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

Health Services Management, Munich School of Management, Munich University, Germany.
Health and Quality of Life Outcomes (Impact Factor: 2.12). 10/2009; 7(1):91. DOI: 10.1186/1477-7525-7-91
Source: PubMed


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.
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.
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).
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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    • "The MCID has been defined as 'the smallest difference that patients perceive as beneficial and which would mandate, in the absence of troublesome side effects and excessive cost, a change in the patient's management' (Jaeschke et al., 1989 quoted in Burback et al., 1999). Published studies have recommended the use of both distribution-based (for example standard deviation (SD) of distribution of change scores from baseline to outcome), and anchorbased (for example change defined by a set number of points on a scale determined by clinical expertise, or achievement of a nominated target scale value again determined by clinical experience) methods to determine MCID (Revicki et al., 2008; Stargardt et al., 2009; Barber et al., 2009). Results generated by these methods can be integrated systematically using the method of triangulation (Leidy, 2006), which is particularly valuable when distribution-based and anchor-based methods generate widely differing values for the MCID (Leidy and Wyrwich, 2005). "
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    ABSTRACT: Although less likely to be reported in clinical trials than expressions of the statistical significance of differences in outcomes, whether or not a treatment has delivered a specified minimum clinically important difference (MCID) is also relevant to patients and their caregivers and doctors. Many dementia treatment randomised controlled trials (RCTs) have not reported MCIDs and, where they have been done, observed differences have not reached these. As part of the development of the Statistical Analysis Plan for the DOMINO trial, investigators met to consider expert opinion- and distribution-based values for the MCID and triangulated these to provide appropriate values for three outcome measures, the Standardised Mini-mental State Examination (sMMSE), Bristol Activities of Daily Living Scale (BADLS) and Neuropsychiatric Inventory (NPI). Only standard deviations (SD) were presented to investigators who remained blind to treatment allocation. Adoption of values for MCIDs based upon 0.4 of the SD of the change in score from baseline on the sMMSE, BADLS and NPI in the first 127 participants to complete DOMINO yielded MCIDs of 1.4 points for sMMSE, 3.5 for BADLS and 8.0 for NPI. Reference to MCIDs is important for the full interpretation of the results of dementia trials and those conducting such trials should be open about the way in which they have determined and chosen their values for the MCIDs.
    International Journal of Geriatric Psychiatry 08/2011; 26(8):812-7. DOI:10.1002/gps.2607 · 2.87 Impact Factor
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    • "In balancing the urge to avoid the acute effects of hypoglycemia and the need to prevent long-term complications, immediate unpleasant consequences can be more important to patients than future complications.6 The symptoms and negative consequences associated with hypoglycemia, as well as the higher level of variability in blood glucose levels, or the need for assistance, may result in major anxiety and fear of hypoglycemia, which have significant clinical implications for diabetes management.6,17 Fear of hypoglycemia impacts on well-being and quality of life, and reduces treatment satisfaction and adherence to diabetes therapies.7,18–20 "
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    Diabetes Therapy 05/2011; 2(2):51-66. DOI:10.1007/s13300-010-0018-0
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    • "Anchor-based approaches involve relating change scores on the PRO to change in a factor of known importance. These methods usually involve using other PROs, [11,15,16] clinical variables [17,18] or patient global rating of change questions [12,19,20] as an anchor. Each approach has strengths and limitations. "
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