| Literature DB >> 35413917 |
Ross C Brownson1,2, Rachel C Shelton3, Elvin H Geng4, Russell E Glasgow5.
Abstract
BACKGROUND: Evidence, in multiple forms, is a foundation of implementation science. For public health and clinical practice, evidence includes the following: type 1 evidence on etiology and burden; type 2 evidence on effectiveness of interventions; and type 3: evidence on dissemination and implementation (D&I) within context. To support a vision for development and use of evidence in D&I science that is more comprehensive and equitable (particularly for type 3 evidence), this article aims to clarify concepts of evidence, summarize ongoing debates about evidence, and provide a set of recommendations and tools/resources for addressing the "how-to" in filling evidence gaps most critical to advancing implementation science. MAIN TEXT: Because current conceptualizations of evidence have been relatively narrow and insufficiently characterized in our opinion, we identify and discuss challenges and debates about the uses, usefulness, and gaps in evidence for implementation science. A set of questions is proposed to assist in determining when evidence is sufficient for dissemination and implementation. Intersecting gaps include the need to (1) reconsider how the evidence base is determined, (2) improve understanding of contextual effects on implementation, (3) sharpen the focus on health equity in how we approach and build the evidence-base, (4) conduct more policy implementation research and evaluation, and (5) learn from audience and stakeholder perspectives. We offer 15 recommendations to assist in filling these gaps and describe a set of tools for enhancing the evidence most needed in implementation science.Entities:
Keywords: Context; Equity; Evidence; Implementation science
Mesh:
Year: 2022 PMID: 35413917 PMCID: PMC9004065 DOI: 10.1186/s13012-022-01201-y
Source DB: PubMed Journal: Implement Sci ISSN: 1748-5908 Impact factor: 7.960
Selected terminology related to evidence and implementation science
| Type 1 evidence: Etiology and burden | Descriptive epidemiology | The study of the occurrence of disease or other health-related characteristics in human populations, often classified under the headings of person, place, and time. | Incidence, prevalence mortality |
| Burden | The impact of disease on a population | Excess risk in patients, populations, subgroups, costs | |
| Access | The ability to connect patients to healthcare practitioners and healthcare services | Incidence of preventable diseases, early detection, treatment | |
| Disparity | A particular type of health difference that is closely linked with economic, social, or environmental disadvantage | Incidence, prevalence mortality | |
| Etiology | The study of the causes of diseases | Effect sizes and other indicators of effect | |
| Social determinants and structural factors | Conditions in which people are born, grow, live, work, and age as well as the complex, interrelated social structures, and economic/political systems that shape these health outcomes and conditions | Effect sizes and other indicators of effect | |
| Type 2 evidence: Effectiveness of interventions | Effectiveness of interventions (programs, guidelines, and policies) | Activities designed to assess, improve, maintain, promote, or modify health, health behaviors, functioning, or health conditions | Effect sizes and other indicators of effect (including heterogeneity of results) |
| Effectiveness of healthcare | The study of the structure, processes, and organization of healthcare services | Performance, quality, effectiveness, efficiency, patient centeredness, equity, safety | |
| Practice guidelines | A standardized set of information based on scientific evidence of the effectiveness and efficiency of the best practices for addressing health issues commonly encountered in public health or clinical practice. | Recommendation (e.g., recommended, not recommended, insufficient evidence), applicability across populations and settings | |
| Economic evaluation | The comparative analysis of alternative courses of action in terms of both their costs and consequence (e.g., cost-effectiveness analysis) | Intervention and implementation strategy costs, cost-effectiveness ratio, return on investment, budget impact analyses, opportunity and replication costs | |
| Type 3 evidence: Implementation and context | Context | A set of circumstances or unique factors related to the setting or community that surround a particular implementation effort | Policies, regulations, incentives, changes in priorities, setting factors, organizational characteristics, history, social, and environmental factors |
| External validity | The extent to which inferences reported in one study can be applied to different populations, setting, treatments, and outcomes | Staff participation, setting participation, representativeness by geography and population, cost | |
| Implementation strategy | The processes or methods, techniques, activities, and resources that support the adoption, integration, and sustainment of evidence-based interventions into usual settings (e.g., ERIC taxonomy) | Acceptability, adoption, appropriateness, cost, feasibility, cost, penetration, sustainability | |
| Implementation mechanism | The process or event through which an implementation strategy operates to affect desired implementation outcomes | Acceptability, adoption, appropriateness, cost, feasibility, cost, penetration, sustainability | |
| Equity in implementation | The degree to which explicit attention is paid to the culture, history, values, and needs of the community during implementation, including any social and structural factors that may contribute to health inequities and equitable or inequitable implementation | Inequities or differences across settings or populations in acceptability, adoption, appropriateness, cost, feasibility, reach, implementation delivery/fidelity, penetration, sustainability; social determinants (e.g., living conditions, socioeconomic indicators) unintended consequences related to implementation | |
| Adaptation | The degree to which an evidence-based intervention is changed or modified by a user before, during, and after adoption and implementation to (a) suit the needs of the setting/local conditions; (b) respond to emerging evidence; or (c) respond to changing context | Fit with recipients, reach, data, resources, capacity, satisfaction, engagement | |
| Replication and transportability | The ability to transfer an evidence-based intervention to a new setting, balancing fidelity with adaptation | Acceptability, adoption, appropriateness, cost, feasibility, cost, penetration | |
| Scale-up | The ability to expand the coverage of successful interventions, including the financial, human, and capital resources necessary for the expansion | Usability, utility, feasibility, fidelity, adoption | |
| Sustainability | The ability to create structures and processes to allow an implemented EBI to be maintained and adapted in an organization or system and continue to produce benefits over time | Penetration, institutionalization, normalization, integration, capacity, infrastructure, costs, maintenance of EBI/strategy delivery, and/or continuation of health benefits |
Contextual variables for implementation across ecological levels
| Individual | Education level Race/ethnicity/age/gender Geography/rurality Basic human needsa Personal health history Readiness/motivation to undergo testing or therapy Literacy and numeracy Trust, mistrust, distrust Stigma Stress and distress Resilience Genotype and phenotype Motivation Values |
| Interpersonal | Family health history Support from peers Social capital Social networks Social support from family, friends, coworkers, healthcare providers |
| Organizational | Staff composition Staff expertise, experience, and skills Physical infrastructure Organizational and financial resources Organizational climate and culture Leadership Degree of participatory decision-making Density of organizational ties Centrality of agencies in a community Institutional racism Psychological safety Mission and priorities Guidelines and incentives Processes and procedures Training and retraining Norms Stability |
| Socio-cultural and community | Social norms and values Cultural norms, values, traditions Health equity History Societal stigma Community capacity, priorities, assets Local resources and investments Structural racism Shared mental models Neighborhood characteristics Access to healthcare and health promoting resources |
| Political and economic structures and systems | Societal values Political will Political ideology Lobbying and special interests Costs and benefits Professional guidelines Policies and regulations (both Big P and small p) |
It is not anticipated that any single study would address this full list of variables; rather, this is a set of examples that can be described and narrowed via review of the literature, formative research, and stakeholder engagement
aBasic human needs include food, shelter, warmth, safety
Determining when evidence is sufficient for dissemination and implementation
° How pressing is the health issue? ° Is there an EBI? If so, what is the quality and quantity of evidence on the EBI? ° How long will it take to develop the evidence base? ° Are there emerging or established health equity issues? ° If the study addresses social or structural determinants, might multiple health conditions benefit? ° Is the issue a priority among stakeholders? How many? Which ones? ° Are you equipped to measure a range of contextual variables? ° Are there resources to implement a study? ° Might a hybrid trial that addresses both effectiveness and implementation, be appropriate? ° Is there implementation already happening that you might evaluate? ° Is action going to be taken regardless of whether the program or policy is evidence-based or not? ° What are the consequences of not implementing? ° What are the consequences of getting it wrong? |
Recommendations to advance evidence and implementation science
| Domain | Recommendation | Rationale | Potential solutions | Actors |
|---|---|---|---|---|
| 1. Use an evidence typology rather than an evidence hierarchy | The choice and strength of study design is dependent on the research questions and setting, particularly the context for the study | • Identify and implement alternatives and modifications (e.g., natural experiments; interrupted time series, adaptive designs, systems modeling, mixed methods, participatory modeling, multi-level pragmatic trials, policy implementation) to the efficacy RCT • Match the research question with the study design, balanced with considerations of rigor and pragmatism | • Funders • Researchers • Policy makersb | |
| 2. Increase focus on practice-based and community-defined evidence | Much of the existing evidence base is developed by university researchers in high-resource settings | • Strike a better balance between explicit (research) knowledge and tacit (lived experience) knowledge • Conduct practice-based research, particularly for low-resource settings and settings that face numerous structural and social impediments to health and well-being • Engage multi-level stakeholders and practice-based partners in substantive and meaningful ways in the context of and beyond research and research grants, including identifying stakeholder prioritized issues and outcomes | • Funders • Researchers • Practitioners | |
| 3. Speed the pace of evidence development | The research enterprise (review processes, conducting research, publishing and disseminating research) moves slowly, often much more slowly than practice and policy | • Conduct rapid reviews/living syntheses (so-called living meta-analyses) • Use rapid methods, designs, analyses • Bring together practitioners, researchers, community members, and policy makers to identify promising innovations in need of evaluation (including realist evaluation) • Reorient funding mechanisms to be more adaptive and flexible, and to support rapid-cycle evaluation (e.g., quick addition of measures to existing studies) | • Funders • Researchers • Practitioners • Policy makers | |
| 4. Address potential biases in implementation | Biases are often present in small scale studies that are not taken into account in larger studies or studies do not account for context | • Reconfigure small scale studies to account for generalizability biases (bias in intervention intensity, implementation support, delivery agent, target audience, duration, setting, measurement, resources required, directional conclusion, outcome) • Specify which communities, organizations, staff, and individuals are included and which are excluded and why at multiple levels and stages of a study, and their characteristics | • Researchers • Practitioners | |
| 5. Document ways in which context drives implementation | When context is taken into account in research, study findings are more applicable to different populations, settings, and time periods | • Employ new theories, models, and frameworks (e.g., Normalization Process Theory) to understand context, including ones outside the field of implementation science that address social and community context in depth • Use mixed-methods and user-centered design approaches to study context, particularly at organizational, community, policy, and society levels • Define and apply contextual variables that lead to effective replication and may facilitate sustainability and scale-up • Investigate mechanisms of implementation strategies to enable greater generalization into different contexts | • Researchers • Practitioners | |
| 6. Further develop pragmatic methods and measures to assess and address context | Pragmatic methods show promise by engaging multiple stakeholders, heterogeneous settings, and real-world conditions | • Make use of pragmatic measures (e.g., those that are user-friendly, sensitive to change, low cost, important to practitioners) • Apply pragmatic tools such as PRECIS-2 PS • Make use of guidelines to develop and evaluate complex interventions (e.g., the MRC guidance) | • Researchers • Practitioners | |
| 7. Apply lessons from LMICs and other low-resource settings | There are particular challenges and opportunities for development of new evidence in LMICs | • Document and seek to replicate conditions under which innovations emerge and thrive • Apply principles of transportability research across different countries and diverse settings that have a range of capacity, resources, and infrastructure • Apply findings from task shifting research | • Funders • Researchers • Practitioners | |
| 8. Further develop the science of adaptation | The process of modifying and refining EBIs and implementation strategies has not been well documented and understood | • Apply tools such as FRAME, FRAME IS, and other emerging coding systems to address and study key considerations in adaptation (e.g., when and how adaptations occur, whether planned or unplanned, their impact) • Use adaptation process models to guide cultural and contextual adaptations to address fit and dynamic context, while also remaining true to the original function • Better link implementation with the field of cultural adaptation to enhance the reach and equity of EBIs • Investigate ways of guiding adaptations that center on equity and investigate contexts in which EBIs may be adapted successfully versus when new EBIs may need to be developed to address specific health issues, historical experiences of populations, or sociocultural contexts | • Funders • Researchers • Practitioners | |
| 9. Place greater emphasis on social determinants and structural factors that shape health inequities and inequitable implementation | Much of the evidence base is narrowly developed on diseases and risk behaviors, neglecting root and structural causes; many EBIs have not been evaluated among populations and settings experiencing inequities | • Show the value and impact of interventions that address health equity, root causes, and social determinants • Include structural racism and other equity relevant structural factors (economic inequality, stigma) in measures, frameworks, and models in assessing context and barriers/facilitators to implementation, or in planning for implementation • Map the pathways and mechanism through which upstream interventions operate to impact more proximal downstream factors and ultimately health inequities • Identify interventions that consider social context, prioritize community priorities, and build off existing community strengths/assets | • Funders • Researchers • Practitioners | |
| 10. Integrate equity-relevant methods and measures | Equity has been under-addressed in implementation science and should be a feature of all studies | • Develop and apply models and frameworks that place a central focus on equity in both determinants and outcomes • Determine how well existing implementation strategies apply to a range of diverse populations and settings facing social and health inequities • Explicitly measure and track health equity, health inequities, and their determinants (structural racism) and how they are reduced or exacerbated by EBIs/strategies • Consider and track differential indicators of implementation (e.g., reach, feasibility, acceptability, appropriateness, adoption, implementation, sustainability) across different social groups (e.g., by race, ethnicity, age, gender, sexual orientation) or settings (e.g., urban, rural) • Prioritize equity indicators and determinants based on community and stakeholder input. | • Funders • Researchers • Practitioners | |
| 11. Expand the scope of policy implementation research | Despite its potential impact, there are many gaps in policy implementation research | • Focus on structural interventions and community-defined interventions and policies and consider both health and social policies (that have health impacts) • Determine ways in which to build equity in all policies • Study how the meaning of evidence and processes are shaped via the interactions between policy implementation and practice change • Develop reliable and valid measures for policy implementation | • Funders • Researchers • Policy makers | |
| 12. Apply concepts from other fields to policy implementation research | Other disciplines (e.g., political science, law, sociology) have a long history of policy research that is relevant to implementation scientists | • Apply theories from other fields to policy implementation in health • Use principles of team science to build new and vibrant transdisciplinary teams • Seek to understand the culture, norms, processes, and context of policy makers | • Researchers • Policy makers | |
| 13. Expand knowledge of the spread of policy-relevant information | For effective dissemination of policy information, tailoring of messages and channels is needed | • Compare different messaging strategies for policy makers (e.g., social good versus cost-savings, return on investments) • Expand knowledge of the role of social media in policy implementation research (e.g., disseminating research, understanding the socio-political environment) • Expand knowledge on how to combat mis- and dis-information in policy implementation | • Researchers • Policy makers | |
| 14. Apply principles of audience segmentation and human-centered or user-centered design | Implementation research can be informed by audience segmentation principles, which were developed outside the health sector | • Select and describe characteristics of discrete audiences for dissemination and implementation • Engage community members/patients as a core audience with a commitment to return research evidence to those affected • Develop messages and channels of high salience to various stakeholders (e.g., visually appealing, brief summaries for policy makers) • Apply audience segmentation approaches from the marketing world | • Researchers • Practitioners | |
| 15. Apply principles of framing and other communication strategies | Individuals interpret the same data in different ways depending on the mental model through which they perceive information | • Compare the effectiveness of gain versus loss framing to various audiences • Identify ways in which framing in policy advocacy can be applied to implementation science • Apply principles of narrative communication to framing to turn scientific evidence into meaningful narratives for specific audiences | • Funders • Researchers • Policy makers |
aIndividuals, groups, and community partners most likely to take action to address the recommendation
bPolicy makers include those addressing both Big P and small p policies
Fig. 1Number of annual publications on health disparities and health equity
Differences in evidence-related characteristics and needs among audiences
| Longer | Middle to longer | Shorter | |
| Specialized | Specialized for some, but generalized for others | Generalized | |
| Low | Moderate to high | Moderate to high | |
| Deeper knowledge on a small number of issues | Moderate knowledge on wide set of issues (often more specialized in larger agencies) | Less depth, wider breadth | |
| Low | Moderate | High | |
| Longer | Moderate | Shorter | |
| Generation, synthesis, publication, implementation, dissemination | Planning, evaluation, implementation, dissemination, sustainment | Adoption, implementation, dissemination, sustainment, funding | |
Science, evidence reviews, experimental experience from the field, general evidence | Science, evidence reviews, real-world experience from the field, personal experience, local evidence | Real-world stories, constituents, gatekeepers, party priorities, media, science, policy briefs | |
| Time, predominant focus on RCTs, lack of attention to context, slow speed of research | Time, lack of access to peer-reviewed evidence, lack of incentives, low priority of leadership, perceived lack of relevance, competing demands | Time, lack of interest, complexity of evidence, new demands, rapidly changing context |
aPolicy makers include funders of research
bExternal factors commonly include habit, stereotypes, and cultural norms
Selected resources and tools to support practice and research on evidence-based dissemination and implementation
| Community Tool Box | The Community Tool Box is a free, online resource for those working to build healthier communities and bring about social change. The Tool Box seeks to promote community health and development by connecting people, ideas, and resources. | ||
| Engage for Equity | The tools provide a step-by-step approach for research partnerships to examine where they are now and where they want to be in the future. Each step includes a short description and an interactive exercise or tool. | ||
| Advancing Health Equity Toolkit | This practice-oriented toolkit leads agencies, teams, community-based organizations, and community partnerships through different public health processes using a health equity lens. The modules include interactive reflection questions across a framework for evidence-based decision-making. | ||
| Stakeholder Engagement Navigator | The Navigator is designed to help teams select the most appropriate engagement method or tool for a particular project. It is an interactive tool that takes into account the purpose, resources, frequency of engagement, and expertise. | ||
| Dissemination and Implementation Models in Health Research and Practice | An interactive, online resource designed to help researchers and practitioners navigate dissemination and implementation theories, models, and frameworks through planning, selecting, combining, adapting, using, and linking to measures. Newly added frameworks address the interface between health equity and implementation science. | ||
| T-CaST (Theory, Model, and Framework Comparison and Selection Tool) | T-CaST offers explicit criteria to facilitate theory comparison during the selection process. The tool is also potentially useful in selecting theories, models, and framework beyond the field of implementation science. | ||
| PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary) and PRECIS-2 PS | PRECIS-2 is a tool to help in designing health services research and to consider where a trial lies across 9 dimensions across the pragmatic/explanatory (efficacy) continuum; the newer PRECIS-2 PS is focused on designs related to provider strategies for implementation studies. | ||
| APEASE (Acceptability, Practicability, Effectiveness, Affordability, Side-effects, and Equity) | The APEASE criteria provide a framework for assessing interventions, intervention components, and ideas. APEASE can be applied to anything from a general concept to a detailed plan for a proposed intervention, or a formal evaluation of an intervention that has already been implemented. | ||
| MOST (Multiphase Optimization Strategy) | MOST is a research framework, based on engineering principles, for determining the most efficient and effective version of an intervention. It uses a 3-phase approach to assess the effectiveness of individual program elements and consider whether effectiveness varies depending on context. | ||
| The Hexagon Tool | At any stage of implementation, the Hexagon Tool can be used by communities and organizations to better understand how a new or existing program or practice fits into an implementing site’s existing work and context. | ||
| Annotated Bibliography of Economic Analysis Resources for Implementation Science | This tool is a compilation of resources, tools, and studies about cost/cost-effectiveness research in implementation science. It covers costing methods and cost-effectiveness analyses that are important for measuring and improving the value of healthcare and public health practices. | ||
| Measuring Health Policy Implementation | This website is designed to help policy researchers, evaluators, and implementation science researchers identify and select measures to assess the implementation of health policies in a variety of settings (e.g., hospitals, outpatient clinics, neighborhoods, schools). | ||
| Tool for Rating Research Proposals for Sensitivity to Health Equity Issues | This tool assesses research proposals for their sensitivity to health equity issues. The tool consists of a series of questions that prompt for evaluation of how well equity issues have been considered in terms of the population context, study rationale, intervention design, sample design, data collection and analysis plan, evidence of community engagement, and team composition. | ||
| GRADE (Grading of Recommendations, Assessment, Development and Evaluations) | GRADE is a transparent framework for developing and presenting summaries of evidence and provides a systematic approach for making clinical practice recommendations. | ||
| Expanded CONSORT (Consolidated Standards of Reporting Trials) | The expanded CONSORT includes data about participation and representativeness at multiple levels of settings, as well as staff and individual recipients, and about intervention sustainability after project support ends. It adds a focus on transparent reporting of inclusions, exclusions, and participation at multiple levels and includes a fillable PDF for manuscript submissions. | ||
| Standards for Reporting Implementation Studies (StaRI) Statement | StaRI is used for reporting of implementation studies, which employ a range of study designs to develop and evaluate implementation strategies with the aim of enhancing adoption and sustainability of effective interventions | ||
| Dissemination Planning Tool | A tool to help researchers evaluate their research and develop appropriate dissemination plans, if the research is determined to have “real-world” impact | ||
| ExpandNet | A global network of representatives from international organizations, non-governmental organizations, academic and research institutions, ministries of health, and specific projects who seek to advance the science and practice of scaling up | ||
| Clinical Assessment Sustainability Tool (CSAT) | |||
| Program Assessment Sustainability Tool (PSAT) |
This table is illustrative and is not meant to be comprehensive. We have focused on sources that are more regularly updated