IntroductionPilot and feasibility trials aim to test whether a full trial can be conducted or if any procedures must be changed for the full trial. Pilot trials must be reported in a transparent, accurate and complete way. In this report, we present a protocol for a methodological survey with the following aims: (1) to determine the percentage of physiotherapy trial reports which claim to be pilot or feasibility trials that evaluate feasibility, (2) to determine the aspect of feasibility evaluated in the primary objectives of the pilot or feasibility trials, (3) to describe the completeness of reporting of abstracts and full articles of pilot or feasibility trials using the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials and (4) to investigate factors associated with completeness of reporting of pilot or feasibility trials.Methods and analysisReports of randomised controlled trials indexed in the Physiotherapy Evidence Database (PEDro) that claim to be pilot or feasibility trials and published in 2011–2017 will be included. Two independent reviewers will confirm eligibility and classify the aspect of feasibility being evaluated in the objectives of the included pilot or feasibility trials. Completeness of reporting of both the abstract and the full article will be evaluated using the CONSORT extension to randomised pilot and feasibility trials. The primary analysis will be a descriptive analysis about the reporting quality of abstracts and full texts of pilot and feasibility trials. We will use generalised estimating equation analysis to explore factors associated with completeness of reporting.Ethics and disseminationThe results of this study will be disseminated by presentation at conferences and will be submitted for publication in a peer-reviewed journal. Ethical approval is not necessary for this study.
This is an open access article under the CC BY-NC license. www.medicaljournals.se/jrm COMMENTARY ON: "KINESIO TAPING IN TREATMENT OF CHRONIC NON-SPECIFIC LOW BACK PAIN: A SYSTEMATIC REVIEW AND META-ANALYSIS"We recently read the systematic review by Sheng et al. on the effects of Kinesio Taping in patients with chronic non-specific low back pain (1). Although the research question of this systematic review was similar to those addressed in other reviews (2, 3), the results were completely different. This is the first systematic review to conclude that Kinesio Taping is efficacious for patients with low back pain.A possible reason for this unique finding is that the authors only included trials published between 2012 and 2015 (despite Table I presenting trials published in 2016 and 2017). Also, the authors only included trials published in Chinese or English. Finally, no trials that compared Kinesio Taping with placebo, minimal interventions, or a wait-and-see approach were included in the review. The Cochrane Handbook for Systematic Reviews of Interventions (3) clearly warns of "language bias" (4), as studies published in non-English languages appear to have larger effects on interventions than studies published in English (most of the included trials are from China). In addition, the Cochrane Handbook strongly recommends that authors do not restrict the eligibility criteria based on publication dates. Finally, excluding placebo-controlled trials neglects the gold standard of clinical research. It is a pity that the reviewers did not point out these major fatal flaws, which ended up completely spinning the results.The results of Sheng et al.'s review (1) are highly misleading for the following reasons: Firstly, by using questionable inclusion criteria many trials with very large samples and low risk of bias were excluded (e.g. Added et al. 2016 (5) and Parreira et al. 2014 (6)). Such trials can easily be found in PubMed and Physiotherapy Evidence Database (PEDro), for example. Secondly, the review included only trials that showed results in favour of Kinesio Taping, and ignored trials with negative results (i.e. spinning of results ( 7)). This is evident in both of the forest plots included in the systematic review. The issue of selection bias, due to including only positive trials, is clearly evident in the review. We strongly suggest that the results of this systematic review are interpreted with scepticism, as the positive effects were clearly overestimated. Systematic reviews are considered the "gold standard" for determining the effectiveness of interventions and should be conducted in the most rigorous way possible. In this letter we have summarized the main points that could mislead readers to believe that Kinesio Taping could benefit people with chronic nonspecific low back pain.
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