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.author | Orozco-Beltrán, Domingo | |
dc.contributor.author | Artola, Sara | |
dc.contributor.author | Jansà, Margarida | |
dc.contributor.author | Lopez de la Torre-Casares, Martin | |
dc.contributor.author | Fuster, Eva | |
dc.date.accessioned | 2023-01-25T10:05:29Z | |
dc.date.available | 2023-01-25T10:05:29Z | |
dc.date.issued | 2018-03-23 | |
dc.description.abstract | Hypoglycemia 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.doi | 10.1186/s12955-018-0875-1 | |
dc.identifier.essn | 1477-7525 | |
dc.identifier.pmc | PMC5865352 | |
dc.identifier.pmid | 29566707 | |
dc.identifier.pubmedURL | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5865352/pdf | |
dc.identifier.unpaywallURL | https://doi.org/10.1186/s12955-018-0875-1 | |
dc.identifier.uri | http://hdl.handle.net/10668/12266 | |
dc.issue.number | 1 | |
dc.journal.title | Health and quality of life outcomes | |
dc.journal.titleabbreviation | Health Qual Life Outcomes | |
dc.language.iso | en | |
dc.organization | Hospital Universitario Virgen de las Nieves | |
dc.page.number | 52 | |
dc.pubmedtype | Journal Article | |
dc.pubmedtype | Multicenter Study | |
dc.pubmedtype | Observational Study | |
dc.pubmedtype | Validation Study | |
dc.rights | Attribution 4.0 International | |
dc.rights.accessRights | open access | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | |
dc.subject | Health-related quality of life | |
dc.subject | Hypoglycemia | |
dc.subject | Questionnaire development | |
dc.subject | Questionnaire validation | |
dc.subject | Type-2 diabetes mellitus | |
dc.subject.mesh | Adult | |
dc.subject.mesh | Aged | |
dc.subject.mesh | Diabetes Mellitus, Type 2 | |
dc.subject.mesh | Female | |
dc.subject.mesh | Health Surveys | |
dc.subject.mesh | Humans | |
dc.subject.mesh | Hypoglycemia | |
dc.subject.mesh | Longitudinal Studies | |
dc.subject.mesh | Male | |
dc.subject.mesh | Middle Aged | |
dc.subject.mesh | Prospective Studies | |
dc.subject.mesh | Psychometrics | |
dc.subject.mesh | Quality of Life | |
dc.subject.mesh | Reproducibility of Results | |
dc.subject.mesh | Surveys and Questionnaires | |
dc.title | 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.type | research article | |
dc.type.hasVersion | VoR | |
dc.volume.number | 16 | |
dspace.entity.type | Publication |
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