Tobacco use is the leading cause of preventable cancer mortality worldwide, responsible for more than 20% of global cancer-related deaths and about 70% of global lung cancer–related deaths (1). While tobacco use has been declining in most high-income countries (HIC), thanks to effective tobacco control measures, the burden is shifting to low- and middle-income countries (LMIC) where more than 80% of the world's tobacco users now reside. Thus, the future burden of tobacco-related morbidity and mortality will fall primarily on LMICs.
The World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC), an international treaty that went into force in 2005, has provided an impetus for adoption of new tobacco control measures across the globe. As of 2020, 182 countries are parties to the treaty (2). The FCTC includes a range of tobacco control provisions, including increased tobacco taxes, protection from secondhand smoke, warning labels, advertising and sponsorship restrictions, product regulation, restrictions on sales to minors, and support for tobacco cessation. The United Nation's 2030 Agenda for Sustainable Development cites strengthened implementation of the FCTC as one of the targets for achieving sustainable development goals for health and well-being. Moreover, an evidence-based package of tobacco control strategies already exists in the form of the WHO MPOWER strategies (Monitor tobacco use; Protect from tobacco smoke; Offer help to quit; Warn about dangers; Enforce bans on promotions; and Raise taxes).
However, the global reach of the FCTC remains incomplete. The 2019 WHO report on the global tobacco epidemic (3) concludes that about 65% of the world's population, and 61% of those living in LMICs, are now covered by at least one MPOWER measure (not including monitoring) at the highest level of achievement, a substantial increase over the previous decade. Yet progress is uneven across the MPOWER measures; for example, while 52% of the world's population are covered by graphic health warnings on tobacco packages, only 22% are covered by smoke-free policies that meet FCTC guidelines. In addition, some FCTC measures are widely adopted, but do not fully meet best practice guidelines. For example, while more than 80% of FCTC countries impose a tax on cigarettes, only a fraction of countries (14%) meet FCTC tax guidelines.
Increasing the reach and impact of the FCTC, particularly for LMICs, requires both: (i) increasing adoption of FCTC and MPOWER measures in the form of tobacco control policies and programs, and (ii) ensuring successful dissemination and implementation of these measures in the specific country environment. Annual WHO reports on progress of the FCTC regularly track the former, providing updates on policy adoption at the country level. However, adoption of laws or policies does not necessarily ensure full implementation. For example, although comprehensive smoke-free legislation is in place in 55 countries, only 22 of these countries have high compliance rates (4).
Given the importance of effective implementation of tobacco control measures, it is surprising that there has been limited application, to date, of the tools and methods of dissemination and implementation (D&I) research to tobacco control, particularly in LMICs. The Global Tobacco Surveillance System (5) and the International Tobacco Control Policy Evaluation Project (6) provide essential data to track the impact of policy changes. However, beyond monitoring, in-depth research is needed to identify and understand factors that impede or facilitate the successful implementation of tobacco control measures or enable their adaptation to new settings.
There is a growing interest in D&I research among global health leadership. For example, the WHO has published an Implementation Research Toolkit (7) and its global action plan for the prevention and control of noncommunicable diseases prioritized research agenda includes studying “contextual factors that affect research–policy–practice processes promoting the use of research findings.” A summary of research gaps and priorities for FCTC policy implementation included expanding D&I research, specifically noting the lack of research on how to successfully translate tobacco control evidence across different national contexts (8).
As cancer prevention and control researchers, members of the American Society of Preventive Oncology (ASPO) are committed to reducing the burden of cancer across the globe. In 2019, the 43rd Annual Meeting of ASPO hosted its first-ever symposium on D&I research, reflecting its growing prominence within cancer prevention and control. Building on this new focus, the Global Cancer Research Special Interest Group organized several events over the past year to highlight global D&I research, including webinars with leaders in the field and a session at the 44th Annual Meeting focused on global tobacco control opportunities. In this report, we describe how D&I research can provide essential tools to build the evidence base for successful implementation of the FCTC and MPOWER measures in LMICs.
D&I Research in the Context of Global Tobacco Control
D&I research is the study of methods to create and apply knowledge that promotes the integration of evidence-based interventions and policies into real-world settings to improve population health and health equity (9). The field builds on multiple disciplines, but has its own set of principles, methods, and frameworks that can contribute to global efforts to accelerate D&I of the FCTC.
Core D&I concepts include an emphasis on stakeholder-driven agenda setting and collaborative problem solving to increase practice and policy relevance, a focus on analyzing multilevel contextual factors (e.g., political, organizational, and individual) that influence the implementation process to understand what works and at what level and why, the application of theoretical frameworks to guide the full spectrum of translational research, the study of strategies for implementing evidence-based interventions, and an emphasis on measuring implementation outcome that includes acceptability, feasibility, fidelity, adaptation, cost, sustainability, and equity. D&I research also makes explicit the need to balance fidelity and adaptation, and to produce generalizable knowledge while attending to local needs and context, and emphasizes that effective implementation requires a process of continuous learning and iteration.
Article 14 of the FCTC provides an example for illustrating the role of D&I research in reducing the disproportionate burden of tobacco use in LMICs. Article 14 recommends that all parties offer their populations access to evidence-based support for tobacco cessation. Despite overwhelming evidence for the effectiveness and affordability of a range of tobacco cessation options, a 2019 MPOWER report found that only 13 countries provide comprehensive programs (3). LMICs were less likely to achieve a “comprehensive program” designation, compared with HICs, defined as establishing population-based treatment approaches (e.g., quitlines), ensuring that brief advice to quit is integrated as part of routine primary care and that cessation pharmacotherapy is available and affordable. The WHO guidelines for implementing Article 14 clearly outline these best practice intervention components. The WHO further encourages countries to leverage existing infrastructure to expand treatment and secure sustainable funding sources to support population-based tobacco cessation. What is missing from the literature is guidance to facilitate the systematic adoption and implementation of these evidence-based recommendations.
On the basis of a recent assessment of barriers to Article 14 globally (10), the primary reasons for the lack of progress are a lack of political commitment and prioritization of Article 14 among policymakers, the associated lack of funding, and the need for public health and health system infrastructure to ensure that evidence‐based treatment is widely available. Other barriers included a persistent lack of knowledge of the evidence among policymakers and tobacco industry interference. In addition, much of the existing evidence base for tobacco cessation interventions comes from HICs. Transferring these findings to LMIC contexts will require engaging stakeholders in adaptation and evaluation. Moreover, in LMICs, novel, low-cost implementation strategies that leverage existing infrastructure (e.g., health worker task-shifting models) may be required in settings where resources are limited.
Examples of D&I research questions that start to address the range of implementation challenges outlined above include: how do we effectively disseminate evidence to policymakers to influence priority setting and inform resource allocations (e.g., increasing availability and supply of low-cost medications), what is the readiness and capacity of health systems to implement routine screening and tobacco cessation, and what are the most feasible and cost-effective strategies to increase provider adoption of tobacco use treatment guidelines in healthcare delivery settings. D&I research methods offer the tools to optimize the response to these questions; however, the approach will vary depending on the sociopolitical and health system context and the specific priorities and needs defined by the implementers, policymakers, and other stakeholders.
Theoretical Approaches to D&I Research
D&I research uses theories, models, and frameworks that can be organized into three main categories: (i) models that describe and guide the process of translating research into practice, (ii) determinants frameworks that describe factors that influence implementation outcomes, and (iii) evaluation frameworks to assess implementation success. Process models describe the steps, stages, or phases involved in the implementation of evidence-based programs or interventions into practice. The Knowledge to Action Framework is an example of a process model that offers guidance across the full spectrum of the D&I process, from knowledge synthesis through achieving sustained use of evidence-based interventions. A recently published framework, the “FRAME” (11), offers guidance on the process of adapting intervention components. Acknowledging and documenting what is modified, when, and why can inform efforts to reproduce, sustain, and scale programs.
In contrast, determinants frameworks include theories from various fields such as psychology, sociology, and organizational theory to describe mechanisms of change at multiple intervention levels. Determinants frameworks can, therefore, guide the selection of theory-driven strategies to overcome implementation barriers and leverage facilitators and analyses of hypothesized predictors of implementation outcomes, and why outcomes may vary across populations and settings. Finally, evaluation frameworks include distinct implementation outcomes, such as adoption, fidelity, cost, and sustainability, and provide a structure for measuring implementation success.
These models and frameworks, often used in combination and across multiple stages of research, provide a roadmap for adaptation, implementation, and evaluation. For example, in seeking to adapt and integrate a protocol for offering brief cessation advice into an existing healthcare setting, a determinants framework can help to identify barriers to implementation (such as lack of training or record keeping) and guide the selection of implementation strategies, with an evaluation framework guiding the choice and definition of relevant measures of implementation success.
D&I Research Designs
D&I research uses the full range of study designs including randomized trials, quasi-experimental designs (e.g., time series), and mixed methods approaches. However, design decisions are influenced by the complexity of the real-world context in which these studies are conducted, and the need to respond to the implementation problems and questions that are relevant to stakeholders and end users. For example, qualitative research methods have significant advantages in eliciting perspectives that are meaningful and contextually salient to stakeholders, and these methods can be valuable throughout the implementation process to identify the barriers and facilitators of implementation. In addition, mixed methods research designs involving the integration of qualitative and quantitative methods have been used broadly in D&I research to investigate the factors that explain the level of implementation success, as well as to assess the feasibility, acceptability, and utility of various implementation strategies.
Hybrid effectiveness implementation designs also offer potential advantages over the typical approach of analyzing these stages separately and sequentially. Findings from these designs offer stakeholders information that may reduce the timeline for translating and scaling effective interventions. For example, a study that combines an analysis of the effectiveness of an mCessation intervention with a mixed methods assessment of potential barriers, facilitators, and resources needed to implement and scale this intervention nationally, provides policymakers with both the clinical outcome data they need to argue for resource allocation and guidance on strategies for effectively scaling the program.
Economic Evaluation in D&I Research
Economic evaluation plays a central role in evidence translation and is often requested by decision makers. This includes considering the analytic perspective in the analysis to improve comparability across settings, in addition to specifying health outcomes, time horizons, sensitivity analysis, and potential temporal changes in the intervention and stages of implementation. In D&I research, the role of economic evaluations is to identify the resources and costs that are required to implement the program in another setting which includes the preimplementation costs, such as those associated with planning and designing the intervention or program, but excludes research costs. In addition, less attention has been paid to costs for adapting, sustaining, and scaling effective implementation strategies. Without this information, it is difficult to develop plans to support this next translational stage of D&I research. Whereas early costs of implementation may be covered by an external grant or another form of a one-time investment, ongoing support for an intervention or program will rely on decision-makers' assessment of its cost-benefit based on their perspective. For example, one reason for the slow adoption of pharmacotherapy for tobacco cessation, particularly in LMICs, is the perceived cost. Thus, providing country-specific information on long-term cost-effectiveness, particularly framing it in the context of the broader goals of reducing the cost of noncommunicable diseases, is important for decision makers.
Resources for Learning and Conducting D&I Research
A variety of resources is available for those interested in applying D&I research methods to global tobacco control. The NCI Implementation Science program (12) provides resources such as funding announcements, tools for research and practice, webinars, and training and educational content. The site hosts open-access courses from the Training Institute for Dissemination and Implementation Research in Cancer, which deliver an in-depth orientation to D&I research with a focus on cancer. NCI recently developed the Implementation Science Centers in Cancer Control (ISC3) program (13), a consortium of sites which host “implementation laboratories” engaged in research across the cancer continuum. Several ISC3 sites offer resource hubs with guidance on conducting D&I research and relevant training opportunities. Dissemination & Implementation Models in Health Research & Practice (14) is an interactive website designed to help researchers and practitioners to select the D&I model that best fits their research question or practice problem, adapt the model to the study or practice context, fully integrate the model into the research or practice process, and identify existing measurement instruments for the model constructs. In addition, the Annual Conference on the Science of D&I in Health intends to support collective understanding of the research agenda to incorporate these challenges into D&I research through a combination of plenaries, concurrent, and poster sessions that present research findings and identify the next set of research priorities. Finally, The Global Implementation Conference (15) is a biennial meeting launched in 2011 with a focus on implementation.
Call to Action for ASPO Members
With strong support for implementing the WHO FCTC, there has never been a greater need to expand D&I research, particularly in LMICs where the burden of tobacco use is greatest. D&I research concepts and methods provide a critical set of tools for informing and supporting global tobacco control and increasing the reach and impact of the FCTC with a goal of ultimately reducing the burden of tobacco-related morbidity and mortality (16).
Over the past decade, the NIH has supported research in LMICs under the D&I research program. Recently, several NIH funding opportunities in the areas of tobacco control and cancer prevention have prioritized D&I research in LMICs. These funding announcements recognize that evidence-based interventions that have been effective in HICs are underutilized in LMICs and may have limited impact because of implementation challenges that have yet to be identified, researched, and addressed. Continued development of this research field can serve to build an evidence base to increase the reach and impact of evidence-based tobacco control interventions worldwide, especially in LMICs.
We encourage researchers and practitioners working on global cancer prevention and tobacco control to explore and apply the tools and frameworks of D&I research. ASPO members are well-positioned to make an impact in D&I research with relevant multidisciplinary expertise in behavioral science, health communication, epidemiology, and comparative effectiveness research. Next steps include building D&I research capacity to facilitate meaningful multidisciplinary stakeholder engagement in LMICs, research on strategies for sustaining and scaling evidence-based interventions, and funding mechanisms that acknowledge the multistep process of adapting the evidence to local settings to optimize effective implementation, evaluating what worked and did not work and why, and continuing to improve.