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      Republished: How to study improvement interventions: a brief overview of possible study types

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          Abstract

          Improvement (defined broadly as purposive efforts to secure positive change) has become an increasingly important activity and field of inquiry within healthcare. This article offers an overview of possible methods for the study of improvement interventions. The choice of available designs is wide, but debates continue about how far improvement efforts can be simultaneously practical (aimed at producing change) and scientific (aimed at producing new knowledge), and whether the distinction between the practical and the scientific is a real and useful one. Quality improvement projects tend to be applied and, in some senses, self-evaluating. They are not necessarily directed at generating new knowledge, but reports of such projects if well conducted and cautious in their inferences may be of considerable value. They can be distinguished heuristically from research studies, which are motivated by and set out explicitly to test a hypothesis, or otherwise generate new knowledge, and from formal evaluations of improvement projects. We discuss variants of trial designs, quasi-experimental designs, systematic reviews, programme evaluations, process evaluations, qualitative studies, and economic evaluations. We note that designs that are better suited to the evaluation of clearly defined and static interventions may be adopted without giving sufficient attention to the challenges associated with the dynamic nature of improvement interventions and their interactions with contextual factors. Reconciling pragmatism and research rigour is highly desirable in the study of improvement. Trade-offs need to be made wisely, taking into account the objectives involved and inferences to be made.

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          Most cited references 51

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          Evaluating the successful implementation of evidence into practice using the PARiHS framework: theoretical and practical challenges

          Background The PARiHS framework (Promoting Action on Research Implementation in Health Services) has proved to be a useful practical and conceptual heuristic for many researchers and practitioners in framing their research or knowledge translation endeavours. However, as a conceptual framework it still remains untested and therefore its contribution to the overall development and testing of theory in the field of implementation science is largely unquantified. Discussion This being the case, the paper provides an integrated summary of our conceptual and theoretical thinking so far and introduces a typology (derived from social policy analysis) used to distinguish between the terms conceptual framework, theory and model – important definitional and conceptual issues in trying to refine theoretical and methodological approaches to knowledge translation. Secondly, the paper describes the next phase of our work, in particular concentrating on the conceptual thinking and mapping that has led to the generation of the hypothesis that the PARiHS framework is best utilised as a two-stage process: as a preliminary (diagnostic and evaluative) measure of the elements and sub-elements of evidence (E) and context (C), and then using the aggregated data from these measures to determine the most appropriate facilitation method. The exact nature of the intervention is thus determined by the specific actors in the specific context at a specific time and place. In the process of refining this next phase of our work, we have had to consider the wider issues around the use of theories to inform and shape our research activity; the ongoing challenges of developing robust and sensitive measures; facilitation as an intervention for getting research into practice; and finally to note how the current debates around evidence into practice are adopting wider notions that fit innovations more generally. Summary The paper concludes by suggesting that the future direction of the work on the PARiHS framework is to develop a two-stage diagnostic and evaluative approach, where the intervention is shaped and moulded by the information gathered about the specific situation and from participating stakeholders. In order to expedite the generation of new evidence and testing of emerging theories, we suggest the formation of an international research implementation science collaborative that can systematically collect and analyse experiences of using and testing the PARiHS framework and similar conceptual and theoretical approaches. We also recommend further refinement of the definitions around conceptual framework, theory, and model, suggesting a wider discussion that embraces multiple epistemological and ontological perspectives.
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            Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and meta-analysis.

            The effectiveness of quality improvement (QI) strategies on diabetes care remains unclear. We aimed to assess the effects of QI strategies on glycated haemoglobin (HbA(1c)), vascular risk management, microvascular complication monitoring, and smoking cessation in patients with diabetes. We identified studies through Medline, the Cochrane Effective Practice and Organisation of Care database (from inception to July 2010), and references of included randomised clinical trials. We included trials assessing 11 predefined QI strategies or financial incentives targeting health systems, health-care professionals, or patients to improve management of adult outpatients with diabetes. Two reviewers independently abstracted data and appraised risk of bias. We reviewed 48 cluster randomised controlled trials, including 2538 clusters and 84,865 patients, and 94 patient randomised controlled trials, including 38,664 patients. In random effects meta-analysis, the QI strategies reduced HbA(1c) by a mean difference of 0·37% (95% CI 0·28-0·45; 120 trials), LDL cholesterol by 0·10 mmol/L (0·05-0.14; 47 trials), systolic blood pressure by 3·13 mm Hg (2·19-4·06, 65 trials), and diastolic blood pressure by 1·55 mm Hg (0·95-2·15, 61 trials) versus usual care. We noted larger effects when baseline concentrations were greater than 8·0% for HbA(1c), 2·59 mmol/L for LDL cholesterol, and 80 mm Hg for diastolic and 140 mm Hg for systolic blood pressure. The effectiveness of QI strategies varied depending on baseline HbA(1c) control. QI strategies increased the likelihood that patients received aspirin (11 trials; relative risk [RR] 1·33, 95% CI 1·21-1·45), antihypertensive drugs (ten trials; RR 1·17, 1·01-1·37), and screening for retinopathy (23 trials; RR 1·22, 1·13-1·32), renal function (14 trials; RR 128, 1·13-1·44), and foot abnormalities (22 trials; RR 1·27, 1·16-1·39). However, statin use (ten trials; RR 1·12, 0·99-1·28), hypertension control (18 trials; RR 1·01, 0·96-1·07), and smoking cessation (13 trials; RR 1·13, 0·99-1·29) were not significantly increased. Many trials of QI strategies showed improvements in diabetes care. Interventions targeting the system of chronic disease management along with patient-mediated QI strategies should be an important component of interventions aimed at improving diabetes management. Interventions solely targeting health-care professionals seem to be beneficial only if baseline HbA(1c) control is poor. Ontario Ministry of Health and Long-term Care and the Alberta Heritage Foundation for Medical Research (now Alberta Innovates--Health Solutions). Copyright © 2012 Elsevier Ltd. All rights reserved.
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              Getting evidence into practice: the role and function of facilitation.

              This paper presents the findings of a concept analysis of facilitation in relation to successful implementation of evidence into practice. In 1998, we presented a conceptual framework that represented the interplay and interdependence of the many factors influencing the uptake of evidence into practice. One of the three elements of the framework was facilitation, alongside the nature of evidence and context. It was proposed that facilitators had a key role in helping individuals and teams understand what they needed to change and how they needed to change it. As part of the on-going development and refinement of the framework, the elements within it have undergone a concept analysis in order to provide theoretical and conceptual clarity. The concept analysis approach was used as a framework to review critically the research literature and seminal texts in order to establish the conceptual clarity and maturity of facilitation in relation to its role in the implementation of evidence-based practice. The concept of facilitation is partially developed and in need of delineation and comparison. Here, the purpose, role and skills and attributes of facilitators are explored in order to try and make distinctions between this role and other change agent roles such as educational outreach workers, academic detailers and opinion leaders. We propose that facilitation can be represented as a set of continua, with the purpose of facilitation ranging from a discrete task-focused activity to a more holistic process of enabling individuals, teams and organizations to change. A number of defining characteristics of facilitation are proposed. However, further research to clarify and evaluate different models of facilitation is required.
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                Author and article information

                Journal
                Postgrad Med J
                Postgrad Med J
                postgradmedj
                pmj
                Postgraduate Medical Journal
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                0032-5473
                1469-0756
                June 2015
                25 March 2015
                : 91
                : 1076
                : 343-354
                Affiliations
                [1 ]Social Science Applied to Healthcare Research (SAPPHIRE) Group, Department of Health Sciences, School of Medicine, University of Leicester , Leicester, UK
                [2 ]Department of Health Administration and Planning, National School of Public Health, Oswaldo Cruz Foundation , Rio de Janeiro, RJ, Brazil
                [3 ]Departments of Anesthesiology, Critical Care Medicine, and Surgery, Armstrong Institute for Patient Safety and Quality, School of Medicine, and Bloomberg School of Public Health, Johns Hopkins University , Baltimore, Maryland, USA
                [4 ]NIHR CLAHRC for Northwest London, Imperial College London, Chelsea and Westminster Hospital , London, UK
                Author notes
                [Correspondence to ] Dr Margareth C Portela, Departamento de Administração e Planejamento em Saúde, Escola Nacional de Saúde Pública, Fundação Oswaldo Cruz, Rua Leopoldo Bulhões 1480, sala 724—Manguinhos, Rio de Janeiro, RJ 21041-210, Brazil; mportela@ 123456ensp.fiocruz.br
                Article
                postgradmedj-2014-003620rep
                10.1136/postgradmedj-2014-003620rep
                4484358
                26045562
                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 in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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