PDF(Pubmed)
Abstract：
Patient-reported outcomes (PROs) are valuable for shared decision making and research. Patient-reported outcome measures (PROMs) are questionnaires used to measure PROs, such as health-related quality of life (HRQL). Although core outcome sets for trials and clinical practice have been developed separately, they, as well as other initiatives, recommend different PROs and PROMs. In research and clinical practice, different PROMs are used (some generic, some disease-specific), which measure many different things. This is a threat to the validity of research and clinical findings in the field of diabetes. In this narrative review, we aim to provide recommendations for the selection of relevant PROs and psychometrically sound PROMs for people with diabetes for use in clinical practice and research. Based on a general conceptual framework of PROs, we suggest that relevant PROs to measure in people with diabetes are: disease-specific symptoms (e.g. worries about hypoglycaemia and diabetes distress), general symptoms (e.g. fatigue and depression), functional status, general health perceptions and overall quality of life. Generic PROMs such as the 36-Item Short Form Health Survey (SF-36), WHO Disability Assessment Schedule (WHODAS 2.0), or Patient-Reported Outcomes Measurement Information System (PROMIS) measures could be considered to measure commonly relevant PROs, supplemented with disease-specific PROMs where needed. However, none of the existing diabetes-specific PROM scales has been sufficiently validated, although the Diabetes Symptom Self-Care Inventory (DSSCI) for measuring diabetes-specific symptoms and the Diabetes Distress Scale (DDS) and Problem Areas in Diabetes (PAID) for measuring distress showed sufficient content validity. Standardisation and use of relevant PROs and psychometrically sound PROMs can help inform people with diabetes about the expected course of disease and treatment, for shared decision making, to monitor outcomes and to improve healthcare. We recommend further validation studies of diabetes-specific PROMs that have sufficient content validity for measuring disease-specific symptoms and consider generic item banks developed based on item response theory for measuring commonly relevant PROs.
摘要：
患者报告的结果（PRO）对于共享决策和研究很有价值。患者报告结果测量(PROMs)是用于测量PROs的问卷，如健康相关生活质量(HRQL)。虽然试验和临床实践的核心结果集已经单独开发，they,以及其他举措，推荐不同的PRO和PROM。在研究和临床实践中，使用不同的PROM(一些通用的，一些疾病特异性)，衡量许多不同的东西。这对糖尿病领域的研究和临床发现的有效性构成威胁。在这篇叙述性评论中，我们的目标是为糖尿病患者选择相关的PRO和心理测量合理的PROM提供建议,用于临床实践和研究.基于PRO的一般概念框架，我们建议在糖尿病患者中测量的相关PRO是：疾病特异性症状（例如对低血糖和糖尿病困扰的担忧），一般症状（例如疲劳和抑郁），功能状态，一般健康观念和整体生活质量。通用项目，如36项简短形式健康调查(SF-36)，世卫组织残疾评估时间表（WHODAS2.0），或患者报告的结果测量信息系统(PROMIS)措施可被考虑用于测量通常相关的PRO，在需要的地方补充疾病特异性PROM。然而,现有的糖尿病特异性PROM量表均未得到充分验证，尽管用于测量糖尿病特定症状的糖尿病症状自我护理量表（DSSCI）和用于测量困扰的糖尿病困扰量表（DDS）和糖尿病问题领域（PAID）显示出足够的内容效度。标准化和使用相关PRO和心理测量合理的PROM可以帮助糖尿病患者了解预期的疾病和治疗过程。为了共同决策，监测结果并改善医疗保健。我们建议对糖尿病特异性PROM进行进一步的验证研究，这些研究具有足够的内容效度来测量疾病特异性症状，并考虑基于项目反应理论开发的通用项目库来测量通常相关的PRO。
