560 research outputs found

    Effects of placebos without deception compared with no treatment: a systematic review and meta-analysis

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    Aim Our aim was to address the clinical efficacy of open-label placebos compared with no treatment by systematic review, and meta-analysis where possible. Methods We searched the Cochrane Injuries Group's Specialised Register, The Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE(R) In-Process & Other NonIndexed Citations (OvidSP), EMBASE (OvidSP), and clinical trials registers and screened reference lists. We ran the most recent search on April 27 2015. All randomised controlled trials of any medical condition, which had both open-label placebo and no-treatment or treatment as usual groups were included. Two authors independently applied the selection criteria and extracted data. The risk of bias of included studies was assessed using the Cochrane criteria. We used random-effects model for meta-analysis. Results After removing duplicates we screened 348 publications, assessed 24 articles for eligibility and identified 5 trials (260 participants) that met our inclusion criteria. The clinical conditions were: irritable bowel syndrome (IBS), depression, allergic rhinitis, back pain and attention deficit hyperactivity disorder (ADHD). The overall risk of bias was moderate. All 5 trials were eligible for meta-analysis. We found a positive effect for non-deceptive placebos (standardized mean difference (SMD) 0.88, 95% CI 0.62 to 1.14, P<0.00001, I2= 1%). Conclusions Open-label placebos appear to have favorable clinical outcomes, compared to no treatment or no additional treatment. Caution is warranted when interpreting the results due to the limitations including the small number of trials and lack of blinding. Larger definitive trials are now warranted to explore the potential patient benefit of open-label placebos

    Scoping trauma

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    From the Editor

    Reporting of social deprivation in musculoskeletal trials: an analysis of 402 randomised controlled trials

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    Background: Social deprivation is broadly defined as the restriction of access an individual has to social or cultural interactions due to poverty, discrimination or other disadvantages. While social deprivation is a widely acknowledged determinant of outcome in musculoskeletal conditions, it remains unclear how this is considered in the conduct and interpretation of musculoskeletal trials.  Aim: To determine the frequently to which measures of social deprivation are reported in trials recruiting people with musculoskeletal diseases.  Materials and Methods: We conducted a Pubmed search of randomised controlled trials published between 01 January 2019 and 01 June 2020. We included full-text papers of trials recruiting people with musculoskeletal diseases, irrespective of intervention type or origin. We extracted data relating to trial characteristics, setting, trial design, funding source and musculoskeletal disease. We extracted data on any reported social deprivation index or measure of social deprivation based on internationally adopted indicators. We analysed data descriptively to summarise the reporting of each social deprivation index and measure of social deprivation within trials.  Results: From 2133 potentially eligible citations, 402 were eligible. Mean age of participants was 51.7 years; 63% were female. Trials most frequently recruited people with spinal pain (24.6%) or osteoarthritis (10.0%). Two trials (0.5%) reported social deprivation indices/scores. When assessed by discrete measures of social deprivation, 164 trials (40.8%) reported one or more social deprivation measures. The most commonly reported measures were morbidity (20.2%), employment status (17.7%) and educational attainment (15.5%). Race (6.7%), ethnicity (6.2%) and annual salary (1.3%) were infrequently reported. One trial (0.3%) presented subgroup results by social deprivation measures.  Discussion and Conclusion: Social deprivation is inconsistently reported in musculoskeletal trials. Trialists should report baseline measures of social deprivation in trial reports and aid generalisability to target population, and to examine whether social deprivation might modify treatment effects of interventions for musculoskeletal conditions

    Protocol for the development of a CONSORT-equity guideline to improve reporting of health equity in randomized trials.

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    BACKGROUND: Health equity concerns the absence of avoidable and unfair differences in health. Randomized controlled trials (RCTs) can provide evidence about the impact of an intervention on health equity for specific disadvantaged populations or in general populations; this is important for equity-focused decision-making. Previous work has identified a lack of adequate reporting guidelines for assessing health equity in RCTs. The objective of this study is to develop guidelines to improve the reporting of health equity considerations in RCTs, as an extension of the Consolidated Standards of Reporting Trials (CONSORT). METHODS/DESIGN: A six-phase study using integrated knowledge translation governed by a study executive and advisory board will assemble empirical evidence to inform the CONSORT-equity extension. To create the guideline, the following steps are proposed: (1) develop a conceptual framework for identifying "equity-relevant trials," (2) assess empirical evidence regarding reporting of equity-relevant trials, (3) consult with global methods and content experts on how to improve reporting of health equity in RCTs, (4) collect broad feedback and prioritize items needed to improve reporting of health equity in RCTs, (5) establish consensus on the CONSORT-equity extension: the guideline for equity-relevant trials, and (6) broadly disseminate and implement the CONSORT-equity extension. DISCUSSION: This work will be relevant to a broad range of RCTs addressing questions of effectiveness for strategies to improve practice and policy in the areas of social determinants of health, clinical care, health systems, public health, and international development, where health and/or access to health care is a primary outcome. The outcomes include a reporting guideline (CONSORT-equity extension) for equity-relevant RCTs and a knowledge translation strategy to broadly encourage its uptake and use by journal editors, authors, and funding agencies
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