Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.
School of Clinical Sciences, University of Bristol, UK.
Rheumatology (Oxford). 2018 Feb 1;57(2):263-272. doi: 10.1093/rheumatology/kex085.
To qualitatively develop and test a set of candidate items for a new RA stiffness patient-reported outcome measure (PROM) that capture the patient perspective. This is an essential first step in PROM development, prior to quantitative development, assessment and validation.
Focus groups further examined the previously developed stiffness conceptual model and explored the patient perspective regarding stiffness assessment. Data were analysed using thematic analysis. An iterative process of item development was then performed by the expert study team of researchers, patients and clinicians, based on the two qualitative datasets and informed by measurement theory and guidelines. Finally, these candidate items were tested using formal cognitive interview methodology and subsequently refined.
Sixteen RA patients from the UK participated in focus groups. Data confirmed the conceptual model of the RA patient experience of stiffness and provided insight into stiffness assessment, including suggestions regarding patient-relevant stiffness assessment categories such as impact, location and timing. These data informed the development of 77 candidate stiffness PROM items, including multiple formats for some. Eleven RA patients participated in cognitive interviews. Minor changes were made to items to enhance understanding and 32 items were removed, resulting in 45 candidate PROM items.
Rigorous qualitative methodology and considerable patient involvement has underpinned items for a new RA stiffness PROM with strong content validity. Crucially, patient involvement broadened assessment beyond early morning stiffness duration, which may address existing PROM limitations. Items are now suitable for quantitative item reduction, structural development of the final PROM and validation.
定性开发和测试一套新的 RA 僵硬患者报告结局测量（PROM）的候选项目，以捕捉患者的观点。这是 PROM 开发、定量评估和验证之前的必要的第一步。
焦点小组进一步检查了先前开发的僵硬概念模型，并探讨了患者对僵硬评估的看法。使用主题分析对数据进行分析。然后，研究人员、患者和临床医生的专家研究团队根据这两个定性数据集，并根据测量理论和指南，对项目进行了迭代开发。最后，使用正式的认知访谈方法对这些候选项目进行了测试，并随后进行了改进。
来自英国的 16 名 RA 患者参加了焦点小组。数据证实了 RA 患者僵硬体验的概念模型，并提供了对僵硬评估的深入了解，包括对与患者相关的僵硬评估类别（如影响、位置和时间）的建议。这些数据为 77 个候选僵硬 PROM 项目的开发提供了信息，其中一些项目有多种格式。11 名 RA 患者参加了认知访谈。对项目进行了细微的更改，以增强理解，删除了 32 个项目，最终得到 45 个候选 PROM 项目。
严格的定性方法和大量的患者参与为新的 RA 僵硬 PROM 奠定了基础，具有很强的内容效度。至关重要的是，患者的参与拓宽了评估范围，超越了清晨僵硬持续时间，这可能解决了现有的 PROM 局限性。这些项目现在适合进行定量项目删减、最终 PROM 的结构发展和验证。
