Perelman School of Medicine, University of Pennsylvania.
Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.
J Pediatr Orthop. 2021 Jan;41(1):e74-e79. doi: 10.1097/BPO.0000000000001659.
Given that patient-reported outcome measures (PROMs) are increasingly used to inform clinical decision-making, it is vital that they are validated, reliable, responsive, and appropriate for the population under study. The purpose of this systematic review was to assess the rate of PROM use in the pediatric orthopaedic literature, characterize whether each use was in the PROM-validated demographic, and analyze the association between bibliometric factors and the use of PROMs with incomplete validation.
The Institute for Scientific Information (ISI) Web of Science database was queried for all clinical pediatric orthopaedic studies from 2014 to 2017. All PROMs were recorded for each study independently by 2 reviewers and cross-referenced with the published orthopaedic literature as of 2017 to determine if the PROM had been validated for the study population. PROMs that had not been validated, had been shown to be invalid, or had conflicting validity studies for use in the population of interest were designated as incompletely validated or used without complete validation. The following covariates were recorded for each study: subspecialty, inclusion of a statistician coauthor, sample size, journal, and the journal impact factor. χ analysis was used to evaluate the association between categorical variables and the use of at least 1 incompletely validated PROM.
In total, 1000 articles were screened, yielding 653 studies that met our inclusion criteria. A total of 104/653 (16%) publications-reported PROMs. PROMs were used without complete validation 120/165 (73%) times, and 77/104 (74%) studies used at least 1 PROM without complete validation. The most frequent reasons for incomplete validation were (1) using PROMs that had been validated in adults, but not pediatrics (n=47; 28.5%), and (2) using PROMs that had been designated in the literature as invalid for pediatrics (n=27; 16.4%). The incomplete validation of at least 1 PROM was associated with smaller sample size (P=0.01) and subspecialty (P<0.01). Overall rates of PROM use and the proportion of PROMs used without complete validation were both found to be higher than those previously reported.
The majority of pediatric orthopaedic studies reporting PROMs used at least 1 PROM without complete validation for their study population.
Level IV-systematic review of level I, II, III, and IV studies.
鉴于患者报告的结局测量（PROM）越来越多地用于为临床决策提供信息，因此验证、可靠、敏感和适合研究人群的 PROM 至关重要。本系统评价的目的是评估儿科骨科文献中 PROM 的使用情况，描述每种使用是否在 PROM 验证的人群中，并分析文献计量学因素与使用不完全验证的 PROM 之间的关联。
通过科学信息研究所（ISI）Web of Science 数据库查询 2014 年至 2017 年的所有临床儿科骨科研究。由 2 名评审员独立记录每项研究的所有 PROM，并与截至 2017 年的已发表骨科文献进行交叉引用，以确定 PROM 是否已针对研究人群进行验证。未经过验证、已被证明无效或在感兴趣人群中使用的有效性研究存在冲突的 PROM 被指定为不完全验证或未经过完整验证使用。记录了每项研究的以下协变量：亚专业、是否有统计学家合著者、样本量、期刊和期刊影响因子。使用卡方分析评估分类变量与使用至少 1 个不完全验证的 PROM 之间的关联。
共筛选出 1000 篇文章，得出 653 项符合纳入标准的研究。共有 104/653（16%）篇文章报告了 PROM。120/165（73%）次使用 PROM 未经过完整验证，77/104（74%）项研究至少使用 1 个未经完整验证的 PROM。不完全验证的最常见原因是（1）使用已在成人中验证但未在儿科中验证的 PROM（n=47；28.5%），以及（2）使用文献中指定为儿科无效的 PROM（n=27；16.4%）。至少有 1 个 PROM 的不完全验证与样本量较小（P=0.01）和亚专业有关（P<0.01）。使用 PROM 的总体比例和未经完整验证的 PROM 比例均高于先前报告的比例。
报告 PROM 的大多数儿科骨科研究都至少使用了 1 种未经完整验证的 PROM 来评估其研究人群。
对 I、II、III 和 IV 级研究进行 IV 级系统评价。
