Background 

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?

Methods 

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.

Results 

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/m² 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/m² than older patients, and patients with the lowest baseline scores had higher proportions of BMI measurements more than 30 kg/m² 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).

Conclusion 

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 of Evidence 

Level III, therapeutic study.

中文翻译：

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如何比较国际髋关节和膝关节置换术登记中患者报告的结果评分？

背景 

患者报告的结果测量 (PROM) 是唯一的系统方法，外科医生（在确定程序的有效性或适当性时）或医疗保健系统（在基于价值的医疗保健的背景下）可以考虑患者的观点。登记处的 PROM 可以对全关节置换术后以患者为中心的结果进行国际比较，但这些分数在不同登记人群之间的差异程度尚未明确定义。

问题/目的 

(1) 一般和关节特定的 PROM 分数的平均变化在多大程度上因关节成形术登记而不同，以及个体登记中缺失的 PROM 分数的比例在多大程度上与报告的平均变化分数的差异相关？(2) PROM 分数是否随患者 BMI 的不同而不同？(3) 登记处的合并症水平是否具有可比性，它们是否与 PROM 分数的差异相关？

方法 

来自 9 个国家的 13 个国家、地区或机构登记处报告了术前和术后 6 和/或 12 个月完成 PROM 的患者的 PROM 总分。要求的 PROM 总分是 EuroQol-5 维度问卷 (EQ-5D) 指数值，其中 1 分表示“完全健康”，0 分表示“像死亡一样糟糕”。关节特定的 PROM 是牛津膝关节评分 (OKS) 和牛津髋关节评分 (OHS)，总分范围从 0 到 48（最差-最好），以及髋关节残疾和骨关节炎结果评分-身体功能简表（HOOS- PS) 和膝关节损伤和骨关节炎结果评分-身体功能简表 (KOOS-PS) 值，评分为 0 到 100（最差-最好）。符合条件的患者在 2016 年至 2019 年期间接受了初次单侧 THA 或 TKA 治疗骨关节炎。登记处被要求排除在其 PROM 收集期内进行后续修订的患者。描述性检查原始聚合 PROM 分数和根据年龄、性别和基线值调整的分数。在所有登记处和 PROM 中，报告的丢失 PROM 数据的百分比从 9%（1354 人中的 119 人）到 97%（5445 人中的 5305 人）不等。因此，我们以图形方式探讨了 PROM 分数是否与数据完整性水平相关。对于每个 PROM 队列，对跨登记处和 12 个预定义的 PROM 层（男性与女性；年龄 20 至 64 岁、65 至 74 岁和大于 75 岁；以及高或低术前 PROM 评分）的 BMI 分布进行了卡方检验).

结果 

EQ-5D 指数值（10 个登记处）的平均改善范围为髋关节登记处 0.16 至 0.33 和膝关节登记处 0.12 至 0.25。OHS（七个注册中心）的平均改善范围为 18 到 24，HOOS-PS（三个注册中心）的平均改善范围为 29 到 35。OKS（六个注册中心）的平均改善范围为 15 到 20，并且对于 KOOS-PS（四个注册表），它的范围是 19 到 23。对于所有 PROM，在根据年龄、性别和基线值的差异调整分数时，变化较小。在我们比较了注册表之后，PROM 数据丢失的水平与 PROM 分数的平均变化之间似乎没有任何关联。^{BMI 30 kg/m 2}的患者比例或更高范围从 16% 到 43%（11 个髋关节登记处）和 35% 到 62%（10 个膝关节登记处）。六个 BMI 类别的患者分布在髋关节和膝关节登记处不同。此外，对于所有 PROM，分布在 12 个预定义的 PROM 层中也不同。对于 EQ-5D，较年轻年龄组（20 至 64 岁和 65 至 74 岁）的患者 BMI 测量值大于 30 kg/m ²的比例高于老年患者，基线得分最低的患者比例更高BMI 测量值超过 30 kg/m ²与基线得分较高的患者相比。这些关联对于 OHS 和 OKS 队列是相似的。ASA 等级至少为 3 的患者比例在 6% 至 35%（8 个髋关节登记处）和 9% 至 42%（9 个膝关节登记处）之间。

结论 

PROM 分数的改善因国际登记处而异，这可能部分是由于年龄、性别和术前分数的差异所致。较高的 BMI 往往与较低的术前 PROM 评分相关。不同登记处 BMI 和合并症分布的巨大差异表明，未来的国际研究应该考虑调整这些因素的影响。尽管我们无法具体评估其效果，但缺少 PROM 数据对注册管理机构来说是一个反复出现的挑战。证明结果的普遍性和评估响应偏差的程度对于使用基于注册表的 PROM 数据来评估结果差异至关重要。登记处在特定 PROM 收集、术后时间点、

证据等级 

III 级，治疗研究。