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Stargardt, T. ; Gonder-Frederick, L.* ; Krobot, K.J.* ; Alexander, C.M.*

Fear of hypoglycaemia: Defining a minimum clinically important difference in patients with type 2 diabetes.

Health Qual. Life Outcomes 7:91 (2009)
Verlagsversion Volltext DOI PMC
Open Access Gold
Creative Commons Lizenzvertrag
BACKGROUND: To explore the concept of the Minimum Clinically Important Difference (MID) of the Worry Scale of the Hypoglycaemia Fear Survey (HFS-II) and to quantify the clinical importance of different types of patient-reported hypoglycaemia. METHODS: An observational study was conducted in Germany with 392 patients with type 2 diabetes mellitus treated with combinations of oral anti-hyperglycaemic agents. Patients completed the HFS-II, the Treatment Satisfaction Questionnaire for Medication (TSQM), and reported on severity of hypoglycaemia. Distribution- and anchor-based methods were used to determine MID. In turn, MID was used to determine if hypoglycaemia with or without need for assistance was clinically meaningful compared to having had no hypoglycaemia. RESULTS: 112 patients (28.6%) reported hypoglycaemic episodes, with 15 patients (3.8%) reporting episodes that required assistance from others. Distribution- and anchor-based methods resulted in MID between 2.0 and 5.8 and 3.6 and 3.9 for the HFS-II, respectively. Patients who reported hypoglycaemia with (21.6) and without (12.1) need for assistance scored higher on the HFS-II (range 0 to 72) than patients who did not report hypoglycaemia (6.0). CONCLUSION: We provide MID for HFS-II. Our findings indicate that the differences between having reported no hypoglycaemia, hypoglycaemia without need for assistance, and hypoglycaemia with need for assistance appear to be clinically important in patients with type 2 diabetes mellitus treated with oral anti-hyperglycaemic agents.
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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Korrespondenzautor
Schlagwörter MINIMALLY IMPORTANT DIFFERENCES; OF-LIFE DATA; GLYCEMIC CONTROL; HEALTH-STATUS; METFORMIN; MELLITUS; MONOTHERAPY; OUTCOMES; THERAPY; RESPONSIVENESS
ISSN (print) / ISBN 1477-7525
e-ISSN 1477-7525
Zeitschrift Health and Quality of Life Outcomes
Quellenangaben Band: 7, Heft: , Seiten: , Artikelnummer: 91 Supplement: ,
Verlag BioMed Central
Nichtpatentliteratur Publikationen
Begutachtungsstatus Peer reviewed
Institut(e) Institute of Health Economics and Health Care Management (IGM)