Reporting of equity in observational epidemiology: A methodological review.

Background: Observational studies can inform how we understand and address persisting health inequities through the collection, reporting and analysis of health equity factors. However, the extent to which the analysis and reporting of equity-relevant aspects in observational research are generally unknown. Thus, we aimed to systematically evaluate how equity-relevant observational studies reported equity considerations in the study design and analyses. Methods: We searched MEDLINE for health equity-relevant observational studies from January 2020 to March 2022, resulting in 16 828 articles. We randomly selected 320 studies, ensuring a balance in focus on populations experiencing inequities, country income settings, and coronavirus disease 2019 (COVID-19) topic. We extracted information on study design and analysis methods. Results: The bulk of the studies were conducted in North America (n = 95, 30%), followed by Europe and Central Asia (n = 55, 17%). Half of the studies (n = 171, 53%) addressed general health and well-being, while 49 (15%) focused on mental health conditions. Two-thirds of the studies (n = 220, 69%) were cross-sectional. Eight (3%) engaged with populations experiencing inequities, while 22 (29%) adapted recruitment methods to reach these populations. Further, 67 studies (21%) examined interaction effects primarily related to race or ethnicity (48%). Two-thirds of the studies (72%) adjusted for characteristics associated with inequities, and 18 studies (6%) used flow diagrams to depict how populations experiencing inequities progressed throughout the studies. Conclusions: Despite over 80% of the equity-focused observational studies providing a rationale for a focus on health equity, reporting of study design features relevant to health equity ranged from 0-95%, with over half of the items reported by less than one-quarter of studies. This methodological study is a baseline assessment to inform the development of an equity-focussed reporting guideline for observational studies as an extension of the well-known Strengthening Reporting of Observational Studies in Epidemiology (STROBE) guideline.

A scoping review establishes need for consensus guidance on reporting health equity in observational studies.

OBJECTIVES: To evaluate the support from the available guidance on reporting of health equity in research for our candidate items and to identify additional items for the Strengthening Reporting of Observational studies in Epidemiology-Equity extension. STUDY DESIGN AND SETTING: We conducted a scoping review by searching Embase, MEDLINE, CINAHL, Cochrane Methodology Register, LILACS, and Caribbean Center on Health Sciences Information up to January 2022. We also searched reference lists and gray literature for additional resources. We included guidance and assessments (hereafter termed "resources") related to conduct and/or reporting for any type of health research with or about people experiencing health inequity. RESULTS: We included 34 resources, which supported one or more candidate items or contributed to new items about health equity reporting in observational research. Each candidate item was supported by a median of six (range: 1-15) resources. In addition, 12 resources suggested 13 new items, such as "report the background of investigators". CONCLUSION: Existing resources for reporting health equity in observational studies aligned with our interim checklist of candidate items. We also identified additional items that will be considered in the development of a consensus-based and evidence-based guideline for reporting health equity in observational studies.

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

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.

Introducing the Library of Guidance for Health Scientists (LIGHTS): A Living Database for Methods Guidance.

Importance: Improving methodological quality is a priority in the health research community. Finding appropriate methods guidance can be challenging due to heterogeneous terminology, poor indexing in medical databases, and variation in formats. The Library of Guidance for Health Scientists (LIGHTS) is a new searchable database for methods guidance articles. Observations: Journal articles that aim to provide guidance for performing (including planning, design, conduct, analysis, and interpretation), reporting, and assessing the quality of health-related research involving humans or human populations (ie, excluding basic and animal research) are eligible for LIGHTS. A team of health researchers, information specialists, and methodologists continuously identifies and manually indexes eligible guidance documents. The search strategy includes focused searches of specific journals, specialized databases, and suggestions from researchers. A current limitation is that a keyword-based search of MEDLINE (and other general databases) and manual screening of records were not feasible because of the large number of hits (n = 915 523). As of September 20, 2022, LIGHTS included 1246 articles (336 reporting guidelines, 80 quality assessment tools, and 830 other methods guidance articles). The LIGHTS website provides a user-oriented search interface including filters for study type, specific methodological topic, research context, guidance type, and development process of the guidance. Automated matching of alternative methodological expressions (eg, enter loss to follow-up and find articles indexed with missing data) enhances search queries. Conclusions and Relevance: LIGHTS is a peer-supported initiative that is intended to increase access to and use of methods guidance relevant to health researchers, statisticians, methods consultants, methods developers, ethics boards, peer reviewers, journal editors, and funding bodies.

Black Canadians' Exposure to Everyday Racism: Implications for Health System Access and Health Promotion among Urban Black Communities.

This study explores the social determinants of Black Canadians' exposure to everyday racism, its relationship to health system access, and implications for health promotion. We used data from the A/C Study survey on HIV transmission and prevention among Black Canadians. We implemented the survey (N = 1360) in 2018-2019 in Toronto and Ottawa-two large cities that together account for 42% of Canada's Black population-among self-identified Black residents aged 15-64 years, who were born in sub-Sahara Africa or the Caribbean or had a parent who was born in those regions. Participants reported racist encounters in the preceding 12 months using the Everyday Discrimination Scale. We assessed the socio-demographic correlates of racist experiences and the impact of racism on health system access using multivariable generalised linear models. Sixty percent of participants reported experiencing racism in the preceding 12 months. Based on the adjusted odds ratios, participants were more likely to experience racism if they were older, employed, Canadian-born, had higher levels of education, self-identified as LGBTQ + and reported generally moderate access to basic needs and adequate housing; and less likely to experience racism if they lived in Ottawa, self-identified as female or reported higher levels of social capital. Visiting a healthcare provider or facility, and difficulty accessing healthcare were associated with racist experiences. Racist experiences diminished the likelihood of being tested for HIV. Racist experiences were widespread, especially among those with higher levels of social wellbeing or greater exposure to Canadian institutions. Study participants also associated racist experiences with the healthcare system.

Lessons from the COVID-19 pandemic and recent developments on the communication of clinical trials, publishing practices, and research integrity: in conversation with Dr. David Moher.

BACKGROUND: The torrent of research during the coronavirus (COVID-19) pandemic has exposed the persistent challenges with reporting trials, open science practices, and scholarship in academia. These real-world examples provide unique learning opportunities for research methodologists and clinical epidemiologists-in-training. Dr. David Moher, a recognized expert on the science of research reporting and one of the founders of the Consolidated Standards of Reporting Trials (CONSORT) statement, was a guest speaker for the 2021 Hooker Distinguished Visiting Professor Lecture series at McMaster University and shared his insights about these issues. MAIN TEXT: This paper covers a discussion on the influence of reporting guidelines on trials and issues with the use of CONSORT as a measure of quality. Dr. Moher also addresses how the overwhelming body of COVID-19 research reflects the "publish or perish" paradigm in academia and why improvement in the reporting of trials requires policy initiatives from research institutions and funding agencies. We also discuss the rise of publication bias and other questionable reporting practices. To combat this, Dr. Moher believes open science and training initiatives led by institutions can foster research integrity, including the trustworthiness of researchers, institutions, and journals, as well as counter threats posed by predatory journals. He highlights how metrics like journal impact factor and quantity of publications also harm research integrity. Dr. Moher also discussed the importance of meta-science, the study of how research is carried out, which can help to evaluate audit and feedback systems and their effect on open science practices. CONCLUSION: Dr. Moher advocates for policy to further improve the reporting of trials and health research. The COVID-19 pandemic has exposed how a lack of open science practices and flawed systems incentivizing researchers to publish can harm research integrity. There is a need for a culture shift in assessing careers and "productivity" in academia, and this requires collaborative top-down and bottom-up approaches.

A systematic survey of methods guidance suggests areas for improvement regarding access, development, and transparency.

BACKGROUND: To assess the current practice of developing and presenting methods guidance and explore opportunities for improvement. STUDY DESIGN AND SETTING: We systematically surveyed methods guidance published in high-impact general and methodology-focused medical journals indexed in MEDLINE in 2020. We included articles that explicitly stated the objective to provide methods guidance for health research. We extracted characteristics related to findability, methods used for development, presentation, and transparency. RESULTS: We included 105 methods guidance articles published in 12 different journals. Less than half had a structured abstract (42%) or was indexed with medical subject headings (38%) or author keywords (17%) related to guidance. Methods for development, reported in 42%, differed between reporting guidelines (n = 13, 100% reported methods) and other guidance articles (n = 92, 34% reported methods). Frequent methods for presentation were illustrative case studies (45%), research checklists (34%), and step-by-step guides (10%). Most articles did not describe the authors' expertise (22%). Conflicts of interest, reported in 34%, were often unclear. CONCLUSION: Potential areas for improving methods guidance include better findability through more consistent labeling and indexing and standards for development and reporting.

Guidance relevant to the reporting of health equity in observational research: a scoping review protocol.

INTRODUCTION: Health inequities are defined as unfair and avoidable differences in health between groups within a population. Most health research is conducted through observational studies, which are able to offer real-world insights about etiology, healthcare policy/programme effectiveness and the impacts of socioeconomic factors. However, most published reports of observational studies do not address how their findings relate to health equity. Our team seeks to develop equity-relevant reporting guidance as an extension of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement. This scoping review will inform the development of candidate items for the STROBE-Equity extension. We will operationalise equity-seeking populations using the PROGRESS-Plus framework of sociodemographic factors. As part of a parallel stream of the STROBE-Equity project, the relevance of candidate guideline items to Indigenous research will be led by Indigenous coinvestigators on the team. METHODS AND ANALYSIS: We will follow the Joanna Briggs Institute method for conducting scoping reviews. We will evaluate the extent to which the identified guidance supports or refutes our preliminary candidate items for reporting equity in observational studies. These candidate items were developed based on items from equity-reporting guidelines for randomised trials and systematic reviews, developed by members of this team. We will consult with our knowledge users, patients/public partners and Indigenous research steering committee to invite suggestions for relevant guidance documents and interpretation of findings. If the identified guidance suggests the need for additional candidate items, they will be developed through inductive thematic analysis. ETHICS AND DISSEMINATION: We will follow a principled approach that promotes ethical codevelopment with our community partners, based on principles of cultural safety, authentic partnerships, addressing colonial structures in knowledge production and the shared ownership, interpretation, and dissemination of research. All products of this research will be published as open access.

Developing Reporting Guidelines for Studies of HIV Drug Resistance Prevalence: Protocol for a Mixed Methods Study.

BACKGROUND: HIV drug resistance is a global health problem that limits the effectiveness of antiretroviral therapy. Adequate surveillance of HIV drug resistance is challenged by heterogenous and inadequate data reporting, which compromises the accuracy, interpretation, and usability of prevalence estimates. Previous research has found that the quality of reporting in studies of HIV drug resistance prevalence is low, and thus better guidance is needed to ensure complete and uniform reporting. OBJECTIVE: This paper contributes to the process of developing reporting guidelines for prevalence studies of HIV drug resistance by reporting the methodology used in creating a reporting item checklist and generating key insights on items that are important to report. METHODS: We will conduct a sequential explanatory mixed methods study among authors and users of studies of HIV drug resistance. The two-phase design will include a cross-sectional electronic survey (quantitative phase) followed by a focus group discussion (qualitative phase). Survey participants will rate the essentiality of various reporting items. This data will be analyzed using content validity ratios to determine the items that will be retained for focus group discussions. Participants in these discussions will revise the items and any additionally suggested items and settle on a complete reporting item checklist. We will also conduct a thematic analysis of the group discussions to identify emergent themes regarding the agreement process. RESULTS: As of November 2021, data collection for both phases of the study is complete. In July 2021, 51 participants had provided informed consent and completed the electronic survey. In October 2021, focus group discussions were held. Nine participants in total participated in two virtual focus group discussions. As of May 2022, data are being analyzed. CONCLUSIONS: This study supports the development of a reporting checklist for studies of HIV drug resistance by achieving agreement among experts on what items should be reported in these studies. The results of this work will be refined and elaborated on by a writing committee of HIV drug resistance experts and external reviewers to develop finalized reporting guidelines. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35969.

Pilot and Feasibility Studies in Rehabilitation Research: A Review and Educational Primer for the Physiatrist Researcher.

ABSTRACT: Pilot and feasibility studies are conducted early in the clinical research pathway to evaluate whether a future, definitive study can or should be done and, if so, how. Poor planning and reporting of pilot and feasibility studies can compromise subsequent research efforts. Inappropriate labeling of studies as pilots also compromises education. In this review, first, a systematic survey of the current state of pilot and feasibility studies in rehabilitation research was performed, and second, recommendations were made for improvements to their design and reporting. In a random sample of 100 studies, half (49.5%) were randomized trials. Thirty (30.0%) and three (3.0%) studies used "pilot" and "feasibility" in the study title, respectively. Only one third (34.0%) of studies provided a primary objective related to feasibility. Most studies (92.0%) stated an intent for hypothesis testing. Although many studies (70.0%) mentioned outcomes related to feasibility in the methods, a third (30.0%) reported additional outcomes in the results and discussion only or commented on feasibility anecdotally. The reporting of progression plans to a main study (21.0%) and progression criteria (4.0%) was infrequent. Based on these findings, it is recommended that researchers correctly label studies as a pilot or feasibility design based on accepted definitions, explicitly state feasibility objectives, outcomes, and criteria for determining success of feasibility, justify the sample size, and appropriately interpret and report the implications of feasibility findings for the main future study.

A cross-sectional investigation of HIV prevalence and risk factors among African, Caribbean and Black people in Ontario: The A/C Study.

Background: The human immunodeficiency virus (HIV) epidemic has disproportionately affected African, Caribbean and Black (ACB) communities in Canada. We investigated the prevalence and factors associated with HIV infection among ACB people in Ontario. Methods: A cross-sectional survey of first- and second-generation ACB people aged 15-64 years in Toronto and Ottawa (Ontario, Canada). We collected sociodemographic information, self-reported HIV status and offered dried blood spot (DBS) testing to determine the prevalence of HIV infection. Factors associated with HIV infection were investigated using regression models. Results: A total of 1,380 people were interviewed and 834 (60.4%) tested for HIV. The HIV prevalence was 7.5% overall (95% confidence interval [CI] 7.1-8.0) and 6.6% (95% CI 6.1-7.1) in the adult population (15-49 years). Higher age (adjusted odds ratio [aOR] 2.8; 95% CI 2.77-2.82), birth outside of Canada (aOR 4.7; 95% CI 1.50-14.71), French language (aOR 9.83; 95% CI 5.19-18.61), unemployment (aOR 1.85; 95% CI 1.62-2.11), part-time employment (aOR 4.64; 95% CI 4.32-4.99), substance use during sex (aOR 1.66; 95% CI 1.47-1.88) and homosexual (aOR 19.68; 95% CI 7.64-50.71) and bisexual orientation (aOR 2.82; 95% CI 1.19-6.65) were associated with a positive HIV test. Those with a high school (aOR 0.01; 95% CI 0.01-0.02), college (aOR 0.00; 95% CI 0.00-0.01) or university education (aOR 0.00; 95% CI 0.00-0.01), more adequate housing (aOR 0.85; 95% CI 0.82-0.88), a higher social capital score (aOR 0.61; 95% CI 0.49-0.74) and a history of sexually transmitted infections (aOR 0.40; 95% CI 0.18-0.91) were less likely to have a positive HIV test. Conclusion: Human immunodeficiency virus infection is linked to sociodemographic, socioeconomic, and behavioural factors among ACB people in Ontario.

Improving Social Justice in COVID-19 Health Research: Interim Guidelines for Reporting Health Equity in Observational Studies.

The COVID-19 pandemic has highlighted the global imperative to address health inequities. Observational studies are a valuable source of evidence for real-world effects and impacts of implementing COVID-19 policies on the redistribution of inequities. We assembled a diverse global multi-disciplinary team to develop interim guidance for improving transparency in reporting health equity in COVID-19 observational studies. We identified 14 areas in the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist that need additional detail to encourage transparent reporting of health equity. We searched for examples of COVID-19 observational studies that analysed and reported health equity analysis across one or more social determinants of health. We engaged with Indigenous stakeholders and others groups experiencing health inequities to co-produce this guidance and to bring an intersectional lens. Taking health equity and social determinants of health into account contributes to the clinical and epidemiological understanding of the disease, identifying specific needs and supporting decision-making processes. Stakeholders are encouraged to consider using this guidance on observational research to help provide evidence to close the inequitable gaps in health outcomes.

The impact of routine HIV drug resistance testing in Ontario: A controlled interrupted time series study.

BACKGROUND: Knowledge of HIV drug resistance informs the choice of regimens and ensures that the most efficacious options are selected. In January 2014, a policy change to routine resistance testing was implemented in Ontario, Canada. The objective of this study was to investigate the policy change impact of routine resistance testing in people with HIV in Ontario, Canada since January 2014. METHODS: We used data on people with HIV living in Ontario from administrative databases of the Institute for Clinical Evaluative Sciences (ICES) and Public Health Ontario (PHO), and ran ordinary least squares (OLS) models of interrupted time series to measure the levels and trends of 2-year mortality, 2-year hospitalizations and 2-year emergency department visits before (2005-2013) and after the policy change (2014-2017). Outcomes were collected in biannual periods, generating 18 periods before the intervention and 8 periods after. We included a control series of people who did not receive a resistance test within 3 months of HIV diagnosis. RESULTS: Data included 12,996 people with HIV, of which 8881 (68.3%) were diagnosed between 2005 and 2013, and 4115 (31.7%) were diagnosed between 2014 and 2017. Policy change to routine resistance testing within 3 months of HIV diagnosis led to a decreasing trend in 2-year mortality of 0.8% every six months compared to the control group. No significant differences in hospitalizations or emergency department visits were noted. INTERPRETATION: The policy of routine resistance testing within three months of diagnosis is beneficial at the population level.

Characteristics and quality of systematic reviews and meta-analyses of observational nutritional epidemiology: a cross-sectional study.

BACKGROUND: Dietary recommendations and policies should be guided by rigorous systematic reviews. Reviews that are of poor methodological quality may be ineffective or misleading. Most of the evidence in nutrition comes from nonrandomized studies of nutritional exposures (usually referred to as nutritional epidemiology studies), but to date methodological evaluations of the quality of systematic reviews of such studies have been sparse and inconsistent. OBJECTIVES: We aimed to investigate the quality of recently published systematic reviews and meta-analyses of nutritional epidemiology studies and to propose guidance addressing major limitations. METHODS: We searched MEDLINE (January 2018-August 2019), EMBASE (January 2018-August 2019), and the Cochrane Database of Systematic Reviews (January 2018-February 2019) for systematic reviews of nutritional epidemiology studies. We included a random sample of 150 reviews. RESULTS: Most reviews were published by authors from Asia (n = 49; 32.7%) or Europe (n = 43; 28.7%) and investigated foods or beverages (n = 60; 40.0%) and cancer morbidity and mortality (n = 54; 36%). Reviews often had important limitations: less than one-quarter (n = 30; 20.0%) reported preregistration of a protocol and almost one-third (n = 42; 28.0%) did not report a replicable search strategy. Suboptimal practices and errors in the synthesis of results were common: one-quarter of meta-analyses (n = 30; 26.1%) selected the meta-analytic model based on statistical indicators of heterogeneity and almost half of meta-analyses (n = 50; 43.5%) did not consider dose-response associations even when it was appropriate to do so. Only 16 (10.7%) reviews used an established system to evaluate the certainty of evidence. CONCLUSIONS: Systematic reviews of nutritional epidemiology studies often have serious limitations. Authors can improve future reviews by involving statisticians, methodologists, and researchers with substantive knowledge in the specific area of nutrition being studied and using a rigorous and transparent system to evaluate the certainty of evidence.

Pregnancy outcomes in women with ankylosing spondylitis: a scoping literature and methodological review.

In this scoping review, we sought to summarize the types of outcomes collected in pregnant patients with ankylosing spondylitis (AS), and to identify some methodological limitations related to pregnancy research in these patients. A comprehensive search was done to identify relevant articles in MEDLINE and Embase. We included 21 studies assessing pregnancy outcomes in AS. Most studies reported disease flare during pregnancy, and few reported improved disease activity or stable disease. Disease flare occurred in 25-80% of patients during pregnancy and in 30-100% during the postpartum. There was no increased risk of pre-eclampsia across all studies. Based on two case-control studies, there was an increased risk for prematurity and small for gestational age in AS pregnancies, pooled odds ratio (95% confidence interval) 1.99 (1.30-3.05) and 2.41 (1.22-4.77), respectively. The etiologies of cesarean section were not related to joint issues from AS but were related to other causes like pre-eclampsia and prematurity. Some key methodological issues were related to the study design, selection of study participants, disease classification, choice of control participants, and outcome measures. Based on the current literature review, some key areas for future research should evaluate the disease state at conception, effects of pharmacological treatment for AS during pregnancy, and long-term outcomes of children born to women with AS. The use of pregnancy registers and validated measurement tools in pregnancy will help to improve the state and quality of evidence in this field. Key Points • Disease flare during pregnancy in patients with ankylosing spondylitis (AS) occurred in 25-80% of the cases in the various studies, and in 30-100% of the cases during the postpartum period. • There was an increased risk for prematurity, and no increased risk of pre-eclampsia or small for gestational age. Etiologies of cesarean section were not related to the hip or sacroiliac joint affection of the disease but to other causes like pre-eclampsia and prematurity. • This study provides a comprehensive overview of issues related to research on pregnant women with ankylosing spondylitis (AS). We addressed methodological issues related to the study design, selection of study participants, disease classification, control choice, assessment of outcomes measures, and statistical analysis. • The use of pregnancy registers and validated disease activity measurement tools for pregnancy can enhance pregnancy research in women with AS.

Tumor Necrosis Factor Inhibitor Dose Reduction for Axial Spondyloarthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

OBJECTIVE: The present study was undertaken to investigate the effectiveness and safety of dose reduction of tumor necrosis factor inhibitor (TNFi) therapy in the treatment of axial spondyloarthritis (SpA) compared to usual care. METHODS: We searched the Cochrane Central Register of Controlled Trials, Embase, Medline, and trial registries. We screened, extracted data, and assessed risk of bias in duplicate. Data were pooled using random-effects models; subgroup analyses were performed for type of TNFi, prior TNFi exposure, and follow-up duration. Outcomes of interest were Assessment of SpondyloArthritis international Society (ASAS) response and remission criteria, disease activity, relapse, and safety. RESULTS: We included 6 randomized trials with 747 participants (442 with ankylosing spondylitis and 305 with nonradiographic axial SpA). Compared to the standard dose, there were fewer events with the reduced dose for the ASAS criteria for 40% improvement (risk ratio [RR] 0.62 [95% confidence interval (95% CI) 0.49, 0.78]) and for ASAS partial remission (RR 0.17 [95% CI 0.06, 0.46]). There was a mean increase in the Bath Ankylosing Spondylitis Disease Activity Index score (mean difference [MD] 0.35 [95% CI 0.10, 0.60]) and no difference in C-reactive protein levels (MD 0.16 [95% CI -0.76, 1.07]) with the reduced dose. There were more disease flares/relapses (RR 1.73 [95% CI 1.32, 2.27]) with the reduced dose. There were no differences in infection rates (incidence rate ratio [IRR] 0.98 [95% CI 0.76, 1.25]) or injection/infusion reactions (IRR 0.71 [95% CI 0.42, 1.19]). CONCLUSION: Patients with axial SpA may experience little to no clinical benefit from reduction of TNFi therapy. Maintaining the standard dose probably improves the sustained effect on disease activity and helps to prevent disease flare.

Assessments of risk of bias in systematic reviews of observational nutritional epidemiologic studies are often not appropriate or comprehensive: a methodological study.

BACKGROUND: An essential component of systematic reviews is the assessment of risk of bias. To date, there has been no investigation of how reviews of non-randomised studies of nutritional exposures (called 'nutritional epidemiologic studies') assess risk of bias. OBJECTIVE: To describe methods for the assessment of risk of bias in reviews of nutritional epidemiologic studies. METHODS: We searched MEDLINE, EMBASE and the Cochrane Database of Systematic Reviews (Jan 2018-Aug 2019) and sampled 150 systematic reviews of nutritional epidemiologic studies. RESULTS: Most reviews (n=131/150; 87.3%) attempted to assess risk of bias. Commonly used tools neglected to address all important sources of bias, such as selective reporting (n=25/28; 89.3%), and frequently included constructs unrelated to risk of bias, such as reporting (n=14/28; 50.0%). Most reviews (n=66/101; 65.3%) did not incorporate risk of bias in the synthesis. While more than half of reviews considered biases due to confounding and misclassification of the exposure in their interpretation of findings, other biases, such as selective reporting, were rarely considered (n=1/150; 0.7%). CONCLUSION: Reviews of nutritional epidemiologic studies have important limitations in their assessment of risk of bias.

Reporting of methodological studies in health research: a protocol for the development of the MethodologIcal STudy reportIng Checklist (MISTIC).

INTRODUCTION: Methodological studies (ie, studies that evaluate the design, conduct, analysis or reporting of other studies in health research) address various facets of health research including, for instance, data collection techniques, differences in approaches to analyses, reporting quality, adherence to guidelines or publication bias. As a result, methodological studies can help to identify knowledge gaps in the methodology of health research and strategies for improvement in research practices. Differences in methodological study names and a lack of reporting guidance contribute to lack of comparability across studies and difficulties in identifying relevant previous methodological studies. This paper outlines the methods we will use to develop an evidence-based tool-the MethodologIcal STudy reportIng Checklist-to harmonise naming conventions and improve the reporting of methodological studies. METHODS AND ANALYSIS: We will search for methodological studies in the Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Embase, MEDLINE, Web of Science, check reference lists and contact experts in the field. We will extract and summarise data on the study names, design and reporting features of the included methodological studies. Consensus on study terms and recommended reporting items will be achieved via video conference meetings with a panel of experts including researchers who have published methodological studies. ETHICS AND DISSEMINATION: The consensus study has been exempt from ethics review by the Hamilton Integrated Research Ethics Board. The results of the review and the reporting guideline will be disseminated in stakeholder meetings, conferences, peer-reviewed publications, in requests to journal editors (to endorse or make the guideline a requirement for authors), and on the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network and reporting guideline websites. REGISTRATION: We have registered the development of the reporting guideline with the EQUATOR Network and publicly posted this project on the Open Science Framework (www.osf.io/9hgbq).

More pilot trials could plan to use qualitative data: a meta-epidemiological study.

BACKGROUND: Pilot trials often use quantitative data such as recruitment rate and retention rate to inform the design and feasibility of a larger trial. However, qualitative data such as patient, healthcare provider, and research staff perceptions of an intervention may also provide insights for a larger trial. METHODS: As part of a larger study investigating the reporting of progression criteria in pilot studies, we sought to determine how often pilot studies planned to use qualitative data to inform the design and feasibility of a larger trial and the factors associated with plans to use qualitative data. We searched for protocols of pilot studies of randomized trials in PubMed between 2013 and 2017. RESULTS: We included 227 articles. Only 92 (40.5%; 95% confidence interval [CI] 34.1-47.2) reported plans to collect qualitative data. The factors associated with collecting qualitative data were large studies (defined as sample size ≥ 60; adjusted odds ratio [aOR] 2.77; 95% CI 1.47-5.23; p = 0.002) and studies from Europe (aOR 3.86; 95% CI 1.68-8.88; p = 0.001) compared to North America and the rest of the world. Pilot trials with pharmacological interventions were less likely to plan to collect qualitative data (aOR 0.20; 95% CI 0.07-0.58; p = 0.003). CONCLUSIONS: Qualitative data is not used enough in pilot trials. Large pilot trials, pilot trials from Europe, and pilot trials of non-pharmacological interventions are more likely to plan for qualitative data.