Spin Reporting Is Common in Pilot Randomized Controlled Trials in Surgery: A Methodological Survey

IF 1.8 3区医学 Q2 SURGERY

Journal of Surgical Research Pub Date : 2025-02-01 DOI:10.1016/j.jss.2024.12.019

Tyler McKechnie MD, MSc , Tania Kazi BScH , Victoria Shi MA , Austine Wang BHSc , Sophia Zhang BSc , Alex Thabane MSc , Keean Nanji MD , Phillip Staibano MD, MSc , Lily J. Park MD, MSc , Aristithes Doumouras MD, MPH , Cagla Eskicioglu MD, MSc , Lehana Thabane PhD , Sameer Parpia PhD , Mohit Bhandari MD, PhD

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引用次数: 0

Abstract

Introduction

Spin reporting has been studied across a variety of study types and domains; however, it has yet to be studied in the context of pilot and feasibility trials. We designed this methodological survey to evaluate spin reporting in surgical pilot and feasibility trials.

Methods

Medline, Embase, and Cochrane Central Register of Controlled Trials were searched from January 1, 2011, to December 31, 2011, and January 1, 2021, to December 31, 2021. Studies were included if they were pilot or feasibility randomized trials evaluating a surgical intervention. The primary objective was to determine the proportion of pilot and feasibility trials utilizing spin reporting defined as primary focus on efficacy as opposed to feasibility, focus on statistically significant findings as opposed to feasibility, and/or presentation of results as feasible despite not actually being feasible. Secondary objectives included determining the type of spin reporting and exploring the association between study characteristics and spin reporting.

Results

After screening 1991 citations, 38 studies from 2011 to 34 studies from 2021 were included. Overall, 59 of the included pilot and feasibility trials (81.9%: 59/72, 95% confidence interval [CI] 71.4-89.3%) utilized spin reporting. Fifty-eight trials (80.6%, 95% CI 69.8-88.2%) primarily focused on efficacy as opposed to feasibility, 34 trials (47.2%, 95% CI 36.1-58.6%) focused on statistically significant findings as opposed to feasibility, and four trials (5.6%, 95% CI 1.8-13.8%) suggested feasibility objectives were met when they were not. Spin was identified in 94.7% (95% CI 81.8-99.5%) and 67.6% (95% CI 50.7-81.0%) of studies published in 2011 and 2021, respectively.

Conclusions

Most pilot and feasibility trials in surgery inappropriately focus on clinical outcomes and statistical significance as opposed to feasibility outcomes for the main future trial. This practice is concerning given that pilot trials are not adequately powered and are intended to serve as exploratory study to increase the likelihood of a successful definitive trial.

查看原文本刊更多论文

自旋报告在外科随机对照试验中很常见：一项方法学调查。

简介：Spin报告已经在各种研究类型和领域进行了研究；然而，它还需要在试点和可行性试验的背景下进行研究。我们设计了这个方法学调查来评估外科飞行员和可行性试验中的自旋报告。方法：检索2011年1月1日至2011年12月31日、2021年1月1日至2021年12月31日的Medline、Embase和Cochrane中央对照试验注册库。纳入评估手术干预的试验或可行性随机试验。主要目标是确定利用自旋报告的试点和可行性试验的比例，自旋报告定义为主要关注有效性而不是可行性，关注统计上显著的发现而不是可行性，和/或将结果呈现为可行，尽管实际上并不可行。次要目标包括确定自旋报道的类型和探索研究特征与自旋报道之间的关系。结果：在筛选1991篇引文后，纳入了2011年的38篇研究至2021年的34篇研究。总体而言，纳入的试验和可行性试验中有59项（81.9%:59/72,95%置信区间[CI] 71.4-89.3%）使用了自旋报告。58项试验（80.6%,95% CI 698 -88.2%）主要关注疗效而不是可行性，34项试验（47.2%,95% CI 36.1-58.6%）主要关注统计上显著的发现而不是可行性，4项试验（5.6%,95% CI 1.8-13.8%）表明可行性目标没有得到满足。在2011年和2021年发表的研究中，分别有94.7% （95% CI 81.8-99.5%）和67.6% （95% CI 50.7-81.0%）发现了Spin。结论：大多数外科的试点和可行性试验不恰当地关注临床结果和统计学意义，而不是未来主要试验的可行性结果。这种做法令人担忧，因为试点试验没有足够的动力，旨在作为探索性研究，以增加成功确定试验的可能性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Surgical Research 医学-外科

CiteScore

3.90

自引率

4.50%

发文量

627

审稿时长

138 days

期刊介绍： The Journal of Surgical Research: Clinical and Laboratory Investigation publishes original articles concerned with clinical and laboratory investigations relevant to surgical practice and teaching. The journal emphasizes reports of clinical investigations or fundamental research bearing directly on surgical management that will be of general interest to a broad range of surgeons and surgical researchers. The articles presented need not have been the products of surgeons or of surgical laboratories. The Journal of Surgical Research also features review articles and special articles relating to educational, research, or social issues of interest to the academic surgical community.