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1.  Designing theoretically-informed implementation interventions: Fine in theory, but evidence of effectiveness in practice is needed 
The Improved Clinical Effectiveness through Behavioural Research Group (ICEBeRG) authors assert that a key weakness in implementation research is the unknown applicability of a given intervention outside its original site and problem, and suggest that use of explicit theory offers an effective solution. This assertion is problematic for three primary reasons. First, the presence of an underlying theory does not necessarily ease the task of judging the applicability of a piece of empirical evidence. Second, it is not clear how to translate theory reliably into intervention design, which undoubtedly involves the diluting effect of "common sense." Thirdly, there are many theories, formal and informal, and it is not clear why any one should be given primacy. To determine whether explicitly theory-based interventions are, on average, more effective than those based on implicit theories, pragmatic trials are needed. Until empirical evidence is available showing the superiority of theory-based interventions, the use of theory should not be used as a basis for assessing the value of implementation studies by research funders, ethics committees, editors or policy decision makers.
PMCID: PMC1436014  PMID: 16722583
2.  A framework for effective management of change in clinical practice: dissemination and implementation of clinical practice guidelines 
Quality in Health Care : QHC  1999;8(3):177-183.
Theories from social and behavioural science can make an important contribution to the process of developing a conceptual framework for improving use of clinical practice guidelines and clinician performance. A conceptual framework for guideline dissemination and implementation is presented which draws on relevant concepts from diffusion of innovation theory, the transtheoretical model of behaviour change, health education theory, social influence theory, and social ecology, as well as evidence from systematic literature reviews on the effectiveness of various behaviour change strategies. The framework emphasises the need for pre-implementation assessment of (a) readiness of clinicians to adopt guidelines into practice, (b) barriers to change as experienced by clinicians, and (c) the level at which interventions should be targeted. It also incorporates the need for multifaceted interventions, identifies the type of barriers which will be addressed by each strategy, and develops the concept of progression through stages of guideline adoption by clinicians, with the use of appropriately targeted support strategies. The potential value of the model is that it may enable those involved in the process of guideline dissemination and implementation to direct strategies to target groups more effectively. Clearly, the effectiveness and utility of the model in facilitating guideline dissemination and implementation requires validation by further empirical research. Until such research is available, it provides a theoretical framework that may assist in the selection of appropriate guideline dissemination and implementation strategies.
PMCID: PMC2483658  PMID: 10847875
3.  IMPLEmenting a clinical practice guideline for acute low back pain evidence-based manageMENT in general practice (IMPLEMENT): Cluster randomised controlled trial study protocol 
Evidence generated from reliable research is not frequently implemented into clinical practice. Evidence-based clinical practice guidelines are a potential vehicle to achieve this. A recent systematic review of implementation strategies of guideline dissemination concluded that there was a lack of evidence regarding effective strategies to promote the uptake of guidelines. Recommendations from this review, and other studies, have suggested the use of interventions that are theoretically based because these may be more effective than those that are not. An evidence-based clinical practice guideline for the management of acute low back pain was recently developed in Australia. This provides an opportunity to develop and test a theory-based implementation intervention for a condition which is common, has a high burden, and for which there is an evidence-practice gap in the primary care setting.
This study aims to test the effectiveness of a theory-based intervention for implementing a clinical practice guideline for acute low back pain in general practice in Victoria, Australia. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of patients who are referred for a plain x-ray, and improving mean level of disability for patients three months post-consultation.
This study protocol describes the details of a cluster randomised controlled trial. Ninety-two general practices (clusters), which include at least one consenting general practitioner, will be randomised to an intervention or control arm using restricted randomisation. Patients aged 18 years or older who visit a participating practitioner for acute non-specific low back pain of less than three months duration will be eligible for inclusion. An average of twenty-five patients per general practice will be recruited, providing a total of 2,300 patient participants. General practitioners in the control arm will receive access to the guideline using the existing dissemination strategy. Practitioners in the intervention arm will be invited to participate in facilitated face-to-face workshops that have been underpinned by behavioural theory. Investigators (not involved in the delivery of the intervention), patients, outcome assessors and the study statistician will be blinded to group allocation.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN012606000098538 (date registered 14/03/2006).
PMCID: PMC2291069  PMID: 18294375
4.  A systematic review of the use of theory in randomized controlled trials of audit and feedback 
Audit and feedback is one of the most widely used and promising interventions in implementation research, yet also one of the most variably effective. Understanding this variability has been limited in part by lack of attention to the theoretical and conceptual basis underlying audit and feedback. Examining the extent of theory use in studies of audit and feedback will yield better understanding of the causal pathways of audit and feedback effectiveness and inform efforts to optimize this important intervention.
A total of 140 studies in the 2012 Cochrane update on audit and feedback interventions were independently reviewed by two investigators. Variables were extracted related to theory use in the study design, measurement, implementation or interpretation. Theory name, associated reference, and the location of theory use as reported in the study were extracted. Theories were organized by type (e.g., education, diffusion, organization, psychology), and theory utilization was classified into seven categories (justification, intervention design, pilot testing, evaluation, predictions, post hoc, other).
A total of 20 studies (14%) reported use of theory in any aspect of the study design, measurement, implementation or interpretation. In only 13 studies (9%) was a theory reportedly used to inform development of the intervention. A total of 18 different theories across educational, psychological, organizational and diffusion of innovation perspectives were identified. Rogers’ Diffusion of Innovations and Bandura’s Social Cognitive Theory were the most widely used (3.6% and 3%, respectively).
The explicit use of theory in studies of audit and feedback was rare. A range of theories was found, but not consistency of theory use. Advancing our understanding of audit and feedback will require more attention to theoretically informed studies and intervention design.
PMCID: PMC3702512  PMID: 23759034
Audit and feedback; Systematic review; Theory; Intervention design
5.  Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science 
Many interventions found to be effective in health services research studies fail to translate into meaningful patient care outcomes across multiple contexts. Health services researchers recognize the need to evaluate not only summative outcomes but also formative outcomes to assess the extent to which implementation is effective in a specific setting, prolongs sustainability, and promotes dissemination into other settings. Many implementation theories have been published to help promote effective implementation. However, they overlap considerably in the constructs included in individual theories, and a comparison of theories reveals that each is missing important constructs included in other theories. In addition, terminology and definitions are not consistent across theories. We describe the Consolidated Framework For Implementation Research (CFIR) that offers an overarching typology to promote implementation theory development and verification about what works where and why across multiple contexts.
We used a snowball sampling approach to identify published theories that were evaluated to identify constructs based on strength of conceptual or empirical support for influence on implementation, consistency in definitions, alignment with our own findings, and potential for measurement. We combined constructs across published theories that had different labels but were redundant or overlapping in definition, and we parsed apart constructs that conflated underlying concepts.
The CFIR is composed of five major domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation. Eight constructs were identified related to the intervention (e.g., evidence strength and quality), four constructs were identified related to outer setting (e.g., patient needs and resources), 12 constructs were identified related to inner setting (e.g., culture, leadership engagement), five constructs were identified related to individual characteristics, and eight constructs were identified related to process (e.g., plan, evaluate, and reflect). We present explicit definitions for each construct.
The CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. It can be used to guide formative evaluations and build the implementation knowledge base across multiple studies and settings.
PMCID: PMC2736161  PMID: 19664226
6.  Improving the care for people with acute low-back pain by allied health professionals (the ALIGN trial): A cluster randomised trial protocol 
Variability between clinical practice guideline recommendations and actual clinical practice exists in many areas of health care. A 2004 systematic review examining the effectiveness of guideline implementation interventions concluded there was a lack of evidence to support decisions about effective interventions to promote the uptake of guidelines. Further, the review recommended the use of theory in the development of implementation interventions. A clinical practice guideline for the management of acute low-back pain has been developed in Australia (2003). Acute low-back pain is a common condition, has a high burden, and there is some indication of an evidence-practice gap in the allied health setting. This provides an opportunity to develop and test a theory-based implementation intervention which, if effective, may provide benefits for patients with this condition.
This study aims to estimate the effectiveness of a theory-based intervention to increase allied health practitioners' (physiotherapists and chiropractors in Victoria, Australia) compliance with a clinical practice guideline for acute non-specific low back pain (LBP), compared with providing practitioners with a printed copy of the guideline. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of acute non-specific LBP patients who are either referred for or receive an x-ray, and improving mean level of disability for patients three months post-onset of acute LBP.
The design of the study is a cluster randomised trial. Restricted randomisation was used to randomise 210 practices (clusters) to an intervention or control group. Practitioners in the control group received a printed copy of the guideline. Practitioners in the intervention group received a theory-based intervention developed to address prospectively identified barriers to practitioner compliance with the guideline. The intervention primarily consisted of an educational symposium. Patients aged 18 years or older who visit a participating practitioner for acute non-specific LBP of less than three months duration over a two-week data collection period, three months post the intervention symposia, are eligible for inclusion. Sample size calculations are based on recruiting between 15 to 40 patients per practice. Outcome assessors will be blinded to group allocation.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12609001022257 (date registered 25th November 2009)
PMCID: PMC2994785  PMID: 21067614
7.  Understanding Self-Controlled Motor Learning Protocols through the Self-Determination Theory 
The purpose of the present review was to provide a theoretical understanding of the learning advantages underlying a self-controlled practice context through the tenets of the self-determination theory (SDT). Three micro-theories within the macro-theory of SDT (Basic psychological needs theory, Cognitive Evaluation Theory, and Organismic Integration Theory) are used as a framework for examining the current self-controlled motor learning literature. A review of 26 peer-reviewed, empirical studies from the motor learning and medical training literature revealed an important limitation of the self-controlled research in motor learning: that the effects of motivation have been assumed rather than quantified. The SDT offers a basis from which to include measurements of motivation into explanations of changes in behavior. This review suggests that a self-controlled practice context can facilitate such factors as feelings of autonomy and competence of the learner, thereby supporting the psychological needs of the learner, leading to long term changes to behavior. Possible tools for the measurement of motivation and regulation in future studies are discussed. The SDT not only allows for a theoretical reinterpretation of the extant motor learning research supporting self-control as a learning variable, but also can help to better understand and measure the changes occurring between the practice environment and the observed behavioral outcomes.
PMCID: PMC3576889  PMID: 23430980
self-control; practice; feedback; motor tasks; motivation; autonomy support
8.  How Much Is Too Much Assessment? Insight into Assessment-Driven Student Learning Gains in Large-Scale Undergraduate Microbiology Courses 
Designing and implementing assessment tasks in large-scale undergraduate science courses is a labor-intensive process subject to increasing scrutiny from students and quality assurance authorities alike. Recent pedagogical research has provided conceptual frameworks for teaching introductory undergraduate microbiology, but has yet to define best-practice assessment guidelines. This study assessed the applicability of Biggs’ theory of constructive alignment in designing consistent learning objectives, activities, and assessment items that aligned with the American Society for Microbiology’s concept-based microbiology curriculum in MICR2000, an introductory microbiology course offered at the University of Queensland, Australia. By improving the internal consistency in assessment criteria and increasing the number of assessment items explicitly aligned to the course learning objectives, the teaching team was able to efficiently provide adequate feedback on numerous assessment tasks throughout the semester, which contributed to improved student performance and learning gains. When comparing the constructively aligned 2011 offering of MICR2000 with its 2010 counterpart, students obtained higher marks in both coursework assignments and examinations as the semester progressed. Students also valued the additional feedback provided, as student rankings for course feedback provision increased in 2011 and assessment and feedback was identified as a key strength of MICR2000. By designing MICR2000 using constructive alignment and iterative assessment tasks that followed a common set of learning outcomes, the teaching team was able to effectively deliver detailed and timely feedback in a large introductory microbiology course. This study serves as a case study for how constructive alignment can be integrated into modern teaching practices for large-scale courses.
PMCID: PMC3706145  PMID: 23858350
9.  The Place and Promise of Theory in Rehabilitation Psychology 
Rehabilitation psychology  2008;53(3):254-267.
Although rehabilitation psychology is more focused on empirical evidence and clinical application than theory development, we argue for the primacy of theory, and explain why theories are needed in and useful for rehabilitation psychology. Impediments to theory development are discussed, including the difficulties of applying psychological theories in multidisciplinary enterprises, and the difficulties in developing a theory-driven research program. We offer suggestions by reviewing research settings, knowledge gained through controlled studies, grantsmanship, and then identify topical areas where new theories are needed. We remind researcher-practitioners that rehabilitation psychology benefits from a judicious mix of scientific rigor and real-world vigor.
We close by advocating for theory-driven research programs that embrace a methodological pluralism, which will in turn advance new theory, produce meaningful research programs that inform practice, and realize the goals of this special issue of Rehabilitation Psychology—advances in research and methodology.
PMCID: PMC2600846  PMID: 19649146
10.  Suggestions for improving the study of health program implementation. 
Health Services Research  1984;19(1):117-125.
More will be learned about health programs and the implementation of health policy in this country if we pay more attention to issues of program implementation. Of particular use would be more studies which explicitly link program implementation with program outcomes and which recognize the need to combine quantitative and qualitative analysis of program implementation; the use of triangulated methods in focusing on the relationship between program implementation and program outcomes; the incorporation and study of planned variation in the methods of implementing programs; recognition that the process is essentially one of organizational change and innovation, and the incorporation of existing theory and evidence relevant to these issues; and recognition that the ongoing nature of the implementation process requires longitudinal study designs for implementation as well as for outcome assessment. Cronbach [9] has remarked that evaluation research "lights a candle in the darkness, but it never brings dazzling clarity." It may be that more attention to program implementation and better research on the process, such as that suggested in this note, will provide a little more light and will bring if not dazzling , at least modest, improvements in clarity.
PMCID: PMC1068792  PMID: 6724951
11.  Study of the composition of the various forms of coordination in the case management practice 
In 2004, Quebec’s Health and Social Care Ministry implemented an integrative reform aiming to systematize coordination which employed prescriptive devices. The will to systematize coordination practices is supported by formal coordination devices, such as case management. However, many obstacles lay in the path of these devices’ usage.
This presentation is based on Boltanski and Thévenot’s (1991) theory of conventions. This theory was utilized to analyze the operations that lead to the convened agreements which serve coordination in its formal and emergent aspects.
We utilized a qualitative and exploratory embedded case study design in which we employed three data collection and analysis methods: a documentary analysis of the integrative prescriptions, interviews aiming to make explicit the concrete coordination practices and direct observation of professional practices.
Results and conclusions
We identified different types of coordination systems in case management practices. Notably, the so-called ‘peri-professional’ system that grants the family caregivers the role of intermediate between the frail elder and the health and social care network, as well as the so-called ‘virtual’ system produced by the technological means of the computerized clinical files.
PMCID: PMC3031801
case management; coordination
12.  Difficulties implementing a mental health guideline: an exploratory investigation using psychological theory 
Evaluations of interventions to improve implementation of guidelines have failed to produce a clear pattern of results favouring a particular method. While implementation depends on clinicians and managers changing a variety of behaviours, psychological theories of behaviour and behaviour change are seldom used to try to understand difficulties in implementation or to develop interventions to overcome them.
This study applied psychological theory to examine explanations for difficulties in implementation. It used a theoretical framework derived from an interdisciplinary consensus exercise to code interviews across 11 theoretical domains. The focus of the study was a National Institute for Health and Clinical Excellence's Schizophrenia guideline recommendation that family intervention should be offered to the families of people with schizophrenia.
Participants were recruited from community mental health teams from three United Kingdom National Health Service (NHS) Trusts; 20 members (social workers, nurses, team managers, psychologists, and psychiatrists) participated. Semi-structured interviews were audio-taped and transcribed. Interview questions were based on the theoretical domains and addressed respondents' knowledge, attitudes and opinions regarding the guideline. Two researchers independently coded the transcript segments from each interview that were related to each theoretical domain. A score of 1 indicated that the transcript segments relating to the domain did not appear to contain description of difficulties in implementation of the family therapy guidelines; similarly a score of 0.5 indicated possible difficulties and a score of 0 indicated definite difficulties.
Coding respondents' answers to questions related to the three domains 'beliefs about consequences,' 'social/professional role and identity,' and 'motivation' produced the three highest total scores indicating that factors relating to these domains were unlikely to constitute difficulties in implementation. 'Environmental context and resources' was the lowest scoring domain, with 'Emotion' scoring the second lowest, suggesting that these were likely to be areas for considering intervention. The two main resources identified as problems were time and training. The emotions that appeared to potentially influence the offer of family therapy were self-doubt and fear.
This exploratory study demonstrates an approach to developing a theoretical understanding of implementation difficulties.
PMCID: PMC1864990  PMID: 17386102
13.  “It is a good idea, but…” A qualitative study of implementation of ‘Individual Plan’ in Norwegian mental health care 
Aim of the study
The aim of the study is to explore and describe what hampers and promotes the implementation of ‘Individual Plan’—Norway’s answer to integrated care, and to discuss the findings according to implementation theory and research.
‘Individual Plan’ is a master-plan intended to increase user-participation and provide better coordination of measures for patients in need of extensive and long-term health-care services. Norwegian Health Authorities used a dissemination strategy to implement ‘Individual Plan’ but managers within health and social care could choose their own way of implementation in their organisation.
Twenty-two managers from different clinics and organisational levels within mental health care were interviewed with an in-depth semi-structured interview about the implementation process in their organisation. The analysis was primarily made according to systematic text condensation.
The findings describe different implementation processes and how the managers identified with the usefulness of ‘Individual Plan’ as a tool, choice of practical implementation strategies, the manager’s own role, characteristics of organisational culture as well as how the manager considered external factors such as administration, lack of time and resources. The evolved implementation themes are discussed within a frame of existing knowledge and theory.
A complex picture of barriers, dilemmas and benefits emerges, both internal and external to an organisation as well as at a personal level that need to be taken into consideration in forthcoming implementation processes to increase the rate of success.
PMCID: PMC3429142  PMID: 22977428
Implementation; management; integrated care model; mental health
14.  How to develop a theory-driven evaluation design? Lessons learned from an adolescent sexual and reproductive health programme in West Africa 
BMC Public Health  2010;10:741.
This paper presents the development of a study design built on the principles of theory-driven evaluation. The theory-driven evaluation approach was used to evaluate an adolescent sexual and reproductive health intervention in Mali, Burkina Faso and Cameroon to improve continuity of care through the creation of networks of social and health care providers.
Based on our experience and the existing literature, we developed a six-step framework for the design of theory-driven evaluations, which we applied in the ex-post evaluation of the networking component of the intervention. The protocol was drafted with the input of the intervention designer. The programme theory, the central element of theory-driven evaluation, was constructed on the basis of semi-structured interviews with designers, implementers and beneficiaries and an analysis of the intervention's logical framework.
The six-step framework proved useful as it allowed for a systematic development of the protocol. We describe the challenges at each step. We found that there is little practical guidance in the existing literature, and also a mix up of terminology of theory-driven evaluation approaches. There is a need for empirical methodological development in order to refine the tools to be used in theory driven evaluation. We conclude that ex-post evaluations of programmes can be based on such an approach if the required information on context and mechanisms is collected during the programme.
PMCID: PMC3001738  PMID: 21118510
15.  Developing program theory for purveyor programs 
Frequently, social interventions produce less for the intended beneficiaries than was initially planned. One possible reason is that ideas embodied in interventions are not self-executing and require careful and systematic translation to put into practice. The capacity of implementers to deliver interventions is thus paramount. Purveyor organizations provide external support to implementers to develop that capacity and to encourage high-fidelity implementation behavior. Literature on the theory underlying this type of program is not plentiful. Research shows that detailed, explicit, and agreed-upon program theory contributes to and encourages high-fidelity implementation behavior. The process of developing and depicting program theory is flexible and leaves the researcher with what might be seen as an overwhelming number of options.
This study was designed to develop and depict the program theory underlying the support services delivered by a South African purveyor. The purveyor supports seventeen local organizations in delivering a peer education program to young people as an HIV/AIDS prevention intervention. Purposive sampling was employed to identify and select study participants. An iterative process that involved site visits, a desktop review of program documentation, one-on-one unstructured interviews, and a subsequent verification process, was used to develop a comprehensive program logic model.
The study resulted in a formalized logic model of how the specific purveyor is supposed to function; that model was accepted by all study participants.
The study serves as an example of how program theory of a ‘real life’ program can be developed and depicted. It highlights the strengths and weakness of this evaluation approach, and provides direction and recommendations for future research on programs that employ the purveyor method to disseminate interventions.
PMCID: PMC3607884  PMID: 23421855
Program theory; Logic models; Purveyor; Dissemination; Implementation fidelity
16.  The Increasing Use of Theory in Social Gerontology: 1990–2004 
To determine how often theory is used in published research in social gerontology, compare theory use over a 10-year period (1990–1994 to 2000–2004), and identify the theories most frequently used in social gerontology research.
Systematic review of articles published in eight leading journals from 2000 to 2004 (N = 1,046) and comparison with a review conducted 10 years earlier.
Theory was mentioned in 39% of articles published from 2000 to 2004, representing a 12% increase in the use of theory over 10 years. This increase was driven by theories outside the core sociology of aging theories identified by Bengtson, V. L., Burgess, E. O., and Parrott, T. M. (1997). Theory, explanation, and a third generation of theoretical development in social gerontology. Journal of Gerontology: Social Sciences, 52B, S72–S88. The five most frequently used theories included the life course perspective, life-span developmental theories, role theory, exchange theory, and person–environment theory/ecological theories of aging. Commonly used models included stress process/stress and coping models, successful aging models, the Andersen behavioral model of health services use, models of control/self-efficacy/mastery, and disablement process models.
Theory use in social gerontology increased between 1990 and 2004, with a shift toward theories that cross disciplines. However, the majority of research in social gerontology continues to be atheoretical. Models are widely used as a supplement to or substitute for theory. Many of these models are currently being debated and elaborated, and over time, they may emerge as important theoretical contributions to social gerontology.
PMCID: PMC2920947  PMID: 20675614
Models; Science of gerontology; Theories of aging
17.  Improving the use of research evidence in guideline development: 16. Evaluation 
The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the last of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this.
We reviewed the literature on evaluating guidelines and recommendations, including their quality, whether they are likely to be up-to-date, and their implementation. We also considered the role of guideline developers in undertaking evaluations that are needed to inform recommendations.
We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments.
Key questions and answers
Our answers to these questions were informed by a review of instruments for evaluating guidelines, several studies of the need for updating guidelines, discussions of the pros and cons of different research designs for evaluating the implementation of guidelines, and consideration of the use of uncertainties identified in systematic reviews to set research priorities.
How should the quality of guidelines or recommendations be appraised?
• WHO should put into place processes to ensure that both internal and external review of guidelines is undertaken routinely.
• A checklist, such as the AGREE instrument, should be used.
• The checklist should be adapted and tested to ensure that it is suitable to the broad range of recommendations that WHO produces, including public health and health policy recommendations, and that it includes questions about equity and other items that are particularly important for WHO guidelines.
When should guidelines or recommendations be updated?
• Processes should be put into place to ensure that guidelines are monitored routinely to determine if they are in need of updating.
• People who are familiar with the topic, such as Cochrane review groups, should do focused, routine searches for new research that would require revision of the guideline.
• Periodic review of guidelines by experts not involved in developing the guidelines should also be considered.
• Consideration should be given to establishing guideline panels that are ongoing, to facilitate routine updating, with members serving fixed periods with a rotating membership.
How should the impact of guidelines or recommendations be evaluated?
• WHO headquarters and regional offices should support member states and those responsible for policy decisions and implementation to evaluate the impact of their decisions and actions by providing advice regarding impact assessment, practical support and coordination of efforts.
• Before-after evaluations should be used cautiously and when there are important uncertainties regarding the effects of a policy or its implementation, randomised evaluations should be used when possible.
What responsibility should WHO take for ensuring that important uncertainties are addressed by future research when the evidence needed to inform recommendations is lacking?
• Guideline panels should routinely identify important uncertainties and research priorities. This source of potential priorities for research should be used systematically to inform priority-setting processes for global research.
PMCID: PMC1702533  PMID: 17156460
18.  Toward Evidence-Based Quality Improvement: Evidence (and its Limitations) of the Effectiveness of Guideline Dissemination and Implementation Strategies 1966–1998 
Journal of General Internal Medicine  2006;21(Suppl 2):S14-S20.
To determine effectiveness and costs of different guideline dissemination and implementation strategies.
MEDLINE (1966 to 1998), HEALTHSTAR (1975 to 1998), Cochrane Controlled Trial Register (4th edn 1998), EMBASE (1980 to 1998), SIGLE (1980 to 1988), and the specialized register of the Cochrane Effective Practice and Organisation of Care group.
Randomized-controlled trials, controlled clinical trials, controlled before and after studies, and interrupted time series evaluating guideline dissemination and implementation strategies targeting medically qualified health care professionals that reported objective measures of provider behavior and/or patient outcome. Two reviewers independently abstracted data on the methodologic quality of the studies, characteristics of study setting, participants, targeted behaviors, and interventions. We derived single estimates of dichotomous process variables (e.g., proportion of patients receiving appropriate treatment) for each study comparison and reported the median and range of effect sizes observed by study group and other quality criteria.
We included 309 comparisons derived from 235 studies. The overall quality of the studies was poor. Seventy-three percent of comparisons evaluated multifaceted interventions. Overall, the majority of comparisons (86.6%) observed improvements in care; for example, the median absolute improvement in performance across interventions ranged from 14.1% in 14 cluster-randomized comparisons of reminders, 8.1% in 4 cluster-randomized comparisons of dissemination of educational materials, 7.0% in 5 cluster-randomized comparisons of audit and feedback, and 6.0% in 13 cluster-randomized comparisons of multifaceted interventions involving educational outreach. We found no relationship between the number of components and the effects of multifaceted interventions. Only 29.4% of comparisons reported any economic data.
Current guideline dissemination and implementation strategies can lead to improvements in care within the context of rigorous evaluative studies. However, there is an imperfect evidence base to support decisions about which guideline dissemination and implementation strategies are likely to be efficient under different circumstances. Decision makers need to use considerable judgment about how best to use the limited resources they have for quality improvement activities.
PMCID: PMC2557130  PMID: 16637955
practice guideline; systematic review; implementation research.
19.  Understanding general practice: a conceptual framework developed from case studies in the UK NHS 
General practice in the UK is undergoing a period of rapid and profound change. Traditionally, research into the effects of change on general practice has tended to regard GPs as individuals or as members of a professional group. To understand the impact of change, general practices should also be considered as organisations.
To use the organisational studies literature to build a conceptual framework of general practice organisations, and to test and develop this empirically using case studies of change in practice. This study used the implementation of National Service Frameworks (NSFs) and the new General Medical Services (GMS) contract as incidents of change.
Design of study
In-depth, qualitative case studies. The design was iterative: each case study was followed by a review of the theoretical ideas. The final conceptual framework was the result of the dynamic interplay between theory and empirical evidence.
Five general practices in England, selected using purposeful sampling.
Semi-structured interviews with all clinical and managerial personnel in each practice, participant and non-participant observation, and examination of documents.
A conceptual framework was developed that can be used to understand how and why practices respond to change. This framework enabled understanding of observed reactions to the introduction of NSFs and the new GMS contract. Important factors for generating responses to change included the story that the practice members told about their practice, beliefs about what counted as legitimate work, the role played by the manager, and previous experiences of change.
Viewing general practices as small organisations has generated insights into factors that influence responses to change. Change tends to occur from the bottom up and is determined by beliefs about organisational reality. The conceptual framework suggests some questions that can be asked of practices to explain this internal reality.
PMCID: PMC2032702  PMID: 17244426
change; conceptual framework; general practice; organisations
20.  Welcome to Implementation Science 
Implementation research is the scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice, and, hence, to improve the quality and effectiveness of health services and care. This relatively new field includes the study of influences on healthcare professional and organisational behaviour.
Implementation Science will encompass all aspects of research in this field, in clinical, community and policy contexts. This online journal will provide a unique platform for this type of research and will publish a broad range of articles – study protocols, debate, theoretical and conceptual articles, rigorous evaluations of the process of change, and articles on methodology and rigorously developed tools – that will enhance the development and refinement of implementation research. No one discipline, research design, or paradigm will be favoured.
Implementation Science looks forward to receiving manuscripts that facilitate the continued development of the field, and contribute to healthcare policy and practice.
PMCID: PMC1436009
21.  Nothing as Practical as a Good Theory? The Theoretical Basis of HIV Prevention Interventions for Young People in Sub-Saharan Africa: A Systematic Review 
AIDS Research and Treatment  2012;2012:345327.
This paper assesses the extent to which HIV prevention interventions for young people in sub-Saharan Africa are grounded in theory and if theory-based interventions are more effective. Three databases were searched for evaluation studies of HIV prevention interventions for youth. Additional articles were identified on websites of international organisations and through searching references. 34 interventions were included; 25 mentioned the use of theory. Social Cognitive Theory was most prominent (n = 13), followed by Health Belief Model (n = 7), and Theory of Reasoned Action/Planned Behaviour (n = 6). These cognitive behavioural theories assume that cognitions drive sexual behaviour. Reporting on choice and use of theory was low. Only three articles provided information about why a particular theory was selected. Interventions used theory to inform content (n = 13), for evaluation purposes (n = 4) or both (n = 7). No patterns of differential effectiveness could be detected between studies using and not using theory, or according to whether a theory informed content, and/or evaluation. We discuss characteristics of the theories that might account for the limited effectiveness observed, including overreliance on cognitions that likely vary according to type of sexual behaviour and other personal factors, inadequately address interpersonal factors, and failure to account for contextual factors.
PMCID: PMC3415137  PMID: 22900155
22.  Improving the use of research evidence in guideline development: 1. Guidelines for guidelines 
The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the first of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this.
We reviewed the literature on guidelines for the development of guidelines.
We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments.
Key questions and answers
We found no experimental research that compared different formats of guidelines for guidelines or studies that compared different components of guidelines for guidelines. However, there are many examples, surveys and other observational studies that compared the impact of different guideline development documents on guideline quality.
What have other organizations done to develop guidelines for guidelines from which WHO can learn?
• Establish a credible, independent committee that evaluates existing methods for developing guidelines or that updates existing ones.
• Obtain feedback and approval from various stakeholders during the development process of guidelines for guidelines.
• Develop a detailed source document (manual) that guideline developers can use as reference material.
What should be the key components of WHO guidelines for guidelines?
• Guidelines for guidelines should include information and instructions about the following components: 1) Priority setting; 2) Group composition and consultations; 3) Declaration and avoidance of conflicts of interest; 4) Group processes; 5) Identification of important outcomes; 6) Explicit definition of the questions and eligibility criteria ; 7) Type of study designs for different questions; 8) Identification of evidence; 9) Synthesis and presentation of evidence; 10) Specification and integration of values; 11) Making judgments about desirable and undesirable effects; 12) Taking account of equity; 13) Grading evidence and recommendations; 14) Taking account of costs; 15) Adaptation, applicability, transferability of guidelines; 16) Structure of reports; 17) Methods of peer review; 18) Planned methods of dissemination & implementation; 19) Evaluation of the guidelines.
What have other organizations done to implement guidelines for guidelines from which WHO can learn?
• Obtain buy-in from regions and country level representatives for guidelines for guidelines before dissemination of a revised version.
• Disseminate the guidelines for guidelines widely and make them available (e.g. on the Internet).
• Develop examples of guidelines that guideline developers can use as models when applying the guidelines for guidelines.
• Ensure training sessions for those responsible for developing guidelines.
• Continue to monitor the methodological literature on guideline development.
PMCID: PMC1665445  PMID: 17118181
23.  Dynamics of change in the practice of female genital cutting in Senegambia: Testing predictions of social convention theory 
Social science & medicine (1982)  2011;73(8):1275-1283.
Recent reviews of intervention efforts aimed at ending female genital cutting (FGC) have concluded that progress to date has been slow, and call for more efficient programs informed by theories on behavior change. Social convention theory, first proposed by Mackie (1996), posits that in the context of extreme resource inequality, FGC emerged as a means of securing a better marriage by signaling fidelity, and subsequently spread to become a prerequisite for marriage for all women. Change is predicted to result from coordinated abandonment in intermarrying groups so as to preserve a marriage market for uncircumcised girls. While this theory fits well with many general observations of FGC, there have been few attempts to systematically test the theory. We use data from a three year mixed-method study of behavior change that began in 2004 in Senegal and The Gambia to explicitly test predictions generated by social convention theory. Analyses of 300 in-depth interviews, 28 focus group discussions, and survey data from 1220 women show that FGC is most often only indirectly related to marriageability via concerns over preserving virginity. Instead we find strong evidence for an alternative convention, namely a peer convention. We propose that being circumcised serves as a signal to other circumcised women that a girl or woman has been trained to respect the authority of her circumcised elders and is worthy of inclusion in their social network. In this manner, FGC facilitates the accumulation of social capital by younger women and of power and prestige by elder women. Based on this new evidence and reinterpretation of social convention theory, we suggest that interventions aimed at eliminating FGC should target women’s social networks, which are intergenerational, and include both men and women. Our findings support Mackie’s assertion that expectations regarding FGC are interdependent; change must therefore be coordinated among interconnected members of social networks.
PMCID: PMC3962676  PMID: 21920652
Senegal; The Gambia; Female genital cutting; Behavior change; Social convention theory; Social capital
24.  Bridging Research and Practice 
Theories and frameworks (hereafter called models) enhance dissemination and implementation (D&I) research by making the spread of evidence-based interventions more likely. This work organizes and synthesizes these models by: (1) developing an inventory of models used in D&I research; (2) synthesizing this information; and (3) providing guidance on how to select a model to inform study design and execution.
Evidence acquisition
This review began with commonly cited models and model developers and used snowball sampling to collect models developed in any year from journal articles, presentations, and books. All models were analyzed and categorized in 2011 based on three author-defined variables: construct flexibility, focus on dissemination and/or implementation activities (D/I), and the socio-ecological framework (SEF) level. Five-point scales were used to rate construct flexibility from broad to operational and D/I activities from dissemination-focused to implementation-focused. All SEF levels (system, community, organization, and individual) applicable to a model were also extracted. Models that addressed policy activities were noted.
Evidence synthesis
Sixty-one models were included in this review. Each of the five categories in the construct flexibility and D/I scales had/contained at least four models. Models were distributed across all levels of the SEF; the fewest models (n=8) addressed policy activities. To assist researchers in selecting and utilizing a model throughout the research process, the authors present and explain examples of how models have been used.
These findings may enable researchers to better identify and select models to inform their D&I work.
PMCID: PMC3592983  PMID: 22898128
25.  A cluster randomized controlled trial of a behavioral intervention to facilitate the development and implementation of clinical practice guidelines in Latin American maternity hospitals: the Guidelines Trial: Study protocol [ISRCTN82417627] 
BMC Women's Health  2005;5:4.
A significant proportion of the health care administered to women in Latin American maternity hospitals during labor and delivery has been demonstrated to be ineffective or harmful, whereas effective interventions remain underutilized. The routine use of episiotomies and the failure to use active management of the third stage of labor are good examples.
The aim of this trial is to evaluate the effect of a multifaceted behavioral intervention on the use of two evidence-based birth practices, the selective use of episiotomies and active management of the third stage of labor (injection of 10 International Units of oxytocin). The intervention is based on behavioral and organizational change theories and was based on formative research. Twenty-four hospitals in three urban districts of Argentina and Uruguay will be randomized. Opinion leaders in the 12 intervention hospitals will be identified and trained to develop and implement evidence-based guidelines. They will then disseminate the guidelines using a multifaceted approach including academic detailing, reminders, and feedback on utilization rates. The 12 hospitals in the control group will continue with their standard in-service training activities. The main outcomes to be assessed are the rates of episiotomy and oxytocin use during the third stage of labor. Secondary outcomes will be perineal sutures, postpartum hemorrhages, and birth attendants' opinions.
PMCID: PMC1090598  PMID: 15823211

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