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

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

Stakeholder views regarding ethical issues in the design and conduct of pragmatic trials : study protocol

This work is supported by the Canadian Institutes of Health Research through the Project Grant competition (competitive, peer reviewed), award number PJT-153045. Jeremy Grimshaw holds a Canada Research Chair in Health Knowledge Transfer and Uptake and a CIHR Foundation Grant (FDN-143269). Charles Weijer holds a Canada Research Chair in Bioethics. Joanne McKenzie is supported by an Australian National Health and Medical Research Council Career Development Fellowship (1143429). Vipul Jairath hold a personal Endowed Chair at Western University (John and Susan McDonald Endowed Chair). Marion Campbell is based with the Health Services Research Unit which is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. Ian Graham is a CIHR Foundation Grant recipient (FDN# 143237).Peer reviewedPublisher PD

Not all mitochondrial carrier proteins support permeability transition pore formation: no involvement of uncoupling protein 1

The mPTP (mitochondrial permeability transition pore) is a non-specific channel that is formed in the mitochondrial inner membrane in response to several stimuli, including elevated levels of matrix calcium. The pore is proposed to be composed of the ANT (adenine nucleotide translocase), voltage-dependent anion channel and cyclophilin D. Knockout studies, however, have demonstrated that ANT is not essential for permeability transition, which has led to the proposal that other members of the mitochondrial carrier protein family may be able to play a similar function to ANT in pore formation. To investigate this possibility, we have studied the permeability transition properties of BAT (brown adipose tissue) mitochondria in which levels of the mitochondrial carrier protein, UCP1 (uncoupling protein 1), can exceed those of ANT. Using an improved spectroscopic assay, we have quantified mPTP formation in de-energized mitochondria from wild-type and Ucp1KO (Ucp1-knockout) mice and assessed the dependence of pore formation on UCP1. When correctly normalized for differences in mitochondrial morphology, we find that calcium-induced mPTP activity is the same in both types of mitochondria, with similar sensitivity to GDP (approximately 50% inhibited), although the portion sensitive to cyclosporin A is higher in mitochondria lacking UCP1 (approximately 80% inhibited, compared with approximately 60% in mitochondria containing UCP1). We conclude that UCP1 is not a component of the cyclosporin A-sensitive mPTP in BAT and that playing a role in mPTP formation is not a general characteristic of the mitochondrial carrier protein family but is, more likely, restricted to specific members including ANT