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Objectives: To quantify variation in the association between episiotomy and obstetric anal sphincter injury (OASI) by maternity care provider in spontaneous and operative vaginal deliveries (SVDs and OVDs)., Methods: Population-based retrospective cohort study of vaginal, term deliveries among nullipara in Canada (2004-2015). Adjusted rate ratios (ARRs) and 95% CIs were estimated using log-binomial regression to quantify the associations between episiotomy and OASI, stratified by care provider (obstetrician [OB], family physician [FP], or registered midwife [RM]) while adjusting for potential confounders., Results: The study included 631 642 deliveries. Episiotomy use varied by provider: among SVDs, the episiotomy rate was 19.6%, 14.4%, and 8.4% in the OB, FP, and RM groups, respectively. The rate of OASI was higher among SVDs with versus without episiotomy (5.8% vs 4.6%). Conversely, OASI occurred less frequently in operative vaginal deliveries with episiotomy (15.3%) compared with those without (16.7%). In all provider groups, the ARR for OASI was increased with episiotomy in SVD and decreased with episiotomy with forceps delivery. No differences in these associations were observed by provider except among vacuum delivery (ARR with episiotomy vs. without, OB: 0.88, 95% CI 0.84-0.92; FP: 0.89, 95% CI 0.83-0.96, RM: 1.22, 95% CI 1.02-1.48)., Conclusions: In nullipara, irrespective of maternity care provider, there is a positive association between episiotomy and OASI among SVDs and an inverse association between episiotomy and deliveries with forceps. The relationship between episiotomy and OASI is modified by maternity care providers among vacuum deliveries., (Copyright © 2024 The Author. Published by Elsevier Inc. All rights reserved.)

Background: A 2017 systematic review suggested patient engagement in clinical trials has been limited, with little active engagement in trial design or data analysis, interpretation or dissemination. Additionally, there remains limited sex/gender reporting in clinical trial research., Objectives: The overall goal of this project was to disseminate sex/gender knowledge and build capacity for patient engagement in clinical trials. Specific objectives were to (1) create capacity and identify opportunities for patient engagement in clinical trials and sponsor- or investigator-led activities (e.g. clinical trial design and conduct); and (2) enhance new/early investigator sex/gender knowledge and skills related to patient-oriented research (POR)., Methods: We used the Canadian Institutes of Health Research Strategy for Patient-Oriented Research (SPOR) Capacity Development Framework and the SPOR Patient Engagement Framework to guide three phases of this project: (1) conduct a scoping review using methods described by the Evidence for Policy and Practice Information (EPPI) and the Coordinating Centre at the Institute of Education (Phase 1); (2) host a 1-day POR consultation workshop (Phase 2); and (3) deliver a new/early investigator POR training day (Phase 3). Six electronic databases (CINAHL, MEDLINE, EMBASE, PsychInfo, the Cochrane Library, and AMED) were searched from 1996 using keywords and Medical Subject Heading (MeSH) terms in accordance with the International Association for Public Participation (IAP2) and the search criteria in the bibliographic databases. Standard approaches were used to search the grey literature., Results: A total of 79 studies and over 150 websites were subject to data abstraction by team members, capturing information on sex/gender and SPOR's patient engagement guiding principles of inclusiveness, support, mutual respect, and co-building. Results were presented to 32 key stakeholders at the consultation workshop and input was sought on next steps using nominal group techniques. Based on the plethora of existing POR resources, relevant POR information from the scoping review was collated into two decision aids (patient and investigator) to determine readiness to engage with/as a patient partner in a clinical trial. The decision aids were presented at a POR training day with 88 new/early investigators, clinicians, patient partners and decision makers. The decision aids showed 'good' usability, assessed using the System Usability Scale (SUS). Attendees thought the decision aids were engaging, they increased their understanding of sex/gender, patient engagement and POR, and they would recommend them to others. POR principles and practices were integrated across all phases of the project. Patient partners (1) identified research priorities/search terms; (2) collected/analyzed data; (3) designed the patient partner decision aid; and (4) disseminated the results through presentation., Conclusion: Our digital patient partner and investigator decision aids are the first to provide information technology to deliver sex/gender, POR knowledge, and decision support beyond the traditional decision aids used for health screening and/or treatment decisions. The decision aids have the potential to make a significant contribution to Canada's Strategy for POR and support the collaborative efforts of patients and investigators to build a sustainable, accessible and equitable health care system.

Introduction: More women experience cardiac pain related to coronary artery disease and cardiac procedures compared with men. The overall goal of this programme of research is to develop an integrated smartphone and web-based intervention (HEARTPA♀N) to help women recognise and self-manage cardiac pain., Methods and Analysis: This protocol outlines the mixed methods strategy used for the development of the HEARTPA♀N content/core feature set (phase 2A), usability testing (phase 2B) and evaluation with a pilot randomised controlled trial (RCT) (phase 3). We are using the individual and family self-management theory, mobile device functionality and pervasive information architecture of mHealth interventions, and following a sequential phased approach recommended by the Medical Research Council to develop HEARTPA♀N. The phase 3 pilot RCT will enable us to refine the prototype, inform the methodology and calculate the sample size for a larger multisite RCT (phase 4, future work). Patient partners have been actively involved in setting the HEARTPA♀N research agenda, including defining patient-reported outcome measures for the pilot RCT: pain and health-related quality of life (HRQoL). As such, the guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols (SPIRIT-PRO) are used to report the protocol for the pilot RCT (phase 3). Quantitative data (eg, demographic and clinical information) will be summarised using descriptive statistics (phases 2AB and 3) and a content analysis will be used to identify themes (phase 2AB). A process evaluation will be used to assess the feasibility of the implementation of the intervention and a preliminary efficacy evaluation will be undertaken focusing on the outcomes of pain and HRQoL (phase 3)., Ethics and Dissemination: Ethics approval was obtained from the University of Toronto (36415; 26 November 2018). We will disseminate knowledge of HEARTPA♀N through publication, conference presentation and national public forums (Café Scientifique), and through fact sheets, tweets and webinars., Trial Registration Number: NCT03800082., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: Using representative school-based data and community-level primary data, we investigated how environmental factors (e.g., school and community climate) might be protective against substance use behaviors among a vulnerable population of adolescents. Methods: We analyzed a sample of 2678 sexual minority adolescents using a combination of student-level data (British Columbia Adolescent Health Survey) and primary community-level data (assessing lesbian, gay, bisexual, transgender, and queer [LGBTQ]-specific community and school environments). Using multilevel logistic regression models, we examined associations between lifetime substance use (alcohol, illegal drugs, marijuana, nonmedical use of prescription drugs, and smoking) and community-level predictors (community and school LGBTQ supportiveness). Results: Above and beyond student characteristics (e.g., age and years living in Canada), sexual minority adolescents residing in communities with more LGBTQ supports (i.e., more supportive climates) had lower odds of lifetime illegal drug use (for boys and girls), marijuana use (for girls), and smoking (for girls). Specifically, in communities with more frequent LGBTQ events (such as Pride events), the odds of substance use among sexual minority adolescents living in those communities was lower compared with their counterparts living in communities with fewer LGBTQ supports. Conclusions: The availability of LGBTQ community-level organizations, events, and programs may serve as protective factors for substance use among sexual minority adolescents. In particular, LGBTQ-supportive community factors were negatively associated with substance use, which has important implications for our investment in community programs, laws, and organizations that advance the visibility and rights of LGBTQ people.