Statistical analysis, while at first glance an objective way to extract insights from data, remains at its core a human endeavor. Elements of subjectivity are introduced by the many decisions that... Show moreStatistical analysis, while at first glance an objective way to extract insights from data, remains at its core a human endeavor. Elements of subjectivity are introduced by the many decisions that go into the selection of a statistical method. Such subjectivity may harm the evidentiary value of results from statistical analyses. Standardization of statistical methods decreases the degrees of freedom available to researchers and may thus be seen as a way to increase the objectivity of the analysis. Here, we argue that standardization of methods is not only impossible because statistical methods rely on assumptions that need to be considered on a case-by-case basis but also undesirable because it may block innovation. We propose that the entheseal changes field is better served by standardization of reporting and discuss how reporting guidelines may be developed based on examples from biostatistics. Show less
'Blinding' involves concealing knowledge of which trial participants received the interventions from participants themselves and other trial personnel throughout the trial. Blinding reduces bias... Show more'Blinding' involves concealing knowledge of which trial participants received the interventions from participants themselves and other trial personnel throughout the trial. Blinding reduces bias arising from the beliefs and expectations of these groups. It is agreed that where possible, blinding should be attempted, for example by ensuring that experimental and control treatments look the same. However, there is a debate about if we should measure whether blinding has been successful, this manuscript will discuss this controversy, including the benefits and risks of measuring blinding within the randomised controlled trial. (c) 2021 Elsevier Inc. All rights reserved. Show less
Objective: The objective of this study was to identify key features to be addressed in the reporting of deprescribing trials and to elab-orate and explain CONSORT items in this regard.Study Design... Show moreObjective: The objective of this study was to identify key features to be addressed in the reporting of deprescribing trials and to elab-orate and explain CONSORT items in this regard.Study Design and Setting: As a first step in a multistage process and based on a systematic review of deprescribing trials, we elab-orated variation in design, intervention, and reporting of the included trials of the review. We identified items that were missed or insufficiently described, using the CONSORT and TIDieR checklists. The resulting list of items, which we considered relevant to be reported in deprescribing trials, were discussed in a single-round Delphi exercise and subsequently in a full-day face-to-face meeting with an international panel of 14 experts. We agreed on CONSORT items for further elaboration with regard to design and reporting of deprescribing trials.Results: We identified seven CONSORT items on trial design, participants, intervention, outcomes, flowchart, and harms, where the investigators of deprescribing trials should take into consideration specific aspects, such as whether or not to use placebo or how to inform participants.Conclusion: This article presents an elaboration to the CONSORT statement for the reporting of deprescribing trials. It may also support investigators in motivated design choices. (c) 2020 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). Show less
