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Producing a preference-based quality of LIFE measure to quantify the impact of HYPOGLYCAEMIA on people living with diabetes: A mixed-methods research protocol
journal contributionposted on 2023-03-17, 03:25 authored by J Carlton, P Powell, D Rowen, M Broadley, F Pouwer, Jane SpeightJane Speight, S Heller, MA Gall, M Rosilio, CJ Child, J Comins, RJ McCrimmon, B de Galan, J Brazier
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.
Publication classificationC1 Refereed article in a scholarly journal
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Science & TechnologyLife Sciences & BiomedicineEndocrinology & Metabolismdiabeteshypoglycaemiapatient-reported outcome measurespreference-based measurepsychometricsqualitative researchquality of lifeOUTCOMES PRO INSTRUMENTSTASK-FORCEVALIDATIONCHECKLISTAWARENESSAdultHumansQuality of LifeReproducibility of ResultsResearch DesignPsychometricsSurveys and QuestionnairesDiabetes MellitusHypoglycemiaHypo-RESOLVE CONSORTIUMBehavioral and Social ScienceClinical ResearchDiabetes7 Management of diseases and conditions8 Health and social care services research7.1 Individual care needs8.4 Research design and methodologies (health services)Metabolic and endocrine