Looking inside the black box : a theory-based process evaluation alongside a randomised controlled trial of printed educational materials (the Ontario printed educational message, OPEM) to improve referral and prescribing practices in primary care in Ontario, Canada

Background: Randomised controlled trials of implementation strategies tell us whether (or not) an intervention results in changes in professional behaviour but little about the causal mechanisms that produce any change. Theory-based process evaluations collect data on theoretical constructs alongside randomised trials to explore possible causal mechanisms and effect modifiers. This is similar to measuring intermediate endpoints in clinical trials to further understand the biological basis of any observed effects (for example, measuring lipid profiles alongside trials of lipid lowering drugs where the primary endpoint could be reduction in vascular related deaths). This study protocol describes a theory-based process evaluation alongside the Ontario Printed Educational Message (OPEM) trial. We hypothesize that the OPEM interventions are most likely to operate through changes in physicians' behavioural intentions due to improved attitudes or subjective norms with little or no change in perceived behavioural control. We will test this hypothesis using a well-validated social cognition model, the theory of planned behaviour (TPB) that incorporates these constructs. Methods/design: We will develop theory-based surveys using standard methods based upon the TPB for the second and third replications, and survey a subsample of Ontario family physicians from each arm of the trial two months before and six months after the dissemination of the index edition of informed, the evidence based newsletter used for the interventions. In the third replication, our study will converge with the "TRY-ME" protocol (a second study conducted alongside the OPEM trial), in which the content of educational messages was constructed using both standard methods and methods informed by psychological theory. We will modify Dillman's total design method to maximise response rates. Preliminary analyses will initially assess the internal reliability of the measures and use regression to explore the relationships between predictor and dependent variable (intention to advise diabetic patients to have annual retinopathy screening and to prescribe thiazide diuretics for first line treatment of uncomplicated hypertension). We will then compare groups using methods appropriate for comparing independent samples to determine whether there have been changes in the predicted constructs (attitudes, subjective norms, or intentions) across the study groups as hypothesised, and will assess the convergence between the process evaluation results and the main trial results.The OPEM trial and OPEM process evaluation are funded by the Canadian Institute of Health Research (CIHR). The OPEM process evaluation study was developed as part of the CIHR funded interdisciplinary capacity enhancement team KT-ICEBeRG. Gaston Godin, Jeremy Grimshaw and France Légaré hold Canada Research Chairs. Louise Lemyre holds an R.S. McLaughlin Research Chair

The development and application of audit criteria for assessing knowledge exchange plans in health research grant applications.

Background: Research funders expect evidence of end user engagement and impact plans in research proposals. Drawing upon existing frameworks, we developed audit criteria to help researchers and their institutions assess the knowledge exchange plans of health research proposals. Findings: Criteria clustered around five themes: problem definition; involvement of research users; public and patient engagement; dissemination and implementation; and planning, management and evaluation of knowledge exchange. We applied these to a sample of grant applications from one research institution in the United Kingdom to demonstrate feasibility. Conclusion: Our criteria may be useful as a tool for researcher self-assessment and for research institutions to assess the quality of knowledge exchange plans and identify areas for systematic improvement

Who needs what from a national health research system: Lessons from reforms to the English Department of Health's R&D system

This article has been made available through the Brunel Open Access Publishing Fund.Health research systems consist of diverse groups who have some role in health research, but the boundaries around such a system are not clear-cut. To explore what various stakeholders need we reviewed the literature including that on the history of English health R&D reforms, and we also applied some relevant conceptual frameworks. We first describe the needs and capabilities of the main groups of stakeholders in health research systems, and explain key features of policymaking systems within which these stakeholders operate in the UK. The five groups are policymakers (and health care managers), health professionals, patients and the general public, industry, and researchers. As individuals and as organisations they have a range of needs from the health research system, but should also develop specific capabilities in order to contribute effectively to the system and benefit from it. Second, we discuss key phases of reform in the development of the English health research system over four decades - especially that of the English Department of Health's R&D system - and identify how far legitimate demands of key stakeholder interests were addressed. Third, in drawing lessons we highlight points emerging from contemporary reports, but also attempt to identify issues through application of relevant conceptual frameworks. The main lessons are: the importance of comprehensively addressing the diverse needs of various interacting institutions and stakeholders; the desirability of developing facilitating mechanisms at interfaces between the health research system and its various stakeholders; and the importance of additional money in being able to expand the scope of the health research system whilst maintaining support for basic science. We conclude that the latest health R&D strategy in England builds on recent progress and tackles acknowledged weaknesses. The strategy goes a considerable way to identifying and more effectively meeting the needs of key groups such as medical academics, patients and industry, and has been remarkably successful in increasing the funding for health research. There are still areas that might benefit from further recognition and resourcing, but the lessons identified, and progress made by the reforms are relevant for the design and coordination of national health research systems beyond England.This article is available through the Brunel Open Access Publishing Fund

Supporting knowledge translation through collaborative translational research initiatives: 'bridging' versus 'blurring' boundary-spanning approaches in the UK CLAHRC initiative

Recent policy initiatives in the UK and internationally have sought to promote knowledge translation between the 'producers' and 'users' of research. Within this paper we explore how boundary-spanning interventions used within such initiatives can support knowledge translation between diverse groups. Using qualitative data from a 3-year research study conducted from January 2010 to December 2012 of two case-sites drawn from the CLAHRC initiative in the UK, we distinguish two different approaches to supporting knowledge translation; a 'bridging' approach that involves designated roles, discrete events and activities to span the boundaries between communities, and a 'blurring' approach that de-emphasises the boundaries between groups, enabling a more continuous process of knowledge translation as part of day-to-day work-practices. In this paper, we identify and differentiate these boundary-spanning approaches and describe how they emerged from the context defined by the wider CLAHRC networks. This highlights the need to develop a more contextualised analysis of the boundary-spanning that underpins knowledge translation processes, relating this to the distinctive features of a particular case

Printed educational messages fail to increase use of thiazides as first-line medication for hypertension in primary care: a cluster randomized controlled trial [ISRCTN72772651]

BACKGROUND: Evidence on the effectiveness of printed educational messages in contributing to increasing evidence-based clinical practice is contradictory. Nonetheless, these messages flood physician offices, in an attempt to promote treatments that can reduce costs while improving patient outcomes. This study evaluated the ability of printed educational messages to promote the choice of thiazides as the first-line treatment for individuals newly diagnosed with hypertension, a practice supported by good evidence and included in guidelines, and one which could reduce costs to the health care system. METHODS: The study uses a pragmatic, cluster randomized controlled trial (randomized by physician practice group). SETTING: The setting involves all Ontario general/family practice physicians. Messages advising the use of thiazides as the first-line treatment of hypertension were mailed to each physician in conjunction with a widely read professional newsletter. Physicians were randomized to receive differing versions of printed educational messages: an "insert" (two-page evidence-based article) and/or one of two different versions of an "outsert" (short, directive message stapled to the outside of the newsletter). One outsert was developed without an explicit theory and one with messages developed targeting factors from the theory of planned behaviour or neither (newsletter only, with no mention of thiazides). The percentage of patients aged over 65 and newly diagnosed with hypertension who were prescribed a thiazide as the sole initial prescription medication. The effect of the intervention was estimated using a logistic regression model estimated using generalized estimating equation methods to account for the clustering of patients within physician practices. RESULTS: Four thousand five hundred four physicians (with 23,508 patients) were randomized, providing 97 % power to detect a 5 % absolute increase in prescription of thiazides. No intervention effect was detected. Thiazides were prescribed to 27.6 % of the patients who saw control physicians, 27.4 % for the insert, 26.8 % for the outsert and 28.3 % of the patients who saw insert + outsert physicians, p = 0.54. CONCLUSIONS: The study conclusively failed to demonstrate any impact of the printed educational messages on increasing prescribing of thiazide diuretics for first-line management of hypertension. TRIAL REGISTRATION: ISRCTN72772651

Looking inside the black box: results of a theory-based process evaluation exploring the results of a randomized controlled trial of printed educational messages to increase primary care physicians' diabetic retinopathy referrals [Trial registration number ISRCTN72772651]

Background: Theory-based process evaluations conducted alongside randomized controlled trials provide the opportunity to investigate hypothesized mechanisms of action of interventions, helping to build a cumulative knowledge base and to inform the interpretation of individual trial outcomes. Our objective was to identify the underlying causal mechanisms in a cluster randomized trial of the effectiveness of printed educational materials (PEMs) to increase referral for diabetic retinopathy screening. We hypothesized that the PEMs would increase physicians’ intention to refer patients for retinal screening by strengthening their attitude and subjective norm, but not their perceived behavioral control. Methods: Design: A theory based process evaluation alongside the Ontario Printed Educational Material (OPEM) cluster randomized trial. Postal surveys based on the Theory of Planned Behavior were sent to a random sample of trial participants two months before and six months after they received the intervention. Setting: Family physicians in Ontario, Canada. Participants: 1,512 family physicians (252 per intervention group) from the OPEM trial were invited to participate, and 31.3% (473/1512) responded at time one and time two. The final sample comprised 437 family physicians fully completing questionnaires at both time points. Main outcome measures: Primary: behavioral intention related to referring patient for retinopathy screening; secondary: attitude, subjective norm, perceived behavioral control. Results: At baseline, family physicians reported positive intention, attitude, subjective norm, and perceived behavioral control to advise patients about retinopathy screening suggesting limited opportunities for improvement in these constructs. There were no significant differences on intention, attitude, subjective norm, and perceived behavioral control following the intervention. Respondents also reported additional physician- and patient-related factors perceived to influence whether patients received retinopathy screening. Conclusions: Lack of change in the primary and secondary theory-based outcomes provides an explanation for the lack of observed effect of the main OPEM trial. High baseline levels of intention to advise patients to attend retinopathy screening suggest that post-intentional and other factors may explain gaps in care. Process evaluations based on behavioral theory can provide replicable and generalizable insights to aid interpretation of randomized controlled trials of complex interventions to change health professional behavior

Utilization of a population health survey in policy and practice: a case study

BackgroundThere is growing interest by funding bodies and researchers in assessing the impact of research on real world policy and practice. Population health monitoring surveys provide an important source of data on the prevalence and patterns of health problems, but few empirical studies have explored if and how such data is used to influence policy or practice decisions. Here we provide a case study analysis of how the findings from an Australian population monitoring survey series of children&rsquo;s weight and weight-related behaviors (Schools Physical Activity and Nutrition Survey (SPANS)) have been used, and the key facilitators and barriers to their utilization.MethodsData collection included semi-structured interviews with the chief investigators (n = 3) and end-users (n = 9) of SPANS data to explore if, how and under what circumstances the survey findings had been used, bibliometric analysis and verification using documentary evidence. Data analysis involved thematic coding of interview data and triangulation with other data sources to produce case summaries of policy and practice impacts for each of the three survey years (1997, 2004, 2010). Case summaries were then reviewed and discussed by the authors to distil key themes on if, how and why the SPANS findings had been used to guide policy and practice.ResultsWe found that the survey findings were used for agenda setting (raising awareness of issues), identifying areas and target groups for interventions, informing new policies, and supporting and justifying existing policies and programs across a range of sectors. Reported factors influencing use of the findings were: i) the perceived credibility of survey findings; ii) dissemination strategies used; and, iii) a range of contextual factors.ConclusionsUsing a novel approach, our case study provides important new insights into how and under what circumstances population health monitoring data can be used to influence real world policy and practice. The findings highlight the importance of population monitoring programs being conducted by independent credible agencies, researchers engaging end-users from the inception of survey programs and utilizing existing policy networks and structures, and using a range of strategies to disseminate the findings that go beyond traditional peer review publications.<br /

Policy and practice impacts of applied research: a case study analysis of the New South Wales Health Promotion Demonstration Research Grants Scheme 2000-2006

BackgroundIntervention research provides important information regarding feasible and effective interventions for health policy makers, but few empirical studies have explored the mechanisms by which these studies influence policy and practice. This study provides an exploratory case series analysis of the policy, practice and other related impacts of the 15 research projects funded through the New South Wales Health Promotion Demonstration Research Grants Scheme during the period 2000 to 2006, and explored the factors mediating impacts.MethodsData collection included semi-structured interviews with the chief investigators (n = 17) and end-users (n = 29) of each of the 15 projects to explore if, how and under what circumstances the findings had been used, as well as bibliometric analysis and verification using documentary evidence. Data analysis involved thematic coding of interview data and triangulation with other data sources to produce case summaries of impacts for each project. Case summaries were then individually assessed against four impact criteria and discussed at a verification panel meeting where final group assessments of the impact of research projects were made and key influences of research impact identified.ResultsFunded projects had variable impacts on policy and practice. Project findings were used for agenda setting (raising awareness of issues), identifying areas and target groups for interventions, informing new policies, and supporting and justifying existing policies and programs across sectors. Reported factors influencing the use of findings were: i) nature of the intervention; ii) leadership and champions; iii) research quality; iv) effective partnerships; v) dissemination strategies used; and, vi) contextual factors.ConclusionsThe case series analysis provides new insights into how and under what circumstances intervention research is used to influence real world policy and practice. The findings highlight that intervention research projects can achieve the greatest policy and practice impacts if they address proximal needs of the policy context by engaging end-users from the inception of projects and utilizing existing policy networks and structures, and using a range of strategies to disseminate findings that go beond traditional peer review publications.<br /

Reflections on using a community-based and multisystem approach to transforming school-based intervention for children with developmental motor disorders

Evidence-based management of Developmental Coordination Disorder (DCD) in school-age children requires putting into practice the best and most current research findings, including evidence that early identification, self-management, prevention of secondary disability, and enhanced participation are the most appropriate foci of school-based occupational therapy. Partnering for Change (P4C) is a new school-based intervention based upon these principles that has been developed and evaluated in Ontario, Canada over an 8-year period. Our experience to date indicates that its implementation in schools is highly complex with involvement of multiple stakeholders across health and education sectors. In this paper, we describe and reflect upon our team’s experience in using community-based participatory action research, knowledge translation, and implementation science to transform evidence-informed practice with children who have DCD