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      Health-related quality of life associated with daytime and nocturnal hypoglycaemic events: a time trade-off survey in five countries

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          Abstract

          Background

          Hypoglycaemic events, particularly nocturnal, affect health-related quality of life (HRQoL) via acute symptoms, altered behaviour and fear of future events. We examined the respective disutility associated with a single event of daytime, nocturnal, severe and non-severe hypoglycaemia.

          Methods

          Representative samples were taken from Canada, Germany, Sweden, the United States and the United Kingdom. Individuals completed an internet-based questionnaire designed to quantify the HRQoL associated with different diabetes- and/or hypoglycaemia-related health states. HRQoL was measured on a utility scale: 1 (perfect health) to 0 (death) using the time trade-off method. Three populations were studied: 8286 respondents from the general population; 551 people with type 1 diabetes; and 1603 with type 2 diabetes. Respondents traded life expectancy for improved health states and evaluated the health states of well-controlled diabetes and diabetes with non-severe/severe and daytime/nocturnal hypoglycaemic events.

          Results

          In the general population, non-severe nocturnal hypoglycaemic events were associated with a 0.007 disutility compared with 0.004 for non-severe daytime episodes, equivalent to a significant 63% increase in negative impact. Severe daytime and nocturnal events were associated with a 0.057 and a 0.062 disutility, respectively, which were not significantly different.

          Conclusions

          This study applies an established health economic methodology to derive disutilities associated with hypoglycaemia stratified by onset time and severity using a large multinational population. It reveals substantial individual and cumulative detrimental effects of hypoglycaemic events – particularly nocturnal – on HRQoL, reinforcing the clinical imperative of avoiding hypoglycaemia.

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          Most cited references32

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          Measurement of health status. Ascertaining the minimal clinically important difference.

          In recent years quality of life instruments have been featured as primary outcomes in many randomized trials. One of the challenges facing the investigator using such measures is determining the significance of any differences observed, and communicating that significance to clinicians who will be applying the trial results. We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change. Using this approach we have established a plausible range within which the minimal clinically important difference (MCID) falls. In three studies in which instruments measuring dyspnea, fatigue, and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item, when responses were presented on a seven point Likert scale. Furthermore, we have established ranges for changes in questionnaire scores that correspond to moderate and large changes in the domains of interest. This information will be useful in interpreting questionnaire scores, both in individuals and in groups of patients participating in controlled trials, and in the planning of new trials.
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            Nonparametric estimates of standard error: The jackknife, the bootstrap and other methods

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              QALYs: the basics.

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                Author and article information

                Journal
                Health Qual Life Outcomes
                Health Qual Life Outcomes
                Health and Quality of Life Outcomes
                BioMed Central
                1477-7525
                2013
                3 June 2013
                : 11
                : 90
                Affiliations
                [1 ]Department of Diabetes, University Hospital Llandough, Llandough Hospital, Penlan Road, Cardiff, Penarth, CF64 2XX, UK
                [2 ]Diabetes Research Unit, University of Leicester, Leicester, LE1 7RH, UK
                [3 ]Applied Health Research Centre (AHRC), Li Sha King Center and Department of Health Policy, Management, and Evaluation (Faculty of Medicine) and Leslie Dan Faculty of Pharmacy, University of Toronto, 30 Bond Street, Toronto, ON, M5B 1W8, Canada
                [4 ]Incentive Partners, Holte Stationsvej 14, 1, Holte, DK-2840, Denmark
                [5 ]Novo Nordisk A/S, Vandtårnsvej 114, Søborg, DK-2860, Denmark
                [6 ]Schulich School of Medicine and Dentistry, Western University, 245-100 Collip Circle, UWO Research Park, London, ON, N6G 4X8, Canada
                Article
                1477-7525-11-90
                10.1186/1477-7525-11-90
                3679729
                23731777
                412c05ee-abe2-444b-bae2-1c52d2a7500d
                Copyright ©2013 Evans et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 7 March 2013
                : 22 May 2013
                Categories
                Research

                Health & Social care
                time trade-off,hypoglycaemia,quality of life,disutility
                Health & Social care
                time trade-off, hypoglycaemia, quality of life, disutility

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