Introduction

The timely and effective translation of evidence-based interventions (EBI) into practice is crucial for advancing health and health equity.1 2 However, this translation does not always happen, and when it does, it often faces significant delays.3 This implementation gap not only affects the general population but also disproportionately impacts traditionally underserved communities, thereby exacerbating existing public health challenges and disparities.4 Addressing these challenges necessitates the development of effective implementation strategies to enhance the translation of EBIs into practice.3 5 Implementation strategies are described as methods or techniques employed to enhance the adoption, implementation, sustainment and scaling of EBIs.6

Two major issues that hinder the development of effective implementation strategies include a lack of thorough understanding of the mechanisms within these strategies and insufficient active community engagement during their development.7–10 First, the mechanisms of implementation strategies—defined as the processes through which the strategy produces the desired implementation outcomes—are often not well understood, specified or tested.7 8 This limitation hinders the creation of tailored and effective strategies and prevents the generation of generalisable and replicable evidence in implementation science.7 8 Second, the absence of, or inadequate, community engagement in the development of these strategies presents challenges in understanding implementation contexts in depth and effectively addressing the unique needs of priority populations.10 11 This, in turn, can result in suboptimal implementation strategy development and EBI translation in practice.

Recent work advocates for using guiding frameworks to facilitate more rigorous exploration, specification and evaluation of the mechanisms of implementation strategies, along with the integration of active community engagement in their development.11–14 An in-depth understanding of implementation mechanisms can inform why and how the strategies work or do not work, allowing for the refinement, adaptation, replication and generalisation of the strategies.7 8 15 16 Engaging with community members such as adopters, implementers, maintainers, EBI target populations or other relevant individuals (eg, administrative leaders) in implementation strategy development is essential for understanding the implementation context from their perspectives and producing ecologically valid strategies.4 17 Thus, these two approaches are critical in facilitating the production of effective strategies.

Implementation Mapping (IM) has become increasingly used for the design and/or selection and tailoring of implementation strategies to promote the effective translation of EBI into practice.6 IM guides the systematic, iterative, step-by-step development of theory-based, evidence-informed implementation strategies.6 Integrating knowledge from implementation science, this approach extends Intervention Mapping,18 a tool designed to develop, implement and evaluate evidence-based practices. It specifically builds on the fifth step in Intervention Mapping18: developing plans for programme adoption, implementation and sustainment. Implementation Mapping includes five iterative tasks: (1) conducting an implementation needs and assets assessment, (2) determining adoption and implementation outcomes, performance objectives, determinants, and change objectives, (3) selecting change methods and implementation strategies, (4) producing implementation protocols and materials, and (5) evaluating implementation outcomes.6

A key feature of IM is its systematic process for understanding and specifying the mechanisms of an implementation strategy.6 This process involves comprehending the implementation context, identifying implementation determinants and specifying implementation behaviours and outcomes, alongside change methods and practical applications.6 Furthermore, this iterative mapping process is completed through active community engagement across development activities including needs and assets assessments, co-creation of logic models and co-design of implementation strategies.6 This approach fosters a deeper insight into how the strategies achieve desired outcomes, ensuring that they are theoretically sound, practically viable and tailored to the needs of the implementation context and the priority community.6

Several studies have demonstrated the utility of IM in guiding the specification of implementation strategy mechanisms and facilitating community engagement.19 For instance, Markham et al (2022) used IM subtasks to guide the layout of the inter-relationship among determinants, implementation behaviours, change methods and parameters, which ultimately aids in specifying the mechanisms of how implementation strategies are designed to achieve the desired outcomes.20 Additionally, Savas et al (2023) used A Taxonomy of Behavioural Change to study and specify the mechanisms of implementation strategies, in conjunction with IM.21 During Task 3 of IM, Savas et al (2023) used A Taxonomy of Behavioural Change to identify theoretical methods for enacting desired changes in behaviours and influencing implementation environments, thereby elucidating the theoretical implementation mechanisms.21

Other studies have showcased collaboration with community members such as practitioners, patient priority populations, programme coordinators and other relevant stakeholders throughout the IM tasks to develop implementation strategies.19 Community engagement in IM varies in approaches and extent. For example, Kang and Foster (2022) conducted a qualitative needs assessment, semi-structured individual interviews and interactive group discussions, involving community partners throughout IM.22 Watson et al (2022) engaged a wide range of community members, including coordinators, programme facilitators, priority population advocates and organisational leaders.23 Watson et al (2022) used both quantitative (eg, using a readiness quantitative measure) and qualitative approaches (eg, interviews) throughout the IM tasks in developing implementation strategies.23 While these highlight individual examples of the practical application of IM, there is a notable gap in synthesised evidence of the current state of the art in using IM. This specifically includes the current landscape of IM in developing implementation strategies, the mechanisms of implementation strategies developed using IM and how community engagement is used throughout the IM.

Therefore, there is a need for synthesised evidence to (1) examine the overall landscape of IM in developing implementation strategies, (2) explore the mechanisms of implementation strategies developed using IM and (3) investigate the use of IM and community engagement in the development of implementation strategies. This can better inform the practice of using IM in developing effective implementation strategies. This protocol outlines the methods of a systematic review designed to address these significant research gaps. From this review, we aim to produce three publications. Below are the working titles and research questions for the three proposed publications:

Systematic Review #1 Working Title: The Use of Implementation Mapping in Developing Implementation Strategies: A Systematic Review. Research questions #1–3 are as follows: (1) What are the context of IM studies that developed implementation strategies? (2) What types of implementation strategies have been developed by IM studies? (3) To what extent did the IM studies use each IM task? In the first question, we operationally define the context as the background elements, including the country of study, health issues addressed, target demographics, the setting in which the implementation occurs and the conceptual models applied.

Systematic Review #2 Working Title: Identifying the Mechanisms of Implementation Strategies Developed Using Implementation Mapping: A Systematic Review. Research questions #1–2 are as follows: (1) How are the mechanisms of implementation studied, specified or tested using any of IM tasks? (2) How are the mechanisms of implementation strategies operationalised within the IM tasks?

Systematic Review #3 Working Title: Community Engagement and Implementation Mapping: A Systematic Review. Research questions are as follows: (1) To what extent is community engagement used in developing implementation strategies using IM? (2) What community engagement approaches are used in developing implementation strategies using IM? (3) What are the challenges, approaches and benefits of engaging community members during implementation mapping tasks? In this review, we define community engagement as the process of collaboration with and through groups of people affiliated by shared health matters, including those involved in the adoption, implementation and maintenance of interventions, to address issues affecting their well-being.24

For both scientific and logistical reasons, we have proposed three publications. Most importantly, because the proposed research questions for each publication are conceptually distinct, comprehensive as standalone topics and address important implementation science issues, they warrant separate publications to delve deeply into each research question. From a logistical standpoint, we expect to include more than 160 articles in each review. Given the vast number of included articles, having very focused research questions for each publication will help us produce meaningful, in-depth syntheses on these important implementation matters.

Methods and analysis

This systematic review protocol is registered in Open Science Framework [https://doi.org/10.17605/OSF.IO/TZHCJ] and reports the methods according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) (online supplemental material).25 The planned analysis start date for this systematic review is 1 July 2024.

Eligibility criteria

We will include articles that meet the following inclusion criteria: (1) peer-reviewed original articles that describe the process of using any step of Implementation Mapping or Intervention Mapping Step 5 to design implementation strategies; and (2) articles written in English. Implementation Mapping is essentially step 5 of Intervention Mapping. Planning the implementation of an intervention has always been an integral part of the Intervention Mapping process which describes intervention development, evaluation and implementation. Some scientists were using step 5 of Intervention Mapping to plan implementation strategies. We have operationally defined implementation strategies as methods or techniques employed to enhance the adoption, implementation, sustainment and scale-up of EBI.6 The exclusion criteria will include grey literature, dissertations, conference abstracts and papers, reviews, meta-analyses and white papers.

Information sources and search strategy

Table 1 describes the full search strategy and included databases. An expert health sciences librarian (JS) executed the systematic searches from inception to January 2024. We have included both ‘Intervention Mapping’ and ‘Implementation Mapping’ terms because before the publishing of the 2019 article, some scientists were using step 5 of Intervention Mapping to plan implementation strategies. We did not want to miss articles describing the use of essentially the same process simply because they were not labelling it as ‘Implementation Mapping’.

Table 1

Full search strategy

Study records: data management, selection process, data collection process

The librarian extracted search records from five databases and manually removed duplicates. The lead author (EK) has uploaded the records to an online systematic review screening platform, Covidence, and removed the duplicates one more time using the automatic process built in the platform. Four authors (EK, GtH, SR, DC) will conduct title and abstract screening. Two random reviewers will independently screen each record. The same four authors will complete the same selection process for full-text screening. Any screening discrepancies between two reviewers will be resolved by the independent third author or through discussion among the four authors. If they are unable to resolve a discrepancy, we will consult with the senior author (MF) to reach a consensus. The same four authors will pilot the data extraction form independently by extracting the data for 10% of the final included articles and refine the form together. This process will allow us to establish a data extraction form and consistent data collection approach with the authors. We will then randomly assign articles to each reviewer for independent coding and resolve any uncertainty in regular monthly author meetings. At least 20% of the initially extracted data will be double-checked for accuracy and completeness by a second reviewer. After an internal evaluation of the data extraction results and discrepancies, if the team decides that further double-checking is necessary, we will continue to double-check the data until we confirm consistent coding among the authors. Any questions or discussion items from the authors will be resolved in regular co-author meetings. Four authors (EK, GtH, SR, DC) will be involved in the data extraction and double-checking process. If discrepancies cannot be resolved, we will resolve them through consultation with a senior author (MF).

Data items, outcomes, and Prioritization

Table 2 describes the data items for each research question across three publications in detail. For Publication 1, we will focus on variables that aid in understanding the overall landscape of IM studies in developing implementation strategies, as well as how these studies use IM subtasks. For Publication 2, our focus will be on variables relevant to the functions and forms of strategies developed through IM. For Publication 3, we will examine variables that inform community engagement during IM tasks. When evaluating the level of community engagement, we will use the following four engagement levels described for participatory implementation science projects by Ramanadhan et al (2023): consultative, collaborative, collegial and practice-/community-led.11 The consultative level of engagement refers to when the practice/community partners are consulted infrequently for specific purposes with minimal burden on them (eg, consulting on dissemination audience).11 The collaborative approach refers to when the practice/community partners have deeper engagement, yet their collaboration is led by research or academic teams.11 The collegial approach involves sharing equal power and benefits between the practice/community partners and research teams.11 Lastly, the practice-/community-led approach refers to when practice or community partners direct the direction of the research efforts.11 The primary and additional outcomes for these publications are specified in table 2. We selected variables that directly respond to the research questions as primary outcomes, with additional outcomes chosen because they are either necessary to address the primary outcomes or are relevant.

Table 2

Data items for each publication

Risk of bias in individual studies

We will use the quality assessment tool developed by Hawker et al (2002).26 This tool comprises nine items for examining the abstract and title, introduction and aims, method and data, sampling, data analysis, ethics and bias, results, transferability or generalisability, and implications and usefulness, with a 4-point scale (good, fair, poor and very poor). Online supplemental material 2 provides a description of all assessment items. Given that we expect most included articles to be methods-based papers, rather than traditional empirical papers with data reporting, we chose an assessment tool with a broader assessment scope covering the overall sections of the paper, rather than tools with detailed assessment criteria focused primarily on study designs and result data reporting. After pilot-testing of several included articles in the future, we will consider the possibility of adapting the assessment tool to be better tailored to methods-based papers.

Data synthesis

We will synthesise and organise the extracted data according to the research questions outlined in table 2. By synthesising the findings, we will suggest a future research agenda for using IM.

Patient and public involvement

This review does not plan to involve patients or the public in the planning or conduct of the research.