Beyond Sterilization: A Comprehensive Review on the Safety and Efficacy of Opportunistic Salpingectomy as a Preventative Strategy for Ovarian Cancer.

Ovarian cancer (OC) is Canada's third most common gynecological cancer, with an estimated 3000 new cases and 1950 deaths projected in 2022. No effective screening has been found to identify OC, especially the most common subtype, high-grade serous carcinoma (HGSC), at an earlier, curable stage. In patients with hereditary predispositions such as BRCA mutations, the rates of HGSC are significantly elevated, leading to the use of risk-reducing salpingo-oophorectomy as the key preventative intervention. Although surgery has been shown to prevent HGSC in high-risk women, the associated premature menopause has adverse long-term sequelae and mortality due to non-cancer causes. The fact that 75% of HGSCs are sporadic means that most women diagnosed with HGSC will not have had the option to avail of either screening or prevention. Recent research suggests that the fimbrial distal fallopian tube is the most likely origin of HGSC. This has led to the development of a prevention plan for the general population: opportunistic salpingectomy, the removal of both fallopian tubes. This article aims to compile and review the studies evaluating the effect of opportunistic salpingectomy on surgical-related complications, ovarian reserve, cost, and OC incidence when performed along with hysterectomy or instead of tubal ligation in the general population.

Specialty Care and Counselling about Hereditary Cancer Risk Improves Adherence to Cancer Screening and Prevention in Newfoundland and Labrador Patients with BRCA1/2 Pathogenic Variants: A Population-Based Retrospective Cohort Study.

Pathogenic variants (PVs) in BRCA1 and BRCA2 increase the lifetime risks of breast and ovarian cancer. Guidelines recommend breast screening (magnetic resonance imaging (MRI) and mammogram) or risk-reducing mastectomy (RRM) and salpingo-oophorectomy (RRSO). We sought to (1) characterize the population of BRCA1/2 PV carriers in Newfoundland and Labrador (NL), (2) evaluate risk-reducing interventions, and (3) identify factors influencing screening and prevention adherence. We conducted a retrospective study from a population-based provincial cohort of BRCA1/2 PV carriers. The eligibility criteria for risk-reducing interventions were defined for each case and patients were categorized based on their level of adherence with recommendations. Chi-squared and regression analyses were used to determine which factors influenced uptake and level of adherence. A total of 276 BRCA1/2 PV carriers were identified; 156 living NL biological females composed the study population. Unaffected females were younger at testing than those with a cancer diagnosis (44.4 years versus 51.7 years; p = 0.002). Categorized by eligibility, 61.0%, 61.6%, 39.0%, and 75.7% of patients underwent MRI, mammogram, RRM, and RRSO, respectively. Individuals with breast cancer were more likely to have RRM (64.7% versus 35.3%; p < 0.001), and those who attended a specialty hereditary cancer clinic were more likely to be adherent to recommendations (73.2% versus 13.4%; p < 0.001) and to undergo RRSO (84.1% versus 15.9%; p < 0.001). Nearly 40% of the female BRCA1/2 PV carriers were not receiving breast surveillance according to evidence-based recommendations. Cancer risk reduction and uptake of breast imaging and prophylactic surgeries are significantly higher in patients who receive dedicated specialty care. Organized hereditary cancer prevention programs will be a valuable component of Canadian healthcare systems and have the potential to reduce the burden of disease countrywide.

Public attitudes towards genomic data sharing: results from a provincial online survey in Canada.

BACKGROUND: While genomic data sharing can facilitate important health research and discovery benefits, these must be balanced against potential privacy risks and harms to individuals. Understanding public attitudes and perspectives on data sharing is important given these potential risks and to inform genomic research and policy that aligns with public preferences and needs. METHODS: A cross sectional online survey measured attitudes towards genomic data sharing among members of the general public in an Eastern Canadian province. RESULTS: Results showed a moderate comfort level with sharing genomic data, usually into restricted scientific databases with controlled access. Much lower comfort levels were observed for sharing data into open or publicly accessible databases. While respondents largely approved of sharing genomic data for health research permitted by a research ethics board, many general public members were concerned with who would have access to their data, with higher rates of approval for access from clinical or academic actors, but much more limited approval of access from commercial entities or governments. Prior knowledge about sequencing and about research ethics boards were both related to data sharing attitudes. CONCLUSIONS: With evolving regulations and guidelines for genomics research and data sharing, it is important to consider the perspectives of participants most impacted by these changes. Participant information materials and informed consent documents must be explicit about the safeguards in place to protect genomic data and the policies governing the sharing of data. Increased public awareness of the role of research ethics boards and of the need for genomic data sharing more broadly is also needed.

"I think there has to be a mutual respect for there to be value": Evaluating patient engagement in a national clinical trial on de-implementation of low value care.

BACKGROUND: The evaluation of patient engagement in research is understudied and under-reported, making it difficult to know what engagement strategies work best and when. We provide the results of an evaluation of patient engagement in a large Canadian research program focused on the de-implementation of low-value care. We aimed to evaluate the experience and impact of patient engagement in the study. METHODS: An online cross-sectional survey was administered using Microsoft Forms to (1) researchers and study staff and (2) patient partners. The survey was developed following iterative reviews by the project's patient partnership council and evaluation committee. Survey content areas included opinions on patient engagement to date, including challenges to engagement and suggestions for improvement. Patient partners also evaluated the partnership council. Descriptive statistics including counts and percentages described Likert scale survey items, while open comments were analyzed using descriptive content analysis. RESULTS: The survey response rate was 46% (17/37). There were positive attitudes about the value of patient engagement in this project. There was also a high degree of willingness to be involved with patient engagement in future projects, whether as a patient partner or as a researcher including patients on the research team. Most patient partners felt their contributions to the project were valued by researchers and study research staff. Open comments revealed that a co-design approach and full inclusion on the research team were integral to demonstrating the value of patient partner input. Areas for improvement included more frequent and ongoing communication among all team members, as well as earlier training about patient engagement, particularly addressing role expectations and role clarity. CONCLUSIONS: Our data revealed that despite some challenges, team members recognized the value of patient engagement in research and agreed project decisions had been impacted by patient partner input. Ongoing communication was highlighted as an area for improvement, as well as earlier training and ongoing support for all team members, but particularly researchers and study staff. In response to evaluation data, the team has reinstated a quarterly newsletter and plans to use specific patient engagement planning templates across study sites for all project activities. These tools should help make expectations clear for all team members and contribute to a positive patient engagement experience. Findings can inform patient engagement planning and evaluation for other health research projects.

Evaluating patient engagement in research is often not done or not reported, making it hard to know what engagement strategies work best and when. Here, we provide the results of an evaluation of patient engagement in a Canadian Institutes for Health Research (CIHR) Strategy for Patient Oriented Research (SPOR) Innovative Clinical Trial Multi-Year Grant. The project focuses on strategies to reduce two low-value care practices (pre-operative testing in low-risk day surgery and imaging for low back pain). An online survey was sent to project researchers, study staff and patient partners to get their opinions on the patient engagement in the project. Generally, there were positive attitudes about the value of patient engagement in the project. Both patient partners and research study staff were very willing to be involved with patient engagement in future projects. Most patient partners felt their contributions to the project were valued by researchers and study research staff. An important part of showing the value of patient partners was working together to design the project and making sure that the patient partners were considered full members of the research team. Areas for improvement included better communication among all team members and earlier training about patient engagement with a focus on patient roles and expectations. The results from this survey will be used to improve the patient engagement in this project but will also help patient engagement planning and evaluation for other health research projects.

A qualitative study exploring perceived barriers and enablers to fidelity of training and delivery for an intervention to reduce non-indicated imaging for low back pain.

BACKGROUND: Non-specific low back pain (LBP) commonly presents to primary care, where inappropriate use of imaging remains common despite guideline recommendations against its routine use. Little is known about strategies to enhance intervention fidelity (i.e., whether interventions were implemented as intended) for interventions developed to reduce non-indicated imaging for LBP. OBJECTIVES: We aim to inform the development of an intervention to reduce non-indicated imaging among general practitioners (GPs) and chiropractors in Newfoundland and Labrador (NL), Canada. The study objectives are: [1] To explore perceived barriers and enablers to enhancing fidelity of training of GPs and chiropractors to deliver a proposed intervention to reduce non-indicated imaging for LBP and [2] To explore perceived barriers and enablers to enhancing fidelity of delivery of the proposed intervention. METHODS: An exploratory, qualitative study was conducted with GPs and chiropractors in NL. The interview guide was informed by the National Institutes of Health Behavior Change Consortium fidelity checklist; data analysis was guided by the Theoretical Domains Framework (TDF). Participant quotes were coded into TDF domains, belief statements were generated at each domain, and domains relevant to enhancing fidelity of provider training or intervention delivery were identified. RESULTS: The study included five GPs and five chiropractors from urban and rural settings. Barriers and enablers to enhancing fidelity to provider training related to seven TDF domains: [1] Beliefs about capabilities, [2] Optimism, [3] Reinforcement, [4] Memory, attention, and decision processes, [5] Environmental context and resources, [6] Emotion, and [7] Behavioural regulation. Barriers and enablers to enhancing fidelity to intervention delivery related to seven TDF domains: [1] Beliefs about capabilities, [2] Optimism, [3] Goals, [4] Memory, attention, and decision processes, [5] Environmental context and resources, [6] Social influences, and [7] Behavioural regulation. CONCLUSION: The largest perceived barrier to attending training was time; perceived enablers were incentives and flexible training. Patient pressure, time, and established habits were perceived barriers to delivering the intervention as intended. Participants suggested enhancement strategies to improve their ability to deliver the intervention as intended, including reminders and check-ins with researchers. Most participants perceived intervention fidelity as important. These results may aid in the development of a more feasible and pragmatic intervention to reduce non-indicated imaging for GPs and chiropractors in NL.

The Effects of Cancer Beliefs and Sociodemographic Factors on Colorectal Cancer Screening Behaviours in Newfoundland and Labrador.

Objectives: This study investigated the beliefs about cancer treatment, outcomes, and screening among adults aged 50−74 in Newfoundland and Labrador and whether these beliefs or sociodemographic factors were associated with differences in colorectal cancer (CRC) screening behaviours. Methods: This analysis uses data collected from an online survey of adults on cancer awareness and prevention in NL. Chi-square tests were used to assess differences in distributions of beliefs based on CRC screening behaviour. Logistic regression was used to identify sociodemographic factors independently associated with CRC screening behaviour. Results: A total of 724 participants were included in the analysis, 57.4% of which had ever had CRC screening. Most held positive beliefs about cancer outcomes and treatment. Only beliefs about screening affected CRC screening behaviour. People who never had CRC screening were more likely to believe their worries about what might be found would prevent them from screening (χ2 = 9.380, p = 0.009); screening is only necessary if they have symptoms (χ2 = 15.680, p < 0.001); and screening has a high risk of leading to unnecessary surgery (χ2 = 6.824, p = 0.032). Regression identified that men had higher likelihood of having had CRC screening than women in our study (OR = 1.689, 95%CI = 1.135−2.515), as did all age groups compared to ages 50−54. No associations were found with the other sociodemographic factors studied. Conclusion: Beliefs about cancer screening appear to play some role in CRC screening behaviour, but the absolute effect was small. The relatively few sociodemographic associations with screening behaviour suggest that NL's CRC screening program is equitably reaching people from different socioeconomic backgrounds.

Cancer prevention in cancer predisposition syndromes: A protocol for testing the feasibility of building a hereditary cancer research registry and nurse navigator follow up model.

Monogenic, high penetrance syndromes, conferring an increased risk of malignancies in multiple organs, are important contributors to the hereditary burden of cancer. Early detection and risk reduction strategies in patients with a cancer predisposition syndrome can save their lives. However, despite evidence supporting the benefits of early detection and risk reduction strategies, most Canadian jurisdictions have not implemented programmatic follow up of these patients. In our study site in the province of Newfoundland and Labrador (NL), Canada, there is no centralized, provincial registry of high-risk individuals. There is no continuity or coordination of care providing cancer genetics expertise and no process to ensure that patients are referred to the appropriate specialists or risk management interventions. This paper describes a study protocol to test the feasibility of obtaining and analyzing patient risk management data, specifically patients affected by hereditary breast ovarian cancer syndrome (HBOC; BRCA 1 and BRCA 2 genes) and Lynch syndrome (LS; MLH1, MSH2, MSH6, and PMS2 genes). Through a retrospective cohort study, we will describe these patients' adherence to risk management guidelines and test its relationship to health outcomes, including cancer incidence and stage. Through a qualitative interviews, we will determine the priorities and preferences of patients with any inherited cancer mutation for a follow up navigation model of risk management. Study data will inform a subsequent funding application focused on creating and evaluating a research registry and follow up nurse navigation model. It is not currently known what proportion of cancer mutation carriers are receiving care according to guidelines. Data collected in this study will provide clinical uptake and health outcome information so gaps in care can be identified. Data will also provide patient preference information to inform ongoing and planned research with cancer mutation carriers.

Physician-reported barriers to using evidence-based antibiotic prescription guidelines in primary care: protocol for a systematic review and synthesis of qualitative studies using the Theoretical Domains Framework.

INTRODUCTION: Overprescription of antibiotics poses a significant threat to healthcare globally as it contributes to the issue of antibiotic resistance. While antibiotics should be predominately prescribed for bacterial infections, they are often inappropriately given for uncomplicated upper respiratory tract infections (URTIs) and related conditions, such as the common cold. This study will involve a qualitative systematic review of physician-reported barriers to using evidence-based antibiotic prescription guidelines in primary care settings and synthesise the findings using a theoretical basis. METHODS AND ANALYSIS: We will conduct a systematic review of qualitative studies that assess physicians' reported barriers to following evidence-based antibiotic prescription guidelines in primary care settings for URTIs. We plan to search the following databases with no date or language restrictions: MEDLINE, Web of Science, CINAHL, Embase, the Cochrane Library and PsycInfo. Qualitative studies that explore the barriers and enablers to following antibiotic prescription guidelines for URTIs for primary care physicians will be included. We will analyse our findings using the Theoretical Domains Framework (TDF), which is a theoretically designed resource based on numerous behaviour change theories grouped into 14 domains. Using the TDF approach, we will be able to identify the determinants of our behaviour of interest (ie, following antibiotic prescription guidelines for URTIs) and categorise them into the 14 TDF domains. This will provide the necessary information to develop future evidence-based interventions that will target the identified issues and apply the most effective behaviour change techniques to affect change. This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols guidelines. ETHICS AND DISSEMINATION: Ethical approval is not required. Findings will be published in a peer-reviewed journal and presented at conferences.

The Use of Patient Engagement to Gather Perceptions on the Cost of Infant Feeding.

Purpose: Patient-oriented research (POR) and patient engagement (PE) has highlighted the value of incorporating patients' ideas and priorities in health research. Using the guiding principles of POR and PE, the current study conducted PE sessions to gain insight on the perceptions of mothers regarding the costs of infant feeding. Methods: Four patient engagement sessions were held with mothers residing in Newfoundland and Labrador between November 2019 and January 2020. Mothers were targeted through the Brighter Futures Coalition of St. John's, a not-for-profit community organization. PE sessions were designed in a two-hour format, allowing the research team to engage mothers and identify costs of infant feeding from a mothers' perspective. Results: Through the guiding principles of patient-oriented research and patient engagement, our research team successful engaged with mothers in discussions surrounding the costs of infant feeding. The sessions allowed for an in-depth discussion surrounding monetary costs (eg, incidentals of breast or formula feeding), the associated costs of infant feeding and the workplace (eg, perceived productivity) and environment impacts (eg, single use plastics). During each session, evaluations were provided to solicit feedback on whether the goals and expectations of mothers had been met, and whether they felt their opinions were heard and understood. Conclusion: By conducting patient engagement sessions, informed by patient-oriented research guiding principles, we were able to successfully recruit and engage mothers in discussions that led to a better understanding of their perspectives on the costs of infant feeding.

Patient education materials for non-specific low back pain and sciatica: A systematic review and meta-analysis.

INTRODUCTION: Guidelines recommend patient education materials (PEMs) for low back pain (LBP), but no systematic review has assessed PEMs on their own. We investigated the effectiveness of PEMs on process, clinical, and health system outcomes for LBP and sciatica. METHODS: Systematic searches were performed in MEDLINE, EMBASE, CINAHL, PsycINFO, SPORTDiscus, trial registries and grey literature through OpenGrey. We included randomized controlled trials of PEMs for LBP. Data extraction, risk of bias, and quality of evidence gradings were performed independently by two reviewers. Standardized mean differences or risk ratios and 95% confidence intervals were calculated, and effect sizes pooled using random-effects models. Analyses of acute/subacute LBP were performed separately from chronic LBP at immediate, short, medium, and long-term (6, 12, 24, and 52 weeks, respectively). RESULTS: 27 studies were identified. Compared to usual care for chronic LBP, we found moderate to low-quality evidence that PEMs improved pain intensity at immediate (SMD = -0.16 [95% CI: -0.29, -0.03]), short (SMD = -0.44 [95% CI: -0.88, 0.00]), medium (SMD = -0.53 [95% CI: -1.01, -0.05]), and long-term (SMD = -0.21 [95% CI: -0.41, -0.01]), medium-term disability (SMD = -0.32 [95% CI: -0.61, -0.03]), quality of life at short (SMD = -0.17 [95% CI: -0.30, -0.04]) and medium-term (SMD = -0.23 [95% CI: -0.41, -0.04]) and very low-quality evidence that PEMs improved global improvement ratings at immediate (SMD = -0.40 [95% CI: -0.58, -0.21]), short (SMD = -0.42 [95% CI: -0.60, -0.24]), medium (SMD = -0.46 [95% CI: -0.65, -0.28]), and long-term (SMD = -0.43 [95% CI: -0.61, -0.24]). We found very low-quality evidence that PEMs improved pain self-efficacy at immediate (SMD = -0.21 [95% CI: -0.39, -0.03]), short (SMD = -0.25 [95% CI: -0.43, -0.06]), medium (SMD = -0.23 [95% CI: -0.41, -0.05]), and long-term (SMD = -0.32 [95% CI: -0.50, -0.13]), and reduced medium-term fear-avoidance beliefs (SMD = -0.24 [95% CI: -0.43, -0.06]) and long-term stress (SMD = -0.21 [95% CI: -0.39, -0.03]). Compared to usual care for acute LBP, we found high to moderate-quality evidence that PEMs improved short-term pain intensity (SMD = -0.24 [95% CI: -0.42, -0.06]) and immediate-term quality of life (SMD = -0.24 [95% CI: -0.42, -0.07]). We found low to very low-quality evidence that PEMs increased knowledge at immediate (SMD = -0.51 [95% CI: -0.72, -0.31]), short (SMD = -0.48 [95% CI: -0.90, -0.05]), and long-term (RR = 1.28 [95% CI: 1.10, 1.49]) and pain self-efficacy at short (SMD = -0.78 [95% CI: -0.98, -0.58]) and long-term (SMD = -0.32 [95% CI: -0.52, -0.12]). We found moderate to very low-quality evidence that PEMs reduced short-term days off work (SMD = -0.35 [95% CI: -0.63, -0.08]), long-term imaging referrals (RR = 0.60 [95% CI: 0.41, 0.89]), and long-term physician visits (SMD = -0.16 [95% CI: -0.26, -0.05]). Compared to other interventions (e.g., yoga, Pilates), PEMs had no effect or were less effective for acute/subacute and chronic LBP. CONCLUSIONS: There was a high degree of variability across outcomes and time points, but providing PEMs appears favorable to usual care as we observed many small, positive patient and system impacts for acute/subacute and chronic LBP. PEMs were generally less effective than other interventions; however, no cost effectiveness analyses were performed to weigh the relative benefits of these interventions to the likely less costly PEMs.

Public Interest Group on Cancer Research: a successful patient-researcher partnership in Newfoundland and Labrador.

BACKGROUND: Partnering with patients and family members affected by cancer is essential for meaningful research, public engagement and outreach, and advocacy activities. OBJECTIVE: Our objective was to create a public interest group through an academic-community partnership focused on cancer research and public engagement. METHODS: A purposeful recruitment process was implemented to ensure a diverse and inclusive group. The group meets virtually and communicates by email. The group's activities focus on identifying the needs, priorities, and interests of cancer-affected individuals in the province; consultations; and designing research projects and public outreach activities together. Comprehensive meeting minutes are kept and used to distill discussion points. The work of the group is disseminated through a variety of channels. RESULTS: The public interest group includes 12 cancer patient and family member representatives, in addition to researchers. Discussions by the interest group identified key themes related to: (1) equity issues and regional disparity in provincial oncocare; (2) information needs; (3) need for patient empowerment and public understanding; and (4) family member and partner needs and experiences. To date, the group has co-designed a cancer research proposal and a public engagement/outreach activity. The group also provides consultations on cancer-related projects/public engagement activities and members act as patient partners in specific research and public engagement proposals. The group evolves over time, and increasingly advocates on behalf of cancer patients and families. Retention and satisfaction of the public partners with group activities have been high. The group's work and findings are disseminated to the Provincial Cancer Care Program, as well as to public and scientific stakeholders through local media, academic conferences and presentations, and a dedicated website. CONCLUSION: Public Interest Group on Cancer Research represents a highly successful patient-researcher partnership in oncology. It designs meaningful and patient-oriented studies and outreach activities in cancer. It also elevates and widely supports cancer patient and family voice.

Cancer patients and their family members have unique and lived experience with the condition. Therefore, collaborating with them is important in cancer science. We aimed to create such a collaboration in Newfoundland and Labrador, Canada. In 2021, we successfully formed our diverse collaborative group. Currently, our group includes 12 public representatives. We meet online and discuss matters important to members. We also design studies and events together. Our discussions have identified four topics that need further research and policy changes such as information needs and unique needs of caregivers and family members. Our activities expand over time. For example, lately we started to advocate for other cancer patients and families. In conclusion, we formed a successful cancer patient, family member, and researcher collaborative group. Our work informs the public, healthcare systems, and scientists on important cancer related matters.

Patient-centered care in the emergency department: a systematic review and meta-ethnographic synthesis.

BACKGROUND: Patient-centered care (PCC) is an emerging priority in many healthcare settings but lacks clarity in the emergency department (ED). It is of interest to know what PCC practices are most important to patients to better their experience. The objective of this study was to conduct a mixed-methods systematic review of PCC in the ED. METHODS: We used stakeholder and patient engagement to consult with clinicians, subject-matter experts, patient partners, and community organizations to determine patient needs. We examined all articles in the ED context with PCC as the intervention. Two independent reviewers screened 3136 articles and 13 were included. A meta-ethnographic analysis was conducted to determine common themes of PCC. RESULTS: Themes included emotional support, communication, education, involvement of patient/family in information sharing and decision making, comfort of environment, respect and trust, continuity, and transition of care. Challenges in the ED reflected a lack of PCC. Moreover, implementation of PCC had many benefits including higher patient satisfaction with their care. Though there were commonalities of PCC components, there was no consistently used definition for PCC in the ED. CONCLUSION: The findings of this review support the evidence that PCC is of high value to the ED setting and should be standardized in practice.

Implementation of an ED surge management platform: a study protocol.

BACKGROUND: Emergency departments (EDs) around the world are struggling with long wait times and overcrowding. To address these issues, a quality improvement program called SurgeCon was created to improve ED efficiency and patient satisfaction. This paper presents a framework for managing and evaluating the implementation of an ED surge management platform. Our framework builds on the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to structure our approach and the Consolidated Framework for Implementation Research (CFIR) to guide our choice of outcome variables and scalability. METHODS: Four hospital EDs will receive the SurgeCon quality improvement intervention. Using a stepped wedge cluster design, each ED will be randomized to one of four start dates. Data will be collected before, during, and after the implementation of the intervention. RE-AIM will be used to guide the assessment of SurgeCon, and guided by CFIR, we will measure ED key performance indicators (KPI), patient-reported outcomes, and implementation outcomes related to SurgeCon's scalability, adaptability, sustainability, and overall costs. Participants in this study consist of patients who visit any of the four selected EDs during the study period, providers/staff, and health system managers. A mixed-methods approach will be utilized to evaluate implementation outcomes. DISCUSSION: This study will provide important insight into the implementation and evaluation techniques to enhance uptake and benefits associated with an ED surge-management platform. The proposed framework bridges research and practice by involving researchers, practitioners, and patients in the implementation and evaluation process, to produce an actionable framework that others can follow. We anticipate that the implementation approach would be generalizable to program implementations in other EDs. TRIAL REGISTRATION: • Name of the registry: ClinicalTrials.gov • Trial registration number: NCT04789902 • Date of registration: 03/10/2021.

A Quality Improvement Emergency Department Surge Management Platform (SurgeCon): Protocol for a Stepped Wedge Cluster Randomized Trial.

BACKGROUND: Despite many efforts, long wait times and overcrowding in emergency departments (EDs) have remained a significant health service issue in Canada. For several years, Canada has had one of the longest wait times among the Organisation for Economic Co-operation and Development countries. From a patient's perspective, this challenge has been described as "patients wait in pain or discomfort for hours before being seen at EDs." To overcome the challenge of increased wait times, we developed an innovative ED management platform called SurgeCon that was designed based on continuous quality improvement principles to maintain patient flow and mitigate the impact of patient surge on ED efficiency. The SurgeCon quality improvement intervention includes a protocol-driven software platform, restructures ED organization and workflow, and aims to establish a more patient-centric environment. We piloted SurgeCon at an ED in Carbonear, Newfoundland and Labrador, and found that there was a 32% reduction in ED wait times. OBJECTIVE: The primary objective of this trial is to determine the effects of SurgeCon on ED performance by assessing its impact on length of stay, the time to a physician's initial assessment, and the number of patients leaving the ED without being seen by a physician. The secondary objectives of this study are to evaluate SurgeCon's effects on patient satisfaction and patient-reported experiences with ED wait times and its ability to create better-value care by reducing the per-patient cost of delivering ED services. METHODS: The implementation of the intervention will be assessed using a comparative effectiveness-implementation hybrid design. This type of hybrid design is known to shorten the amount of time associated with transitioning interventions from being the focus of research to being used for practice and health care services. All EDs with 24/7 on-site physician support (category A hospitals) will be enrolled in a 31-month, pragmatic, stepped wedge cluster randomized trial. All clusters (hospitals) will start with a baseline period of usual care and will be randomized to determine the order and timing of transitioning to intervention care until all hospitals are using the intervention to manage and operationalize their EDs. RESULTS: Data collection for this study is continuing. As of February 2022, a total of 570 randomly selected patients have participated in telephone interviews concerning patient-reported experiences and patient satisfaction with ED wait times. The first of the 4 EDs was randomly selected, and it is currently using SurgeCon's eHealth platform and applying efficiency principles that have been learned through training since September 2021. The second randomly selected site will begin intervention implementation in winter 2022. CONCLUSIONS: By assessing the impact of SurgeCon on ED services, we hope to be able to improve wait times and create better-value ED care in this health care context. TRIAL REGISTRATION: ClinicalTrials.gov NCT04789902; https://clinicaltrials.gov/ct2/show/NCT04789902. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30454.

Public interest in unexpected genomic findings: a survey study identifying aspects of sequencing attitudes that influence preferences.

We describe public preferences for unexpected genomic findings and explore predictors of preferences using an online survey in an Eastern Canadian province. Items measuring attitudes toward features of unexpected findings and genomic sequencing concerns were entered in logistic regression models predicting interest in unexpected findings. Very high levels of interest were observed in unexpected findings for treatable disorders and carrier results, with lesser interest in unexpected findings for non-treatable disorders and unclassified variants. Respondents who endorsed items measuring features of patient control and choice over their genomic data and testing options were 3-5 times more likely to be very interested in receiving unexpected findings. Respondents with high genomic sequencing concerns were less interested in the return of any unexpected result. Self-reported history of a genetic condition was significantly related to interest in receiving most categories of unexpected genomic information, while prior use of direct-to-consumer testing was significantly related only to interest in the return of unexpected genomic findings for disorders not currently treatable. Findings highlight the need for specific elements of information and transparency regarding the return of unexpected findings and can inform the development of patient-centered materials and return of results policies.

Operationalizing a patient engagement plan for health research: Sharing a codesigned planning template from a national clinical trial.

INTRODUCTION: Engaging with patients about their lived experience of health and illness and their experience within the healthcare system can help inform the provision of care, health policies and health research. In the context of health research, however, operationalizing the levels of patient engagement is not straightforward. We suggest that a key challenge to the routine inclusion of patients as partners in health research is a lack of tangible guidance regarding how this can be accomplished. METHODS: In this article, we provide guidance on how to codesign and operationalize a concrete patient engagement plan for any health research project. RESULTS: We illustrate a seven-step approach using the example of a national clinical trial in Canada and provide a patient engagement planning template for use in any health research project. CONCLUSION: Such concrete guidance should improve the design and reporting of patient engagement in health research. PATIENT OR PUBLIC CONTRIBUTION: The De-Implementing Wisely Research group is informed by a national 9-member patient partner council (PPC). The research team includes three lead patient partners who are coinvestigators on the grant that funds the program of research. Members of the council advise on all aspects of the study design and implementation. The ideas presented in this paper were informed by regular communication and planning with the PPC; specific contributions of lead patient partner authors are outlined as follows: Brian Johnston, Susan Goold and Vanessa Francis are patient partners with a wide breadth of experience in the healthcare system and health research projects. The guidance in this article draws on their lived and professional expertise. All patient partner authors contributed to the planning of the manuscript, participated in meetings to develop content and provided critical manuscript edits and comments on drafts.

Psychological Distress and Quality of Life in Participants Undergoing Genetic Testing for Arrhythmogenic Right Ventricular Cardiomyopathy Caused by TMEM43 p.S358L: Is It Time to Offer Population-Based Genetic Screening?

PURPOSE: We have identified 27 families in Newfoundland and Labrador (NL) with the founder variant TMEM43 p.S358L responsible for 1 form of arrhythmogenic right ventricular cardiomyopathy. Current screening guidelines rely solely on cascade genetic screening, which may result in unrecognized, high-risk carriers who would benefit from preemptive implantable cardioverter-defibrillator therapy. This pilot study explored the acceptability among subjects to TMEM43 p.S358L population-based genetic screening (PBGS) in this Canadian province. METHODS: A prospective cohort study assessed attitudes, psychological distress, and health-related quality of life (QOL) in unselected individuals who underwent genetic screening for the TMEM43 p.S358L variant. Participants (n = 73) were recruited via advertisements and completed 2 surveys at baseline, 6 months, and 1 year which measured health-related QOL (SF-36v2) and psychological distress (Impact of Events Scale). RESULTS: No variant-positive carriers were identified. Of those screened through a telephone questionnaire, >95% felt positive about population-genetic screening for TMEM43 p.S358L, though 68% reported some degree of anxiety after seeing the advertisement. There were no significant changes in health-related QOL or psychological distress scores over the study period. CONCLUSION: Despite some initial anxiety, we show support for PBGS among research subjects who screened negative for the TMEM43 p.S358L variant in NL. These findings have implications for future PBGS programs in the province.

What behaviour change techniques have been used to improve adherence to evidence-based low back pain imaging?

BACKGROUND: Despite international guideline recommendations, low back pain (LBP) imaging rates have been increasing over the last 20 years. Previous systematic reviews report limited effectiveness of implementation interventions aimed at reducing unnecessary LBP imaging. No previous reviews have analysed these implementation interventions to ascertain what behaviour change techniques (BCTs) have been used in this field. Understanding what techniques have been implemented in this field is an essential first step before exploring intervention effectiveness. METHODS: We searched EMBASE, Ovid (Medline), CINAHL and Cochrane CENTRAL from inception to February 1, 2021, as well as and hand-searched 6 relevant systematic reviews and conducted citation tracking of included studies. Two authors independently screened titles, abstracts, and full texts for eligibility and extracted data on study and intervention characteristics. Study interventions were qualitatively analysed by three coders to identify BCTs, which were mapped to mechanisms of action from the theoretical domains framework (TDF) using the Theory and Techniques Tool. RESULTS: We identified 36 eligible studies from 1984 citations in our electronic search and a further 2 studies from hand-searching resulting in 38 studies that targeted physician behaviour to reduce unnecessary LBP imaging. The studies were conducted in 6 countries in primary (n = 31) or emergency care (n = 7) settings. Thirty-four studies were included in our BCT synthesis which found the most frequently used BCTs were '4.1 instruction on how to perform the behaviour' (e.g. Active/passive guideline dissemination and/or educational seminars/workshops), followed by '9.1 credible source', '2.2 feedback on behaviour' (e.g. electronic feedback reports on physicians' image ordering) and 7.1 prompts and cues (electronic decision support or hard-copy posters/booklets for the office). This review highlighted that the majority of studies used education and/or feedback on behaviour to target the domains of knowledge and in some cases also skills and beliefs about capabilities to bring about a change in LBP imaging behaviour. Additionally, we found there to be a growing use of electronic or hard copy reminders to target the domains of memory and environmental context and resources. CONCLUSIONS: This is the first study to identify what BCTs have been used to target a reduction in physician image ordering behaviour. The majority of included studies lacked the use of theory to inform their intervention design and failed to target known physician-reported barriers to following LBP imaging guidelines. PROTOCOL REGISTATION: PROSPERO CRD42017072518.

Identifying Aspects of Public Attitudes Toward Whole Genome Sequencing to Inform the Integration of Genomics into Care.

INTRODUCTION: The growth of global sequencing initiatives and commercial genomic test offerings suggests the public will increasingly be confronted with decisions about sequencing. Understanding public attitudes can assist efforts to integrate sequencing into care and inform the development of public education and outreach strategies. METHODS: A 48-item online survey was advertised on Facebook in Eastern Canada and hosted on SurveyMonkey in late 2018. The survey measured public interest in whole genome sequencing and attitudes toward various aspects of sequencing using vignettes, scaled, and open-ended items. RESULTS: While interest in sequencing was high, critical attitudes were observed. In particular, items measuring features of patient control and choice regarding genomic data were strongly endorsed by respondents. Majority wanted to specify upfront how their data could be used, retain the ability to withdraw their sample at a later date, sign a written consent form, and speak to a genetic counselor prior to sequencing. Concerns about privacy and unauthorized access to data were frequently observed. Education level was the sociodemographic variable most often related to attitude statements such that those with higher levels of education generally displayed more critical attitudes. CONCLUSIONS: Attitudes identified here could be used to inform the development of implementation strategies for genomic medicine. Findings suggest health systems must address patient concerns about privacy, consent practices, and the strong desire to control what happens to their genomic data through public outreach and education. Specific oversight procedures and policies that are clearly communicated to the public will be required.

Ethical, Legal, and Social Issues (ELSI) in Clinical Genetics Research.

ELSI (Ethical, Legal, and Social Issues) is a widely used acronym in the bioethics literature that encompasses a broad range of research examining the various impacts of science and technology on society. In Canada, GE3LS (Genetics, Ethical, Economic, Environmental, Legal, Social issues) is the term used to describe ELSI studies in the context of genetics and genomics research. It is intentionally more expansive in that GE3LS explicitly brings economic and environmental issues under its purview. ELSI/GE3LS research is increasingly relevant in recent years as there has been a greater emphasis on "translational research" that moves genomic discoveries from the bench to the clinic. The purpose of this chapter is to outline a range of ELSI-related work that might be conducted as part of a large scale genetics or genomics research project, and to provide some practical insights on how a scientific research team might incorporate a strong and effective ELSI program within its broader research mandate. We begin by describing the historical context of ELSI research and the development of GE3LS research in the Canadian context. We then illustrate how some ELSI research might unfold by outlining a variety of GE3LS research questions or content domains and the methodologies that might be employed in studying them. We conclude with some practical suggestions about how to build an effective ELSI/GE3LS team and focus within a broader scientific research program.