Publications by authors named "Peter Tugwell"

612 Publications

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

Int J Environ Res Public Health 2021 09 4;18(17). Epub 2021 Sep 4.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON L8S 4L8, Canada.

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.
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http://dx.doi.org/10.3390/ijerph18179357DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8431098PMC
September 2021

Development of a patient-centered core domain set for prospective observational longitudinal outcome studies in rheumatoid arthritis: an OMERACT initiative.

Semin Arthritis Rheum 2021 Oct 19;51(5):1113-1116. Epub 2021 Aug 19.

Department of Health Services Research and Section of Rheumatology and Clinical Immunology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address:

Objectives: To identify patient-centered core domains for prospective longitudinal observational studies (LOS) in rheumatoid arthritis.

Methods: Our working group held a virtual meeting in November 2020 to review data from a literature review and patient qualitative interviews, and to discuss strategies to move forward on domain identification and selection using the OMERACT 2.1 domain selection process.

Results: Important candidate domains and subdomains were identified including in the areas of life impact. Consensus was reached on moving forward with a Delphi process.

Conclusions: The meeting provided future directions to identify and select a core set of domains for use in LOS.
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http://dx.doi.org/10.1016/j.semarthrit.2021.08.003DOI Listing
October 2021

Bias Assessment in Outcomes Research: The Role of Relative Versus Absolute Approaches.

Value Health 2021 Aug 19;24(8):1145-1149. Epub 2021 May 19.

Department of Population Medicine, College of Medicine, QU Health, Qatar University, Doha, Qatar. Electronic address:

Objectives: Bias assessment tools vary in content and detail, and the method used for assessment may produce different assessment results in a study if not carefully considered. Therefore, taking an approach to the assessment of studies that produces a similar result regardless of the tool used for assessment (tool independence) is important.

Methods: A preexisting study that used 25 different quality scales was assessed to examine tool dependence of 2 common approaches to bias assessments-absolute value judgments (defined as the qualitative risk of bias judgment based on a threshold across studies) and relative ranks (defined as the relative probability toward bias of a study relative to the best assessed study). Agreement between each of the 25 scales and a composite scale (that includes all unique safeguards across all scales) was computed (using the intraclass correlation coefficient [ICC]; consistency). Tool dependence was considered present when the ICCs were inconsistent across the 25 scales for the same study.

Results: We found that using relative ranks for tools with different numbers and types of items produced consistent results, with only small differences in the agreement for the various tools with the composite tool, whereas consistency (measured by the ICC) varied considerably when using absolute judgments. Inconsistency is problematic because it means that the assessment result is linked to the scale and not to the study.

Conclusions: Tool independence is an important attribute of a bias assessment tool. On the basis of this study, the use of relative ranks retains tool independence and therefore produces consistent ranks for the same study across tools.
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http://dx.doi.org/10.1016/j.jval.2021.02.011DOI Listing
August 2021

Considerations and priorities for incorporating the patient perspective on remission in rheumatoid arthritis: An OMERACT 2020 special interest group report.

Semin Arthritis Rheum 2021 Oct 11;51(5):1108-1112. Epub 2021 Jul 11.

Department of Epidemiology & Data Science; and Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands.

Objective: To determine how best to incorporate the patient perspective into rheumatoid arthritis remission criteria.

Methods: At OMERACT 2020, several studies, including a longitudinal multi-centre study testing the validity of adding patient-valued domains to the ACR/EULAR criteria, were presented and discussed by the virtual Special Interest Group.

Results: Overall consensus was that there is insufficient evidence to change the remission criteria at this point. Future work should focus on measurement of the new domain of independence, clarifying the value of the patient global assessment, and optimizing the input of domains that patients value in the criteria.

Conclusion: Incorporating the patient perspective into remission criteria should be further explored.
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http://dx.doi.org/10.1016/j.semarthrit.2021.07.010DOI Listing
October 2021

Developing a composite outcome tool to measure response to treatment in ANCA-associated vasculitis: A mixed methods study from OMERACT 2020.

Semin Arthritis Rheum 2021 Oct 8;51(5):1134-1138. Epub 2021 Jul 8.

Division of Rheumatology, Department of Medicine, and Division of Clinical Epidemiology, Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, PA, United States.

Objective: The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group aims to develop composite response criteria for ANCA-Associated Vasculitis (AAV).

Methods: The project follows the OMERACT approach for composite measures: (i) choose relevant domains; (ii) define high-quality instruments; (iii) decide on a scoring system approach; (iv) put through the OMERACT Filter 2.1 for validation.

Results: A systematic literature review of outcome measures used in clinical trials in AAV and an international Delphi exercise among patients with AAV and clinician-investigators with expertise in AAV have been completed to inform the candidate domains/instruments for the composite response criteria, which are the first two steps in the OMERACT approach for developing composite measures. Results of the systematic literature review and Delphi were presented at the OMERACT 2020 virtual workshop, and feedback was received on the next steps of the project, including the development of a scoring system approach.

Conclusion: The ultimate goal of this project is to develop validated composite response criteria for use in clinical trials of AAV.
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http://dx.doi.org/10.1016/j.semarthrit.2021.07.001DOI Listing
October 2021

Improving benefit-harm assessment of glucocorticoid therapy incorporating the patient perspective: The OMERACT glucocorticoid core domain set.

Semin Arthritis Rheum 2021 Oct 25;51(5):1139-1145. Epub 2021 Jun 25.

Discipline of Medicine, Faculty of Health and Medical Sciences, The University of Adelaide, South Australia, Australia, Rheumatology Research Group, Basil Hetzel Institute for Translational Health Research, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia.

Objective: Our primary objective was to develop an Outcome Measures in Rheumatology (OMERACT) core domain set to capture the impact of glucocorticoids (GC), both positive and negative, on patients with Rheumatic conditions.

Methods: The OMERACT Filter 2.1 was used to guide core domain selection. Systematic literature reviews, qualitative studies and quantitative surveys were conducted by the OMERACT GC Impact working group to identify candidate domains for a core domain set. A summary of prior work and Delphi exercise were presented at the OMERACT 2020 virtual GC workshop. A proposed GC Impact core domain set derived from this work was presented for discussion in facilitated breakout groups. Participants voted on the proposed GC Impact core domain set.

Results: 113 people, including 23 patient research partners, participated in two virtual workshops conducted at different times on the same day. The proposed mandatory domains to be evaluated in clinical trials involving GCs were: infection, bone fragility, hypertension, diabetes, weight, fatigue, mood disturbance and death. In addition, collection of disease specific outcomes was included in the core domain set as "mandatory in specific circumstances". The proposed core domain set was endorsed by 100% (23/23) of the patient research partners and 92% (83/90) of the remaining participants, including clinicians, researchers and industry stakeholders.

Conclusion: A GC Impact core domain set was endorsed at the OMERACT 2020 virtual workshop. The OMERACT GC Impact working group will now progress to identify, develop and validate measurement tools to best address these domains in clinical trials.
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http://dx.doi.org/10.1016/j.semarthrit.2021.06.010DOI Listing
October 2021

Researchers' perspectives on methodological challenges and outcomes selection in interventional studies targeting medication adherence in rheumatic diseases: an OMERACT-adherence study.

BMC Rheumatol 2021 Jul 8;5(1):26. Epub 2021 Jul 8.

Collaboration for Outcomes Research and Evaluation, Faculty of Pharmaceutical Sciences, University of British Columbia, 2405 Wesbrook Mall, Vancouver, BC, V6T 1Z3, Canada.

Background: Research on adherence interventions in rheumatology is limited by methodological issues, particularly heterogeneous outcomes. We aimed to describe researchers' experiences with conducting interventional studies targeting medication adherence in rheumatology and their perspectives on establishing core outcomes.

Methods: Semi-structured interviews using audio conference were conducted with researchers who had conducted an adherence study of any design in the past 10 years. Data collection and thematic analysis were performed iteratively, until saturation.

Results: We interviewed 13 researchers, most of whom worked in academia and specialized in epidemiology and/or health services research. We identified three themes: 1) improving measurement of adherence (considering all phases of adherence, using appropriate and relevant measures, and establishing clinically meaningful thresholds); 2) challenges in designing and appraising adherence intervention studies (considering the confusion over a plethora of outcomes, difficulties with powering studies to demonstrate meaningful changes, and suboptimal descriptions of adherence interventions in published studies); and 3) advancing outcome assessment in adherence intervention studies (capturing rationale for developing a core domain set as well as recommendations and anticipated challenges by participants).

Conclusions: Uniquely gathering perspectives from international adherence researchers, our findings led to researcher-informed recommendations for improving adherence research including specifying the targeted adherence phase in designing interventions and studies and providing a glossary of terms to promote consistency in reporting. We also identified recommendations for developing a core domain set for interventional studies targeting medication adherence including involvement of patients, clinicians, and other stakeholders and methodological and practical considerations to establish rigor and support uptake.
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http://dx.doi.org/10.1186/s41927-021-00193-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8265120PMC
July 2021

Improving the quality of toxicology and environmental health systematic reviews: What journal editors can do.

ALTEX 2021 22;38(3):513-522. Epub 2021 Jun 22.

Program on Reproductive Health and the Environment, University of California San Francisco, San Francisco, CA, USA.

Systematic reviews are fast increasing in prevalence in the toxicology and environmental health literature. However, how well these complex research projects are being conducted and reported is unclear. Since editors have an essential role in ensuring the scientific quality of manuscripts being published in their journals, a workshop was convened where editors, systematic review practitioners, and research quality control experts could discuss what editors can do to ensure the systematic reviews they publish are of sufficient scientific quality. Interventions were explored along four themes: setting standards; reviewing protocols; optimizing editorial workflows; and measuring the effectiveness of editorial interventions. In total, 58 editorial interventions were proposed. Of these, 26 were shortlisted for being potentially effective, and 5 were prioritized as short-term actions that editors could relatively easily take to improve the quality of published systematic reviews. Recent progress in improving systematic reviews is summarized, and outstanding challenges to further progress are highlighted.
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http://dx.doi.org/10.14573/altex.2106111DOI Listing
June 2021

Towards development of core domain sets for short term and long term studies of calcium pyrophosphate crystal deposition (CPPD) disease: A framework paper by the OMERACT CPPD working group.

Semin Arthritis Rheum 2021 Aug 14;51(4):946-950. Epub 2021 Jun 14.

Bone and Joint Research Group, Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, 85 Park Road, Auckland, New Zealand.

Introduction: Although calcium pyrophosphate deposition (CPPD) is common, there are no published outcome domains or validated measurement instruments for CPPD studies. In this paper, we describe the framework for development of the Outcome Measures in Rheumatology (OMERACT) CPPD Core Domain Sets.

Methods: The OMERACT CPPD working group performed a scoping literature review and qualitative interview study. Generated outcomes were presented at the 2020 OMERACT CPPD virtual Special Interest Group (SIG) meeting with discussion focused on whether different core domain sets should be developed for different calcium pyrophosphate deposition (CPPD) clinical presentations and how the future CPPD Core Domain Set may overlap with already established osteoarthritis (OA) domains. These discussions informed development of a future work plan for development of the OMERACT CPPD Core Domain Sets.

Findings: Domains identified from a scoping review of 112 studies and a qualitative interview study of 36 people (28 patients with CPPD, 7 health care professionals, one stakeholder) were mapped to core areas of OMERACT Filter 2.1. The majority of SIG participants agreed there was need to develop separate core domain sets for "short term" and "long term" studies of CPPD. Although CPPD + OA is common and core domain sets for OA have been established, participants agreed that existing OA core domain sets should not influence the development of OMERACT core domain sets for CPPD. Prioritization exercises (using Delphi methodology) will consider 40 potential domains for short term studies of CPPD and 47 potential domains for long term studies of CPPD.

Conclusion: Separate OMERACT CPPD Core Domain Sets will be developed for "short term" studies for an individual flare of acute CPP crystal arthritis and for "long term" studies that may include participants with any clinical presentation of CPPD (acute CPP crystal arthritis, chronic CPP crystal inflammatory arthritis, and/or CPPD + OA).
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http://dx.doi.org/10.1016/j.semarthrit.2021.04.019DOI Listing
August 2021

Patient preferences to value health outcomes in rheumatology clinical trials: Report from the OMERACT special interest group.

Semin Arthritis Rheum 2021 Aug 24;51(4):919-924. Epub 2021 May 24.

Department of Community Health Sciences, University of Calgary, Calgary, Canada; Department of Medicine, University of Calgary, Calgary, Canada. Electronic address:

Objective: To inform a research plan for future studies by obtaining stakeholder input on the application of preference-based methods to clinical trial design.

Methods: We conducted a virtual OMERACT session to encourage stakeholder engagement. We developed materials for the session to facilitate discussion based on identified case examples and feedback sessions.

Results: Participants prioritized incorporating patient preferences in all aspects of trial design with an emphasis on outcome selection. Participants highlighted the need for careful consideration around preference heterogeneity and equity factors.

Conclusion: Including patient preferences in trial design was considered a priority requiring further exploration to develop comprehensive guidance.
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http://dx.doi.org/10.1016/j.semarthrit.2021.05.008DOI Listing
August 2021

Experts prioritize osteoarthritis non-surgical interventions from Cochrane systematic reviews for translation into "Evidence4Equity" summaries.

Int J Equity Health 2021 06 10;20(1):136. Epub 2021 Jun 10.

Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.

Objective: Osteoarthritis generates substantial health and socioeconomic burden, which is particularly marked in marginalized groups. It is imperative that practitioners have ready access to summaries of evidence-based interventions for osteoarthritis that incorporate equity considerations. Summaries of systematic reviews can provide this. The present study surveyed experts to prioritize a selection ofinterventions, from which equity focused summaries will be generated. Specifically, the prioritized interventions will be developed into Cochrane Evidence4Equity (E4E) summaries.

Methods: Twenty-seven systematic reviews of OA interventions were found. From these, twenty-nine non-surgical treatments for osteoarthritis were identified, based on statistically significant findings for desired outcome variables or adverse events. Key findings from these studies were summarised and provided to 9 experts in the field of osteoarthritis.. Expert participants were asked to rate interventions based on feasibility, health system effects, universality, impact on inequities, and priority for translation into equity based E4E summaries. Expert participants were also encouraged to make comments to provide context for each rating. Free text responses were coded inductively and grouped into subthemes and themes.

Results: Expert participants rated the intervention home land-based exercise for knee OA highest for priority for translation into an E4E summaries, followed by the interventions individual land-based exercise for knee OA, class land-based exercise for knee OA, exercise for hand OA and land-based exercise for hip OA. Upon qualitative analysis of the expert participants' comments, fifteen subthemes were identified and grouped into three overall themes: (1) this intervention or an aspect of this intervention is unnecessary or unsafe; (2) this intervention or an aspect of this intervention may increase health inequities; and (3) experts noted difficulties completing rating exercise.

Conclusion: The list of priority interventions and corresponding expert commentary generated information that will be used to direct and support knowledge translation efforts.
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http://dx.doi.org/10.1186/s12939-021-01477-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8193871PMC
June 2021

Update on the JCE GRADE series and other GRADE article types.

J Clin Epidemiol 2021 Jun 2. Epub 2021 Jun 2.

Department of Health Research Methods, Evidence, and Impact, Michael G. DeGroote Cochrane Canada & McMaster GRADE Centres, McMaster University, Hamilton, ON, Canada; Institute for Evidence in Medicine, Medical Center and Faculty of Medicine, University of Freiburg, Germany.

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http://dx.doi.org/10.1016/j.jclinepi.2021.05.023DOI Listing
June 2021

Behavioural interventions delivered through interactive social media for health behaviour change, health outcomes, and health equity in the adult population.

Cochrane Database Syst Rev 2021 05 31;5:CD012932. Epub 2021 May 31.

Methods Centre, Bruyère Research Institute, Ottawa, Canada.

Background: Social networking platforms offer a wide reach for public health interventions allowing communication with broad audiences using tools that are generally free and straightforward to use and may be combined with other components, such as public health policies. We define interactive social media as activities, practices, or behaviours among communities of people who have gathered online to interactively share information, knowledge, and opinions.

Objectives: We aimed to assess the effectiveness of interactive social media interventions, in which adults are able to communicate directly with each other, on changing health behaviours, body functions, psychological health, well-being, and adverse effects. Our secondary objective was to assess the effects of these interventions on the health of populations who experience health inequity as defined by PROGRESS-Plus. We assessed whether there is evidence about PROGRESS-Plus populations being included in studies and whether results are analysed across any of these characteristics.

Search Methods: We searched CENTRAL, CINAHL, Embase, MEDLINE (including trial registries) and PsycINFO. We used Google, Web of Science, and relevant web sites to identify additional studies and searched reference lists of included studies. We searched for published and unpublished studies from 2001 until June 1, 2020. We did not limit results by language.

Selection Criteria: We included randomised controlled trials (RCTs), controlled before-and-after (CBAs) and interrupted time series studies (ITSs). We included studies in which the intervention website, app, or social media platform described a goal of changing a health behaviour, or included a behaviour change technique. The social media intervention had to be delivered to adults via a commonly-used social media platform or one that mimicked a commonly-used platform. We included studies comparing an interactive social media intervention alone or as a component of a multi-component intervention with either a non-interactive social media control or an active but less-interactive social media comparator (e.g. a moderated versus an unmoderated discussion group). Our main outcomes were health behaviours (e.g. physical activity), body function outcomes (e.g. blood glucose), psychological health outcomes (e.g. depression), well-being, and adverse events. Our secondary outcomes were process outcomes important for behaviour change and included knowledge, attitudes, intention and motivation, perceived susceptibility, self-efficacy, and social support.

Data Collection And Analysis: We used a pre-tested data extraction form and collected data independently, in duplicate. Because we aimed to assess broad outcomes, we extracted only one outcome per main and secondary outcome categories prioritised by those that were the primary outcome as reported by the study authors, used in a sample size calculation, and patient-important.

Main Results: We included 88 studies (871,378 participants), of which 84 were RCTs, three were CBAs and one was an ITS. The majority of the studies were conducted in the USA (54%). In total, 86% were conducted in high-income countries and the remaining 14% in upper middle-income countries. The most commonly used social media platform was Facebook (39%) with few studies utilising other platforms such as WeChat, Twitter, WhatsApp, and Google Hangouts. Many studies (48%) used web-based communities or apps that mimic functions of these well-known social media platforms. We compared studies assessing interactive social media interventions with non-interactive social media interventions, which included paper-based or in-person interventions or no intervention. We only reported the RCT results in our 'Summary of findings' table. We found a range of effects on health behaviours, such as breastfeeding, condom use, diet quality, medication adherence, medical screening and testing, physical activity, tobacco use, and vaccination. For example, these interventions may increase physical activity and medical screening tests but there was little to no effect for other health behaviours, such as improved diet or reduced tobacco use (20,139 participants in 54 RCTs). For body function outcomes, interactive social media interventions may result in small but important positive effects, such as a small but important positive effect on weight loss and a small but important reduction in resting heart rate (4521 participants in 30 RCTs). Interactive social media may improve overall well-being (standardised mean difference (SMD) 0.46, 95% confidence interval (CI) 0.14 to 0.79, moderate effect, low-certainty evidence) demonstrated by an increase of 3.77 points on a general well-being scale (from 1.15 to 6.48 points higher) where scores range from 14 to 70 (3792 participants in 16 studies). We found no difference in effect on psychological outcomes (depression and distress) representing a difference of 0.1 points on a standard scale in which scores range from 0 to 63 points (SMD -0.01, 95% CI -0.14 to 0.12, low-certainty evidence, 2070 participants in 12 RCTs). We also compared studies assessing interactive social media interventions with those with an active but less interactive social media control (11 studies). Four RCTs (1523 participants) that reported on physical activity found an improvement demonstrated by an increase of 28 minutes of moderate-to-vigorous physical activity per week (from 10 to 47 minutes more, SMD 0.35, 95% CI 0.12 to 0.59, small effect, very low-certainty evidence). Two studies found little to no difference in well-being for those in the intervention and control groups (SMD 0.02, 95% CI -0.08 to 0.13, small effect, low-certainty evidence), demonstrated by a mean change of 0.4 points on a scale with a range of 0 to 100. Adverse events related to the social media component of the interventions, such as privacy issues, were not reported in any of our included studies. We were unable to conduct planned subgroup analyses related to health equity as only four studies reported relevant data.

Authors' Conclusions: This review combined data for a variety of outcomes and found that social media interventions that aim to increase physical activity may be effective and social media interventions may improve well-being. While we assessed many other outcomes, there were too few studies to compare or, where there were studies, the evidence was uncertain. None of our included studies reported adverse effects related to the social media component of the intervention. Future studies should assess adverse events related to the interactive social media component and should report on population characteristics to increase our understanding of the potential effect of these interventions on reducing health inequities.
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http://dx.doi.org/10.1002/14651858.CD012932.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8406980PMC
May 2021

PRIME-IPD SERIES Part 1. The PRIME-IPD tool promoted verification and standardization of study datasets retrieved for IPD meta-analysis.

J Clin Epidemiol 2021 Aug 24;136:227-234. Epub 2021 May 24.

School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, K1G 5Z3, Canada; WHO Collaborating Centre for Knowledge Translation and Health Technology Assessment in Health Equity, Bruyère Research Institute, 85 Primrose Ave, Ottawa, Ontario, K1R 6M1, Canada; Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario, K1Y 4W7, Canada.

Objectives: We describe a systematic approach to preparing data in the conduct of Individual Participant Data (IPD) analysis.

Study Design And Setting: A guidance paper proposing methods for preparing individual participant data for meta-analysis from multiple study sources, developed by consultation of relevant guidance and experts in IPD. We present an example of how these steps were applied in checking data for our own IPD meta analysis (IPD-MA).

Results: We propose five steps of Processing, Replication, Imputation, Merging, and Evaluation to prepare individual participant data for meta-analysis (PRIME-IPD). Using our own IPD-MA as an exemplar, we found that this approach identified missing variables and potential inconsistencies in the data, facilitated the standardization of indicators across studies, confirmed that the correct data were received from investigators, and resulted in a single, verified dataset for IPD-MA.

Conclusion: The PRIME-IPD approach can assist researchers to systematically prepare, manage and conduct important quality checks on IPD from multiple studies for meta-analyses. Further testing of this framework in IPD-MA would be useful to refine these steps.
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http://dx.doi.org/10.1016/j.jclinepi.2021.05.007DOI Listing
August 2021

PRIME-IPD SERIES Part 3. The PRIME-IPD tool fills a gap in guidance for preparing IPD for analysis.

J Clin Epidemiol 2021 Aug 15;136:224-226. Epub 2021 May 15.

School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, K1G 5Z3, Canada; Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario, K1Y 4W7, Canada.

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http://dx.doi.org/10.1016/j.jclinepi.2021.05.001DOI Listing
August 2021

Canadian Rheumatology Association Recommendation for the Use of COVID-19 Vaccination for Patients With Autoimmune Rheumatic Diseases.

J Rheumatol 2021 08 15;48(8):1330-1339. Epub 2021 May 15.

R. Nieuwlaat, MSc, PhD, Associate Professor, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

Objective: To develop guidance on the use of coronavirus disease 2019 (COVID-19) vaccines in patients with autoimmune rheumatic diseases (ARD).

Methods: The Canadian Rheumatology Association (CRA) formed a multidisciplinary panel including rheumatologists, researchers, methodologists, vaccine experts, and patients. The panel used the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach. Outcomes were prioritized according to their importance for patients and clinicians. Evidence from the COVID-19 clinical trials was summarized. Indirect evidence for non-COVID-19 vaccines in ARD was also considered. The GRADE evidence-to-decision (EtD) framework was used to develop a recommendation for the use of the 4 COVID-19 vaccines approved in Canada as of March 25, 2021 (BNT162b2, mRNA-1273, ChAdOx1, and Ad26.COV2.S), over 4 virtual panel meetings.

Results: The CRA guideline panel suggests using COVID-19 vaccination in persons with ARD. The panel unanimously agreed that for the majority of patients, the potential health benefits of vaccination outweigh the potential harms in people with ARDs. The recommendation was graded as conditional because of low or very low certainty of the evidence on the effects in the population of interest, primarily due to indirectness and imprecise effect estimates. The panel felt strongly that persons with autoimmune rheumatic diseases who meet local eligibility should not be required to take additional steps compared to people without ARDs to obtain their vaccination. Guidance on medications, implementation, monitoring of vaccine uptake, and research priorities are also provided.

Conclusion: This recommendation will be updated over time as new evidence emerges, with the latest recommendation, evidence summaries, and EtD available on the CRA website.
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http://dx.doi.org/10.3899/jrheum.210288DOI Listing
August 2021

Patient Perspectives on Outcome Domains of Medication Adherence Trials in Inflammatory Arthritis: An International OMERACT Focus Group Study.

J Rheumatol 2021 Sep 15;48(9):1480-1487. Epub 2021 May 15.

B.J. van den Bemt, Professor, PharmD, Radboud University Medical Centre, Research Institute for Health Sciences, and Sint Maartenskliniek, Nijmegen, the Netherlands. The authors declare no conflicts of interest relevant to this article.

Objective: To describe the perspectives of patients with inflammatory arthritis (IA) on outcome domains of trials evaluating medication adherence interventions.

Methods: Adult patients (≥ 18 yrs) with IA taking disease-modifying antirheumatic drugs from centers across Australia, Canada, and the Netherlands participated in 6 focus groups to discuss outcome domains that they consider important when participating in medication adherence trials. We analyzed the transcripts using inductive thematic analysis.

Results: Of the 38 participants, 23 (61%) had rheumatoid arthritis and 21 (55%) were female. The mean age was 57.3 ± (SD 15.0) years. Improved outcome domains that patients wanted from participating in an adherence trial were categorized into 5 types: medication adherence, adherence-related factors (supporting adherence; e.g., medication knowledge), pathophysiology (e.g., physical functioning), life impact (e.g., ability to work), and economic impact (e.g., productivity loss). Three overarching themes reflecting why these outcome domains matter to patients were identified: how taking medications could improve patients' emotional and physical fitness to maintain their social function; how improving knowledge and confidence in self-management increases patients' trust and motivation to take medications as agreed with minimal risk of harms; and how respect and reassurance, reflecting health care that values patients' opinions and is sensitive to patients' individual goals, could improve medication-taking behavior.

Conclusion: Patients value various outcome domains related to their overall well-being, confidence in medication use, and patient-healthcare provider relationships to be evaluated in future adherence trials.
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http://dx.doi.org/10.3899/jrheum.201568DOI Listing
September 2021

Endorsement of the OMERACT core domain set for shared decision making interventions in rheumatology trials: Results from a multi-stepped consensus-building approach.

Semin Arthritis Rheum 2021 06 6;51(3):593-600. Epub 2021 Apr 6.

Institute for Work & Health, Institute Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.

Objective: To gain consensus on the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials of shared decision making (SDM) interventions.

Methods: The process followed the OMERACT Filter 2.1 methodology, and used consensus-building methods, with patients involved since the inception. After developing the draft core domain set in previous research, we conducted five steps: (i) improving the draft core domain set; (ii) developing and disseminating white-board videos to promote its understanding; (iii) conducting an electronic survey to gather feedback on the draft core domain set; (iv) finalizing the core domain set and developing summaries, a plenary session video and discussion boards to promote its understanding; and (v) conducting virtual workshops with voting to endorse the core domain set.

Results: A total of 167 participants from 28 countries answered the survey (62% were patients/caregivers). Most participants rated domains as relevant (81%-95%) and clear (82%-93%). A total of 149 participants (n = 48 patients/caregivers, 101 clinicians/researchers) participated in virtual workshops and voted on the proposed core domain set which received endorsement by 95%. Endorsed domains are: 1- Knowledge of options, their potential benefits and harms; 2- Chosen option aligned with each patient's values and preferences; 3- Confidence in the chosen option; 4- Satisfaction with the decision-making process; 5- Adherence to the chosen option and 6- Potential negative consequences of the SDM intervention.

Conclusion: We achieved consensus among an international group of stakeholders on the OMERACT core domain set for rheumatology trials of SDM interventions. Future research will develop the Core Outcome Measurement Set.

Clinical Significance: Prior to this study, there had been no consensus on the OMERACT core domain set for SDM interventions. The current study shows that the OMERACT core domain set achieved a high level of endorsement by key stakeholders, including patients/caregivers, clinicians and researchers.
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http://dx.doi.org/10.1016/j.semarthrit.2021.03.017DOI Listing
June 2021

Are we measuring the right function outcomes for older adults in reviews by the Cochrane Musculoskeletal Group?

Semin Arthritis Rheum 2021 06 3;51(3):523-529. Epub 2021 Apr 3.

Bruyere Research Institute, 43 Bruyère Street, Ottawa K1N 5C8, Ontario, Canada. Electronic address:

Background: Musculoskeletal conditions are the leading cause of years lived with disability for older adults. Limitations in functional ability affect healthy aging for aging populations worldwide. Thus, it is important to assess effects of interventions on the multiple dimensions of function for older adults.

Objectives: To assess: (1) which domains of function are assessed in reviews published by the Cochrane Musculoskeletal Group inclusive of older adults, and (2) the extent to which these reviews evaluate effects and/or applicability of findings for older adults.

Methods: We included all reviews published by the Cochrane Musculoskeletal Review Group after 2015 including participants over the age of 50 (n = 52). We extracted data on how the activities and participation domains of the International Classification of Functioning (ICF) were measured. We assessed the extent to which reviews included methods to evaluate effects across age, according to the framework in the Cochrane Handbook chapter on equity and specific populations.

Results: The median age of participants across reviews was 54 years (range 16-94). ICF domains assessed in reviews, in descending order of frequency, were: domestic life (90%), mobility (89%), self-care (87%), interpersonal interactions and relationships (65%), community, social, and civic life (64%), major life areas (31%), communication (2%), general tasks and demands (0%) and learning and applying knowledge (0%). In evaluating effects across age, the age of participants was described by 73% of reviews and 54% mentioned age in the description of the condition, 21% planned subgroup analysis by age and none were able to conduct this analysis. Only 17% described applicability of results to older people.

Conclusions: Reviews published by the Cochrane Musculoskeletal Group inclusive of older adults assess most domains of functional ability with the exception of communication, general tasks and knowledge domains. None of these reviews were able to conduct a subgroup analysis across age, indicating a need to improve the consideration of age in both Cochrane reviews as well as in primary studies.
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http://dx.doi.org/10.1016/j.semarthrit.2021.04.001DOI Listing
June 2021

OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study.

Semin Arthritis Rheum 2021 06 2;51(3):601-606. Epub 2021 Apr 2.

Section for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark. Electronic address:

Objectives: To develop an operational definition of contextual factors (CF) [1].

Methods: Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying -, Outcome Influencing - and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs.

Results: Of 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consensus (≥70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive.

Conclusion: Through consensus we developed an operational definition of CFs, which was well received by OMERACT members.
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http://dx.doi.org/10.1016/j.semarthrit.2021.03.013DOI Listing
June 2021

The REPRISE project: protocol for an evaluation of REProducibility and Replicability In Syntheses of Evidence.

Syst Rev 2021 04 16;10(1):112. Epub 2021 Apr 16.

School of Public Health and Preventive Medicine, Monash University, 553 St. Kilda Road, Melbourne, Victoria, 3004, Australia.

Background: Investigations of transparency, reproducibility and replicability in science have been directed largely at individual studies. It is just as critical to explore these issues in syntheses of studies, such as systematic reviews, given their influence on decision-making and future research. We aim to explore various aspects relating to the transparency, reproducibility and replicability of several components of systematic reviews with meta-analysis of the effects of health, social, behavioural and educational interventions.

Methods: The REPRISE (REProducibility and Replicability In Syntheses of Evidence) project consists of four studies. We will evaluate the completeness of reporting and sharing of review data, analytic code and other materials in a random sample of 300 systematic reviews of interventions published in 2020 (Study 1). We will survey authors of systematic reviews to explore their views on sharing review data, analytic code and other materials and their understanding of and opinions about replication of systematic reviews (Study 2). We will then evaluate the extent of variation in results when we (a) independently reproduce meta-analyses using the same computational steps and analytic code (if available) as used in the original review (Study 3), and (b) crowdsource teams of systematic reviewers to independently replicate a subset of methods (searches for studies, selection of studies for inclusion, collection of outcome data, and synthesis of results) in a sample of the original reviews; 30 reviews will be replicated by 1 team each and 2 reviews will be replicated by 15 teams (Study 4).

Discussion: The REPRISE project takes a systematic approach to determine how reliable systematic reviews of interventions are. We anticipate that results of the REPRISE project will inform strategies to improve the conduct and reporting of future systematic reviews.
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http://dx.doi.org/10.1186/s13643-021-01670-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8052676PMC
April 2021

Provisional title: old world, new world.

J Clin Epidemiol 2021 04;132:A5-A6

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http://dx.doi.org/10.1016/j.jclinepi.2021.02.018DOI Listing
April 2021

Development of a checklist to guide equity considerations in health technology assessment.

Int J Technol Assess Health Care 2021 Jan 25;37:e17. Epub 2021 Jan 25.

Unité d'évaluation des technologies et des modes d'intervention en santé et services sociaux (UETMISSS), CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada J1G 2E8.

Objectives: Health technology assessment (HTA) can impact health inequities by informing healthcare priority-setting decisions. This paper presents a novel checklist to guide HTA practitioners looking to include equity considerations in their work: the equity checklist for HTA (ECHTA). The list is pragmatically organized according to the generic HTA phases and can be consulted at each step.

Methods: A first set of items was based on the framework for equity in HTA developed by Culyer and Bombard. After rewording and reorganizing according to five HTA phases, they were complemented by elements emerging from a literature search. Consultations with method experts, decision makers, and stakeholders further refined the items. Further feedback was sought during a presentation of the tool at an international HTA conference. Lastly, the checklist was piloted through all five stages of an HTA.

Results: ECHTA proposes elements to be considered at each one of the five HTA phases: Scoping, Evaluation, Recommendations and Conclusions, Knowledge Translation and Implementation, and Reassessment. More than a simple checklist, the tool provides details and examples that guide the evaluators through an analysis in each phase. A pilot test is also presented, which demonstrates the ECHTA's usability and added value.

Conclusions: ECHTA provides guidance for HTA evaluators wishing to ensure that their conclusions do not contribute to inequalities in health. Several points to build upon the current checklist will be addressed by a working group of experts, and further feedback is welcome from evaluators who have used the tool.
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http://dx.doi.org/10.1017/S0266462320002275DOI Listing
January 2021

When is systematic review replication useful, and when is it wasteful?

Rev Panam Salud Publica 2021 15;45:e11. Epub 2021 Jan 15.

Pan American Health Organization Washington, DC United States of America Pan American Health Organization, Washington, DC, United States of America.

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http://dx.doi.org/10.26633/RPSP.2021.11DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7815168PMC
January 2021

The MethodologicAl STandards for Epidemiological Research (MASTER) scale demonstrated a unified framework for bias assessment.

J Clin Epidemiol 2021 Jun 21;134:52-64. Epub 2021 Jan 21.

Department of Population Medicine, College of Medicine, QU Health, Qatar University, Doha, Qatar P.O. Box 2713, Qatar University Drive, Al Tarfa, Doha, Qatar. Electronic address:

Objective: This paper presents a unified framework for assessment of the methodological quality of analytic study designs.

Study Design And Setting: A systematic review of 393 methodological quality assessment tools that updated a previous assessment with 100 tools. Tool items were extracted, examined and reworded. Bias domains and finally methodological standards to be fulfilled were defined.

Results: There were 36 unique methodological safeguards that were categorized into seven methodological standards to be fulfilled in the MASTER scale. These methodological standards reflect initial and ongoing equivalence in particular areas, including equal recruitment, equal retention, equal ascertainment, equal implementation, equal prognosis, sufficient analysis, and temporal precedence.

Conclusion: This approach unifies existing methods for methodological quality assessment and will be useful for (1) clinical researchers when a bias assessment of clinical research studies is required across analytical designs, (2) promoting a unified framework for bias assessment.
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http://dx.doi.org/10.1016/j.jclinepi.2021.01.012DOI Listing
June 2021

Harms reported by patients in rheumatology drug trials: a systematic review of randomized trials in the cochrane library from an OMERACT working group.

Semin Arthritis Rheum 2021 06 9;51(3):607-617. Epub 2021 Jan 9.

Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark. Electronic address:

Background: Underreporting of harms in randomized controlled trials (RCTs) may lead to incomplete or erroneous assessments of the perceived benefit-to-harm profile of an intervention. To compare benefit with harm in clinical practice and future clinical studies, adverse event (AE) profiles including severity need to be understood. Even though patients report harm symptoms earlier and more frequently than clinicians, rheumatology RCTs currently do not provide a reporting framework from the patient's perspective regarding harms. Our objective for this meta-research project was to identify AEs in order to determine harm clusters and whether these could be self-reported by patients. Our other objective was to examine reported severity grading of the reported harms.

Methods: We considered primary publications of RCTs eligible if they were published between 2008 and 2018 evaluating pharmacological interventions in patients with a rheumatic or musculoskeletal condition and if they were included in Cochrane reviews. We extracted data on harms such as reported AE terms together with severity (if described), and categorized AE- and severity-terms into overall groups. We deemed all AEs with felt components appropriate for patient self-reporting.

Results: The literature search identified 187 possible Cochrane reviews, of which 94 were eligible for evaluation, comprising 1,297 articles on individual RCTs. Of these RCTs, 93 pharmacological trials met our inclusion criteria (including 31,023 patients; representing 20,844 accumulated patient years), which reported a total of 21,498 AEs, corresponding to 693 unique reported terms for AEs. We further sub-categorized these terms into 280 harm clusters (i.e., themes). AEs appropriate for patient self-reporting accounted for 58% of the AEs reported. Among the reported AEs, we identified medical terms for all of the 117 harm clusters appropriate for patient reporting and lay language terms for 86%. We intended to include severity grades of the reported AEs, but there was no evidence for systematic reporting of clinician- or patient-reported severity in the primary articles of the 93 trials. However, we identified 33 terms suggesting severity, but severity grading was discernible in only 9%, precluding a breakdown by severity in this systematic review.

Conclusions: Our results support the need for a standardized framework for patients' reporting of harms in rheumatology trials. Reporting of AEs with severity should be included in future reporting of harms, both from the patients' and investigators' perspectives.

Registration: PROSPERO: CRD42018108393.
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http://dx.doi.org/10.1016/j.semarthrit.2020.09.023DOI Listing
June 2021
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