Klokker Louise, Terwee Caroline B, Wæhrens Eva Ejlersen, Henriksen Marius, Nolte Sandra, Liegl Gregor, Kloppenburg Margreet, Westhoven Rene, Wittoek Ruth, Kjeken Ingvild, Haugen Ida K, Schalet Ben, Gershon Richard, Bliddal Henning, Christensen Robin
The Parker Institute, Bispebjerg & Frederiksberg Hospital, Copenhagen, Denmark.
Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.
BMJ Open. 2016 Dec 14;6(12):e011174. doi: 10.1136/bmjopen-2016-011174.
There is no consensus about what constitutes the most appropriate patient-reported outcome measurement (PROM) instrument for measuring physical function in patients with rheumatic hand conditions. Existing instruments lack psychometric testing and vary in feasibility and their psychometric qualities. We aim to develop a PROM instrument to assess hand-related physical function in rheumatic hand conditions.
We will perform a systematic search to identify existing PROMs to rheumatic hand conditions, and select items relevant for hand-related physical function as well as those items from the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) item bank that are relevant to patients with rheumatic hand conditions. Selection will be based on consensus among reviewers. Content validity of selected items will be established through the use of focus groups. If patients deem necessary, we will develop new items based on the patients' input. We will examine whether it is valid to score all selected and developed items on the same scale as the original items from the PROMIS PF item bank. Our analyses will follow the methods used for calibrating the original PROMIS PF item bank in US samples, which were largely based on the general PROMIS approach.
This study will be carried out in accordance with the Helsinki Declaration. Ethics approvals will be obtained where necessary, and signed informed consent will be obtained from all participants. We aim to disseminate the results of the study through publication in international peer-reviewed journals and at international conferences.
对于测量风湿性手部疾病患者身体功能而言，何种患者报告结局测量（PROM）工具最为合适，目前尚无共识。现有工具缺乏心理测量学测试，在可行性及其心理测量学质量方面存在差异。我们旨在开发一种PROM工具，以评估风湿性手部疾病患者与手部相关的身体功能。
我们将进行系统检索，以识别针对风湿性手部疾病的现有PROM，并选择与手部相关身体功能相关的条目，以及从患者报告结局测量信息系统（PROMIS）身体功能（PF）条目库中选取与风湿性手部疾病患者相关的那些条目。选择将基于评审人员之间的共识。所选条目的内容效度将通过焦点小组来确定。如果患者认为有必要，我们将根据患者的意见开发新条目。我们将检验对所有选定和开发的条目采用与PROMIS PF条目库中的原始条目相同的量表进行评分是否有效。我们的分析将遵循在美国样本中校准原始PROMIS PF条目库所使用的方法，这些方法在很大程度上基于一般的PROMIS方法。
本研究将按照《赫尔辛基宣言》进行。必要时将获得伦理批准，并从所有参与者处获得签署的知情同意书。我们旨在通过在国际同行评审期刊上发表以及在国际会议上报告来传播研究结果。
