PMID- 29566707 OWN - NLM STAT- MEDLINE DCOM- 20180726 LR - 20191210 IS - 1477-7525 (Electronic) IS - 1477-7525 (Linking) VI - 16 IP - 1 DP - 2018 Mar 23 TI - Impact of hypoglycemic episodes on health-related quality of life of type-2 diabetes mellitus patients: development and validation of a specific QoLHYPO((c)) questionnaire. PG - 52 LID - 10.1186/s12955-018-0875-1 [doi] LID - 52 AB - BACKGROUND: 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((c)) questionnaire). METHODS: 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. RESULTS: 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. CONCLUSIONS: The QoLHYPO((c)) questionnaire is a tool that can be used in routine clinical practice to assess the impact of hypoglycemia on the HRQoL of T2DM patients. FAU - Orozco-Beltran, Domingo AU - Orozco-Beltran D AD - Cabo Huertas Healthcare Center, San Juan de Alicante, Universidad Miguel Hernandez, Alicante, Spain. dorozcobeltran@gmail.com. FAU - Artola, Sara AU - Artola S AD - Jose Marva Healthcare Center, RedGDPS Foundation, Madrid, Spain. FAU - Jansa, Margarida AU - Jansa M AD - Endocrinology and Diabetes Center, Hospital Clinic, Barcelona, Spain. FAU - Lopez de la Torre-Casares, Martin AU - Lopez de la Torre-Casares M AD - Hospital Virgen de las Nieves, Granada, Spain. FAU - Fuster, Eva AU - Fuster E AD - Novartis, Barcelona, Spain. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Validation Study DEP - 20180323 PL - England TA - Health Qual Life Outcomes JT - Health and quality of life outcomes JID - 101153626 SB - IM MH - Adult MH - Aged MH - Diabetes Mellitus, Type 2/complications/*psychology MH - Female MH - Health Surveys MH - Humans MH - Hypoglycemia/complications/*psychology MH - Longitudinal Studies MH - Male MH - Middle Aged MH - Prospective Studies MH - Psychometrics MH - *Quality of Life MH - Reproducibility of Results MH - *Surveys and Questionnaires PMC - PMC5865352 OTO - NOTNLM OT - Health-related quality of life OT - Hypoglycemia OT - Questionnaire development OT - Questionnaire validation OT - Type-2 diabetes mellitus COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: The study was conducted according to the principles of the Declaration of Helsinki and developed in compliance with Good Clinical Practice guidelines (International Conference on Harmonization, ICH, 1996). The study protocol was classified by the Agencia Espanola de Medicamentos y Productos Sanitarios (Spanish Agency for Medicines and Medical Devices) and was approved by the Ethics Committee of Hospital Clinic, Barcelona. All of the study participants gave their informed consent to participate in the study. CONSENT FOR PUBLICATION: Not Applicable. COMPETING INTERESTS: This study was funded by Novartis. Fuster E. works for Novartis. The remaining authors declare no conflicts of interest. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2018/03/24 06:00 MHDA- 2018/07/27 06:00 PMCR- 2018/03/23 CRDT- 2018/03/24 06:00 PHST- 2017/05/08 00:00 [received] PHST- 2018/03/06 00:00 [accepted] PHST- 2018/03/24 06:00 [entrez] PHST- 2018/03/24 06:00 [pubmed] PHST- 2018/07/27 06:00 [medline] PHST- 2018/03/23 00:00 [pmc-release] AID - 10.1186/s12955-018-0875-1 [pii] AID - 875 [pii] AID - 10.1186/s12955-018-0875-1 [doi] PST - epublish SO - Health Qual Life Outcomes. 2018 Mar 23;16(1):52. doi: 10.1186/s12955-018-0875-1.