Background 

Patient-reported outcome measures (PROMs), including the Patient-reported Outcomes Measurement Information System (PROMIS), are increasingly used to measure healthcare value. The minimum clinically important difference (MCID) is a metric that helps clinicians determine whether a statistically detectable improvement in a PROM after surgical care is likely to be large enough to be important to a patient or to justify an intervention that carries risk and cost. There are two major categories of MCID calculation methods, anchor-based and distribution-based. This variability, coupled with heterogeneous surgical cohorts used for existing MCID values, limits their application to clinical care.

Questions/purposes 

In our study, we sought (1) to determine MCID thresholds and attainment percentages for PROMIS after common orthopaedic procedures using distribution-based methods, (2) to use anchor-based MCID values from published studies as a comparison, and (3) to compare MCID attainment percentages using PROMIS scores to other validated outcomes tools such as the Hip Disability and Osteoarthritis Outcome Score (HOOS) and Knee Disability and Osteoarthritis Outcome Score (KOOS).

Methods 

This was a retrospective study at two academic medical centers and three community hospitals. The inclusion criteria for this study were patients who were age 18 years or older and who underwent elective THA for osteoarthritis, TKA for osteoarthritis, one-level posterior lumbar fusion for lumbar spinal stenosis or spondylolisthesis, anatomic total shoulder arthroplasty or reverse total shoulder arthroplasty for glenohumeral arthritis or rotator cuff arthropathy, arthroscopic anterior cruciate ligament reconstruction, arthroscopic partial meniscectomy, or arthroscopic rotator cuff repair. This yielded 14,003 patients. Patients undergoing revision operations or surgery for nondegenerative pathologies and patients without preoperative PROMs assessments were excluded, leaving 9925 patients who completed preoperative PROMIS assessments and 9478 who completed other preoperative validated outcomes tools (HOOS, KOOS, numerical rating scale for leg pain, numerical rating scale for back pain, and QuickDASH). Approximately 66% (6529 of 9925) of patients had postoperative PROMIS scores (Physical Function, Mental Health, Pain Intensity, Pain Interference, and Upper Extremity) and were included for analysis. PROMIS scores are population normalized with a mean score of 50 ± 10, with most scores falling between 30 to 70. Approximately 74% (7007 of 9478) of patients had postoperative historical assessment scores and were included for analysis. The proportion who reached the MCID was calculated for each procedure cohort at 6 months of follow-up using distribution-based MCID methods, which included a fraction of the SD (1/2 or 1/3 SD) and minimum detectable change (MDC) using statistical significance (such as the MDC 90 from p < 0.1). Previously published anchor-based MCID thresholds from similar procedure cohorts and analogous PROMs were used to calculate the proportion reaching MCID.

Results 

Within a given distribution-based method, MCID thresholds for PROMIS assessments were similar across multiple procedures. The MCID threshold ranged between 3.4 and 4.5 points across all procedures using the 1/2 SD method. Except for meniscectomy (3.5 points), the anchor-based PROMIS MCID thresholds (range 4.5 to 8.1 points) were higher than the SD distribution-based MCID values (2.3 to 4.5 points). The difference in MCID thresholds based on the calculation method led to a similar trend in MCID attainment. Using THA as an example, MCID attainment using PROMIS was achieved by 76% of patients using an anchor-based threshold of 7.9 points. However, 82% of THA patients attained MCID using the MDC 95 method (6.1 points), and 88% reached MCID using the 1/2 SD method (3.9 points). Using the HOOS metric (scaled from 0 to 100), 86% of THA patients reached the anchor-based MCID threshold (17.5 points). However, 91% of THA patients attained the MCID using the MDC 90 method (12.5 points), and 93% reached MCID using the 1/2 SD method (8.4 points). In general, the proportion of patients reaching MCID was lower for PROMIS than for other validated outcomes tools; for example, with the 1/2 SD method, 72% of patients who underwent arthroscopic partial meniscectomy reached the MCID on PROMIS Physical Function compared with 86% on KOOS.

Conclusion 

MCID calculations can provide clinical correlation for PROM scores interpretation. The PROMIS form is increasingly used because of its generalizability across diagnoses. However, we found lower proportions of MCID attainment using PROMIS scores compared with historical PROMs. By using historical proportions of attainment on common orthopaedic procedures and a spectrum of MCID calculation techniques, the PROMIS MCID benchmarks are realizable for common orthopaedic procedures. For clinical practices that routinely collect PROMIS scores in the clinical setting, these results can be used by individual surgeons to evaluate personal practice trends and by healthcare systems to quantify whether clinical care initiatives result in meaningful differences. Furthermore, these MCID thresholds can be used by researchers conducting retrospective outcomes research with PROMIS.

Level of Evidence 

Level III, therapeutic study.

中文翻译：

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与其他经过验证的结果工具相比，PROMIS 评估的常见骨科手术的临床益处是什么？

背景 

患者报告结果测量 (PROM)，包括患者报告结果测量信息系统 (PROMIS)，越来越多地用于测量医疗保健价值。最小临床重要差异 (MCID) 是一个指标，可帮助临床医生确定手术治疗后 PROM 的统计上可检测到的改善是否可能大到足以对患者重要或证明具有风险和成本的干预措施是合理的。MCID计算方法主要有两大类，基于anchor的和基于分布的。这种变异性，再加上用于现有 MCID 值的异质手术队列，限制了它们在临床护理中的应用。

问题/目的 

在我们的研究中，我们寻求 (1) 使用基于分布的方法确定常见骨科手术后 PROMIS 的 MCID 阈值和达到百分比，(2) 使用已发表研究中基于锚定的 MCID 值作为比较，以及 (3)将使用 PROMIS 评分的 MCID 达到百分比与其他经过验证的结果工具（例如髋关节残疾和骨关节炎结果评分 (HOOS) 以及膝关节残疾和骨关节炎结果评分 (KOOS)）进行比较。

方法 

这是在两个学术医疗中心和三个社区医院进行的回顾性研究。本研究的纳入标准为年龄在 18 岁或以上，因骨关节炎接受择期 THA、因骨关节炎接受全膝关节置换术、因腰椎管狭窄或滑脱而接受单节段后路腰椎融合术、因腰椎管狭窄或滑脱而接受解剖型全肩关节置换术或反向全肩关节置换术的患者。盂肱关节炎或肩袖关节病、关节镜下前交叉韧带重建、关节镜下半月板部分切除术或关节镜下肩袖修复术。这产生了 14,003 名患者。因非退行性病变而接受翻修手术或手术的患者以及未进行术前 PROM 评估的患者被排除在外，剩下 9925 名患者完成了术前 PROMIS 评估，9478 名患者完成了其他术前验证的结果工具（HOOS、KOOS、腿部疼痛数字评定量表、数字评定量表）用于治疗背痛和 QuickDASH）。大约 66%（9925 名患者中的 6529 名）有术后 PROMIS 评分（身体功能、心理健康、疼痛强度、疼痛干扰和上肢）并被纳入分析。PROMIS 评分采用群体标准化，平均评分为 50 ± 10，大多数评分在 30 至 70 之间。大约 74%（9478 例中的 7007 例）患者有术后历史评估评分并被纳入分析。使用基于分布的 MCID 方法计算每个手术队列在 6 个月的随访时达到 MCID 的比例，其中包括 SD 的一部分（1/2 或 1/3 SD）和最小可检测变化 (MDC)使用统计显着性（例如 p < 0.1 的 MDC 90）。之前发布的来自类似手术队列和类似 PROM 的基于锚定的 MCID 阈值用于计算达到 MCID 的比例。

结果 

在给定的基于分布的方法中，PROMIS 评估的 MCID 阈值在多个程序中是相似的。使用 1/2 SD 方法的所有程序的 MCID 阈值范围在 3.4 到 4.5 点之间。除半月板切除术（3.5 分）外，基于锚的 PROMIS MCID 阈值（范围 4.5 至 8.1 分）高于基于 SD 分布的 MCID 值（2.3 至 4.5 分）。基于计算方法的 MCID 阈值的差异导致了 MCID 达到的类似趋势。以 THA 为例，使用基于锚定的 7.9 分阈值，76% 的患者使用 PROMIS 达到了 MCID。然而，82% 的 THA 患者使用 MDC 95 方法达到 MCID（6.1 分），88% 使用 1/2 SD 方法达到 MCID（3.9 分）。使用 HOOS 指标（范围从 0 到 100），86% 的 THA 患者达到了基于锚的 MCID 阈值（17.5 分）。然而，91% 的 THA 患者使用 MDC 90 方法达到 MCID（12.5 分），93% 使用 1/2 SD 方法达到 MCID（8.4 分）。一般来说，PROMIS 达到 MCID 的患者比例低于其他经过验证的结果工具；例如，采用 1/2 SD 方法，接受关节镜部分半月板切除术的患者在 PROMIS 身体功能上达到 MCID 的比例为 72%，而在 KOOS 上达到 MCID 的比例为 86%。

结论 

MCID 计算可以为 PROM 评分解释提供临床相关性。PROMIS 形式因其在诊断中的通用性而被越来越多地使用。然而，我们发现与历史 PROM 相比，使用 PROMIS 分数实现 MCID 的比例较低。通过使用常见骨科手术的历史比例和一系列 MCID 计算技术，可以为常见骨科手术实现 PROMIS MCID 基准。对于在临床环境中定期收集 PROMIS 评分的临床实践来说，这些结果可以由个体外科医生用来评估个人实践趋势，并由医疗保健系统用来量化临床护理举措是否会产生有意义的差异。此外，这些 MCID 阈值可供研究人员使用 PROMIS 进行回顾性结果研究。

证据水平 

III级，治疗研究。