Diabetes complications

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

DiabetologiaPublished Mixed-methods measure development and validation study

Authors' conclusion

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.

Study context

Population
People with diabetes who experience hypoglycaemiaStage 3 survey
Participants
1,246 people
Outcome
Psychometric performance of the final 14-item Hypo-RESOLVE QoL
Methodological detailssemi-structured interviews, cognitive debriefing interviews, cross-sectional observational survey, Stage 1: semi-structured interviews (N=31), Stage 2: cognitive debriefing interviews (N=70 people with diabetes; N=14 clinicians)
  • Semi-structured interviews
  • Cognitive debriefing interviews
  • Cross-sectional observational survey
  • Stage 1: semi-structured interviews (N=31)
  • Stage 2: cognitive debriefing interviews (N=70 people with diabetes; N=14 clinicians)

Performance

As reported in the abstract

Final measure items (from 76-item draft)
14
Structural validity χ2
472.27, df=74, p<0.001
Comparative fit index
0.943
Root mean square error of approximation
0.069
Convergent validity with related constructs (r)
0.46-0.59
Internal consistency (α)
0.91
Test-retest reliability (intraclass correlation coefficient)
0.87

Further findings

Conceptual model of hypoglycaemia-related health-related quality of life

Themes, organised by physical, social and psychological aspects
19

Original publication

Development of a new health-related quality of life measure for people with diabetes who experience hypoglycaemia: the Hypo-RESOLVE QoL. Diabetologia. Published 22 May 2024. doi:10.1007/s00125-024-06182-9

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