Division of Rheumatology, University of Michigan, Ann Arbor, MI 48106, USA.
Value Health. 2012 Jan;15(1):128-34. doi: 10.1016/j.jval.2011.08.006. Epub 2011 Oct 22.
The National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) roadmap initiative is a cooperative group program of research designed to develop, evaluate, and standardize item banks to measure patient-reported outcomes relevant across medical conditions. The objective of the current study was to assess feasibility and evaluation of the construct validity of PROMIS item banks versus legacy measures in an observational study in systemic sclerosis (SSc). We hypothesized that the PROMIS item banks can be administered in a clinical setting if there is adequate staff support without disrupting the flow of clinic.
Patients with SSc in a single academic center completed computerized adaptive test (CAT) administered PROMIS item banks during the clinic visit and legacy measures (using paper and pencil). The construct validity of PROMIS items was evaluated by examining correlations with corresponding legacy measures using multitrait-multimethod analysis.
Participants consisted of 143 SSc patients with an average age of 51.5 years; 71% were female and 68% were white. The average number of items completed for each CAT-administered item bank ranged from 5 to 8 (69 CAT items per patient), and the average time to complete each CAT-administered item bank ranged from 48 seconds to 1.9 minutes per patient (average time = 11.9 minutes/per patient for 11 banks). All correlations between PROMIS domains and respective legacy measures were large and in the hypothesized direction (ranged from 0.61 to 0.82).
Our study supports the construct validity of the CAT-administered PROMIS item banks and shows that they can be administered successfully in a clinic with support staff. Future studies should assess the feasibility of PROMIS item banks in a busy clinical practice.
美国国立卫生研究院患者报告结局测量信息系统（PROMIS）路线图计划是一个合作组研究计划，旨在开发、评估和标准化项目库，以测量与多种疾病相关的患者报告结局。本研究的目的是在系统性硬化症（SSc）的观察性研究中评估 PROMIS 项目库的可行性和结构有效性，与传统测量方法进行比较。我们假设，如果有足够的员工支持，PROMIS 项目库可以在临床环境中进行管理，而不会干扰诊所的流程。
单一学术中心的 SSc 患者在就诊时完成计算机自适应测试（CAT）管理的 PROMIS 项目库和传统测量方法（纸笔）。使用多特质-多方法分析评估 PROMIS 项目的结构有效性，方法是检查与相应传统测量方法的相关性。
参与者包括 143 名 SSc 患者，平均年龄为 51.5 岁；71%为女性，68%为白人。每位患者完成的每个 CAT 管理项目库的平均项目数为 5 到 8 个（每位患者 69 个 CAT 项目），每位患者完成每个 CAT 管理项目库的平均时间为 48 秒到 1.9 分钟（每位患者完成 11 个库的平均时间为 11.9 分钟）。PROMIS 各领域与相应传统测量方法的相关性均较大，且与假设方向一致（r 值范围为 0.61 到 0.82）。
我们的研究支持 CAT 管理的 PROMIS 项目库的结构有效性，并表明在有支持人员的情况下，它们可以在诊所中成功管理。未来的研究应该评估 PROMIS 项目库在繁忙的临床实践中的可行性。
