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American Heart Association Diabetes and Cardiometabolic Health Summit: Summary and Recommendations

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      Most cited references 9

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      Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association.

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        The stepped wedge trial design: a systematic review

        Background Stepped wedge randomised trial designs involve sequential roll-out of an intervention to participants (individuals or clusters) over a number of time periods. By the end of the study, all participants will have received the intervention, although the order in which participants receive the intervention is determined at random. The design is particularly relevant where it is predicted that the intervention will do more good than harm (making a parallel design, in which certain participants do not receive the intervention unethical) and/or where, for logistical, practical or financial reasons, it is impossible to deliver the intervention simultaneously to all participants. Stepped wedge designs offer a number of opportunities for data analysis, particularly for modelling the effect of time on the effectiveness of an intervention. This paper presents a review of 12 studies (or protocols) that use (or plan to use) a stepped wedge design. One aim of the review is to highlight the potential for the stepped wedge design, given its infrequent use to date. Methods Comprehensive literature review of studies or protocols using a stepped wedge design. Data were extracted from the studies in three categories for subsequent consideration: study information (epidemiology, intervention, number of participants), reasons for using a stepped wedge design and methods of data analysis. Results The 12 studies included in this review describe evaluations of a wide range of interventions, across different diseases in different settings. However the stepped wedge design appears to have found a niche for evaluating interventions in developing countries, specifically those concerned with HIV. There were few consistent motivations for employing a stepped wedge design or methods of data analysis across studies. The methodological descriptions of stepped wedge studies, including methods of randomisation, sample size calculations and methods of analysis, are not always complete. Conclusion While the stepped wedge design offers a number of opportunities for use in future evaluations, a more consistent approach to reporting and data analysis is required.
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          Impact of recent increase in incidence on future diabetes burden: U.S., 2005-2050.


            Author and article information

            [ 1 ] American Heart Association Dallas TX
            [ 2 ] University of Colorado Aurora CO
            [ 3 ] Baylor University Houston TX
            [ 4 ] University of Alabama Birmingham AL
            [ 5 ] University of Illinois at Chicago IL
            [ 6 ] University of California San Francisco Fresno CA
            [ 7 ] American Medical Association Chicago IL
            [ 8 ] Stanford University Stanford CA
            [ 9 ] Duke University Durham NC
            Author notes
            [* ] Correspondence to: Comilla Sasson, MD, PhD, American Heart Association, 7272 Greenville Ave, Dallas, TX 75231. E‐mail: comilla.sasson@
            J Am Heart Assoc
            J Am Heart Assoc
            Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
            John Wiley and Sons Inc. (Hoboken )
            31 July 2018
            07 August 2018
            : 7
            : 15 ( doiID: 10.1002/jah3.2018.7.issue-15 )
            © 2018 The Authors and American Medical Association. Published on behalf of the American Heart Association, Inc., by Wiley.

            This is an open access article under the terms of the License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

            Figures: 3, Tables: 4, Pages: 12, Words: 7404
            Funded by: AstraZeneca
            Funded by: Boehringer Ingelheim
            Funded by: Eli Lilly and Company
            Funded by: Pfizer‐Merck Alliance
            Funded by: Novo Nordisk
            Special Report
            Special Report
            Custom metadata
            07 August 2018
            Converter:WILEY_ML3GV2_TO_NLMPMC version:version=5.4.4 mode:remove_FC converted:07.08.2018


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