IRCSS-Fondazione G.B. Bietti, Rome, Italy.
Department of Translational Surgery and Medicine, University of Florence, Florence, Italy.
PLoS One. 2017 Dec 14;12(12):e0189716. doi: 10.1371/journal.pone.0189716. eCollection 2017.
Research has shown a modest adherence of diagnostic test accuracy (DTA) studies in glaucoma to the Standards for Reporting of Diagnostic Accuracy Studies (STARD). We have applied the updated 30-item STARD 2015 checklist to a set of studies included in a Cochrane DTA systematic review of imaging tools for diagnosing manifest glaucoma.
Three pairs of reviewers, including one senior reviewer who assessed all studies, independently checked the adherence of each study to STARD 2015. Adherence was analyzed on an individual-item basis. Logistic regression was used to evaluate the effect of publication year and impact factor on adherence.
We included 106 DTA studies, published between 2003-2014 in journals with a median impact factor of 2.6. Overall adherence was 54.1% for 3,286 individual rating across 31 items, with a mean of 16.8 (SD: 3.1; range 8-23) items per study. Large variability in adherence to reporting standards was detected across individual STARD 2015 items, ranging from 0 to 100%. Nine items (1: identification as diagnostic accuracy study in title/abstract; 6: eligibility criteria; 10: index test (a) and reference standard (b) definition; 12: cut-off definitions for index test (a) and reference standard (b); 14: estimation of diagnostic accuracy measures; 21a: severity spectrum of diseased; 23: cross-tabulation of the index and reference standard results) were adequately reported in more than 90% of the studies. Conversely, 10 items (3: scientific and clinical background of the index test; 11: rationale for the reference standard; 13b: blinding of index test results; 17: analyses of variability; 18; sample size calculation; 19: study flow diagram; 20: baseline characteristics of participants; 28: registration number and registry; 29: availability of study protocol; 30: sources of funding) were adequately reported in less than 30% of the studies. Only four items showed a statistically significant improvement over time: missing data (16), baseline characteristics of participants (20), estimates of diagnostic accuracy (24) and sources of funding (30).
Adherence to STARD 2015 among DTA studies in glaucoma research is incomplete, and only modestly increasing over time.
研究表明,在诊断测试准确性(DTA)研究中,仅有少量研究符合诊断准确性研究报告标准(STARD)。我们应用更新的 30 项 STARD 2015 清单,对一项纳入 Cochrane DTA 系统评价的影像学工具诊断显性青光眼的研究进行了评估。
由三组评审员进行评估,其中一位资深评审员评估了所有研究,评审员们独立地检查了每项研究对 STARD 2015 的遵守情况。遵守情况基于各个项目进行分析。采用逻辑回归来评估发表年份和影响因子对遵守情况的影响。
我们纳入了 106 项 DTA 研究,这些研究于 2003-2014 年发表在影响因子中位数为 2.6 的期刊上。在 31 个项目的 3286 个单项评分中,整体遵守率为 54.1%,平均每个研究有 16.8 个项目(SD:3.1;范围 8-23)。在 STARD 2015 各项具体标准的报告中,发现遵守率存在很大差异,从 0%到 100%不等。有 9 个项目(1:标题/摘要中明确识别为诊断准确性研究;6:纳入标准;10:检测方法(a)和参考标准(b)的定义;12:检测方法(a)和参考标准(b)的截断值定义;14:诊断准确性测量的估计;21a:疾病的严重程度谱;23:检测方法和参考标准结果的交叉列表)在超过 90%的研究中得到了充分的报告。相反,有 10 个项目(3:检测方法的科学和临床背景;11:参考标准的理由;13b:检测方法结果的盲法;17:变异性分析;18:样本量计算;19:研究流程图;20:参与者的基线特征;28:注册编号和注册处;29:研究方案的可获取性;30:资金来源)在不到 30%的研究中得到了充分的报告。仅 4 个项目显示出随时间的统计学显著改善:缺失数据(16)、参与者的基线特征(20)、诊断准确性估计(24)和资金来源(30)。
在青光眼研究的 DTA 研究中,对 STARD 2015 的遵守情况并不完整,并且仅随时间略有增加。