Division of Urology, The Hospital for Sick Children, Department of Surgery, University of Toronto, Toronto, Ontario, Canada; Section of Paediatric Urology, Urology Unit, University Hospital of Padua, Padua, Italy.
Department of Surgery/Urology, McMaster University, Hamilton, Ontario, Canada.
J Pediatr Urol. 2019 May;15(3):204-212. doi: 10.1016/j.jpurol.2019.02.014. Epub 2019 Mar 7.
BACKGROUND/INTRODUCTION: Randomized controlled trials (RCTs) are considered the "gold standard" methodology for examining the effects of clinical interventions, yet only 1% of urology literature employs this design. The Consolidated Standards of Reporting Trials (CONSORT) statement contains a standardized checklist of 37 items to be included when reporting RCTs to ensure transparency and completeness of information [2]. Despite the robust design of RCTs, the number of events can greatly change the significance of the results, which can be represented by the fragility index (FI).
The objective was to assess the quality of reporting of RCTs in the pediatric vesicoureteral reflux (VUR) literature using the 2010 CONSORT statement and, for studies with significant positive findings, to determine the FI as a measure of robustness of the results.
A comprehensive search was conducted through MEDLINE® and Embase® to identify RCTs in VUR literature from 2000 to 2016. Two reviewers independently selected articles, which were evaluated using the CONSORT checklist. An overall quality of reporting score (OQS) (%) was calculated by dividing the number of checklist items present in each study by the maximum possible score (34) and expressed as a percentage. Studies were classified as low (<40%), moderate (40-70%) and high quality (>70%) based on the modified assessing the methodological quality of systematic reviews (AMSTAR) checklist. Of the 2052 initial matches, 98% were excluded due to methodology or content, a further 28 studies were found not to meet inclusion criteria after full text review. The FI was calculated for the 7 studies that met inclusion criteria with significantly different results by manually adding events to the study groups until p>0.05.
Twenty-two studies met inclusion criteria. The mean OQS was 46+17% with 9 (41%) identified as low quality (score <40%), 11 (50%) as moderate (40-70%) and 2 (9%) as high quality (>70%). There was no significant difference in OQS between RCTs with a sample size > 100 (n=15) versus <100 patients (n=7) (45+17% vs. 47+17%, p=0.7). However, we noted a difference when we compared RCTs with biostatistician support (n=4) vs. those without (n=18) (59+20% vs. 43+15%, p<0.05). Seven studies reported significant positive results making calculation of FI possible. The mean FI was 5.8+5.1 indicating that most studies were fragile. There was no correlation between the OQS and FI.
The mean OQS of VUR RCTs was suboptimal (46%), with most studies having low FI scores indicating the instability of the findings. The only variable that significantly impacted the OQS was biostatistician support. Implementation of the CONSORT checklist with a minimum of 50% inclusion as a prerequisite for submission of manuscripts may improve the quality and transparency of reporting. Calculation of the FI could provide readers with an objective measure of robustness for the published trials, allowing for appropriate interpretation of the results.
背景/引言：随机对照试验（RCT）被认为是检验临床干预效果的“金标准”方法，但只有 1%的泌尿科文献采用这种设计。CONSORT 报告标准包含了 37 项标准化检查表条目，用于报告 RCT，以确保信息的透明度和完整性[2]。尽管 RCT 的设计很稳健，但事件的数量会极大地改变结果的意义，这可以用脆弱指数（FI）来表示。
本研究旨在使用 2010 年 CONSORT 声明评估小儿膀胱输尿管反流（VUR）文献中 RCT 报告的质量，并对具有显著阳性发现的研究进行 FI 分析，以衡量结果的稳健性。
通过 MEDLINE®和 Embase®进行全面检索，以确定 2000 年至 2016 年 VUR 文献中的 RCT。两名评审员独立选择文章，并使用 CONSORT 检查表进行评估。通过将每个研究中存在的检查表条目数除以最大可能得分（34）来计算总体报告质量评分（OQS）（%），并表示为百分比。根据改良的评估系统评价方法学质量（AMSTAR）检查表，将研究分为低质量（<40%）、中质量（40-70%）和高质量（>70%）。在 2052 条初始匹配中，由于方法或内容，98%被排除在外，进一步对 28 篇全文审查后不符合纳入标准的研究进行了评估。对 7 项符合纳入标准且结果差异显著的研究进行了 FI 计算，通过手动向研究组添加事件，直到 p>0.05。
22 项研究符合纳入标准。OQS 的平均得分是 46+17%，其中 9 项（41%）被认为是低质量（得分<40%），11 项（50%）是中质量（40-70%），2 项（9%）是高质量（>70%）。样本量>100 例（n=15）与<100 例患者（n=7）的 RCT 之间的 OQS 无显著差异（45+17% vs. 47+17%，p=0.7）。然而，当我们比较有生物统计学家支持的 RCT（n=4）与没有支持的 RCT（n=18）时，我们注意到了差异（59+20% vs. 43+15%，p<0.05）。7 项研究报告了显著的阳性结果，使 FI 的计算成为可能。平均 FI 为 5.8+5.1，表明大多数研究的结果不稳定。OQS 与 FI 之间没有相关性。
VUR RCT 的平均 OQS 较差（46%），大多数研究的 FI 评分较低，表明结果不稳定。唯一显著影响 OQS 的变量是生物统计学家的支持。实施 CONSORT 检查表，将 50%的纳入率作为提交稿件的最低要求，可能会提高报告的质量和透明度。FI 的计算可以为已发表的试验提供一个客观的稳健性衡量标准，允许对结果进行适当的解释。
