Gries Katharine, Berry Pamela, Harrington Magdalena, Crescioni Mabel, Patel Mira, Rudell Katja, Safikhani Shima, Pease Sheryl, Vernon Margaret
1Janssen Global Services LLC, 700 US 202, Raritan Ave, Raritan, NJ 08869 USA.
Shire Pharmaceuticals, 500 Shire Way, Lexington, MA 02421 USA.
J Patient Rep Outcomes. 2018 Sep 6;2:41. doi: 10.1186/s41687-018-0056-3. eCollection 2017.
In the development of patient-reported outcome (PRO) instruments, little documentation is provided on the justification of response scale selection. The selection of response scales is often based on the developers' preferences or therapeutic area conventions. The purpose of this literature review was to assemble evidence on the selection of response scale types, in PRO instruments. The literature search was conducted in EMBASE, MEDLINE, and PsycINFO databases. Secondary search was conducted on supplementary sources including reference lists of key articles, websites for major PRO-related working groups and consortia, and conference abstracts. Evidence on the selection of verbal rating scale (VRS), numeric rating scale (NRS), and visual analogue scale (VAS) was collated based on pre-determined categories pertinent to the development of PRO instruments: reliability, validity, and responsiveness of PRO instruments, select therapeutic areas, and optimal number of response scale options.
A total of 6713 abstracts were reviewed; 186 full-text references included. There was a lack of consensus in the literature on the justification for response scale type based on the reliability, validity, and responsiveness of a PRO instrument. The type of response scale varied within the following therapeutic areas: asthma, cognition, depression, fatigue in rheumatoid arthritis, and oncology. The optimal number of response options depends on the construct, but quantitative evidence suggests that a 5-point or 6-point VRS was more informative and discriminative than fewer response options.
The VRS, NRS, and VAS are acceptable response scale types in the development of PRO instruments. The empirical evidence on selection of response scales was inconsistent and, therefore, more empirical evidence needs to be generated. In the development of PRO instruments, it is important to consider the measurement properties and therapeutic area and provide justification for the selection of response scale type.
在患者报告结局（PRO）工具的开发过程中，关于反应量表选择的合理性，所提供的文献资料较少。反应量表的选择通常基于开发者的偏好或治疗领域的惯例。本综述的目的是收集关于PRO工具中反应量表类型选择的证据。文献检索在EMBASE、MEDLINE和PsycINFO数据库中进行。二级检索在补充来源上进行，包括关键文章的参考文献列表、主要PRO相关工作组和联盟的网站以及会议摘要。基于与PRO工具开发相关的预先确定的类别，整理了关于言语评定量表（VRS）、数字评定量表（NRS）和视觉模拟量表（VAS）选择的证据：PRO工具的信度、效度和反应度、选定的治疗领域以及反应量表选项的最佳数量。
共审查了6713篇摘要；纳入了186篇全文参考文献。关于基于PRO工具的信度、效度和反应度来选择反应量表类型的合理性，文献中缺乏共识。反应量表的类型在以下治疗领域有所不同：哮喘、认知、抑郁、类风湿关节炎中的疲劳以及肿瘤学。反应选项的最佳数量取决于所构建的内容，但定量证据表明，5点或6点的VRS比更少的反应选项更具信息量和区分度。
在PRO工具的开发中，VRS、NRS和VAS是可接受的反应量表类型。关于反应量表选择的实证证据并不一致，因此需要生成更多的实证证据。在PRO工具的开发中，重要的是要考虑测量属性和治疗领域，并为反应量表类型的选择提供理由。
