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. 2024 Aug;67(8):1536-1551.
doi: 10.1007/s00125-024-06182-9. Epub 2024 May 22.

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

Jill Carlton  1 , Philip A Powell  2 , Melanie Broadley  3 , Bastiaan E de Galan  4   5   6 , Simon Heller  7 , Jonathan Comins  8 , Myriam Rosilio  9 , Frans Pouwer  3   10 , Mari-Anne Gall  11 , Christopher J Child  12 , Rory J McCrimmon  13 , Donna Rowen  2
Affiliations

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

Jill Carlton et al. Diabetologia. 2024 Aug.

Abstract

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 (χ2=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 ).

Keywords: Diabetes; Health-related quality of life; Hypoglycaemia; Patient-reported outcome measure; Preference-based measure; Psychometrics; Qualitative research.

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Figures

Fig. 1
Fig. 1
Overview of Hypo-RESOLVE QoL development
See this image and copyright information in PMC

References

    1. Chatwin H, Broadley M, Speight J et al (2021) The impact of hypoglycaemia on quality of life outcomes among adults with type 1 diabetes: a systematic review. Diabetes Res Clin Pract 174:108752. 10.1016/j.diabres.2021.108752 10.1016/j.diabres.2021.108752 - DOI - PubMed
    1. Matlock KA, Broadley M, Hendrieckx C et al (2022) Changes in quality of life following hypoglycaemia in adults with type 2 diabetes: a systematic review of longitudinal studies. Diabet Med 39(1):e14706. 10.1111/dme.14706 10.1111/dme.14706 - DOI - PMC - PubMed
    1. International Hypoglycaemia Study Group (2015) Minimizing hypoglycemia in diabetes. Diabetes Care 38(8):1583–1591. 10.2337/dc15-0279 10.2337/dc15-0279 - DOI - PubMed
    1. Carlton J, Leaviss J, Pouwer F et al (2021) The suitability of patient-reported outcome measures used to assess the impact of hypoglycaemia on quality of life in people with diabetes: a systematic review using COSMIN methods. Diabetologia 64(6):1213–1225. 10.1007/s00125-021-05382-x 10.1007/s00125-021-05382-x - DOI - PMC - PubMed
    1. Kluetz PG, O’Connor DJ, Soltys K (2018) Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada. Lancet Oncol 19(5):e267–e274. 10.1016/S1470-2045(18)30097-4 10.1016/S1470-2045(18)30097-4 - DOI - PubMed