PROSPERO International prospective register of systematic reviews

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PROSPERO International prospective register of systematic reviews Health behaviour change in the community pharmacy setting: a realist review Aikaterini Kassavou, Liz Steed, Carol Rivas, Trisha Greenhalgh, Robert Walton, Geoff Wong Citation Aikaterini Kassavou, Liz Steed, Carol Rivas, Trisha Greenhalgh, Robert Walton, Geoff Wong. Health behaviour change in the community pharmacy setting: a realist review. PROSPERO 2014:CRD42014007097 Available from http://www.crd.york.ac.uk/prospero_rebranding/display_record.asp?id=crd42014007097 Review question(s) This Realist Review seeks to answer the following questions: 1) what theories are used in the literature to explain how and why community pharmacy interventions change health behaviours in clients attending pharmacies? 2) what theories underpin professional behaviour change in pharmacy staff which facilitates health behaviour change in their clients (customers)? 3) under what contexts, from whom and in what extent do these behaviour changes occur? The final outcome of this review will be the development of a realist programme theory that describes what works best, over what duration, to what extent, for whom and how the context impacts on implementation of effective behaviour change interventions in the community pharmacy setting. Given the complexity and heterogeneity of such interventions, this review will develop a feasible and applicable programme theory for future intervention development and to inform policy making. The programme theory will include description of the context, mechanisms and outcome patterns that are most likely to change behaviours. Quality standards for realist synthesis set by the RAMSES project will be adhered to (http://www.ramesesproject.org/index.php?pr=project_outputs) Searches We will initially include the papers identified by the Cochrance EPOC review Community pharmacy interventions for health promotion: effects on professional practice and health outcomes Using these studies as a starting point we will perform cluster searching (Booth et al. 2013)*. Cluster searching identifies all sibling studies and documents that provide information on the theoretical basis of the intervention and the context in which these interventions worked or did not work. Cluster searching enables idenitification of a diverse range of studies and documents (e.g. qualitative and quantitative studies, website information, reports, book chapters, unpublished material by contacting authors etc.) which may be used to help in the development and testing of a programme theory. * http://www.biomedcentral.com/1471-2288/13/118 Types of study to be included Any study that can provide data relevant to the review will be included (e.g. quantitative studies, qualitative studies, reports, website process evaluation, project sharing etc). Condition or domain being studied In this review we will include both healthy adults and adults with chronic conditions (e.g. diabetes, asthma, cardiovascular diseases) Page: 1 / 5

Phenomena of interest: We will include studies or documents which contain data that will enable us to develop and test our programme theory (e.g. studies with data on facilitators and barriers to health behavior change affecting community pharmacists and their customers (clients) ) The outcomes of interest are: Uptake of health behaviour change interventions Change in health promotion behaviour of pharmacy staff Psychological outcomes (e.g. wellbeing, quality of life) Health outcomes (e.g. blood pressure) Maintenance of change relevant to health Even though the focus of this review will start on the outcomes described above, the aim is to describe how and why these outcomes or other relevant outcomes are expected to be achieved and in particular under what circumstances. The theories that have been used to change health behaviours within the community pharmacy will be reviewed and presented to address our first research question described above (see Section review questions). Participants/ population Participants in this review were of two types: (a) community pharmacy staff asked to deliver or delivering a behaviour change intervention, (b) clients who attend participating community pharmacies. Intervention(s), exposure(s) The following types of studies will be included: (a) health behaviour change interventions targeted at and/or delivered by community pharmacy staff, and (b) interventions aiming at changing health behaviours (e.g. reduce smoking, reduce alcohol use) and/or health outcomes (e.g. blood pressure, weight loss) of community pharmacy clients. Studies will be excluded when they focussed on medication management only. Comparator(s)/ control In realist reviews, comparisons are often made between interventions of the same family in order to gain some understanding of how differing context might influence the outcomes obtained. Context The context of the studies will be any community pharmacy setting worldwide encompassing high middle and low income countries. Outcome(s) Primary outcomes Any measures of: (a) community pharmacists professional practice relevant to health behaviour change of their customers (b) clients psychological and health outcomes Page: 2 / 5

(d) adverse effects and (e) process data (e.g. theoretical components/ theories used to bring about the outcomes) Secondary outcomes None Data extraction, (selection and coding) Documents will be included on the basis of relevance and rigour as defined by Pawson (2006)*. In brief, relevance relates to whether data within a document can contribute to theory building and/or testing. Rigour may be considered as whether the methods used to generate the relevant data are credible and trustworthy. Decisions as to relevance and rigour will necessarily be an iterative process with the decisions having to be made during the screening stages and at times repeated on previously 'excluded' or new documents as more data is needed (and searching undertaken) as the review progresses. Data extraction processes has been developed, piloted and refined to ensure that they capture relevant data to enable refinement of programme theory. We will seek to extract data from documents that enable us to understand (for as many steps / components as possible of our programme theory) how and why the outcome has occurred. In other words, for each outcome (O), what has caused it - the mechanism (M) and under what contexts (C) did the mechanism 'fire'. * Pawson R. Evidenced based policy: A realist perspective, 2006, Sage, London Risk of bias (quality) assessment Studies will be included under the criteria of relevance and rigour, as described in RAMESES project s quality standards for realist reviews: http://www.ramesesproject.org/media/rs_qual_standards_researchers.pdf Strategy for data synthesis Data analysis will be guided by the need to make sense of our initial 'rough' programme theory. When analysing the findings from included documents we will use interpretive cross-case comparison to understand and explain how and why observed outcomes have occurred. For example, where possible, we will compare interventions where pharmacists have been able to change clients' health behaviours against those which have not; to try to understand how context has (or has not) influenced the reported findings. Specifically, when analysing included documents, we will be using a realist logic that seeks to construct context-mechanism-outcome configurations (CMOCs) for the findings in the successful and less successful pharmacist delivered behavioural change interventions. The purpose of this process is to construct for each finding (outcome) an explanation of what has caused the outcome to occur (mechanism) and the conditions (context) that have triggered this putative mechanism. If necessary, we will seek to develop iteratively one or more explanatory theories to account for these CMOCs. An important process is to build an understanding of how the CMOCs we have constructed fit in with our initial programme theory. In other words, for any one CMOC, how does it (if at all) explain how different pharmacist-delivered behaviour change interventions go about producing its potential benefits? For example, do the CMOC s tell us anything about how we might need to refine our initial programme theory? Thus throughout the realist review, we move iteratively between the analysis of particular examples, a refinement of the over-arching programme theory, and (if necessary) further iterative searching for data to test particular theories or sub-theories. Analysis of subgroups or subsets Not applicable (see Section 28 above) Contact details for further information Aikaterini Kassavou Centre for Primary Care and Public Health Blizard Institute Page: 3 / 5

Yvonne Carter Building 58 Turner Street London E1 2AT k.kassavou@qmul.ac.uk Organisational affiliation of the review Barts and the London School of Medicine and Dentistry, Centre for Primary Care and Public Health, Blizard Institute, Yvonne Carter Building, 58 Turner Street, London, E1 2AT http://blizard.qmul.ac.uk/centres/centre-for-primary-care-and-public-health.html Review team Dr Aikaterini Kassavou, Barts and the London School of Medicine and Dentistry, Centre for Primary Care and Public Health, Dr Liz Steed, Barts and the London School of Medicine and Dentistry, Centre for Primary Care and Public Health, Dr Carol Rivas, Barts and the London School of Medicine and Dentistry, Centre for Primary Care and Public Health, Professor Trisha Greenhalgh, Barts and the London School of Medicine and Dentistry, Centre for Primary Care and Public Health, Professor Robert Walton, Barts and the London School of Medicine and Dentistry, Centre for Primary Care and Public Health, Dr Geoff Wong, Barts and the London School of Medicine and Dentistry, Centre for Primary Care and Public Health, Collaborators Professor Carolyn Summerbell, School of Medicine, Pharmacy and Health, Durham University Dr Adam Todd, School of Medicine, Pharmacy and Health, Durham University Details of any existing review of the same topic by the same authors The authors' work on the Cochrane EPOC review Community pharmacy interventions for health promotion: effects on professional practice and health outcomes, which is complementary to this review Anticipated or actual start date 01 October 2013 Anticipated completion date 31 July 2014 Funding sources/sponsors National Institute for Health Research. Programme Grants for Applied Research Conflicts of interest None known Language English Country England Page: 4 / 5

Powered by TCPDF (www.tcpdf.org) Subject index terms status Subject indexing assigned by CRD Subject index terms Chronic Disease; Community Pharmacy Services; Health Behavior; Health Promotion; Humans Stage of review Ongoing Date of registration in PROSPERO 09 January 2014 Date of publication of this revision 09 January 2014 DOI 10.15124/CRD42014007097 Stage of review at time of this submission Started Completed Preliminary searches Yes No Piloting of the study selection process Yes No Formal screening of search results against eligibility criteria Yes No Data extraction Yes No Risk of bias (quality) assessment Yes No Data analysis Yes No PROSPERO International prospective register of systematic reviews The information in this record has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Page: 5 / 5