Reporting transparency: making the ethical mandate explicit.

Improving the transparency and quality of reporting in biomedical research is considered ethically important; yet, this is often based on practical reasons such as the facilitation of peer review. Surprisingly, there has been little explicit discussion regarding the ethical obligations that underpin reporting guidelines. In this commentary, we suggest a number of ethical drivers for the improved reporting of research. These ethical drivers relate to researcher integrity as well as to the benefits derived from improved reporting such as the fair use of resources, minimizing risk of harms, and maximizing benefits. Despite their undoubted benefit to reporting completeness, questions remain regarding the extent to which reporting guidelines can influence processes beyond publication, including researcher integrity or the uptake of scientific research findings into policy or practice. Thus, we consider investigation on the effects of reporting guidelines an important step in providing evidence of their benefits

The RECORD reporting guidelines: meeting the methodological and ethical demands of transparency in research using routinely-collected health data.

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

The importance of decision intent within descriptions of pragmatic trials

ACKNOWLEGEMENTS This work is supported by the Canadian Institutes of Health Research through the Project Grant competition (competitive, peer-reviewed), award number PJT-153045. CRediT authorship contribution statement Stuart G. Nicholls: Writing - review & editing. Merrick Zwarenstein: Writing - review & editing. Spencer Phillips Hey: Writing - review & editing. Bruno Giraudeau: Writing - review & editing. Marion K. Campbell: Writing - review & editing. Monica Taljaard: Writing - review & editing.Peer reviewedPostprin

A protocol for a scoping review of equity measurement in mental health care for children and youth

Background: Mental health (MH) problems are among the most important causes of morbidity and mortality for children and youth. Problems of lack of equity in child and youth MH services (CYMHS)-including, but not limited to, problems in inaccessibility and quality of services-are widespread. Characterizing the nature of equity in CYMHS is an ongoing challenge because the field lacks a consistent approach to conceptualizing equity. We will conduct a scoping review of how equity in MH services for children and youth has been defined, operationalized, and measured. Our objectives are to discover: (1) What conceptual definitions of equity are used by observational studies of CYMHS?; (2) What service characteristics of CYMHS care do indices of equity cover?; (3) What population dimensions have been used to operationalize equity?; (4) What statistical constructs have been used in indices that measure CYMHS equity?; and (5) What were the numerical values of those indices? Methods: The following databases will be searched: Medline, Embase, PsycINFO, Cochrane Controlled Register of Trials, CINAHL, EconLit, and Sociological Abstracts. Searches will be conducted from the date of inception to the end of the last full calendar year (December 2019). Studies will be included if they include an evaluation of a mental health service for children or youth (defined as those under 19 years of age) and which quantify variation in some aspect of child or youth mental health services (e.g., accessibility, volume, duration, or quality) as a function of socio-demographic and/or geographic variables. Study selection will occur over two stages. Stage one will select articles based on title and abstract using the liberal-accelerated method. Stage two will review the full texts of selected titles. Two reviewers will work independently on full-text reviewing, with each study screened twice using pre-specified eligibility criteria. One reviewer will chart study characteristics and indices to be verified by a second reviewer. Reviewers will resolve full-text screening and data extraction disagreements through discussion. Synthesis of the collected data will focus on compiling and mapping the types and characteristics of the indices used to evaluate MH services equity. Discussion: The planned, systematic scoping review will survey the literature regarding how equity in MH services for children and youth has been operationalized and help inform future studies of equity in CYMHS. Systematic review registration: Open Science Foundation ID SYSR-D-19-00371, https://osf.io/58srv/

A protocol for a scoping review of equity measurement in mental health care for children and youth

Background: Mental health (MH) problems are among the most important causes of morbidity and mortality for children and youth. Problems of lack of equity in child and youth MH services (CYMHS)-including, but not limited to, problems in inaccessibility and quality of services-are widespread. Characterizing the nature of equity in CYMHS is an ongoing challenge because the field lacks a consistent approach to conceptualizing equity. We will conduct a scoping review of how equity in MH services for children and youth has been defined, operationalized, and measured. Our objectives are to discover: (1) What conceptual definitions of equity are used by observational studies of CYMHS?; (2) What service characteristics of CYMHS care do indices of equity cover?; (3) What population dimensions have been used to operationalize equity?; (4) What statistical constructs have been used in indices that measure CYMHS equity?; and (5) What were the numerical values of those indices? Methods: The following databases will be searched: Medline, Embase, PsycINFO, Cochrane Controlled Register of Trials, CINAHL, EconLit, and Sociological Abstracts. Searches will be conducted from the date of inception to the end of the last full calendar year (December 2019). Studies will be included if they include an evaluation of a mental health service for children or youth (defined as those under 19 years of age) and which quantify variation in some aspect of child or youth mental health services (e.g., accessibility, volume, duration, or quality) as a function of socio-demographic and/or geographic variables. Study selection will occur over two stages. Stage one will select articles based on title and abstract using the liberal-accelerated method. Stage two will review the full texts of selected titles. Two reviewers will work independently on full-text reviewing, with each study screened twice using pre-specified eligibility criteria. One reviewer will chart study characteristics and indices to be verified by a second reviewer. Reviewers will resolve full-text screening and data extraction disagreements through discussion. Synthesis of the collected data will focus on compiling and mapping the types and characteristics of the indices used to evaluate MH services equity. Discussion: The planned, systematic scoping review will survey the literature regarding how equity in MH services for children and youth has been operationalized and help inform future studies of equity in CYMHS. Systematic review registration: Open Science Foundation ID SYSR-D-19-00371, https://osf.io/58srv/

The REporting of Studies Conducted Using Observational Routinely-Collected Health Data (RECORD) Statement: Methods for Arriving at Consensus and Developing Reporting Guidelines.

OBJECTIVE: Routinely collected health data, collected for administrative and clinical purposes, without specific a priori research questions, are increasingly used for observational, comparative effectiveness, health services research, and clinical trials. The rapid evolution and availability of routinely collected data for research has brought to light specific issues not addressed by existing reporting guidelines. The aim of the present project was to determine the priorities of stakeholders in order to guide the development of the REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. METHODS: Two modified electronic Delphi surveys were sent to stakeholders. The first determined themes deemed important to include in the RECORD statement, and was analyzed using qualitative methods. The second determined quantitative prioritization of the themes based on categorization of manuscript headings. The surveys were followed by a meeting of RECORD working committee, and re-engagement with stakeholders via an online commentary period. RESULTS: The qualitative survey (76 responses of 123 surveys sent) generated 10 overarching themes and 13 themes derived from existing STROBE categories. Highest-rated overall items for inclusion were: Disease/exposure identification algorithms; Characteristics of the population included in databases; and Characteristics of the data. In the quantitative survey (71 responses of 135 sent), the importance assigned to each of the compiled themes varied depending on the manuscript section to which they were assigned. Following the working committee meeting, online ranking by stakeholders provided feedback and resulted in revision of the final checklist. CONCLUSIONS: The RECORD statement incorporated the suggestions provided by a large, diverse group of stakeholders to create a reporting checklist specific to observational research using routinely collected health data. Our findings point to unique aspects of studies conducted with routinely collected health data and the perceived need for better reporting of methodological issues

Intraoperative Blood Management Strategies for Patients Undergoing Noncardiac Surgery:The Ottawa Intraoperative Transfusion Consensus

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.</p

Patient and public involvement in pragmatic trials : online survey of corresponding authors of published trials

Acknowledgements The authors acknowledge Dr. Paxton Montgomery Moon, Alison Howie, Hayden Nix and Dr. Merrick Zwarenstein for their contributions to the data extraction. They also thank Drs. Bruno Giraudeau and Agnes Caille (University of Tours), Dr. Laura Hanson (University of North Carolina School of Medicine) and Dr. Jill Harrison (Brown University) for assistance with pilot testing of the survey questionnaire. Funding: This work was supported by the Canadian Institutes of Health Research through the Project Grant competition (competitive, peer-reviewed), award number PJT-153045, and the National Institute of Aging ( NIA) of the National Institutes of Health under Award Number U54AG063546, which funds NIA Imbedded Pragmatic Alzheimer’s Disease and Related Dementias Clinical Trials Collaboratory ( NIA IMPACT Collaboratory). The funders had no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.Peer reviewedPublisher PD

Systematic scoping review of cluster randomised trials conducted exclusively in low-income and middle-income countries between 2017 and 2022

Acknowledgements The authors would also like to thank Laura Quinn for assisting with full text screening, and Spencer Phillip Hey for assisting with ClincalTrials.gov data extraction and linkage.Peer reviewe

Systematic scoping review of cluster randomised trials conducted exclusively in low-income and middle-income countries between 2017 and 2022

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