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Improving social justice in observational studies: protocol for the development of a global and Indigenous STROBE-equity reporting guideline

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) 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 implementation 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 adoption and use by journal editors, authors, and funding agencies, using diverse strategies tailored to specific audiences.

Background

The COVID-19 pandemic has magnified existing inequities in health and revealed systemic biases and discrimination in societal structures (such as racism, sexism, ableism), including health systems [1, 2]. Health inequities are defined as disparities that are avoidable and unfair [3, 4]. Acknowledging and addressing health inequities has been the subject of investigations and reports dating back to the 19th century, with continued commissions including the Black report in 1980, WHO Commission on Social Determinants of Health in 2008 and National Academies of Sciences, Engineering and Medicine in 2017 [5,6,7,8,9].

Health inequities are driven by structural inequities in opportunities and resources, which shape the conditions in which people live and their opportunities for health [10]. By structural inequities we mean the unequal distribution of power, resources, and privilege that favour some people and place others in vulnerable or disadvantaged circumstances, limiting their health opportunities across gender, age, ethnicity, and other sociodemographic factors [4, 11, 12]. Such limitations lead the most vulnerable due to systemic and structural barriers to struggle to adequately meet their health care needs [13].

Many nations and peoples have suffered the deleterious effects of colonization or control by external military and political forces throughout history. This has resulted in many nations continuing to struggle with inadequate health and health care resources. For example, in India, healthcare workers are unable to maintain standards of care due to colonial-era regulatory policies creating disputes between federal and union government that impact resource allocation [14]. Moreover, wealthier countries continue to fail to honour global treaties to support health and health research, exemplified by profound inequities in access to vaccination for COVID-19 globally, with only 4% of people vaccinated in low-and-middle-income countries (LMIC) compared to over 70% in Canada and the United States of America (USA) [15, 16] in the year 2021.

In many countries, specific ethnic groups, such as Indigenous people, continue to suffer from the legacy of colonization and persistent discrimination and oppression [17,18,19]. Despite global instruments such as the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP) [20] to build a more just and equitable future, Indigenous people continue to face individual and systemic discrimination, limiting their opportunities for education, justice, and health [21]. Research about Indigenous people has often failed to partner with communities and consequently generated little social value for communities [22]. Instead, research has a legacy of exploitation and harm of Indigenous people through experimentation (e.g., the recently documented experiences of Indigenous peoples in Canada at Indian hospitals [23] and residential schools [24], Qu’Appelle BCG Vaccine Trial in Canada [25]. Historical exploitation has contributed to a culture of mistrust of health research in Indigenous populations, which must be considered in conducting Indigenous-centric health research. For Indigenous people, factors that drive opportunities for health may differ from other populations, such as the right to self-determination, and connection to the land and culture, which is central to wellbeing [26, 27].

Studies where the researcher is not in control of the exposure or intervention are known as observational studies. These studies could be prospective or retrospective or both. Observational studies have become increasingly popular as a key tool in national and international health monitoring, such as demographic health surveillance systems. Furthermore, there is an increasing focus on harnessing “Big Data” to link socioeconomic, administrative, and other biomedical data to inform planning [28,29,30,31,32]. Observational studies are also used to evaluate the effects of policies and programs in real-world situations, especially when an experimental study (e.g., randomized controlled trial) would be impractical or unethical [33]. Observational studies are also meaningful for exploring complex systems and their influence on health [34,35,36,37]. The informative value of results from interventions (e.g., policies and programs) addressing to mitigate inequities relies on the quality of data. However, the availability of data to monitor, understand and intervene to mitigate health inequities between and within countries continues to be a challenge [38, 39].

Implementing programs and policies to mitigate inequities effectively requires high quality data to monitor the impacts of policies and programs on health inequities over time and across settings. Many observational studies fail to assess inequitable differences in health or health care due to inadequate collection or reporting of equity-related data in participants, adjusting for available sociodemographic factors as confounders rather than exploring potential for differential effects for populations experiencing inequities, or due to a failure to evaluate variation in treatment effects [40,41,42]. Globally, decision-makers have endorsed the need for better evidence about health equity, exemplified by the Sustainable Development Goals (SDGs) of the UN General Assembly [4]. The Pan-American Health Organization (PAHO), the World Health Organization (WHO) and the World Health Assembly have all explicitly advocated for standards in reporting and analyzing equity [43,44,45,46]. Academic support for better evidence on health inequities is exemplified by an increasing number of global and national guidelines on assessing sex, gender and health equity, such as the 2015 Sex and Gender Equity in Research (SAGER) guidelines [47] and funder guidelines on considering sex, gender and health inequities [48, 49]. Justice and equity concerns are also central to research ethics [50, 51].

Reporting guidelines have been shown to improve the reporting of some aspects of their respective studies [52, 53]. The STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) guidelines were developed to improve the reporting of observational studies, including cohort, case control and cross-sectional studies. Of the 13 STROBE extensions addressing nuances of design and types of data; none focus on health equity [54]. The development of equity extensions for STROBE items may improve the reporting of equity in observational studies.

Given the pervasiveness of observational studies and the growing attention to the need to examine inequities, especially inequities observed during the COVID-19 pandemic, methodological research, and guidance to improve their reporting is needed to improve the social value and global impact of health research.

Overall goal

Our overall goal is to develop guidance on reporting health equity considerations in observational studies to make health equity data more readily available for synthesis and decision-making.

This goal has two distinct components, which are:

  1. 1)

    to develop a global reporting guideline on health equity as an extension of STROBE in partnership with members of the public, diverse collaborators, and multiple disciplines, and

  2. 2)

    to develop a reporting guideline for reporting health equity in Indigenous research in Australia, Canada, New Zealand and the USA with leadership by Indigenous people from these countries.

We recognize that the harms of colonization have affected Indigenous Peoples globally. However, we decided to focus on these four countries since they have a similar experience of colonization which included land dispossession and policies for assimilation [55]. We sought Indigenous scholars from each of these countries to join our Indigenous Steering Committee and designed methods to collect data on research methods in these countries (see below). We considered that this project did not have sufficient resources to adequately appraise the empirical data and seek sufficient global representation to develop reporting guidelines for all global Indigenous Peoples. By transparently reporting our methods and processes, we hope this guideline may be helpful for adaptation for other Indigenous Peoples in different global contexts. Indigenous Peoples, scholars, public members will be given opportunities to review the global consensus guidelines as well. We feel the entire project benefits from Indigenous perspectives.

The research to achieve this goal will be interconnected and empowering, with opportunities for reciprocal learning through joint meetings and communication. Indigenous approaches to research include taking a strengths-based, anti-oppressive and anti-colonial approach [56], founded on authentic, ethical partnerships [57, 58] and following principles of Indigenous data sovereignty [59]. These approaches are central to understanding health inequities and social justice in designing, conducting, and reporting research.

Specific objectives

This project aims to improve the consistency of reporting of health equity in observational studies, by fulfilling the following specific objectives over the span of 4 years:

  1. 1.

    To assess reporting of health equity through empirical studies by:

    1. 1.1.

      identifying available guidance for reporting health equity in observational studies, globally and in studies focused on Indigenous People

    2. 1.2.

      describing analysis and reporting of health equity in observational studies, globally and in studies focused on Indigenous People

    3. 1.3.

      exploring and mapping diverse viewpoints of knowledge users and researchers, globally and in studies focused on Indigenous People

  2. 2.

    To seek wide international feedback on items to improve reporting of health equity

  3. 3.

    To establish consensus amongst knowledge users and researchers on reporting items for the global guidance and for the guidance focused on Indigenous Peoples in Australia, Canada, New Zealand, and the USA

  4. 4.

    To evaluate outcomes of collaboration between and across global guidance and guidance focused on Indigenous populations

  5. 5.

    To widely disseminate and seek endorsement from relevant knowledge users

Methods

Study design

The study will comprise five phases, adapted from guidance for developing reporting guidelines by Moher et al. [60], including establishing the need for guidance, seeking comprehensive feedback, establishing consensus, evaluating outcomes of learning across streams and implementation over the span of 4 years. Members of our team have adopted this approach for other reporting guidelines on equity in systematic reviews [61, 62] and randomized trials [CONSORT-Equity] [63]. The five phases of the current study are: (1) Assess available guidance, viewpoints, and reporting of health equity in observational studies, (2) Seek wide international input using a survey on potential items to improve reporting of health equity, (3) Establish consensus amongst knowledge users and researchers on the health equity reporting guideline, (4) Evaluate the relevance of the reporting guideline for Indigenous research, and, (5) Widely disseminate and encourage uptake of STROBE-Equity (Fig. 1). In our study, we focus on Indigenous Peoples in Australia, Canada, New Zealand and the USA given the similarity in colonization experience and representation on the Indigenous Steering Committee for this project, as described above.

Fig. 1
figure 1

Project Overview- reporting of health equity in observational studies. Indigenous refers to Indigenous peoples living in Australia, Canada, New Zealand, and the USA

We will review the candidate items supported from scoping review and the items found to be poorly reported in the methods study. Study design details regarding the methods studies will be published on open access platforms or published in peer review journals when possible [64,65,66]. We will analyze focus groups thematically and 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 question. 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 will be interconnected and empowering with opportunities for joint learning through regular communication. To articulate the connections between the two streams of research, we consulted with an Indigenous artist Claire Brascoupé (Algonquin Anishinaabe artist) to design a figure of our shared vision for parallel streams, with interconnected elements (Fig. 2). The process of co-designing this figure with our steering committees helped to establish our methods for enabling separate streams with multiple points for connection and learning from each other.

Fig. 2
figure 2

STROBE-Equity logo showing parallel global and Indigenous streams, with interconnections between them. Footnote: This figure was designed in collaboration with Claire Brascoupé (Algonquin Anishinaabe artist). The geography and landscape reflect the focus of the Indigenous stream on research with Indigenous people in Australia, Canada, New Zealand and the USA. The global stream is intended to be global and phase 2 and phase 3 of the project will seek participation and viewpoints from across the globe

Phase 1: assess available guidance, viewpoints, and reporting of health equity in observational studies

We will conduct six linked empirical studies on how health equity is reported in observational studies; three focused on global research and three on research on Indigenous people. We define observational studies according to those relevant to the STROBE reporting guideline as case-control, cohort, and cross-sectional studies, which collect and report quantitative data, e.g., studies conducted using administrative data, natural experiments, and prospective cohorts.

We will use an organizing framework to document evidence about health inequities defined by the acronym: PROGRESS-Plus, which stands for Place of residence (urban/rural), Race/ethnicity/culture/language, Occupation, Gender or sex, Religion, Education, Socioeconomic status and Social capital [11]. The “Plus” characteristics are other characteristics associated with health inequities such as age, disability, sexual orientation, and temporary exposure to vulnerable circumstances such as discharge from hospital and food security [67]. We will apply this PROGRESS-Plus lens to our global studies as well as to our studies focused on observational studies with, for and about Indigenous peoples.

Studies focused on observational studies specific to indigenous people

For each of the studies below we will conduct a parallel project focused on research with Indigenous people. We define Indigenous Peoples as “… distinct social and cultural groups that share collective ancestral ties to the lands and natural resources where they live, occupy or from which they have been displaced.” [68] Throughout the conduct of the Indigenous studies and design of the Indigenous reporting guideline, we focus on research with Indigenous Peoples in Australia, Canada, New Zealand and the USA given their similarity in colonization experiences. When engaging stakeholders in the development of the reporting guideline, we will involve representatives from these four countries. As part of the implementation and dissemination strategy, we will work towards extending the STROBE-Equity guideline to Indigenous populations in other geographies in the future. We will ensure representation and leadership from such populations accordingly. We decided that there is a need for leadership by Indigenous and allied scholars and representatives, people with lived experience, and decision-makers and also data sovereignty in interpreting results for the Indigenous reporting guideline. Designing these as two separate guideline processes allows for divergence of methods to hold true to Indigenous ways of knowing and respect importance of different types of knowledge and experience in developing this guidance, and to explore similarities and differences. We might incorporate variations in methodology to conduct the Indigenous studies in more depth, identifying not only the extent of reporting, but how steps were carried out.

Scoping review of guidance on reporting equity in observational studies

Despite increasing awareness about health equity by journals and funding agencies, there is no synthesis of available guidance for reporting equity in observational studies. We will conduct a scoping review of guidance in journal policies, funding agencies, and institutional ethical guidance related to criteria for inclusion, recruitment, retention, analysis, reporting and dissemination of research evidence from observational studies relevant to people who experience inequity across one or more PROGRESS-Plus factors to identify guidance supporting or refuting our candidate list of items. Scoping reviews can help clarify key concepts and definitions and identify key characteristics of the assessed concepts [69]. We will follow the transparent and rigorous methods of the Joanna Briggs Institute (JBI) for scoping reviews and the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guideline for reporting scoping reviews [69]. We will also capture guidance that contributes to informing new items.

Will conduct a comprehensive search of electronic databases such as MEDLINE, LILACS (Latin American and Caribbean Centre on Health Sciences Information), Embase, CINAHL and EbscoHost. However, we anticipate much of the information on guidance to be in grey literature sources, such as institutional reports, ethics, and funder guidelines, and journal editorial policies, so we will design a tailored grey literature search strategy with an experienced librarian scientist (TR). This search will include random sample of each of the previously listed sources as well as relevant websites (e.g., Institute of Medicine, Canadian Task Force on Preventive Health Care, and World Association of Medical Editors). We will seek to balance relevant grey literature sources from high-income countries and from low- and middle-income countries. In addition, we will ask for suggestions from our Technical Oversight and steering committees. After selecting documents, two independent reviewers will extract data on the methods of development, guidance on items related to considering PROGRESS-Plus in study design, conduct and reporting. We will synthesize the information quantitively using descriptive statistics to present the frequency of each supported or refuted candidate item [65]. We will construct tables to present the findings.

Methodological assessment of 320 observational studies

We will conduct a methodological assessment of reporting of health equity considerations in a random sample of 320 observational studies to establish the extent of reporting the inclusion/exclusion criteria, recruitment, retention, analysis, and interpretation of populations across socially, economically and geographically stratifying variables defined by the PROGRESS-Plus framework published in 2020 and 2021. Our team members have used such methodological assessments to inform the development of other reporting guidelines, such as for randomized cluster trials [70] and systematic reviews [71]. We chose this sample size since we expect that about half of the studies will conduct a subgroup analysis across one or more PROGRESS-Plus factors based on our prior methodological study [63]; this sample size provides 95% confidence intervals of + 6% for observed proportions of 50% reporting items of interest. This sample size has also been used in similar studies [71,72,73].

We will search for observational studies with help from our experienced information scientist (TR). We will stratify sampling across characteristics of interest such as focus on Indigenous People, low- and middle-income countries, and COVID-19 studies.

We will collect data on the inclusion, recruitment, retention, analysis, and interpretation of results across PROGRESS-Plus factors (sample items in Additional file 1). The data extraction form will be pre-tested on ten studies to check for clarity and feasibility of assessment and agreement between two independent reviewers. After the extraction form is finalized, two reviewers will independently collect data on whether the study and design account for PROGRESS-Plus factors in matching, adjusting for confounding, or other methods, including whether a pre-analysis plan is available. We will describe any methods used to assess subgroup effects and interactive effects or test effects in specific populations (e.g., intercept dummy variable for the group or slope dummy), ethical considerations and consideration of context (sample items in Additional file 1). Since we are aware that published manuscripts may have limited detail on health equity we will also search for study protocols of the identified studies. In addition, we will survey the authors of these studies by email to ask whether data was collected on equity variables. We will use survey strategies shown to increase response rates [74, 75]. Despite the risk of a low response rate, this survey will compare what equity variables were collected to what is reported. We will descriptively report the frequency and proportion of each candidate item reported in our sample of observational studies. We will collate the data into a table. This study will establish a baseline of existing reporting and identify potential key informants.

Qualitative study on key informants’ perspectives

We will conduct a qualitative study to understand stakeholders’ perceptions of how health equity is reported in observational studies, their needs regarding reporting of this information, and the barriers that may limit such reporting (e.g., privacy issues). In our prior research on health equity in randomized trials, we found that key informants identified important additional items, provided in-depth views on concepts that were not otherwise described in the literature (e.g., ethical issues), and that engaging patients/public participants was an effective way to elucidate views that were not represented in the planned survey or meeting [76].

We will conduct key informant semi-structured interviews, either individually or in focus groups, with members of the public, patients, funders, policy makers, researchers, organizations that support people who experience health inequities, knowledge users and journal editors. We will use semi-structured interviews because they are efficient and allow respondents to illustrate concepts [77]. We will design the interview guide with input from our Technical Oversight and Steering committees. An initial set of key informants will be selected from the corresponding authors of observational studies and leaders of guidance identified in the preceding steps. We will use purposeful sampling for a maximum variation of geographic diversity, types of observational studies and use of the STROBE guideline. We will expand our sample by snowball sampling, i.e., by asking each informant to identify additional possible people who might have different opinions from themselves. Theoretical saturation will determine the sample size, defined when subsequent interviews contribute no new data, based on the research question [78]. Theoretical saturation will be considered when no further new information is identified. Saturation is estimated at about 15-18 interviews, and analysis will be concurrent with data collection [78].

We will conduct a parallel and independent study with Indigenous key informants from Australia, Canada, New Zealand, and the USA including members of the public, patients, funders, policy makers, researchers, organizations that support people who experience health inequities, knowledge users and journal editors. We expect that the narrative structure of interviews applied to global interviews will apply to the Indigenous research as well. However, different issues may arise related to anti-oppressive and anti-colonial methods and Indigenous knowledge sovereignty. Thus, we will assess for saturation of concepts within Indigenous key informants. We will carry out a thematic analysis of these interviews using coding, categorizing, identifying themes and conceptualization. Two coders will verify and agree on categories and use NVivo12 software (http://www.qsrinternational.com/products_nvivo.aspx) to facilitate the qualitative analysis. This analysis will be conducted by trainees under supervision of JJ and CJP.

Phase 2: seek wide international input on potential items to reporting of health equity

We will develop an online survey of potential items by triangulating, synthesizing and integrating findings from each of the studies conducted in Phase 1 (survey findings the scoping review, the methods review, the key informant interviews) to develop good practice examples. The steering committees and Technical Oversight will be consulted for feedback, and the draft survey will be tested with potential respondents. Our Technical Oversight and steering committees will be asked to identify at least 200 global individuals to participate in an online survey using Survey Monkey (https://www.surveymonkey.com/) on the importance of potential items and will be invited to provide open-ended comments about each item. The participants will represent different intended knowledge users, researchers who conduct observational studies, ethics board representatives, journal editors, funders, decision-makers, and patients/public. Similarly with other aspects of our project, we will seek diverse respondents to include people with experience across all aspects of PROGRESS-Plus, geographic diversity, age, gender, and country income balance. We will collect details on sociodemographic characteristics and disciplinary background. For patients/public, we will conduct face-to-face video or phone interviews according to their preference. We have used this approach successfully for other guidelines, achieving over 200 responses across diverse collaborators [63, 79]. We will use the CHERRIES checklist for reporting the survey results quantitatively [80], including tables and figures.

We will carry out a separate survey of Indigenous knowledge holders, decision-makers, and the public, and these results will be reported according to CHERRIES and summarized with descriptive statistics in tables and figures.

Phase 3: establish consensus amongst knowledge users and researchers on health equity reporting guidelines

For the global guidance, we will hold a consensus meeting of 25-30 international, multidisciplinary and diverse collaborators to develop the STROBE-Equity extension. The Technical Oversight and steering committees will suggest people according to the following criteria: opinion leaders, standard setters, and experts in disciplines relevant to observational studies and equity (e.g., methodology, social sciences, public health, health equity), intergovernmental organizations and multilateral agencies, collaborators with diverse perspectives (e.g., funders, editors, practitioners) and patients with lived experience of health inequity. We will consider balance in participants across characteristics such as career stage/age, gender and low- and middle-income countries (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 participants is based on our experience of similar meetings as the maximum to allow meaningful discussion and is similar to the number recommended by other organizations such as the James Lind Alliance [81]. Two weeks prior to the meeting, participants will be given pre-reading materials, including results of empirical studies. To ensure sufficient time, we will hold a pre-meeting vote by all invited participants to identify areas where more discussion is needed. We will summarize evidence from the above studies (conducted in Phase 1) and exemplars of best practices for each item. We have found this promotes discussion. For each item, we will seek consensus using the Nominal Group Technique [82]. We will discuss and decide whether to publish a single manuscript on the STROBE-Equity extension or develop a short Statement paper, and a separate Elaboration paper with examples, e.g., Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Equity (PRISMA-Equity) was published as two papers [61, 62]. A writing team will be formed to develop the manuscript(s). These will be refined through iterative discussion with all participants, steering committees, and Technical Oversight members by email, face-to-face meetings, and videoconference calls. Discussion will be documented regarding the rationale for each item.

We will conduct a separate consensus meeting for guidance on reporting health equity in Indigenous research in Australia, Canada, New Zealand and USA. This meeting will be led by Indigenous peoples and will include Indigenous researchers, knowledge holders such as community elders, decision-makers, and patients/public from Australia, Canada, New Zealand and USA. The participants will be determined in collaboration with our Indigenous research steering committee. The approach will be based on community-based participatory research and Ownership, Control, Access and Possession (OCAP®) [83] and Collective Benefit, Authority to Control, Responsibility, Ethics (CARE) [84] principles. We approach this research from a relational perspective and will focus on communities and populations who are represented on the Indigenous steering committee.

The focus on Australia, Canada, New Zealand and the USA may limit applicability and relevance of this reporting guideline for Indigenous Peoples in different countries with different colonization experiences. However, we hope that our approach and results may be useful for adapting or adopting this guidance for other global Indigenous Peoples, with leadership from Indigenous Peoples in those countries.

Phase 4: evaluate outcomes of collaboration between and across the global and indigenous streams

We plan to explicitly document the outcomes of collaboration between the parallel stream of the global guidance and the Indigenous stream focussed on Australia, Canada, New Zealand and USA. As indicated in Fig. 1, we plan to share methods and processes developed within each stream. We anticipate that there may be innovations developed in one stream than can inform the other. Documenting these examples may be helpful in designing future studies with parallel processes.

Phase 5: widely disseminate and encourage uptake of STROBE-equity

After discussing with the journal editors involved, we plan to publish the STROBE-Equity extension as a pre-print to allow early access and feedback prior to publication. This will allow feedback from a wider audience. Also, it will allow us to begin the end of grant knowledge translation activities soon after the consensus meeting when the participants are actively engaged. As mentioned earlier, the lack of implementation tools has been described as a barrier to the uptake of reporting guidelines [85]. Thus, we will develop practical tools (e.g., checklists for journal editors and short podcasts or stories for the public) based on consultations with the steering committee that include journal editors, and we will promote these through our connections with journal editors.

While there is no systematic strategy to disseminate reporting guidelines, we will disseminate the products to a wide range of global and targeted audiences through publications and presentations, and dialogues and exchange activities with knowledge user groups. We have registered this planned reporting guideline with EQUATOR (http://www.equator-network.org/). We host a web page on the Campbell and Cochrane Equity Methods Group website (https://methods.cochrane.org/equity/) where we will post publications, and links to surveys, tweets, and other news. Our collaborators will also be asked to suggest ways to reach their communities, for instance, through dialogues and face-to-face sessions.

We will develop an evaluation framework to assess these activities using indicators such as LinkedIn and Twitter activity (numbers of tweets, retweets, likes, and reach), invited presentations (online or face to face), number of people reached by presentations, news articles and outlets, Facebook activity (likes, shares), LinkedIn likes and replications, citations of our articles or blogs in journal articles, or presentations.

Governance plan

In developing this project, we first identified common interests in health equity in observational studies amongst our international network of patients, practitioners, and researchers with expertise in systematic reviews and scoping reviews, observational studies, health equity and knowledge translation. We established three steering committees: one for Indigenous research, one for knowledge users, and one for any other members of the public. We set up a governance structure of an executive team of four principal investigators (PIs) and a lead for each of three steering committees and a Technical Oversight committee to guide how we would work together. This team has expertise in statistics, social science, epidemiology, Indigenous health, knowledge translation, equity, reporting guidelines, lived experience of inequities, and using evidence to inform decisions. We defined terms of reference based on our prior experience, including principles of equitable partnership [86, 87]. We have co-developed an inclusive governance plan to support our plan to co-produce this research through a partnership that values different types of knowledge and participation [86, 88] (Fig. 3).

Fig. 3
figure 3

Inclusive governance plan, founded in shared goals, transparency and ethical partnerships

The executive team of four Principal Investigators (VW, LM, JJ, SF), a research coordinator and a post-doctoral fellow will meet regularly to consult on study methods and issues that arise during the conduct and provide quarterly updates to the whole team. The executive team will meet quarterly by video conference with the Technical Oversight Committee and the Indigenous research, patient/public and knowledge user steering committees.

Co-investigators will be invited to sign up online for all studies/papers they are interested in co-authoring. Also, we will use online tools to enable the informal exchange of ideas amongst co-investigators. Authorship for papers will be governed by terms of reference (76, 87) (Additional file 2).

Coinvestigators will participate in quarterly Technical Oversight calls for strategic direction, study design planning with their expertise in Indigenous health research. Graduate trainees will lead or co-lead empirical studies with mentorship from senior investigators.

Patient and public engagement

We have developed a patient and public steering committee inclusive of diverse populations with an interest in health equity across dimensions of PROGRESS-Plus co-led by patient and patient representatives. The representatives have been engaged since the development of the project and will convene bimonthly to advise on the design and conduct of the studies, and the interpretation of the data. We will seek diverse viewpoints based on lived experience and values [89] and evaluate experiences of engagement using available tools [90, 91].

Discussion

Integrated knowledge translation

This 4-year project has been developed using an integrated knowledge translation approach with a diverse, global multidisciplinary team, including patients, authors of observational studies, statisticians, social scientists, epidemiologists, methodologists, funders, ethicists and knowledge users [86]. Our team is diverse and representative of LMIC and HIC, gender, ethnicity, career stage and disciplines. We have assembled knowledge users from (PAHO/WHO), the Royal College of Physicians and Surgeons of Canada, journal editors, the Canadian Agency for Drugs and Technologies in Health, the Public Health Agency of Canada. We will design an evaluation framework to assess the process and outcomes of this approach, including the experiences of all involved, led by JJ [87].

We will use twitter (e.g., @cochraneequity, @vawelch, @EquityStrobe), mailing lists and other fora to seek input from external collaborators. Our geographic and disciplinary diversity will help us seek diverse opinions and reach a broad audience. We will develop a one-page policy brief lay summary of each deliverable aimed at government decision-makers and journal editors. We will develop digital stories to engage the public and patients [92]. Accessibility of results will be enhanced by using reading level assessments for our policy summaries, blogs, surveys and presentations. We will translate the results into Portuguese, French and Spanish. Other translations will be encouraged (e.g., Chinese) as conducted for the CONSORT and original STROBE guidelines (https://www.equator-network.org/library/translations-of-reporting-guidelines).

Potential challenges and mitigation strategies

A strength of our approach is the development of a parallel stream on Indigenous research which may be used as a model for creating guidance for other specific populations with different lived experience of health inequities. This requires ethical processes to facilitate culturally competent research that respects Indigenous values and ensures space for culturally safe dialogue [93]. To address this, one of our co-PIs is an Indigenous researcher with training in Ownership, Control, Access and Possession (OCAP(R)) [83]. Our Co-PI responsible for leading the development and evaluation of integrated KT is also trained in OCAP(R) and has experience working with Indigenous communities [93, 94]. We have developed an Indigenous Steering Committee with Indigenous researchers from Australia, Canada, New Zealand and the USA to bring a high-income country and shared British colonial experience perspective. We will follow the principles of the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP) [19].

We will ensure regular communication with videoconference software, with screen share capabilities, thus minimizing environmental impact. Minutes will be distributed to allow all team members the opportunity to participate. One-on-one videoconferencing meetings (or small groups) will be used to seek specific expertise where needed.

Observational studies include diverse studies from cross-sectional surveys and natural experiments to analyses of administrative health records and longitudinal cohorts. The feasibility of taking on this broad range of studies is increased by having members of the original STROBE statement. The team includes global leaders in non-randomized studies from the Cochrane and Campbell Collaborations [95] and expertise in consensus methods [96].

A strength of our approach is the use of different methods to seek input and perspectives on the proposed items, which include an in depth key informant qualitative study, a global survey (phase 2) and a consensus process which integrates the empirical findings and survey findings with a diverse group of stakeholders. These three ways to integrate external perspectives aim to bring global perspectives to the work.

Poor implementation and lack of integration with policies, plans and the structure of research publication and knowledge management (e.g., international research registry data providers) has hindered the impact of prior STROBE guidelines [97,98,99]. To mitigate this risk, we have planned for 1 year of knowledge translation activities after the consensus meeting and resources for end-of-grant implementation activities, including the development, implementation, and evaluation of tools for authors, sponsors, standard setters, and editors.

Expected impact

Given the widespread recognition of the need to redress systemic racism, sexism and all forms of discrimination in medicine [100], education [101], and justice [18], these reporting guidelines have the potential to expand awareness about the need to consider health equity in observational studies change and reporting practices on health equity in observational studies, which comprise the majority of health research. In turn, uptake and use of this 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 focused on research with Indigenous People is a novel aspect of this guideline development, and the approach could be modelled for research with other populations who face systemic discrimination, such as people living with disabilities. We believe this will subsequently improve the evidence base on health equity in observational studies to improve social justice in policy and practice decisions.

Availability of data and materials

Not applicable.

Abbreviations

CONSORT:

Consolidated Standards of Reporting Trials

HIC:

High-income Country

JBI:

Joanna Briggs Institute

KT:

Knowledge Translation

LMIC:

Low-middle Income Country

PAHO:

Pan-American Health Organization

PROGRESS:

Place of residence (urban/rural), Race/ethnicity/culture/language, Occupation, Gender or sex, Religion, Education, Socioeconomic status and Social capital

SAGER:

Sex and Gender Equity in Research

PRISMA-Equity:

Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Equity

PRISMA-ScR:

Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews

SDG:

Sustainable Development Goal

STROBE:

STrengthening the Reporting of OBservational studies in Epidemiology

UNDRIP:

United Nations Declaration on the Rights of Indigenous Peoples

WHO:

World Health Organization

References

  1. Khazanchi R, Evans CT, Marcelin JR. Racism, not race, drives inequity across the COVID-19 continuum. JAMA Netw Open. 2020;3(9):e2019933.

    Article  PubMed  Google Scholar 

  2. Pagel C. There is a real danger that covid-19 will become entrenched as a disease of poverty. BMJ. 2021;373:n986.

    Article  PubMed  Google Scholar 

  3. Schrecker T, Taler V. How to think about social determinants of health: revitalizing the agenda in Canada. Toronto: Canadian Scholars’ Press; 2017.

    Google Scholar 

  4. Marmot M, Bell R. The sustainable development goals and health equity. Epidemiology. 2018;29(1):5–7.

    Article  PubMed  Google Scholar 

  5. ‘Black report’ on health inequalities The Health Foundation [cited 2021 Jun 21]. Available from: https://navigator.health.org.uk/theme/black-report-health-inequalities.

  6. Closing the gap in a generation: health equity through action on the social determinants of health - Final report of the commission on social determinants of health: WHO; [Available from: https://www.who.int/publications/i/item/WHO-IER-CSDH-08.1.

  7. Gibbons MC. A historical overview of health disparities and the potential of eHealth solutions. J Med Internet Res. 2005;7(5):e50.

    Article  PubMed  PubMed Central  Google Scholar 

  8. Snow J. On the mode of communication of cholera. Edinb Med J. 1856;1(7):668–70.

    PubMed  PubMed Central  Google Scholar 

  9. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on Community-Based Solutions to Promote Health Equity in the United States. In: Baciu A, Negussie Y, Geller A, et al., editors. Communities in action: pathways to health equity. Washington (DC): National Academies Press (US); 2017. The Root Causes of Health Inequity. Available from: https://www.ncbi.nlm.nih.gov/books/NBK425845/.

    Google Scholar 

  10. Whitehead M. The concepts and principles of equity and health. Int J Health Serv. 1992;22(3):429–45.

    Article  CAS  PubMed  Google Scholar 

  11. O'Neill J, Tabish H, Welch V, Petticrew M, Pottie K, Clarke M, et al. Applying an equity lens to interventions: using PROGRESS ensures consideration of socially stratifying factors to illuminate inequities in health. J Clin Epidemiol. 2014;67(1):56–64.

    Article  PubMed  Google Scholar 

  12. Whitehead M, Gr D, World Health Organization. Regional Office for E. Levelling up (part 1) : a discussion paper on concepts and principles for tackling social inequities in health / by Margaret Whitehead and Göran Dahlgren. Copenhagen: WHO Regional Office for Europe; 2006.

    Google Scholar 

  13. Fiscella K, Shin P. The inverse care law: implications for healthcare of vulnerable populations. J Ambul Care Manage. 2005;28(4):304–12.

    Article  PubMed  Google Scholar 

  14. Sriram V, Keshri VR, Kumbhar K. The impact of colonial-era policies on health workforce regulation in India: lessons for contemporary reform. Hum Resour Health. 2021;19(1):100.

    Article  PubMed  PubMed Central  Google Scholar 

  15. Ye Y, Zhang Q, Wei X, Cao Z, Yuan H-Y, Zeng DD. Equitable access to COVID-19 vaccines makes a life-saving difference to all countries. Nat Hum Behav. 2022;6(2):207–16.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Ramachandran R, Ross JS, Miller JE. Access to COVID-19 vaccines in high-, middle-, and low-income countries hosting clinical trials. JAMA Netw Open. 2021;4(11):e2134233-e.

    Article  Google Scholar 

  17. Truth and Reconciliation Commission of Canada. Honouring the truth, reconciling for the future: summary of the final report of the truth and reconciliation commission of Canada. Canada: McGill-Queen’s University Press; 2015. Available from: http://www.chaireconditionautochtone.fss.ulaval.ca/documents/pdf/Honouring-the-truth-reconciling-for-the-future.pdf

    Google Scholar 

  18. Reclaiming Power and Place: The Final Report of the National Inquiry into Missing and Murdered Indigenous Women and Girls [Available from: https://www.mmiwg-ffada.ca/final-report/.

  19. United Nations General Assembly. United Nations Declaration on the Rights of Indigenous Peoples A/RES/61/295 - E - A/RES/61/295 2007 [Available from: https://undocs.org/A/RES/61/295.

  20. United Nations Declaration on the Rights of Indigenous Peoples: United Nations; [Available from: https://www.un.org/development/desa/indigenouspeoples/declaration-on-the-rights-of-indigenous-peoples.html.

  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.

    Article  PubMed  Google Scholar 

  22. Truth and Reconciliation Commission of Canada: Calls to Action: Truth and Reconciliation Commision of Canada; 2015 [Available from: https://www2.gov.bc.ca/assets/gov/british-columbians-our-governments/indigenous-people/aboriginal-peoples-documents/calls_to_action_english2.pdf.

  23. Lux MK. Separate beds: a history of Indian hospitals in Canada, 1920s-1980s: University of Toronto Press; 2016.

  24. Mosby I. Administering colonial science: nutrition research and human biomedical experimentation in Aboriginal communities and residential schools, 1942–1952. Histoire sociale/Social history. 2013;46:145–72.

    Article  Google Scholar 

  25. Lux M. Perfect subjects: race, tuberculosis, and the Qu'Appelle BCG Vaccine Trial. Can Bull Med Hist. 1998;15(2):277–95. https://doi.org/10.3138/cbmh.15.2.277.

  26. Dudgeon P, Milroy H, Walker R. Working together: Aboriginal and Torres Strait islander mental health and wellbeing principles and practice. 2nd ed: Commonwealth of Australia; 2014.

  27. Dudgeon P, Milroy H, Walker R. Aboriginal and Torres Strait islander social and emotional wellbeing. 2nd ed. Canberra: Commonwealth Government of Australia; 2014.

  28. Capitalizing on Big Data: Toward a Policy Framework for Advancing Digital Scholarship in Canada 2013 [Available from: https://www.sshrc-crsh.gc.ca/about-au_sujet/publications/digital_scholarship_consultation_e.pdf.

  29. Government of India. Big Data Initiative. 2016 Available from: https://dst.gov.in/big-data-initiative-1.

    Google Scholar 

  30. Cuervo LG, Martínez-Herrera E, Cuervo D, Jaramillo C. Improving equity using dynamic geographic accessibility data for urban health services planning. Gac Sanit. 2022;36(6):497–9.

    Article  PubMed  Google Scholar 

  31. The federal big data research and development strategic plan 2016 [Available from: https://bigdatawg.nist.gov/pdf/bigdatardstrategicplan.pdf.

  32. UKRI. The UK’s research and innovation infrastructure: opportunities to grow our capability [Available from: https://www.ukri.org/wp-content/uploads/2020/10/UKRI-201020-UKinfrastructure-opportunities-to-grow-our-capacity-FINAL.pdf.

  33. Waddington HS, Villar PF, Valentine JC. Can non-randomised studies of interventions provide unbiased effect estimates? A systematic review of internal replication studies. Eval Rev. 2022;0(0). https://doi.org/10.1177/0193841X221116721.

  34. Craig P, Cooper C, Gunnell D, Haw S, Lawson K, Macintyre S, et al. Using natural experiments to evaluate population health interventions: new Medical Research Council guidance. J Epidemiol Community Health. 2012;66(12):1182–6.

    Article  PubMed  Google Scholar 

  35. Craig P, Petticrew M. Developing and evaluating complex interventions: reflections on the 2008 MRC guidance. Int J Nurs Stud. 2013;50(5):585–7.

    Article  PubMed  Google Scholar 

  36. Petticrew M. When are complex interventions ‘complex’? When are simple interventions ‘simple’? Eur J Public Health. 2011;21:397–8.

    Article  PubMed  Google Scholar 

  37. Craig P, Katikireddi SV, Leyland A, Popham F. Natural experiments: an overview of methods, approaches, and contributions to public health intervention research. Annu Rev Public Health. 2017;38:39–56.

    Article  PubMed  PubMed Central  Google Scholar 

  38. Moser KA, Leon DA, Gwatkin DR. How does progress towards the child mortality millennium development goal affect inequalities between the poorest and least poor? Analysis of demographic and health survey data. BMJ. 2005;331(7526):1180–2.

    Article  PubMed  PubMed Central  Google Scholar 

  39. Reidpath DD, Morel CM, Mecaskey JW, Allotey P. The millennium development goals fail poor children: the case for equity-adjusted measures. PLoS Med. 2009;6(4):e1000062.

    Article  PubMed  PubMed Central  Google Scholar 

  40. Smith M, Hosking J, Woodward A, Witten K, MacMillan A, Field A, et al. Systematic literature review of built environment effects on physical activity and active transport - an update and new findings on health equity. Int J Behav Nutr Phys Act. 2017;14(1):158.

    Article  PubMed  PubMed Central  Google Scholar 

  41. Daskalopoulou C, Stubbs B, Kralj C, Koukounari A, Prince M, Prina AM. Physical activity and healthy ageing: a systematic review and meta-analysis of longitudinal cohort studies. Ageing Res Rev. 2017;38:6–17.

    Article  CAS  PubMed  Google Scholar 

  42. Freeman S, Bishop K, Spirgiene L, Koopmans E, Botelho FC, Fyfe T, et al. Factors affecting residents transition from long term care facilities to the community: a scoping review. BMC Health Serv Res. 2017;17(1):689.

    Article  PubMed  PubMed Central  Google Scholar 

  43. 49th Directing Council, 61st session of the regional committee. Pan American Health Organization (PAHO/WHO) policy on research for health. Washington: PAHO; 2009. p. 40.

    Google Scholar 

  44. The WHO strategy on research for health Geneve: World Health Organization; 2012 [Available from: https://www.who.int/phi/WHO_Strategy_on_research_for_health.pdf?ua=1.

  45. World Health O. Strategy on health policy and systems research: changing the mindset, vol. 2012. Geneva: World Health Organization; 2012.

    Google Scholar 

  46. Thirteenth General Programme of Work 2019-2023: World Health Organization; [Available from: https://www.who.int/about/what-we-do/thirteenth-general-programme-of-work-2019%2D%2D-2023.

  47. Heidari S, Babor TF, De Castro P, Tort S, Curno M. Sex and gender equity in research: rationale for the SAGER guidelines and recommended use. Res Integr Peer Rev. 2016;1:2.

    Article  PubMed  PubMed Central  Google Scholar 

  48. Johnson JL, Beaudet A. Sex and gender reporting in health research: why Canada should be a leader. Can J Public Health. 2012;104(1):e80–1.

    Article  PubMed  Google Scholar 

  49. Johnson J, Sharman Z, Vissandjée B, Stewart DE. Does a change in health research funding policy related to the integration of sex and gender have an impact? PLoS One. 2014;9(6):e99900.

    Article  PubMed  PubMed Central  Google Scholar 

  50. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2018): Government of Canada; [Available from: https://ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2018.html.

  51. Council for international organizations of medical sciences [Available from: https://cioms.ch/.

  52. Turner L, Shamseer L, Altman DG, Schulz KF, Moher D. Does use of the CONSORT statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane reviewa. Systematic Reviews. 2012;1(1):60.

    Article  PubMed  PubMed Central  Google Scholar 

  53. Stevens A, Shamseer L, Weinstein E, Yazdi F, Turner L, Thielman J, et al. Relation of completeness of reporting of health research to journals’ endorsement of reporting guidelines: systematic review. BMJ. 2014;348:g3804.

    Article  PubMed  PubMed Central  Google Scholar 

  54. Antequera A, Lawson DO, Noorduyn SG, Dewidar O, Avey M, Bhutta ZA, et al. Improving social justice in COVID-19 Health Research: interim guidelines for reporting health equity in observational studies. Int J Environ Res Public Health. 2021;18(17):9357.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  55. Cooke M, Mitrou F, Lawrence D, Guimond E, Beavon D. Indigenous well-being in four countries: an application of the UNDP’S human development index to indigenous peoples in Australia, Canada, New Zealand, and the United States. BMC Int Health Hum Rights. 2007;7(1):9.

    Article  PubMed  PubMed Central  Google Scholar 

  56. Castellano MB. Ethics of Aboriginal Research. Int J Indigenous Health. 2004;1:98–115.

  57. Partnership | Closing The Gap [Available from: https://www.closingthegap.gov.au/partnership.

  58. Lavery JV, C IJ. The research fairness initiative: filling a critical gap in global research ethics. Gates Open Res. 2018;2:58.

    Article  PubMed  PubMed Central  Google Scholar 

  59. Walter M, Lovett R, Maher B, Williamson B, Prehn J, Bodkin-Andrews G, et al. Indigenous data sovereignty in the era of big data and open data. Aust J Soc Issues. 2021;56(2):143–56.

    Article  Google Scholar 

  60. Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of Health Research reporting guidelines. PLoS Med. 2010;7(2):e1000217.

    Article  PubMed  PubMed Central  Google Scholar 

  61. Welch V, Petticrew M, Tugwell P, Moher D, O'Neill J, Waters E, et al. PRISMA-equity 2012 extension: reporting guidelines for systematic reviews with a focus on health equity. PLoS Med. 2012;9(10):e1001333.

    Article  PubMed  PubMed Central  Google Scholar 

  62. Welch V, Petticrew M, Petkovic J, Moher D, Waters E, White H, et al. Extending the PRISMA statement to equity-focused systematic reviews (PRISMA-E 2012): explanation and elaboration. J Clin Epidemiol. 2016;70:68–89.

    Article  PubMed  Google Scholar 

  63. Welch VA, Norheim OF, Jull J, Cookson R, Sommerfelt H, Tugwell P, et al. CONSORT-equity 2017 extension and elaboration for better reporting of health equity in randomised trials. BMJ. 2017;359:j5085.

    Article  PubMed  Google Scholar 

  64. Dewidar O, Rader T, Waddington H, Nicholls SG, Little J, Hardy BJ, et al. Reporting of health equity considerations in equity-relevant observational studies: protocol for a systematic assessment [version 1; peer review: awaiting peer review]. F1000Research. 2022;11:615. https://doi.org/10.12688/f1000research.122185.1.

  65. Welch V, Rizvi A, Dewidar O. STROBE-equity reporting guidelines; 2020 Available from. https://doi.org/10.17605/OSF.IO/H57SE.

    Book  Google Scholar 

  66. Rizvi A, Lawson DO, Young T, Dewidar O, Nicholls S, Akl EA, et al. Guidance relevant to the reporting of health equity in observational research: a scoping review protocol. BMJ Open. 2022;12(5):e056875.

    Article  PubMed  PubMed Central  Google Scholar 

  67. Kavanagh J, Oliver S, Caird J, et al. Inequalities and the mental health of young people: a systematic review of secondary school-based cognitive behavioural interventions. In: Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews. York: Centre for Reviews and Dissemination (UK); 2009. Available from: https://www.ncbi.nlm.nih.gov/books/NBK76588/.

    Google Scholar 

  68. Bank TW. Indigenous Peoples Overview: The World Bank; 2022. Available from: https://www.worldbank.org/en/topic/indigenouspeoples

    Google Scholar 

  69. Peters MDJ, Godfrey C, McInerney P, Munn Z, Tricco AC, Khalil H. Chapter 11: scoping reviews (2020 version). In: Aromataris E, Munn Z, editors. JBI manual for evidence synthesis, JBI; 2020. Available from https://synthesismanual.jbi.global. https://doi.org/10.46658/JBIMES-20-12.

    Google Scholar 

  70. Ivers NM, Taljaard M, Dixon S, Bennett C, McRae A, Taleban J, et al. Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8. BMJ. 2011;343:d5886.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  71. Page MJ, Shamseer L, Altman DG, Tetzlaff J, Sampson M, Tricco AC, et al. Epidemiology and reporting characteristics of systematic reviews of biomedical research: a cross-sectional study. PLoS Med. 2016;13(5):e1002028.

    Article  PubMed  PubMed Central  Google Scholar 

  72. Moher D, Tetzlaff J, Tricco AC, Sampson M, Altman DG. Epidemiology and reporting characteristics of systematic reviews. PLoS Med. 2007;4(3):e78.

    Article  PubMed  PubMed Central  Google Scholar 

  73. Taljaard M, McRae AD, Weijer C, Bennett C, Dixon S, Taleban J, et al. Inadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials. BMJ. 2011;342:d2496.

    Article  PubMed  PubMed Central  Google Scholar 

  74. Chaudhry SH, Brehaut JC, Grimshaw JM, Weijer C, Boruch R, Donner A, et al. Challenges in the research ethics review of cluster randomized trials: international survey of investigators. Clin Trials. 2013;10(2):257–68.

    Article  PubMed  Google Scholar 

  75. Danko KJ, Dahabreh IJ, Ivers NM, Moher D, Grimshaw JM. Contacting authors by telephone increased response proportions compared with emailing: results of a randomized study. J Clin Epidemiol. 2019;115:150–9.

    Article  PubMed  Google Scholar 

  76. Jull J, Petticrew M, Kristjansson E, Yoganathan M, Petkovic J, Tugwell P, et al. Engaging knowledge users in development of the CONSORT-equity 2017 reporting guideline: a qualitative study using in-depth interviews. Res Involv Engagem. 2018;4(1):34.

    Article  PubMed  PubMed Central  Google Scholar 

  77. Nct. The Effect of Guided Counseling in Improving Dietary Practice, Nutritional Status and Birth Weight of Pregnant Women. In: The Effect of Guided Counseling in Improving Dietary Practice, Nutritional Status and Birth Weight of Pregnant Women in West Gojjam Zone, Amhara Region, Ethiopia: a Cluster Randomized Controlled Community Trial; 2018.

    Google Scholar 

  78. Creswell JW. Qualitative inquiry and research design: choosing among five approaches, vol. xvii. 2nd ed. Thousand Oaks: Sage Publications, Inc; 2007. p. 395–xvii.

    Google Scholar 

  79. Welch V, Petticrew M, Petkovic J, Moher D, Waters E, White H, et al. Extending the PRISMA statement to equity-focused systematic reviews (PRISMA-E 2012): explanation and elaboration. Int J Equity Health. 2015;14:92.

    Article  PubMed  PubMed Central  Google Scholar 

  80. Eysenbach G. Improving the quality of Web surveys: the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). J Med Internet Res. 2004;6:e34.

    Article  PubMed  PubMed Central  Google Scholar 

  81. The James Lind Alliance 2021 [Available from: https://www.jla.nihr.ac.uk/.

  82. OMERACT. OMERACT Handbook, Chapter 7: Reaching Consensus 2021 Available from: https://omeracthandbook.org/handbook.

    Google Scholar 

  83. First Nations Information Governance Centre.: OCAP® | FNIGC; Available from: https://fnigc.ca/.

  84. Carroll SR, Garba I, Figueroa-Rodríguez OL, Holbrook J, Lovett R, Materechera 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.

    Article  Google Scholar 

  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.

    Article  PubMed  PubMed Central  Google Scholar 

  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.

    Article  PubMed  PubMed Central  Google Scholar 

  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 observational study. BMJ Open. 2019;9(7):e026866.

    Article  PubMed  PubMed Central  Google Scholar 

  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.

    Article  PubMed  PubMed Central  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  92. Moreau KA, Eady K, Sikora L, Horsley T. Digital storytelling in health professions education: a systematic review. BMC Med Educ. 2018;18(1):208.

    Article  PubMed  PubMed Central  Google Scholar 

  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.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  94. Jull J, Morton-Ninomiya M, Compton I, Picard A. Fostering the conduct 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.

    Article  PubMed  PubMed Central  Google Scholar 

  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. Cochrane handbook for systematic reviews of interventions version 6.2 (updated February 2021): Cochrane; 2021.

    Google Scholar 

  96. OMERACT. OMERACT Handbook, Chapter 7: Reaching Consensus [Available from: https://omeracthandbook.org/handbook.

  97. Pfadenhauer LM, Gerhardus A, Mozygemba K, Lysdahl KB, Booth A, Hofmann B, et al. Making sense of complexity in context and implementation: the context and implementation of complex interventions (CICI) framework. Implement Sci. 2017;12(1):21.

    Article  PubMed  PubMed Central  Google Scholar 

  98. Sharp MK, Bertizzolo L, Rius R, Wager E, Gómez G, Hren D. Using the STROBE statement: survey findings emphasized the role of journals in enforcing reporting guidelines. J Clin Epidemiol. 2019;116:26–35.

    Article  PubMed  Google Scholar 

  99. Sharp M. The use of reporting guidelines as an educational intervention for teaching research methods and writing (doctoral thesis). France: University of Split; 2020.

    Google Scholar 

  100. Chokshi DA, Foote MMK, Morse ME. How to act upon racism—not race—as a risk factor. JAMA Health Forum. 2022;3(2):e220548-e.

    Article  Google Scholar 

  101. Gee GC, Ford CL. Structural racism and health inequities: old issues, New Directions. Du Bois Rev. 2011;8(1):115–32.

    Article  PubMed  PubMed Central  Google Scholar 

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Acknowledgements

We are greatly saddened by the loss of our colleague, Ainsley Moore, whose contributions to this work were invaluable. We would like to acknowledge the amazing effort of the wonderful artist, Claire Brascoupé, who designed our logo of the STROBE-Equity project.

Funding

This work was supported by the Canadian Institutes of Health Research (CIHR), grant number 173269.

Author information

Authors and Affiliations

Authors

Contributions

SF, JJ, LM, VW all contributed equally to this manuscript. SF, JJ, LM, VW are responsible for conceptualization, funding acquisition, methodology, supervision and validation. LM, VW, SF and JJ are all co-principal investigators of the project. OD, XW, ML, EG, AR are responsible for investigation and data collection. VW is responsible for project administration. TR will be responsible for designing search strategies. EAA, MTA, AA, ZAB, CC, PC, LGC, AD, HE, CF, DF, RGS, BJH, MH, JHR, TH, CJP, MK, MKennedy, TK, AK, EK, LL, JL, EL, OM, MJM, GMT, AM, LLN, SGN, MNN, DOL, EO, PO, TP, JP, MP, KP, TR, JR, AR, LS, MS, BV, PT, PTugwell, JT, EVE, HSW, HW, LW, GW, HWhite, CSW, LWolfenden, TY contributed to the methodology of the project. VW drafted the manuscript. All remaining authors critically reviewed, provided feedback, and approved the final manuscript.

Corresponding author

Correspondence to Vivian Welch.

Ethics declarations

Ethics approval and consent to participate

This protocol was approved by the Bruyère Research Institute Ethics Board (M16-21-025). The study will be conducted in accordance with all applicable government regulations and University of Ottawa Faculty of Medicine policies and procedures. Consent will be collected for participants involved in IRB-approved processes.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests. LGC is employed by the Pan American Health Organization (PAHO/WHO). The ideas expressed in this manuscript are the authors’ own and do not necessarily reflect the decisions and policies of PAHO/WHO)

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Sarah Funnell, Janet Jull, Lawrence Mbuagbaw and Vivian Welch are joint first authors.

Supplementary Information

Additional file 1.

Draft coding categories for methodological assessment.

Additional file 2.

Draft Terms of reference for STROBE-Equity.

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Funnell, S., Jull, J., Mbuagbaw, L. et al. Improving social justice in observational studies: protocol for the development of a global and Indigenous STROBE-equity reporting guideline. Int J Equity Health 22, 55 (2023). https://doi.org/10.1186/s12939-023-01854-1

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  • DOI: https://doi.org/10.1186/s12939-023-01854-1

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