White Samuel J, Chau Minh, Arruzza Elio, Ong Mervyn, John Hritik, Theiss Rebecca, Yaxley Kaspar L, To Minh-Son
Faculty of Health and Medical Sciences, Adelaide Medical School, University of Adelaide, Adelaide, South Australia 5005, Australia; South Australia Medical Imaging, Royal Adelaide Hospital, Adelaide, South Australia 5000, Australia.
Faculty of Science and Health, Charles Sturt University, Wagga Wagga, New South Wales 2678, Australia.
J Clin Epidemiol. 2025 Mar;179:111654. doi: 10.1016/j.jclinepi.2024.111654. Epub 2024 Dec 27.
The Standards for Reporting of Diagnostic Accuracy (STARD) 2015 guideline facilitates evaluation of key aspects of diagnostic test accuracy (DTA) studies and their findings, including the risk of bias and applicability of findings.
To evaluate the completeness of reporting in medical imaging DTA research in a sample of studies published in 2023.
A systematic search of Medline, Embase, and the Cochrane Library was performed to identify medical imaging DTA studies published between January and June 2023 that assessed one or more index imaging tests compared to a reference standard and reported test performance using relevant outcome measures. Completeness of reporting amongst the included studies was assessed using the 30-item STARD-2015 guideline. Multiple linear regression was subsequently performed to identify study characteristics associated with more complete reporting.
A total of 116 studies were included in our analysis with a median journal impact factor of 2.7 (range 0.9-19.7). The mean number of items reported was 17.5/30 (58%, SD 2.2). Items that were infrequently reported (reported in less than 33% of included studies) included items 9 ('whether participants formed a consecutive, random or convenience series'), 13.2 ('whether clinical information and index test results were available to the assessors of the reference standard'), 15 ('how indeterminate index test or reference standard results were handled'), 16 ('how missing data on the index test and reference standard were handled'), 22.1 ('time interval between the index test and the reference standard'), 22.2 ('clinical interventions between the index test and the reference standard') and 29 ('where the full study protocol can be accessed'). Adherence was significantly higher in journals with a higher than median journal impact factor (18.1/30 vs 16.8/30 items reported; P < .001).
The completeness of reporting in medical imaging DTA research is moderate and remains relatively static in absolute terms compared to a previous evaluation of studies published in 2016 performed by Hong and colleagues, acknowledging differences in sample study characteristics limit direct comparison. Potential strategies to support more complete reporting in medical imaging DTA research include mandating adherence to the STARD guideline in journal instructions to authors, requiring completed STARD checklists to be submitted alongside all DTA study manuscripts, and integrating quality of reporting assessment as a routine component of the peer review process.
《诊断准确性报告标准》（STARD）2015指南有助于评估诊断试验准确性（DTA）研究及其结果的关键方面，包括偏倚风险和结果的适用性。
评估2023年发表的一部分医学影像DTA研究报告的完整性。
对Medline、Embase和Cochrane图书馆进行系统检索，以识别2023年1月至6月发表的医学影像DTA研究，这些研究评估了一种或多种索引影像检查与参考标准相比的情况，并使用相关结局指标报告了检查性能。使用30项STARD-2015指南评估纳入研究的报告完整性。随后进行多元线性回归，以确定与更完整报告相关的研究特征。
我们的分析共纳入116项研究，期刊影响因子中位数为2.7（范围0.9-19.7）。报告的项目平均数量为17.5/30（58%，标准差2.2）。报告频率较低的项目（在纳入研究中报告比例低于33%）包括项目9（“参与者是否构成连续、随机或便利系列”）、13.2（“参考标准评估者是否可获得临床信息和索引检查结果”）、15（“如何处理不确定的索引检查或参考标准结果”）、16（“如何处理索引检查和参考标准中的缺失数据”）、22.1（“索引检查和参考标准之间的时间间隔”）、22.2（“索引检查和参考标准之间的临床干预”）和29（“可获取完整研究方案的位置”）。在期刊影响因子高于中位数的期刊中，依从性显著更高（报告的项目为18.1/30对16.8/30；P<0.001）。
医学影像DTA研究的报告完整性中等，与Hong及其同事之前对2016年发表的研究进行的评估相比，绝对水平上保持相对稳定，承认样本研究特征的差异限制了直接比较。支持医学影像DTA研究更完整报告的潜在策略包括在期刊给作者的指南中强制要求遵守STARD指南，要求在提交所有DTA研究手稿时一并提交完整的STARD清单，并将报告质量评估作为同行评审过程的常规组成部分。
