Department of Psychosomatic Medicine, Center for Internal Medicine and Dermatology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.
Department of Quantitative Health Sciences, Medical School, University of Massachusetts, Worcester, MA, USA.
Qual Life Res. 2023 Jun;32(6):1521-1536. doi: 10.1007/s11136-022-03261-5. Epub 2022 Oct 1.
Patient-Reported Outcomes (PROs) and its measures (PROMs) are key to outcome assessment in Fibromyalgia (FM) trials. The aim of this review was to investigate which domains and instruments were assessed in recent FM trials and to compare them to recommendations by the Outcome Measures in Rheumatology (OMERACT) initiative. In addition, we investigated the overlap with a generic health assessment approach, i.e. eight domains suggested by the Patient-Reported Outcome Measurement Information System® (PROMIS®).
In compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a systematic literature search in scientific databases including PubMed, PsycInfo, and Embase was conducted to identify studies that assessed at least two dimensions of health-related quality of life (HRQoL) from 2015 to June 2022. Non-randomized and randomized controlled trials were included in the analysis. We extracted PROs and PROMs used in each study.
From 1845 identified records, 107 records out of 105 studies met the inclusion criteria. Studies investigated 50 PROs using 126 different PROMs. Most frequently assessed domains were pain, depression, fatigue, and anxiety (> 95% of the studies). The disease-specific FIQ was the most frequently applied PROM (82%). Overall, only 9% of the studies covered all domains deemed mandatory by OMERACT. Very few studies covered all eight generic health domains suggested by PROMIS.
The majority of trials covered most OMERACT domains or generic PROMIS health domains. There was, however, great variability in the instruments used to assess the domains, which points at a limited degree of standardization in the field.
患者报告的结局（PROs）及其测量工具（PROMs）是纤维肌痛（FM）试验中结局评估的关键。本研究旨在调查最近 FM 试验中评估了哪些领域和工具，并将其与风湿病结局测量倡议（OMERACT）的建议进行比较。此外，我们还研究了与通用健康评估方法的重叠，即患者报告结局测量信息系统®（PROMIS®）建议的 8 个领域。
根据系统评价和荟萃分析的首选报告项目（PRISMA）指南，对包括 PubMed、PsycInfo 和 Embase 在内的科学数据库进行了系统文献检索，以确定从 2015 年至 2022 年 6 月评估至少两个健康相关生活质量（HRQoL）维度的研究。非随机和随机对照试验被纳入分析。我们提取了每项研究中使用的 PROs 和 PROMs。
从 1845 条记录中，105 项研究中的 107 项记录符合纳入标准。研究使用 126 种不同的 PROM 调查了 50 种 PRO。评估最多的领域是疼痛、抑郁、疲劳和焦虑（>95%的研究）。疾病特异性 FIQ 是应用最广泛的 PROM（82%）。总体而言，只有 9%的研究涵盖了 OMERACT 认为强制性的所有领域。很少有研究涵盖了 PROMIS 建议的所有 8 个通用健康领域。
大多数试验涵盖了大多数 OMERACT 领域或通用 PROMIS 健康领域。然而，用于评估这些领域的工具存在很大的差异，这表明该领域的标准化程度有限。
