Schougaard Liv Marit Valen, Laurberg Tinne, Lomborg Kirsten, Hansen Troels Krarup, Hjollund Niels Henrik, Jensen Annesofie Lunde
AmbuFlex - Center for Patient-Reported Outcomes, Central Denmark Region, Gødstrup Hospital, Møllegade 16, 7400, Herning, Denmark.
Steno Diabetes Centre Aarhus, Aarhus University Hospital, Hedeager 3, 8200, Aarhus N, Denmark.
J Patient Rep Outcomes. 2022 Sep 23;6(1):99. doi: 10.1186/s41687-022-00505-3.
Patient-reported outcome (PRO) measures may be used in telehealth for the clinical assessment of mental health and diabetes distress, which are important aspects in diabetes care, but valid and reliable instruments on these topics are necessary. We aimed to evaluate the test-retest reliability and measurement error of the Danish versions of the WHO-Five Well-being Index (WHO-5) and Problem Areas in Diabetes (PAID) questionnaires used in a PRO-based telehealth intervention among patients with type 1 diabetes. A further aim was to evaluate the test-retest reliability of single items concerning patients' symptom burden and general health status.
Outpatients with type 1 diabetes from the Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark, were enrolled from April 2019 to June 2020. Patients aged ≥ 18 who had type 1 diabetes for > 1 year, internet access, and the ability to understand, read, and write Danish were included. Intraclass correlation coefficients (ICC) and weighted Kappa values were used to assess test-retest reliability, and measurement error was assessed by estimating the minimal detectable change (MDC).
A total of 146/255 (57%) patients completed the web questionnaire twice. The median response time between the two-time points was five days. The ICC of the WHO-5 scale was 0.87 (95% CI 0.82-0.90), and MDC was 18.56 points (95% CI 16.65-20.99). The ICC of the PAID scale was 0.89 (95% CI 0.84-0.92), and MDC was 11.86 points (95% CI 10.46-13.70). Overall, test-retest reliability of single symptoms and general health status items was substantial.
The WHO-5 and PAID questionnaires, and single symptoms and general health status items showed substantial test-retest reliability among patients with type 1 diabetes. Measurement error of the PAID questionnaire was considered acceptable; however, a larger measurement error of the WHO-5 questionnaire was observed. Further research is recommended to explore these findings.
患者报告结局（PRO）指标可用于远程医疗中对心理健康和糖尿病困扰的临床评估，这是糖尿病护理的重要方面，但需要关于这些主题的有效且可靠的工具。我们旨在评估在1型糖尿病患者基于PRO的远程医疗干预中使用的丹麦版世界卫生组织五福安康指数（WHO-5）和糖尿病问题领域（PAID）问卷的重测信度和测量误差。另一个目的是评估关于患者症状负担和总体健康状况的单项指标的重测信度。
2019年4月至2020年6月期间，招募了丹麦奥胡斯大学医院斯滕诺糖尿病中心的1型糖尿病门诊患者。纳入年龄≥18岁、患1型糖尿病超过1年、能上网且具备理解、阅读和书写丹麦语能力的患者。组内相关系数（ICC）和加权Kappa值用于评估重测信度，测量误差通过估计最小可检测变化（MDC）来评估。
共有146/255（57%）名患者完成了两次网络问卷。两个时间点之间的中位响应时间为5天。WHO-5量表的ICC为0.87（95%CI 0.82 - 0.90），MDC为18.56分（95%CI 16.65 - 20.99）。PAID量表的ICC为0.89（95%CI 0.84 - 0.92），MDC为11.86分（95%CI 10.46 - 13.70）。总体而言，单项症状和总体健康状况指标的重测信度较高。
WHO-5和PAID问卷以及单项症状和总体健康状况指标在1型糖尿病患者中显示出较高的重测信度。PAID问卷的测量误差被认为是可接受的；然而，观察到WHO-5问卷的测量误差较大。建议进一步开展研究以探索这些发现。
