Office of Medical Student Research, Oklahoma State University Center for Health Sciences.
Department of Orthopaedic Surgery, Oklahoma State University Medical Center, Tulsa, OK.
J Pediatr Orthop. 2022 Feb 1;42(2):e218-e223. doi: 10.1097/BPO.0000000000002002.
Randomized control trials (RCTs) serve as evidentiary support for recommendations underpinning clinical practice guidelines (CPGs) with the goal of optimizing patient care. A knowledge gap exists within scientific literature when evaluating the quality of RCTs used as evidence in the American Academy of Orthopaedic Surgery (AAOS) pediatric CPGs. We aim to evaluate the reporting quality and risk of bias in RCTs underlying AAOS Pediatric CPG recommendations.
We located all AAOS Pediatric CPGs. We then extracted all RCTs from the CPG reference sections. All included RCTs were evaluated using the Consolidated Standards of Reporting Trials (CONSORT) checklist and Cochrane Collaboration risk of bias assessment tool (RoB 2.0). Descriptive statistics were recorded, and bivariate analysis was used to account for variance in CONSORT scores. A Mann-Whitney U test was completed to compare CONSORT studies published before and after 2010.
Three CPGs and 23 RCTs met inclusion criteria. Mean CONSORT adherence was 69.8% (21.6/31). The lowest adhered to CONSORT items were 10, 23, and 24, while items 2a, 13a, and 18 displayed the highest adherence. Ten RCTs (43.5%, 10/23) had "low" risk of bias, 5 RCTs (21.7%, 5/23) were of "some concerns," and 8 RCTs (34.8%, 8/23) received a "high" designation for risk of bias. There were no statistically significant associations in the bivariate regression analysis or Mann-Whitney U test.
Our results suggest that CONSORT adherence within RCTs used as evidence in AAOS Pediatric CPGs is substandard-relying on evidence that, in some cases, is >20 years old. Many of the RCTs cited as supporting evidence have a "high" risk of bias. Altogether, these CPGs may need to be updated or expanded to include more recent evidence relevant to pediatric orthopaedic surgery.
随机对照试验(RCT)为临床实践指南(CPG)所依据的建议提供了证据支持,目的是优化患者护理。在评估作为美国骨科医师学会(AAOS)儿科 CPG 证据使用的 RCT 质量时,科学文献中存在知识空白。我们旨在评估 AAOS 儿科 CPG 推荐背后的 RCT 的报告质量和偏倚风险。
我们找到了所有的 AAOS 儿科 CPG。然后,我们从 CPG 参考部分提取了所有的 RCT。所有纳入的 RCT 均使用 CONSORT 清单和 Cochrane 协作风险偏倚评估工具(RoB 2.0)进行评估。记录描述性统计数据,并使用双变量分析来解释 CONSORT 评分的差异。完成 Mann-Whitney U 检验以比较 2010 年前后发表的 CONSORT 研究。
有 3 项 CPG 和 23 项 RCT 符合纳入标准。平均 CONSORT 依从性为 69.8%(21.6/31)。依从性最低的 CONSORT 项目为 10、23 和 24,而项目 2a、13a 和 18 的依从性最高。10 项 RCT(43.5%,10/23)的偏倚风险为“低”,5 项 RCT(21.7%,5/23)的偏倚风险为“有一定担忧”,8 项 RCT(34.8%,8/23)的偏倚风险为“高”。在双变量回归分析或 Mann-Whitney U 检验中均未发现统计学显著关联。
我们的研究结果表明,AAOS 儿科 CPG 中用作证据的 RCT 的 CONSORT 依从性不达标,依赖的证据在某些情况下已有 20 多年的历史。许多被引用为支持证据的 RCT 存在“高”偏倚风险。总的来说,这些 CPG 可能需要更新或扩展,以纳入与儿科骨科手术相关的最新证据。