Publication Bias and Selective Outcome Reporting in Randomized Controlled Trials Related to Rehabilitation: A Literature Review.

OBJECTIVE: To investigate the rate of registered protocols published as research papers as a measure of publication bias, and the concordance rates of the primary outcomes between research protocol and published papers as a measure of selective outcome reporting bias in randomized controlled trials (RCTs) related to rehabilitation. DATA SOURCES: Protocols related to RCTs were extracted from electronic databases, the University Hospital Medical Information Network (UMIN), International Standard Research Clinical Trial Number (ISRCTN), ClinicalTrials.gov, and MEDLINE. Published papers were retrieved from MEDLINE. STUDY SELECTION: The inclusion criteria were as follows: (1) initial registration (UMIN, ISRCTN, ClinicalTrials.gov) within the designated period; (2) published as a paper from a research protocol in MEDLINE (PubMed); and (3) written in English or Japanese. The search period was from January 1, 2013, to December 31, 2020. DATA EXTRACTION: The outcome of this study was set as the rate of published papers that were consistent with the extracted research protocol and the concordance rate between the primary outcomes in published papers and in protocols. The concordance rate of the primary outcomes was evaluated by checking whether the description in the research protocol matched that in the paper's abstract and main text. DATA SYNTHESIS: Out of the 5597 research protocols registered, only 727 were published (13.0%). The concordance rates of the primary outcomes were 48.7% and 72.6% in the abstract and main text, respectively. CONCLUSIONS: This study revealed major discrepancies between the number of research protocols and published papers, and difference of description regarding the primary outcomes in published papers which were already defined in the research protocols.

Effects of self-management education programmes on self-efficacy for osteoarthritis of the knee: a systematic review of randomised controlled trials.

BACKGROUND: Enhancing self-efficacy to manage symptoms and functions is an important aspect of self-management for patients with knee osteoarthritis (OA). Many reports have investigated the effects of self-management education programmes for arthritis patients. However, a study that exclusively focuses on patients with OA in the same joints is required to clarify the effects of self-management programmes because individuals with knee OA experience physical and psychological difficulties different from those experienced by individuals with other arthritis diseases. Furthermore, previous studies have reported a wide range of delivery styles of self-management education programmes. This systematic review aimed to evaluate the effects of group-based and face-to-face self-management education programmes conducted by health professionals targeting self-efficacy for knee OA exclusively. METHODS: The MEDLINE, CENTRAL, EMBASE, CINAHL, Web of Science, and PEDro databases were searched to identify quantitative measures used in randomised controlled trials (RCTs) to assess the effects of self-management education programmes targeting self-efficacy in patients with knee OA. We included studies in which medical professional-delivered self-management education programmes were conducted in a group-based and face-to-face manner in community or outpatient settings. RESULTS: Seven RCTs from five countries were included in this review. Our retrieved studies included various types of self-management education programmes such as cognitive behavioural counselling, pain management education, physical education, weight management education, and arthritis self-efficacy management education, and control arms. They assessed various aspects of self-efficacy, including pain, physical function, arthritis symptoms excluding pain, weight management, mobility, and self-regulation. The total score of the Arthritis Self-Efficacy Scale was also measured. Some studies have reported beneficial effects of group-based and face-to-face self-management education programmes on self-efficacy for management of pain and other symptoms and for self-regulatory, knee OA. However, the results of the included studies were varied and inconsistent. CONCLUSIONS: The current review only included seven studies, and there was a wide range of clinical heterogeneity among these studies. Thus, the effects of group-based and face-to-face self-management education programmes conducted by health professionals on self-efficacy for knee OA exclusively are inconclusive to date. Therefore, high-quality studies are required to provide significant information on clinicians, patients, and healthcare professionals in the future.

Cognitive behavior therapy-based intervention for a subacute stroke patient with severe fear of falling: a case report.

We present the case of a 42-year-old man with subacute stroke who developed remarkable fear of falling and eventually recovered with an approach based on cognitive behavioral therapy (CBT). The CBT-based approach was implemented after the patient developed significant fear of falling with exacerbated obsessive-compulsive symptoms appeared immediately after a fall. The patient's anxiety decreased over time, and his ability to perform these tasks and activities of daily living improved accordingly. After 6 weeks of intervention, his anxiety toward gait and stairs almost disappeared; additionally, he achieved modified independence for gait and supervision for stairs and was discharged home successfully. These findings in the present case suggest the effectiveness of an evaluation and interventional approach based on CBT for stroke patients with a severe fear of falling.

Effect of mental processing on low back load while lifting an object.

STUDY DESIGN: Biomechanical study using a 3D motion analysis system conducted in a laboratory setting. OBJECTIVE: To determine the effect of mental processing on low back load during lifting. SUMMARY OF BACKGROUND DATA: In addition to ergonomic factors such as frequent lifting, work-related psychosocial factors are significant in the onset of disabling back pain. Although the ergonomic effects on low back load while lifting have been investigated and are widely accepted in the workplace, few studies have investigated the effect of psychosocial factors on low back load while lifting. METHODS: Thirteen healthy subjects lifted a box from the ground in 4 different lifting tasks in randomized order: (1) squat posture with knees flexed; (2) stoop posture with knees extended; (3) squat posture with mental processing using arithmetic tasks; and (4) stoop posture with mental processing using arithmetic tasks. We used a 3D motion analysis system and 4 force plates to record kinematic and kinetic data. We calculated dynamic triaxial low back joint moments and low back compression force as index parameters of low back load under these experimental conditions. RESULTS: Mental processing significantly increased peak low back compression force and low back extension moment, but not lateral flexion or rotation moment, while lifting in both lifting postures. Also, mental processing increased trunk bending angles in the squat posture. Although a tendency for decreased pelvic forward tilt was observed, mental processing did not significantly decrease forward pelvic tilt in the stoop posture. CONCLUSION: Mental processing during lifting tasks seems to affect both trunk and pelvis angles in the sagittal plane for squat and stoop postures, resulting in increased low back load. The present findings might help explain the effect of ergonomic demands of lifting tasks as well as psychosocial factors responsible for the onset of disabling back pain. LEVEL OF EVIDENCE: 2.