Walking Alongside Indigenous Communities and Organizations to Enhance Health Programs: A Global Scoping Review Protocol on Indigenous-Led and Partnered Implementation Science

1.1 Review objective and questions

The objective of this scoping review is to identify and describe implementation science projects conducted with Indigenous communities worldwide, specifying the regions, settings, populations, health areas, and program types involved.

The primary review question is: What is known from peer-reviewed and grey empirical literature about Indigenous-led and partnered implementation science in health and health-related settings globally?

Subquestions will examine:

2.1 Review design

Scoping reviews are particularly useful to explore, identify, map and discuss characteristics of concepts across a wide range of evidence sources.¹³ The proposed scoping review will be conducted in accordance with the Joanna Briggs Institute (JBI) methodology¹⁴ for scoping reviews (which expands on the work of Arksey and O’Malley¹⁵ and Levac et al.¹⁶). It emphasizes appropriateness, feasibility, and meaningfulness of the literature and includes nine sequential steps. First, defining the scoping review objective(s) and question(s). Second, developing and aligning the inclusion criteria with the objective(s) and question(s). Third, specifying the approach to evidence searching, selection, data extraction, and presentation. The next four steps involve searching for, selecting, extracting and analyzing the evidence. The eighth is the presentation of the results, while the ninth and last step is summarizing the evidence, making conclusions and noting implications of the findings.¹³ The review will be reported according to PRISMA-ScR guidelines.¹⁷

2.2 Eligibility criteria

2.2.1 Population

We will include studies conducted in Indigenous communities or with people who identify as Indigenous, from any country and without date restrictions. Recognizing that there is considerable global diversity in the terms used to describe Indigenous Peoples, this study could include a wide range of terminology including but not limited to Indigenous, First Nations, Inuit, Métis, Aboriginal, Alaska Natives, Indian, and Maōri. For the purposes of this review, we will use the terms “Indigenous communities” and “Indigenous peoples” broadly, to encompass any community or individuals who self-identify as Indigenous or who are recognized as such within their local, national or regional context.¹⁸ Studies that do not involve Indigenous peoples or communities will be excluded.

2.2.2 Concept

The concept of interest is empirical implementation research, or closely related empirical work, concerning the uptake, integration, adaptation, scale-up, sustainment, or de-implementation of health programs, services, practices, or policies with Indigenous peoples, communities, or organizations. Studies will be eligible if they explicitly address at least one implementation-related element, such as:

Studies will not be excluded solely because they are labelled as knowledge translation, quality improvement, service improvement, program implementation, or systems change. Instead, eligibility will depend on whether the study includes an explicit empirical implementation focus according to the criteria above. Studies that assess only clinical or public health effectiveness, with no implementation aim, data, or analytic component, will be excluded.

2.2.3 Context

We will include studies conducted in any health or health-related setting involving Indigenous peoples, communities, organizations, or services. Eligible settings may include Indigenous-led or mainstream primary care services, hospitals, community-based services, public health programs, social and outreach services, and cross-sector settings such as schools or justice settings when the intervention or program has an explicit health objective.

To align with the focus on Indigenous-led and partnered implementation science, eligible studies must report at least one explicit form of Indigenous involvement in the implementation effort or the study itself, such as Indigenous leadership, Indigenous governance, formal partnership with an Indigenous community or organization, co-design, co-creation, or Indigenous advisory structures. Studies involving Indigenous participants but reporting no Indigenous community, organizational, governance, or partnership component will be excluded.

2.2.4 Study design and types of sources

Any empirical study design will be eligible, including quantitative, qualitative, mixed-methods, and case study designs, provided that the implementation focus criterion is met. Eligible sources will be full-text empirical studies published in peer-reviewed journals or as grey literature (such as government or organizational reports) with identifiable methods and results. Conference abstracts, blogs and other non-methodological sources will be excluded. Opinion pieces, commentaries and narrative discussions will also be excluded from data charting, although relevant reviews may be retrieved to identify additional primary studies through reference-list screening.

2.2.5 Other restrictions

There will be no restrictions on language and year of publication; all eligible studies published to date will be considered.

2.3 Search strategy and information sources

The search strategy will be developed in collaboration with an experienced health sciences information specialist following the PRISMA extension for literature searches (PRISMA-S).²¹ The electronic search strategy will be peer reviewed by a second information specialist using the Peer Review of Electronic Search Strategies (PRESS) 2015 guideline.²²

Following JBI guidance, we will use an iterative, multi-step approach to searching. First, an initial limited search will be undertaken in MEDLINE and CINAHL to identify relevant articles and to analyze text words in titles and abstracts, as well as controlled vocabulary terms used to describe the topic. These terms will then be used to develop a comprehensive search strategy tailored to each information source. The final search strategy will combine terms related to¹: Indigenous Peoples and communities globally²; implementation science and related concepts; and³ health or health-related programs, services, or systems. Because implementation science terminology is heterogeneous, the search will intentionally include a broad range of related terms, such as implementation, dissemination, uptake, adoption, scale-up, sustainability, knowledge translation, hybrid designs, process evaluation, fidelity, adaptation, and barriers and facilitators. Terms related to quality improvement or knowledge translation may be included at the search stage to maximize sensitivity, but eligibility will ultimately depend on whether the study has an explicit implementation science focus according to the review criteria.

Electronic searches will be conducted from database inception to the date of the final search in the following bibliographic databases: MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCOhost), PsycINFO (Ovid or EBSCOhost), Web of Science Core Collection, Scopus, and Global Health. Additional databases may be added during strategy development if they are judged likely to improve coverage of Indigenous health or implementation science literature. No limits will be applied for year of publication or language. Where potentially eligible reports are published in languages not spoken by the review team, translation support will be sought where feasible.

To capture evidence not indexed in bibliographic databases, we will also undertake a structured grey literature search. This will be informed by CADTH’s Grey Matters tool.²³ Grey literature sources will include targeted searches of government and health system websites, Indigenous organizations and networks, research institutes, funding agencies, and other relevant organizational websites from countries and regions where Indigenous health research is prominent. We will also use Google Advanced Search and screen a predefined number of results for each targeted search string, documenting the search date, search terms, website, and number of records screened to enhance transparency and reproducibility. Indigenous co-authors and collaborators will also be invited to suggest additional organizational reports, project documents, or other non-indexed sources that may be relevant to the review.

To ensure comprehensiveness, we will hand-search the reference lists of all included studies and of relevant reviews, and we will conduct forward citation searching of key included papers where feasible. If needed, we will contact study authors to clarify publication details or identify related reports. A draft full search strategy for at least one database is available upon request, and all searches will be documented in sufficient detail to permit replication. If there is a substantial delay between the original search and submission of the completed review, the searches will be updated prior to final manuscript submission.

2.4 Study selection

All records identified through database and grey literature searches will first be imported into a citation management program, where duplicate entries will be removed. The study selection process will occur in two stages: title and abstract screening, followed by full-text screening. In the first stage, two reviewers will independently screen titles and abstracts against the pre-specified eligibility criteria for population, concept, context, study design and other restrictions. Studies that clearly do not meet the inclusion criteria will be excluded at this stage, while any record that appears potentially relevant, or for which eligibility is unclear, will be retained for full-text review.

In the second stage, the same two reviewers will independently assess the full text of all retained articles to determine final inclusion. Reasons for exclusion at the full-text stage (for example, not involving Indigenous populations, no explicit implementation focus, non-health context, or non-empirical design) will be documented. For all review stages, discrepancies between reviewers will be resolved through discussion; if consensus cannot be reached, a third reviewer from the research team will adjudicate. Where necessary, we will contact authors to clarify aspects of the study relevant to eligibility (such as whether the work is framed as implementation science or the nature of the population involved). The overall study selection process and numbers of records at each stage will be summarized in a flow diagram consistent with PRISMA-ScR guidance.

2.5 Data extraction

Data from included records will be extracted by two independent reviewers using a data extraction tool developed specifically for this review. The tool will be designed to capture details related to the descriptive characteristics of each study, the methodological and conceptual features, the contextual and Indigenous governance aspects and the main implementation-related findings.

For each included record, we will extract information such as the year of publication, the country or countries where the study took place, the Indigenous population(s) involved, the stated aims or research questions, the health area or topic addressed and, where available, the cultural background of the first author. Methodological information will include the study design, any theories, models or frameworks (TMFs) used, whether these TMFs are Indigenous, Western or combined, the methods of data collection and analysis and, where applicable, a brief description of the intervention or implementation strategy under study.

We will also collect contextual information on the settings in which the study was conducted, including whether the setting is community-based, primary care, hospital-based, public health or another health service context; which Indigenous communities, nations or groups were involved; and the number and characteristics of participants where this is reported. We will classify the type of program or intervention (for example, prevention, screening, treatment, health promotion or systems-level change) based on the descriptions provided.

Because this review focuses on Indigenous implementation science, particular attention will be paid to Indigenous leadership, governance, and relational aspects of the work. We will therefore extract information on whether Indigenous leadership or partnership is reported, including whether the project is described as Indigenous-led, co-led or co-governed, guided by Indigenous advisory structures, community-engaged, consultative, or unclear/not reported. We will also extract information on data-governance and data-sovereignty practices, including any reference to OCAP^®, CARE, FAIR, Inuit research principles, Métis data-governance principles, or local data agreements.^24–29

In addition, we will extract whether the publication explicitly reports Indigenous authorship, author positionality, or researcher reflexivity. Where relevant, we will record whether any authors explicitly self-identify as Indigenous in the publication or linked report; however, we will not infer author identity where this is not self-reported.

Finally, we will extract key findings related to implementation processes and outcomes, including reported strategies, determinants, barriers and enablers, as well as any information on implementation outcomes such as reach, adoption, fidelity, adaptation, sustainability or equity, where these are described.^30,31 We will also record any explicit recommendations for practice, policy or future research that relate to implementation with Indigenous communities.

The extraction form will be piloted independently by two reviewers on an initial sample of five studies. Based on this piloting, the tool will be refined to improve clarity and consistency, and any changes will be documented.

2.6 Planned analysis and synthesis

We will employ a descriptive and interpretive approach to analysis that is consistent with the JBI methodology for scoping reviews. Once data extraction is complete, we will collate the charted data in a master dataset and examine it for patterns across studies.

Quantitative and categorical variables (such as year of publication, country or region, health area, study design, type of setting, type of TMF and program focus) will be summarized using simple descriptive statistics, including counts and proportions. These summaries will allow us to map the distribution of Indigenous implementation science projects across regions, health topics, settings and methodological approaches, and to identify under-represented areas. Where appropriate, we will present these findings in summary tables and figures that visually depict the landscape (for example, by region, health area or type of implementation design).

For more qualitative and conceptual variables, such as how implementation science is defined, how Indigenous and Western TMFs are applied, the nature of partnership and governance arrangements, data-sovereignty practices, and reported barriers and enablers, we will use a reflective, iterative, thematic and content-analytic approach. The research team will review the extracted textual data to identify recurrent patterns and themes related to the operationalization of implementation science with Indigenous communities. These themes will be refined through discussion and will be interpreted with respectful consideration of Indigenous self-determination, equity, colonial impacts, and cultural awareness.

In synthesizing the findings, we will first provide a descriptive overview of the included studies and then organize the results around the key elements specified in our objectives: populations and settings, health areas and program types, implementation designs and TMFs, partnership and governance models, and ethical and data-sovereignty practices. We will highlight promising practices, common challenges and gaps in reporting, and we will interpret these in relation to current Indigenous and global implementation science agendas. The final narrative synthesis will emphasize implications for future research, capacity-building and policy, and will outline specific areas where further Indigenous-led, co-designed and strengths-based implementation studies are most needed.