Fear of Hypoglycaemia: Defining a Minimum Clinically Important Difference

Health and Quality of Life Outcomes, Vol. 7, p. 91, 2009

8 Pages Posted: 1 Mar 2011

See all articles by Tom Stargardt

Tom Stargardt

University of Hamburg

Linda Gonder-Frederick

University of Virginia - Institute of Law, Psychiatry, & Public Policy

Karl J. Krobot

MSD Sharp & Dohme GMBH

Charles M Alexander

Merck & Co., Inc. - USHH Outcomes Research & Management

Date Written: 2009

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.

Suggested Citation

Stargardt, Tom and Gonder-Frederick, Linda and Krobot, Karl J. and Alexander, Charles M, Fear of Hypoglycaemia: Defining a Minimum Clinically Important Difference (2009). Health and Quality of Life Outcomes, Vol. 7, p. 91, 2009, Available at SSRN: https://ssrn.com/abstract=1772523 or http://dx.doi.org/10.2139/ssrn.1772523

Tom Stargardt (Contact Author)

University of Hamburg ( email )

Hamburg Center for Health Economics
Esplanade 36
Hamburg, 20354
Germany

Linda Gonder-Frederick

University of Virginia - Institute of Law, Psychiatry, & Public Policy ( email )

P.O. Box 800660
Charlottesville, VA 22908-0660
United States

Karl J. Krobot

MSD Sharp & Dohme GMBH ( email )

Lindenplatz 1
Haar, 85540
Germany

Charles M Alexander

Merck & Co., Inc. - USHH Outcomes Research & Management ( email )

770 Sumneytown Pike
WP39-166
West Point, PA 19486
United States

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