Journal Article

Development of a new health-related quality of life measure for people with diabetes who experience hypoglycaemia: the Hypo-RESOLVE QoL

Powell, Philip A., Comins, Jonathan, Rosilio, Myriam, Broadley, Melanie, Carlton, Jill, Heller, Simon, Gall, Mari-Anne, de Galan, Bastiaan E., McCrimmon, Rory J., Child, Christopher J., Rowen, Donna, Pouwer, Frans

2024

Overview

Aims/hypothesis Valid and reliable patient-reported outcome measures are vital for assessing disease impact, responsiveness to healthcare and the cost-effectiveness of interventions. A recent review has questioned the ability of existing measures to assess hypoglycaemia-related impacts on health-related quality of life for people with diabetes. This mixed-methods project was designed to produce a novel health-related quality of life patient-reported outcome measure in hypoglycaemia: the Hypo-RESOLVE QoL. Methods Three studies were conducted with people with diabetes who experience hypoglycaemia. In Stage 1, a comprehensive health-related quality of life framework for hypoglycaemia was elicited from semi-structured interviews ( N =31). In Stage 2, the content validity and acceptability of draft measure content were tested via three waves of cognitive debriefing interviews ( N =70 people with diabetes; N =14 clinicians). In Stage 3, revised measure content was administered alongside existing generic and diabetes-related measures in a large cross-sectional observational survey to assess psychometric performance ( N =1246). The final measure was developed using multiple evidence sources, incorporating stakeholder engagement. Results A novel conceptual model of hypoglycaemia-related health-related quality of life was generated, featuring 19 themes, organised by physical, social and psychological aspects. From a draft version of 76 items, a final 14-item measure was produced with satisfactory structural (χ 2 =472.27, df =74, p <0.001; comparative fit index =0.943; root mean square error of approximation =0.069) and convergent validity with related constructs ( r =0.46–0.59), internal consistency (α=0.91) and test–retest reliability (intraclass correlation coefficient =0.87). Conclusions/interpretation The Hypo-RESOLVE QoL is a rigorously developed patient-reported outcome measure assessing the health-related quality of life impacts of hypoglycaemia. The Hypo-RESOLVE QoL has demonstrable validity and reliability and has value for use in clinical decision-making and as a clinical trial endpoint. Data availability All data generated or analysed during this study are included in the published article and its online supplementary files ( https://doi.org/10.15131/shef.data.23295284.v2 ). Graphical Abstract

• Publisher: Springer Berlin Heidelberg,Springer Nature B.V
• Subject: Adult / Aged / Clinical outcomes / Cross-Sectional Studies / Decision making / Diabetes / Diabetes mellitus / Diabetes Mellitus - psychology / Female / Human Physiology / Humans / Hypoglycemia / Hypoglycemia - psychology / Internal Medicine / Male / Medicine / Medicine & Public Health / Metabolic Diseases / Middle Aged / Patient Reported Outcome Measures / Patients / Psychological aspects / Psychometrics / Quality of Life / Reproducibility of Results / Surveys and Questionnaires / Validity