The 12-Item Hypoglycemia Impact Profile (HIP12): psychometric validation of a brief measure of the impact of hypoglycemia on quality of life among adults with type 1 or type 2 diabetes

Broadley, Melanie; Chatwin, Hannah; Søholm, Uffe; Amiel, Stephanie A.; Carlton, Jill; Galan, Bastiaan E. de; Hendrieckx, Christel; McCrimmon, Rory J.; Skovlund, Søren; Pouwer, Frans; Speight, Jane

doi:10.1136/bmjdrc-2022-002890

Cited by 2 publications

(2 citation statements)

References 37 publications

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“…In particular, there was insufficient supporting evidence for the content and structural validity of the reviewed PROMs to assess the quality of life (QoL) impacts of hypoglycaemia, raising questions over their suitability for use for this purpose. While a recent hypoglycaemia-specific PROM assessing the impact on QoL has been published [6], this was a rapid adaptation of an existing diabetes-specific measure. As acknowledged by the authors, this measure did not follow full developmental rigour (e.g.…”

Section: Introductionmentioning

confidence: 99%

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

Carlton,

Powell,

Broadley

et al. 2024

Diabetologia

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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). Graphical Abstract

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Section: Introductionmentioning

confidence: 99%

“…As acknowledged by the authors, this measure did not follow full developmental rigour (e.g. supporting qualitative content validity interviews [7]) and was not developed for use in health economic evaluations or cost-effectiveness analysis as a result of clinical trials [6].…”

Section: Introductionmentioning

confidence: 99%

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

Carlton,

Powell,

Broadley

et al. 2024

Diabetologia

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Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment (HypoPAST): protocol for a 24-week hybrid type 1 randomised controlled trial of a fully online psycho-educational programme for adults with type 1 diabetes

Halliday,

Holmes-Truscott,

Thuraisingam

et al. 2024

Trials

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Background Management of type 1 diabetes (T1D) requires the use of insulin, which can cause hypoglycaemia (low blood glucose levels). While most hypoglycaemic episodes can be self-treated, all episodes can be sudden, inconvenient, challenging to prevent or manage, unpleasant and/or cause unwanted attention or embarrassment. Severe hypoglycaemic episodes, requiring assistance from others for recovery, are rare but potentially dangerous. Repeated exposure to hypoglycaemia can reduce classic warning symptoms (‘awareness’), thereby increasing risk of severe episodes. Thus, fear of hypoglycaemia is common among adults with T1D and can have a negative impact on how they manage their diabetes, as well as on daily functioning, well-being and quality of life. While advances in glycaemic technologies and group-based psycho-educational programmes can reduce fear, frequency and impact of hypoglycaemia, they are not universally or freely available, nor do they fully resolve problematic hypoglycaemia or associated worries. This study aims to determine the effectiveness of a fully online, self-directed, scalable, psycho-educational intervention for reducing fear of hypoglycaemia: the Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment (HypoPAST) programme. Methods A 24-week, two-arm, parallel-group, hybrid type 1 randomised controlled trial, conducted remotely (online and telephone). Australian adults (≥ 18 years) with self-reported T1D and fear of hypoglycaemia will be recruited, and allocated at random (1:1) to HypoPAST or control (usual care). The primary outcome is the between-group difference in fear of hypoglycaemia (assessed using HFS-II Worry score) at 24 weeks. A sample size of N = 196 is required to detect a 9-point difference, with 90% power and allowing for 30% attrition. Multiple secondary outcomes include self-reported psychological, behavioural, biomedical, health economic, and process evaluation data. Data will be collected at baseline, 12 and 24 weeks using online surveys, 2-week ecological momentary assessments, website analytics and semi-structured interviews. Discussion This study will provide evidence regarding the effectiveness, cost-effectiveness and acceptability of a novel, online psycho-educational programme: HypoPAST. Due to the fully online format, HypoPAST is expected to provide an inexpensive, convenient, accessible and scalable solution for reducing fear of hypoglycaemia among adults with T1D. Trial registration Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623000894695 (21 August 2023).

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The 12-Item Hypoglycemia Impact Profile (HIP12): psychometric validation of a brief measure of the impact of hypoglycemia on quality of life among adults with type 1 or type 2 diabetes

Cited by 2 publications

References 37 publications

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

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

Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment (HypoPAST): protocol for a 24-week hybrid type 1 randomised controlled trial of a fully online psycho-educational programme for adults with type 1 diabetes

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