Observational studyHealth and quality of life outcomes2018
Impact of hypoglycemic episodes on health-related quality of life of type-2 diabetes mellitus patients: development and validation of a specific QoLHYPO
Observational study in Health and quality of life outcomes, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 3 of them syntheses that pooled 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.
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.
Who cites it
9 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Measuring treatment burden in people with Type 2 Diabetes Mellitus (T2DM): a mixed-methods systematic review.BMC primary care · 2024Pooled it
- Patient-reported outcome measures for assessing health-related quality of life in people with type 2 diabetes: A systematic review.Reviews in endocrine & metabolic disorders · 2022Pooled it
- Content Validity of Patient-Reported Outcome Measures Developed for Assessing Health-Related Quality of Life in People with Type 2 Diabetes Mellitus: a Systematic Review.Current diabetes reports · 2022Pooled it
- The relationship between repeated measurements of HbACardiovascular diabetology · 2024Trial
- Design and Usability of an Avatar-Based Learning Program to Support Diabetes Education: Quality Improvement Study in Colombia.Journal of diabetes science and technology · 2023Article
- Patient-reported outcomes for people with diabetes: what and how to measure? A narrative review.Diabetologia · 2023Review
- Impact of fear of hypoglycaemia on self-management in patients with type 2 diabetes mellitus: structural equation modelling.Acta diabetologica · 2022Article
- Patient-Reported Experience and Outcome Measures in People Living with Diabetes: A Scoping Review of Instruments.The patient · 2021Article
- The association between diabetes-related distress and fear of hypoglycaemia in patients with type 2 diabetes mellitus: A cross-sectional descriptive study.Nursing open · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHypoglycemia 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
methodsA 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.
resultsPhase 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.
conclusionsThe QoLHYPO
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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 OpenQuestion graph.