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1.  A systematic review of the use of theory in randomized controlled trials of audit and feedback 
Background
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.
Methods
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).
Results
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).
Conclusions
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.
doi:10.1186/1748-5908-8-66
PMCID: PMC3702512  PMID: 23759034
Audit and feedback; Systematic review; Theory; Intervention design
2.  Developing program theory for purveyor programs 
Background
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.
Methods
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.
Results
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.
Conclusion
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.
doi:10.1186/1748-5908-8-23
PMCID: PMC3607884  PMID: 23421855
Program theory; Logic models; Purveyor; Dissemination; Implementation fidelity
3.  Designing theoretically-informed implementation interventions 
Clinical and health services research is continually producing new findings that may contribute to effective and efficient patient care. However, the transfer of research findings into practice is unpredictable and can be a slow and haphazard process. Ideally, the choice of implementation strategies would be based upon evidence from randomised controlled trials or systematic reviews of a given implementation strategy. Unfortunately, reviews of implementation strategies consistently report effectiveness some, but not all of the time; possible causes of this variation are seldom reported or measured by the investigators in the original studies. Thus, any attempts to extrapolate from study settings to the real world are hampered by a lack of understanding of the effects of key elements of individuals, interventions, and the settings in which they were trialled. The explicit use of theory offers a way of addressing these issues and has a number of advantages, such as providing: a generalisable framework within which to represent the dimensions that implementation studies address, a process by which to inform the development and delivery of interventions, a guide when evaluating, and a way to allow for an exploration of potential causal mechanisms. However, the use of theory in designing implementation interventions is methodologically challenging for a number of reasons, including choosing between theories and faithfully translating theoretical constructs into interventions. The explicit use of theory offers potential advantages in terms of facilitating a better understanding of the generalisability and replicability of implementation interventions. However, this is a relatively unexplored methodological area.
doi:10.1186/1748-5908-1-4
PMCID: PMC1436012  PMID: 16722571
4.  Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science 
Background
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.
Methods
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.
Results
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.
Conclusion
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.
doi:10.1186/1748-5908-4-50
PMCID: PMC2736161  PMID: 19664226
5.  REsearch into implementation STrategies to support patients of different ORigins and language background in a variety of European primary care settings (RESTORE): study protocol 
Background
The implementation of guidelines and training initiatives to support communication in cross-cultural primary care consultations is ad hoc across a range of international settings with negative consequences particularly for migrants. This situation reflects a well-documented translational gap between evidence and practice and is part of the wider problem of implementing guidelines and the broader range of professional educational and quality interventions in routine practice. In this paper, we describe our use of a contemporary social theory, Normalization Process Theory and participatory research methodology—Participatory Learning and Action—to investigate and support implementation of such guidelines and training initiatives in routine practice.
Methods
This is a qualitative case study, using multiple primary care sites across Europe. Purposive and maximum variation sampling approaches will be used to identify and recruit stakeholders—migrant service users, general practitioners, primary care nurses, practice managers and administrative staff, interpreters, cultural mediators, service planners, and policy makers. We are conducting a mapping exercise to identify relevant guidelines and training initiatives. We will then initiate a PLA-brokered dialogue with stakeholders around Normalization Process Theory’s four constructs—coherence, cognitive participation, collective action, and reflexive monitoring. Through this, we will enable stakeholders in each setting to select a single guideline or training initiative for implementation in their local setting. We will prospectively investigate and support the implementation journeys for the five selected interventions. Data will be generated using a Participatory Learning and Action approach to interviews and focus groups. Data analysis will follow the principles of thematic analysis, will occur in iterative cycles throughout the project and will involve participatory co-analysis with key stakeholders to enhance the authenticity and veracity of findings.
Discussion
This research employs a unique combination of Normalization Process Theory and Participatory Learning and Action, which will provide a novel approach to the analysis of implementation journeys. The findings will advance knowledge in the field of implementation science because we are using and testing theoretical and methodological approaches so that we can critically appraise their scope to mediate barriers and improve the implementation processes.
doi:10.1186/1748-5908-7-111
PMCID: PMC3541149  PMID: 23167911
6.  Applications of social constructivist learning theories in knowledge translation for healthcare professionals: a scoping review 
Background
Use of theory is essential for advancing the science of knowledge translation (KT) and for increasing the likelihood that KT interventions will be successful in reducing existing research-practice gaps in health care. As a sociological theory of knowledge, social constructivist theory may be useful for informing the design and evaluation of KT interventions. As such, this scoping review explored the extent to which social constructivist theory has been applied in the KT literature for healthcare professionals.
Methods
Searches were conducted in six databases: Ovid MEDLINE (1948 – May 16, 2011), Ovid EMBASE, CINAHL, ERIC, PsycInfo, and AMED. Inclusion criteria were: publications from all health professions, research methodologies, as well as conceptual and theoretical papers related to KT. To be included in the review, key words such as constructivism, social constructivism, or social constructivist theories had to be included within the title or abstract. Papers that discussed the use of social constructivist theories in the context of undergraduate learning in academic settings were excluded from the review. An analytical framework of quantitative (numerical) and thematic analysis was used to examine and combine study findings.
Results
Of the 514 articles screened, 35 papers published between 1992 and 2011 were deemed eligible and included in the review. This review indicated that use of social constructivist theory in the KT literature was limited and haphazard. The lack of justification for the use of theory continues to represent a shortcoming of the papers reviewed. Potential applications and relevance of social constructivist theory in KT in general and in the specific studies were not made explicit in most papers. For the acquisition, expression and application of knowledge in practice, there was emphasis on how the social constructivist theory supports clinicians in expressing this knowledge in their professional interactions.
Conclusions
This scoping review was the first to examine use of social constructivism in KT studies. While the links between social constructivism and KT have not been fully explored, the Knowledge to Action framework has strong constructivist underpinnings that can be used in moving forward within the broader KT enterprise.
doi:10.1186/1748-5908-9-54
PMCID: PMC4040365  PMID: 24885925
7.  Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions 
Trials  2014;15:267.
Background
The Medical Research Councils’ framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable.
Methods
We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions.
Results
Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework.
Conclusions
Incorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex interventions, thereby increasing the likelihood that the intervention will be ultimately effective, sustainable and scalable. We urge researchers developing and evaluating complex interventions to consider using this approach, to evaluate its usefulness and to build an evidence base to further refine the methodology.
Trial registration
Clinical trials.gov: NCT02160249
doi:10.1186/1745-6215-15-267
PMCID: PMC4227087  PMID: 24996765
Complex interventions; Theory of Change; MRC framework for complex interventions
8.  Embedding mental health interventions in early childhood education systems for at-risk preschoolers: an evidence to policy realist review 
Systematic Reviews  2014;3:84.
Background
Current early childhood systems of care are not geared to respond to the complex needs of preschoolers at risk for mental health problems in a timely, coordinated, multidisciplinary, and comprehensive fashion. Evidence-informed policy represents an opportunity for implementing prevention, promotion, and early intervention at the population or at-risk level. Exposure to risk factors as well as the presence of clinical disorders can derail the developmental trajectories of preschoolers, and problems may persist if left untreated. One way to address these multiple research-to-policy gaps are systematic reviews sensitive to context and knowledge user needs, such as the realist review. The realist review is an iterative process between research teams and knowledge users to build mid-level program theories in order to understand which interventions work best for whom and under what context.
Methods/Design
The realist review employs five ‘iterative’ steps: (1) clarify scope, (2) search for evidence, (3) appraise primary studies and extract data, (4) synthesize the evidence, and (5) disseminate, implement, and evaluate evidence, to answer two research questions: What interventions improve mental health outcomes for preschoolers at risk for socio-emotional difficulties and under what circumstances do they work? and what are the best models of care for integrating mental health interventions within pre-existing early childhood education (ECE) services for at-risk children? Knowledge users and researchers will work together through each stage of the review starting with refining the questions through to decisions regarding program theory building, data extraction, analysis, and design of a policy dissemination plan. The initial questions will guide preliminary literature reviews, but subsequent more focused searches will be informed by knowledge users familiar with local needs and further building of explanatory program theories.
Discussion
Policy makers want to know what works best for whom, but are faced with a wide and disparate intervention literature for at-risk children. Applying evidence-based standards is a good start, but the chain of implementation between research results and how to match interventions sensitive to local context are ongoing challenges.
Trial registration
Prospero registration number: CRD42014007301.
doi:10.1186/2046-4053-3-84
PMCID: PMC4127568  PMID: 25073533
Early childhood; Preschoolers; Mental health interventions; At-risk children; Realist review
9.  Testing a TheoRY-inspired MEssage ('TRY-ME'): a sub-trial within the Ontario Printed Educational Message (OPEM) trial 
Background
A challenge for implementation researchers is to develop principles that could generate testable hypotheses that apply across a range of clinical contexts, thus leading to generalisability of findings. Such principles may be provided by systematically developed theories. The opportunity has arisen to test some of these theoretical principles in the Ontario Printed Educational Materials (OPEM) trial by conducting a sub-trial within the existing trial structure. OPEM is a large factorial cluster-randomised trial evaluating the effects of short directive and long discursive educational messages embedded into informed, an evidence-based newsletter produced in Canada by the Institute for Clinical Evaluative Sciences (ICES) and mailed to all primary care physicians in Ontario. The content of educational messages in the sub-trial will be constructed using both standard methods and methods inspired by psychological theory. The aim of this study is to test the effectiveness of the TheoRY-inspired MEssage ('TRY-ME') compared with the 'standard' message in changing prescribing behaviour.
Methods
The OPEM trial participants randomised to receive the short directive message attached to the outside of informed (an 'outsert') will be sub-randomised to receive either a standard message or a message informed by the theory of planned behaviour (TPB) using a two (long insert or no insert) by three (theory-based outsert or standard outsert or no outsert) design. The messages will relate to prescription of thiazide diuretics as first line drug treatment for hypertension (described in the accompanying protocol, "The Ontario Printed Educational Materials trial"). The short messages will be developed independently by two research teams.
The primary outcome is prescription of thiazide diuretics, measured by routinely collected data available within ICES. The study is designed to answer the question, is there any difference in guideline adherence (i.e., thiazide prescription rates) between physicians in the six groups? A process evaluation survey instrument based on the TPB will be administered pre- and post-intervention (described in the accompanying protocol, "Looking inside the black box"). The second research question concerns processes that may underlie observed differences in prescribing behaviour. We expect that effects of the messages on prescribing behaviour will be mediated through changes in physicians' cognitions.
Trial registration number
Current controlled trial ISRCTN72772651
doi:10.1186/1748-5908-2-39
PMCID: PMC2216024  PMID: 18039363
10.  IMPLEmenting a clinical practice guideline for acute low back pain evidence-based manageMENT in general practice (IMPLEMENT): Cluster randomised controlled trial study protocol 
Background
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.
Aim
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.
Methods/Design
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).
doi:10.1186/1748-5908-3-11
PMCID: PMC2291069  PMID: 18294375
11.  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.
doi:10.1186/1748-5908-1-5
PMCID: PMC1436014  PMID: 16722583
12.  Engaging primary care practitioners in quality improvement: making explicit the program theory of an interprofessional education intervention 
Background
The scientific literature continues to advocate interprofessional collaboration (IPC) as a key component of primary care. It is recommended that primary care groups be created and configured to meet the healthcare needs of the patient population, as defined by patient demographics and other data analyses related to the health of the population being served. It is further recommended that the improvement of primary care services be supported by the delivery of feedback and performance measurements. This paper describes the theory underlying an interprofessional educational intervention developed in Quebec’s Montérégie region (Canada) for the purpose of improving chronic disease management in primary care. The objectives of this study were to explain explicitly the theory underlying this intervention, to describe its components in detail and to assess the intervention’s feasibility and acceptability.
Method
A program impact theory-driven evaluation approach was used. Multiple sources of information were examined to make explicit the theory underlying the education intervention: 1) a literature review and a review of documents describing the program’s development; 2) regular attendance at the project’s committee meetings; 3) direct observation of the workshops; 4) interviews of workshop participants; and 5) focus groups with workshop facilitators. Qualitative data collected were analysed using thematic analysis.
Results
The theoretical basis of the interprofessional education intervention was found to be work motivation theory and reflective learning. Five themes describing the workshop objectives emerged from the qualitative analysis of the interviews conducted with the workshop participants. These five themes were the importance of: 1) adopting a regional perspective, 2) reflecting, 3) recognizing gaps between practice and guidelines, 4) collaborating, and 5) identifying possible practice improvements. The team experienced few challenges implementing the intervention. However, the workshop’s acceptability was found to be very good.
Conclusion
Our observation of the workshop sessions and the interviews conducted with the participants confirmed that the objectives of the education intervention indeed targeted the improvement of interprofessional collaboration and quality of care. However, it is clear that a three-hour workshop alone cannot lead to major changes in practice. Long-term interventions are needed to support this complex change process.
doi:10.1186/1472-6963-13-106
PMCID: PMC3623830  PMID: 23514278
Interprofessional continuing education; Quality improvement; Primary care practice; Program theory-driven evaluation
13.  Explaining clinical behaviors using multiple theoretical models 
Background
In the field of implementation research, there is an increased interest in use of theory when designing implementation research studies involving behavior change. In 2003, we initiated a series of five studies to establish a scientific rationale for interventions to translate research findings into clinical practice by exploring the performance of a number of different, commonly used, overlapping behavioral theories and models. We reflect on the strengths and weaknesses of the methods, the performance of the theories, and consider where these methods sit alongside the range of methods for studying healthcare professional behavior change.
Methods
These were five studies of the theory-based cognitions and clinical behaviors (taking dental radiographs, performing dental restorations, placing fissure sealants, managing upper respiratory tract infections without prescribing antibiotics, managing low back pain without ordering lumbar spine x-rays) of random samples of primary care dentists and physicians. Measures were derived for the explanatory theoretical constructs in the Theory of Planned Behavior (TPB), Social Cognitive Theory (SCT), and Illness Representations specified by the Common Sense Self Regulation Model (CSSRM). We constructed self-report measures of two constructs from Learning Theory (LT), a measure of Implementation Intentions (II), and the Precaution Adoption Process. We collected data on theory-based cognitions (explanatory measures) and two interim outcome measures (stated behavioral intention and simulated behavior) by postal questionnaire survey during the 12-month period to which objective measures of behavior (collected from routine administrative sources) were related. Planned analyses explored the predictive value of theories in explaining variance in intention, behavioral simulation and behavior.
Results
Response rates across the five surveys ranged from 21% to 48%; we achieved the target sample size for three of the five surveys. For the predictor variables, the mean construct scores were above the mid-point on the scale with median values across the five behaviors generally being above four out of seven and the range being from 1.53 to 6.01. Across all of the theories, the highest proportion of the variance explained was always for intention and the lowest was for behavior. The Knowledge-Attitudes-Behavior Model performed poorly across all behaviors and dependent variables; CSSRM also performed poorly. For TPB, SCT, II, and LT across the five behaviors, we predicted median R2 of 25% to 42.6% for intention, 6.2% to 16% for behavioral simulation, and 2.4% to 6.3% for behavior.
Conclusions
We operationalized multiple theories measuring across five behaviors. Continuing challenges that emerge from our work are: better specification of behaviors, better operationalization of theories; how best to appropriately extend the range of theories; further assessment of the value of theories in different settings and groups; exploring the implications of these methods for the management of chronic diseases; and moving to experimental designs to allow an understanding of behavior change.
doi:10.1186/1748-5908-7-99
PMCID: PMC3500222  PMID: 23075284
14.  Family-based interventions to increase physical activity in children: a meta-analysis and realist synthesis protocol 
BMJ Open  2014;4(8):e005439.
Introduction
Despite the established relationship between physical activity and health, data suggest that many children are insufficiently active, and that levels decline into adolescence. Engaging the family in interventions may increase and maintain children's physical activity levels at the critical juncture before secondary school. Synthesis of existing evidence will inform future studies, but the heterogeneity in target populations recruited, behaviour change techniques and intervention strategies employed, and measurement conducted, may require a multifaceted review method. The primary objective of this work will therefore be to synthesis evidence from intervention studies that explicitly engage the family unit to increase children's physical activity using an innovative dual meta-analysis and realist approach.
Methods and analysis
Peer-reviewed studies will be independently screened by two authors for inclusion based on (1) including ‘healthy’ participants aged 5–12 years; (2) having a substantive intervention aim of increasing physical activity, by engaging the family and (3) reporting on physical activity. Duplicate data extraction and quality assessment will be conducted using a specially designed proforma and the Effective Public Health Practice Project Quality Assessment Tool respectively. STATA software will be used to compute effect sizes for meta-analyses, with subgroup analyses conducted to identify moderating characteristics. Realist syntheses will be conducted according to RAMESES quality and publication guidelines, including development of a programme theory and evidence mapping.
Dissemination
This review will be the first to use the framework of a traditional review to conduct a dual meta-analysis and realist synthesis, examining interventions that engage the family to increase physical activity in children. The results will be disseminated through peer-reviewed publications, conferences, formal presentations to policy makers and practitioners and informal meetings. Evidence generated from this synthesis will also be used to inform the development of theory-driven, evidence-based interventions aimed at engaging the family to increase physical activity levels in children.
Protocol registration
International Prospective Register for Systematic Reviews (PROSPERO): number CRD42013005780.
doi:10.1136/bmjopen-2014-005439
PMCID: PMC4127934  PMID: 25099934
PUBLIC HEALTH; EPIDEMIOLOGY; SPORTS MEDICINE
15.  Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) a pragmatic three-arm cluster randomised trial: designing the intervention (ClinicalTrials.gov registration NCT01602705) 
Background
High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions have small/moderate effects on clinical practice, but few trials explicitly compare different forms of feedback. There is growing recognition that intervention development should be theory-informed, and that comprehensive reporting of intervention design is required by potential users of trial findings. The paper describes intervention development for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study, a pragmatic three-arm cluster randomised trial in 262 Scottish general practices.
Methods
The NHS chose to implement a feedback intervention to utilise a new resource, new Prescribing Information System (newPIS). The development phase required selection of high-risk prescribing outcome measures and design of intervention components: (1) educational material (the usual care comparison), (2) feedback of practice rates of high-risk prescribing received by both intervention arms and (3) a theory-informed behaviour change component to be received by one intervention arm. Outcome measures, educational material and feedback design, were developed with a National Health Service Advisory Group. The behaviour change component was informed by the Theory of Planned Behaviour and the Health Action Process Approach. A focus group elicitation study and an email Delphi study with general practitioners (GPs) identified key attitudes and barriers of responding to the prescribing feedback. Behaviour change techniques were mapped to the psychological constructs, and the content was informed by the results of the elicitation and Delphi study.
Results
Six high-risk prescribing measures were selected in a consensus process based on importance and feasibility. Educational material and feedback design were based on current NHS Scotland practice and Advisory Group recommendations. The behaviour change component was resource constrained in development, mirroring what is feasible in an NHS context. Four behaviour change interventions were developed and embedded in five quarterly rounds of feedback targeting attitudes, subjective norms, perceived behavioural control and action planning (2×).
Conclusions
The paper describes a process which is feasible to use in the resource-constrained environment of NHS-led intervention development and documents the intervention to make its design and implementation explicit to potential users of the trial findings.
Trial registration
ClinicalTrials.gov: NCT01602705
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0133-9) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0133-9
PMCID: PMC4201916  PMID: 25304255
Feedback; Medication errors; Medication review; Inappropriate medication; Randomised controlled trial; Primary health care; Family practice; Intervention development; Behaviour change; ePrescribing
16.  Patient adherence to medical treatment: a review of reviews 
Background
Patients' non-adherence to medical treatment remains a persistent problem. Many interventions to improve patient adherence are unsuccessful and sound theoretical foundations are lacking. Innovations in theory and practice are badly needed. A new and promising way could be to review the existing reviews of adherence to interventions and identify the underlying theories for effective interventions. That is the aim of our study.
Methods
The study is a review of 38 systematic reviews of the effectiveness of adherence interventions published between 1990 and 2005. Electronic literature searches were conducted in Medline, Psychinfo, Embase and the Cochrane Library. Explicit inclusion and exclusion criteria were applied. The scope of the study is patient adherence to medical treatment in the cure and care sector.
Results
Significant differences in the effectiveness of adherence interventions were found in 23 of the 38 systematic reviews. Effective interventions were found in each of four theoretical approaches to adherence interventions: technical, behavioural, educational and multi-faceted or complex interventions. Technical solutions, such as a simplification of the regimen, were often found to be effective, although that does not count for every therapeutic regimen.
Overall, our results show that, firstly, there are effective adherence interventions without an explicit theoretical explanation of the operating mechanisms, for example technical solutions. Secondly, there are effective adherence interventions, which clearly stem from the behavioural theories, for example incentives and reminders. Thirdly, there are other theoretical models that seem plausible for explaining non-adherence, but not very effective in improving adherence behaviour. Fourthly, effective components within promising theories could not be identified because of the complexity of many adherence interventions and the lack of studies that explicitly compare theoretical components.
Conclusion
There is a scarcity of comparative studies explicitly contrasting theoretical models or their components. The relative weight of these theories and the effective components in the interventions designed to improve adherence, need to be assessed in future studies.
doi:10.1186/1472-6963-7-55
PMCID: PMC1955829  PMID: 17439645
17.  Understanding the impact of visual arts interventions for people living with dementia: a realist review protocol 
Systematic Reviews  2014;3:91.
Background
Arts-based activities are being increasingly suggested as a valuable activity for people living with dementia in terms of countering the negative aspects of their condition. The potential for such programmes to improve a broad range of psychosocial outcomes is suggested in some studies. However, there is largely an absence of rigorous methodology to demonstrate the benefits, and research results are mixed. Practice variability in terms of the content, contexts and implementation of such interventions raises challenges in terms of identifying an optimal arts programme model that could be adopted by other service providers. Understanding how interventions may have the best chance at broad implementation success and uptake is limited.
Methods/Design
A realist review will be undertaken. This aims to understand how visual arts interventions influence outcomes in people living with dementia. The review will explore how the context, that is the circumstances which enable or constrain, affect outcomes through the activation of mechanisms. An early scoping search and a stakeholder survey formulated the preliminary programme theory. A systematic literature search across a broad range of disciplines (arts, humanities, social sciences, health) will be undertaken to identify journal articles and grey literature. Data will be extracted in relation to the programme theory, contextual factors, mechanisms and outcomes and their configurations, background information about the study design and participant characteristics, detail about the quantity (‘dose’) of an intervention, theoretical perspectives proposed by the authors of the paper and further theorising by the reviewer. Thematic connections/patterns will be sought across the extracted data, identifying patterns amongst contextual factors, the mechanisms they trigger and the associated outcomes.
Discussion
Along with stakeholder engagement and validation, this review will help inform the development of an optimal, replicable arts intervention for people with dementia as part of our broader research programme, titled ‘Dementia and Imagination’ (funded by the Arts and Humanities Research Council). Forthcoming work under this programme of research will test this theoretically informed intervention in three different geographical areas of the UK. The production of freely available practice guidance is a key aspect of dissemination.
Trial registration
PROSPERO registration number CRD42014008702.
doi:10.1186/2046-4053-3-91
PMCID: PMC4141269  PMID: 25128286
Realist synthesis; Realist review; Art interventions; Art programmes; Creative activities; Dementia; Visual art; Imagination
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.
OBJECTIVES
To determine effectiveness and costs of different guideline dissemination and implementation strategies.
DATA SOURCES
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.
REVIEW METHODS: INCLUSION CRITERIA
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.
RESULTS
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.
CONCLUSIONS
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.
doi:10.1111/j.1525-1497.2006.00357.x
PMCID: PMC2557130  PMID: 16637955
practice guideline; systematic review; implementation research.
19.  Methods for the comparative evaluation of pharmaceuticals 
Political background
As a German novelty, the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen; IGWiG) was established in 2004 to, among other tasks, evaluate the benefit of pharmaceuticals. In this context it is of importance that patented pharmaceuticals are only excluded from the reference pricing system if they offer a therapeutic improvement.
The institute is commissioned by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) or by the Ministry of Health and Social Security. The German policy objective expressed by the latest health care reform (Gesetz zur Modernisierung der Gesetzlichen Krankenversicherung, GMG) is to base decisions on a scientific assessment of pharmaceuticals in comparison to already available treatments. However, procedures and methods are still to be established.
Research questions and methods
This health technology assessment (HTA) report was commissioned by the German Agency for HTA at the Institute for Medical Documentation and Information (DAHTA@DIMDI). It analysed criteria, procedures, and methods of comparative drug assessment in other EU-/OECD-countries. The research question was the following: How do national public institutions compare medicines in connection with pharmaceutical regulation, i.e. licensing, reimbursement and pricing of drugs?
Institutions as well as documents concerning comparative drug evaluation (e.g. regulations, guidelines) were identified through internet, systematic literature, and hand searches. Publications were selected according to pre-defined inclusion and exclusion criteria. Documents were analysed in a qualitative matter following an analytic framework that had been developed in advance. Results were summarised narratively and presented in evidence tables.
Results and discussion
Currently licensing agencies do not systematically assess a new drug's added value for patients and society. This is why many countries made post-licensing evaluation of pharmaceuticals a requirement for reimbursement or pricing decisions. Typically an explicitly designated drug review body is involved.
In all eleven countries included (Austria, Australia, Canada, Switzerland, Finland, France, the Netherlands, Norway, New Zealand, Sweden, and the United Kingdom) a drug's therapeutic benefit in comparison to treatment alternatives is leading the evaluation. A medicine is classified as a therapeutic improvement if it demonstrates an improved benefit-/risk-profile compared to treatment alternatives. However, evidence of superiority to a relevant degree is requested.
Health related quality of life is considered as the most appropriate criterion for a drug's added value from patients' perspective. Review bodies in Australia, New Zealand, and the United Kingdom have committed themselves to include this outcome measure whenever possible.
Pharmacological or innovative characteristics (e.g. administration route, dosage regime, new acting principle) and other advantages (e.g. taste, appearance) are considered in about half of the countries. However, in most cases these aspects rank as second line criteria for a drug's added value.
All countries except France and Switzerland perform a comparative pharmacoeconomic evaluation to analyse costs caused by a drug intervention in relation to its benefit (preferably by cost utility analysis). However, the question if a medicine is cost effective in relation to treatment alternatives is answered in a political and social context. A range of remarkably varying criteria are considered.
Countries agree that randomised controlled head-to-head trials (head-to-head RCT) with a high degree of internal and external validity provide the most reliable and least biased evidence of a drug's relative treatment effects (as do systematic reviews and meta-analyses of these RCT). Final outcome parameters reflecting long-term treatment objectives (mortality, morbidity, quality of life) are preferred to surrogate parameters. Following the concept of community effectiveness, drug review institutions also explicitly favour RCT in a "natural" design, i.e. in daily routine and country specific care settings.
The countries' requirements for pharmacoeconomic studies are similar despite some methodological inconsistencies, e.g. concerning cost calculation.
Outcomes of clinical and pharmacoeconomic analyses are largely determined by the choice of comparator. Selecting an appropriate comparative treatment is therefore crucial. In theory, the best or most cost effective therapy is regarded as appropriate comparator for clinical and economic studies. Pragmatically however, institutions accept that the drug is compared to the treatment of daily routine or to the least expensive therapy.
If a pharmaceutical offers several approved indications, in some countries all of them are assessed. Others only evaluate a drug's main indication. Canada is the only country which also considers a medicine's off-label use.
It is well known that clinical trials and pharmacoeconomic studies directly comparing a drug with adequate competitors are lacking - in quantitative as well as in qualitative terms. This is specifically the case before or shortly after marketing authorisation. Yet there is the need to support reimbursement or pricing decisions by scientific evidence. In this situation review bodies are often forced to rely on observational studies or on other internally less valid data (including expert and consensus opinions). As a second option they use statistical approaches like indirect adjusted comparisons (in Australia and the United Kingdom) and, commonly, economic modelling. However, there is consensus that results provided by these techniques need to be verified by valid head-to-head comparisons as soon as possible.
Conclusions
In the majority of countries reimbursement and pricing decisions are based on systematic and evidence-based evaluation comparing a drug's clinical and economic characteristics to daily treatment routine. However, further evaluation criteria, requirements and specific methodological issues still lack internationally consented standards.
PMCID: PMC3011319  PMID: 21289930
20.  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
21.  Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis 
PLoS Medicine  2013;10(8):e1001498.
Background
Clinical practice guidelines (CPGs) aim to improve professionalism in health care. However, current CPG development manuals fail to address how to include ethical issues in a systematic and transparent manner. The objective of this study was to assess the representation of ethical issues in general CPGs on dementia care.
Methods and Findings
To identify national CPGs on dementia care, five databases of guidelines were searched and national psychiatric associations were contacted in August 2011 and in June 2013. A framework for the assessment of the identified CPGs' ethical content was developed on the basis of a prior systematic review of ethical issues in dementia care. Thematic text analysis and a 4-point rating score were employed to assess how ethical issues were addressed in the identified CPGs. Twelve national CPGs were included. Thirty-one ethical issues in dementia care were identified by the prior systematic review. The proportion of these 31 ethical issues that were explicitly addressed by each CPG ranged from 22% to 77%, with a median of 49.5%. National guidelines differed substantially with respect to (a) which ethical issues were represented, (b) whether ethical recommendations were included, (c) whether justifications or citations were provided to support recommendations, and (d) to what extent the ethical issues were explained.
Conclusions
Ethical issues were inconsistently addressed in national dementia guidelines, with some guidelines including most and some including few ethical issues. Guidelines should address ethical issues and how to deal with them to help the medical profession understand how to approach care of patients with dementia, and for patients, their relatives, and the general public, all of whom might seek information and advice in national guidelines. There is a need for further research to specify how detailed ethical issues and their respective recommendations can and should be addressed in dementia guidelines.
Please see later in the article for the Editors' Summary
Editors’ Summary
Background
In the past, doctors tended to rely on their own experience to choose the best treatment for their patients. Faced with a patient with dementia (a brain disorder that affects short-term memory and the ability tocarry out normal daily activities), for example, a doctor would use his/her own experience to help decide whether the patient should remain at home or would be better cared for in a nursing home. Similarly, the doctor might have to decide whether antipsychotic drugs might be necessary to reduce behavioral or psychological symptoms such as restlessness or shouting. However, over the past two decades, numerous evidence-based clinical practice guidelines (CPGs) have been produced by governmental bodies and medical associations that aim to improve standards of clinical competence and professionalism in health care. During the development of each guideline, experts search the medical literature for the current evidence about the diagnosis and treatment of a disease, evaluate the quality of that evidence, and then make recommendations based on the best evidence available.
Why Was This Study Done?
Currently, CPG development manuals do not address how to include ethical issues in CPGs. A health-care professional is ethical if he/she behaves in accordance with the accepted principles of right and wrong that govern the medical profession. More specifically, medical professionalism is based on a set of binding ethical principles—respect for patient autonomy, beneficence, non-malfeasance (the “do no harm” principle), and justice. In particular, CPG development manuals do not address disease-specific ethical issues (DSEIs), clinical ethical situations that are relevant to the management of a specific disease. So, for example, a DSEI that arises in dementia care is the conflict between the ethical principles of non-malfeasance and patient autonomy (freedom-to-move-at-will). Thus, healthcare professionals may have to decide to physically restrain a patient with dementia to prevent the patient doing harm to him- or herself or to someone else. Given the lack of guidance on how to address ethical issues in CPG development manuals, in this thematic text analysis, the researchers assess the representation of ethical issues in CPGs on general dementia care. Thematic text analysis uses a framework for the assessment of qualitative data (information that is word-based rather than number-based) that involves pinpointing, examining, and recording patterns (themes) among the available data.
What Did the Researchers Do and Find?
The researchers identified 12 national CPGs on dementia care by searching guideline databases and by contacting national psychiatric associations. They developed a framework for the assessment of the ethical content in these CPGs based on a previous systematic review of ethical issues in dementia care. Of the 31 DSEIs included by the researchers in their analysis, the proportion that were explicitly addressed by each CPG ranged from 22% (Switzerland) to 77% (USA); on average the CPGs explicitly addressed half of the DSEIs. Four DSEIs—adequate consideration of advanced directives in decision making, usage of GPS and other monitoring techniques, covert medication, and dealing with suicidal thinking—were not addressed in at least 11 of the CPGs. The inclusion of recommendations on how to deal with DSEIs ranged from 10% of DSEIs covered in the Swiss CPG to 71% covered in the US CPG. Overall, national guidelines differed substantially with respect to which ethical issues were included, whether ethical recommendations were included, whether justifications or citations were provided to support recommendations, and to what extent the ethical issues were clearly explained.
What Do These Findings Mean?
These findings show that national CPGs on dementia care already address clinical ethical issues but that the extent to which the spectrum of DSEIs is considered varies widely within and between CPGs. They also indicate that recommendations on how to deal with DSEIs often lack the evidence that health-care professionals use to justify their clinical decisions. The researchers suggest that this situation can and should be improved, although more research is needed to determine how ethical issues and recommendations should be addressed in dementia guidelines. A more systematic and transparent inclusion of DSEIs in CPGs for dementia (and for other conditions) would further support the concept of medical professionalism as a core element of CPGs, note the researchers, but is also important for patients and their relatives who might turn to national CPGs for information and guidance at a stressful time of life.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001498.
Wikipedia contains a page on clinical practice guidelines (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The US National Guideline Clearinghouse provides information on national guidelines, including CPGs for dementia
The Guidelines International Network promotes the systematic development and application of clinical practice guidelines
The American Medical Association provides information about medical ethics; the British Medical Association provides information on all aspects of ethics and includes an essential tool kit that introduces common ethical problems and practical ways to deal with them
The UK National Health Service Choices website provides information about dementia, including a personal story about dealing with dementia
MedlinePlus provides links to additional resources about dementia and about Alzheimers disease, a specific type of dementia (in English and Spanish)
The UK Nuffield Council on Bioethics provides the report Dementia: ethical issues and additional information on the public consultation on ethical issues in dementia care
doi:10.1371/journal.pmed.1001498
PMCID: PMC3742442  PMID: 23966839
22.  Improving the use of research evidence in guideline development: 2. Priority setting 
Background
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 second 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.
Objectives
We reviewed the literature on priority setting for health care guidelines, recommendations and technology assessments.
Methods
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
There is little empirical evidence to guide the choice of criteria and processes for establishing priorities, but there are broad similarities in the criteria that are used by various organisations and practical arguments for setting priorities explicitly rather than implicitly,
What criteria should be used to establish priorities?
• WHO has limited resources and capacity to develop recommendations. It should use these resources where it has the greatest chance of improving health, equity, and efficient use of healthcare resources.
• We suggest the following criteria for establishing priorities for developing recommendations based on WHO's aims and strategic advantages:
• Problems associated with a high burden of illness in low and middle-income countries, or new and emerging diseases.
• No existing recommendations of good quality.
• The feasibility of developing recommendations that will improve health outcomes, reduce inequities or reduce unnecessary costs if they are implemented.
• Implementation is feasible, will not exhaustively use available resources, and barriers to change are not likely to be so high that they cannot be overcome.
• Additional priorities for WHO include interventions that will likely require system changes and interventions where there might be a conflict in choices between individual and societal perspectives.
What processes should be used to agree on priorities?
• The allocation of resources to the development of recommendations should be part of the routine budgeting process rather than a separate exercise.
• Criteria for establishing priorities should be applied using a systematic and transparent process.
• Because data to inform judgements are often lacking, unmeasured factors should also be considered – explicitly and transparently.
• The process should include consultation with potential end users and other stakeholders, including the public, using well-constructed questions, and possibly using Delphi-like procedures.
• Groups that include stakeholders and people with relevant types of expertise should make decisions. Group processes should ensure full participation by all members of the group.
• The process used to select topics should be documented and open to inspection.
Should WHO have a centralised or decentralised process?
• Both centralised and decentralised processes should be used. Decentralised processes can be considered as separate "tracks".
• Separate tracks should be used for considering issues for specific areas, populations, conditions or concerns. The rationales for designating special tracks should be defined clearly; i.e. why they warrant special consideration.
• Updating of guidelines could also be considered as a separate "track", taking account of issues such as the need for corrections and the availability of new evidence.
doi:10.1186/1478-4505-4-14
PMCID: PMC1702532  PMID: 17134481
23.  A test of cognitive mediation in a 12-month physical activity workplace intervention: does it explain behaviour change in women? 
Background
Attempts to demonstrate the efficacy of interventions aimed at increasing physical activity (PA) have been mixed. Further, studies are seldom designed in a manner that facilitates the understanding of how or why a treatment is effective or ineffective and PA intervention designs should be guided by a heavier reliance upon behavioral theory. The use of a mediating variable framework offers a systematic methodological approach to testing the role of theory, and could also identify the effectiveness of specific intervention components. The primary purpose of this paper was to test the mediating role that cognitive constructs may have played in regards to the positive effect that a workplace behavioral intervention had on leisure-time PA for women. A subsidiary purpose was to examine the cross-sectional relationships of these cognitive constructs with PA behavior.
Methods
The Physical Activity Workplace Study was a randomized controlled trial which compared the effects of stage-matched and standard print materials upon self-reported leisure-time PA, within a workplace sample at 6 and 12-months. In this secondary analysis we examined the mediation effects of 14 psychosocial constructs across 3 major social-cognitive theories which were operationalized for the intervention materials and measured at baseline, 6 and 12-months. We examined change in PA and change in the psychological constructs employing a mediation strategy proposed by Baron and Kenny for: (1) the first 6-months (i.e., initial change), (2) the second 6-months (i.e., delayed change), and (3) the entire 12-months (overall change) of the study on 323 women (n = 213 control/standard materials group; n = 110 stage-matched materials group).
Results
Of the 14 constructs and 42 tests (including initial, delayed and overall change) two positive results were identified (i.e., overall change in pros, initial change in experiential powerful intervention approaches processes), with very small effect sizes. However, these mediating results were eliminated after adjusting for the multiple statistical tests.
Conclusions
The intervention did not change these mediators in any substantive way, and show a similar pattern to prior research where interventions generally do not result in a change in mediation of behavior change. It is important to report mediation results in randomized controlled trials whether the findings are null or positive. Future studies may wish to focus on more detailed dose-response issues between mediators and behavior, the inclusion of moderators that could affect individual change, or different mediator constructs at higher levels of measurement specificity. Continued work on innovative and more powerful PA intervention approaches are needed.
doi:10.1186/1479-5868-7-32
PMCID: PMC2874508  PMID: 20438632
24.  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.
Background
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.
Methods/design
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.
Discussion
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.
doi:10.1186/1471-2458-10-741
PMCID: PMC3001738  PMID: 21118510
25.  Group interventions to improve health outcomes: a framework for their design and delivery 
BMC Public Health  2010;10:800.
Background
Delivering an intervention to a group of patients to improve health outcomes is increasingly popular in public health and primary care, yet "group" is an umbrella term which encompasses a complex range of aims, theories, implementation processes and evaluation methods. We propose a framework for the design and process evaluation of health improvement interventions occurring in a group setting, which will assist practitioners, researchers and policy makers.
Methods
We reviewed the wider literature on health improvement interventions delivered to patient groups and identified a gap in the literature for designing, evaluating and reporting these interventions. We drew on our experiences conducting systematic reviews, intervention, mixed method and ethnographic studies of groups for breastfeeding and weight management. A framework for health improvement group design and delivery evolved through an iterative process of primary research, reference to the literature and research team discussion.
Results
Although there is an extensive literature on group processes in education, work, politics and psychological therapies, far less is known about groups where the aim is health improvement. Theories of behaviour change which are validated for individual use are often assumed to be generalisable to group settings, without being rigorously tested. Health improvement or behaviour change interventions delivered in a group setting are complex adaptive social processes with interactions between the group leader, participants, and the wider community and environment. Ecological models of health improvement, which embrace the complex relationship between behaviour, systems and the environment may be more relevant than an individual approach to behaviour change.
Conclusion
The evidence for effectiveness and cost-effectiveness of group compared with one-to-one interventions for many areas of health improvement in public health and primary care is weak or unknown. Our proposed framework is the first step towards advocating a more systematic approach to designing, evaluating and reporting interventions in group settings, which is necessary to improve this currently weak evidence base. This framework will enable policy makers and practitioners to be better informed about what works, how it works and in which contexts when aiming to improve health in a group setting.
doi:10.1186/1471-2458-10-800
PMCID: PMC3022868  PMID: 21194466

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