Oklahoma State University Medical Center, Department of Orthopaedic Surgery, Tulsa, OK, USA.
Center for Health Sciences, Oklahoma State University, Tulsa, OK, USA.
J Shoulder Elbow Surg. 2022 Dec;31(12):e620-e627. doi: 10.1016/j.jse.2022.06.021. Epub 2022 Aug 9.
Results produced from randomized controlled trials (RCTs) help guide clinical decision making and health policy. Therefore, it is essential that RCT outcomes- including harms (eg, adverse events)-are adequately reported such that clinicians, patients, and policy makers are equipped with all necessary information to complete risk-benefit assessment of the RCT's intervention. Here, we evaluated the quality of reporting of harms (eg, adverse events) in RCTs cited as supporting evidence for recommendations in the American Academy of Orthopaedic Surgeons (AAOS) Management of Rotator Cuff Injuries clinical practice guidelines (CPGs) using the Consolidated Standards of Reporting Trials (CONSORT) Extension for Harms Checklist.
To quantify adherence to CONSORT Extension for Harms items, each RCT was screened for pertinent information satisfying each checklist item. Screening of CPG reference sections for RCTs underpinning CPG recommendations, as well as data extraction from each of the included RCTs, was performed in a blind and duplicate manner. Descriptive statistics-including frequencies, percentages, and 95% confidence intervals-were used to summarize overall percent adherence to checklist items. A linear regression model assessed the relationship of CONSORT Harms reporting over time.
Ninety-nine RCTs were included in our final sample. Fifty-seven RCTs (of 99; 57.6%) were conducted at a single center. Common funding sources included private (nonindustry) (17/99; 17.2%), private (industry) (8/99; 8.1%), and public (7/99; 7.1%) sources. Sample size for each trial most often consisted of <50 participants (29/99; 29.3%) or 51-100 participants (50/99; 50.5%). The average number of CONSORT Extension for Harms items adequately reported across all included RCTs was 5.7 (of 18; 31.7%). None of the included trials reported all 18 items. Twenty-six RCTs (of 99; 26.3%) adequately reported ≥50% of eligible checklist items. Fifty-nine RCTs (of 99; 59.6%) adequately reported ≤33% of eligible checklist items. Items with ≥50% adherence included item 2, item 7a, and item 8a. Items with ≤20% adherence included item 3b, item 4d, and item 5. Results from our linear regression demonstrated a slight, yet nonsignificant, improvement in adherence to the Harms Extension over time (R = 0.009; P = .407).
Our results illustrate the poor state of harms reporting within RCTs cited as supporting evidence for the AAOS Management of Rotator Cuff Injuries CPG. Efforts to address these gaps in reporting are warranted, as complete knowledge of potential harms is critical to patients, clinicians, and health policy makers when determining best practice decisions in orthopedic surgery.
随机对照试验（RCT）的结果有助于指导临床决策和卫生政策。因此，至关重要的是，RCT 结果——包括危害（例如不良事件）——要得到充分报告，以便临床医生、患者和政策制定者能够获得所有必要的信息，从而对 RCT 干预措施进行风险-效益评估。在这里，我们使用 CONSORT 扩展危害清单评估了美国骨科医师学会（AAOS）肩袖损伤管理临床实践指南（CPG）中支持建议的 RCT 中危害（例如不良事件）报告的质量。
为了量化对 CONSORT 扩展危害清单项目的遵守情况，对每项 RCT 进行了筛查，以确定符合每个清单项目的相关信息。以盲法和重复的方式对 CPG 推荐依据的 RCT 进行 CPG 参考部分筛查，并从每个纳入的 RCT 中提取数据。使用频率、百分比和 95%置信区间等描述性统计数据总结清单项目总体遵守百分比。线性回归模型评估了 CONSORT 危害报告随时间的变化关系。
我们的最终样本包括 99 项 RCT。57 项 RCT（99 项中的 57.6%）在单个中心进行。常见的资助来源包括私人（非工业）（17/99；17.2%）、私人（工业）（8/99；8.1%）和公共（7/99；7.1%）。每个试验的样本量通常由 <50 名参与者（29/99；29.3%）或 51-100 名参与者（50/99；50.5%）组成。所有纳入的 RCT 中平均报告的 CONSORT 扩展危害清单项目数量为 5.7（18 项中的 31.7%）。没有一项纳入的试验报告了所有 18 项。26 项 RCT（99 项中的 26.3%）充分报告了≥50%的合格清单项目。59 项 RCT（99 项中的 59.6%）充分报告了≤33%的合格清单项目。遵守率≥50%的项目包括项目 2、项目 7a 和项目 8a。遵守率≤20%的项目包括项目 3b、项目 4d 和项目 5。我们的线性回归结果表明，危害扩展的遵守情况随着时间的推移略有改善，但无统计学意义（R=0.009；P=0.407）。
我们的结果说明了在作为 AAOS 肩袖损伤管理 CPG 支持证据的 RCT 中危害报告的不良状况。有必要解决这些报告中的差距，因为当确定骨科手术的最佳实践决策时，全面了解潜在危害对患者、临床医生和卫生政策制定者至关重要。
