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Stuart G Nicholls,1,2 Sinead M Langan,3 Henrik Toft Sørensen,4 Irene Petersen,4,5 Eric I Benchimol1,6 1Children’s Hospital of Eastern Ontario (CHEO) Research Institute, 2School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada; 3London School of Hygiene and Tropical Medicine, London, UK; 4Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 5Department of Primary Care and Population Health, University College London, London, UK; 6Department of Pediatrics and School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, ON, Canada Abstract: Routinely-collected health data (RCD) are now used for a wide range of studies, including observational studies, comparative effectiveness research, diagnostics, studies of adverse effects, and predictive analytics. At the same time, limitations inherent in using data collected without specific a priori research questions are increasingly recognized. There is also a growing awareness of the suboptimal quality of reports presenting research based on RCD. This has created a perfect storm of increased interest and use of RCD for research, together with inadequate reporting of the strengths and weaknesses of these data resources. The REporting of studies Conducted using Observational Routinely-collected Data (RECORD) statement was developed to address these limitations and to help researchers using RCD to meet their ethical obligations of complete and accurate reporting, as well as improve the utility of research conducted using RCD. The RECORD statement has been endorsed by more than 15 journals, including Clinical Epidemiology. This journal now recommends that authors submit the RECORD checklist together with any manuscript reporting on research using RCD. Keywords: observational studies, standards, research waste, assessment, publication

Brenda J Wilson, Stuart G Nicholls Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada Abstract: The language of “personalized medicine” and “personal genomics” has now entered the common lexicon. The idea of personalized medicine is the integration of genomic risk assessment alongside other clinical investigations. Consistent with this approach, testing is delivered by health care professionals who are not medical geneticists, and where results represent risks, as opposed to clinical diagnosis of disease, to be interpreted alongside the entirety of a patient's health and medical data. In this review we consider the evidence concerning the application of such personalized genomics within the context of population screening, and potential implications that arise from this. We highlight two general approaches which illustrate potential uses of genomic information in screening. The first is a narrowly targeted approach in which genetic profiling is linked with standard population-based screening for diseases; the second is a broader targeting of variants associated with multiple single gene disorders, performed opportunistically on patients being investigated for unrelated conditions. In doing so we consider the organization and evaluation of tests and services, the challenge of interpretation with less targeted testing, professional confidence, barriers in practice, and education needs. We conclude by discussing several issues pertinent to health policy, namely: avoiding the conflation of genetics with biological determinism, resisting the “technological imperative”, due consideration of the organization of screening services, the need for professional education, as well as informed decision making and public understanding. Keywords: genomics, personalized medicine, ethics, population health, evidence, education

Purpose: While there is limited patient-centred evidence (i.e., evidence that is important for patients and end-users) to inform the use of pharmacologic opioid minimization strategies (i.e., the use of opioid alternatives) for adult surgical patients requiring general anesthesia, such strategies are increasingly being adopted into practice. Our objectives were to describe anesthesiologists' beliefs regarding intraoperative opioid minimizing strategies use and utility, and to explore important clinical decision-making factors., Methods: We conducted a pan-Canadian web-based survey of anesthesiologists that was distributed using a modified Dillman technique. Our multidisciplinary team, including a patient partners panel, participated in the process of domains and items generation, items reduction, formatting, and composition. Our sampling frames were members of the Canadian Anesthesiologists' Society and members of the Association des Anesthésiologistes du Québec. We used the newsletters of each organization to distribute our survey, which was available in English and French and housed on the LimeSurvey (LimeSurvey GmbH, Hamburg, Germany) platform., Results: From our eligible sampling frame, 18% completed the survey (356 respondents out of 2,008 eligible participants). Most of the respondents believed that using opioid minimization strategies during general anesthesia could improve postoperative clinical outcomes, including pain control (84% agree or strongly agree, n = 344/409). Reported use of pharmacologic opioid minimization strategies was variable; however, most respondents believed that nonsteroidal anti-inflammatory drugs, acetaminophen, N-methyl-D-aspartate receptor antagonists (ketamine), α 2 -adrenoceptor agonists (dexmedetomidine), corticosteroids, and intravenous lidocaine improve prostoperative clinical outcomes. The primary factors guiding decision-making regarding the use of opioid minimization strategies were postoperative acute pain intensity, the impact of acute pain on functioning, patient well-being (i.e., quality of recovery) and patient satisfaction with care. A lack of evidence was the most important barrier limiting the use of opioid minimization strategies., Conclusion: In our survey of Canadian anesthesiologists, several opioid minimization strategies were believed to be effective complements to general anesthesia, although there was substantial variation in their reported use. Future randomized controlled trials and systematic reviews evaluating the effectiveness of opioid minimization strategies should prioritize patient-centred outcome measures assessment such as the quality of recovery or the impact of acute pain on functioning., (© 2024. Canadian Anesthesiologists' Society.)

Objective: Cluster randomised trials (CRTs) are used for evaluating health-related interventions in low-income and middle-income countries (LMICs) but raise complex ethical issues. To inform the development of future ethics guidance, we aim to characterise CRTs conducted exclusively in LMICs by examining the types of clusters, settings, author affiliations and primary clinical focus and to evaluate adherence to trial registration and ethics reporting requirements over time., Design: A systematic scoping review using the Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for Scoping Reviews., Data Sources: We searched MEDLINE between 1 January 2017 and 17 August 2022., Eligibility Criteria for Selecting Studies: We included primary reports of CRTs evaluating health-related interventions, conducted exclusively in LMICs and published in English between 2017 and 2022., Data Extraction and Synthesis: Data were extracted by one reviewer; a second reviewer verified accuracy by extracting data from 10% of the reports. Results were summarised overall and categorised by country's economic level or publication year., Results: Among 800 identified CRTs, 400 (50.0%) randomised geographical areas and 373 (46.6%) were conducted in Africa. 30 (3.7%) had no authors with an LMIC affiliation, and 246 (30.8%) had neither first nor last author with an LMIC affiliation. The relative frequency of first or last authors holding an LMIC affiliation increases as a country's economic level increases. Most CRTs focused on reducing maternal and neonatal disorders (106, 13.3%). 670 (83.8%) CRTs reported trial registration, 786 (98.2%) reported research ethics committee review and 757 (94.6%) reported consent statements. Among the 757 CRTs, 46 (6.1%) reported a waiver or no consent and, among these, 10 (21.7%) did not provide a rationale. Gatekeepers were identified in 403 (50.4%) CRTs. No meaningful trends were observed in adherence to trial registration or ethics reporting requirements over time., Conclusion: Our findings suggest existing inequity in authorship practices. There is high adherence to trial registration and ethics reporting requirements, although greater attention to reporting a justification for using a waiver of consent is needed., Competing Interests: Competing interests: CW receives consulting income from Cardialen and Eli Lilly & Company. Other authors declare no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Dexmedetomidine is increasingly used for surgical patients requiring general anaesthesia. However, its effectiveness on patient-centred outcomes remains uncertain. Our main objective was to evaluate the patient-centred effectiveness of intraoperative dexmedetomidine for adult patients requiring surgery under general anaesthesia., Methods: We conducted a systematic search of MEDLINE, Embase, CENTRAL, Web of Science, and CINAHL from inception to October 2023. Randomised controlled trials (RCTs) comparing intraoperative use of dexmedetomidine with placebo, opioid, or usual care in adult patients requiring surgery under general anaesthesia were included. Study selection, data extraction, and risk of bias assessment were performed by two reviewers independently. We synthesised data using a random-effects Bayesian regression framework to derive effect estimates and the probability of a clinically important effect. For continuous outcomes, we pooled instruments with similar constructs using standardised mean differences (SMDs) and converted SMDs and credible intervals (CrIs) to their original scale when appropriate. We assessed the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. Our primary outcome was quality of recovery after surgery. To guide interpretation on the original scale, the Quality of Recovery-15 (QoR-15) instrument was used (range 0-150 points, minimally important difference [MID] of 6 points)., Results: We identified 49,069 citations, from which 44 RCTs involving 5904 participants were eligible. Intraoperative dexmedetomidine administration was associated with improvement in postoperative QoR-15 (mean difference 9, 95% CrI 4-14, n=21 RCTs, moderate certainty of evidence). We found 99% probability of any benefit and 88% probability of achieving the MID. There was a reduction in chronic pain incidence (odds ratio [OR] 0.42, 95% CrI 0.19-0.79, n=7 RCTs, low certainty of evidence). There was also increased risk of clinically significant hypotension (OR 1.98, 95% CrI 0.84-3.92, posterior probability of harm 94%, n=8 RCTs) and clinically significant bradycardia (OR 1.74, 95% CrI 0.93-3.34, posterior probability of harm 95%, n=10 RCTs), with very low certainty of evidence for both. There was limited evidence to inform other secondary patient-centred outcomes., Conclusions: Compared with placebo or standard of care, intraoperative dexmedetomidine likely results in meaningful improvement in the quality of recovery and chronic pain after surgery. However, it might increase clinically important bradycardia and hypotension., Systematic Review Protocol: PROSPERO (CRD42023439896)., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance., (Copyright © 2024 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.)

Background: Postoperative patient-centred outcome measures are essential to capture the patient's experience after surgery. Although a large number of pharmacologic opioid minimisation strategies (i.e. opioid alternatives) are used for patients undergoing surgery, it remains unclear which strategies are most promising in terms of patient-centred outcome improvements. This scoping review had two main objectives: (1) to map and describe evidence from clinical trials assessing the patient-centred effectiveness of pharmacologic intraoperative opioid minimisation strategies in adult surgical patients, and (2) to identify promising pharmacologic opioid minimisation strategies., Methods: We searched MEDLINE, Embase, CENTRAL, Web of Science, and CINAHL databases from inception to February 2023. We included trials investigating the use of opioid minimisation strategies in adult surgical patients and reporting at least one patient-centred outcome. Study screening and data extraction were conducted independently by at least two reviewers., Results: Of 24,842 citations screened for eligibility, 2803 trials assessed the effectiveness of intraoperative opioid minimisation strategies. Of these, 457 trials (67,060 participants) met eligibility criteria, reporting at least one patient-centred outcome. In the 107 trials that included a patient-centred primary outcome, patient wellbeing was the most frequently used domain (55 trials). Based on aggregate findings, dexmedetomidine, systemic lidocaine, and COX-2 inhibitors were promising strategies, while paracetamol, ketamine, and gabapentinoids were less promising. Almost half of the trials (253 trials) did not report a protocol or registration number., Conclusions: Researchers should prioritise and include patient-centred outcomes in the assessment of opioid minimisation strategy effectiveness. We identified three potentially promising pharmacologic intraoperative opioid minimisation strategies that should be further assessed through systematic reviews and multicentre trials. Findings from our scoping review may be influenced by selective outcome reporting bias., Study Registration: OSF - https://osf.io/7kea3., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Objectives: To enhance equity in clinical and epidemiological research, it is crucial to understand researcher motivations for conducting equity-relevant studies. Therefore, we evaluated author motivations in a randomly selected sample of equity-relevant observational studies published during the COVID-19 pandemic., Study Design and Setting: We searched MEDLINE for studies from 2020 to 2022, resulting in 16,828 references. We randomly selected 320 studies purposefully sampled across income setting (high vs low-middle-income), COVID-19 topic (vs non-COVID-19), and focus on populations experiencing inequities. Of those, 206 explicitly mentioned motivations which we analyzed thematically. We used discourse analysis to investigate the reasons behind emerging motivations., Results: We identified the following motivations: (1) examining health disparities, (2) tackling social determinants to improve access, and (3) addressing knowledge gaps in health equity. Discourse analysis showed motivations stem from commitments to social justice and recognizing the importance of highlighting it in research. Other discourses included aspiring to improve health-care efficiency, wanting to understand cause-effect relationships, and seeking to contribute to an equitable evidence base., Conclusion: Understanding researchers' motivations for assessing health equity can aid in developing guidance that tailors to their needs. We will consider these motivations in developing and sharing equity guidance to better meet researchers' needs., Competing Interests: Declaration of competing interest L.G.C. is employed by the Pan American Health Organization (PAHO/WHO). The ideas expressed in this manuscript are the authors' own and do not necessarily reflect the decisions and policies of PAHO/WHO. There are no competing interests for any other author., (Copyright © 2024 Elsevier Inc. All rights reserved.)

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., Competing Interests: Disclosure of interest: The authors completed the ICMJE Disclosure of Interest Form (available upon request from the corresponding author) and declare the following activities and relationships: LGC is employed by the Pan American Health Organization (PAHO/WHO). The ideas expressed in this manuscript are the authors’ own and do not necessarily reflect the decisions and policies of PAHO/WHO. The remaining authors have no conflicts to declare., (Copyright © 2024 by the Journal of Global Health. All rights reserved.)

Background: Patient engagement in research is the meaningful and collaborative interaction between patients and researchers throughout the research process. Patient engagement can help to ensure patient-oriented values and perspectives are incorporated into the development, conduct, and dissemination of research. While patient engagement is increasingly prevalent in clinical research, it remains relatively unrealized in preclinical laboratory research. This may reflect the nature of preclinical research, in which routine interactions or engagement with patients may be less common. Our team of patient partners and researchers has previously identified few published examples of patient engagement in preclinical laboratory research, as well as a paucity of guidance on this topic. Here we propose the development of a process framework to facilitate patient engagement in preclinical laboratory research., Methods: Our team, inclusive of researchers and patient partners, will develop a comprehensive, empirically-derived, and stakeholder-informed process framework for 'patient engagement in preclinical laboratory research.' First, our team will create a 'deliberative knowledge space' to conduct semi-structured discussions that will inform a draft framework for preclinical patient engagement. Over the course of several sessions, we will identify actions, activities, barriers, and enablers (e.g. considerations and motivations for patient engagement in preclinical laboratory research, define roles of key players). The resulting draft process framework will be further populated with examples and refined through an international consensus-building Delphi survey with patients, researchers, and other collaborator organizations. We will then conduct pilot field tests to evaluate the framework with preclinical laboratory research groups paired with patient partners. These results will be used to create a refined framework enriched with real-world examples and considerations. All resources developed will be made available through an online repository., Discussion: Our proposed process framework will provide guidance, best practices, and standardized procedures to promote patient engagement in preclinical laboratory research. Supporting and facilitating patient engagement in this setting presents an exciting new opportunity to help realize the important impact that patients can make., (© 2024. The Author(s).)

Introduction: Children with chronic conditions have greater health care needs than the general paediatric population but may not receive care that centres their needs and preferences as identified by their families. Clinicians and researchers are interested in developing interventions to improve family-centred care need information about the characteristics of existing interventions, their development and the domains of family-centred care that they address. We conducted a scoping review that aimed to identify and characterize recent family-centred interventions designed to improve experiences with care for children with chronic conditions., Methods: We searched Medline, Embase, PsycInfo and Cochrane databases, and grey literature sources for relevant articles or documents published between 1 January 2019 and 11 August 2020 (databases) or 7-20 October 2020 (grey literature). Primary studies with ≥10 participants, clinical practice guidelines and theoretical articles describing family-centred interventions that aimed to improve experiences with care for children with chronic conditions were eligible. Following citation and full-text screening by two reviewers working independently, we charted data covering study characteristics and interventions from eligible reports and synthesized interventions by domains of family-centred care., Results: Our search identified 2882 citations, from which 63 articles describing 61 unique interventions met the eligibility criteria and were included in this review. The most common study designs were quasiexperimental studies (n = 18), randomized controlled trials (n = 11) and qualitative and mixed-methods studies (n = 9 each). The most frequently addressed domains of family-centred care were communication and information provision (n = 45), family involvement in care (n = 37) and access to care (n = 30)., Conclusion: This review, which identified 61 unique interventions aimed at improving family-centred care for children with chronic conditions across a range of settings, is a concrete resource for researchers, health care providers and administrators interested in improving care for this high-needs population., Patient or Public Contribution: This study was co-developed with three patient partner co-investigators, all of whom are individuals with lived experiences of rare chronic diseases as parents and/or patients and have prior experience in patient engagement in research (I. J., N. P., M. S.). These patient partner co-investigators contributed to this study at all stages, from conceptualization to dissemination., (© 2023 The Authors. Health Expectations published by John Wiley & Sons Ltd.)

Background: An integral aspect of patient engagement in research, also known as patient and public involvement, is appropriately recognising patient partners for their contributions through compensation (e.g., coauthorship, honoraria). Despite known benefits to compensating patient partners, our previous work suggested compensation is rarely reported and researchers perceive a lack of guidance on this issue. To address this gap, we identified and summarised available guidance and policy documents for patient partner compensation., Methods: We conducted this scoping review in accordance with methods suggested by the JBI. We searched the grey literature (Google, Google Scholar) in March 2022 and Overton (an international database of policy documents) in April 2022. We included articles, guidance or policy documents regarding the compensation of patient partners for their research contributions. Two reviewers independently extracted and synthesised document characteristics and recommendations., Results: We identified 65 guidance or policy documents. Most documents were published in Canada (57%, n = 37) or the United Kingdom (26%, n = 17). The most common recommended methods of nonfinancial compensation were offering training opportunities to patient partners (40%, n = 26) and facilitating patient partner attendance at conferences (38%, n = 25). The majority of guidance documents (95%) suggested financially compensating (i.e., offering something of monetary value) patient partners for their research contributions. Across guidance documents, the recommended monetary value of financial compensation was relatively consistent and associated with the role played by patient partners and/or specific engagement activities. For instance, the median monetary value for obtaining patient partner feedback (i.e., consultation) was $19/h (USD) (range of $12-$50/h). We identified several documents that guide the compensation of specific populations, including youth and Indigenous peoples., Conclusion: Multiple publicly available resources exist to guide researchers, patient partners and institutions in developing tailored patient partner compensation strategies. Our findings challenge the perception that a lack of guidance hinders patient partner financial compensation. Future efforts should prioritise the effective implementation of these compensation strategies to ensure that patient partners are appropriately recognised., Patient or Public Contributions: The patient partner coauthor informed protocol development, identified data items, and interpreted findings., (© 2024 The Authors. Health Expectations published by John Wiley & Sons Ltd.)

Background: The transition from childhood to adolescence is associated with an increase in rates of some psychiatric disorders, including major depressive disorder, a debilitating mood disorder. The aim of this systematic review is to update the evidence on the benefits and harms of screening for depression in primary care and non-mental health clinic settings among children and adolescents., Methods: This review is an update of a previous systematic review, for which the last search was conducted in 2017. We searched Ovid MEDLINE® ALL, Embase Classic+Embase, PsycINFO, Cochrane Central Register of Controlled Trials, and CINAHL on November 4, 2019, and updated on February 19, 2021. If no randomized controlled trials were found, we planned to conduct an additional search for non-randomized trials with a comparator group. For non-randomized trials, we applied a non-randomized controlled trial filter and searched the same databases except for Cochrane Central Register of Controlled Trials from January 2015 to February 2021. We also conducted a targeted search of the gray literature for unpublished documents. Title and abstract, and full-text screening were completed independently by pairs of reviewers., Results: In this review update, we were unable to find any randomized controlled studies that satisfied our eligibility criteria and evaluated the potential benefits and harms of screening for depression in children and adolescents. Additionally, a search for non-randomized trials yielded no studies that met the inclusion criteria., Conclusions: The findings of this review indicate a lack of available evidence regarding the potential benefits and harms of screening for depression in children and adolescents. This absence of evidence emphasizes the necessity for well-conducted clinical trials to evaluate the effectiveness of depression screening among children and adolescents in primary care and non-mental health clinic settings., Systematic Review Registration: PROSPERO CRD42020150373 ., (© 2024. The Author(s).)

Importance: There is marked variability in red blood cell (RBC) transfusion during the intraoperative period. The development and implementation of existing clinical practice guidelines have been ineffective in reducing this variability., Objective: To develop an internationally endorsed consensus statement about intraoperative transfusion in major noncardiac surgery., Evidence Review: A Delphi consensus survey technique with an anonymous 3-round iterative rating and feedback process was used. An expert panel of surgeons, anesthesiologists, and transfusion medicine specialists was recruited internationally. Statements were informed by extensive preparatory work, including a systematic reviews of intraoperative RBC guidelines and clinical trials, an interview study with patients to explore their perspectives about intraoperative transfusion, and interviews with physicians to understand the various behaviors that influence intraoperative transfusion decision-making. Thirty-eight statements were developed addressing (1) decision-making (interprofessional communication, clinical factors, procedural considerations, and audits), (2) restrictive transfusion strategies, (3) patient-centred considerations, and (4) research considerations (equipoise, outcomes, and protocol suspension). Panelists were asked to score statements on a 7-point Likert scale. Consensus was established with at least 75% agreement., Findings: The 34-member expert panel (14 of 33 women [42%]) included 16 anesthesiologists, 11 surgeons, and 7 transfusion specialists; panelists had a median of 16 years' experience (range, 2-50 years), mainly in Canada (52% [17 of 33]), the US (27% [9 of 33]), and Europe (15% [5 of 33]). The panel recommended routine preoperative and intraoperative discussion between surgeons and anesthesiologists about intraoperative RBC transfusion as well as postoperative review of intraoperative transfusion events. Point-of-care hemoglobin testing devices were recommended for transfusion guidance, alongside an algorithmic transfusion protocol with a restrictive hemoglobin trigger; however, more research is needed to evaluate the use of restrictive triggers in the operating room. Expert consensus recommended a detailed preoperative consent discussion with patients of the risks and benefits of both anemia and RBC transfusion and routine disclosure of intraoperative transfusion. Postoperative morbidity and mortality were recommended as the most relevant outcomes associated with intraoperative RBC transfusion, and transfusion triggers of 70 and 90 g/L were considered acceptable hemoglobin triggers to evaluate restrictive and liberal transfusion strategies, respectively, in clinical trials., Conclusions and Relevance: This consensus statement offers internationally endorsed expert guidance across several key domains on intraoperative RBC transfusion practice for noncardiac surgical procedures for which patients are at medium or high risk of bleeding. Future work should emphasize knowledge translation strategies to integrate these recommendations into routine clinical practice and transfusion research activities.

Objectives: Children and families are increasingly involved as equal partners in child health research, however, considerations around authorship have received little attention and there is limited guidance on the topic. Our objective was to determine the frequency and nature of patient partner authorship and/or acknowledgment among articles focused on patient engagement in child health research., Study Design and Setting: In this umbrella review, we searched MEDLINE, Embase, APA PsycINFO, Cochrane Database of Systematic Reviews, CINAHL, and Web of Science for systematic/scoping reviews on patient engagement in child health research. Individual articles included in eligible reviews comprised the sample of articles for analysis and were examined to identify patient partner authorship. Descriptive statistics were used to quantify patient partner authorship and/or acknowledgment and to summarize article characteristics., Results: Twelve systematic/scoping reviews met eligibility criteria, from which 230 individual articles were examined. In 16/230 (7%) articles, there was at least one patient partner author, and in 6/230 (3%) articles, patient partners were included as group authors. Within article Acknowledgments sections, patient partners were acknowledged by name in 41/230 (18%) articles, and anonymously or as a group in 98/230 (43%) articles. Patient partner authorship and/or acknowledgment was more frequent among articles published more recently (after 2015) and among articles where patient engagement was explicitly reported in the article., Conclusion: Patient partners were more likely to be acknowledged than listed as an author on articles on patient engagement in child health research. Understanding patient partner preferences about authorship and acknowledgment, examination of the unique aspects of child and youth authorship and developing supports to empower patient partner authorship are needed., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: There are few data on patient and public involvement (PPI) in pragmatic trials. We aimed to describe the prevalence and nature of PPI within pragmatic trials, describe variation in prevalence of PPI by trial characteristics and compare prevalence of PPI reported by trial authors to that reported in trial publications., Methods: We applied a search filter to identify pragmatic trials published from 2014 to 2019 in MEDLINE. We invited the corresponding authors of pragmatic trials to participate in an online survey about their specific trial., Results: Of 3163 authors invited, 2585 invitations were delivered, 710 (27.5%) reported on 710 unique trials and completed the survey; 334 (47.0%) conducted PPI. Among those who conducted PPI, for many the aim was to increase the research relevance (86.3%) or quality (76.5%). Most PPI partners were engaged at protocol development stages (79.1%) and contributed to the co-design of interventions (70.9%) or recruitment or retention strategies (60.5%). Patient and public involvement was more common among trials involving children, trials conducted in the United Kingdom, cluster randomized trials, those explicitly labelled as "pragmatic" in the study manuscript, and more recent trials. Less than one-quarter of trials (22.8%) that reported PPI in the survey also reported PPI in the trial manuscript., Interpretation: Nearly half of trialists in this survey reported conducting PPI and listed several benefits of doing so, but researchers who did not conduct PPI often cited a lack of requirement for it. Patient and public involvement appears to be significantly underreported in trial publications. Consistent and standardized reporting is needed to promote transparency about PPI methods, outcomes, challenges and benefits., Competing Interests: Competing interests: Charles Weijer reports receiving consulting fees from Cardialen and Eli Lilly & Company. Shelley Vanderhout reports receiving a Postdoctoral Fellowship Award and a System Impact Fellowship Award from the Canadian Institutes of Health Research (in support of the current manuscript). Anne Spinewine reports receiving a Mobility Grant from Fondation Mont-Godinne. No other competing interests were declared., (© 2023 CMA Impact Inc. or its licensors.)

Background: Patient engagement in research refers to collaboration between researchers and patients (i.e., individuals with lived experience including informal caregivers) in developing or conducting research. Offering non-financial (e.g., co-authorship, gift) or financial (e.g., honoraria, salary) compensation to patient partners can demonstrate appreciation for patient partner time and effort. However, little is known about how patient partners are currently compensated for their engagement in research. We sought to assess the prevalence of reporting patient partner compensation, specific compensation practices (non-financial and financial) reported, and identify benefits, challenges, barriers and enablers to offering financial compensation., Methods: We conducted a systematic review of studies citing the Guidance for Reporting the Involvement of Patients and the Public (GRIPP I and II) reporting checklists (October 2021) within Web of Science and Scopus. Studies that engaged patients as research partners were eligible. Two independent reviewers screened full texts and extracted data from included studies using a standardized data abstraction form. Data pertaining to compensation methods (financial and non-financial) and reported barriers and enablers to financially compensating patient partners were extracted. No formal quality assessment was conducted since the aim of the review is to describe the scope of patient partner compensation. Quantitative data were presented descriptively, and qualitative data were thematically analysed., Results: The search identified 843 studies of which 316 studies were eligible. Of the 316 studies, 91% (n = 288) reported offering a type of compensation to patient partners. The most common method of non-financial compensation reported was informal acknowledgement on research outputs (65%, n = 206) and co-authorship (49%, n = 156). Seventy-nine studies (25%) reported offering financial compensation (i.e., honoraria, salary), 32 (10%) reported offering no financial compensation, and 205 (65%) studies did not report on financial compensation. Two key barriers were lack of funding to support compensation and absence of institutional policy or guidance. Two frequently reported enablers were considering financial compensation when developing the project budget and adequate project funding., Conclusions: In a cohort of published studies reporting patient engagement in research, most offered non-financial methods of compensation to patient partners. Researchers may need guidance and support to overcome barriers to offering financial compensation., (© 2023. BioMed Central Ltd., part of Springer Nature.)

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., Competing Interests: Declaration of Competing Interest Although Luis Gabriel Cuervo is an official of the Pan American Health Organization, the views expressed in this publication are his sole responsibility and do not necessarily represent the decisions or policies of the Pan American Health Organization (PAHO/WHO)., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Despite known analgesic effects of breastfeeding (BF), skin-to-skin care (SSC), and sweet solutions (sucrose) for newborns, these interventions remain underutilized. Our team produced a five-minute parent-targeted video (BSweet2Babies) demonstrating BF, SSC, and sucrose during newborn blood sampling. We conducted a sequential exploratory mixed-methods study with eight maternal-newborn units across Ontario, Canada to identify barriers and facilitators to implementing the video and the three pain management strategies.Over a 6-month period, data collection included 15 telephone interviews, two email communications, and three community of practice teleconferences with the participating sites ( n = 8). We used the Theoretical Domains Framework as the coding matrix. Participants discussed integrating the video in prenatal education and the importance of involving leadership when planning for practice change. Key barriers included lack of comfort with parental presence, perception of high complexity of the strategies, short postpartum stays, competing priorities, and interprofessional challenges. Key facilitators included alignment with the Baby-Friendly Hospital Initiative, modeling by Lactation Consultants, and frequent reminders.

There is evidence of significant intraoperative red blood cell (RBC) transfusion variability that cannot be explained by case-mix, and may reflect unwarranted transfusions. The objective was to explore the source of intraoperative RBC transfusion variability by eliciting the beliefs of anesthesiologists and surgeons that underlie transfusion decisions. Interviews based on the Theoretical Domains Framework were conducted to identify beliefs about intraoperative transfusion. Content analysis was performed to group statements into domains. Relevant domains were selected based on frequency of beliefs, perceived influence on transfusion, and the presence of conflicting beliefs within domains. Of the 28 transfusion experts recruited internationally (16 anesthesiologists, 12 surgeons), 24 (86%) were Canadian or American and 11 (39%) identified as female. Eight relevant domains were identified: (1) Knowledge (insufficient evidence to guide intraoperative transfusion), (2) Social/professional role and identity (surgeons/anesthesiologists share responsibility for transfusions), (3) Beliefs about consequences (concerns about morbidity of transfusion/anemia), (4) Environmental context/resources (transfusions influenced by type of surgery, local blood supply, cost of transfusion), (5) Social influences (institutional culture, judgment by peers, surgeon-anesthesiologist relationship, patient preference influencing transfusion decisions), (6) Behavioral regulation (need for intraoperative transfusion guidelines, usefulness of audits and educational sessions to guide transfusion), (7) Nature of the behaviors (overtransfusion remains commonplace, transfusion practice becoming more restrictive over time), and (8) Memory, attention, and decision processes (various patient and operative characteristics are incorporated into transfusion decisions). This study identified a range of factors underlying intraoperative transfusion decision-making and partly explain the variability in transfusion behavior. Targeted theory-informed behavior-change interventions derived from this work could help reduce intraoperative transfusion variability., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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., (© 2023. The Author(s).)

Introduction: To improve dementia care delivery for persons across all backgrounds, it is imperative that health equity is integrated into pragmatic trials., Methods: We reviewed 62 pragmatic trials of people with dementia published 2014 to 2019. We assessed health equity in the objectives; design, conduct, analysis; and reporting using PROGRESS-Plus which stands for Place of residence, Race/ethnicity, Occupation, Gender/sex, Religion, Education, Socioeconomic status, Social capital, and other factors such as age and disability., Results: Two (3.2%) trials incorporated equity considerations into their objectives; nine (14.5%) engaged with communities; 4 (6.5%) described steps to increase enrollment from equity-relevant groups. Almost all trials (59, 95.2%) assessed baseline balance for at least one PROGRESS-Plus characteristic, but only 10 (16.1%) presented subgroup analyses across such characteristics. Differential recruitment, attrition, implementation, adherence, and applicability across PROGRESS-Plus were seldom discussed., Discussion: Ongoing and future pragmatic trials should more rigorously integrate equity considerations in their design, conduct, and reporting., Highlights: Few pragmatic trials are explicitly designed to inform equity-relevant objectives.Few pragmatic trials take steps to increase enrollment from equity-relevant groups.Disaggregated results across equity-relevant groups are seldom reported.Adherence to existing tools (e.g., IMPACT Best Practices, CONSORT-Equity) is key., Competing Interests: C.W. receives consulting income from Cardialen, Eli Lilly & Company, and Research Triangle Institute International. The other authors have no conflicting interests. Author disclosures are available in the supporting information., (© 2023 The Authors. Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring published by Wiley Periodicals, LLC on behalf of Alzheimer's Association.)

Background: While red blood cell (RBC) transfusions are frequently administered during surgery, little is known about patient perspectives regarding intraoperative transfusion. The aim of this study was to understand patient perspectives about intraoperative RBC transfusion and explore their willingness to engage in transfusion prevention strategies., Study Design and Methods: This descriptive qualitative study used semi-structured patient interviews before and after surgery. Purposive sampling was used to select adult patients with varying perioperative courses, including having perioperative transfusion or postoperative anemia. Inductive and deductive thematic analyses were conducted to identify themes., Results: Twenty patients (nine preoperative and 11 postoperative patients) were interviewed. The following themes were identified: Risk-benefit perception of transfusion, transfusion acceptance, trust, patient involvement in transfusion decisions, acceptance of transfusion prevention interventions, and communication. Patients perceived transfusions as low-risk compared to the surgery itself. Factors influencing transfusion acceptance included trust in the healthcare system and the perception of the treatability of transfusion-related complications. Some patients preferred to defer transfusion decision making to the perioperative team, citing trust in professional judgment and building a positive relationship with their surgeon. Others wished for their preferences to be incorporated into transfusion decisions. Some desired detailed blood consent conversations and most were willing to participate in strategies to reduce intraoperative transfusion., Conclusion: In our sample, patients consider intraoperative transfusions as low-risk high-reward interventions and trust the healthcare system and perioperative team to guide intraoperative transfusion decision making. However, preoperative transfusion consent discussions were recalled as being superficial and lacking nuance. Targeted strategies are required to improve blood consent discussions to better integrate patient preferences., (© 2023 AABB.)

Background: Institutional Review Boards (IRBs) are federally mandated to include both nonscientific and unaffiliated representatives in their membership. Despite this, there is no guidance or policy on the selection of unaffiliated or non-scientist members and reports indicate a lack of clarity regarding members' roles. In the present study we sought to explore processes of recruitment, training, and the perceived roles for unaffiliated and non-scientist members of IRBs., Methods: We distributed a self-administered REDCap survey of members of the Association for the Accreditation of Human Research Protection Programs familiar with IRB member recruitment. The survey included closed and open-ended questions regarding: the operation of the HRPP/IRB(s), how unaffiliated and non-scientist members are recruited, whether they had faced challenges recruiting for these roles, and training and mentorship offered. The survey also collected information regarding the perceived value and roles of unaffiliated and non-scientist members., Results: 76 responses were included in the analysis (38% completion rate). The most common approach for recruitment was referral from current IRB members, with almost half of respondents indicating challenges recruiting unaffiliated members. Over 75% indicated no additional training was provided to unaffiliated or non-scientist members compared to affiliated or scientist members. Most common supports provided were travel/parking expenses and honoraria. Commonly perceived roles were to provide an independent voice from the participant perspective, notably regarding consent processes and materials., Conclusions: Respondents indicated challenges in defining unaffiliated and non-scientist members and limited practices toward recruitment and support. Future work should more closely examine the challenges in defining these roles and applying the definitions in practice, as well as strategies that may improve recruitment and retention of unaffiliated and non-scientist members.

Objectives: To describe the extent to which pragmatic trials underachieved or overachieved their target sample sizes, examine explanations and identify characteristics associated with under-recruitment and over-recruitment., Study Design and Setting: Secondary analysis of an existing database of primary trial reports published during 2014-2019, registered in ClinicalTrials.gov, self-labelled as pragmatic and with target and achieved sample sizes available., Results: Of 372 eligible trials, the prevalence of under-recruitment (achieving <90% of target sample size) was 71 (19.1%) and of over-recruitment (>110% of target) was 87 (23.4%). Under-recruiting trials commonly acknowledged that they did not achieve their targets (51, 71.8%), with the majority providing an explanation, but only 11 (12.6%) over-recruiting trials acknowledged recruitment excess. The prevalence of under-recruitment in individually randomised versus cluster randomised trials was 41 (17.0%) and 30 (22.9%), respectively; prevalence of over-recruitment was 39 (16.2%) vs 48 (36.7%), respectively. Overall, 101 025 participants were recruited to trials that did not achieve at least 90% of their target sample size. When considering trials with over-recruitment, the total number of participants recruited in excess of the target was a median (Q1-Q3) 319 (75-1478) per trial for an overall total of 555 309 more participants than targeted. In multinomial logistic regression, cluster randomisation and lower journal impact factor were significantly associated with both under-recruitment and over-recruitment, while using exclusively routinely collected data and educational/behavioural interventions were significantly associated with over-recruitment; we were unable to detect significant associations with obtaining consent, publication year, country of recruitment or public engagement., Conclusions: A clear explanation for under-recruitment or over-recruitment in pragmatic trials should be provided to encourage transparency in research, and to inform recruitment to future trials with comparable designs. The issues and ethical implications of over-recruitment should be more widely recognised by trialists, particularly when designing cluster randomised trials., Competing Interests: Competing interests: CW receives consulting income from Cardialen, Eli Lilly & Company, and Research Triangle Institute International. The other authors declare that they have no competing interests., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Randomized trials labelled as "pragmatic" are attractive to funders, patients, and clinicians as the label implies that the results are directly applicable to clinical care. We examined how authors justify use of the label (e.g., by referring to one or more PRECIS [PRagmatic Explanatory Continuum Indicator Summary]-2 domains)., Study Design and Setting: We reviewed primary trial reports published 2014-2019, registered in ClinicalTrials.gov and using the pragmatic label anywhere in the report., Results: Among 415 trials, the label was justified by reference to at least one design element in 282 (68.0%); of these, 240 (85.1%) referenced trial characteristics that can be mapped to one or more of the PRECIS-2 domains, most commonly eligibility (91, 32.3%), setting (90, 31.9%), flexibility delivery (89, 31.6%), and organization (75, 26.6%); 42 (14.9%) referenced characteristics that are not PRECIS-2 domains, most commonly type of intervention/comparator (48, 17%), recruitment without consent (22, 7.8%), routinely collected data (22, 7.8%), and cluster randomization (20, 7.1%). Most reports referenced only one or two design elements. Overall, 9/415 (2.2%) provided PRECIS wheels., Conclusion: Current use of pragmatic labels is uninformative. Authors should clarify the decision the trial is intended to support and include a PRECIS-2 table to make the design transparent., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Purpose: To inform recommendations by the Canadian Task Force on Preventive Health Care on potentially inappropriate prescribing and over-the-counter (OTC) medication use among adults aged 65 years and older in primary care settings. This protocol outlines the planned scope and methods for a systematic review of the benefits and harms and acceptability of interventions to reduce potentially inappropriate prescriptions and OTC medication use., Methods: De novo systematic reviews will be conducted to synthesize the available evidence on (a) the benefits and harms of interventions to reduce potentially inappropriate prescriptions and OTC medications compared to no intervention, usual care, or non- or minimally active intervention among adults aged 65 years and older and (b) the acceptability of these interventions or attributes among patients. Outcomes of interest for the benefits and harms review are all-cause mortality, hospitalization, non-serious adverse drug reactions, quality of life, emergency department visits, injurious falls, medical visits, and the number of medications (and number of pills). Outcomes for the acceptability review are the preference for and relative importance of different interventions or their attributes. For the benefits and harms review, we will search MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for randomized controlled trials. For the acceptability review, we will search MEDLINE, Embase, PsycInfo, Cochrane Central Register of Controlled Trials, and the NHS Economic Evaluation Database for experimental and observational studies with a comparator. Websites of relevant organizations, other grey literature sources, and reference lists of included studies and reviews will be searched. Title and abstract screening will be completed by two independent reviewers using the liberal accelerated approach. Full-text review, data extraction, risk of bias assessments, and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will be completed independently by two reviewers, with any disagreements resolved by consensus or by consulting with a third reviewer. The GRADE approach will be used to assess the certainty of the evidence for outcomes., Discussion: The results of this systematic review will be used by the Canadian Task Force on Preventive Health Care to inform their recommendation on potentially inappropriate prescribing and OTC medication use among adults aged 65 years and older., Systematic Review Registration: PROSPERO (KQ1: CRD42022302313; KQ2: CRD42022302324); Open Science Framework ( https://osf.io/urj4b/ )., (© 2022. The Author(s).)

Background: A key component of patient-oriented research is the engagement of patients as partners in the design and conduct of health research. While there is now national infrastructure and networks to support the engagement of patients as partners, there remain calls for promising practices and success stories. In particular, there remains a keen interest in evaluating the impact that patient engagement has on health research studies. We aimed to investigate the impact that patient engagement had on health research conducted in Ontario, Canada., Methods: Our sampling frame was studies that were awarded funding by the Ontario SPOR SUPPORT Unit. Semi-structured interviews were conducted with 10 principal investigators, members of research teams, and patient partners. Interviews explored the role of patient partners, the perceived impact of the patient engagement on the study, challenges faced, and advice for other researchers considering patient engagement. Data were analysed using the thematic analysis method with transcripts coded independently by two members of the study team. All coding and subsequent theme generation were discussed until consensus was achieved., Results: There was variation in the methods used to engage patients and other stakeholders, the roles that patients and stakeholders occupied, and where they had input. Interviewees discussed two major areas of impact of patient engagement on research: impact on the study about which they were being interviewed, which tended to relate to improved relevancy of the research to the study population, and impact on themselves which led to changes in their own practice or approaches to future research. Identified challenges to patient engagement included: identifying and reaching patient advisors or patient partners, time-related challenges, and maintaining engagement over the course of the research., Conclusions: There remains a need to further build out the concept of relevancy and how it may be operationalised in practice. Further, the longer-term impacts of patient engagement on researchers and research teams remains under-explored and may reveal additional elements for evaluation. Challenges to patient engagement remain, including identifying and maintaining engagement with partners that reflect the diversity of the population of interest., (© 2022. The Author(s).)

Background: Depression affects an individual's physical health and mental well-being and, in pregnant and postpartum women, has specific adverse short- and long-term effects on maternal, child, and family health. The aim of these two systematic reviews is to identify evidence on the benefits and harms of screening for depression compared to no screening in the general adult and pregnant and postpartum populations in primary care or non-mental health clinic settings. These reviews will inform recommendations by the Canadian Task Force on Preventive Health Care., Methods: We searched MEDLINE, Embase, PsycINFO, CINAHL, and the Cochrane Library using a randomized controlled trial filter, where applicable, October 4, 2018, and updated to May 11, 2020. We also searched for gray literature (e.g., websites of organizations of health professionals and patients). Study selection for depression screening trials was performed first on title and abstract, followed by full-text screening. Data extraction, assessment of the risk of bias using the Cochrane risk of bias tool, and application of Grading of Recommendations Assessment, Development and Evaluation were performed by one reviewer and validated by a second reviewer., Results: A total of three trials were included. All three trials were included in the general adult review, while one of the three trials was included in the pregnant and postpartum review. We did not pool results due to substantial differences between studies and high risk of bias. In the general adult review, the first trial (n = 1001) evaluated whether screening for depression in adults with acute coronary syndrome compared to usual care improves health-related quality of life, depression symptoms, or harms of screening at 6, 12, and 18 months. There were little to no differences between the groups at 18 months for the outcomes. The second trial included adults (n = 1412) undergoing initial consultation for osteoarthritis, evaluated for depression and general health (mental and physical) after initial consultation and at 3, 6, and 12 months. The physical component score was statistically significantly lower (worse health) in the screened group at 6 months; however, this difference was not significant at 3 or at 12 months. There were no clinically important or statistically significant differences for other outcomes between groups at any time. The third trial (included in both reviews) reported on 462 postpartum women. At 6 months postpartum, fewer women in the screening group were identified as possibly depressed compared to the control group (RR 0.59, 95% confidence interval (CI) 0.39 to 0.89) and mean EPDS scores were also statistically significantly lower in the screened group (standardized mean difference 0.34 lower (95% CI 0.15 to 0.52 lower)). All other outcomes did not differ between groups at follow-up. There were serious concerns about the cut-offs used for the questionnaire used to screen, diagnostic confirmation, selective outcome reporting, and the reported magnitude of effects., Discussion: There are limitations of the evidence included in the reviews. There was moderate certainty in the evidence from one trial that screening for depression in the general adult population in primary care or non-mental health clinic settings likely results in little to no difference on reported outcomes; however, the evidence was uncertain from the other two included trials. The evidence is very uncertain about the effect of screening for depression in pregnant or postpartum women in primary care or non-mental health clinic settings. Well-conducted and better-reported trials are needed that meet the screening trial criteria used in this review., Systematic Review Registration: Both protocols have been registered in the International Prospective Registry of Systematic Reviews (PROSPERO) [adult: CRD42018099690 ; pregnancy and postpartum: CRD42018099689 ] and published ( https://systematicreviewsjournal.biomedcentral.com/track/pdf/10.1186/s13643-018-0930-3 )., (© 2022. The Author(s).)

Background: The overall aim of this program of research is to assess when/how patient partners are compensated financially for their contributions to health research. The research program consists of three studies to address the following questions: (1) What is the prevalence of reporting patient partner financial compensation? (2) What are researcher and institutional attitudes around patient partner financial compensation? (3) What are the current practices of patient partner financial compensation and what guidance exists to inform these practices?, Methods: In our first project, we will conduct a systematic review to assess the prevalence of reporting patient partner financial compensation and identify current financial compensation practices on an international scale. We will identify a cohort of published studies that have engaged patients as partners through a forward citation search of the Guidance for Reporting the Involvement of Patients and the Public (GRIPP I and II) checklists. We will extract details of financial compensation (type of financial compensation, amount, payment frequency etc.) and reported benefits, challenges, barriers and enablers to financially compensating patient partners. Quantitative data will be analyzed descriptively, and qualitative data will undergo thematic analysis. In our second project, we will conduct a cross-sectional survey of researchers who have engaged patient partners. We will also survey members of their affiliated institutions to gain further understanding of stakeholder experiences and attitudes with patient partner financial compensation. Survey responses will be analyzed by calculating prevalence. In our third project, we will conduct a scoping review to identify all published guidance and policy documents that guide patient partner financial compensation. Overton, the largest available online database of international policy documents, and the grey literature will be systematically searched. Data items will be extracted and presented descriptively. A comprehensive overview of guidance documents will be presented, which will represent a repository of resources that stakeholders can refer to when developing a financial compensation strategy., Discussion: Our three studies will not only inform and assist patient partners and researchers by informing compensation strategies, but also support the inclusion of diverse perspectives. We will disseminate findings through traditional mediums (publications, conferences) as well as social media, non-technical summaries, and visual abstracts., (© 2022. The Author(s).)

Introduction: This review aims to describe the landscape of pragmatic randomized controlled trials (RCTs) in the context of Alzheimer's disease (AD) and related dementias with respect to ethical considerations., Methods: Searches of MEDLINE were performed from January 2014 until April 2019. Extracted information included: trial setting, interventions, data collection, study population, and ethical protections (including ethics approvals, capacity assessment, and informed consent)., Results: We identified 62 eligible reports. More than two-thirds (69%) included caregivers or health-care professionals as research participants. Fifty-eight (94%) explicitly identified at least one vulnerable group. Two studies did not report ethics approval. Of 57 studies in which patients were participants, 55 (96%) reported that consent was obtained but in 37 studies (67%) no mention was made regarding assessment of the patients' capacity to consent to research participation., Discussion: Few studies reported protections implemented when vulnerable participants were included. Shortcomings remain when reporting consent approaches and capacity assessment., Competing Interests: Charles Weijer receives consulting income from Cardialen, Eli Lilly & Company, and Research Triangle Institute International. The other authors declare no conflicting interests., (© 2022 The Authors. Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring published by Wiley Periodicals, LLC on behalf of Alzheimer's Association.)

Introduction: Acromio-clavicular (AC) joint pathology is a disabling condition that can restrict quality of life through chronic pain and functional limitation. The objective of this study was to determine symptoms and patient-centred outcomes identified by patients with AC pathology and from experienced shoulder surgeons., Methods: Qualitative research methods were undertaken with patient and surgeon focus groups. Patients with AC-joint pathology were invited to participate and were stratified into two cohorts: AC instability and AC osteoarthritis (OA)., Results: Sixteen patients participated in five patient focus group discussions including 10 patients with AC instability and six patients with AC OA. Four surgeons participated in two focus groups. Although some themes were common to both AC Instability and AC OA, a number of themes were unique to each. A number of themes were identified that do not appear in existing AC joint scores., Conclusion: Although many factors affecting the AC joint were common to instability and OA pathology, several factors appear to be unique to each and do not appear in existing AC joint metrics. These symptoms and patient-centered outcomes may be used by clinicians in the assessment of patients with AC pathology and in the development of rehabilitation programs.Implications for rehabilitationA thorough understanding of symptoms and patient-centred outcomes associated with acromio-clavicular arthritis and instability is necessary in order to conduct an accurate clinical assessment and design an effective rehabilitation program that meets the clinical needs of patients.Patients in this study identified several themes relevant to assessment and rehabilitation program development including pain location, type of pain (eg. burning pain), and specific activities that induced pain that do not exist in current existing tools.Our finding that certain themes were only raised in either acromio-clavicular instability or osteoarthritis suggests that there may be differences in important outcomes for patients depending on the underlying cause of the acromio-clavicular joint pathology. By incorporating these themes into clinical assessments, outcomes important to patients may be elicited to monitor response to rehabilitation following injury or surgery.

Meta-research is the discipline of studying research itself. A core investigative tool in meta-research is the use of systematic or scoping reviews to study the characteristics, methods and reporting of primary research studies. In the context of identifying eligible publications for methodological reviews of randomized controlled trials (RCTs), a challenge is to efficiently distinguish the primary trial report - which reports results for the primary outcome - from other types of reports, including design papers and secondary or supplementary analyses, or what we collectively refer to as non-primary reports. This may not be a straightforward task and may contribute to inefficiencies in the review process. Here, we draw on our recent methodological review of over 13,000 records to identify primary reports of pragmatic RCTs. We offer recommendations to improve the reporting of RCTs to facilitate more efficient identification of primary trial reports. We suggest that future updates to existing CONSORT guidelines include consideration of multiple trial reports and recommendations to clarify the primary or non-primary nature of each report. Our recommendations, together with improved adherence to inclusion of the trial registration number in the abstract and citation of a protocol or previously published primary report, would facilitate the conduct of methodological reviews., (Copyright © 2022. Published by Elsevier Inc.)

Objectives: To describe prevalence of multiple primary outcomes, changes in primary outcomes and target sample sizes between protocols and final reports, and how issues of multiplicity are addressed in pragmatic trials., Study Design and Setting: Individually randomized trials labeled as pragmatic, published 2014-2019 in MEDLINE and registered with ClinicalTrials.gov., Results: We identified 262 final reports and located protocols for 159 (61%); primary outcomes were clearly reported in 145 (91%) protocols and 256 (98%) final reports. Thirty (19%) protocols and 38 (15%) final reports had multiple primary outcomes. Primary outcomes were present and identical in 128 (81%) matched protocol-final reports. Among 140 pairs with target sample sizes reported, 28 (20.0%) reduced their target sample size (mean 543 fewer participants per trial) and 16 (11.4%) increased it (mean 192 more participants per trial). Thirteen (29.5%) provided an explanation. Only 2 of 30 (7%) protocols and 4 of 38 (11%) final reports with co-primary outcomes explained how results would be interpreted in light of multiplicity; 21 of 30 (70%) protocols and 20 of 38 (53%) final reports accounted for co-primary outcomes in power calculations., Conclusion: Co-primary outcomes are common in pragmatic trials; improved transparency around design and analysis decisions involving co-primary outcomes is required., (Copyright © 2021. Published by Elsevier Inc.)

Introduction: Children with inherited metabolic diseases (IMDs) often have complex and intensive healthcare needs and their families face challenges in receiving high-quality, family centred health services. Improvement in care requires complex interventions involving multiple components and stakeholders, customised to specific care contexts. This study aims to comprehensively understand the healthcare experiences of children with IMDs and their families across Canada., Methods and Analysis: A two-stage explanatory sequential mixed methods design will be used. Stage 1: quantitative data on healthcare networks and encounter experiences will be collected from 100 parent/guardians through a care map, 2 baseline questionnaires and 17 weekly diaries over 5-7 months. Care networks will be analysed using social network analysis. Relationships between demographic or clinical variables and ratings of healthcare experiences across a range of family centred care dimensions will be analysed using generalised linear regression. Other quantitative data related to family experiences and healthcare experiences will be summarised descriptively. Ongoing analysis of quantitative data and purposive, maximum variation sampling will inform sample selection for stage 2: a subset of stage 1 participants will participate in one-on-one videoconference interviews to elaborate on the quantitative data regarding care networks and healthcare experiences. Interview data will be analysed thematically. Qualitative and quantitative data will be merged during analysis to arrive at an enhanced understanding of care experiences. Quantitative and qualitative data will be combined and presented narratively using a weaving approach (jointly on a theme-by-theme basis) and visually in a side-by-side joint display., Ethics and Dissemination: The study protocol and procedures were approved by the Children's Hospital of Eastern Ontario's Research Ethics Board, the University of Ottawa Research Ethics Board and the research ethics boards of each participating study centre. Findings will be published in peer-reviewed journals and presented at scientific conferences., Competing Interests: Competing interests: SD has been or is a member of advisory boards for, received indirect educational grants from, and/or received indirect speakers’ fees from Sanofi-Genzyme, Takeda, and Horizon Therapeutics. IDG is a recipient of a CIHR Foundation Grant (FDN# 143237). MP has been an advisory board member with honoraria from Ultragenyx (Mar/Apr 2021) and Horizon Therapeutics (Oct 2020), and received a speakers’ honorarium (Sep 2020) and small investigator grant ($6,000, 2019) from Horizon Therapeutics. SS received educational grants from Biomarin, Shire, Recordati and serves/served as PI in clinical trials and postmarketing registries sponsored by Actelion, Biomarin, Shire, Ultragenyx. KW is the CEO of CANImmunize Inc., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Aims: We need more pragmatic trials of interventions to improve care and outcomes for people living with Alzheimer's disease and related dementias. However, these trials present unique methodological challenges in their design, analysis, and reporting-often, due to the presence of one or more sources of clustering. Failure to account for clustering in the design and analysis can lead to increased risks of Type I and Type II errors. We conducted a review to describe key methodological characteristics and obtain a "baseline assessment" of methodological quality of pragmatic trials in dementia research, with a view to developing new methods and practical guidance to support investigators and methodologists conducting pragmatic trials in this field., Methods: We used a published search filter in MEDLINE to identify trials more likely to be pragmatic and identified a subset that focused on people living with Alzheimer's disease or other dementias or included them as a defined subgroup. Pairs of reviewers extracted descriptive information and key methodological quality indicators from each trial., Results: We identified N  = 62 eligible primary trial reports published across 36 different journals. There were 15 (24%) individually randomized, 38 (61%) cluster randomized, and 9 (15%) individually randomized group treatment designs; 54 (87%) trials used repeated measures on the same individual and/or cluster over time and 17 (27%) had a multivariate primary outcome (e.g. due to measuring an outcome on both the patient and their caregiver). Of the 38 cluster randomized trials, 16 (42%) did not report sample size calculations accounting for the intracluster correlation and 13 (34%) did not account for intracluster correlation in the analysis. Of the 9 individually randomized group treatment trials, 6 (67%) did not report sample size calculations accounting for intracluster correlation and 8 (89%) did not account for it in the analysis. Of the 54 trials with repeated measurements, 45 (83%) did not report sample size calculations accounting for repeated measurements and 19 (35%) did not utilize at least some of the repeated measures in the analysis. No trials accounted for the multivariate nature of their primary outcomes in sample size calculation; only one did so in the analysis., Conclusion: There is a need and opportunity to improve the design, analysis, and reporting of pragmatic trials in dementia research. Investigators should pay attention to the potential presence of one or more sources of clustering. While methods for longitudinal and cluster randomized trials are well developed, accessible resources and new methods for dealing with multiple sources of clustering are required. Involvement of a statistician with expertise in longitudinal and clustered designs is recommended.

Objectives: To describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent., Methods: Survey of primary trial reports, published 2014-2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov., Results: Among 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (p<0.0001) were significantly associated with not reporting on consent, while trial recency, cluster randomisation, higher-income country settings, health services research and explicit labelling as pragmatic were significantly associated with not obtaining consent (all p<0.0001)., Discussion: Not obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public's trust in research., Competing Interests: Competing interests: CW receives consulting income from Cardialen, Eli Lilly & Company, and Research Triangle Institute International. Other authors report no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and have no relevant interests to declare. The authors alone are responsible for the views expressed and they do not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated. Provenance and peer review: Not commissioned; externally peer reviewed.

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.

Objective: We established a large database of trials to serve as a resource for future methodological and ethical analyses. Here, we use meta-data to describe the broad landscape of pragmatic trials including research areas, identification as pragmatic, quality of trial registry data and enrolment., Study Design and Setting: Trials were identified by a validated search filter and included if a primary report of a health-related randomized trial published January 2014-April 2019. Data were collated from MEDLINE, Web of Science, ClinicalTrials.gov, and full text., Results: 4337 eligible trials were identified from 13,065 records, of which 1988 were registered in ClinicalTrials.gov. Research areas were diverse, with the most common being general and internal medicine; public, environmental and occupational health; and health care sciences and services. The term "pragmatic" was seldom used in titles or abstracts. Several domains in ClinicalTrials.gov had questionable data quality. We estimated that one-fifth of trials under-accrued by at least 15%., Conclusion: There is a need to improve reporting of pragmatic trials and quality of trial registry data. Under accrual remains a challenge in pragmatic RCTs despite calls for more streamlined recruitment approaches. The diversity of pragmatic trials should be reflected in future ethical analyses., (Copyright © 2021 Elsevier Inc. All rights reserved.)