School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
Department of Psychology, University of Southern Denmark, Odense, Denmark.
Diabet Med. 2023 Mar;40(3):e15007. doi: 10.1111/dme.15007. Epub 2022 Nov 29.
Assessment of patient-reported outcome measures (PROMs), including quality of life (QoL), is essential in diabetes research and care. However, a recent review concluded that current hypoglycaemia-specific PROMs have limited evidence of validity, reliability and responsiveness for assessing the impact of hypoglycaemia on QoL in people living with diabetes. None of the PROMs identified could be used directly to inform the cost-effectiveness of treatments and interventions. There is a need for a new hypoglycaemia-specific QoL PROM, which can be used directly to inform economic evaluations.
This project has three aims: (a) To develop draft PROM content for measuring the impact of hypoglycaemia on QoL in adults with diabetes. (b) To refine the draft content using cognitive debriefing interviews and psychometrics. This will result in a condition-specific PROM that can be used to quantify the impact of hypoglycaemia upon QoL. (c) To generate a preference-based measure (PBM) that will enable utility values to be calculated for economic evaluation.
A mixed-methods, three-stage design is used: (a) Qualitative interviews will inform the draft PROM content. (b) Cognitive debriefing interview data will be used to refine the draft PROM content. The PROM will be administered in a large-scale survey to enable psychometric validation. Final item selection for the PROM will be informed by psychometric performance, translatability assessment and input from stakeholder groups. (c) A classification system will be generated, comprising a reduced number of items from the PROM. A valuation survey will be conducted to derive a value set for the PBM.
评估患者报告的结局测量指标（PROMs），包括生活质量（QoL），在糖尿病研究和护理中至关重要。然而，最近的一项综述得出结论，目前针对低血糖的特定 PROMs 在评估低血糖对糖尿病患者生活质量的影响方面，其有效性、可靠性和反应性的证据有限。确定的任何 PROM 都不能直接用于告知治疗和干预措施的成本效益。需要有一种新的针对低血糖的特定 QoL PROM，可直接用于告知经济评估。
本项目有三个目标：(a) 制定用于测量糖尿病成人低血糖对 QoL 影响的 PROM 内容草案。(b) 通过认知性访谈和心理计量学对草案内容进行完善。这将产生一种特定于疾病的 PROM，可用于量化低血糖对 QoL 的影响。(c) 生成偏好加权测量法（PBM），以计算用于经济评估的效用值。
使用混合方法、三阶段设计：(a) 定性访谈将为 PROM 内容草案提供信息。(b) 认知性访谈数据将用于完善 PROM 内容草案。该 PROM 将在一项大规模调查中进行管理，以实现心理计量学验证。PROM 的最终项目选择将由心理计量学表现、可翻译性评估以及利益相关者群体的投入来决定。(c) 将生成一个分类系统，由 PROM 中的少量项目组成。将进行价值评估调查，为 PBM 生成价值集。
