Background:The American Academy of Orthopaedic Surgeons (AAOS) has developed a clinical practice guideline (CPG) for management of anterior cruciate ligament (ACL) injuries. Primary studies such as randomized controlled trials (RCTs) are cited as evidence for the guidelines. Given the influence that these trials have on patient care, adherence to standardized protocols for conducting and reporting RCTs is essential.Purpose:To evaluate the CONSORT (Consolidated Standards of Reporting Trials) Extension for Harms–related reporting of RCTs cited as supporting evidence for the AAOS CPG on the management of ACL tears.Study Design:Cross-sectional study.Methods:The reference section of the AAOS guideline for ACL tears was first screened for RCTs cited in the CPG. Next, each RCT was evaluated for adherence to the CONSORT Extension for Harms checklist. Both identification of RCTs and assessment of adherence were performed in a masked and duplicate process. Descriptive statistics were used to summarize adherence to CONSORT Extension for Harms items. A Pearson correlation test was conducted to assess the relationship between the year of publication and adherence to CONSORT harms reporting.Results:The sample included 113 RCTs, of which 16 (14.2%) were published before the CONSORT Extension for Harms was implemented in 2004. Sample sizes ranged from 24 to 4564 participants, with a mean of 228. None of the included RCTs included all 18 items in the CONSORT Extension for Harms checklist. The mean number of checklist items reported was 4 (of 18; 22.2%). A moderate, positive, and statistically significant correlation was found between the RCT publication year and the adherence with reporting of the CONSORT Extension for Harms ( t111 = 3.54; P < .001) ( r = 0.32; 95% CI, 0.14-0.47).Conclusion:Harms were infrequently reported in RCTs cited as supporting evidence in the AAOS CPG for the management of ACL tears. One encouraging finding was the positive correlation between the year when RCTs were published and how well they adhered to reporting harms. Efforts to improve adverse event reporting are warranted, as RCTs are commonly used to make clinical decisions in orthopaedic surgery.

中文翻译：

---

透明度很重要：在支持 AAOS 前十字韧带损伤临床实践指南的随机对照试验中评估危害报告合规性


背景：美国骨科医师学会 (AAOS) 制定了前十字韧带 (ACL) 损伤治疗的临床实践指南 (CPG)。随机对照试验 (RCT) 等初步研究被引用作为指南的证据。鉴于这些试验对患者护理的影响，遵守进行和报告 RCT 的标准化方案至关重要。 目的：评估 CONSORT（报告试验综合标准）扩展危害相关的 RCT 报告，被引用为支持证据AAOS CPG 对 ACL 撕裂的管理。研究设计：横断面研究。方法：首先筛选 AAOS ACL 撕裂指南的参考部分，以查找 CPG 中引用的 RCT。接下来，评估每个 RCT 是否遵守 CONSORT Extension for Harms 检查表。随机对照试验的识别和依从性的评估都是在隐蔽和重复的过程中进行的。使用描述性统计来总结对 CONSORT Extension for Harms 项目的遵守情况。进行了 Pearson 相关性检验，以评估发布年份与遵守 CONSORT 危害报告之间的关系。结果：样本包括 113 个 RCT，其中 16 个（14.2%）是在 2004 年实施 CONSORT Extension for Harms 之前发布的。样本量范围为 24 至 4564 名参与者，平均为 228 名。纳入的 RCT 均未包含 CONSORT Extension for Harms 清单中的全部 18 项。报告的清单项目的平均数量为 4 个（共 18 个；22.2%）。研究发现，RCT 发表年份与 CONSORT Extension for Harms 报告的遵守情况之间存在中度、正向且具有统计显着性的相关性（t 111 = 3.54； P < .001) ( r = 0。32； 95% CI, 0.14-0.47）。结论：在 AAOS CPG 中引用作为 ACL 撕裂治疗支持证据的随机对照试验中，很少报告危害。一个令人鼓舞的发现是随机对照试验发表的年份与他们遵守报告危害的程度之间呈正相关。由于随机对照试验通常用于骨科手术的临床决策，因此有必要努力改进不良事件报告。