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. 2023 Mar;40(3):e15007.
doi: 10.1111/dme.15007. Epub 2022 Nov 29.

Producing a preference-based quality of LIFE measure to quantify the impact of HYPOGLYCAEMIA on people living with diabetes: A mixed-methods research protocol

Jill Carlton  1 , Philip Powell  1 , Donna Rowen  1 , Melanie Broadley  2 , Frans Pouwer  2   3 , Jane Speight  2   4   5 , Simon Heller  6 , Mari-Anne Gall  7 , Myriam Rosilio  8 , Christopher J Child  9 , Jonathan Comins  10 , Rory J McCrimmon  11 , Bastiaan de Galan  12   13   14 , John Brazier  1 ; Hypo-RESOLVE CONSORTIUM
Affiliations

Producing a preference-based quality of LIFE measure to quantify the impact of HYPOGLYCAEMIA on people living with diabetes: A mixed-methods research protocol

Jill Carlton et al. Diabet Med. 2023 Mar.

Abstract

Background: 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.

Aims: 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.

Methods: 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.

Keywords: diabetes; hypoglycaemia; patient-reported outcome measures; preference-based measure; psychometrics; qualitative research; quality of life.

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Figures

FIGURE 1
FIGURE 1
Overview of project stages
See this image and copyright information in PMC

References

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    1. Carlton J, Leaviss J, Pouwer F, et al. 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. [published correction appears in Diabetologia. 2022 Jun;65(6):1063]. Diabetologia. 2021;64(6):1213‐1225. - PMC - PubMed

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