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PROMISing development for standardising the assessment of self-reported health worldwide? An exploration of the potential application of U.S. developed patient-reported outcome measures to Germany

全球自我报告健康评估标准化的发展前景如何？

基本信息

批准号：
317400733
负责人：
Privatdozentin Dr. Sandra Nolte, Ph.D.
金额：
--
依托单位：
Medizinische Klinik mit Schwerpunkt Psychosomatik (CCM)
依托单位国家：
德国
项目类别：
Research Grants
财政年份：
2016
资助国家：
德国
起止时间：
2015-12-31 至 2020-12-31
项目状态：
已结题

来源：
https://gepris.dfg.de/gepris/projekt/317400733?language=en
关键词：
PROMISing development standardising assessment self

项目摘要

Patient-reported outcomes (PROs) are of growing importance in the assessment of benefits and harms of medical interventions. As observers (proxy) do not accurately capture the patient perspective, regulatory authorities worldwide recommend the application of PROs in clinical trials. However, for these data to be used for comparative purposes across studies and crucial subgroups, it is imperative to develop standards for the assessment of self-reported health. Recent publications in this field recommend crosswalk tables or a calibration of different instruments on the same, a common, metric, which is a ground-breaking step towards standardised assessment of PROs. A major pioneer in the context of standardised PRO assessment is the Patient-Reported Outcomes Measurement Information System (PROMIS®) initiative, launched in 2004 by the U.S. National Institutes of Health. PROMIS is based on the idea that items measuring the same construct can be merged in one item bank and calibrated on the same metric. Since its launch, PROMIS researchers have developed and largely validated over 50 item banks. In 2012, PROMIS started expanding its efforts to other countries, which is a unique opportunity to standardise PROs worldwide. However, it comes with a range of challenges that need to be explored before item banks can be launched globally. These challenges relate to (1) cultural adequacy, (2) unidimensionality and generalisability, (3) transferability of U.S. item parameters to other language versions, and (4) applicability of reference data based on the U.S. general population for norming purposes. As a result, this proposal aims at a thorough testing of PROMIS items, using the PROMIS Physical Function (PF) Item Bank as an example. Specifically, to answer research question (1), the PF items are tested qualitatively. To explore (2) and (3), PROMIS items are tested in n=600 patients from three clinical samples (rheumatology, cardiology, psychosomatic medicine). First, confirmatory factor analyses explore unidimensionality of the construct. Second, tests of differential item functioning (DIF) explore generalisability (disease group-DIF), and third, new item parameter estimates derived from the German data explore transferability of the U.S. item parameters to the translated version (language-DIF). Finally, to answer (4), reference data from the German general population are obtained (n=1,000). The overarching aim of the present project is to make a fundamental contribution to answering some of the remaining psychometric challenges involved with the translation and cultural adaptation of items aimed at measuring self-reported health. This study shall make an important contribution to the standardisation of PRO assessment not only in Germany, but it shall contribute to the international body of knowledge of the assessment of subjective well-being.

患者报告结局（PRO）在评估医疗干预的获益和危害方面越来越重要。由于观察员（代理人）无法准确捕捉患者的观点，全球监管机构建议在临床试验中应用PRO。然而，为了将这些数据用于跨研究和关键亚组的比较，必须制定评估自我报告健康状况的标准。该领域的最新出版物建议使用人行横道表或在同一个通用度量标准上校准不同仪器，这是迈向PRO标准化评估的突破性一步。PRO标准化评估背景下的主要先驱是美国国立卫生研究院于2004年推出的患者报告结果测量信息系统（PROMIS®）倡议。PROMIS基于这样的想法，即测量相同结构的项目可以合并到一个题库中，并在相同的度量标准上进行校准。自推出以来，PROMIS研究人员已经开发并验证了50多个项目库。2012年，PROMIS开始将其工作扩展到其他国家，这是一个独特的机会，可以在全球范围内推广PROs。然而，它带来了一系列挑战，需要在全球范围内推出试题库之前进行探索。这些挑战涉及（1）文化的充分性，（2）单维性和普遍性，（3）美国项目参数到其他语言版本的可转移性，以及（4）基于美国普通人群的参考数据的适用性。因此，本提案旨在以PROMIS物理功能项目库为例，对PROMIS项目进行彻底测试。具体而言，为了回答研究问题（1），PF项目进行了定性测试。为了探索（2）和（3），在来自三个临床样本（风湿病学、心脏病学、心身医学）的n=600名患者中测试PROMIS项目。首先，验证性因素分析探讨了单维度的结构。第二，测试的差异项目功能（DIF）探索的普遍性（疾病组-DIF），第三，新的项目参数估计来自德国的数据，探索美国项目参数的翻译版本（语言-DIF）的可转移性。最后，为了回答（4），获得了德国一般人群的参考数据（n= 1，000）。本项目的总体目标是做出根本性的贡献，以回答与翻译和文化适应的项目，旨在测量自我报告的健康所涉及的一些剩余的心理测量的挑战。这项研究将作出重要贡献，不仅在德国的PRO评估的标准化，但它将有助于主观幸福感的评估知识的国际机构。