{"paper_id":"23408b68-d37c-402d-8faa-3039a27de508","body_text":"This guideline extends the STROBE reporting guidelines for specific attention to reporting health equity relevant methods, data, and considerations in observational studies. We describe the STROBE-Equity reporting guideline checklist and elaborate on each extension item.\n\nThe STROBE-Equity extension is designed to guide the reporting of health equity data and considerations in observational studies of any topic that aims to investigate differences in health that are avoidable and considered unjust (see  box 1  for definitions of health equity relevant observational studies). The STROBE-Equity extension applies to the three observational study designs addressed in the STROBE statement: cohort, case-control, and cross sectional. It is intended to complement the STROBE statement rather than replace it. Similarly, it can be used alongside the RECORD (REporting of studies Conducted using Observational Routinely collected Data) guidelines. 52  This extension focuses on transparent reporting, not to inform study design or implementation. Given the sensitive nature of health equity research, authors are encouraged to carefully consider how data are reported to avoid reinforcing stigma or discrimination. The guideline does not apply to qualitative studies as they require a different reporting structure. 53 \n 54\nA study that does not involve any intervention (experimental or otherwise) on the part of the investigator. 37\nStudies that investigate outcomes related to populations experiencing, or that may experience, inequities and/or examine variations in outcomes among groups experiencing different levels of inequities or no inequities at all. In some cases, these observational studies may meet both criteria by focusing on populations experiencing inequities and assessing subgroup differences. Importantly, this definition does not require the studies to explicitly state that the objective of the observational study is linked to health equity. 38  It is intended for studies that address unfair or unjust differences and may not apply to differences that are unavoidable (eg, biological). For example, a study reporting differences in breast cancer incidence between age groups may reflect biological variation, as age is a non-modifiable risk factor. In contrast, a study reporting inequities in breast cancer mortality between ethnic groups due to delays in diagnosis or unequal access to treatment would qualify as health equity relevant.\nPROGRESS-Plus items can be used to identify factors that are known to socially stratify health opportunities and outcomes. 6 \n 39  PROGRESS stands for: Place of residence, Race or ethnicity or culture or language, Occupation or out of work, Gender or sex, Religion, Education, Socioeconomic status, and Social capital. “Plus” recognises additional factors, including personal characteristics, time dependent situations, and relationships. These characteristics may be associated with each other (eg, educational attainment and socioeconomic status) and may interact with each other (eg, socioeconomic status and ethnicity) or with systems of oppression, power, and privilege, to drive the experience of health inequities (intersectionality). 40  The importance of these characteristics may depend on the context and setting. EQUALSS GUIDE MULTIPLE 41  is another tool that can be used, which includes: ethnicity (and race), Qualifications and education, Underserved area, Age, Language and religion, Sex, Sexual orientation, Gender identification, Underrepresented groups (inclusion groups), Income and wealth, Disability (physical, mental, and learning), Employment and occupation, and Multiple disadvantage.\nVarious terms have been used to describe populations experiencing health inequities—that is, “inclusion health populations,” 42 \n 43 \n 44  “equity-seeking,” “equity-deserving,” “underserved,” “marginalised,” or “disadvantaged” populations. 45 \n 46  In this reporting guideline, the term “populations experiencing inequities” is utilised to acknowledge individuals with firsthand experience of inequity, whether current or historical. This term emphasises inclusivity and recognises that inequities are not inherent to a given population, can evolve over time, and are context dependent. Those with past and/or present experiences offer a comprehensive perspective on accessing care and services. The importance of using terms that best fit the study context and meet the needs of the populations experiencing inequities involved or affected by the study are recognised.\nStatistics and information related to health inequities as well as other characteristics associated with inequities. 47\nThe Patient-Centered Outcomes Research Institute’s (PCORI) definition of individuals with lived experience of inequities was adopted, which includes patients, caregivers, clinicians, and other healthcare partners involved in patient care. 48\nThese are groups with legitimate interests in the health issue under consideration: patients, health research funders, healthcare service purchasers, peer reviewed journal editors, policy makers, research leaders, review creators and commissioners, product developers, programme overseers, care providers, and the general public. 49  The term interest holders provides an alternative to stakeholders, given its colonial roots and extensive consultation with the MuSE Consortium to find a favoured replacement. 50\nIndividuals who are likely to use the research results to make informed decisions about health policies, programmes, or practices. 51  Knowledge users may originate from different interest holder groups to ensure usefulness and relevance of the research.\nAccording to the MuSE Consortium (previously known as Multi-Stakeholder Engagement), 49  engagement can take two forms: shared decision making, where individuals with lived experience of inequities contribute equally to decisions, or providing advice or feedback, where the perspectives of interest holders are sought and considered by the larger research team.\n\nTo develop the STROBE-Equity extension, we adhered to a published protocol, 55  informed by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network’s methodological framework for developing reporting guidelines. 56  We followed two parallel streams: one for the global guidance and another for creating Indigenous related guidance, led by Indigenous scholars. This paper presents the development of the global reporting guideline, covering phases 1-3 as specified in the protocol. Phases 4 and 5, which involve evaluating the outcomes of collaboration between the global and Indigenous streams and outline the knowledge translation plan, will be reported separately. We reported patient and public engagement and the Delphi process according to the Guidance for Reporting Involvement of Patients and the Public 2.0 (GRIPP2) 57  and ACcurate COnsensus Reporting Document (ACCORD) 58  reporting guidelines (see supplementary appendix 1).\nA diverse, global multidisciplinary team (n=57) developed the STROBE-Equity extension, including members of the public, authors of observational studies, statisticians, social scientists, epidemiologists, methodologists, funders, healthcare practitioners, ethicists, and knowledge users. We sought diversity in our research team and steering committees across geography, genders, ethnicities, and career stages (see supplementary appendix 2). The group included knowledge users from the Pan American Health Organization/World Health Organization, the Royal College of Physicians and Surgeons of Canada, scientific journal editors, the Canadian Drug Agency, and the Public Health Agency of Canada. All the team members were part of the technical oversight committee, which oversaw the whole project. In parallel, we established a knowledge user committee (n=12) and a patient and public steering committee (n=3). Both committees were consulted at all stages of the guideline development process. An executive committee (n=10) comprising the co-principal investigators, trainees, and researchers was responsible for leading the empirical studies. Recognising the Indigenous right to self-determination as outlined in the United Declaration on the Rights of Indigenous peoples (Article 3), 59  we established an Indigenous steering committee (n=6) comprising an Indigenous Elder, researchers, clinicians, and trainees. This Indigenous stream provided a culturally safe way to co-produce ethical and relevant guidance for reporting health equity in Indigenous related health research. We describe our values and positionality statements in supplementary appendix 2.\nIn phase 1 the STROBE-Equity project team proposed 36 extension items to the STROBE reporting guideline that would be required to ensure transparent and complete reporting of health equity data and considerations. These items formed the interim guidance for the STROBE-Equity extension. 2  A scoping review of equity guidance found that all 36 items proposed in the interim guidance 2  were supported by existing guidance, 60 \n 61  and 13 additional items were identified ( fig 1 ). Then a methodological review of health equity data and reporting and considerations in 320 observational studies indicated that the reporting of study design features ranged from 0% (0/320) to 95% (307/320) of the studies, with more than half of the items being reported by less than one quarter of the studies. 15 \n 62  We conducted eight key informant interviews with eight members of the STROBE-Equity project group from diverse backgrounds, genders, and ethnicities. These interviews identified six key themes that guided reflection, consideration, and confirmation of final checklist items. These themes highlighted the importance of clarity, feasibility, contextual relevance, and the inclusion of diverse perspectives to improve the reporting of health equity in observational research. A detailed table in supplementary appendix 3 outlines the themes and their impact on the development of the extension items.\nFlow of proposed STROBE-Equity extension items. For items where no extension to the STROBE reporting guideline was proposed, survey participants were able to provide feedback on their level of agreement. “Items combined” refers to collapsing at least two items into a single item to enhance clarity and reduce redundancy. *Methods review aimed to inform current reporting practices in observational studies, whereas key informant interviews identified principles to guide the consensus meeting and finalise the extension checklist, but neither were intended to identify new items. STROBE=STrengthening the Reporting of OBservational studies in Epidemiology\nIn phase 2, we gathered feedback from diverse interest holders (eg, researchers, members of the public, individuals with lived experiences of inequities) with different backgrounds by deploying a global online survey from June 2023 to January 2024 (see supplementary appendix 4 for recruitment details and survey questions). The survey consisted of 24 recommendations for new items to STROBE and 17 items for which no extension was proposed. We received 162 responses to the global online survey (see supplementary appendix 5), with representation from different self-identifying knowledge users, including research methodologists (36%, 58/162), epidemiologists (20%, 33/162), clinicians (14%, 22/162), scientific journal editors (10%, 17/162), policy makers (7%, 12/162), and patients (6%, 9/162). A third of the survey participants self-identified as individuals with lived experiences of health inequities. Overall, 76% (123/162) had more than 10 years of experience in healthcare research. Content expertise varied from public health and health promotion (32%, 52/162) to clinical research (15%, 24/162), equity oriented research (8%, 13/162), and health systems research (8%, 13/162). We obtained 25% (41/162) of respondents from people based in low and middle income countries (see supplementary appendix 5). The survey showed >80% agreement for 22 out of the 24 proposed extension items (see supplementary appendix 5). However, 63% (85/135) to 75% (91/121) of respondents indicated that 17 items without proposed extension items should have extension items, suggesting a strong interest in further refinement. Open ended comments indicated endorsement for developing guidance describing minimal standards for health equity reporting. Additionally, participants felt a need for better definitions for populations experiencing health inequities.\nIn phase 3, we convened a consensus panel of the team members and all steering committee members and held two online consensus meetings at different times to be inclusive of multiple time zones. A pre-consensus survey evaluated inclusion of items with <70% agreement and helped focus the consensus discussion on items where opinions differed. Survey participants contributed detailed comments to support their judgments, which were synthesised into main themes and presented at the consensus meeting. We then held two 1.5-hour online consensus meetings to discuss and finalise the checklist items. The consensus threshold was defined a priori as ≥80% agreement among 80% of the respondents. The consensus meetings endorsed 21 items with ≥80% agreement. Two items were rejected based on consensus that they were adequately covered by the original STROBE item, and one item was contested (see details reported in supplementary appendix 6). We established a synthesis working group to consolidate the feedback from the consensus meetings and discuss how to increase the feasibility of health equity reporting while safeguarding items the working group considered essential for good practice. This team consisted of 10 project members who convened for two one-hour meetings and discussed drafts by email. The groups’ focus was to improve clarity of wording, maximise parsimony, and maintain essential items. This team was guided by values and principles expressed during the consensus panel discussions and by themes identified in the key informant study. Supplementary appendix 7 provides additional details.\nIn accordance with the GRIPP2 reporting checklists (see supplementary appendix 1), 63  we involved both patients and members of the public at various stages of the guideline’s development. Our patient and public steering committee was led by three of our team members (JT, RGS, and HE) who were also decision makers in the development of the STROBE-Equity extension. JT and RGS have lived experience of health inequities and participation in health equity research, and they were also involved from the funding acquisition stage. They convened every two months to guide the project’s design and received regular project updates through quarterly technical advisory meetings and steering committee sessions, with study progress shared through project newsletters. The patient and public partners played a pivotal role in establishing the need for these guidelines and refining the STROBE-Equity guideline by identifying areas for integrating equity considerations. They also contributed to designing the three empirical studies and discussions regarding interpreting the key findings. The patient and public partners received annual financial compensation for their contributions during the project. Additional patient and public perspectives were gathered through the key informant interviews and the online global survey.\n\nTable 1  shows the original STROBE checklist (22 items) alongside the STROBE-Equity extension items. STROBE-Equity introduces 10 items that are specific to health equity relevant observational studies. The items apply to the three study designs covered by the original STROBE statement. Identical to the STROBE statement, the items in the STROBE-Equity guidelines are organised into sections: Title and abstract (1.1), Introduction (2.1), Methods (4.1-12.1), Results (13.1-14.1), and Discussion (18.1). Authors of health equity relevant observational studies should address all items of the STROBE-Equity checklist (although some information may be best placed in supplementary materials, if journals have space constraints).\nEquity extension to the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) statement\n\nStudy title : “Trends in Racial and Ethnic Disparities in Barriers to Timely Medical Care Among Adults in the US, 1999 to 2018” 64\nAbstract objective : “To identify variation in several measures of health equity from 1993 to 2017 in the United States and to test whether there are significant time trends.” 65\nAbstract methods : “We use population at risk and mortality data covering 1991-2019 to calculate the mortality rate at age 65-69 at the Local Authority level. We use the 2019 Index of Multiple Deprivation to examine geographical inequalities.” 66\nAbstract results : “Those with a foreign first language had lower testing rates, higher incidence, and higher positivity.” 67\nAbstract discussion : “Management of high fasting plasma glucose remains a major challenge for older people with T1DM [type 1 diabetes mellitus], and targeted clinical guidelines are needed.” 68\nReporting health equity objectives in the title or the abstract helps patients, policy makers, and practitioners to more easily identify health equity relevant studies and understand how they relate to health equity. 60  This is especially important because health equity studies often focus on specific populations, 15 \n 69  such as those defined by PROGRESS-Plus (see  box 1 ), and the findings should clearly describe the populations studied and any limitations in applicability to other settings. Clear reporting ensures that the study’s reference and potential limitations in the applicability of the findings to other settings are easily understood. Moreover, making equity relevant studies easily searchable in databases such as Medline or Embase as indexing terms (eg, MeSH or Emtree) are influenced by the terms used in the title and abstract, which also guide search strategies.\nWe recommend that authors incorporate specific terms such as “health equity” or other more specific terms in the title, when appropriate. 70 \n 71  Additionally, the relevance of health equity should be highlighted across different sections of the abstract (ie, as an objective, emphasising equity relevant results, or interpreting findings while considering the impact on health equity). To further improve searchability, authors (and journals) are encouraged to describe their work using appropriate standardised subject terms (MeSH or Emtree). For example, MeSH terms for the concept of health equity include “health equity”, “health inequities”, and “health status disparities” for the purposes of indexing. 72  Each concept of a robust search strategy should consist of text words and subject terms. 73\n\n“Marginalized populations have approximately 5 times greater risk of adverse COVID-19 consequences related to social determinants of health that may exacerbate patient comorbidities. Equitable distribution would eliminate vaccination disparities while mitigating the disproportionate effect of the COVID-19 pandemic in underserved populations, which are disadvantaged because of limited access to health care, low socioeconomic status, or race.” 74\n“Substantial racial and ethnic disparities persist in cancer survival, reflecting systemic barriers to cancer screening, treatment, and survivorship care and differences in the prevalence of comorbidities.” 75\n“The importance of non-traditional risk factors for atherosclerotic diseases, such as socioeconomic deprivation, has also been increasingly recognised. Whether socioeconomic deprivation is as strongly associated with other CVDs [cardiovascular diseases] as with atherosclerosis is uncertain, but it is important to understand as many countries have reported an increase in socioeconomic inequalities.” 76\nDescribing how the aim of health equity relates to the author’s motivation for conducting the study clarifies its purpose and demonstrates its contribution to addressing health inequities. 77  Understanding these motivations helps to contextualise the research design and explains why specific research questions were prioritised. 78 \n 79\nWe advise authors to emphasise the relevance of the health condition to populations experiencing inequities, using context specific language and acknowledging the role of intersectionality 80 \n 81 \n 82  and systemic causes of health inequities (eg, racism, sexism, heterosexism, ableism, and colonialism). Authors should provide a rationale that elucidates the underlying theory for why the issue is particularly relevant to these populations, indicating where differences reflect inequities. 83 \n 84  Using a logic model to illustrate this theory can further clarify the study’s equity focused objectives. 85 \n 86\n\n“The survey was refined in consultation with people with lived experience of mental health conditions involving a citizen’s jury participatory methodology process. Items were modified, and questions added to reflect the Canadian context, with the aim to examine indicators of mental health, stress, and coping in the previous two weeks among the Canadian population 18 years and older during the COVID-19 pandemic.” 87\n“The study was conceptualized and led by the first author (MK, Wiradjuri woman), in partnership with NAATSIHWP and Aboriginal communities represented by: HL, SB, PH, KB.” 88\n“Study findings will be disseminated through the Provincial Advisory Committee that was assembled to oversee the entire Provincial Prescribed Safer Supply evaluation project. The committee includes people with lived/living experience of overdose and/or substance use who have been engaged in this project from its establishment. We will also disseminate results through the British Columbia Overdose Emergency Response Centre and social media posts through our organisational partners such as the Centre for Advancing Health, British Columbia Centre for Disease Control, and Canadian Institutes for Substance Use Research.” 89\n“Although formal patient and public involvement was not integrated into the study’s design, we engaged with the public by inviting a patient to review our manuscript, whose insights contributed to refining our presentation and interpretation of findings.” 90\nThe reporting of ethical research necessitates respecting the voices and experiences of those directly affected by the study. 91 \n 92 \n 93 \n 94 \n 95  This includes reporting on any engagement of individuals with lived experiences in the conduct or implementation of the study. Not only is this a demonstration of the researchers’ accountability to their ethical responsibility, 96 \n 97 \n 98  it reflects a clear commitment to prioritising health equity by describing the efforts put in place to engage those experiencing health inequities. 99  It also signals to readers, funders, and interest holders that the study is relevant to these populations. 100  Transparent reporting offers readers an opportunity to assess the level of engagement and determine whether it was meaningful or tokenistic. 101 \n 102 \n 103 \n 104 \n 105 \n 106  When engagement was not undertaken, researchers should reflect on how its absence may affect the study’s findings. 107\nAuthors should report who was engaged, the strategies for engagement, how people with lived experience were involved (shared decision making, providing advice or feedback, collaborating, informing, or other), and the reasons behind these decisions. Following standards for reporting engagement, such as the GRIPP2 checklists 57  or other standards for specific populations (eg, Indigenous peoples 108 \n 109 ), can guide authors in reporting these practices comprehensively. In supplementary appendix 1 we report how our engagement process for this guideline adheres to the GRIPP2 checklists.\n\n“People with lived or living experience of substance use and/or overdose from across British Columbia were engaged as research assistants and advisors in the broader evaluation project of which this study is a part.” 89\n“This project is informed, implemented, and reported by an Indigenous-led research team, we recognize that our lived experience and worldviews influence the way that the study was conducted which is central to developing an Indigenous-led evidence base for SCC [smoking cessation care]. Our team brings Aboriginal and Torres Strait Islander lived experience (MK, KB, HL, SB), Indigenous lived experience (RM), expertise in Aboriginal health services (PH, HL, SB), Aboriginal Health Workers (HL, SB, KB), Indigenous tobacco research (AM, MK, RM, YBZ) and epidemiology (RM, YBZ).” 88\n“Relationality is foundational to Indigenous research practice and paradigm. We recognize that our own lived experience and standpoint are central to this research including the conceptualization, development, conduct, and interpretation of findings. Our team embodies Aboriginal and Torres Strait Islander lived experience (MK, CC, KC, JF, and KRB), Indigenous lived experience (RM), expertise in Indigenous tobacco research (MK, CC, RM, AGM, CS, and BB), Aboriginal health services (BD), qualitative research (MK, KB, and CC), and tobacco behavioral counseling (JF and CS). This study privileges Indigenous knowledge and recognizes the ongoing scientific rigor of Aboriginal and Torres Strait Islander people and their knowledge systems.” 110\nThe composition of a research team plays a critical role in determining how the research is conducted, interpreted, and applied. 111 \n 112 \n 113 \n 114  Including voices of individuals with lived experience of health inequities may help the research address the realities of those affected by health inequities. 115 \n 116 \n 117  Reporting the composition of the research team, particularly in terms of including individuals with lived experiences of inequities, helps readers understand how power dynamics, 117 \n 118 \n 119  bias, 96 \n 120  and contextual factors 116 \n 121  shaped the conducted research. This is especially important in health equity research, where team diversity can directly influence the framing and interpretation of the findings. 122\nAuthors should construct a statement that specifies the team’s representation and roles, particularly focusing on expertise relevant to the health equity objectives of the study. During our consensus meeting discussions, it was noted that disclosing this information, particularly at the individual level, could compromise individuals’ privacy and expose them to stigma or discrimination, and potential harm. Therefore, a possible approach to mitigate this would be to report the data in aggregate for the whole team. We report our team composition statement as an example in supplementary appendix 2.\n\n“We plan to recruit 1000 participants in the GTA [Greater Toronto Area] and 500 participants in Ottawa using a peer recruitment strategy. Survey venues that are frequented by ACB [African, Caribbean, and Black] people will be selected with input from local team members and collaborators. This form of recruitment should generate a sample that is similar in age, gender, and country of birth to Statistics Canada data pertaining to the GTA and Ottawa. These approaches have been used in previous studies to limit selection bias and create representative samples.” 123\n“Quota sampling will be used for the quantitative surveys. The Spanish survey (n=500) will include 250 SGM [sexual and gender minorities] and 250 non-SGM. The English survey (n=3000) will include non-Hispanic Black (1000/3000, 33%), non-Hispanic White (1000/3000, 33%), and Hispanic or Latino/a/x persons of any race (1000/3000, 33%), with 50% (250/500 for Spanish and 1500/3000 for English) of each group being composed of SGM. We will further stratify recruitment by gender to generate sample sizes of approximately 250 at each race and ethnicity *SGM* gender intersection (e.g., White non-SGM women). Transgender and gender nonbinary respondents will be grouped by gender identity (e.g., transgender men and transmasculine persons with men).” 124\n“First, to accommodate a relatively young Latino population and, therefore, a large proportion of working-age subjects, both field and clinic schedules included weekdays, weekday evenings, and weekends. Second, to accommodate language barriers and trust issues, given that many participants are first-generation immigrants who do not speak English and a relatively high prevalence of illegal immigrants, all field and clinic staff were Latino and fully bilingual. Third, because many younger adult Latinos in Los Angeles do not have access to childcare facilities and, therefore, have nowhere to leave their children when asked to come to the clinic, we provided in-clinic free childcare. Finally, because many older Latinos do not drive and have no transportation to get to the clinic for an appointment, we offered free transportation to and from the clinic.” 125\nTailoring sampling or recruitment strategies helps to minimise biases that may arise from traditional sampling methods, 126 \n 127 \n 128 \n 129 \n 130  which might not reach populations experiencing inequities. 131 \n 132 \n 133 \n 134  Reporting these methods allows for transparency in how the researchers actively sought to reach and include populations experiencing inequities by adapting their recruitment strategies. 135  This is particularly important when the populations of interest are typically underrepresented in studies, 98  as it clarifies how efforts were made to achieve inclusivity. 98\nAuthors should report how their sampling or recruitment strategies were adapted to improve the representation of populations experiencing health inequities, including the rationale behind their choices. In the case of sampling, authors should describe their sampling approach (eg, proportionate stratification versus disproportionate stratification) and explain how it aligns with answering research questions related to health equity. The use of recruitment in the study design requires authors to describe if they used specific outreach methods, location based recruitment strategies, or tailored recruitment processes to address language, cultural and logistical barriers, and disabilities, and have a representative sample.\n\n“To account for differences in baseline characteristics between the 2 groups [males and females], a propensity score-matching (PSM) model was developed using logistic regression to derive two well-matched groups for comparative outcome analysis [from registry data]. Variables included in the PSM model included age, race, and key comorbidities (hypertension, diabetes, chronic obstructive lung disease, heart failure, obesity, nicotine dependence, and history of stroke).” 136\nReporting whether characteristics associated with health inequities were considered in the selection process provides insights about the representation of the study sample to populations most affected, and it informs the applicability of the study’s results to these populations. 137 \n 138  Doing so allows readers to assess whether imbalances in these factors could have influenced the study findings or biased their interpretation. In certain contexts, characteristics such as race or ethnicity in the US are often proxies for social determinants, such as systemic racism. 139 \n 140  Thus, reporting them helps with contextualising the results with a more nuanced and deeper understanding of potential biases and inequities 141  and informs the relevance of the findings to other settings.\nAuthors should describe the rationale for including or excluding specific populations with characteristics associated with inequities in the selection process. This may include the eligibility criteria, propensity score when matching in case-control and controlled cohort studies, or adjusting eligibility criteria to ensure balanced groups. In line with the original STROBE statement, authors should describe the source of the study population (eg, the general population of a region or country), method of recruitment (eg, referral or self-selection through advertisements), and follow-up procedures. Additionally, they should report whether efforts to minimise non-response and loss to follow-up were made, as well comment on the consistency of study procedures for all the included participants.\n\n“We calculated hazard ratios (HR) and 95%CI [confidence interval] to estimate the difference in SARS-CoV-2 incidence between ethnic groups, using the Dutch origin group as a reference, adjusting for current age in years and sex.” 142\n“Thirdly, as boys are more likely to receive a diagnosis of neurodevelopmental disorders than girls, we evaluated the association by sex of the infants.” 143\nAdditional analyses are often conducted to assess whether effects or associations differ across groups experiencing inequities (eg, based on race, gender, socioeconomic status, or other relevant factors), 144 \n 145  or to assess how potential biases could obscure the true impact of inequity related characteristics on outcomes. 146  Reporting these analyses allows readers to understand how differences between groups were evaluated and whether any findings could indicate a reduction or increase in health inequities.\nAuthors should clearly state whether subgroup analyses were preplanned or exploratory, as post hoc analyses can introduce bias. 147 \n 148  They should describe the methods used to examine differences between groups and the assumptions underlying them. For example, authors should report whether interaction tests were conducted and specify how they were reported, 149  and report if any sensitivity analyses were performed to assess the robustness of the findings. Consideration should be given to how the choice of presenting analyses—whether in absolute or relative terms—could substantially influence judgments about whether health inequities are widening or narrowing. 150 \n 151\n\n“We excluded individuals with missing information on race/ethnicity (n=112) and those who identified as Alaskan Native or American Indian or ‘Other’ Race (n=6,673) due to small numbers.” 64\nPeople experiencing health inequities may be less inclined to participate in studies and more inclined to withdraw than other populations. 152 \n 153 \n 154 \n 155  Explaining why participants were lost to follow-up, excluded, or failed to respond and how these factors relate to characteristics of people experiencing inequities, allows readers to judge the representativeness of the final sample. Additionally, this detailed reporting helps identify whether biases related to inequities were potentially introduced to the study 156  and highlight what needs to be done in future studies for populations experiencing inequities.\nAuthors should explain the reasons behind participant loss, exclusions, or non-responses, especially about characteristics linked to inequities. Authors could present these data through a flow diagram or through narrative description in the text. 157  Such a flow diagram could become challenging to create if the equity factor involves more than two levels or if multiple characteristics of interest, such as poverty and rurality, are considered. Using tables may more effectively convey this information.\n\n“The 8.5% of BAME [Black, Asian, and minority ethnic] is the sum of approximately 2% Bangladeshi, Indian and Pakistani (BIP), and 6.5% of other minority ethnic groups (non-BIP: White Other, Mixed, Black, Asian, and Arab).” 158\n“We included 3,574,903 individuals who did not have atrial fibrillation at index age 45 years or older, of whom 1,727,703 were men (48.3%) and 1,847,200 were women (51.7%).” 159\nDisaggregating baseline characteristics of study participants and examining how these characteristics relate to the exposure allows readers to better assess the applicability 160 \n 161  and representation 162 \n 163 \n 164 \n 165 \n 166  of different populations in the study. Depending on the study design, these data can highlight potential biases in healthcare practices 120 \n 167  and provide insight into the effectiveness of recruitment strategies focused on specific populations, if used. Additionally, stratifying follow-up time by relevant characteristics offers a clearer understanding of how follow-up duration and missing data may differ across population groups, 168 \n 169  improving the overall interpretation of the findings.\nAuthors should present baseline characteristics disaggregated by characteristics of interest associated with health inequities, such as socioeconomic status or ethnicity, and explain how these factors relate to the exposure of interest. Authors should report the number of participants with missing data and follow-up time stratified by these characteristics.\n\n“Our male-to-female breakdown was representative of the national sample, of which 15% of the Brazilian Society of Head and Neck Surgery members are females.” 170\n“Also, our online survey study design excluded individuals who have no access to internet, especially rural residents. Thus, our sample cannot be considered representative of the Chinese population, which might generate biased results. The rural residents recruited in our study might have higher social economic status than other rural residents because our rural sample have regular access to internet.” 171\nInterpretating the study results helps readers understand the implications for health equity. 144 \n 172  For instance, if a study’s sample does not adequately reflect the populations most affected by health inequities, the results may not be generalisable or applicable to those populations, potentially leading to biased conclusions. 173 \n 174 \n 175\nThe discussion of the findings should reflect on the results of the health equity objectives. Authors can highlight any gaps in the study or emphasise important findings. Authors need to consider the study’s limitations, such as method of data collection, whether populations experiencing inequities were underrepresented or over-represented, and whether data collection approaches could lead to selection bias. The results should be interpreted with caution to avoid overinterpretation or misinterpretation, as previously observed with race or ethnicity and several differences in health outcomes, 176  and linking them to the social determinants of health. 177 \n 178 \n 179  Identified biases should be considered when interpreting the findings for accurate reporting. Furthermore, when comparing findings with those of previous studies, authors may explain how their results contribute to, and impact, the existing evidence base on health equity.\n\nThe STROBE-Equity extension was developed to address a recognised need for improved reporting of health equity data and considerations in observational studies. It is designed to complement the original STROBE statement and checklist.\nThe STROBE-Equity extension aligns with the existing guidelines for reporting on health equity in randomised controlled trials (CONSORT (Consolidated Standards of Reporting Trials)-Equity) and systematic reviews (PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses)-Equity)) developed by members of our team, and it clarifies the process for conducting equity relevant research. We will include the STROBE-Equity extension in the EQUATOR Network’s library of reporting guidelines. To promote its adoption, we will engage the editors in chief of scholarly journals in epidemiology and global health, encouraging them to endorse and require the extension for equity relevant studies. We have established a knowledge translation working group to develop strategies to ensure widespread dissemination and use, such as road testing 180  the reporting guideline, translations, and producing various patient oriented tools such as digital stories. We are also surveying our team members about the perceived benefits, challenges, and impact of our integrated knowledge translation approach on the development process.\nWe followed a prespecified process to gather evidence on the necessity of the reporting guideline extension 55  and adhered to widely accepted methods for developing reporting guidelines. 56  Also, we engaged a diverse group of 57 people, employed empirical studies, and obtained input from 162 individuals through an online survey, capturing a wide range of perspectives. The robustness and inclusivity of our approach, combined with high agreement with the extension items, enhances the guideline’s applicability across diverse populations and settings. Nonetheless, we recognise that no guideline can comprehensively include the perspectives of all possible populations and situations where minor adaptations to the guideline may arise.\nAdditionally, our collective understanding of health equity in research is rapidly evolving with frequent new methodological developments, reflecting advances in understanding how health equity can be conceptualised 181  and the factors at different levels that create inequities 182  and how to overcome them. 183  We recognise that these guidelines may need to be updated to encompass evolving concepts, such as intersectionality, 40  as well as considerations for certain populations.\nWe acknowledge that the ability of researchers to report on health equity data and considerations is limited by the availability, quality, and type of data they can collect (ie, culturally sensitive data, lack of standardisation). 39 \n 184  Reporting these challenges could help bring these obstacles to light and foster opportunities for developing innovative solutions.\nThe STROBE-Equity extension provides essential guidelines for reporting of health equity data and considerations in observational studies. We recommend using the STROBE-Equity extension alongside the main STROBE statement to enhance the clarity and completeness of health equity reporting in research. We encourage all interest holders to promote using this extension to improve the evidence base for health equity.","source_license":"public-domain-us","license_restricted":false}