Publication:
Impact of hypoglycemic episodes on health-related quality of life of type-2 diabetes mellitus patients: development and validation of a specific QoLHYPO© questionnaire.

dc.contributor.authorOrozco-Beltrán, Domingo
dc.contributor.authorArtola, Sara
dc.contributor.authorJansà, Margarida
dc.contributor.authorLopez de la Torre-Casares, Martin
dc.contributor.authorFuster, Eva
dc.date.accessioned2023-01-25T10:05:29Z
dc.date.available2023-01-25T10:05:29Z
dc.date.issued2018-03-23
dc.description.abstractHypoglycemia is a limiting factor to achieving optimal glycemic control in patients with type-2 diabetes mellitus (T2DM), increasing risk of death and complications, reducing health-related quality of life (HRQoL) and work productivity and increasing healthcare costs. The study's primary objective was to develop and validate a specific questionnaire to assess the impact of hypoglycemia on the HRQoL of T2DM patients (QoLHYPO© questionnaire). A two-phase multicenter prospective, longitudinal, observational, epidemiologic study of consecutively enrolled patients, not involving any drug, was conducted: In phase 1 (questionnaire development), patients who had given their written informed consent, who were at least 30 years of age, had been diagnosed with T2DM at least 5 years prior, had an HbA1c test in the previous 3 months, and a hypoglycemic episode in the previous 6 months were included. To validate the questionnaire and assess reliability and responsiveness, phase 2 included two cohorts of patients. Patients in the reliability cohort would likely have stable clinical course during the 3 weeks following inclusion in the study and patients in the responsiveness cohort would likely experience changes in their clinical course in the 3 months after enrollment. Phase 1 included 168 patients: 10 attended semi-structured interviews, 18 for face validity, and 140 for the pilot test (Rasch analysis). Phase 2 included 227 patients: 142 in the reliability cohort and 85 in the responsiveness cohort. Of the 37 items initially included in Phase 1, 11 (floor/ceiling effect analysis) and 13 (Rasch analysis) were discarded. The final version of the questionnaire consisted of 13 items. Phase 2 results showed the questionnaire was unidimensional and able to accurately assess HRQoL. Intra-observer reproducibility (ICC = 0.920) and internal consistency (Cronbach's alpha: visit 1 = 0.912; visit 2 = 0.901) were high, showing high reliability. Internal responsiveness was moderate (standardized effect size 0.5-0.8) and external responsiveness was lower (AUC > 0.5; not statistically significant). Minimal clinically important difference (MCID) was estimated to be 3.2 points. The QoLHYPO© questionnaire is a tool that can be used in routine clinical practice to assess the impact of hypoglycemia on the HRQoL of T2DM patients.
dc.identifier.doi10.1186/s12955-018-0875-1
dc.identifier.essn1477-7525
dc.identifier.pmcPMC5865352
dc.identifier.pmid29566707
dc.identifier.pubmedURLhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5865352/pdf
dc.identifier.unpaywallURLhttps://doi.org/10.1186/s12955-018-0875-1
dc.identifier.urihttp://hdl.handle.net/10668/12266
dc.issue.number1
dc.journal.titleHealth and quality of life outcomes
dc.journal.titleabbreviationHealth Qual Life Outcomes
dc.language.isoen
dc.organizationHospital Universitario Virgen de las Nieves
dc.page.number52
dc.pubmedtypeJournal Article
dc.pubmedtypeMulticenter Study
dc.pubmedtypeObservational Study
dc.pubmedtypeValidation Study
dc.rightsAttribution 4.0 International
dc.rights.accessRightsopen access
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectHealth-related quality of life
dc.subjectHypoglycemia
dc.subjectQuestionnaire development
dc.subjectQuestionnaire validation
dc.subjectType-2 diabetes mellitus
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshDiabetes Mellitus, Type 2
dc.subject.meshFemale
dc.subject.meshHealth Surveys
dc.subject.meshHumans
dc.subject.meshHypoglycemia
dc.subject.meshLongitudinal Studies
dc.subject.meshMale
dc.subject.meshMiddle Aged
dc.subject.meshProspective Studies
dc.subject.meshPsychometrics
dc.subject.meshQuality of Life
dc.subject.meshReproducibility of Results
dc.subject.meshSurveys and Questionnaires
dc.titleImpact of hypoglycemic episodes on health-related quality of life of type-2 diabetes mellitus patients: development and validation of a specific QoLHYPO© questionnaire.
dc.typeresearch article
dc.type.hasVersionVoR
dc.volume.number16
dspace.entity.typePublication

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