Pathways, journeys and experiences: Integrating curricular activities related to social accountability within an undergraduate medical curriculum.

BACKGROUND: Health professions education curricula are undergoing reform towards social accountability (SA), defined as an academic institution's obligation to orient its education, service and research to respond to societal needs. However, little is known about how or which educational experiences transform learners and the processes behind such action. For example, those responsible for the development and implementation of undergraduate medical education (UGME) programs can benefit from a deeper understanding of educational approaches that foster the development of competencies related to SA. The purpose of this paper was to learn from the perspectives of the various partners involved in a program's delivery about what curricular aspects related to SA are expressed in a UGME program. METHODS: We undertook a qualitative descriptive study at a francophone Canadian university. Through purposive convenience and snowball sampling, we conducted 16 focus groups (virtual) with the following partners: (a) third- and fourth-year medical students, (b) medical teachers, (c) program administrators (e.g., program leadership), (d) community members (e.g., community organisations) and (e) patient partners. We used inductive thematic analysis to interpret the data. RESULTS: The participants' perspectives organised around four key themes including (a) the definition of a future socially accountable physician, (b) socially accountable educational activities and experiences, (c) characteristics of a socially accountable MD program and (d) suggestions for curriculum improvement and implementation. CONCLUSIONS: We extend scholarship about curricular activities related to SA from the perspectives of those involved in teaching and learning. We highlight the relevance of experiential learning, engagement with community members and patient partners and collaborative approaches to curriculum development. Our study provides a snapshot of what are the sequential pathways in fostering SA among medical students and therefore addresses a gap between knowledge and practice regarding what contributes to the implementation of educational approaches related to SA. We emphasise the need for educational innovation and research to develop and align assessment methods with teaching and learning related to SA.

Patients' and Members of the Public's Wishes Regarding Transparency in the Context of Secondary Use of Health Data: Scoping Review.

BACKGROUND: Secondary use of health data has reached unequaled potential to improve health systems governance, knowledge, and clinical care. Transparency regarding this secondary use is frequently cited as necessary to address deficits in trust and conditional support and to increase patient awareness. OBJECTIVE: We aimed to review the current published literature to identify different stakeholders' perspectives and recommendations on what information patients and members of the public want to learn about the secondary use of health data for research purposes and how and in which situations. METHODS: Using PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines, we conducted a scoping review using Medline, CINAHL, PsycINFO, Scopus, Cochrane Library, and PubMed databases to locate a broad range of studies published in English or French until November 2022. We included articles reporting a stakeholder's perspective or recommendations of what information patients and members of the public want to learn about the secondary use of health data for research purposes and how or in which situations. Data were collected and analyzed with an iterative thematic approach using NVivo. RESULTS: Overall, 178 articles were included in this scoping review. The type of information can be divided into generic and specific content. Generic content includes information on governance and regulatory frameworks, technical aspects, and scientific aims. Specific content includes updates on the use of one's data, return of results from individual tests, information on global results, information on data sharing, and how to access one's data. Recommendations on how to communicate the information focused on frequency, use of various supports, formats, and wording. Methods for communication generally favored broad approaches such as nationwide publicity campaigns, mainstream and social media for generic content, and mixed approaches for specific content including websites, patient portals, and face-to-face encounters. Content should be tailored to the individual as much as possible with regard to length, avoidance of technical terms, cultural competence, and level of detail. Finally, the review outlined 4 major situations where communication was deemed necessary: before a new use of data, when new test results became available, when global research results were released, and in the advent of a breach in confidentiality. CONCLUSIONS: This review highlights how different types of information and approaches to communication efforts may serve as the basis for achieving greater transparency. Governing bodies could use the results: to elaborate or evaluate strategies to educate on the potential benefits; to provide some knowledge and control over data use as a form of reciprocity; and as a condition to engage citizens and build and maintain trust. Future work is needed to assess which strategies achieve the greatest outreach while striking a balance between meeting information needs and use of resources.

Essential requirements for the governance and management of data trusts, data repositories, and other data collaborations.

Introduction: Around the world, many organisations are working on ways to increase the use, sharing, and reuse of person-level data for research, evaluation, planning, and innovation while ensuring that data are secure and privacy is protected. As a contribution to broader efforts to improve data governance and management, in 2020 members of our team published 12 minimum specification essential requirements (min specs) to provide practical guidance for organisations establishing or operating data trusts and other forms of data infrastructure. Approach and Aims: We convened an international team, consisting mostly of participants from Canada and the United States of America, to test and refine the original 12 min specs. Twenty-three (23) data-focused organisations and initiatives recorded the various ways they address the min specs. Sub-teams analysed the results, used the findings to make improvements to the min specs, and identified materials to support organisations/initiatives in addressing the min specs. Results: Analyses and discussion led to an updated set of 15 min specs covering five categories: one min spec for Legal, five for Governance, four for Management, two for Data Users, and three for Stakeholder & Public Engagement. Multiple changes were made to make the min specs language more technically complete and precise. The updated set of 15 min specs has been integrated into a Canadian national standard that, to our knowledge, is the first to include requirements for public engagement and Indigenous Data Sovereignty. Conclusions: The testing and refinement of the min specs led to significant additions and improvements. The min specs helped the 23 organisations/initiatives involved in this project communicate and compare how they achieve responsible and trustworthy data governance and management. By extension, the min specs, and the Canadian national standard based on them, are likely to be useful for other data-focused organisations and initiatives.

Canadian general internal medicine residents' perception of a pedagogical tool of online cases in obstetric medicine.

Background: Sufficient exposure to rarer medical problems around pregnancy is a challenge during short rotations in obstetric medicine (OM). A Canadian research group created online clinical cases, the CanCOM cases, to overcome this. Methods: We conducted an exploratory study to document the use and perceived utility of the CanCOM cases. 77 residents doing an OM rotation participated in our study. We used a survey to document their perception of CanCOM cases (12 items, 7-point scale), clinical exposure to several conditions (pre and post rotation; 41 items, 7-point scale) and use of the educational tool (1 item, 4-option scale). Results: CanCOM cases was perceived as an accessible and useful tool. Participants completed a median of 6/20 cases (range 1-20), and highly recommended the cases (6.48 ± 0.73 SD on a 7-point Likert scale). Conclusion: Despite some technical limitations, CanCOM cases was shown to contribute to clinical exposure to rare but essential medical conditions.

Physician Perspectives on Including Pregnant Women in Covid-19 Clinical Trials: Time for a Paradigm Change.

Excluding pregnant people from Covid-19 clinical trials may lead to unintended harmful consequences. For this study, an online questionnaire was sent to physicians belonging to Canadian professional medical associations in order to evaluate their perspectives on the participation of pregnant women in Covid-19 clinical trials. The majority of respondents expressed support for including pregnant women in Covid-19 trials (119/165; 72%), especially those investigating therapies with a prior safety record in pregnancy (139/164; 85%). The main perceived barriers to inclusion identified were unwillingness of pregnant patients to participate and of treating teams to offer participation, the burden of regulatory approval, and a general "culture of exclusion" of pregnant women from trials. We describe why some physicians may be reluctant to include pregnant individuals in trials, and we identify barriers to the appropriate participation of pregnant people in clinical research.

Meta-consent for the secondary use of health data within a learning health system: a qualitative study of the public's perspective.

BACKGROUND: The advent of learning healthcare systems (LHSs) raises an important implementation challenge concerning how to request and manage consent to support secondary use of data in learning cycles, particularly research activities. Current consent models in Quebec were not established with the context of LHSs in mind and do not support the agility and transparency required to obtain consent from all involved, especially the citizens. Therefore, a new approach to consent is needed. Previous work identified the meta-consent model as a promising alternative to fulfill the requirements of LHSs, particularly large-scale deployments. We elicited the public's attitude toward the meta-consent model to evaluate if the model could be understood by the citizens and would be deemed acceptable to prepare for its possible implementation in Quebec. METHODS: Eight focus groups, with a total of 63 members of the general public from various backgrounds were conducted in Quebec, Canada, in 2019. Explicit attention was given to literacy levels, language spoken at home and rural vs urban settings. We assessed attitudes, concerns and facilitators regarding key components of the meta-consent model: predefined categories to personalized consent requests, a dynamic web-based infrastructure to record meta-consent, and default settings. To analyse the discussions, a thematic content analysis was performed using a qualitative software. RESULTS: Our findings showed that participants were supportive of this new approach of consent as it promotes transparency and offers autonomy for the management of their health data. Key facilitators were identified to be considered in the implementation of a meta-consent model in the Quebec LHSs: information and transparency, awareness campaigns, development of educational tools, collaboration of front-line healthcare professionals, default settings deemed acceptable by the society as well as close partnerships with recognized and trusted institutions. CONCLUSIONS: This qualitative study reveals the openness of a sample of the Quebec population regarding the meta-consent model for secondary use of health data for research. This first exploratory study conducted with the public is an important step in guiding decision-makers in the next phases of implementing the various strategies to support access and use of health data in Quebec.

Pregnancy-associated pelvic vein thrombosis: Insights from a multicenter case series.

BACKGROUND: Pelvic vein thrombosis (PVT) is a rare complication of pregnancy that can lead to life-threatening complications, such as pulmonary embolism (PE). OBJECTIVE: To describe characteristics of PVT and its treatment in pregnancy in the province of Quebec, Canada. PATIENTS/METHODS: We developed a province-wide case series of PVT in pregnancy including four tertiary care centers and the Registry of Rare Diseases of the Groupe d'Étude en Médecine Obstétricale du Québec. Using diagnostic codes, we included cases with confirmed PVT on imaging during pregnancy or within 6 weeks postpartum from July 2003 to June 2018. RESULTS: A total of 47 cases were identified. PVT diagnosis was generally made in the early postpartum period (median of 9 [interquartile range (IQR) 4.5-12] days postpartum). Most PVT (94%) included in this series were symptomatic. Women presented primarily with abdominal pain (77%) and fever (55%), often prolonged despite antibiotics (mean 4.45 ± 2.39 days, with 39% having fever for more than 5 days). The most common risk factor was surgery (57%) and peripartum infections (54%). Thirty-eight (83%) women received antibiotics and 41 (89%) were anticoagulated. Three cases of PE (7%) occurred concomitantly, 11% of women required intensive care, and 19% had inferior vena cava (IVC) clot extension. The episode resulted in prolonged hospitalization (median 6 [IQR 3-10.75] days), with 48% being hospitalized more than 7 days. CONCLUSION: Symptomatic PVT has significant clinical implications with prolonged fever and risks of extension in the IVC and PE, leading to prolonged hospitalization including in the intensive care unit. Therapeutic anticoagulation and antibiotics, when infection is documented, should be considered for management.

Citizens, Research Ethics Committee Members and Researchers' Attitude Toward Information and Consent for the Secondary Use of Health Data: Implications for Research Within Learning Health Systems.

A survey was conducted to assess citizens, research ethics committee members, and researchers' attitude toward information and consent for the secondary use of health data for research within learning health systems (LHSs). Results show that the reuse of health data for research to advance knowledge and improve care is valued by all parties; consent regarding health data reuse for research has fundamental importance particularly to citizens; and all respondents deemed important the existence of a secure website to support the information and consent processes. This survey was part of a larger project that aims at exploring public perspectives on alternate approaches to the current consent models for health data reuse to take into consideration the unique features of LHSs. The revised model will need to ensure that citizens are given the opportunity to be better informed about upcoming research and have their say, when possible, in the use of their data.

Impact of an Educational Pamphlet on Knowledge About Health Risks After Hypertensive Disorders of Pregnancy: A Randomized Trial.

OBJECTIVE: To evaluate patients' knowledge, risk perception, and anxiety about future health risks after an episode of hypertensive disorder of pregnancy (HDP), as well as their satisfaction with an educational pamphlet. METHODS: From January 2016 to June 2017, participants were randomly assigned to one of 2 groups and asked to complete questionnaire #1 (demographics, knowledge, risk perception, anxiety, and satisfaction) after receiving medical counselling at the HDP postpartum clinic. Participants in the intervention group then received the educational pamphlet. One month later, both groups completed the questionnaire again (questionnaire #2). The primary outcome of this study was improvement in the global knowledge score at 1 month, reflecting improved understanding of the health risks of HDP. Secondary outcomes included retention of information, risk perception, satisfaction, and anxiety level. RESULTS: Of 137 eligible women, 57 were randomly assigned to the intervention group and 56, to the control group. Participants in both groups had similar baseline characteristics. Thirteen percent of participants did not complete questionnaire #2. The knowledge score was higher in the intervention group than the control group at 1 month, (88.2%; 95% confidence interval [CI] 26.37-28.32 and 71.3%; 95% CI 20.78-23.45, respectively [P <0.0001]). No difference was seen in anxiety level between the groups (4.0 ± 1.00 vs. 3.8 ± 0.92; P = 0.6746). The intervention group was highly satisfied with the medical counselling they received (5.5 ± 0.84 out 6) and with the pamphlet (5.6 ± 0.66 out 6). CONCLUSION: The educational pamphlet increased women's knowledge about future health risks of HDP without increasing anxiety and it may be helpful in promoting lifestyle changes necessary to modify these risks.

Evaluation of Complications in Postpartum Women Receiving Therapeutic Anticoagulation.

OBJECTIVE: To evaluate complications associated with early postpartum therapeutic anticoagulation. METHODS: A multicenter retrospective cohort study was done to evaluate the association between therapeutic anticoagulation postpartum and major complications (hemorrhagic and wound complications). Secondary outcomes included minor complications, risk factors associated with total complications (including the time to therapeutic anticoagulation resumption after delivery) and recurrent thrombotic events within 6 weeks postpartum. RESULTS: From 2003 to 2015, 232 consecutive women were treated with therapeutic anticoagulation within 96 hours postpartum; among those treated, 91 received unfractionated heparin, 138 received low-molecular-weight heparin, and three received other anticoagulants. The primary outcome, a composite of major hemorrhagic complications (requiring transfusion, hospitalization, volume resuscitation, transfer to intensive care unit, or surgery) and major wound complications, occurred in 7 of 83 (8.4%) for cesarean deliveries and 9 of 149 (6.0%) for vaginal deliveries (P=.490). Total complications (including major and minor hemorrhagic and wound complications) occurred in 13 of 83 (15.7%) for cesarean deliveries compared with 9 of 149 (6.0%) for vaginal deliveries (P=.016). When comparing cases associated with and without complications, the median delay before resuming anticoagulation was significantly shorter for both cesarean (12 vs 33 hours, P=.033) and vaginal deliveries (6 vs 19 hours, P=.006). For vaginal deliveries, 8 of 51 (15.7%) women had complications when anticoagulation was started before 9.25 hours postpartum, compared with 1 of 98 (1.0%) when started after 9.25 hours. For cesarean deliveries, 7 of 21 (33.3%) of women experienced complications compared with 6 of 62 (9.7%) if anticoagulation was started before or after 15.1 hours, respectively. Two (0.9%) episodes of venous thromboembolism occurred within 6 weeks postpartum. CONCLUSION: Among postpartum women who received early therapeutic anticoagulation, major complications occurred in 8.4% for cesarean deliveries and 6.0% for vaginal deliveries. Complications were associated with earlier resumption of therapeutic anticoagulation, particularly before 9.25 hours for vaginal deliveries and before 15.1 hours for cesarean deliveries.

Informed consent within a learning health system: A scoping review.

INTRODUCTION: A major consideration for the implementation of a learning health system (LHS) is consent from participants to the use of their data for research purposes. The main objective of this paper was to identify in the literature which types of consent have been proposed for participation in research observational activities in a LHS. We were particularly interested in understanding which approaches were seen as most feasible and acceptable and in which context, in order to inform the development of a Quebec-based LHS. METHODS: Using a scoping review methodology, we searched scientific and legal databases as well as the gray literature using specific terms. Full-text articles were reviewed independently by two authors on the basis of the following concepts: (a) LHS and (b) approach to consent. The selected papers were imported in NVivo software for analysis in the light of a conceptual framework that distinguishes various, largely independent dimensions of consent. RESULTS: A total of 93 publications were analysed for this review. Several studies reach opposing conclusions concerning the best approach to consent within a LHS. However, in the light of the conceptual framework we developed, we found that many of these results are distorted by the conflation between various characteristics of consent. Thus, when these characteristics are distinguished, the results mainly suggest the prime importance of the communication process, by contrast to the scope of consent or the kind of action required by participants (opt-in/opt-out). We identified two models of consent that were especially relevant for our purpose: metaconsent and dynamic consent. CONCLUSIONS: Our review shows the importance of distinguishing carefully the various features of the consent process. It also suggests that the metaconsent model is a valuable model within a LHS, as it addresses many of the issues raised with regards to feasibility and acceptability. We propose to complement this model by adding the modalities of the information process to the dimensions relevant in the metaconsent process.

Validation of content of clinical cases in obstetric medicine for a shared web-based educational tool.

Subsequent to the validation of a Canadian Curriculum blueprint for Obstetric Medicine (OM), the Canadian Consensus for a Curriculum in Obstetric Medicine (CanCOM) research group was approached to develop 20 cases to address gaps in clinical exposure during clinical rotations in OM. Forty-nine Obstetric Internists were identified and 43 confirmed their affiliation to the group. Participants (N = 22) reviewed the content of the CanCOM blueprint and identified curriculum content that they considered essential for a rotation for senior General Internal Medicine residents. This survey led to the creation of the CanCOM II essential content blueprint for General Internal Medicine. Following this step, a second subgroup of participants (N = 21) participated in a Delphi survey to identify the content that should be addressed by a teaching case for senior General Internal Medicine residents. A high-level of consensus was obtained for 13 topics and a moderate level for the 7 subsequent topics resulting in the creation of the CanCOM II clinical cases available at http://gemoq.ca/cancom-ii-clinical-case-databank/.

Pregnancy in a Woman with Latent Myeloproliferative Neoplasm Induced Chronic Portal Vein Thrombosis, Portal Cavernoma, and Gastric Varices.

Extra-hepatic portal vein thrombosis (EHPVO) represents the obstruction of the portal vein outside the liver and is not related to chronic liver disease or neoplasia. In chronic EHPVO, collateral veins and portal hypertension develop, resulting in splenomegaly and variceal formation. Myeloproliferative neoplasms (MPN) are the most frequent acquired etiology of EHPVO. These conditions put pregnant women at increased risk of vascular complications, including venous thrombosis, occlusion of the placental circulation, and variceal bleeding. In this report, we present a 36-year-old pregnant woman with chronic, anticoagulated EHPVO secondary to latent MPN who developed severe intrauterine growth restriction and had cesarean section at 32+1 weeks for increased umbilical doppler resistance and breech presentation. The article will emphasize outcome and management of pregnancies complicated by chronic EHPVO, portal hypertension, and MPN.

Renal physiology and fluid and electrolyte disorders in pregnancy.

The majority of women are healthy entering pregnancy and do not require measurement of renal function or serum electrolytes. Clinicians must remain alert to the possibility of renal as well as fluid and electrolyte disorders in pregnancy, as the presenting complaints are often vague and mistaken for the normal physiology of pregnancy. In this chapter, our objectives are 1) to review the renal physiology from a practical/clinical standpoint; 2) to provide the clinical obstetrician a case-based approach to fluid and electrolyte disorders commonly encountered in pregnancy; 3) to consolidate knowledge on renal physiology and fluid and electrolyte disorders in pregnancy with MCQs that are directly aligned with content; and 4) to highlight key practice points and present a research agenda.

Atrial fibrillation with a structurally normal heart in pregnancy: An international survey on current practice.

BACKGROUND: Little evidence exists for the optimal management of atrial fibrillation with a structurally normal heart in pregnancy. METHODS: A survey was sent to members of two associations to obtain input on optimal management of atrial fibrillation in pregnancy. The survey presented four cases with respect to (1) baseline investigations; (2) rate versus rhythm control; (3) chemical versus electrical cardioversion; and (4) anticoagulation. RESULTS: Sixty-one responders from 11 countries participated. High agreement was noted for baseline investigations. A quarter (25%) of participants chose elective cardioversion even with a reversible precipitant. Electrical cardioversion was preferred over chemical (p < 0.05). Anticoagulation strategies were heterogeneous except in the presence of a left atrial appendage thrombus. DISCUSSION: This study revealed that there was little consensus in current practice in pregnancy beyond basic investigations. An adaptation of established guidelines to the pregnant population would require a meeting of Cardiologists with input from colleagues in Obstetric Medicine.

Atrial Fibrillation in a Structurally Normal Heart during Pregnancy: A Review of Cases From a Registry and From the Literature.

OBJECTIVES: Atrial fibrillation (AF) in a structurally normal heart is rare during pregnancy. We wished to use our experience to expand the literature on the causes and management of this condition. METHODS: All members of Groupe d'Étude en Médecine Obstétricale du Québec (GÉMOQ) were invited to record cases of AF in a structurally normal heart during pregnancy to the group's Registry. We searched Medline, PubMed, and Google Scholar (1946 to 15 April 2016) for relevant articles using the key words "atrial fibrillation" and "pregnancy." RESULTS: Sixteen pregnancies with AF in 12 women were recorded in the Registry, and 19 pregnancies with AF in 18 women were retrieved from the literature. The majority (94% in the Registry and 89% in the literature) presented with paroxysmal AF. We found differences between characteristics recorded in the literature and in the Registry; these were the presence of classic triggers for AF (37% in the literature vs. 0% in the Registry), the rate of recurrence of AF in the same pregnancy (5% vs. 31%) or in subsequent pregnancies (1 vs. 4), the rate of spontaneous cardioversion (50% vs. 81%), the use of acetylsalicylic acid and/or low molecular weight heparin as stroke preventive therapy (35% vs. 71%), and the rate of AF influencing the decision to deliver (21% vs. 6%). One woman in the Registry with persistent AF had a left atrial appendage thrombus. CONCLUSION: The GÉMOQ's Registry added 12 cases (16 pregnancies) to the existing literature. AF during pregnancy is an arrhythmia that is mainly unprovoked, paroxysmal, and stable, with spontaneous cardioversion occurring usually within 24 hours. It is associated with good pregnancy outcomes.

A comprehensive process of content validation of curriculum consensus guidelines for a medical specialty.

In this article, we outline an innovative and comprehensive approach to the development by consensus of curriculum content guidelines for a medical specialty. We initially delineated the content domain by triangulation of sources, validated a curriculum blueprint by both quantitative and qualitative methodology, and finally reached consensus on content by Delphi methodology. Development of curricular objectives is an important step in curriculum development. Content definition or "blueprinting" refers to the systematic definition of content from a specified domain for the purpose of creating test items with validity evidence. Content definition can be achieved in a number of ways and we demonstrate how the concepts of content definition or validation can be transferred beyond assessment, to other steps in curriculum development and instructional design. Validity in Education refers to the multiple sources of evidence to support the use or interpretation of different aspects of a curriculum. In this approach, there are multiple sources of content-related validity evidence which, when accumulated, give credibility and strength to curriculum consensus guidelines.

Validation of a Canadian curriculum in obstetric medicine.

A comprehensive curriculum for obstetric medicine was created through review and synthesis of several existing sources including a recent textbook, published curricula and a review of cases seen in a specialized clinical setting. The preliminary curriculum document then underwent local validation and reformulation of educational objectives with reference to the CanMEDS framework promoted by the Royal College of Physicians and Surgeons of Canada. This draft 'Canadian' Curriculum Content Validation Instrument, covering 34 medical conditions, was then distributed to a cohort of 29 Canadian obstetric internists (the study group) for review. All responders gave feedback on each of the 402 curricular items, with a high level of inter-rater agreement. A subgroup was subsequently convened (n = 15) and Delphi methodology was used to review the major recommendations from the group, as well as nine additional problematic items, achieving a consensus on 38/43 survey items (88%). The final validated document was presented at the North American Society of Obstetric Medicine meeting in April 2010 in Toronto, Canada and distributed to study group members for local adaptation and implementation. Wider dissemination is planned in the near future.