Sudah Suleiman Y, Bragg Jack T, Mojica Edward S, Moverman Michael A, Puzzitiello Richard N, Pagani Nicholas R, Salzler Matthew J, Denard Patrick J, Menendez Mariano E
Department of Orthopedic Surgery, Monmouth Medical Center, Long Branch, NJ, USA.
Department of Orthopedic Surgery, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA.
HSS J. 2024 May;20(2):254-260. doi: 10.1177/15563316231157760. Epub 2023 Mar 9.
The American Academy of Orthopaedic Surgeons (AAOS) clinical practice guidelines (CPGs) note "strong" evidence that early and delayed mobilization protocols after small to medium arthroscopic rotator cuff repairs achieve similar rotator cuff healing rates. : We utilized the reverse fragility index (RFI) to assess the fragility of randomized controlled trials (RCTs) reporting no statistically significant difference in tendon re-tear rates after rotator cuff repair in those undergoing early versus delayed rehabilitation. : Randomized controlled trials used in the most recent AAOS CPGs on the timing of postoperative mobilization after arthroscopic rotator cuff repairs were analyzed. Only RCTs with a reported value ≥ .05 were included. The RFI at a threshold of < .05 was calculated for each study. The reverse fragility quotient (RFQ) was calculated by dividing the RFI by the study sample size. : In 6 clinical trials with a total of 542 patients, the number of tendon re-tear events was 48. The median RFI at the < .05 threshold was 4 (range: 3.25-4.75), and the median RFQ was .05 (range: 0.03-0.08). The median loss to follow-up was 6 patients. Of the 6 studies investigated, 3 reported a loss to follow-up greater than their respective RFI. : The equivalence in rotator cuff repair healing rates associated with early and delayed mobilization protocols rests on fragile studies, as their statistical non-significance can be reversed by changing the outcome status of only a handful of patients. Consideration should be given to the routine reporting of RFI in clinical practice guidelines including RCTs with statistically non-significant results.
美国骨科医师学会（AAOS）的临床实践指南（CPG）指出，有“强有力”的证据表明，中小型关节镜下肩袖修复术后的早期和延迟活动方案能达到相似的肩袖愈合率。：我们利用反向脆弱性指数（RFI）来评估那些报告在早期与延迟康复的肩袖修复术后肌腱再撕裂率无统计学显著差异的随机对照试验（RCT）的脆弱性。：分析了AAOS最新CPG中关于关节镜下肩袖修复术后活动时机的随机对照试验。仅纳入报告值≥.05的RCT。为每项研究计算阈值<.05时的RFI。反向脆弱性商数（RFQ）通过将RFI除以研究样本量来计算。：在总共542例患者的6项临床试验中，肌腱再撕裂事件的数量为48例。<.05阈值时的RFI中位数为4（范围：3.25 - 4.75），RFQ中位数为.05（范围：0.03 - 0.08）。失访患者中位数为6例。在调查的6项研究中，3项报告的失访人数大于各自的RFI。：与早期和延迟活动方案相关的肩袖修复愈合率的等效性基于脆弱的研究，因为仅改变少数患者的结局状态就能扭转其统计学上的无显著性差异。在临床实践指南中应考虑常规报告RFI，包括结果无统计学显著性的RCT。
