Department of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.
Department of Oncology and Metabolism, The University of Sheffield, Sheffield, UK.
Clin Orthop Relat Res. 2022 Oct 1;480(10):1884-1896. doi: 10.1097/CORR.0000000000002306. Epub 2022 Jul 8.
Patient-reported outcome measures (PROMs) are the only systematic approach through which the patient's perspective can be considered by surgeons (in determining a procedure's efficacy or appropriateness) or healthcare systems (in the context of value-based healthcare). PROMs in registries enable international comparison of patient-centered outcomes after total joint arthroplasty, but the extent to which those scores may vary between different registry populations has not been clearly defined.
QUESTIONS/PURPOSES: (1) To what degree do mean change in general and joint-specific PROM scores vary across arthroplasty registries, and to what degree is the proportion of missing PROM scores in an individual registry associated with differences in the mean reported change scores? (2) Do PROM scores vary with patient BMI across registries? (3) Are comorbidity levels comparable across registries, and are they associated with differences in PROM scores?
Thirteen national, regional, or institutional registries from nine countries reported aggregate PROM scores for patients who had completed PROMs preoperatively and 6 and/or 12 months postoperatively. The requested aggregate PROM scores were the EuroQol-5 Dimension Questionnaire (EQ-5D) index values, on which score 1 reflects "full health" and 0 reflects "as bad as death." Joint-specific PROMs were the Oxford Knee Score (OKS) and the Oxford Hip Score (OHS), with total scores ranging from 0 to 48 (worst-best), and the Hip Disability and Osteoarthritis Outcome Score-Physical Function shortform (HOOS-PS) and the Knee Injury and Osteoarthritis Outcome Score-Physical Function shortform (KOOS-PS) values, scored 0 to 100 (worst-best). Eligible patients underwent primary unilateral THA or TKA for osteoarthritis between 2016 and 2019. Registries were asked to exclude patients with subsequent revisions within their PROM collection period. Raw aggregated PROM scores and scores adjusted for age, gender, and baseline values were inspected descriptively. Across all registries and PROMs, the reported percentage of missing PROM data varied from 9% (119 of 1354) to 97% (5305 of 5445). We therefore graphically explored whether PROM scores were associated with the level of data completeness. For each PROM cohort, chi-square tests were performed for BMI distributions across registries and 12 predefined PROM strata (men versus women; age 20 to 64 years, 65 to 74 years, and older than 75 years; and high or low preoperative PROM scores). Comorbidity distributions were evaluated descriptively by comparing proportions with American Society of Anesthesiologists (ASA) physical status classification of 3 or higher across registries for each PROM cohort.
The mean improvement in EQ-5D index values (10 registries) ranged from 0.16 to 0.33 for hip registries and 0.12 to 0.25 for knee registries. The mean improvement in the OHS (seven registries) ranged from 18 to 24, and for the HOOS-PS (three registries) it ranged from 29 to 35. The mean improvement in the OKS (six registries) ranged from 15 to 20, and for the KOOS-PS (four registries) it ranged from 19 to 23. For all PROMs, variation was smaller when adjusting the scores for differences in age, gender, and baseline values. After we compared the registries, there did not seem to be any association between the level of missing PROM data and the mean change in PROM scores. The proportions of patients with BMI 30 kg/m 2 or higher ranged from 16% to 43% (11 hip registries) and from 35% to 62% (10 knee registries). Distributions of patients across six BMI categories differed across hip and knee registries. Further, for all PROMs, distributions also differed across 12 predefined PROM strata. For the EQ-5D, patients in the younger age groups (20 to 64 years and 65 to 74 years) had higher proportions of BMI measurements greater than 30 kg/m 2 than older patients, and patients with the lowest baseline scores had higher proportions of BMI measurements more than 30 kg/m 2 compared with patients with higher baseline scores. These associations were similar for the OHS and OKS cohorts. The proportions of patients with ASA Class at least 3 ranged across registries from 6% to 35% (eight hip registries) and from 9% to 42% (nine knee registries).
Improvements in PROM scores varied among international registries, which may be partially explained by differences in age, gender, and preoperative scores. Higher BMI tended to be associated with lower preoperative PROM scores across registries. Large variation in BMI and comorbidity distributions across registries suggest that future international studies should consider the effect of adjusting for these factors. Although we were not able to evaluate its effect specifically, missing PROM data is a recurring challenge for registries. Demonstrating generalizability of results and evaluating the degree of response bias is crucial in using registry-based PROMs data to evaluate differences in outcome. Comparability between registries in terms of specific PROMs collection, postoperative timepoints, and demographic factors to enable confounder adjustment is necessary to use comparison between registries to inform and improve arthroplasty care internationally.
Level III, therapeutic study.
患者报告的结局测量（PROMs）是外科医生（在确定手术的疗效或适宜性方面）或医疗保健系统（在基于价值的医疗保健背景下）唯一能够考虑患者观点的系统方法。注册中心的 PROM 使我们能够对全关节置换术后患者的以患者为中心的结局进行国际比较，但尚未明确界定不同登记处人群之间这些评分的差异程度。
问题/目的：（1）在多大程度上，关节置换登记处之间一般和特定关节的 PROM 评分的平均变化程度有所不同，以及个体登记处中缺失 PROM 评分的比例与报告的平均变化评分差异有多大关系？（2）PROM 评分是否会因患者 BMI 而在各登记处有所不同？（3）各登记处的合并症水平是否可比，且与 PROM 评分的差异是否有关？
来自 9 个国家的 13 个国家、地区或机构登记处报告了完成术前和术后 6 个月和/或 12 个月的 PROM 患者的汇总 PROM 评分。请求的汇总 PROM 评分是 EuroQol-5 维度问卷（EQ-5D）指数值，分数 1 表示“完全健康”，分数 0 表示“和死亡一样糟糕”。特定于关节的 PROM 是牛津膝关节评分（OKS）和牛津髋关节评分（OHS），总分范围为 0 至 48（最差-最佳），髋关节残疾和骨关节炎结局评分-物理功能简表（HOOS-PS）和膝关节损伤和骨关节炎结局评分-物理功能简表（KOOS-PS）值，评分为 0 至 100（最差-最佳）。符合条件的患者接受了单侧初次全髋关节置换术或全膝关节置换术治疗骨关节炎，时间为 2016 年至 2019 年。登记处被要求排除在 PROM 收集期间进行后续翻修的患者。所有登记处和 PROM 中，报告的缺失 PROM 数据百分比从 9%（1354 例中的 119 例）到 97%（5445 例中的 5305 例）不等。因此，我们通过图形探索了 PROM 评分是否与数据完整性水平有关。对于每个 PROM 队列，我们对登记处之间的 BMI 分布和 12 个预先定义的 PROM 分层（男性与女性；20 至 64 岁、65 至 74 岁和 75 岁以上；以及术前 PROM 评分较高或较低）进行了卡方检验。对于每个 PROM 队列，我们通过比较美国麻醉师协会（ASA）身体状况分类为 3 或更高的比例，对各登记处的合并症分布进行了描述性评估。
髋关节登记处的 EQ-5D 指数值（10 个登记处）平均改善范围为 0.16 至 0.33，膝关节登记处的平均改善范围为 0.12 至 0.25。OHS 的平均改善程度（7 个登记处）为 18 至 24，HOOS-PS 的平均改善程度（3 个登记处）为 29 至 35。OKS 的平均改善程度（6 个登记处）为 15 至 20，KOOS-PS 的平均改善程度（4 个登记处）为 19 至 23。对于所有 PROM，在调整年龄、性别和基线值差异后的评分中，变化幅度较小。在比较登记处后，缺失 PROM 数据的比例似乎与 PROM 评分的平均变化之间没有关联。BMI 为 30 kg/m 2 或更高的患者比例范围为 16%至 43%（11 个髋关节登记处）和 35%至 62%（10 个膝关节登记处）。髋关节和膝关节登记处的患者分布在六个 BMI 类别中存在差异。此外，对于所有 PROM，分布也因 12 个预先定义的 PROM 分层而异。对于 EQ-5D，年龄在 20 至 64 岁和 65 至 74 岁的患者中，BMI 测量值大于 30 kg/m 2 的比例高于年龄较大的患者，且基线评分较低的患者中，BMI 测量值大于 30 kg/m 2 的比例高于基线评分较高的患者。这些关联在 OHS 和 OKS 队列中也相似。ASA 分级至少为 3 的患者比例在髋关节登记处为 6%至 35%（8 个登记处），在膝关节登记处为 9%至 42%（9 个登记处）。
国际登记处之间的 PROM 评分改善情况存在差异，这可能部分归因于年龄、性别和术前评分的差异。较高的 BMI 往往与各登记处较低的术前 PROM 评分相关。各登记处 BMI 和合并症分布的差异较大，表明未来的国际研究应考虑调整这些因素的影响。尽管我们无法专门评估其效果，但缺失的 PROM 数据是登记处面临的一个反复出现的挑战。在使用基于登记处的 PROM 数据评估结果差异时，展示结果的可推广性并评估反应偏倚程度至关重要。为了能够利用登记处之间的比较来改善国际范围内的关节置换护理，各登记处之间需要在特定的 PROM 收集、术后时间点和人口统计学因素方面具有可比性，以便能够进行混杂因素调整。
III 级，治疗性研究。
