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对于接受髋臼周围截骨术的患者,改良Harris髋关节评分和国际髋关节结果工具12的最小临床重要差异、显著临床益处及患者可接受的症状状态阈值分别是多少?

What Are the Minimum Clinically Important Difference, Substantial Clinical Benefit, and Patient-Acceptable Symptom State Thresholds for the Modified Harris Hip Score and International Hip Outcome Tool 12 Among Patients Who Undergo Periacetabular Osteotomy?

作者信息

Trotzky Zachary A, Smolarsky Ryan G, Madjarova Sophia J, Jochl Olivia M, Ricciardi Benjamin F, Lyman Stephen, MacLean Catherine H, Nwachukwu Benedict U, Sink Ernest L

机构信息

Hospital for Special Surgery, New York, NY, USA.

University of Rochester Medical Center, Rochester, NY, USA.

出版信息

Clin Orthop Relat Res. 2025 Feb 12. doi: 10.1097/CORR.0000000000003393.

Abstract

BACKGROUND

The utility of patient-reported outcome measures (PROMs) has been well established, but their interpretation relies on population-specific definitions of meaningful improvement. As such, the minimum clinically important difference (MCID), substantial clinical benefit (SCB), and patient-acceptable symptom state (PASS) thresholds have become prominent metrics in the orthopaedic evidence to ascribe clinical relevance to numeric PROM scores. Studies assessing outcomes of periacetabular osteotomy (PAO) relative to the MCID and PASS have previously evaluated patients against thresholds defined for hip arthroscopy for the treatment of femoroacetabular impingement or distribution-based MCID calculations. These scores may not accurately reflect the status or expectations of patients with a different symptom profile undergoing open hip preservation surgery.

QUESTIONS/PURPOSES: For patients treated with PAO, we sought to (1) define the MCID, SCB, and PASS threshold values for the mHHS (modified Harris hip score) and International Hip Outcome Tool 12 (iHOT-12) using anchor-based methods; (2) assess the validity of MCID and SCB estimates against minimal detectable change (MDC) values; and (3) determine the proportion of patients who achieved a clinically meaningful threshold.

METHODS

Between February 2011 and May 2023, a total of 690 patients underwent PAO for symptomatic acetabular dysplasia at one institution and were included in a longitudinally maintained hip preservation registry. The cohort used to define and validate MCID, SCB, and PASS threshold values consisted of those with a completed postoperative anchor questionnaire, which yielded 456 patients as potentially eligible. An additional 139 patients were excluded because of missing mHHS or iHOT-12 scores during the eligibility window (1 to 2 years postoperatively), leaving 70% (317 of 456) of patients to define and validate MCID, SCB, and PASS at a mean ± SD of 1.0 ± 0.3 years of follow-up. A minimum 1-year follow-up was chosen to reduce recall bias. The cohort for defining MCID, SCB, and PASS (94% [298 of 317] women, mean ± SD age at time of surgery 27 ± 8 years) included 21% (68 of 317) of patients with prior ipsilateral surgery. From those registry patients without complete anchor questionnaires, 37% (137 of 373) were identified with pre- and postoperative PROM scores at a mean ± SD of 1.0 ± 0.9 years of follow-up to form the sample for assessing the proportion of patients achieving a clinically meaningful threshold. The MCID, SCB, and PASS thresholds for the mHHS and iHOT-12 were calculated through an anchor-based approach, using area under the receiver operating curve to determine cut points that best identified positive responses, according to quality of life-based anchor questions. The MDC was calculated with confidence intervals (CIs) reflecting 80%, 90%, and 95% certainty to determine the smallest change in the PROM scores that can be considered above the level of measurement error. The validity of MCID estimates was assessed by confirming that they exceeded corresponding MDC values. The validity of SCB estimates were assessed by confirming that they exceeded corresponding MCID values. The proportion of patients achieving a clinically meaningful threshold was determined by calculating the percentage of patients who met the defined anchor-based scores.

RESULTS

The MCID, SCB, and PASS thresholds for the mHHS were 18, 23, and 71, respectively. The MCID, SCB, and PASS thresholds for the iHOT-12 were 26, 42, and 65, respectively. The MDC ranged from 8 to 12 for the mHHS and 10 to 16 for the iHOT-12. The MCID values for the mHHS and iHOT-12 exceeded corresponding values of the MDC at all CIs. The SCB thresholds exceeded all corresponding MDC and MCID values. Across the mHHS and iHOT-12, the proportion of patients who achieved an MCID at the first time point ranged from 60% to 73%, the proportion of patients who achieved the SCB ranged from 49% to 56%, and the proportion of patients who achieved the PASS threshold ranged from 55% to 79%. Among the cohort for defining MCID, SCB, and PASS, the proportion of patients achieving any MCID, SCB, or PASS was 79%, 66%, and 81%, respectively. Among the sample for assessing the proportion of patients achieving a clinically meaningful threshold, the proportion achieving any MCID, SCB, or PASS threshold was 74%, 58%, and 72%, respectively.

CONCLUSION

We found that using a sample of patients undergoing PAO, the anchor-based values for the MCID and SCB were generally larger than previous distribution- and anchor-based scores that have been defined for hip preservation, whereas PASS threshold scores were similar. All MCID and SCB thresholds exceeded corresponding MDC values, confirming these scores to be valid estimates. These metrics provide more rigorous, procedure-specific definitions for the evaluation of treatment success and failure after PAO. As anchor-based metrics are defined based on patients' perceptions, they should be used preferentially for postoperative assessment over distribution-based scores.

LEVEL OF EVIDENCE

Level III, therapeutic study.

摘要

背景

患者报告结局测量指标(PROMs)的效用已得到充分证实,但其解读依赖于针对有意义改善的特定人群定义。因此,最小临床重要差异(MCID)、显著临床获益(SCB)和患者可接受症状状态(PASS)阈值已成为骨科证据中的重要指标,用于赋予数字PROM分数临床相关性。此前评估髋臼周围截骨术(PAO)相对于MCID和PASS结局的研究,是根据为治疗股骨髋臼撞击症的髋关节镜检查定义的阈值或基于分布的MCID计算来评估患者的。这些分数可能无法准确反映接受开放性髋关节保留手术、具有不同症状特征患者的状况或期望。

问题/目的:对于接受PAO治疗的患者,我们试图:(1)使用基于锚定的方法定义改良Harris髋关节评分(mHHS)和国际髋关节结局工具12(iHOT - 12)的MCID、SCB和PASS阈值;(2)根据最小可检测变化(MDC)值评估MCID和SCB估计值的有效性;(3)确定达到临床有意义阈值的患者比例。

方法

2011年2月至2023年5月期间,共有690例患者在一家机构接受了PAO治疗有症状的髋臼发育不良,并被纳入一个长期维护的髋关节保留登记系统。用于定义和验证MCID、SCB和PASS阈值的队列包括那些完成了术后锚定问卷的患者,这产生了456例可能符合条件的患者。另外139例患者因在符合条件的时间段(术后1至2年)内缺少mHHS或iHOT - 12评分而被排除,剩下70%(456例中的317例)患者在平均±标准差为1.0±0.3年的随访中定义和验证MCID、SCB和PASS。选择至少1年的随访时间以减少回忆偏倚。用于定义MCID、SCB和PASS的队列(94%[317例中的298例]为女性,手术时平均±标准差年龄为27±8岁)包括21%(317例中的68例)曾接受同侧手术的患者。从那些没有完整锚定问卷的登记患者中,37%(373例中的137例)在平均±标准差为1.0±0.9年的随访中确定了术前和术后的PROM分数,以形成评估达到临床有意义阈值患者比例的样本。mHHS和iHOT - 12的MCID、SCB和PASS阈值通过基于锚定的方法计算,根据基于生活质量的锚定问题,使用受试者工作特征曲线下面积来确定最能识别阳性反应的切点。MDC通过反映80%、90%和95%确定性的置信区间(CIs)计算,以确定PROM分数中可被认为高于测量误差水平的最小变化。通过确认MCID估计值超过相应的MDC值来评估MCID估计值的有效性。通过确认SCB估计值超过相应的MCID值来评估SCB估计值的有效性。通过计算达到基于锚定定义分数的患者百分比来确定达到临床有意义阈值的患者比例。

结果

mHHS的MCID、SCB和PASS阈值分别为18、23和71。iHOT - 12的MCID、SCB和PASS阈值分别为26、42和65。mHHS的MDC范围为8至12,iHOT - 12的MDC范围为10至16。mHHS和iHOT - 12的MCID值在所有置信区间均超过相应的MDC值。SCB阈值超过所有相应的MDC和MCID值。在mHHS和iHOT - 12中,首次达到MCID的患者比例为60%至73%,达到SCB的患者比例为49%至56%,达到PASS阈值的患者比例为55%至79%。在定义MCID、SCB和PASS的队列中,达到任何MCID、SCB或PASS的患者比例分别为79%、66%和81%。在评估达到临床有意义阈值患者比例的样本中,达到任何MCID、SCB或PASS阈值的患者比例分别为74%、58%和72%。

结论

我们发现,使用接受PAO治疗的患者样本,基于锚定的MCID和SCB值通常大于先前为髋关节保留定义的基于分布和锚定的分数,而PASS阈值分数相似。所有MCID和SCB阈值均超过相应的MDC值,证实这些分数是有效的估计值。这些指标为评估PAO治疗成功与失败提供了更严格、针对具体手术的定义。由于基于锚定的指标是根据患者的感知定义的,与基于分布的分数相比,它们应优先用于术后评估。

证据水平

III级,治疗性研究。

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