Evidence mapPaperPMID 38777868Full record

ArticleDiabetologia2024

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

Jill Carlton, Philip A Powell, Melanie Broadley, Bastiaan E de Galan, Simon Heller, Jonathan Comins, Myriam Rosilio, Frans Pouwer, Mari-Anne Gall, Christopher J Child and 2 more

Abstract read
In one paragraph

Article in Diabetologia, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. 'There is more to life than HbADiabetic medicine : a journal of the British Diabetic Association · 2026
    Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Jill CarltonSheffield Centre of Health and Related Research (SCHARR), University of Sheffield, Sheffield, UK. j.carlton@sheffield.ac.uk.ORCID http://orcid.org/0000-0002-9373-7663
Philip A PowellSheffield Centre of Health and Related Research (SCHARR), University of Sheffield, Sheffield, UK.ORCID http://orcid.org/0000-0003-1169-3431
Melanie BroadleyDepartment of Psychology, University of Southern Denmark, Odense, Denmark.ORCID http://orcid.org/0000-0003-4408-6304
Bastiaan E de GalanDepartment of Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands.ORCID http://orcid.org/0000-0002-1255-7741
Simon HellerDepartment of Oncology and Metabolism, University of Sheffield, Sheffield, UK.ORCID http://orcid.org/0000-0002-2425-9565
Jonathan CominsMedical Science Innovation, Centre of Expertise, Patient Focused Drug Development, Novo Nordisk A/S, Søborg, Denmark.ORCID http://orcid.org/0000-0002-8284-114X
Myriam RosilioDiabetes & Obesity Medical Unit, Eli Lilly & Company, Neuilly sur seine, France.ORCID http://orcid.org/0000-0003-0296-9061
Frans PouwerDepartment of Psychology, University of Southern Denmark, Odense, Denmark.ORCID http://orcid.org/0000-0002-8172-9818
Mari-Anne GallMedical & Science, Diabetes, Clinical Drug Development, Novo Nordisk A/S, Søborg, Denmark.ORCID http://orcid.org/0000-0001-7149-0092
Christopher J ChildEli Lilly and Company, Lilly Diabetes and Obesity, Bracknell, UK.ORCID http://orcid.org/0000-0002-6195-2780
Rory J McCrimmonSystems Medicine, School of Medicine, University of Dundee, Dundee, Scotland.ORCID http://orcid.org/0000-0002-3957-1981
Donna RowenSheffield Centre of Health and Related Research (SCHARR), University of Sheffield, Sheffield, UK.ORCID http://orcid.org/0000-0003-3018-5109

Funding

e Innovative Medicines Initiative 2 Joint Undertaking (JU) 777460
6 · The paper itself

Abstract

aims/hypothesisValid 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.

methodsThree 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.

resultsA 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 (χ CONCLUSIONS/

interpretationThe 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 ).

Indexed as

HypoglycemiaPatient Reported Outcome MeasuresQuality of LifeAdultAgedCross-Sectional StudiesDiabetes MellitusFemaleHumansMaleMiddle AgedPsychometricsReproducibility of ResultsSurveys and QuestionnairesDiabetesHealth-related quality of lifeHypoglycaemiaPatient-reported outcome measurePreference-based measurePsychometricsQualitative research

Identifiers

PMID38777868
PMCPMC11343818

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.