p = 0.001).Conclusion: MI-based counseling increased the Iranian rural women's motivation for displaying breast cancer screening behaviors.Practice Implications: The application of MI for enhancing cancer screening programs among Iranian women is suggested. [ABSTRACT FROM AUTHOR]

Introduction: This study examines the feasibility and effectiveness of an intensive lifestyle intervention adapted for people with impaired mobility.Study Design: This was a randomized, wait-list controlled trial. The experimental group immediately received the 12-month weight loss program; the wait-list control group received it after a 6-month delay. Between-group comparisons were conducted for the 6-month RCT study design. Repeated measures were conducted for both groups combined after receiving the 12-month intervention. Data were collected August 2015-February 2017 and analyzed in 2017.Setting/participants: A community-based sample received 23, group-based sessions via a mix of telephone and in-person sessions in a hospital-based setting. Participants with impaired mobility (n=66) were middle-aged (49.80 [SD=11.37] years), mostly White (66.7%), female (66.7%), and most commonly had spinal cord injury (47.0%).Intervention: The 12-month intervention delivered 23 group-based sessions that promoted weight loss through reducing caloric intake and increasing physical activity.Main Outcome Measures: Primary outcomes were effectiveness measured as change in weight and time spent in moderate physical activity. Feasibility was assessed in 12-month combined group analyses, measured as retention, attendance, and dietary self-monitoring.Results: The 6-month RCT results showed that the immediate and delayed groups differed significantly (p<0.05) in weight (-1.66 [SD=4.42] kg loss vs 0.05 [SD=4.15] kg gain) and moderate physical activity (52.93 [SD=90.74] minutes/week increase vs -14.22 [SD=96.02] minutes/week decrease), accounting for baseline weight, time with disability, and age of onset. The 12-month results with groups combined demonstrated 74.2% retention and 77.7% core session attendance. Self-monitoring was higher in the delayed group (77.3%), who used a smartphone app, than the immediate group (47.3%), who mostly used paper trackers. Participants achieved significant 12-month weight loss of 3.31 (SD=10.13) kg (d=0.33) in mixed modeling analyses with groups combined yet did not significantly increase moderate physical activity.Conclusions: Group Lifestyle Balance Adapted for Individuals with Impaired Mobility is a feasible, effective approach to teach healthy lifestyle skills to individuals with mobility impairment, yielding modest weight loss and enhanced self-efficacy.Trial Registration: This study is registered at www.clinicaltrials.gov NCT03307187. [ABSTRACT FROM AUTHOR]

Objective: To determine the effect of nutrition education program on hemodialysis patients' quality of life (QoL) and serum electrolytes levels.Methods: This study was a randomized controlled trial in which 94 eligible hemodialysis patients were randomly assigned to intervention (n = 48) and control (n = 46) groups. In the intervention group, the patients were trained in healthy nutrition for four weeks. After two months, samples of both groups completed the Kidney Disease Quality of Life Instrument (KDQOL) and Na, K, P, Ca and Mg levels were also measured and compared.Results: There were no significant differences in QoL scores and electrolytes between the two groups before intervention (p > 0.05). After intervention the QoL scores in the intervention group were significantly higher than in the control group (p < 0.05). However, after intervention the levels of Na, K, P and Mg in the intervention group were significantly lower than in the control group (p < 0.05). Calcium level was not significantly different between the two groups after intervention (p = 0.16).Conclusion: The results showed that e-learning is effective in improving the QoL and serum electrolytes of hemodialysis patients.Practice Implications: This paper could serve as support for clinical healthcare professionals to improve patient knowledge and QoL through virtual education methods. [ABSTRACT FROM AUTHOR]

Aims: The TTM2-trial is a multi-centre randomised clinical trial where targeted temperature management (TTM) at 33 °C will be compared with normothermia and early treatment of fever (≥37.8 °C) after Out-of-Hospital Cardiac Arrest (OHCA). This paper presents the design and rationale of the TTM2-trial follow-up, where information on secondary and exploratory outcomes will be collected. We also present the explorative outcome analyses which will focus on neurocognitive function and societal participation in OHCA-survivors.Methods: Blinded outcome-assessors will perform follow-up at 30-days after the OHCA with a telephone interview, including the modified Rankin Scale (mRS) and the Glasgow Outcome Scale Extended (GOSE). Face-to-face meetings will be performed at 6 and 24-months, and include reports on outcome from several sources of information: clinician-reported: mRS, GOSE; patient-reported: EuroQol-5 Dimensions-5 Level responses version (EQ-5D-5L), Life satisfaction, Two Simple Questions; observer-reported: Informant Questionnaire on Cognitive Decline in the Elderly-Cardiac Arrest version (IQCODE-CA) and neurocognitive performance measures: Montreal Cognitive Assessment, (MoCA), Symbol Digit Modalities Test (SDMT). Exploratory analyses will be performed with an emphasis on brain injury in the survivors, where the two intervention groups will be compared for potential differences in neuro-cognitive function (MoCA, SDMT) and societal participation (GOSE). Strategies to increase inter-rater reliability and decrease missing data are described.Discussion: The TTM2-trial follow-up is a pragmatic yet detailed pre-planned and standardised assessment of patient's outcome designed to ensure data-quality, decrease missing data and provide optimal conditions to investigate clinically relevant effects of TTM, including OHCA-survivors' neurocognitive function and societal participation. [ABSTRACT FROM AUTHOR]

For decades various pressure ulcer risk assessment scales (PURAS) have been developed and implemented into nursing practice despite uncertainty whether use of these tools helps to prevent pressure ulcers. According to current methodological standards, randomised controlled trials (RCTs) are required to conclusively determine the clinical efficacy and safety of this risk assessment strategy. In these trials, PURAS-aided risk assessment has to be compared to nurses' clinical judgment alone in terms of its impact on pressure ulcer incidence and adverse outcomes. However, RCTs evaluating diagnostic procedures are prone to specific risks of bias and threats to the statistical power which may challenge their validity and feasibility. This discussion paper critically reflects on the rigour and feasibility of experimental research needed to substantiate the clinical efficacy of PURAS-aided risk assessment. Based on reflections of the methodological literature, a critical appraisal of available trials on this subject and an analysis of a protocol developed for a methodologically robust cluster-RCT, this paper arrives at the following conclusions: First, available trials do not provide reliable estimates of the impact of PURAS-aided risk assessment on pressure ulcer incidence compared to nurses' clinical judgement alone due to serious risks of bias and insufficient sample size. Second, it seems infeasible to assess this impact by means of rigorous experimental studies since sample size would become extremely high if likely threats to validity and power are properly taken into account. Third, means of evidence linkages seem to currently be the most promising approaches for evaluating the clinical efficacy and safety of PURAS-aided risk assessment. With this kind of secondary research, the downstream effect of use of PURAS on pressure ulcer incidence could be modelled by combining best available evidence for single parts of this pathway. However, to yield reliable modelling results, more robust experimental research evaluating specific parts of the pressure ulcer risk assessment-prevention pathway is needed. [ABSTRACT FROM AUTHOR]

Background: Many patients undergoing anaesthesia and surgery experience postoperative complications. Our aim was to investigate whether a systematic follow-up smartphone-based assessment, using recovery assessment by phone points (RAPP) compared with standard care, had a positive effect on day surgery patients' postoperative recovery. We also investigated whether there were differences in women and men's recovery and recovery scores.Methods: The study was a single-blind, multicentre randomized controlled trial. A total of 997 patients were randomly allocated to either RAPP or standard care. The Swedish web version of a quality of recovery (SwQoR) questionnaire was used to evaluate the patients' postoperative recovery, either on paper or using an application (RAPP) on postoperative days seven and 14.Results: On postoperative day seven the RAPP group reported significantly better values in seven out of 24 items of the SwQoR: sleeping difficulties; not having a general feeling of wellbeing; having difficulty feeling relaxed/comfortable; and dizziness; headache; pain in the surgical wound; and a swollen surgical wound compared with the control group, implying a good postoperative recovery. Both men and women in the RAPP group reported significantly better values (and, hence good postoperative recovery) compared with the control group in the items sleeping difficulties; not having a general feeling of wellbeing and pain in the surgical wound.Conclusions: Measurement of patient-reported outcomes using a smartphone-based application was associated with decreased discomfort from several postoperative symptoms. Systematic e-assessment can thereby increase patients' quality of recovery and identify key areas for improvement in perioperative care.Clinical Trial Registration: NCT02492191. [ABSTRACT FROM AUTHOR]

Background: The PARAMEDIC cluster randomised trial evaluated the LUCAS mechanical chest compression device, and did not find evidence that use of mechanical chest compression led to an improvement in survival at 30 days. This paper reports patient outcomes from admission to hospital to 12 months after randomisation.Methods: Information about hospital length of stay and intensive care management was obtained through linkage with Hospital Episode Statistics and the Intensive Care National Audit and Research Centre. Patients surviving to hospital discharge were approached to complete questionnaires (SF-12v2, EQ-5D, MMSE, HADS and PTSD-CL) at 90days and 12 months. The study is registered with Current Controlled Trials, number ISRCTN08233942.Results: 377 patients in the LUCAS arm and 658 patients in the manual chest compression were admitted to hospital. Hospital and intensive care length of stay were similar. Long term follow-up assessments were limited by poor response rates (53.7% at 3 months and 55.6% at 12 months). Follow-up rates were lower in those with worse neurological function. Among respondents, long term health related quality of life outcomes and emotional well-being was similar between groups. Cognitive function, measured by MMSE, was marginally lower in the LUCAS arm mean 26.9 (SD 3.7) compared to control mean 28.0 (SD 2.3), adjusted mean difference -1.5 (95% CI -2.6 to -0.4).Conclusion: There were no clinically important differences identified in outcomes at long term follow-up between those allocated to the mechanical chest compression compared to those receiving manual chest compression. [ABSTRACT FROM AUTHOR]

Background: Alcohol, tobacco, and other drug use remains highly prevalent among US adolescents and is a threat to their well-being and to the public health. Evidence from clinical trials and meta-analyses supports the effectiveness of Screening, Brief Intervention and Referral to Treatment (SBIRT) for adolescents with substance misuse but primary care providers have been slow to adopt this evidence-based approach. The purpose of this paper is to describe the theoretically informed methodology of an on-going implementation study.Methods: This study protocol is a multi-site, cluster randomized trial (N=7) guided by Proctor's conceptual model of implementation research and comparing two principal approaches to SBIRT delivery within adolescent medicine: Generalist vs. Specialist. In the Generalist Approach, the primary care provider delivers brief intervention (BI) for substance misuse. In the Specialist Approach, BIs are delivered by behavioral health counselors. The study will also examine the effectiveness of integrating HIV risk screening within an SBIRT model. Implementation Strategies employed include: integrated team development of the service delivery model, modifications to the electronic medical record, regular performance feedback and supervision. Implementation outcomes, include: Acceptability, Appropriateness, Adoption, Feasibility, Fidelity, Costs/Cost-Effectiveness, Penetration, and Sustainability.Discussion: The study will fill a major gap in scientific knowledge regarding the best SBIRT implementation strategy at a time when SBIRT is poised to be brought to scale under health care reform. It will also provide novel data to inform the expansion of the SBIRT model to address HIV risk behaviors among adolescents. Finally, the study will generate important cost data that offer guidance to policymakers and clinic directors about the adoption of SBIRT in adolescent health care. [ABSTRACT FROM AUTHOR]

Shugan granule is derived from Xiaoyao powder, a traditional Chinese medicine that has been shown to be effective in treating emotional disorders. At present, there is no standard drug treatment for mixed anxiety-depressive disorder (MADD), and no evidence-based clinical trial has been performed for any drug, meaning MADD patients are unable to obtain standardized treatment. The purpose of this clinical trial was to test the clinical efficacy and safety of Shugan granules in the treatment of MADD, and to provide clinical trial-based support along with drug recommendations for the treatment of MADD. A multicenter, randomized, double-blind, placebo-controlled study was conducted on 400 patients with MADD recruited from January 1, 2019 to December 31, 2020, and they were randomly divided into test and placebo groups with a 1:1 ratio. Subjects in the test group (n = 200) received oral administration of Shugan granules, while subjects in the placebo group (n = 200) received oral administration of a Shugan granule simulator. The treatment lasted for 8 weeks. The Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale-17 (HAMD-17), Clinical Global Impression Scale (CGIS), Self-rating Anxiety Scale (SAS), and Self-rating Depression Scale (SDS) were used to evaluate efficacy. In addition, the traditional Chinese medicine (TCM) syndrome scale for MADD was developed to observe improvements of related symptoms in patients after treatment based on the disease guidelines of TCM and the clinical manifestations of depression. Furthermore, the safety of Shugan granules was evaluated during and after treatment. After 8 weeks of treatment, the total scores for HAMA, HAMD, SAS, and SDS in the test group were significantly lower than those in the placebo group (P < 0.01). The proportion of patients with efficacy index (EI) > 1 for the CGIS score in the test group was significantly higher than that in the placebo group (P < 0.01). The efficacy of treatment in the test group based on the TCM syndrome scale was 70.16% and 88.27% after 4 weeks and 8 weeks, respectively, which was significantly higher than that in the placebo group (44.27% and 66.67% after 4 weeks and 8 weeks, respectively; P < 0.01). The disappearance rate of single symptoms in the test group was 20–30% higher than that in the placebo group, with a significant difference between groups (P < 0.05). During the treatment period, the incidence of adverse reactions was 2.05% in the test group and 2.06% in the placebo group, with no significant differences noted (P = 1.0000). Shugan granule was more effective than placebo in the treatment of MADD. Moreover, there was no significant difference between the two groups in terms of safety. This paper provides a clinical therapeutic regime using Shugan granule for the treatment of MADD. [Display omitted] • As far as we know, this is the first randomized controlled multicenter clinical trial for MADD in the world. • The indications for usage of Xiaoyao powder was expanded to the treatment or control of MADD. • We developed the TCM symptom scale for evaluation of MADD and therapeutic effects of medications on it. • This study provides a high-quality evidence for the treatment of MADD by using a standardized traditional formula". [ABSTRACT FROM AUTHOR]

Vulnerability–stress models suggest that training in specific stress management techniques should yield benefits to those suffering from schizophrenia and related disorders. In this paper, we describe an evaluation of the impact of adding a stress management program to other medical and psychosocial interventions for such patients. Outcomes were compared for 121 patients randomly assigned to receive either a 12-week stress management program with follow-up sessions or participation in a social activities group. The two treatment conditions did not differ in levels of symptoms, perceived stress or life skills immediately after completion of treatment or at 1-year follow-up. Patients who received the stress management program did have fewer hospital admissions in the year following treatment. This effect of stress management was most apparent for those who showed high levels of attendance for treatment sessions. It was concluded that training in stress management may provide patients with skills for coping with acute stressors and reduce the likelihood of subsequent acute exacerbation of symptoms with need for hospitalization. [Copyright &y& Elsevier]

Objective: The GETSET trial found that guided graded exercise self-help (GES) improved fatigue and physical functioning more than specialist medical care (SMC) alone in adults with chronic fatigue syndrome (CFS) 12 weeks after randomisation. In this paper, we assess the longer-term clinical and health economic outcomes.Methods: GETSET was a randomised controlled trial of 211 UK secondary care patients with CFS. Primary outcomes were the Chalder fatigue questionnaire and the physical functioning subscale of the short-form-36 survey. Postal questionnaires assessed the primary outcomes and cost-effectiveness of the intervention 12 months after randomisation. Service costs and quality-adjusted life years (QALYs) were combined in a cost-effectiveness analysis.Results: Between January 2014 and March 2016, 164 (78%) participants returned questionnaires 15 months after randomisation. Results showed no main effect of intervention arm on fatigue (chi2(1) = 4.8, p = 0.03) or physical functioning (chi2(1) = 1.3, p = 0.25), adjusting for multiplicity. No other intervention arm or time*arm effect was significant. The short-term fatigue reduction was maintained at long-term follow-up for participants assigned to GES, with improved fatigue from short- to long-term follow up after SMC, such that the groups no longer differed. Healthcare costs were £85 higher for GES and produced more QALYs. The incremental cost-effectiveness ratio was £4802 per QALY.Conclusions: The short-term improvements after GES were maintained at long-term follow-up, with further improvement in the SMC group such that the groups no longer differed at long-term follow-up. The cost per QALY for GES compared to SMC alone was below the usual threshold indicating cost-effectiveness, but with uncertainty around the result. [ABSTRACT FROM AUTHOR]