A guide to systems-level, participatory, theory-informed implementation research in global health

Implementation research is a multidisciplinary field that addresses the complex phenomenon of how context influences our ability to deliver evidence-informed healthcare. There is increasing realisation of the importance of applying robust implementation research to scale-up life-saving interventions that meet health-related sustainable development goals. However, the lack of high-quality implementation research is impeding our ability to meet these targets, globally. Within implementation research, theory refers to the proposed hypothesis and/or explanation of how an intervention is expected to interact with the local context and actors to bring about change. Although there is increasing interest in applying theory to understand how and why implementation programmes work in real-world settings, global health actors still tend to favour impact evaluations conducted in controlled environments. This may, in part, be due to the relative novelty as well as methodological complexity of implementation research and the need to draw on divergent disciplines, including epidemiology, implementation science and social sciences. Because of this, implementation research is faced with a particular set of challenges about how to reconcile different ways of thinking and constructing knowledge about healthcare interventions. To help translate some of the ambiguity surrounding how divergent theoretical approaches and methods contribute to implementation research, we draw on our multidisciplinary expertise in the field, particularly in global health. We offer an overview of the different theoretical approaches and describe how they are applied to continuously select, monitor and evaluate implementation strategies throughout the different phases of implementation research. In doing so, we offer a relatively brief, user-focused guide to help global health actors implement and report on evaluation of evidence-based and scalable interventions, programmes and practices.

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A guide to systems-level, participatory, theory-informed implementation research in global health

10.31219/osf.io/k98ef ◽

2021 ◽

Author(s):

Nadine Seward ◽

Charlotte Hanlon ◽

Saba Hinrichs ◽

Crick Lund ◽

Jamie Murdoch ◽

...

Keyword(s):

Global Health ◽

Social Science ◽

Implementation Science ◽

Real World ◽

Implementation Research ◽

Scale Up ◽

High Quality ◽

High Quality Evidence ◽

Participatory Theory ◽

Quality Evidence

Implementation research is a multidisciplinary field that addresses the complex phenomenon of how context influences our ability to deliver evidence-informed healthcare. There is increasing realisation of the importance of applying robust implementation research to scale-up lifesaving interventions that meet health-related sustainable development goals. However, the lack of high-quality implementation research is impeding our ability to meet these targets. In this paper we provide guidance to assist researchers to understand and conceptualise how implementation research methods can be used to deliver high-quality evidence-informed practice at scale. There are four phases to implementation research: pre-implementation, piloting, implementation and evaluation, and post-implementation and scale-up phases. Implementation science and theory-driven approaches can be used to design, pilot, implement and evaluate implementation programmes. Important components of implementation research such as stakeholder engagement can be applied to embed the research into existing health systems therefore ensure applicability in the ‘real world’. Implementation research also needs to be participatory; co-designed by all stakeholders who can influence implementation efforts. Although there is increasing interest in applying robust methodology to understand how and why implementation programmes work in real-world settings, global health actors still tend to favour evaluations conducted in controlled environments. Perhaps this is due to implementation research being a multidisciplinary field requiring expertise from a range of specialist disciplines such as implementation science and social science. To help translate some of the ambiguity surrounding the methodologies applied to implementation research, we draw on our expertise from a range of disciplines including global health, social science, policy, implementation science, epidemiology, and statistics to offer an overview of how to conduct participatory, theory-driven implementation research to design and test the effectiveness of delivering high-quality evidence-informed interventions at scale.

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Scaling-up Shared Decision Making in Multidisciplinary Osteoarthritis Care Teams: A Qualitative Study Using the Consolidated Framework for Implementation Research With Three Demonstration Sites

10.21203/rs.3.rs-493777/v1 ◽

2021 ◽

Author(s):

Lyndal Trevena ◽

Olivia Mac ◽

Danielle M Muscat ◽

Mina Bakhit ◽

Heather L Shepherd ◽

...

Keyword(s):

Decision Making ◽

Shared Decision Making ◽

Implementation Research ◽

Scale Up ◽

Theoretical Domains Framework ◽

Implementation Strategies ◽

Readiness For Change ◽

Shared Decision ◽

Patient Reported ◽

Inner Setting

Abstract BackgroundDespite the development of theory-driven frameworks to guide implementation strategies, their application thus far has largely been limited to evaluating effectiveness within specific contexts. This study describes the use of these frameworks to inform a scale-up strategy for shared decision making (SDM) implementation across a state-wide government-funded health program. MethodsTailored SDM strategies were implemented in three multidisciplinary osteoarthritis care teams over a 3-6 month period during 2019-20 in New South Wales, Australia. Staff interviews occurred across 3 timepoints based on the Organisational Readiness for Change Scale, the Theoretical Domains Framework and the Preparation for Decision-Making (PreP-DM) Scales. Patient interviews based on the PreP-DM were also completed. A hybrid inductive-deductive thematic analysis was followed by mapping the results to the Consolidated Framework for Implementation Research (CFIR) and the OMERACT core domains for SDM. Finally, a ranked list of Expert Recommendations for Implementing Change (ERIC) was derived using a published tool.Results47 interviews were conducted with 18 staff along with 20 interviews with patients. We identified 39 themes for SDM implementation across the five CFIR domains: 1) Interventions need to be flexible to align with different clinical workflows and busy clinics; 2) Outer Settings such as senior managers should formally endorse SDM and clinical protocols and standards need to better align with an SDM approach; 3) Inner Setting teams need early engagement, role clarification and communities of practice in SDM; 4) Individuals are strongly motivated by better patient outcomes and need SDM training and support; and 5) Processes such as patient-reported measures and feedback along with adequate resourcing were key. Recommended strategies therefore focussed on Stakeholder Engagement, Evaluative and Iterative Strategies, Education and Training and Adaptation/Tailoring to the Context. Skills in the identification of decision points, values clarification and deliberation were particularly challenging for staff.ConclusionsTheory-driven scale-up strategies can be developed using qualitative research within demonstration sites. By combining the CFIR and TDF frameworks and prior mapping to the ERIC strategies, health system and program planners can obtain a relevant and evidence-informed roadmap for implementation across complex health systems.

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Contextual equipoise: a novel concept to inform ethical implications for implementation research in low-income and middle-income countries

BMJ Global Health ◽

10.1136/bmjgh-2020-003456 ◽

2020 ◽

Vol 5 (12) ◽

pp. e003456

Author(s):

Nadine Seward ◽

Charlotte Hanlon ◽

Jamie Murdoch ◽

Tim Colbourn ◽

Martin James Prince ◽

...

Keyword(s):

Low Income ◽

Implementation Research ◽

Ethical Issues ◽

Controlled Trial ◽

Scale Up ◽

Local Context ◽

Sufficient Evidence ◽

Clinical Equipoise ◽

Access To Treatment ◽

Ethical Implications

The call for universal health coverage requires the urgent implementation and scale-up of interventions that are known to be effective, in resource-poor settings. Achieving this objective requires high-quality implementation research (IR) that evaluates the complex phenomenon of the influence of context on the ability to effectively deliver evidence-based practice. Nevertheless, IR for global health is failing to apply a robust, theoretically driven approach, leading to ethical concerns associated with research that is not methodologically sound.Inappropriate methods are often used in IR to address and report on context. This may result in a lack in understanding of how to effectively adapt the intervention to the new setting and a lack of clarity in conceptualising whether there is sufficient evidence to generalise findings from previous IR to a new setting, or if a randomised controlled trial (RCT) is needed. Some of the ethical issues arising from this shortcoming include poor-quality research that may needlessly expose vulnerable participants to research that has not been adapted to suit local needs and priorities, and the inappropriate use of RCTs that denies participants in the control arm access to treatment that is effective within the local context.To address these concerns, we propose a complementary approach to clinical equipoise for IR, known as contextual equipoise. We discuss challenges in the evaluation of context and also with assessing the certainty of evidence to justify an RCT. Finally, we describe methods that can be applied to improve the evaluation and reporting of context and to help understand if contextual equipoise can be justified or if significant adaptations are required. We hope our analysis offers helpful insight to better understand and ensure that the ethical principle of beneficence is upheld in the real-world contexts of IR in low-resource settings.

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Using the Consolidated Framework for Implementation Research to design and implement a perinatal education program in a large maternity hospital

BMC Health Services Research ◽

10.1186/s12913-021-07024-9 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Sheridan Guyatt ◽

Megan Ferguson ◽

Michael Beckmann ◽

Shelley A. Wilkinson

Keyword(s):

Health Service ◽

Implementation Research ◽

Theoretical Approach ◽

Research Process ◽

Maternity Hospital ◽

Local Context ◽

Local Implementation ◽

Early Parenting ◽

Worked Example ◽

Theoretical Approaches

Abstract Background Implementation science aims to embed evidence-based practice as ‘usual care’ using theoretical underpinnings to guide these processes. Conceptualising the complementary purpose and application of theoretical approaches through all stages of an implementation project is not well understood and is not routinely reported in implementation research, despite call for this. This paper presents the synthesis and a collective approach to application of a co-design model, a model for understanding need, theories of behaviour change with frameworks and tools to guide implementation and evaluation brought together with the Consolidated Framework for Implementation Research (CFIR). Method Using a determinant framework such as the CFIR provides a lens for understanding, influencing, and explaining the complex and multidimensional variables at play within a health service that contribute to planning for and delivering effective patient care. Complementary theories, models, frameworks, and tools support the research process by providing a theoretical and practical structure to understanding the local context and guiding successful local implementation. Results This paper provides a rationale for conceptualising the multidimensional approach for implementation using the worked example of a pregnancy, birth, postnatal and early parenting education intervention for expectant and new parents at a large maternity hospital. Conclusion This multidimensional theoretical approach provides useful, practical guidance to health service researchers and clinicians to develop project specific rationale for their theoretical approach to implementation projects.

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Strengthening methods for tracking adaptations and modifications to implementation strategies

BMC Medical Research Methodology ◽

10.1186/s12874-021-01326-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Amber D. Haley ◽

Byron J. Powell ◽

Callie Walsh-Bailey ◽

Molly Krancari ◽

Inga Gruß ◽

...

Keyword(s):

Implementation Science ◽

Implementation Strategy ◽

De Novo ◽

Scale Up ◽

Implementation Strategies ◽

Effective Strategies ◽

Implementing Change ◽

Reporting Framework ◽

Health Related ◽

Seeking Help

Abstract Background Developing effective implementation strategies requires adequate tracking and reporting on their application. Guidelines exist for defining and reporting on implementation strategy characteristics, but not for describing how strategies are adapted and modified in practice. We built on existing implementation science methods to provide novel methods for tracking strategy modifications. Methods These methods were developed within a stepped-wedge trial of an implementation strategy package designed to help community clinics adopt social determinants of health-related activities: in brief, an ‘Implementation Support Team’ supports clinics through a multi-step process. These methods involve five components: 1) describe planned strategy; 2) track its use; 3) monitor barriers; 4) describe modifications; and 5) identify / describe new strategies. We used the Expert Recommendations for Implementing Change taxonomy to categorize strategies, Proctor et al.’s reporting framework to describe them, the Consolidated Framework for Implementation Research to code barriers / contextual factors necessitating modifications, and elements of the Framework for Reporting Adaptations and Modifications-Enhanced to describe strategy modifications. Results We present three examples of the use of these methods: 1) modifications made to a facilitation-focused strategy (clinics reported that certain meetings were too frequent, so their frequency was reduced in subsequent wedges); 2) a clinic-level strategy addition which involved connecting one study clinic seeking help with community health worker-related workflows to another that already had such a workflow in place; 3) a study-level strategy addition which involved providing assistance in overcoming previously encountered (rather than de novo) challenges. Conclusions These methods for tracking modifications made to implementation strategies build on existing methods, frameworks, and guidelines; however, as none of these were a perfect fit, we made additions to several frameworks as indicated, and used certain frameworks’ components selectively. While these methods are time-intensive, and more work is needed to streamline them, they are among the first such methods presented to implementation science. As such, they may be used in research on assessing effective strategy modifications and for replication and scale-up of effective strategies. We present these methods to guide others seeking to document implementation strategies and modifications to their studies. Trial registration clinicaltrials.gov ID: NCT03607617 (first posted 31/07/2018).

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When People Come First

10.23943/princeton/9780691157382.001.0001 ◽

2013 ◽

Cited By ~ 1

Keyword(s):

Global Health ◽

Scale Up ◽

Moral Economy ◽

Health Science ◽

Health It ◽

Left Behind ◽

New Research ◽

Health Enterprise ◽

Conceptual Work

This book critically assesses the expanding field of global health. It brings together an international and interdisciplinary group of scholars to address the medical, social, political, and economic dimensions of the global health enterprise through vivid case studies and bold conceptual work. The book demonstrates the crucial role of ethnography as an empirical lantern in global health, arguing for a more comprehensive, people-centered approach. Topics include the limits of technological quick fixes in disease control, the moral economy of global health science, the unexpected effects of massive treatment rollouts in resource-poor contexts, and how right-to-health activism coalesces with the increased influence of the pharmaceutical industry on health care. The chapters explore the altered landscapes left behind after programs scale up, break down, or move on. We learn that disease is really never just one thing, technology delivery does not equate with care, and biology and technology interact in ways we cannot always predict. The most effective solutions may well be found in people themselves, who consistently exceed the projections of experts and the medical-scientific, political, and humanitarian frameworks in which they are cast. This book sets a new research agenda in global health and social theory and challenges us to rethink the relationships between care, rights, health, and economic futures.

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Adaptation in Dissemination and Implementation Science

10.1093/oso/9780190683214.003.0017 ◽

2017 ◽

Cited By ~ 19

Author(s):

Ana A. Baumann ◽

Leopoldo J. Cabassa ◽

Shannon Wiltsey Stirman

Keyword(s):

Implementation Science ◽

Implementation Research ◽

Implementation Strategies ◽

Dissemination And Implementation ◽

Research And Practice ◽

Implementation Outcomes ◽

Dissemination And Implementation Science ◽

Dissemination And Implementation Research

This chapter focuses on adaptations in the context of dissemination and implementation research and practice. Consistent with the existing literature, the authors recommend that adaptations be proactively and iteratively determined, strongly informed by a variety of stakeholders, and that efforts be made to carefully describe and document the nature of the adaptations and evaluate their impact on desired service, health, and implementation outcomes. While this chapter focuses on adaptations to interventions and the context of practice, the authors also note that adaptations may need to be made to implementation strategies. Following the call by Proctor and colleagues for further precision in defining and operationalizing implementation strategies, and based on evidence that scholars are not necessarily reporting what and how they are adapting the interventions, scholars are urged to define and evaluate the adaptations they are making not only to the interventions and context of practice but also to the implementation strategies.

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The Role of the Business Sector in Global Health Politics

The Oxford Handbook of Global Health Politics ◽

10.1093/oxfordhb/9780190456818.013.23 ◽

2018 ◽

pp. 385-408

Author(s):

Kelley Lee ◽

Julia Smith

Keyword(s):

Collective Action ◽

Global Health ◽

Business Sector ◽

Policy Debate ◽

Public And Private ◽

Health Politics ◽

For Profit ◽

Goods And Services ◽

Private Interests ◽

Health Related

The influence of for-profit businesses in collective action across countries to protect and promote population health dates from the first International Sanitary Conferences of the nineteenth century. The restructuring of the world economy since the late twentieth century and the growth of large transnational corporations have led the business sector to become a key feature of global health politics. The business sector has subsequently moved from being a commercial producer of health-related goods and services, contractor, and charitable donor, to being a major shaper of, and even participant in, global health policymaking bodies. This chapter discusses three sites where this has occurred: collective action to regulate health-harming industries, activities to provide for public interest needs, and participation in decision-making within global health institutions. These changing forms of engagement by the business sector have elicited scholarly and policy debate regarding the appropriate relationship between public and private interests in global health.

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Implementing Cancer Care in Rwanda: Capacity Building for Treatment and Scale-Up

Sustainability ◽

10.3390/su13137216 ◽

2021 ◽

Vol 13 (13) ◽

pp. 7216

Author(s):

Paul H. Park ◽

Cyprien Shyirambere ◽

Fred Kateera ◽

Neil Gupta ◽

Christian Rusangwa ◽

...

Keyword(s):

Capacity Building ◽

Scale Up ◽

Implementation Strategies ◽

Sub Saharan Africa ◽

Essential Medicines ◽

Cancer Center ◽

Health Coverage ◽

Cancer Centers ◽

Implementation Approach ◽

Single Cancer

Background: The majority of countries in sub-Saharan Africa are ill-prepared to address the rising burden of cancer. While some have been able to establish a single cancer referral center, few have been able to scale-up services nationally towards universal health coverage. The literature lacks a step-wise implementation approach for resource-limited countries to move beyond a single-facility implementation strategy and implement a national cancer strategy to expand effective coverage. Methods: We applied an implementation science framework, which describes a four-phase approach: Exploration, Preparation, Implementation, and Sustainment (EPIS). Through this framework, we describe Rwanda’s approach to establish not just a single cancer center, but a national cancer program. Results: By applying EPIS to Rwanda’s implementation approach, we analyzed and identified the implementation strategies and factors, which informed processes of each phase to establish foundational cancer delivery components, including trained staff, diagnostic technology, essential medicines, and medical informatics. These cancer delivery components allowed for the implementation of Rwanda’s first cancer center, while simultaneously serving as the nidus for capacity building of foundational components for future cancer centers. Conclusion: This “progressive scaling” approach ensured that initial investments in the country’s first cancer center was a step toward establishing future cancer centers in the country.

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