Beth A. Payne

UNSTRUCTURED Digital therapeutics (DTx) represent a transformative opportunity to advance health equity and expand access to evidence-based care. However, Canada’s fragmented regulatory approach risks widening, rather than narrowing, existing health inequities. While Health Canada’s risk-based classification framework appropriately distinguishes Class I from Class II devices, regulatory ambiguity, institutional variation, and limited transparency prevent life-saving innovations from reaching vulnerable populations who need them most. Drawing on community engagement across healthcare and academic institutions, this viewpoint argues that DTx governance is fundamentally a public health issue and proposes three public health-oriented reforms: standardized institutional quality management, Artificial Intelligence (AI) transparency and accountability, and integrated Research Ethics Boards-Health Canada pathways, alongside a stronger lifecycle governance approach for dynamic digital tools.

Background: Eosinophilic esophagitis (EoE) is a chronic inflammatory disease of the esophagus that effects both pediatrics and adult patients in Canada and is increasing in prevalence. No Canadian focused best practice recommendations currently exist to guide clinical practice. Methods: The study used a modified Delphi technique to develop evidence and expert opinion-based recommendations for providing care for patients with EoE. The Delphi process consisted of 3 rounds of quantitative surveys and qualitative consensus meetings. Experts were included in the Delphi if they had experience caring for EoE patients in Canada within one of the following professional groups: allergist, adult gastroenterologists, pathologists, pediatric gastroenterologists, and dieticians. Results: Delphi rounds were completed between May 1, 2024, and June 30, 2024. A total of 31 experts in EoE care from across Canada were recruited to participate in the Delphi consensus process. All participants completed all 3 rounds of Delphi surveys. The final statement includes 38 recommendations for the care of patients with EoE organized into 3 sections: definition, diagnosis, and management. A table of research gaps is provided to stimulate further knowledge development on this topic. Conclusion: This consensus statement includes actionable recommendations to support quality care of patients with EoE at any age across Canada. We encourage EoE centres in Canada to come together in a multidisciplinary form to not only provide clinical care but also do much needed research on Canadian specific topics and gaps in EoE care.

Background: Digital health innovations provide an opportunity to improve access to care, information, and quality of care during the perinatal period, a critical period of health for mothers and infants. However, research to develop perinatal digital health solutions needs to be informed by actual patient and health system needs in order to optimize implementation, adoption, and sustainability. Objective: Our aim was to co-design a research agenda with defined research priorities that reflected health system realities and patient needs. Methods: Co-design of the research agenda involved a series of activities: (1) review of the provincial Digital Health Strategy and Maternity Services Strategy to identify relevant health system priorities, (2) anonymous survey targeting perinatal care providers to ascertain their current use and perceived need for digital tools, (3) engagement meetings using human-centered design methods with multilingual patients who are currently or recently pregnant to understand their health experiences and needs, and (4) a workshop that brought together patients and other project partners to prioritize identified challenges and opportunities for perinatal digital health in a set of research questions. These questions were grouped into themes using a deductive analysis approach starting with current BC Digital Health Strategy guiding principles. Results: Between September 15, 2022, and August 31, 2023, we engaged with more than 150 perinatal health care providers, researchers, and health system stakeholders and a patient advisory group of women who were recently pregnant to understand the perceived needs and priorities for digital innovation in perinatal care in British Columbia, Canada. As a combined group, partners were able to define 12 priority research questions in 3 themes. The themes prioritized are digital innovation for (1) patient autonomy and support, (2) standardized educational resources for patients and providers, and (3) improved access to health information. Conclusions: Our research agenda highlights the needs for perinatal digital health research to support improvements in the quality of care in British Columbia. By using a human-centered design approach, we were able to co-design research priorities that are meaningful to patients and health system stakeholders. The identified priority research questions are merely a stepping stone in the research process and now need to be actioned by research teams and health systems partners.

BACKGROUND Recent advances in digital health, the growth of wearable device use, and ubiquitous internet access are generating growing amounts of health and well-being data. Yet, people need tools to manage their health and wellness journeys, including trustworthy health access platforms to easily view, share, and manage their data as part of health systems. OBJECTIVE To describe the initial concept and architecture development of a patient-centric platform, TrustSphere, that empowers patients by enabling them to manage and securely share health data with caregivers, healthcare providers and, if desired, researchers. METHODS The TrustSphere digital health platform integrates data through a digital trust layer (using strong digital identity combined with fine-grained consenting capacities) and secure access to digital health applications and patient-generated health data to support patient and healthcare-team coordination for chronic diseases. TrustSphere was designed and developed by a novel collaboration between clinicians, researchers, and digital health innovators (com-panies) using a novel architecture that allows patients and families to securely, ethically, and scalably share patient-generated, clinical, and administrative health data with clinicians and researchers via federated authentication, authorization, and consent management tools. Healthcare providers and researchers can securely access consented data using an array of visualization, cohort, and data export tools. The design allows for the integration of clinical re-search registries using REDCap and other electronic health records systems. The TrustSphere architecture was implemented for an initial use case in pediatric type 1 diabetes while being readily generalizable to patients with other data-intense chronic diseases. RESULTS To address the needs of our initial users (children living with type 1 diabetes, their families, and care providers), TrustSphere allows the acquisition of data from multiple patient sources (e.g., continuous glucose monitoring systems, glucometers, and insulin pumps) and can also extract data from clinical databases to store within a secure clinical repository. With patient consent, research data are exported to TrustSphere’s Research Registry. Interoperable reposi-tories combine diverse data sources using the Fast Healthcare Interoperability Resources (FHIR) clinical data exchange standard. The software applications “BC Children's Hospital Care Hub” and “Researcher Dashboard” are available in the current implementation. Leverag-ing a custom data model, we implemented standalone software components for data import and export from the TrustSphere Research Registry. CONCLUSIONS TrustSphere’s novel architecture provides a single point of access and integrates clinical infor-mation with patient-generated healthcare data. This enables patients to share their data with clinicians and researchers for clinical care delivery and enhances clinical research as part of a learning health system.

Background: Exposure to opioids after surgery is the initial contact for some people who develop chronic opioid use disorder. Hence, effective postoperative pain management, with less reliance on opioids, is critical. The Perioperative Opioid Quality Improvement (POQI) program developed (1) a digital health platform leveraging patient-survey-reported risk factors and (2) a postsurgical pain risk stratification algorithm to personalize perioperative care by integrating several commercially available digital health solutions into a combined platform. Development was reduced in scope by the COVID-19 pandemic. Objective: This pilot study aims to assess the screening performance of the risk algorithm, quantify the use of the POQI platform, and evaluate clinicians’ and patients’ perceptions of its utility and benefit. Methods: A POQI platform prototype was implemented in a quality improvement initiative at a Canadian tertiary care center and evaluated from January to September 2022. After surgical booking, a preliminary risk stratification algorithm was applied to health history questionnaire responses. The estimated risk guided the patient assignment to a care pathway based on low or high risk for persistent pain and opioid use. Demographic, procedural, and medication administration data were extracted retrospectively from the electronic medical record. Postoperative inpatient opioid use of >90 morphine milligram equivalents per day was the outcome used to assess algorithm performance. Data were summarized and compared between the low- and high-risk groups. POQI use was assessed by completed surveys on postoperative days 7, 14, 30, 60, 90, and 120. Semistructured patient and clinician interviews provided qualitative feedback on the platform. Results: Overall, 276 eligible patients were admitted for colorectal procedures. The risk algorithm stratified 203 (73.6%) as the low-risk group and 73 (26.4%) as the high-risk group. Among the 214 (77.5%) patients with available data, high-risk patients were younger than low-risk patients (age: median 53, IQR 40-65 years, vs median 59, IQR 49-69 years, median difference five years, 95% CI 1-9; P=.02) and were more often female patients (45/73, 62% vs 80/203, 39.4%; odds ratio 2.5, 95% CI 1.4-4.5; P=.002). The risk stratification was reasonably specific (true negative rate=144/200, 72%) but not sensitive (true positive rate=10/31, 32%). Only 39.7% (85/214) patients completed any postoperative quality of recovery questionnaires (only 14, 6.5% patients beyond 60 days after surgery), and 22.9% (49/214) completed a postdischarge medication survey. Interviewed participants welcomed the initiative but noted usability issues and poor platform education. Conclusions: An initial POQI platform prototype was deployed operationally; the risk algorithm had reasonable specificity but poor sensitivity. There was a significant loss to follow-up in postdischarge survey completion. Clinicians and patients appreciated the potential impact of preemptively addressing opioid exposure but expressed shortcomings in the platform’s design and implementation. Iterative platform redesign with additional features and reevaluation are required before broader implementation.

BACKGROUND Digital health innovations provide an opportunity to improve access to care, information, and quality of care during the perinatal period, a critical period of health for mothers and infants. However, research to develop perinatal digital health solutions needs to be informed by actual patient and health system needs in order to optimize implementation, adoption, and sustainability. OBJECTIVE Our aim was to co-design a research agenda with defined research priorities that reflected health system realities and patient needs. METHODS Co-design of the research agenda involved a series of activities: (1) review of the provincial Digital Health Strategy and Maternity Services Strategy to identify relevant health system priorities, (2) anonymous survey targeting perinatal care providers to ascertain their current use and perceived need for digital tools, (3) engagement meetings using human-centered design methods with multilingual patients who are currently or recently pregnant to understand their health experiences and needs, and (4) a workshop that brought together patients and other project partners to prioritize identified challenges and opportunities for perinatal digital health in a set of research questions. These questions were grouped into themes using a deductive analysis approach starting with current BC Digital Health Strategy guiding principles. RESULTS Between September 15, 2022, and August 31, 2023, we engaged with more than 150 perinatal health care providers, researchers, and health system stakeholders and a patient advisory group of women who were recently pregnant to understand the perceived needs and priorities for digital innovation in perinatal care in British Columbia, Canada. As a combined group, partners were able to define 12 priority research questions in 3 themes. The themes prioritized are digital innovation for (1) patient autonomy and support, (2) standardized educational resources for patients and providers, and (3) improved access to health information. CONCLUSIONS Our research agenda highlights the needs for perinatal digital health research to support improvements in the quality of care in British Columbia. By using a human-centered design approach, we were able to co-design research priorities that are meaningful to patients and health system stakeholders. The identified priority research questions are merely a stepping stone in the research process and now need to be actioned by research teams and health systems partners.

Introduction: Group B streptococcus(GBS), orStreptococcus agalactiae, remains a leading cause of neonatal morbidity and mortality. Canadian guidelines advise universal maternal screening for GBS colonisation in pregnancy in conjunction with selective antibiotic therapy. This results in over 1000 pregnant individuals receiving antibiotic therapy to prevent one case of early-onset neonatal GBS disease, and over 20 000 pregnant individuals receiving antibiotic therapy to prevent one neonatal death. Given the growing concern regarding the risk of negative sequela from antibiotic exposure, it is vital that alternative approaches to reduce maternal GBS colonisation are explored.Preliminary studies suggest some probiotic strains could confer protection in pregnancy against GBS colonisation.Methods and analysis: This double-blind parallel group randomised trial aims to recruit 450 pregnant participants in Vancouver, BC, Canada and will compare GBS colonisation rates in those who have received a daily oral dose of three strains of probiotics with those who have received a placebo. The primary outcome will be GBS colonisation status, measured using a vaginal/rectal swab obtained between 35 weeks’ gestation and delivery. Secondary outcomes will include maternal antibiotic exposure and urogenital infections. Analysis will be on an intention-to-treat basis.Patient or public involvement: There was no patient or public involvement in the design of the study protocol.Ethics and dissemination: This study protocol received ethics approval from the University of British Columbia’s Clinical Research Ethics Board, Dublin City University and Health Canada. Findings will be presented at research rounds, conferences and in peer-reviewed publications.Trial registration number: NCT03407157.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Exposure to opioids after surgery is the initial contact for some people who develop chronic opioid use disorder. Hence, effective postoperative pain management, with less reliance on opioids, is critical. The Perioperative Opioid Quality Improvement (POQI) program developed (1) a digital health platform leveraging patient-survey-reported risk factors and (2) a postsurgical pain risk stratification algorithm to personalize perioperative care by integrating several commercially available digital health solutions into a combined platform. Development was reduced in scope by the COVID-19 pandemic. Objective: This pilot study aims to assess the screening performance of the risk algorithm, quantify the use of the POQI platform, and evaluate clinicians’ and patients’ perceptions of its utility and benefit. Methods: A POQI platform prototype was implemented in a quality improvement initiative at a Canadian tertiary care center and evaluated from January to September 2022. After surgical booking, a preliminary risk stratification algorithm was applied to health history questionnaire responses. The estimated risk guided the patient assignment to a care pathway based on low or high risk for persistent pain and opioid use. Demographic, procedural, and medication administration data were extracted retrospectively from the electronic medical record. Postoperative inpatient opioid use of >90 morphine milligram equivalents per day was the outcome used to assess algorithm performance. Data were summarized and compared between the low- and high-risk groups. POQI use was assessed by completed surveys on postoperative days 7, 14, 30, 60, 90, and 120. Semistructured patient and clinician interviews provided qualitative feedback on the platform. Results: Overall, 276 eligible patients were admitted for colorectal procedures. The risk algorithm stratified 203 (73.6%) as the low-risk group and 73 (26.4%) as the high-risk group. Among the 214 (77.5%) patients with available data, high-risk patients were younger than low-risk patients (age: median 53, IQR 40-65 years, vs median 59, IQR 49-69 years, median difference five years, 95% CI 1-9; P=.02) and were more often female patients (45/73, 62% vs 80/203, 39.4%; odds ratio 2.5, 95% CI 1.4-4.5; P=.002). The risk stratification was reasonably specific (true negative rate=144/200, 72%) but not sensitive (true positive rate=10/31, 32%). Only 39.7% (85/214) patients completed any postoperative quality of recovery questionnaires (only 14, 6.5% patients beyond 60 days after surgery), and 22.9% (49/214) completed a postdischarge medication survey. Interviewed participants welcomed the initiative but noted usability issues and poor platform education. Conclusions: An initial POQI platform prototype was deployed operationally; the risk algorithm had reasonable specificity but poor sensitivity. There was a significant loss to follow-up in postdischarge survey completion. Clinicians and patients appreciated the potential impact of preemptively addressing opioid exposure but expressed shortcomings in the platform’s design and implementation. Iterative platform redesign with additional features and reevaluation are required before broader implementation. Trial Registration:

Background: There is limited knowledge on the social and economic impacts of a diagnosis of cervical cancer on women and children in low‐ and middle‐income countries (LMICs).Objectives: To determine the social and economic impacts associated with cervical cancer among women and children living in LMICs.Search strategy: The MEDLINE, PsychInfo, CINAHL, Pais International, and CAB Global Health databases were systematically searched to retrieve studies up to June 2021.Selection criteria: Studies were included if they reported on either the social or economic impacts of women or children in a LMIC.Data collection and analysis: Data was independently extracted by two co‐authors. The authors performed a quality assessment on all included articles.Main results: In all, 53 studies were included in the final review. Social impacts identified included social support, education, and independence. Economic impacts included employment and financial security. No study reported the economic impact on children. Studies that utilized quantitative methods typically reported more positive results than those that utilized qualitative methods.Conclusions: Additional mixed‐methods research is needed to further understand the social support needs of women with cervical cancer. Furthermore, research is needed on the impact of a mother's diagnosis of cervical cancer on her children.

Background: The mixed-gender community health worker (CHW) program in Mozambique is a window into the different experiences that male and female CHWs may face in their work. The objective of this study is to investigate how gender influenced the experiences of community health workers using the PIERS on the Move (POM) mHealth app in Mozambique.Methods: This is a secondary analysis by gender of health care workers involved in the Mozambique Community Level Intervention for Pre-eclampsia (CLIP) cluster randomized trial (NCT01911494). A structured survey with 10 open-ended questions was used to elicit CHW experiences using the POM app. Data collection took place in 2017 after completion of the CLIP trial. This analysis examined emergent themes to consider how experiences may have been shaped by health worker gender.Results: Of the 43 CHWs who used the POM app, there were 31 (72%) women and 12 (28%) men. Gender differences emerged in descriptions of how using POM increased their value and respect by pregnant women and community members. Fifty-eight percent of female CHWs (18/31) said that POM positively influenced their status in the community in comparison to 33% of their male counterparts (4/12). While the small sample sizes, particularly of male CHWs who used POM, preclude conclusions, these findings were supported by qualitative results. Female CHWs tended to elaborate more about community perceptions of their increased value and status as health care providers than male CHWs.Conclusion: CHWs work within existing gender norms. While gender norms are perceived to support the comfort of women to speak to another woman about their maternal and child health issues, gender norms also work against female CHWs as their professionalism may be questioned more than for their male counterparts. CHW's narratives suggested that the mHealth intervention was valued beyond the technology itself because it also added symbolic clinical value and demonstrated a tangible investment in their professional capacities, which may have been especially appreciated by the female CHWs.