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Abstract
Introduction The initiation and translation of sex-sensitive and gender-sensitive research programmes into clinically useful considerations for patients with traumatic brain injury (TBI) have been difficult. Clinical frameworks are currently not specific according to sex and gender, despite evidence that these constructs influence the incidence, course and outcome of patients with TBI. The present protocol outlines a strategy for a research programme, supported by the Canadian Institutes of Health Research (CIHR) Institute of Gender and Health, which explores sex and gender topics in the context of TBI, with the goal of building an infrastructure to facilitate the implementation of sex/gender-sensitive research findings into clinical considerations.
Methods and analysis A comprehensive multistep research programme is proposed to support three research objectives: (1) documentation of important concepts and ideas for education on topics of sex and gender in the TBI context using a knowledge-user feedback framework, current scientific evidence and the research team’s expertise; (2) development of educational materials for patients with TBI, significant others and clinicians providing care that account for sex/gender and (3) testing the application of these educational materials for feasibility and effectiveness. This programme supports the CIHR Institute’s mission by facilitating partnership with knowledge users across clinical, research, academic and community sectors, through a range of platforms and activities.
Ethics and dissemination The Research Ethics Board of the University Health Network has approved the programme. It is anticipated that this work will add significant value to the advancement of the field of sex, gender and health by serving as a model to foster the integration of these constructs across the spectrum of disorders. This will transform clinical practices and ensure that generated knowledge is translated into improved training programmes, policies and health services that are responsive to the diverse needs of men and women with TBI.
PROSPERO registration number CRD42018098697
- traumatic brain injury
- sex, gender and health research
- canadian institutes of healthcare research
- research partnerships
- knowledge production
- knowledge translation
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Footnotes
Contributors TM: study conception and design, definition of programme steps, protocol development and questionnaire development, ethics board applications and drafting of the manuscript. AC: study conception and design, research programme supervision and implementation; supervision of ethics board applications; and critical revision of the study protocol. HC, EQ and HH: significant contributions to study conception and design, and protocol development and refinement. SM: literature search and protocol development; and questionnaire development, drafting of the manuscript and all visual presentation featured in this work. VA: ethics board modifications and annual renewal, study piloting and data collection (phase 1 of the programme). AD: literature search and data analysis. All authors critically reviewed the final version of the manuscript and gave the final approval of the submitted manuscript.
Funding This research program is supported by the Canadian Institutes of Health Research (CIHR) Institutes of Gender and Health grant #CGW-126580. The study was peer-reviewed and funded by the CIHR Grant–Institute for Gender and Health (#CGW-126580). Ethics approval was granted by the Toronto Rehabilitation Institute-University Health Network and the University of Toronto Ethics Boards. During the work on this manuscript, the first author was supported by the postdoctoral research grant from the Alzheimer’s Association (AARF-16-442937). The funders had no role in the study design, decision to publish or preparation of the manuscript. This research program was developed with endorsement by patient and public organizations (table 1). The critical need to address sex and gender in brain injury research and rehabilitation, to ensure appropriate, equitable interventions for all patients, was highly endorsed by the leadership of these organizations, which reviewed the research program prior its submission to the funding agency (CIHR). These organizations acted as a liaison between our research team, the patients and the public. Dr Richard Riopelle, a member of the Brain Injury Canada Board of Directors and a primary knowledge user on the grant, and all our other partners are committed to engaging in further knowledge transfer events, meetings and dialogues to expand, share and disseminate project results and educational tools.
Competing interests None declared.
Ethics approval The study protocol was approved by the ethicscommittees at the clinical (Toronto Rehabilitation Institute–UniversityHealth Network, CAPCR: 17–5663) and academic research (University ofToronto, Protocol # 000361174) institutions at which the study is taking place.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators Richard Riopelle; Patrick Archambault; Nora Cullen; Michael Escobar; John Lewko; Cathy Irwin; Judith Gargaro; Bonnie Brayton.
Patient consent for publication Not required.