Funnell et al. International Journal for International Journal for Equity in Health (2023) 22:55 https://doi.org/10.1186/s12939-023-01854-1 Equity in Health STUDY PROTOCOL Open Access Improving social justice in observational studies: protocol for the development of a global and Indigenous STROBE‑equity reporting guideline Sarah Funnell1,2, Janet Jull3, Lawrence Mbuagbaw4, Vivian Welch5,6*, Omar Dewidar5, Xiaoqin Wang7, Miranda Lesperance6, Elizabeth Ghogomu5, Anita Rizvi8, Elie A. Akl4,9, Marc T. Avey10, Alba Antequera11, Zulfiqar A. Bhutta12,13, Catherine Chamberlain14,15, Peter Craig16, Luis Gabriel Cuervo17,18, Alassane Dicko19, Holly Ellingwood20, Cindy Feng21, Damian Francis22, Regina Greer‑Smith23, Billie‑Jo Hardy24,25, Matire Harwood26, Janet Hatcher‑Roberts27, Tanya Horsley28, Clara Juando‑Prats29,30, Mwenya Kasonde31, Michelle Kennedy32, Tamara Kredo33,34, Alison Krentel5,6, Elizabeth Kristjansson35, Laurenz Langer36, Julian Little6, Elizabeth Loder37, Olivia Magwood6,35, Michael Johnson Mahande38, G. J. Melendez‑Torres39, Ainsley Moore40, Loveline Lum Niba41, Stuart G. Nicholls42, Miriam Nguilefem Nkangu6, Daeria O. Lawson4, Ekwaro Obuku43, Patrick Okwen41, Tomas Pantoja44, Jennifer Petkovic5,42, Mark Petticrew45, Kevin Pottie6,46, Tamara Rader47, Jacqueline Ramke48,49, Alison Riddle6, Larissa Shamseer42, Melissa Sharp50, Bev Shea40, Peter Tanuseputro42, Peter Tugwell6,42,51, Janice Tufte52, Erik Von Elm53, Hugh Sharma Waddington54, Harry Wang5,51, Laura Weeks55, George Wells2,56, Howard White57, Charles Shey Wiysonge33,34,58, Luke Wolfenden34 and Taryn Young33 Abstract Background Addressing persistent and pervasive health inequities is a global moral imperative, which has been highlighted and magnified by the societal and health impacts of the COVID-19 pandemic. Observational studies can aid our understanding of the impact of health and structural oppression based on the intersection of gender, race, ethnicity, age and other factors, as they frequently collect this data. However, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline, does not provide guidance related to reporting of health equity. The goal of this project is to develop a STROBE-Equity reporting guideline extension. Methods We assembled a diverse team across multiple domains, including gender, age, ethnicity, Indigenous background, disciplines, geographies, lived experience of health inequity and decision-making organizations. Using an inclusive, integrated knowledge translation approach, we will implement a five-phase plan which will include: (1) Sarah Funnell, Janet Jull, Lawrence Mbuagbaw and Vivian Welch are joint first authors. *Correspondence: Vivian Welch vwelch@campbellcollaboration.org Full list of author information is available at the end of the article © The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://​creat​iveco​mmons.​org/​licen​ses/​by/4.​0/. The Creative Commons Public Domain Dedication waiver (http://​creat​iveco​ mmons.​org/​publi​cdoma​in/​zero/1.​0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Funnell et al. International Journal for Equity in Health (2023) 22:55 Page 2 of 14 assessing the reporting of health equity in published observational studies, (2) seeking wide international feedback on items to improve reporting of health equity, (3) establishing consensus amongst knowledge users and researchers, (4) evaluating in partnership with Indigenous contributors the relevance to Indigenous peoples who have globally experienced the oppressive legacy of colonization, and (5) widely disseminating and seeking endorsement from relevant knowledge users. We will seek input from external collaborators using social media, mailing lists and other communication channels. Discussion Achieving global imperatives such as the Sustainable Development Goals (e.g., SDG 10 Reduced inequalities, SDG 3 Good health and wellbeing) requires advancing health equity in research. The implementa‑ tion of the STROBE-Equity guidelines will enable a better awareness and understanding of health inequities through better reporting. We will broadly disseminate the reporting guideline with tools to enable adop‑ tion and use by journal editors, authors, and funding agencies, using diverse strategies tailored to specific audiences. Keywords Reporting guidelines, Health equity, Social justice, Observational studies Background inequities in access to vaccination for COVID-19 glob- The COVID-19 pandemic has magnified existing ally, with only 4% of people vaccinated in low-and-mid- inequities in health and revealed systemic biases and dle-income countries (LMIC) compared to over 70% in discrimination in societal structures (such as rac- Canada and the United States of America (USA) [15, 16] ism, sexism, ableism), including health systems [1, in the year 2021. 2]. Health inequities are defined as disparities that In many countries, specific ethnic groups, such as are avoidable and unfair [3, 4]. Acknowledging and Indigenous people, continue to suffer from the legacy of addressing health inequities has been the subject of colonization and persistent discrimination and oppres- investigations and reports dating back to the ­19th cen- sion [17–19]. Despite global instruments such as the tury, with continued commissions including the Black United Nations Declaration on the Rights of Indig- report in 1980, WHO Commission on Social Deter- enous Peoples (UNDRIP) [20] to build a more just and minants of Health in 2008 and National Academies of equitable future, Indigenous people continue to face Sciences, Engineering and Medicine in 2017 [5–9]. individual and systemic discrimination, limiting their Health inequities are driven by structural inequities opportunities for education, justice, and health [21]. in opportunities and resources, which shape the con- Research about Indigenous people has often failed to ditions in which people live and their opportunities partner with communities and consequently gener- for health [10]. By structural inequities we mean the ated little social value for communities [22]. Instead, unequal distribution of power, resources, and privilege research has a legacy of exploitation and harm of that favour some people and place others in vulnerable Indigenous people through experimentation (e.g., the or disadvantaged circumstances, limiting their health recently documented experiences of Indigenous peo- opportunities across gender, age, ethnicity, and other ples in Canada at Indian hospitals [23] and residential sociodemographic factors [4, 11, 12]. Such limitations schools [24], Qu’Appelle BCG Vaccine Trial in Canada lead the most vulnerable due to systemic and structural [25]. Historical exploitation has contributed to a culture barriers to struggle to adequately meet their health care of mistrust of health research in Indigenous popula- needs [13]. tions, which must be considered in conducting Indig- Many nations and peoples have suffered the deleteri- enous-centric health research. For Indigenous people, ous effects of colonization or control by external military factors that drive opportunities for health may differ and political forces throughout history. This has resulted from other populations, such as the right to self-deter- in many nations continuing to struggle with inadequate mination, and connection to the land and culture, which health and health care resources. For example, in India, is central to wellbeing [26, 27]. healthcare workers are unable to maintain standards of Studies where the researcher is not in control of the care due to colonial-era regulatory policies creating dis- exposure or intervention are known as observational putes between federal and union government that impact studies. These studies could be prospective or retro- resource allocation [14]. Moreover, wealthier countries spective or both. Observational studies have become continue to fail to honour global treaties to support increasingly popular as a key tool in national and health and health research, exemplified by profound international health monitoring, such as demographic Funnell et al. International Journal for Equity in Health (2023) 22:55 Page 3 of 14 health surveillance systems. Furthermore, there is an Given the pervasiveness of observational studies and increasing focus on harnessing “Big Data” to link socio- the growing attention to the need to examine inequi- economic, administrative, and other biomedical data to ties, especially inequities observed during the COVID- inform planning [28–32]. Observational studies are also 19 pandemic, methodological research, and guidance to used to evaluate the effects of policies and programs improve their reporting is needed to improve the social in real-world situations, especially when an experi- value and global impact of health research. mental study (e.g., randomized controlled trial) would be impractical or unethical [33]. Observational stud- ies are also meaningful for exploring complex systems Overall goal and their influence on health [34–37]. The informative Our overall goal is to develop guidance on reporting value of results from interventions (e.g., policies and health equity considerations in observational studies to programs) addressing to mitigate inequities relies on make health equity data more readily available for syn- the quality of data. However, the availability of data to thesis and decision-making. monitor, understand and intervene to mitigate health This goal has two distinct components, which are: inequities between and within countries continues to be a challenge [38, 39]. 1) to develop a global reporting guideline on health Implementing programs and policies to mitigate ineq- equity as an extension of STROBE in partnership uities effectively requires high quality data to monitor with members of the public, diverse collaborators, the impacts of policies and programs on health inequi- and multiple disciplines, and ties over time and across settings. Many observational 2) to develop a reporting guideline for reporting health studies fail to assess inequitable differences in health or equity in Indigenous research in Australia, Canada, health care due to inadequate collection or reporting of New Zealand and the USA with leadership by Indig- equity-related data in participants, adjusting for avail- enous people from these countries. able sociodemographic factors as confounders rather than exploring potential for differential effects for pop- We recognize that the harms of colonization have ulations experiencing inequities, or due to a failure to affected Indigenous Peoples globally. However, we evaluate variation in treatment effects [40–42]. Globally, decided to focus on these four countries since they have decision-makers have endorsed the need for better evi- a similar experience of colonization which included dence about health equity, exemplified by the Sustain- land dispossession and policies for assimilation [55]. We able Development Goals (SDGs) of the UN General sought Indigenous scholars from each of these countries Assembly [4]. The Pan-American Health Organization to join our Indigenous Steering Committee and designed (PAHO), the World Health Organization (WHO) and methods to collect data on research methods in these the World Health Assembly have all explicitly advocated countries (see below). We considered that this project for standards in reporting and analyzing equity [43–46]. did not have sufficient resources to adequately appraise Academic support for better evidence on health ineq- the empirical data and seek sufficient global representa- uities is exemplified by an increasing number of global tion to develop reporting guidelines for all global Indig- and national guidelines on assessing sex, gender and enous Peoples. By transparently reporting our methods health equity, such as the 2015 Sex and Gender Equity and processes, we hope this guideline may be helpful in Research (SAGER) guidelines [47] and funder guide- for adaptation for other Indigenous Peoples in differ- lines on considering sex, gender and health inequities ent global contexts. Indigenous Peoples, scholars, public [48, 49]. Justice and equity concerns are also central to members will be given opportunities to review the global research ethics [50, 51]. consensus guidelines as well. We feel the entire project Reporting guidelines have been shown to improve the benefits from Indigenous perspectives. reporting of some aspects of their respective studies The research to achieve this goal will be intercon- [52, 53]. The STROBE (STrengthening the Reporting of nected and empowering, with opportunities for OBservational studies in Epidemiology) guidelines were reciprocal learning through joint meetings and commu- developed to improve the reporting of observational nication. Indigenous approaches to research include tak- studies, including cohort, case control and cross-sec- ing a strengths-based, anti-oppressive and anti-colonial tional studies. Of the 13 STROBE extensions address- approach [56], founded on authentic, ethical partner- ing nuances of design and types of data; none focus on ships [57, 58] and following principles of Indigenous data health equity [54]. The development of equity extensions sovereignty [59]. These approaches are central to under- for STROBE items may improve the reporting of equity standing health inequities and social justice in designing, in observational studies. conducting, and reporting research. Funnell et al. International Journal for Equity in Health (2023) 22:55 Page 4 of 14 Specific objectives Methods This project aims to improve the consistency of reporting Study design of health equity in observational studies, by fulfilling the The study will comprise five phases, adapted from guid- following specific objectives over the span of 4 years: ance for developing reporting guidelines by Moher et al. [60], including establishing the need for guidance, seek- 1. To assess reporting of health equity through empiri- ing comprehensive feedback, establishing consensus, cal studies by: evaluating outcomes of learning across streams and implementation over the span of 4 years. Members of 1.1. identifying available guidance for reporting our team have adopted this approach for other report- health equity in observational studies, globally ing guidelines on equity in systematic reviews [61, 62] and in studies focused on Indigenous People and randomized trials [CONSORT-Equity] [63]. The 1.2. describing analysis and reporting of health five phases of the current study are: (1) Assess available equity in observational studies, globally and in guidance, viewpoints, and reporting of health equity in studies focused on Indigenous People observational studies, (2) Seek wide international input 1.3. exploring and mapping diverse viewpoints using a survey on potential items to improve reporting of knowledge users and researchers, glob- of health equity, (3) Establish consensus amongst knowl- ally and in studies focused on Indigenous edge users and researchers on the health equity report- People ing guideline, (4) Evaluate the relevance of the reporting guideline for Indigenous research, and, (5) Widely dis- 2. To seek wide international feedback on items to seminate and encourage uptake of STROBE-Equity improve reporting of health equity (Fig. 1). In our study, we focus on Indigenous Peoples in 3. To establish consensus amongst knowledge users and Australia, Canada, New Zealand and the USA given the researchers on reporting items for the global guid- similarity in colonization experience and representation ance and for the guidance focused on Indigenous on the Indigenous Steering Committee for this project, Peoples in Australia, Canada, New Zealand, and the as described above. USA We will review the candidate items supported from 4. To evaluate outcomes of collaboration between and scoping review and the items found to be poorly reported across global guidance and guidance focused on in the methods study. Study design details regarding the Indigenous populations methods studies will be published on open access plat- 5. To widely disseminate and seek endorsement from forms or published in peer review journals when possible relevant knowledge users [64–66]. We will analyze focus groups thematically and Fig. 1 Project Overview- reporting of health equity in observational studies. Indigenous refers to Indigenous peoples living in Australia, Canada, New Zealand, and the USA Funnell et al. International Journal for Equity in Health (2023) 22:55 Page 5 of 14 use themes to generate additional candidate items. All the items will be complied and synthesized to develop a final list of items to be presented in an online survey. The survey will be used to gather international feedback on the suggested list of items and identify gaps where new items might be required. The results of the survey will be analysed quantitively by calculating the frequencies and percentages of each response option for each ques- tion. We will assess the agreement on the candidate items and hold the consensus meeting to discuss the final list of items. Subsequently, we will develop a writing team to wordcraft and refine the items in response to feedback on drafts, and compile examples identified by the empirical studies and expertise of the team. We will conduct this work in parallel to the stream focused on Indigenous research led by our Indigenous principal investigator (SF), with engagement of relevant Indigenous knowledge holders and knowledge users and will follow the same steps. The two streams of research Fig. 2 STROBE-Equity logo showing parallel global and Indigenous will be interconnected and empowering with opportuni- streams, with interconnections between them. Footnote: This figure ties for joint learning through regular communication. was designed in collaboration with Claire Brascoupé (Algonquin To articulate the connections between the two streams Anishinaabe artist). The geography and landscape reflect the focus of the Indigenous stream on research with Indigenous people in of research, we consulted with an Indigenous artist Claire Australia, Canada, New Zealand and the USA. The global stream is Brascoupé (Algonquin Anishinaabe artist) to design a fig- intended to be global and phase 2 and phase 3 of the project will ure of our shared vision for parallel streams, with inter- seek participation and viewpoints from across the globe connected elements (Fig. 2). The process of co-designing this figure with our steering committees helped to estab- lish our methods for enabling separate streams with mul- our studies focused on observational studies with, for tiple points for connection and learning from each other. and about Indigenous peoples. Studies focused on observational studies specific Phase 1: assess available guidance, viewpoints, to indigenous people and reporting of health equity in observational studies For each of the studies below we will conduct a paral- We will conduct six linked empirical studies on how lel project focused on research with Indigenous people. health equity is reported in observational studies; three We define Indigenous Peoples as “… distinct social and focused on global research and three on research on cultural groups that share collective ancestral ties to the Indigenous people. We define observational studies lands and natural resources where they live, occupy or according to those relevant to the STROBE reporting from which they have been displaced.” [68] Throughout guideline as case-control, cohort, and cross-sectional the conduct of the Indigenous studies and design of the studies, which collect and report quantitative data, e.g., Indigenous reporting guideline, we focus on research studies conducted using administrative data, natural with Indigenous Peoples in Australia, Canada, New experiments, and prospective cohorts. Zealand and the USA given their similarity in coloni- We will use an organizing framework to document evi- zation experiences. When engaging stakeholders in the dence about health inequities defined by the acronym: development of the reporting guideline, we will involve PROGRESS-Plus, which stands for Place of residence representatives from these four countries. As part of (urban/rural), Race/ethnicity/culture/language, Occupa- the implementation and dissemination strategy, we will tion, Gender or sex, Religion, Education, Socioeconomic work towards extending the STROBE-Equity guideline status and Social capital [11]. The “Plus” characteristics to Indigenous populations in other geographies in the are other characteristics associated with health inequities future. We will ensure representation and leadership such as age, disability, sexual orientation, and temporary from such populations accordingly. We decided that exposure to vulnerable circumstances such as discharge there is a need for leadership by Indigenous and allied from hospital and food security [67]. We will apply this scholars and representatives, people with lived experi- PROGRESS-Plus lens to our global studies as well as to ence, and decision-makers and also data sovereignty in Funnell et al. International Journal for Equity in Health (2023) 22:55 Page 6 of 14 interpreting results for the Indigenous reporting guide- study design, conduct and reporting. We will synthesize line. Designing these as two separate guideline pro- the information quantitively using descriptive statistics to cesses allows for divergence of methods to hold true to present the frequency of each supported or refuted can- Indigenous ways of knowing and respect importance of didate item [65]. We will construct tables to present the different types of knowledge and experience in develop- findings. ing this guidance, and to explore similarities and differ- ences. We might incorporate variations in methodology Methodological assessment of 320 observational studies to conduct the Indigenous studies in more depth, iden- We will conduct a methodological assessment of report- tifying not only the extent of reporting, but how steps ing of health equity considerations in a random sample were carried out. of 320 observational studies to establish the extent of reporting the inclusion/exclusion criteria, recruitment, Scoping review of guidance on reporting equity retention, analysis, and interpretation of populations in observational studies across socially, economically and geographically strati- Despite increasing awareness about health equity by fying variables defined by the PROGRESS-Plus frame- journals and funding agencies, there is no synthesis of work published in 2020 and 2021. Our team members available guidance for reporting equity in observational have used such methodological assessments to inform studies. We will conduct a scoping review of guidance the development of other reporting guidelines, such as in journal policies, funding agencies, and institutional for randomized cluster trials [70] and systematic reviews ethical guidance related to criteria for inclusion, recruit- [71]. We chose this sample size since we expect that ment, retention, analysis, reporting and dissemination about half of the studies will conduct a subgroup analy- of research evidence from observational studies relevant sis across one or more PROGRESS-Plus factors based on to people who experience inequity across one or more our prior methodological study [63]; this sample size pro- PROGRESS-Plus factors to identify guidance supporting vides 95% confidence intervals of + 6% for observed pro- or refuting our candidate list of items. Scoping reviews portions of 50% reporting items of interest. This sample can help clarify key concepts and definitions and iden- size has also been used in similar studies [71–73]. tify key characteristics of the assessed concepts [69]. We We will search for observational studies with help will follow the transparent and rigorous methods of the from our experienced information scientist (TR). We will Joanna Briggs Institute (JBI) for scoping reviews and the stratify sampling across characteristics of interest such Preferred Reporting Items for Systematic reviews and as focus on Indigenous People, low- and middle-income Meta-Analyses extension for Scoping Reviews (PRISMA- countries, and COVID-19 studies. ScR) guideline for reporting scoping reviews [69]. We will We will collect data on the inclusion, recruitment, also capture guidance that contributes to informing new retention, analysis, and interpretation of results across items. PROGRESS-Plus factors (sample items in Addi- Will conduct a comprehensive search of electronic tional file 1). The data extraction form will be pre-tested databases such as MEDLINE, LILACS (Latin American on ten studies to check for clarity and feasibility of assess- and Caribbean Centre on Health Sciences Information), ment and agreement between two independent review- Embase, CINAHL and EbscoHost. However, we antici- ers. After the extraction form is finalized, two reviewers pate much of the information on guidance to be in grey will independently collect data on whether the study and literature sources, such as institutional reports, ethics, design account for PROGRESS-Plus factors in matching, and funder guidelines, and journal editorial policies, so adjusting for confounding, or other methods, including we will design a tailored grey literature search strategy whether a pre-analysis plan is available. We will describe with an experienced librarian scientist (TR). This search any methods used to assess subgroup effects and inter- will include random sample of each of the previously active effects or test effects in specific populations (e.g., listed sources as well as relevant websites (e.g., Insti- intercept dummy variable for the group or slope dummy), tute of Medicine, Canadian Task Force on Preventive ethical considerations and consideration of context (sam- Health Care, and World Association of Medical Editors). ple items in Additional file 1). Since we are aware that We will seek to balance relevant grey literature sources published manuscripts may have limited detail on health from high-income countries and from low- and middle- equity we will also search for study protocols of the iden- income countries. In addition, we will ask for suggestions tified studies. In addition, we will survey the authors of from our Technical Oversight and steering committees. these studies by email to ask whether data was collected After selecting documents, two independent reviewers on equity variables. We will use survey strategies shown will extract data on the methods of development, guid- to increase response rates [74, 75]. Despite the risk of a ance on items related to considering PROGRESS-Plus in low response rate, this survey will compare what equity Funnell et al. International Journal for Equity in Health (2023) 22:55 Page 7 of 14 variables were collected to what is reported. We will anti-oppressive and anti-colonial methods and Indig- descriptively report the frequency and proportion of enous knowledge sovereignty. Thus, we will assess for each candidate item reported in our sample of observa- saturation of concepts within Indigenous key informants. tional studies. We will collate the data into a table. This We will carry out a thematic analysis of these interviews study will establish a baseline of existing reporting and using coding, categorizing, identifying themes and con- identify potential key informants. ceptualization. Two coders will verify and agree on cate- gories and use NVivo12 software (http://​www.​qsrin​terna​ Qualitative study on key informants’ perspectives tional.​com/​produ​cts_​nvivo.​aspx) to facilitate the qualita- We will conduct a qualitative study to understand stake- tive analysis. This analysis will be conducted by trainees holders’ perceptions of how health equity is reported in under supervision of JJ and CJP. observational studies, their needs regarding reporting of this information, and the barriers that may limit such Phase 2: seek wide international input on potential items reporting (e.g., privacy issues). In our prior research on to reporting of health equity health equity in randomized trials, we found that key We will develop an online survey of potential items by informants identified important additional items, pro- triangulating, synthesizing and integrating findings from vided in-depth views on concepts that were not other- each of the studies conducted in Phase 1 (survey find- wise described in the literature (e.g., ethical issues), and ings the scoping review, the methods review, the key that engaging patients/public participants was an effec- informant interviews) to develop good practice examples. tive way to elucidate views that were not represented in The steering committees and Technical Oversight will the planned survey or meeting [76]. be consulted for feedback, and the draft survey will be We will conduct key informant semi-structured inter- tested with potential respondents. Our Technical Over- views, either individually or in focus groups, with mem- sight and steering committees will be asked to identify bers of the public, patients, funders, policy makers, at least 200 global individuals to participate in an online researchers, organizations that support people who expe- survey using Survey Monkey (https://​www.​surve​ymonk​ rience health inequities, knowledge users and journal ey.​com/) on the importance of potential items and will editors. We will use semi-structured interviews because be invited to provide open-ended comments about each they are efficient and allow respondents to illustrate con- item. The participants will represent different intended cepts [77]. We will design the interview guide with input knowledge users, researchers who conduct observational from our Technical Oversight and Steering committees. studies, ethics board representatives, journal editors, An initial set of key informants will be selected from the funders, decision-makers, and patients/public. Similarly corresponding authors of observational studies and lead- with other aspects of our project, we will seek diverse ers of guidance identified in the preceding steps. We will respondents to include people with experience across use purposeful sampling for a maximum variation of geo- all aspects of PROGRESS-Plus, geographic diversity, graphic diversity, types of observational studies and use age, gender, and country income balance. We will collect of the STROBE guideline. We will expand our sample details on sociodemographic characteristics and discipli- by snowball sampling, i.e., by asking each informant to nary background. For patients/public, we will conduct identify additional possible people who might have dif- face-to-face video or phone interviews according to their ferent opinions from themselves. Theoretical saturation preference. We have used this approach successfully for will determine the sample size, defined when subsequent other guidelines, achieving over 200 responses across interviews contribute no new data, based on the research diverse collaborators [63, 79]. We will use the CHERRIES question [78]. Theoretical saturation will be considered checklist for reporting the survey results quantitatively when no further new information is identified. Saturation [80], including tables and figures. is estimated at about 15-18 interviews, and analysis will We will carry out a separate survey of Indigenous be concurrent with data collection [78]. knowledge holders, decision-makers, and the public, We will conduct a parallel and independent study with and these results will be reported according to CHER- Indigenous key informants from Australia, Canada, New RIES and summarized with descriptive statistics in Zealand, and the USA including members of the public, tables and figures. patients, funders, policy makers, researchers, organiza- tions that support people who experience health ineq- Phase 3: establish consensus amongst knowledge users uities, knowledge users and journal editors. We expect and researchers on health equity reporting guidelines that the narrative structure of interviews applied to For the global guidance, we will hold a consensus meet- global interviews will apply to the Indigenous research ing of 25-30 international, multidisciplinary and diverse as well. However, different issues may arise related to collaborators to develop the STROBE-Equity extension. Funnell et al. International Journal for Equity in Health (2023) 22:55 Page 8 of 14 The Technical Oversight and steering committees will from a relational perspective and will focus on communi- suggest people according to the following criteria: opin- ties and populations who are represented on the Indig- ion leaders, standard setters, and experts in disciplines enous steering committee. relevant to observational studies and equity (e.g., meth- The focus on Australia, Canada, New Zealand and the odology, social sciences, public health, health equity), USA may limit applicability and relevance of this report- intergovernmental organizations and multilateral ing guideline for Indigenous Peoples in different coun- agencies, collaborators with diverse perspectives (e.g., tries with different colonization experiences. However, funders, editors, practitioners) and patients with lived we hope that our approach and results may be useful for experience of health inequity. We will consider balance adapting or adopting this guidance for other global Indig- in participants across characteristics such as career enous Peoples, with leadership from Indigenous Peoples stage/age, gender and low- and middle-income coun- in those countries. tries (LMIC)/high-income countries (HIC). At least 10% of participants will be people with lived experience, and at least 20% will be Indigenous. The number of par- Phase 4: evaluate outcomes of collaboration ticipants is based on our experience of similar meet- between and across the global and indigenous streams ings as the maximum to allow meaningful discussion We plan to explicitly document the outcomes of collabo- and is similar to the number recommended by other ration between the parallel stream of the global guidance organizations such as the James Lind Alliance [81]. Two and the Indigenous stream focussed on Australia, Can- weeks prior to the meeting, participants will be given ada, New Zealand and USA. As indicated in Fig. 1, we pre-reading materials, including results of empirical plan to share methods and processes developed within studies. To ensure sufficient time, we will hold a pre- each stream. We anticipate that there may be innova- meeting vote by all invited participants to identify areas tions developed in one stream than can inform the other. where more discussion is needed. We will summarize Documenting these examples may be helpful in design- evidence from the above studies (conducted in Phase 1) ing future studies with parallel processes. and exemplars of best practices for each item. We have found this promotes discussion. For each item, we will Phase 5: widely disseminate and encourage uptake seek consensus using the Nominal Group Technique of STROBE‑equity [82]. We will discuss and decide whether to publish a After discussing with the journal editors involved, we single manuscript on the STROBE-Equity extension or plan to publish the STROBE-Equity extension as a pre- develop a short Statement paper, and a separate Elab- print to allow early access and feedback prior to publi- oration paper with examples, e.g., Preferred Report- cation. This will allow feedback from a wider audience. ing Items for Systematic reviews and Meta-Analyses Also, it will allow us to begin the end of grant knowledge extension for Equity (PRISMA-Equity) was published translation activities soon after the consensus meet- as two papers [61, 62]. A writing team will be formed ing when the participants are actively engaged. As men- to develop the manuscript(s). These will be refined tioned earlier, the lack of implementation tools has been through iterative discussion with all participants, steer- described as a barrier to the uptake of reporting guide- ing committees, and Technical Oversight members by lines [85]. Thus, we will develop practical tools (e.g., email, face-to-face meetings, and videoconference calls. checklists for journal editors and short podcasts or sto- Discussion will be documented regarding the rationale ries for the public) based on consultations with the steer- for each item. ing committee that include journal editors, and we will We will conduct a separate consensus meeting for guid- promote these through our connections with journal ance on reporting health equity in Indigenous research in editors. Australia, Canada, New Zealand and USA. This meeting While there is no systematic strategy to disseminate will be led by Indigenous peoples and will include Indige- reporting guidelines, we will disseminate the prod- nous researchers, knowledge holders such as community ucts to a wide range of global and targeted audiences elders, decision-makers, and patients/public from Aus- through publications and presentations, and dialogues tralia, Canada, New Zealand and USA. The participants and exchange activities with knowledge user groups. We will be determined in collaboration with our Indigenous have registered this planned reporting guideline with research steering committee. The approach will be based EQUATOR (http://​www.​equat​or-​netwo​rk.​org/). We ship, Control, Access and Possession (OCAP®) [83] and on community-based participatory research and Owner- host a web page on the Campbell and Cochrane Equity Methods Group website (https://​metho​ds.​cochr​ane.​org/​ Collective Benefit, Authority to Control, Responsibility, equity/) where we will post publications, and links to Ethics (CARE) [84] principles. We approach this research surveys, tweets, and other news. Our collaborators will Funnell et al. International Journal for Equity in Health (2023) 22:55 Page 9 of 14 also be asked to suggest ways to reach their communi- reporting guidelines, lived experience of inequities, ties, for instance, through dialogues and face-to-face and using evidence to inform decisions. We defined sessions. terms of reference based on our prior experience, We will develop an evaluation framework to assess including principles of equitable partnership [86, 87]. these activities using indicators such as LinkedIn We have co-developed an inclusive governance plan to and Twitter activity (numbers of tweets, retweets, support our plan to co-produce this research through likes, and reach), invited presentations (online or a partnership that values different types of knowledge face to face), number of people reached by presenta- and participation [86, 88] (Fig. 3). tions, news articles and outlets, Facebook activity The executive team of four Principal Investigators (likes, shares), LinkedIn likes and replications, cita- (VW, LM, JJ, SF), a research coordinator and a post- tions of our articles or blogs in journal articles, or doctoral fellow will meet regularly to consult on study presentations. methods and issues that arise during the conduct and provide quarterly updates to the whole team. The exec- Governance plan utive team will meet quarterly by video conference with In developing this project, we first identified com- the Technical Oversight Committee and the Indigenous mon interests in health equity in observational stud- research, patient/public and knowledge user steering ies amongst our international network of patients, committees. practitioners, and researchers with expertise in sys- Co-investigators will be invited to sign up online for tematic reviews and scoping reviews, observational all studies/papers they are interested in co-authoring. studies, health equity and knowledge translation. We Also, we will use online tools to enable the informal established three steering committees: one for Indig- exchange of ideas amongst co-investigators. Author- enous research, one for knowledge users, and one for ship for papers will be governed by terms of reference any other members of the public. We set up a govern- (76, 87) (Additional file 2). ance structure of an executive team of four principal Coinvestigators will participate in quarterly Techni- investigators (PIs) and a lead for each of three steer- cal Oversight calls for strategic direction, study design ing committees and a Technical Oversight commit- planning with their expertise in Indigenous health tee to guide how we would work together. This team research. Graduate trainees will lead or co-lead empiri- has expertise in statistics, social science, epidemiol- cal studies with mentorship from senior investigators. ogy, Indigenous health, knowledge translation, equity, Fig. 3 Inclusive governance plan, founded in shared goals, transparency and ethical partnerships Funnell et al. International Journal for Equity in Health (2023) 22:55 Page 10 of 14 Patient and public engagement ensures space for culturally safe dialogue [93]. To address We have developed a patient and public steering com- this, one of our co-PIs is an Indigenous researcher with mittee inclusive of diverse populations with an interest training in Ownership, Control, Access and Posses- in health equity across dimensions of PROGRESS-Plus sion ­(OCAP(R)) [83]. Our Co-PI responsible for lead- co-led by patient and patient representatives. The repre- ing the development and evaluation of integrated KT sentatives have been engaged since the development of is also trained in ­OCAP(R) and has experience working the project and will convene bimonthly to advise on the with Indigenous communities [93, 94]. We have devel- design and conduct of the studies, and the interpreta- oped an Indigenous Steering Committee with Indig- tion of the data. We will seek diverse viewpoints based on enous researchers from Australia, Canada, New Zealand lived experience and values [89] and evaluate experiences and the USA to bring a high-income country and shared of engagement using available tools [90, 91]. British colonial experience perspective. We will follow the principles of the United Nations Declaration on the Discussion Rights of Indigenous Peoples (UNDRIP) [19]. Integrated knowledge translation We will ensure regular communication with vide- This 4-year project has been developed using an inte- oconference software, with screen share capabilities, grated knowledge translation approach with a diverse, thus minimizing environmental impact. Minutes will be global multidisciplinary team, including patients, authors distributed to allow all team members the opportunity of observational studies, statisticians, social scientists, to participate. One-on-one videoconferencing meetings epidemiologists, methodologists, funders, ethicists and (or small groups) will be used to seek specific expertise knowledge users [86]. Our team is diverse and represent- where needed. ative of LMIC and HIC, gender, ethnicity, career stage Observational studies include diverse studies from and disciplines. We have assembled knowledge users cross-sectional surveys and natural experiments to anal- from (PAHO/WHO), the Royal College of Physicians yses of administrative health records and longitudinal and Surgeons of Canada, journal editors, the Canadian cohorts. The feasibility of taking on this broad range of Agency for Drugs and Technologies in Health, the Public studies is increased by having members of the original Health Agency of Canada. We will design an evaluation STROBE statement. The team includes global leaders in framework to assess the process and outcomes of this non-randomized studies from the Cochrane and Camp- approach, including the experiences of all involved, led bell Collaborations [95] and expertise in consensus meth- by JJ [87]. ods [96]. We will use twitter (e.g., @cochraneequity, @vawelch, A strength of our approach is the use of different meth- @EquityStrobe), mailing lists and other fora to seek input ods to seek input and perspectives on the proposed from external collaborators. Our geographic and discipli- items, which include an in depth key informant quali- nary diversity will help us seek diverse opinions and reach tative study, a global survey (phase 2) and a consensus a broad audience. We will develop a one-page policy brief process which integrates the empirical findings and sur- lay summary of each deliverable aimed at government vey findings with a diverse group of stakeholders. These decision-makers and journal editors. We will develop three ways to integrate external perspectives aim to bring digital stories to engage the public and patients [92]. global perspectives to the work. Accessibility of results will be enhanced by using reading Poor implementation and lack of integration with poli- level assessments for our policy summaries, blogs, sur- cies, plans and the structure of research publication and veys and presentations. We will translate the results into knowledge management (e.g., international research Portuguese, French and Spanish. Other translations will registry data providers) has hindered the impact of be encouraged (e.g., Chinese) as conducted for the CON- prior STROBE guidelines [97–99]. To mitigate this risk, SORT and original STROBE guidelines (https://​www.​ we have planned for 1 year of knowledge translation equat​or-​netwo​rk.​org/​libra​r y/​trans​latio​ns-​of-​repor​ting-​ activities after the consensus meeting and resources for guide​lines). end-of-grant implementation activities, including the development, implementation, and evaluation of tools for Potential challenges and mitigation strategies authors, sponsors, standard setters, and editors. A strength of our approach is the development of a par- allel stream on Indigenous research which may be used Expected impact as a model for creating guidance for other specific popu- Given the widespread recognition of the need to redress lations with different lived experience of health inequi- systemic racism, sexism and all forms of discrimina- ties. This requires ethical processes to facilitate culturally tion in medicine [100], education [101], and justice [18], competent research that respects Indigenous values and these reporting guidelines have the potential to expand Funnell et al. International Journal for Equity in Health (2023) 22:55 Page 11 of 14 awareness about the need to consider health equity in Funding This work was supported by the Canadian Institutes of Health Research (CIHR), observational studies change and reporting practices on grant number 173269. health equity in observational studies, which comprise the majority of health research. In turn, uptake and use of this Availability of data and materials Not applicable. guideline can substantially add to our knowledge about which health inequities are prevalent and how to redress them both within and between countries. A parallel stream Declarations focused on research with Indigenous People is a novel Ethics approval and consent to participate aspect of this guideline development, and the approach This protocol was approved by the Bruyère Research Institute Ethics Board (M16-21-025). The study will be conducted in accordance with all applicable could be modelled for research with other populations government regulations and University of Ottawa Faculty of Medicine policies who face systemic discrimination, such as people living and procedures. Consent will be collected for participants involved in IRB- with disabilities. We believe this will subsequently improve approved processes. the evidence base on health equity in observational studies Consent for publication to improve social justice in policy and practice decisions. Not applicable. Competing interests Abbreviations The authors declare no competing interests. LGC is employed by the Pan CONSORT Consolidated Standards of Reporting Trials American Health Organization (PAHO/WHO). The ideas expressed in this HIC High-income Country manuscript are the authors’ own and do not necessarily reflect the decisions JBI Joanna Briggs Institute and policies of PAHO/WHO) KT Knowledge Translation LMIC Low-middle Income Country Author details 1 PAHO Pan-American Health Organization Department of Family Medicine, Queen’s University, Kingston, Canada. 2 PROGRESS Place of residence (urban/rural), Race/ethnicity/culture/ Department of Family Medicine, Faculty of Medicine, University of Ottawa, language, Occupation, Gender or sex, Religion, Education, Ottawa, Canada. 3 School of Rehabilitation Therapy, Faculty of Health Sciences, Socioeconomic status and Social capital Queen’s University, Kingston, Canada. 4 Department of Health Research SAGER Sex and Gender Equity in Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada. 5 PRISMA-Equity Preferred Reporting Items for Systematic reviews and Meta- Bruyère Research Institute, Bruyère Continuing Care and University of Ottawa, Analyses extension for Equity 85 Primrose, Ottawa, Ontario, Canada. 6 School of Epidemiology and Public PRISMA-ScR Preferred Reporting Items for Systematic reviews and Meta- Health, University of Ottawa, Ottawa, Canada. 7 Michael G. DeGroote Institute Analyses extension for Scoping Reviews for Pain Research and Care, McMaster University, Hamilton, Canada. 8 School SDG Sustainable Development Goal of Psychology, University of Ottawa, Ottawa, Canada. 9 Department of Inter‑ STROBE STrengthening the Reporting of OBservational studies in nal Medicine, American University of Beirut, Beirut, Lebanon. 10 Canadian Epidemiology Council on Animal Care, Ottawa, Canada. 11 International Health Department, UNDRIP United Nations Declaration on the Rights of Indigenous Peoples ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain. 12 Centre WHO World Health Organization for Global Child Health, Hospital for Sick Children, Toronto, Canada. 13 Institute for Global Health & Development, The Aga Khan University, Karachi, Pakistan. 14 Indigenous Health Equity Unit, Melbourne School of Population and Global Supplementary Information Health, The University of Melbourne, Melbourne, Australia. 15 Judith Lumley The online version contains supplementary material available at https://​doi.​ Centre, School of Nursing and Midwifery, La Trobe University, Melbourne, org/​10.​1186/​s12939-​023-​01854-1. Australia. 16 MRC/CSO Social and Public Health Sciences Unit, School of Health and Wellbeing, University of Glasgow, Glasgow, UK. 17 Unit of Health Services and Access, Department of Health Systems and Services, Pan American Health Additional file 1. Draft coding categories for methodological assessment. Organization (PAHO/WHO), Washington, DC, USA. 18 Doctoral School, Depart‑ Additional file 2. Draft Terms of reference for STROBE-Equity. ment of Paediatrics, Obstetrics & Gynaecology, and Preventive Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain. 19 Malaria Research and Training Center, University of Sciences, Techniques, and Technologies Acknowledgements of Bamako, Bamako, Mali. 20 Department of Psychology, Department of Law, We are greatly saddened by the loss of our colleague, Ainsley Moore, whose Carleton University, Ottawa, ON, Canada. 21 Department of Community Health contributions to this work were invaluable. We would like to acknowledge the and Epidemiology, Dalhousie University, Halifax, Canada. 22 School of Health amazing effort of the wonderful artist, Claire Brascoupé, who designed our and Human Performance, Georgia College, Milledgville, USA. 23 Healthcare logo of the STROBE-Equity project. Research Associates, LLC/S.T.A.R. Initiative, Los Angeles, USA. 24 Well Living House, Li Ka Shing Knowledge Institute, University of Toronto, Toronto, Authors’ contributions Ontario, Canada. 25 Waakebiness Institute for Indigenous Health, Dalla Lana SF, JJ, LM, VW all contributed equally to this manuscript. SF, JJ, LM, VW are School of Public Health, University of Toronto, Toronto, Canada. 26 General responsible for conceptualization, funding acquisition, methodology, supervi‑ Practice and Primary Healthcare, University of Auckland, Auckland, New sion and validation. LM, VW, SF and JJ are all co-principal investigators of Zealand. 27 WHO Collaborating Centre for Knowledge Translation and Health the project. OD, XW, ML, EG, AR are responsible for investigation and data Technology Assessment in Health Equity, Ottawa, Canada. 28 Royal College collection. VW is responsible for project administration. TR will be responsible of Physicians and Surgeons of Canada, Ottawa, Canada. 29 Applied Health for designing search strategies. EAA, MTA, AA, ZAB, CC, PC, LGC, AD, HE, CF, Research Center, St. Michael’s Hospital, Toronto, Canada. 30 Dalla School DF, RGS, BJH, MH, JHR, TH, CJP, MK, MKennedy, TK, AK, EK, LL, JL, EL, OM, MJM, of Public Health, University of Toronto, Toronto, Canada. 31 Liverpool School GMT, AM, LLN, SGN, MNN, DOL, EO, PO, TP, JP, MP, KP, TR, JR, AR, LS, MS, BV, PT, of Tropical Medicine, Liverpool, UK. 32 School of Medicine and Public Health, PTugwell, JT, EVE, HSW, HW, LW, GW, HWhite, CSW, LWolfenden, TY contributed The University of Newcastle, Callaghan, New South Wales, Australia. 33 Centre to the methodology of the project. VW drafted the manuscript. All remain‑ for Evidence Based Health Care, Department of Global Health, Stellenbosch ing authors critically reviewed, provided feedback, and approved the final University, Stellenbosch, South Africa. 34 Cochrane South Africa, South African manuscript. Medical Research Council, Cape Town, South Africa. 35 Interdisciplinary School Funnell et al. International Journal for Equity in Health (2023) 22:55 Page 12 of 14 of Health Sciences, Faculty of Health Sciences, University of Ottawa, Ottawa, tackling social inequities in health / by Margaret Whitehead and Göran Canada. 36 Africa Centre for Evidence, University of Johannesburg, Johannes‑ Dahlgren. Copenhagen: WHO Regional Office for Europe; 2006. burg, South Africa. 37 The BMJ, London, UK. 38 Department of Epidemiology & 13. Fiscella K, Shin P. The inverse care law: implications for healthcare of Biostatistics, Institute of Public Health, Kilimanjaro Christian Medical College, vulnerable populations. J Ambul Care Manage. 2005;28(4):304–12. Moshi, Tanzania. 39 University of Exeter College of Medicine and Health, Exeter, 14. Sriram V, Keshri VR, Kumbhar K. The impact of colonial-era policies on UK. 40 Department of Family Medicine, McMaster University, Hamilton, Ontario, health workforce regulation in India: lessons for contemporary reform. Canada. 41 Department of Public Health, Faculty of Health Sciences, The Uni‑ Hum Resour Health. 2021;19(1):100. versity of Bamenda, Bamenda, Cameroon. 42 Clinical Epidemiology Program, 15. Ye Y, Zhang Q, Wei X, Cao Z, Yuan H-Y, Zeng DD. Equitable access to Ottawa Hospital Research Institute, Ottawa, Canada. 43 College of Health COVID-19 vaccines makes a life-saving difference to all countries. Nat Sciences, Makerere University College of Health Sciences, Kampala, Uganda. Hum Behav. 2022;6(2):207–16. 44 Department of Family Medicine, School of Medicine, Pontifica Universidad 16. Ramachandran R, Ross JS, Miller JE. Access to COVID-19 vaccines in Católica de Chile, Santiago, Chile. 45 Faculty of Public Health and Policy, London high-, middle-, and low-income countries hosting clinical trials. JAMA School of Hygiene and Tropical Medicine, London, UK. 46 Department of Family Netw Open. 2021;4(11):e2134233-e. Medicine, Epidemiology and Biostatistics, Western University, London, Ontario, 17. Truth and Reconciliation Commission of Canada. Honouring the truth, Canada. 47 Freelance Health Research Librarian, Ottawa, Canada. 48 Interna‑ reconciling for the future: summary of the final report of the truth and tional Centre for Eye Health, London School of Hygiene & Tropical Medicine, reconciliation commission of Canada. Canada: McGill-Queen’s Univer‑ London, UK. 49 School of Optometry and Vision Science, University of Auck‑ sity Press; 2015. Available from: http://​www.​chair​econd​ition​autoc​htone.​ land, Auckland, New Zealand. 50 Health Research Board Centre for Primary fss.​ulaval.​ca/​docum​ents/​pdf/​Honou​ring-​the-​truth-​recon​ciling-​for-​the-​ Care Research, Department of General Practice, Royal College of Surgeons future.​pdf in Ireland, Dublin, Ireland. 51 Department of Medicine , University of Ottawa, 18. Reclaiming Power and Place: The Final Report of the National Inquiry Ottawa, Ontario, Canada. 52 Hassanah Consulting, Seattle, WA 98122, USA. into Missing and Murdered Indigenous Women and Girls [Available 53 Cochrane Switzerland, Centre for Primary Care and Public Health (Unisanté), from: https://​www.​mmiwg-​ffada.​ca/​final-​report/. University of Lausanne, Lausanne, Switzerland. 54 London International Devel‑ 19. United Nations General Assembly. United Nations Declaration on the opment Centre, London School of Hygiene & Tropical Medicine, London, UK. Rights of Indigenous Peoples A/RES/61/295 - E - A/RES/61/295 2007 55 Canadian Agency for Drugs and Technologies in Health, Ottawa, Ontario, [Available from: https://​undocs.​org/A/​RES/​61/​295. Canada. 56 University of Ottawa Heart Institute, Ottawa, Canada. 57 Campbell 20. United Nations Declaration on the Rights of Indigenous Peoples: Collaboration, Oslow, Norway. 58 HIV and other Infectious Diseases Research United Nations; [Available from: https://​www.​un.​org/​devel​opment/​ Unit, Durban, South Africa. desa/​indig​enous​peopl​es/​decla​ration-​on-​the-​rights-​of-​indig​enous-​ peopl​es.​html. Received: 3 November 2022 Accepted: 27 February 2023 21. Anderson I, Robson B, Connolly M, Al-Yaman F, Bjertness E, King A, et al. Indigenous and tribal peoples’ health (the lancet-Lowitja Institute global collaboration): a population study. Lancet. 2016;388(10040):131–57. 22. Truth and Reconciliation Commission of Canada: Calls to Action: Truth References and Reconciliation Commision of Canada; 2015 [Available from: https://​ 1. Khazanchi R, Evans CT, Marcelin JR. Racism, not race, drives www2.​gov.​bc.​ca/​assets/​gov/​briti​sh-​colum​bians-​our-​gover​nments/​ inequity across the COVID-19 continuum. JAMA Netw Open. indig​enous-​people/​abori​ginal-​peopl​es-​docum​ents/​calls_​to_​action_​ 2020;3(9):e2019933. engli​sh2.​pdf. 2. Pagel C. There is a real danger that covid-19 will become entrenched as 23. Lux MK. Separate beds: a history of Indian hospitals in Canada, a disease of poverty. BMJ. 2021;373:n986. 1920s-1980s: University of Toronto Press; 2016. 3. Schrecker T, Taler V. How to think about social determinants of health: 24. Mosby I. Administering colonial science: nutrition research and human revitalizing the agenda in Canada. Toronto: Canadian Scholars’ Press; biomedical experimentation in Aboriginal communities and residential 2017. schools, 1942–1952. Histoire sociale/Social history. 2013;46:145–72. 4. Marmot M, Bell R. The sustainable development goals and health 25. Lux M. Perfect subjects: race, tuberculosis, and the Qu’Appelle BCG equity. Epidemiology. 2018;29(1):5–7. Vaccine Trial. Can Bull Med Hist. 1998;15(2):277–95. https://​doi.​org/​10.​ 5. ‘Black report’ on health inequalities The Health Foundation [cited 2021 3138/​cbmh.​15.2.​277. Jun 21]. Available from: https://​navig​ator.​health.​org.​uk/​theme/​black-​ 26. Dudgeon P, Milroy H, Walker R. Working together: Aboriginal and Torres report-​health-​inequ​aliti​es. Strait islander mental health and wellbeing principles and practice. 2nd 6. Closing the gap in a generation: health equity through action on the ed: Commonwealth of Australia; 2014. social determinants of health - Final report of the commission on social 27. Dudgeon P, Milroy H, Walker R. Aboriginal and Torres Strait islander determinants of health: WHO; [Available from: https://​www.​who.​int/​ social and emotional wellbeing. 2nd ed. Canberra: Commonwealth publi​catio​ns/i/​item/​WHO-​IER-​CSDH-​08.1. Government of Australia; 2014. 7. Gibbons MC. A historical overview of health disparities and the poten‑ 28. Capitalizing on Big Data: Toward a Policy Framework for Advancing tial of eHealth solutions. J Med Internet Res. 2005;7(5):e50. Digital Scholarship in Canada 2013 [Available from: https://​www.​sshrc-​ 8. Snow J. On the mode of communication of cholera. Edinb Med J. crsh.​gc.​ca/​about-​au_​sujet/​publi​catio​ns/​digit​al_​schol​arship_​consu​ltati​ 1856;1(7):668–70. on_e.​pdf. 9. National Academies of Sciences, Engineering, and Medicine; Health 29. Government of India. Big Data Initiative. 2016 Available from: https://​ and Medicine Division; Board on Population Health and Public Health dst.​gov.​in/​big-​data-​initi​ative-1. Practice; Committee on Community-Based Solutions to Promote Health 30. Cuervo LG, Martínez-Herrera E, Cuervo D, Jaramillo C. Improving equity Equity in the United States. In: Baciu A, Negussie Y, Geller A, et al., editors. using dynamic geographic accessibility data for urban health services Communities in action: pathways to health equity. Washington (DC): planning. Gac Sanit. 2022;36(6):497–9. National Academies Press (US); 2017. The Root Causes of Health Inequity. 31. The federal big data research and development strategic plan 2016 [Avail‑ Available from: https://​www.​ncbi.​nlm.​nih.​gov/​books/​NBK42​5845/. able from: https://​bigda​tawg.​nist.​gov/​pdf/​bigda​tards​trate​gicpl​an.​pdf. 10. Whitehead M. The concepts and principles of equity and health. Int J 32. UKRI. The UK’s research and innovation infrastructure: opportunities to Health Serv. 1992;22(3):429–45. grow our capability [Available from: https://​www.​ukri.​org/​wp-​conte​ 11. O’Neill J, Tabish H, Welch V, Petticrew M, Pottie K, Clarke M, et al. Apply‑ nt/​uploa​ds/​2020/​10/​UKRI-​201020-​UKinf​rastr​ucture-​oppor​tunit​ies-​to-​ ing an equity lens to interventions: using PROGRESS ensures considera‑ grow-​our-​capac​ity-​FINAL.​pdf. tion of socially stratifying factors to illuminate inequities in health. J Clin 33. Waddington HS, Villar PF, Valentine JC. Can non-randomised studies of Epidemiol. 2014;67(1):56–64. interventions provide unbiased effect estimates? A systematic review of 12. Whitehead M, Gr D, World Health Organization. Regional Office for E. internal replication studies. Eval Rev. 2022;0(0). https://​doi.​org/​10.​1177/​ Levelling up (part 1) : a discussion paper on concepts and principles for 01938​41X22​11167​21. Funnell et al. International Journal for Equity in Health (2023) 22:55 Page 13 of 14 34. Craig P, Cooper C, Gunnell D, Haw S, Lawson K, Macintyre S, et al. Using 57. Partnership | Closing The Gap [Available from: https://​www.​closi​ngthe​ natural experiments to evaluate population health interventions: new gap.​gov.​au/​partn​ership. Medical Research Council guidance. J Epidemiol Community Health. 58. Lavery JV, C IJ. The research fairness initiative: filling a critical gap in 2012;66(12):1182–6. global research ethics. Gates Open Res. 2018;2:58. 35. Craig P, Petticrew M. Developing and evaluating complex inter‑ 59. Walter M, Lovett R, Maher B, Williamson B, Prehn J, Bodkin-Andrews G, ventions: reflections on the 2008 MRC guidance. Int J Nurs Stud. et al. Indigenous data sovereignty in the era of big data and open data. 2013;50(5):585–7. Aust J Soc Issues. 2021;56(2):143–56. 36. Petticrew M. When are complex interventions ‘complex’? When are 60. Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of simple interventions ‘simple’? Eur J Public Health. 2011;21:397–8. Health Research reporting guidelines. PLoS Med. 2010;7(2):e1000217. 37. Craig P, Katikireddi SV, Leyland A, Popham F. Natural experiments: an 61. Welch V, Petticrew M, Tugwell P, Moher D, O’Neill J, Waters E, et al. overview of methods, approaches, and contributions to public health PRISMA-equity 2012 extension: reporting guidelines for systematic intervention research. Annu Rev Public Health. 2017;38:39–56. reviews with a focus on health equity. PLoS Med. 2012;9(10):e1001333. 38. Moser KA, Leon DA, Gwatkin DR. How does progress towards the child 62. Welch V, Petticrew M, Petkovic J, Moher D, Waters E, White H, et al. Extend‑ mortality millennium development goal affect inequalities between ing the PRISMA statement to equity-focused systematic reviews (PRISMA- the poorest and least poor? Analysis of demographic and health survey E 2012): explanation and elaboration. J Clin Epidemiol. 2016;70:68–89. data. BMJ. 2005;331(7526):1180–2. 63. Welch VA, Norheim OF, Jull J, Cookson R, Sommerfelt H, Tugwell P, et al. 39. Reidpath DD, Morel CM, Mecaskey JW, Allotey P. The millennium devel‑ CONSORT-equity 2017 extension and elaboration for better reporting opment goals fail poor children: the case for equity-adjusted measures. of health equity in randomised trials. BMJ. 2017;359:j5085. PLoS Med. 2009;6(4):e1000062. 64. Dewidar O, Rader T, Waddington H, Nicholls SG, Little J, Hardy BJ, et al. 40. Smith M, Hosking J, Woodward A, Witten K, MacMillan A, Field A, et al. Reporting of health equity considerations in equity-relevant obser‑ Systematic literature review of built environment effects on physical vational studies: protocol for a systematic assessment [version 1; peer activity and active transport - an update and new findings on health review: awaiting peer review]. F1000Research. 2022;11:615. https://​doi.​ equity. Int J Behav Nutr Phys Act. 2017;14(1):158. org/​10.​12688/​f1000​resea​rch.​122185.1. 41. Daskalopoulou C, Stubbs B, Kralj C, Koukounari A, Prince M, Prina AM. 65. Welch V, Rizvi A, Dewidar O. STROBE-equity reporting guidelines; 2020 Physical activity and healthy ageing: a systematic review and meta- Available from. https://​doi.​org/​10.​17605/​OSF.​IO/​H57SE. analysis of longitudinal cohort studies. Ageing Res Rev. 2017;38:6–17. 66. Rizvi A, Lawson DO, Young T, Dewidar O, Nicholls S, Akl EA, et al. 42. Freeman S, Bishop K, Spirgiene L, Koopmans E, Botelho FC, Fyfe T, et al. Guidance relevant to the reporting of health equity in observational Factors affecting residents transition from long term care facilities to research: a scoping review protocol. BMJ Open. 2022;12(5):e056875. the community: a scoping review. BMC Health Serv Res. 2017;17(1):689. 67. Kavanagh J, Oliver S, Caird J, et al. Inequalities and the mental health of 43. 49th Directing Council, 61st session of the regional committee. Pan young people: a systematic review of secondary school-based cogni‑ American Health Organization (PAHO/WHO) policy on research for tive behavioural interventions. In: Database of Abstracts of Reviews of health. Washington: PAHO; 2009. p. 40. Effects (DARE): Quality-assessed Reviews. York: Centre for Reviews and 44. The WHO strategy on research for health Geneve: World Health Organi‑ Dissemination (UK); 2009. Available from: https://​www.​ncbi.​nlm.​nih.​ zation; 2012 [Available from: https://​www.​who.​int/​phi/​WHO_​Strat​egy_​ gov/​books/​NBK76​588/. on_​resea​rch_​for_​health.​pdf?​ua=1. 68. Bank TW. Indigenous Peoples Overview: The World Bank; 2022. Avail‑ 45. World Health O. Strategy on health policy and systems research: chang‑ able from: https://​www.​world​bank.​org/​en/​topic/​indig​enous​peopl​es ing the mindset, vol. 2012. Geneva: World Health Organization; 2012. 69. Peters MDJ, Godfrey C, McInerney P, Munn Z, Tricco AC, Khalil H. Chap‑ 46. Thirteenth General Programme of Work 2019-2023: World Health ter 11: scoping reviews (2020 version). In: Aromataris E, Munn Z, editors. Organization; [Available from: https://​www.​who.​int/​about/​what-​we-​ JBI manual for evidence synthesis, JBI; 2020. Available from https://​ do/​thirt​eenth-​gener​al-​progr​amme-​of-​work-​2019%​2D%​2D-​2023. synth​esism​anual.​jbi.​global. https://​doi.​org/​10.​46658/​JBIMES-​20-​12. 47. Heidari S, Babor TF, De Castro P, Tort S, Curno M. Sex and gender equity 70. Ivers NM, Taljaard M, Dixon S, Bennett C, McRae A, Taleban J, et al. in research: rationale for the SAGER guidelines and recommended use. Impact of CONSORT extension for cluster randomised trials on quality Res Integr Peer Rev. 2016;1:2. of reporting and study methodology: review of random sample of 300 48. Johnson JL, Beaudet A. Sex and gender reporting in health research: trials, 2000-8. BMJ. 2011;343:d5886. why Canada should be a leader. Can J Public Health. 2012;104(1):e80–1. 71. Page MJ, Shamseer L, Altman DG, Tetzlaff J, Sampson M, Tricco AC, 49. Johnson J, Sharman Z, Vissandjée B, Stewart DE. Does a change in et al. Epidemiology and reporting characteristics of systematic health research funding policy related to the integration of sex and reviews of biomedical research: a cross-sectional study. PLoS Med. gender have an impact? PLoS One. 2014;9(6):e99900. 2016;13(5):e1002028. 50. Tri-Council Policy Statement: Ethical Conduct for Research Involving 72. Moher D, Tetzlaff J, Tricco AC, Sampson M, Altman DG. Epidemiol‑ Humans – TCPS 2 (2018): Government of Canada; [Available from: ogy and reporting characteristics of systematic reviews. PLoS Med. https://​ethics.​gc.​ca/​eng/​policy-​polit​ique_​tcps2-​eptc2_​2018.​html. 2007;4(3):e78. 51. Council for international organizations of medical sciences [Available 73. Taljaard M, McRae AD, Weijer C, Bennett C, Dixon S, Taleban J, et al. from: https://​cioms.​ch/. Inadequate reporting of research ethics review and informed consent 52. Turner L, Shamseer L, Altman DG, Schulz KF, Moher D. Does use of in cluster randomised trials: review of random sample of published the CONSORT statement impact the completeness of reporting of trials. BMJ. 2011;342:d2496. randomised controlled trials published in medical journals? A Cochrane 74. Chaudhry SH, Brehaut JC, Grimshaw JM, Weijer C, Boruch R, Donner A, reviewa. Systematic Reviews. 2012;1(1):60. et al. Challenges in the research ethics review of cluster randomized 53. Stevens A, Shamseer L, Weinstein E, Yazdi F, Turner L, Thielman J, et al. trials: international survey of investigators. Clin Trials. 2013;10(2):257–68. Relation of completeness of reporting of health research to jour‑ 75. Danko KJ, Dahabreh IJ, Ivers NM, Moher D, Grimshaw JM. Contact‑ nals’ endorsement of reporting guidelines: systematic review. BMJ. ing authors by telephone increased response proportions compared 2014;348:g3804. with emailing: results of a randomized study. J Clin Epidemiol. 54. Antequera A, Lawson DO, Noorduyn SG, Dewidar O, Avey M, Bhutta 2019;115:150–9. ZA, et al. Improving social justice in COVID-19 Health Research: interim 76. Jull J, Petticrew M, Kristjansson E, Yoganathan M, Petkovic J, Tugwell guidelines for reporting health equity in observational studies. Int J P, et al. Engaging knowledge users in development of the CONSORT- Environ Res Public Health. 2021;18(17):9357. equity 2017 reporting guideline: a qualitative study using in-depth 55. Cooke M, Mitrou F, Lawrence D, Guimond E, Beavon D. Indigenous well- interviews. Res Involv Engagem. 2018;4(1):34. being in four countries: an application of the UNDP’S human develop‑ 77. Nct. The Effect of Guided Counseling in Improving Dietary Practice, ment index to indigenous peoples in Australia, Canada, New Zealand, Nutritional Status and Birth Weight of Pregnant Women. In: The Effect of and the United States. BMC Int Health Hum Rights. 2007;7(1):9. Guided Counseling in Improving Dietary Practice, Nutritional Status and 56. Castellano MB. Ethics of Aboriginal Research. Int J Indigenous Health. Birth Weight of Pregnant Women in West Gojjam Zone, Amhara Region, 2004;1:98–115. Ethiopia: a Cluster Randomized Controlled Community Trial; 2018. Funnell et al. International Journal for Equity in Health (2023) 22:55 Page 14 of 14 78. Creswell JW. Qualitative inquiry and research design: choosing among 100. Chokshi DA, Foote MMK, Morse ME. How to act upon racism—not five approaches, vol. xvii. 2nd ed. Thousand Oaks: Sage Publications, Inc; race—as a risk factor. JAMA Health Forum. 2022;3(2):e220548-e. 2007. p. 395–xvii. 101. Gee GC, Ford CL. Structural racism and health inequities: old issues, 79. Welch V, Petticrew M, Petkovic J, Moher D, Waters E, White H, et al. New Directions. Du Bois Rev. 2011;8(1):115–32. Extending the PRISMA statement to equity-focused systematic reviews (PRISMA-E 2012): explanation and elaboration. Int J Equity Health. 2015;14:92. Publisher’s Note 80. Eysenbach G. Improving the quality of Web surveys: the Checklist for Springer Nature remains neutral with regard to jurisdictional claims in pub‑ Reporting Results of Internet E-Surveys (CHERRIES). J Med Internet Res. lished maps and institutional affiliations. 2004;6:e34. 81. The James Lind Alliance 2021 [Available from: https://​www.​jla.​nihr.​ac.​uk/. 82. OMERACT. OMERACT Handbook, Chapter 7: Reaching Consensus 2021 83. First Nations Information Governance Centre.: OCAP® | FNIGC; Available Available from: https://​omera​cthan​dbook.​org/​handb​ook. from: https://​fnigc.​ca/. 84. Carroll SR, Garba I, Figueroa-Rodríguez OL, Holbrook J, Lovett R, Mater‑ echera S, et al. The CARE principles for indigenous data governance. Data Sci J. 2020;19(1):43. https://​doi.​org/​10.​5334/​dsj-​2020-​043. 85. Blanco D, Altman D, Moher D, Boutron I, Kirkham JJ, Cobo E. Scoping review on interventions to improve adherence to reporting guidelines in health research. BMJ Open. 2019;9(5):e026589. 86. Jull J, Giles A, Graham ID. Community-based participatory research and integrated knowledge translation: advancing the co-creation of knowledge. Implement Sci. 2017;12(1):150. 87. Jull J, Graham ID, Kristjansson E, Moher D, Petkovic J, Yoganathan M, et al. Taking an integrated knowledge translation approach in research to develop the CONSORT-equity 2017 reporting guideline: an observa‑ tional study. BMJ Open. 2019;9(7):e026866. 88. Rycroft-Malone J, Burton CR, Bucknall T, Graham ID, Hutchinson AM, Stacey D. Collaboration and co-production of knowledge in healthcare: opportunities and challenges. Int J Health Policy Manag. 2016;5(4):221–3. 89. Brett J, Staniszewska S, Mockford C, Herron-Marx S, Hughes J, Tysall C, et al. Mapping the impact of patient and public involvement on health and social care research: a systematic review. Health Expect. 2014;17(5):637–50. 90. Staniszewska S, Brett J, Simera I, Seers K, Mockford C, Goodlad S, et al. GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research. BMJ. 2017;358:j3453. 91. Soobiah C, Straus SE, Manley G, Marr S, Paus Jenssen E, Teare S, et al. Engaging knowledge users in a systematic review on the comparative effectiveness of geriatrician-led models of care is possible: a cross- sectional survey using the patient engagement evaluation tool. J Clin Epidemiol. 2019;113:58–63. 92. Moreau KA, Eady K, Sikora L, Horsley T. Digital storytelling in health pro‑ fessions education: a systematic review. BMC Med Educ. 2018;18(1):208. 93. Jull J, Hizaka A, Sheppard AJ, Kewayosh A, Doering P, MacLeod L, et al. An integrated knowledge translation approach to develop a shared decision-making strategy for use by Inuit in cancer care: a qualitative study. Curr Oncol. 2019;26(3):192–204. 94. Jull J, Morton-Ninomiya M, Compton I, Picard A. Fostering the con‑ duct of ethical and equitable research practices: the imperative for integrated knowledge translation in research conducted by and with indigenous community members. Res Involv Engagem. 2018;4(1):45. 95. Reeves BC, Deeks JJ, Higgins JP, Shea B, Tugwell P, Wells GA. Chapter 24: including non-randomized studies on intervention effects. In: JPT H, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editors. Ready to submit your research ? Choose BMC and benefit from: Cochrane handbook for systematic reviews of interventions version 6.2 (updated February 2021): Cochrane; 2021. • fast, convenient online submission 96. OMERACT. OMERACT Handbook, Chapter 7: Reaching Consensus [Available from: https://​omera​cthan​dbook.​org/​handb​ook. • thorough peer review by experienced researchers in your field 97. Pfadenhauer LM, Gerhardus A, Mozygemba K, Lysdahl KB, Booth A, Hof‑ • rapid publication on acceptance mann B, et al. Making sense of complexity in context and implementa‑ • support for research data, including large and complex data types tion: the context and implementation of complex interventions (CICI) framework. Implement Sci. 2017;12(1):21. • gold Open Access which fosters wider collaboration and increased citations 98. Sharp MK, Bertizzolo L, Rius R, Wager E, Gómez G, Hren D. Using the • maximum visibility for your research: over 100M website views per year STROBE statement: survey findings emphasized the role of journals in enforcing reporting guidelines. J Clin Epidemiol. 2019;116:26–35. At BMC, research is always in progress. 99. Sharp M. The use of reporting guidelines as an educational intervention for teaching research methods and writing (doctoral thesis). France: Learn more biomedcentral.com/submissions University of Split; 2020.