背景:临床意义,与统计意义相反,已越来越多地用于评估全肩关节置换术(TSA)后的结果。这项研究的目的是确定最小临床重要差异(MCID)的阈值,实质性临床获益(SCB),和TSA结果指标的患者可接受症状状态(PASS),并确定这些阈值是否受假体类型(解剖或反向TSA)的影响,性别,或术前诊断。
方法:前瞻性收集的包含38名外科医生的国际多中心数据库查询了2003年至2021年间接受原发性aTSA或rTSA的患者。Prospective,结果指标,包括ASES,肩功能评分(SFS),SST,加州大学洛杉矶分校,常数,VAS疼痛,肩关节置换术智能(SAS)评分,前屈,绑架,外部旋转,术前和每次随访时记录内旋.每次随访时都会提出患者满意度问题。基于锚的MCID,SCB,和PASS按先前定义的总体计算,并根据植入物类型,术前诊断,和性爱。达到阈值的患者百分比也被量化。
结果:总共5,851例肩关节置换术,包括aTSA(n=2,236)和rTSA(n=3,615)纳入研究队列。以下被确定为整体(aTSA+rTSA,不考虑诊断或性别)队列的MCID阈值:VAS疼痛(-1.5),SFS(1.2),SST(2.1),常数(7.2),ASES(13.9),UCLA(8.2),SPADI(-21.5),和SAS(7.3),外展(13°),向前高程(16°),外部旋转(4°),内部旋转分数(0.2)。整个队列的SCB阈值为:VAS疼痛(-3.3),SFS(2.9),SST3.8),常数(18.9),ASES(33.1),UCLA(12.3),SPADI(-44.7),和SAS(18.2),外展(30°),向前高程(31°),外部旋转(12°),内部旋转评分(0.9)。总体队列的PASS阈值为:VAS疼痛(0.8),SFS(7.3),SST(9.2),常数(64.2),ASES(79.5),加州大学洛杉矶分校(29.5),SPADI(24.7),和SAS(72.5),外展(104°),向前高程(130°),外旋(30°),内部旋转评分(3.2)。MCID,SCB,和PASS阈值根据术前诊断和性别而变化。
结论:MCID,SCB,和PASS阈值根据植入物类型而变化,术前诊断,和性爱。对这些差异的全面理解以及对传统和新颖指标的临床相关阈值的识别对于帮助外科医生评估患者的结果至关重要。解读文学,术前咨询他们的病人关于改善的期望。鉴于PASS阈值是脆弱的,并且根据队列变异性变化很大,在不同的研究中将它们混为一谈时,应谨慎行事。
BACKGROUND: Clinical significance, as opposed to statistical significance, has increasingly been utilized to evaluate outcomes after total shoulder arthroplasty (TSA). The purpose of this study was to identify thresholds of the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) for TSA outcome metrics and determine if these thresholds are influenced by prosthesis type (anatomic or reverse TSA), sex, or preoperative diagnosis.
METHODS: A prospectively collected international multicenter database inclusive of 38 surgeons was queried for patients receiving a primary aTSA or
rTSA between 2003 and 2021. Prospectively, outcome metrics including ASES, shoulder function score (SFS), SST, UCLA, Constant, VAS Pain, shoulder arthroplasty smart (SAS) score, forward flexion, abduction, external rotation, and internal rotation was recorded preoperatively and at each follow-up. A patient satisfaction question was administered at each follow-up. Anchor-based MCID, SCB, and PASS were calculated as defined previously overall and according to implant type, preoperative diagnosis, and sex. The percentage of patients achieving thresholds was also quantified.
RESULTS: A total of 5851 total shoulder arthroplasties (TSAs) including aTSA (n = 2236) and
rTSA (n = 3615) were included in the study cohort. The following were identified as MCID thresholds for the overall (aTSA +
rTSA irrespective of diagnosis or sex) cohort: VAS Pain (-1.5), SFS (1.2), SST (2.1), Constant (7.2), ASES (13.9), UCLA (8.2), SPADI (-21.5), and SAS (7.3), Abduction (13°), Forward elevation (16°), External rotation (4°), Internal rotation score (0.2). SCB thresholds for the overall cohort were: VAS Pain (-3.3), SFS (2.9), SST 3.8), Constant (18.9), ASES (33.1), UCLA (12.3), SPADI (-44.7), and SAS (18.2), Abduction (30°), Forward elevation (31°), External rotation (12°), Internal rotation score (0.9). PASS thresholds for the overall cohort were: VAS Pain (0.8), SFS (7.3), SST (9.2), Constant (64.2), ASES (79.5), UCLA (29.5), SPADI (24.7), and SAS (72.5), Abduction (104°), Forward elevation (130°), External rotation (30°), Internal rotation score (3.2). MCID, SCB, and PASS thresholds varied depending on preoperative diagnosis and sex.
CONCLUSIONS: MCID, SCB, and PASS thresholds vary depending on implant type, preoperative diagnosis, and sex. A comprehensive understanding of these differences as well as identification of clinically relevant thresholds for legacy and novel metrics is essential to assist surgeons in evaluating their patient\'s outcomes, interpreting the literature, and counseling their patients preoperatively regarding expectations for improvement. Given that PASS thresholds are fragile and vary greatly depending on cohort variability, caution should be exercised in conflating them across different studies.