Reporting of patient-reported outcomes amongst randomized clinical trials in plastic surgery: a systematic review using CONSORT-PRO

IF 2 3区医学 Q2 SURGERY

Journal of Plastic Reconstructive and Aesthetic Surgery Pub Date : 2024-09-11 DOI:10.1016/j.bjps.2024.09.022

Thomas Milazzo , Morgan Yuan , Amy Graham , Patrick Kim , Lucas Gallo , Kathryn Uhlman , Achilleas Thoma , Christopher Coroneos , Sophocles Voineskos

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引用次数: 0

Abstract

Background

Patient-reported outcomes (PROs) are key to investigating patient perspectives in randomized controlled trials (RCTs). Standardization of PRO reporting is critical for trial generalizability and the application of findings to clinical practice. This systematic review aimed to evaluate the reporting quality of RCTs published in the top plastic surgery journals according to the consolidated standards of reporting trials (CONSORT)-PRO extension.

Methods

We completed a comprehensive search of MEDLINE, Embase, and Cochrane Central Register of Controlled Trials. All RCTs with a validated PRO endpoint published in the top 10 plastic surgery journals (based on the 2021 Web of Science Impact Factor) from 2014 to 2023 were included. Two reviewers independently extracted data and scored the included studies using the CONSORT-PRO checklist. Univariate regression was applied to assess factors associated with reporting adherence. Studies were assessed for their risk of bias using the Cochrane Risk of Bias 2.0 tool.

Results

A total of 88 RCTs were included. PROs were the primary endpoint in 50 (57%) and the secondary endpoint of 38 (43%) studies. Mean overall reporting adherence was poor (39% (±12) and 36% (±13) in studies with PRO as primary and secondary endpoints, respectively). The presence of industry support was significantly associated with greater adherence.

Conclusions

There is low adherence to the CONSORT-PRO extension among plastic surgery RCTs published in the top 10 plastic surgery journals. We encourage journals and authors to endorse and apply the CONSORT-PRO extension. This may optimize the dissemination of clinical findings from RCTs and assist patient-centered care.

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整形外科随机临床试验中患者报告结果的报告：使用 CONSORT-PRO 的系统综述。

背景：患者报告结果（PRO）是随机对照试验（RCT）中调查患者观点的关键。PRO报告的标准化对于试验的可推广性以及将研究结果应用于临床实践至关重要。本系统性综述旨在根据试验报告综合标准（CONSORT）-PRO 扩展标准评估发表在顶级整形外科期刊上的 RCT 报告质量：我们对 MEDLINE、Embase 和 Cochrane 对照试验中央注册中心进行了全面检索。纳入了2014年至2023年期间在排名前10位的整形外科期刊（基于2021年的Web of Science影响因子）上发表的所有具有有效PRO终点的RCT。两名审稿人独立提取数据，并使用 CONSORT-PRO 核对表对纳入的研究进行评分。采用单变量回归评估与报告依从性相关的因素。使用 Cochrane Risk of Bias 2.0 工具评估研究的偏倚风险：结果：共纳入了 88 项研究。50项（57%）研究以PRO为主要终点，38项（43%）研究以PRO为次要终点。在以 PRO 为主要终点和次要终点的研究中，平均总体报告依从性较差（分别为 39% (±12) 和 36% (±13)）。行业支持与更高的依从性明显相关：结论：在排名前十的整形外科期刊上发表的整形外科 RCT 中，对 CONSORT-PRO 扩展条款的遵守程度较低。我们鼓励期刊和作者认可并应用 CONSORT-PRO 扩展。这可能会优化 RCT 临床研究结果的传播，并有助于以患者为中心的护理。

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 Plastic Reconstructive and Aesthetic Surgery 医学-外科

CiteScore

3.10

自引率

11.10%

发文量

578

审稿时长

3.5 months

期刊介绍： JPRAS An International Journal of Surgical Reconstruction is one of the world''s leading international journals, covering all the reconstructive and aesthetic aspects of plastic surgery. The journal presents the latest surgical procedures with audit and outcome studies of new and established techniques in plastic surgery including: cleft lip and palate and other heads and neck surgery, hand surgery, lower limb trauma, burns, skin cancer, breast surgery and aesthetic surgery.