Correspondence: Transparency to fully understand randomised controlled trials
Author(s) -
Takashi Ariie
Publication year - 2019
Publication title -
journal of physiotherapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.615
H-Index - 68
eISSN - 1836-9553
pISSN - 1836-9561
DOI - 10.1016/j.jphys.2019.01.009
Subject(s) - medicine , physical therapy , transparency (behavior) , randomized controlled trial , physical medicine and rehabilitation , medline , surgery , political science , law
I have read the research article conducted by Antônio et al, which examines the effect of pelvic floor muscle training in groups stratified by hormonal therapy use. I appreciate the authors’ effort to conduct this randomised controlled study. Since the intervention was described in detail, readers might be able to apply the training protocol to their clinical settings. However, I have two concerns about inadequate reporting of the method in this study. First, sample size calculation of participants was not mentioned; therefore, readers cannot anticipate the impact of a Type II error on statistically non-significant results. Second, there was no information about adverse events. Although the intervention itself is non-invasive, a previous study reported some adverse events such as pain. If the reasons for dropout from the intervention group (such as illness) were related to intervention, caution should be exercised. These two points are important components to fully understand the study, as described in the Consolidated Standards of Reporting Trials (CONSORT) statement. Readers should be aware of the concerns when they interpret the results.
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