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      Integrating Evidence From Systematic Reviews, Qualitative Research, and Expert Knowledge Using Co-Design Techniques to Develop a Web-Based Intervention for People in the Retirement Transition

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          Abstract

          Background

          Integrating stakeholder involvement in complex health intervention design maximizes acceptability and potential effectiveness. However, there is little methodological guidance about how to integrate evidence systematically from various sources in this process. Scientific evidence derived from different approaches can be difficult to integrate and the problem is compounded when attempting to include diverse, subjective input from stakeholders.

          Objective

          The intent of the study was to describe and appraise a systematic, sequential approach to integrate scientific evidence, expert knowledge and experience, and stakeholder involvement in the co-design and development of a complex health intervention. The development of a Web-based lifestyle intervention for people in retirement is used as an example.

          Methods

          Evidence from three systematic reviews, qualitative research findings, and expert knowledge was compiled to produce evidence statements (stage 1). Face validity of these statements was assessed by key stakeholders in a co-design workshop resulting in a set of intervention principles (stage 2). These principles were assessed for face validity in a second workshop, resulting in core intervention concepts and hand-drawn prototypes (stage 3). The outputs from stages 1-3 were translated into a design brief and specification (stage 4), which guided the building of a functioning prototype, Web-based intervention (stage 5). This prototype was de-risked resulting in an optimized functioning prototype (stage 6), which was subject to iterative testing and optimization (stage 7), prior to formal pilot evaluation.

          Results

          The evidence statements (stage 1) highlighted the effectiveness of physical activity, dietary and social role interventions in retirement; the idiosyncratic nature of retirement and well-being; the value of using specific behavior change techniques including those derived from the Health Action Process Approach; and the need for signposting to local resources. The intervention principles (stage 2) included the need to facilitate self-reflection on available resources, personalization, and promotion of links between key lifestyle behaviors. The core concepts and hand-drawn prototypes (stage 3) had embedded in them the importance of time use and work exit planning, personalized goal setting, and acceptance of a Web-based intervention. The design brief detailed the features and modules required (stage 4), guiding the development of wireframes, module content and functionality, virtual mentors, and intervention branding (stage 5). Following an iterative process of intervention testing and optimization (stage 6), the final Web-based intervention prototype of LEAP (Living, Eating, Activity, and Planning in retirement) was produced (stage 7). The approach was resource intensive and required a multidisciplinary team. The design expert made an invaluable contribution throughout the process.

          Conclusions

          Our sequential approach fills an important methodological gap in the literature, describing the stages and techniques useful in developing an evidence-based complex health intervention. The systematic and rigorous integration of scientific evidence, expert knowledge and experience, and stakeholder input has resulted in an intervention likely to be acceptable and feasible.

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          Most cited references49

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          Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide.

          Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.
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            Reaching the parts other methods cannot reach: an introduction to qualitative methods in health and health services research.

            C Pope, N Mays (1995)
            Qualitative research methods have a long history in the social sciences and deserve to be an essential component in health and health services research. Qualitative and quantitative approaches to research tend to be portrayed as antithetical; the aim of this series of papers is to show the value of a range of qualitative techniques and how they can complement quantitative research.
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              • Record: found
              • Abstract: found
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              Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study

              Objective To examine the use of qualitative approaches alongside randomised trials of complex healthcare interventions. Design Review of randomised controlled trials of interventions to change professional practice or the organisation of care. Data sources Systematic sample of 100 trials published in English from the register of the Cochrane Effective Practice and Organisation of Care Review Group. Methods Published and unpublished qualitative studies linked to the randomised controlled trials were identified through database searches and contact with authors. Data were extracted from each study by two reviewers using a standard form. We extracted data describing the randomised controlled trials and qualitative studies, the quality of these studies, and how, if at all, the qualitative and quantitative findings were combined. A narrative synthesis of the findings was done. Results 30 of the 100 trials had associated qualitative work and 19 of these were published studies. 14 qualitative studies were done before the trial, nine during the trial, and four after the trial. 13 studies reported an explicit theoretical basis and 11 specified their methodological approach. Approaches to sampling and data analysis were poorly described. For most cases (n=20) we found no indication of integration of qualitative and quantitative findings at the level of either analysis or interpretation. The quality of the qualitative studies was highly variable. Conclusions Qualitative studies alongside randomised controlled trials remain uncommon, even where relatively complex interventions are being evaluated. Most of the qualitative studies were carried out before or during the trials with few studies used to explain trial results. The findings of the qualitative studies seemed to be poorly integrated with those of the trials and often had major methodological shortcomings.
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                Author and article information

                Contributors
                Journal
                J Med Internet Res
                J. Med. Internet Res
                JMIR
                Journal of Medical Internet Research
                JMIR Publications (Toronto, Canada )
                1439-4456
                1438-8871
                August 2016
                03 August 2016
                : 18
                : 8
                : e210
                Affiliations
                [1] 1Institute of Health and Society Newcastle University Newcastle upon TyneUnited Kingdom
                [2] 2Institute of Design Innovation The Glasgow School of Art GlasgowUnited Kingdom
                [3] 3School of Planning, Architecture and Civil Engineering Queens University, Belfast United Kingdom
                [4] 4UKCRC Centre for Diet & Activity Research (CEDAR) MRC Epidemiology Unit University of Cambridge CambridgeUnited Kingdom
                [5] 5Institute of Cellular Medicine Human Nutrition Research Centre Newcastle University Newcastle upon TyneUnited Kingdom
                [6] 6Institute of Health and Society Centre for Oral Health Research Newcastle University Newcastle upon TyneUnited Kingdom
                Author notes
                Corresponding Author: Paula Moynihan paula.moynihan@ 123456ncl.ac.uk
                Author information
                http://orcid.org/0000-0002-7773-6871
                http://orcid.org/0000-0002-3638-7070
                http://orcid.org/0000-0001-7371-3165
                http://orcid.org/0000-0002-3432-3778
                http://orcid.org/0000-0002-2738-8274
                http://orcid.org/0000-0002-8553-249X
                http://orcid.org/0000-0003-1738-4269
                http://orcid.org/0000-0002-1861-6757
                http://orcid.org/0000-0003-3406-3002
                http://orcid.org/0000-0002-5015-5620
                Article
                v18i8e210
                10.2196/jmir.5790
                4989122
                27489143
                60716284-cc94-4374-bdce-68d2ffdd83e3
                ©Nicola O'Brien, Ben Heaven, Gemma Teal, Elizabeth H Evans, Claire Cleland, Suzanne Moffatt, Falko F Sniehotta, Martin White, John C Mathers, Paula Moynihan. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 03.08.2016.

                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, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.

                History
                : 11 April 2016
                : 4 May 2016
                : 31 May 2016
                Categories
                Original Paper
                Original Paper

                Medicine
                intervention studies,health behavior,retirement,internet
                Medicine
                intervention studies, health behavior, retirement, internet

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