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Health and Quality of Life Outcomes
Published in: Health and Quality of Life Outcomes 1/2009

Open Access 01-12-2009 | Research

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

Authors: Tom Stargardt, Linda Gonder-Frederick, Karl J Krobot, Charles M Alexander

Published in: Health and Quality of Life Outcomes | Issue 1/2009

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Abstract

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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Metadata
Title
Fear of hypoglycaemia: defining a minimum clinically important difference in patients with type 2 diabetes
Authors
Tom Stargardt
Linda Gonder-Frederick
Karl J Krobot
Charles M Alexander
Publication date
01-12-2009
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2009
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/1477-7525-7-91

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