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      INterpreting the Processes of the UMPIRE Trial (INPUT): protocol for a qualitative process evaluation study of a fixed-dose combination (FDC) strategy to improve adherence to cardiovascular medications

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          Abstract

          Introduction

          This paper describes a planned process evaluation of the Use of a Multidrug Pill In Reducing Cardiovascular Events (UMPIRE) trial, one of several randomised clinical trials taking place globally to assess the potential of cardiovascular drugs as a fixed-dose combination (polypill) in cardiovascular disease prevention. A fixed-dose combination may be a promising strategy for promoting adherence to medication; alleviating pill burden through simplifying regimens and reducing cost. This process evaluation will complement the UMPIRE trial by using qualitative research methods to inform understanding of the complex interplay of factors that underpin trial outcomes.

          Methods

          A series of semistructured, in-depth interviews with local health professionals and UMPIRE trial participants in India and the UK will be undertaken. The aim is to understand their views and experiences of the trial context and of day-to-day use of medications more generally. The grounded theory approach will be used to analyse data and help inform the processes of the UMPIRE trial.

          Ethics and dissemination

          The study has received ethical approval for all sites in the UK and India where trial participant interviews will be undertaken. The process evaluation will help inform and enhance the understanding of the UMPIRE trial results and its applicability to clinical practice as well as shaping policy regarding strategies for improving cardiovascular medication adherence.

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          Most cited references 6

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          Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the american heart association/american stroke association.

          The aim of this updated statement is to provide comprehensive and timely evidence-based recommendations on the prevention of ischemic stroke among survivors of ischemic stroke or transient ischemic attack. Evidence-based recommendations are included for the control of risk factors, interventional approaches for atherosclerotic disease, antithrombotic treatments for cardioembolism, and the use of antiplatelet agents for noncardioembolic stroke. Further recommendations are provided for the prevention of recurrent stroke in a variety of other specific circumstances, including arterial dissections; patent foramen ovale; hyperhomocysteinemia; hypercoagulable states; sickle cell disease; cerebral venous sinus thrombosis; stroke among women, particularly with regard to pregnancy and the use of postmenopausal hormones; the use of anticoagulation after cerebral hemorrhage; and special approaches to the implementation of guidelines and their use in high-risk populations.
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            Health beliefs, disease severity, and patient adherence: a meta-analysis.

            A large body of empirical data exists on the prediction of patient adherence from subjective and objective assessments of health status and disease severity. This work can be summarized with meta-analysis. Retrieval and summary analysis of r effect sizes and moderators of the relationship between patient adherence and patients': (1) beliefs in disease threat; (2) rated health status (by physician, self, or parent); and (3) objective disease severity. Comprehensive search of published literature (1948-2005) yielding 116 articles, with 143 separate effect sizes. Calculation of robust, generalizable random effects model statistics, and detailed examination of study diversity with moderator analyses. Adherence is significantly positively correlated with patients' beliefs in the severity of the disease to be prevented or treated ("disease threat"). Better patient adherence is associated with objectively poorer health only for patients experiencing disease conditions lower in seriousness (according to the Seriousness of Illness Rating Scale). Among conditions higher in seriousness, worse adherence is associated with objectively poorer health. Similar patterns exist when health status is rated by patients themselves, and by parents in pediatric samples. Results suggest that the objective severity of patients' disease conditions, and their awareness of this severity, can predict their adherence. Patients who are most severely ill with serious diseases may be at greatest risk for nonadherence to treatment. Findings can contribute to greater provider awareness of the potential for patient nonadherence, and to better targeting of health messages and treatment advice by providers.
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              Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. Prospective Randomized Open Blinded End-Point.

              A novel design for intervention studies is presented, the so called PROBE study (Prospective Randomized Open, Blinded End-point). This design is compared to the classical double-blind design. Among the advantages of the PROBE design are lower cost and greater similarity to standard clinical practice, which should make the results more easily applicable in routine medical care. Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2013
                22 May 2013
                : 3
                : 5
                Affiliations
                [1 ]The George Institute for Global Health , Hyderabad, Andhra Pradesh, India
                [2 ]International Centre for Circulatory Health, Imperial College London and Imperial Healthcare NHS Trust , London, UK
                [3 ]Centre for Chronic Disease Control , New Delhi, India
                [4 ]The George Institute for Global Health , Camperdown, New South Wales, Australia
                [5 ]School of Public Health, Imperial College London , London, UK
                Author notes
                [Correspondence to ] Frances Stewart; frances.stewart@ 123456imperial.nhs.uk
                Article
                bmjopen-2012-002313
                10.1136/bmjopen-2012-002313
                3664347
                23793693
                877a01c6-909b-4ed3-9e06-b0e2eec0f97e
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/3.0/ and http://creativecommons.org/licenses/by-nc/3.0/legalcode

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                Cardiovascular Medicine
                Protocol
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