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斯坦福产科恢复检查表(STORK)的开发与验证:一项德尔菲共识及多中心临床验证研究

Development and Validation of the Stanford Obstetric Recovery Checklist (STORK): A Delphi Consensus and Multicenter Clinical Validation Study.

作者信息

Sultan Pervez, Pandal Perman, Murthy Anarghya, Guo Nan, Farber Michaela K, Toledo Paloma, Higgins Nicole, Fiore Julio F, Domingue Benjamin W, Khorasani Elahe, Jensen Sally E, Lyell Deirdre J, Carvalho Brendan

机构信息

Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.

Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, Massachusetts.

出版信息

JAMA Netw Open. 2025 Apr 1;8(4):e255713. doi: 10.1001/jamanetworkopen.2025.5713.

Abstract

BACKGROUND

Existing patient-reported outcome measures (PROMs) evaluating outpatient postpartum recovery lack content validity and were mostly not designed for this population. A Delphi process was performed, aiming to develop a patient-reported outcome measure for outpatient postpartum recovery and then evaluate it in a multicenter cohort study.

METHODS

Development of the Stanford Obstetric Recovery Checklist (STORK) involved 3 phases: (1) postpartum recovery questions were identified in published reviews; (2) after institutional review board approval, 16 multidisciplinary experts and patient stakeholders participated in 3 Delphi rounds (January 11 to April 12, 2021) to select items, resulting in the development of STORK (47 items; total score range, 0-188, with 0 indicating the worst recovery and 188 indicating the best recovery); and (3) cognitive debriefing interviews were conducted with 10 postpartum individuals to finalize STORK items. Individuals then completed STORK during their inpatient stay and at 2, 6, and 12 weeks post partum in a prospective, 3-center, US longitudinal cohort study conducted from June 13, 2022, to February 28, 2023. Recruitment occurred until 300 six-week STORK surveys were completed. STORK was evaluated at 6 weeks for validity (ability to measure recovery), reliability, and responsiveness. Validity included (1) structural validity (exploratory factor analysis using root mean square residual [RMSR]; <0.08 indicates a good fit); (2) convergent validity (correlation with global health visual analog scale score [GHVAS; scale, 0-100] and EuroQoL Five-Dimensions Three-Levels [EQ-5D-3L]); (3) discriminant validity (mean difference in STORK scores with GHVAS <70 vs ≥70); and (4) confirmatory telephone interviews with postpartum individuals scoring the highest and lowest 10th percentiles of STORK scores. Reliability (consistency of STORK scores) was evaluated using Cronbach α, interitem correlation, split-half reliability, and floor and ceiling effects. Responsiveness (ability of STORK to detect changes in recovery over time) was evaluated using percentage change in score from baseline to 12 weeks.

RESULTS

A total of 525 individuals were recruited after all delivery modes (response rate, 62% [324 of 525] at 6 weeks); 498 (mean [SD] age, 33.3 [4.9] years) completed baseline inpatient postpartum surveys. STORK demonstrated validity: (1) a 4-factor model was the best fit (RMSR = 0.05); (2) correlation with GHVAS scores was ρ = 0.52 (95% CI, 0.43-0.61), and correlation with EQ-5D-3L scores was ρ = -0.67 (95% CI, -0.76 to -0.63); (3) STORK was able to discriminate between patients reporting good and poor recovery (good recovery: median STORK score, 151 [IQR, 136-163] vs poor recovery: median STORK score, 129 [IQR, 107-148]; P < .001); and (4) the highest and lowest scores corresponded to subjective assessments. STORK demonstrated reliability (Cronbach α = 0.92; interitem correlation r = 0.20; and split-half reliability ρ = 0.98). It also demonstrated responsiveness: percentage increases in overall STORK scores from baseline to week 12 were 19% after spontaneous vaginal delivery, 31% after operative vaginal delivery, 27% after scheduled cesarean delivery, and 20% after nonscheduled cesarean delivery (P < .001).

CONCLUSION

In this cohort study of US individuals, STORK was found to be a valid, reliable, and responsive measure of outpatient postpartum recovery. Future clinical trials are needed to determine its clinical utility.

摘要

背景

现有的评估门诊产后恢复情况的患者报告结局量表(PROMs)缺乏内容效度,且大多并非为此人群设计。我们开展了一项德尔菲法流程,旨在开发一种用于门诊产后恢复情况的患者报告结局量表,随后在一项多中心队列研究中对其进行评估。

方法

斯坦福产科恢复清单(STORK)的开发涉及三个阶段:(1)在已发表的综述中确定产后恢复相关问题;(2)经机构审查委员会批准后,16名多学科专家和患者利益相关者参与了三轮德尔菲法(2021年1月11日至4月12日)以选择条目,由此开发出STORK(47个条目;总分范围为0 - 188分,0分表示恢复最差,188分表示恢复最佳);(3)对10名产后个体进行认知反馈访谈以确定STORK的最终条目。然后,在一项于2022年6月13日至2023年2月28日在美国进行的前瞻性、三中心纵向队列研究中,个体在住院期间以及产后2周、6周和12周完成STORK量表。招募工作持续进行,直至完成300份产后6周的STORK调查。在产后6周时对STORK进行效度(测量恢复情况的能力)、信度和反应度评估。效度评估包括:(1)结构效度(使用均方根残差[RMSR]进行探索性因子分析;RMSR<0.08表示拟合良好);(2)收敛效度(与全球健康视觉模拟量表评分[GHVAS;范围为0 - 100]以及欧洲五维度健康量表三级版[EQ - 5D - 3L]的相关性);(3)区分效度(GHVAS<70与≥70时STORK评分的均值差异);(4)对STORK评分处于最高和最低十分位的产后个体进行确认性电话访谈。使用克朗巴哈α系数、条目间相关性、分半信度以及地板效应和天花板效应评估信度(STORK评分的一致性)。使用从基线到12周的评分百分比变化评估反应度(STORK检测恢复情况随时间变化的能力)。

结果

在纳入所有分娩方式的个体后,共招募了525人(6周时的应答率为62%[525人中的324人]);498人(平均[标准差]年龄为33.3[4.9]岁)完成了基线住院产后调查。STORK显示出效度:(1)四因子模型拟合最佳(RMSR = 0.05);(2)与GHVAS评分的相关性为ρ = 0.52(95%CI,0.43 - 0.61),与EQ - 5D - 3L评分的相关性为ρ = -0.67(95%CI,-0.76至-0.63);(3)STORK能够区分报告恢复良好和恢复不佳的患者(恢复良好:STORK评分中位数为151[四分位间距,136 - 163],恢复不佳:STORK评分中位数为129[四分位间距,107 - 148];P<0.001);(4)最高和最低评分与主观评估结果相符。STORK显示出信度(克朗巴哈α系数 = 0.92;条目间相关性r = 0.20;分半信度ρ = 0.98)。它还显示出反应度:从基线到第12周,STORK总分的百分比增幅分别为自发阴道分娩后19%、手术助产阴道分娩后31%(产钳或胎头吸引)、择期剖宫产术后27%以及非择期剖宫产术后20%(P<0.001)。

结论

在这项针对美国个体的队列研究中,发现STORK是一种有效、可靠且具有反应度的门诊产后恢复情况测量工具。未来需要进行临床试验以确定其临床效用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6033/12006865/648fcc39c46f/jamanetwopen-e255713-g001.jpg

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