Relationship Between Diet Quality and Antihypertensive Medication Intensity Among Adults With Metabolic Syndrome-Associated High Blood Pressure.

Background: Management of high blood pressure (BP), a key feature of the metabolic syndrome (MetS), relies on diet and medication. Whether these modalities are used as complements has never been evaluated in real-world settings. This study assessed the relationship between diet quality and antihypertensive medication intensity among adults with MetS-associated high BP. Methods: This cross-sectional study included 915 adults with MetS-associated high BP from the CARTaGENE cohort (Québec, Canada), of whom 677 reported using BP-lowering medication. Antihypertensive medication intensity was graded per the number of BP-lowering classes used simultaneously. Diet quality was assessed using the Dietary Approach to Stop Hypertension (DASH) score. Results: No evidence of a relationship between antihypertensive medication intensity and diet quality was found (ß for each additional antihypertensive = -0.05; 95% CI, -0.35; 0.26 DASH score points). However, among men aged < 50 years and women aged < 60 years, the DASH score was inversely associated with medication intensity (ß = -0.72; 95% CI, -1.24, -0.19), whereas this relationship tended to be positive among older participants (ß = 0.32; 95% CI, -0.05, 0.69). Among participants with low Framingham risk score, the DASH score was inversely associated with medication intensity (ß = -0.70; 95% CI, -1.31, -0.09), but no evidence of an association was found among individuals at moderate (ß = 0.00; 95% CI, -0.45, 0.45) or high (ß = 0.30, 95% CI, -0.24, 0.84) risk. Conclusions: In this cohort of adults with MetS-associated high BP, there was an overall lack of complementarity between diet quality and BP-lowering medication, especially among younger individuals and those with a lower risk for cardiovascular disease for whom diet quality was inversely associated with intensity of medication.

Introduction: La prise en charge de la pression artérielle (PA) élevée, l'une des caractéristiques principales du syndrome métabolique (SMet), repose sur une saine alimentation et l'usage de médicaments hypotenseurs. Il n'a jamais été évalué si ces modalités étaient utilisées de façon complémentaire en contexte réel. La présente étude portait sur la relation entre la qualité de l'alimentation et la médication antihypertensive au sein d'adultes ayant une PA élevée associée au SMet. Méthodes: Cette étude transversale regroupait 915 adultes de la cohorte CARTaGENE (Québec, Canada) ayant une PA élevée associée au SMet, dont 677 ont rapporté prendre des médicaments abaissant la PA. L'intensité de la médication antihypertensive a été évaluée par le nombre de classes de médicaments abaissant la PA utilisées simultanément. La qualité du régime alimentaire a été évaluée à l'aide du score Dietary Approache to Stop Hypertension (DASH). Résultats: Aucune évidence d'une relation entre l'intensité des médicaments antihypertenseurs et la qualité de l'alimentation n'a été observée (ß pour chaque antihypertenseur supplémentaire = ­0,05 ; intervalle de confiance [IC] à 95 %, ­0,35 ; 0,26 point au score DASH). Toutefois, chez les hommes âgés < 50 ans et chez les femmes âgées < 60 ans, le score DASH était inversement associé à l'intensité des médicaments (ß = ­0,72 ; IC à 95 %, ­1,24, ­0,19), alors que cette relation avait tendance à être positive chez les participants plus âgés (ß = 0,32 ; IC à 95 %, ­0,05, 0,69). Chez les participants qui avaient un score de risque de Framingham faible, le score DASH était inversement associé à l'intensité des médicaments (ß = ­0,70 ; IC à 95 %, ­1,31, ­0,09), mais aucune évidence d'une association n'a été observée chez les individus qui avaient un risque modéré (ß = 0,00 ; IC à 95 %, ­0,45, 0,45) ou élevé (ß = 0,30, IC à 95 %, ­0,24, 0,84). Conclusions: Au sein de cette cohorte d'adultes qui avaient une PA élevée associée au SMet, aucune évidence de complémentarité entre la qualité de l'alimentation et l'intensité de la médication antihypertensive n'a été observée, particulièrement chez les individus plus jeunes et chez ceux exposés à un risque plus faible de maladies cardiovasculaires pour qui la qualité du régime alimentaire était inversement associée à l'intensité des médicaments.

Spontaneous Scaling of a Primary Care Innovation in Real-Life Conditions: Protocol for a Case Study.

BACKGROUND: Scaling effective primary care innovations to benefit more people is of interest to decision makers. However, we know little about how promising innovations are being scaled "spontaneously," that is, without deliberate guidance. OBJECTIVE: We aim to observe, document, and analyze how, in real-life conditions, 1 primary care innovation spontaneously scales up across Quebec, Canada. METHODS: We will conduct a participative study using a descriptive single-case study. It will be guided by the McLean and Gargani principles for scaling and reported according to the COREQ (Consolidated Criteria for Reporting Qualitative Research) guidelines. Informed by an integrated knowledge translation approach, our steering committee will include patient users throughout the project. Inspired by the Quebec College of Family Physician's "Dragons' Den" primary care program, we will identify a promising primary care innovation that is being or will be scaled spontaneously. We will interview the innovation team about their scaling experiences every month for 1 year. We will conduct interviews and focus groups with decision makers, health care providers, and end users in the innovation team and the target site about their experience of both scaling and receiving the scaled innovation and document meetings as nonparticipant observers. Interview transcripts and documentary data will be analyzed to (1) compare the spontaneous scaling plan and implementation with the McLean and Gargani principles for scaling and (2) determine how it was consistent with or diverged from the 4 McLean and Gargani guiding principles: justification, optimal scale, coordination, and dynamic evaluation. RESULTS: This study was funded in March 2020 by the Canadian Institutes of Health Research. Recruitment began in November 2023 and data collection began in December 2023. Results are expected to be published in the first quarter of 2024. CONCLUSIONS: Our study will advance the science of scaling by providing practical evidence-based material about scaling health and social care innovations in real-world settings using the 4 guiding principles of McLean and Gargani. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54855.

The Longevity Protein Klotho: A Promising Tool to Monitor Lifestyle Improvements.

Aging is not a disease; it is a natural evolution of human physiology. Medical advances have extended our life expectancy, but chronic diseases and geriatric syndrome continue to affect the increasingly aging population. Yet modern medicine perpetuates an approach based on treatment rather than prevention and education. In order to help solve this ever-growing problem, a new discipline has emerged: lifestyle medicine. Nutrition, physical activity, stress management, restorative sleep, social connection, and avoidance of risky substances are the pillars on which lifestyle medicine is founded. The aim of this discipline is to increase healthspan and reduce the duration of morbidity by making changes to our lifestyle. In this review, we propose the use of klotho protein as a novel biomarker for lifestyle medicine in order to quantify and monitor the health status of individuals, as no integrative tool currently exists.

Clinical Integration of Digital Patient-Reported Outcome Measures in Primary Health Care for Chronic Disease Management: Protocol for a Systematic Review.

BACKGROUND: Health measurement guides policies and health care decisions are necessary to describe and attain the quintuple aim of improving patient experience, population health, care team well-being, health care costs, and equity. In the primary care setting, patient-reported outcome measurement allows outcome comparisons within and across settings and helps improve the clinical management of patients. However, these digital patient-reported outcome measures (PROMs) are still not adapted to the clinical context of primary health care, which is an indication of the complexity of integrating these tools in this context. We must then gather evidence of their impact on chronic disease management in primary health care and understand the characteristics of effective implementation. OBJECTIVE: We will conduct a systematic review to identify and assess the impact of electronic PROMs (ePROMs) implementation in primary health care for chronic disease management. Our specific objectives are to (1) determine the impact of ePROMs in primary health care for chronic disease management and (2) compare and contrast characteristics of effective ePROMs' implementation strategies. METHODS: We will conduct a systematic review of the literature in accordance with the guidelines of the Cochrane Methods Group and in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for its reporting. A specific search strategy was developed for relevant databases to identify studies. Two reviewers will independently apply the inclusion criteria using full texts and will extract the data. We will use a 2-phase sequential mixed methods synthesis design by conducting a qualitative synthesis first, and use its results to perform a quantitative synthesis. RESULTS: This study was initiated in June 2022 by assembling the research team and the knowledge transfer committee. The preliminary search strategy will be developed and completed in September 2022. The main search strategy, data collection, study selection, and application of inclusion criteria were completed between October and December 2022. CONCLUSIONS: Results from this review will help support implementation efforts to accelerate innovations and digital adoption for primary health care and will be relevant for improving clinical management of chronic diseases and health care services and policies. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42022333513; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=333513. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48155.

Collaboration and Partnership in a 5-Level Engagement Framework for Diabetic Foot Ulcer Management: A Patient-oriented Scoping Review.

OBJECTIVE: The management of diabetic foot ulcers (DFUs) is complex, and patient engagement is essential for DFU healing, but it often comes down to the patient's consultation. Therefore, we sought to document patients' engagement in terms of collaboration and partnership for DFUs in 5 levels (direct care, organizational, policy level, research, and education), as well as strategies for patient engagement using an adapted engagement framework. METHODS: We conducted a scoping review of the literature from inception to April 2022 using the Joanna Briggs Institute method and a patient-oriented approach. We also consulted DFU stakeholders to obtain feedback on the findings. The data were extracted using PROGRESS+ factors for an equity lens. The effects of engagement were described using Bodenheimer's quadruple aims for value-based care. RESULTS: Of 4,211 potentially eligible records, 15 studies met our eligibility criteria, including 214 patients involved in engagement initiatives. Most studies were recent (9 of 15 since 2020) and involved patient engagement at the direct medical care level (8 of 15). Self-management (7 of 15) was the principal way to clinically engage the patients. None of the studies sought to define the direct influence of patient engagement on health outcomes. CONCLUSIONS: Very few studies described patients' characteristics. Engaged patients were typically men from high-income countries, in their 50s, with poorly managed type 2 diabetes. We found little rigorous research of patient engagement at all levels for DFUs. There is an urgent need to improve the reporting of research in this area and to engage a diversity of patients.

Understanding the impacts of the COVID-19 pandemic on the care experiences of people with mental-physical multimorbidity: protocol for a mixed methods study.

BACKGROUND: Primary care and other health services have been disrupted during the COVID-19 pandemic, yet the consequences of these service disruptions on patients' care experiences remain largely unstudied. People with mental-physical multimorbidity are vulnerable to the effects of the pandemic, and to sudden service disruptions. It is thus essential to better understand how their care experiences have been impacted by the current pandemic. This study aims to improve understanding of the care experiences of people with mental-physical multimorbidity during the pandemic and identify strategies to enhance these experiences. METHODS: We will conduct a mixed-methods study with multi-phase approach involving four distinct phases. Phase 1 will be a qualitative descriptive study in which we interview individuals with mental-physical multimorbidity and health professionals in order to explore the impacts of the pandemic on care experiences, as well as their perspectives on how care can be improved. The results of this phase will inform the design of study phases 2 and 3. Phase 2 will involve journey mapping exercises with a sub-group of participants with mental-physical multimorbidity to visually map out their care interactions and experiences over time and the critical moments that shaped their experiences. Phase 3 will involve an online, cross-sectional survey of care experiences administered to a larger group of people with mental disorders and/or chronic physical conditions. In phase 4, deliberative dialogues will be held with key partners to discuss and plan strategies for improving the delivery of care to people with mental-physical multimorbidity. Pre-dialogue workshops will enable us to synthesize an prepare the results from the previous three study phases. DISCUSSION: Our study results will generate much needed evidence of the positive and negative impacts of the COVID-19 pandemic on the care experiences of people with mental-physical multimorbidity and shed light on strategies that could improve care quality and experiences.

Risk of Bias Mitigation for Vulnerable and Diverse Groups in Community-Based Primary Health Care Artificial Intelligence Models: Protocol for a Rapid Review.

BACKGROUND: The current literature identifies several potential benefits of artificial intelligence models for populations' health and health care systems' efficiency. However, there is a lack of understanding on how the risk of bias is considered in the development of primary health care and community health service artificial intelligence algorithms and to what extent they perpetuate or introduce potential biases toward groups that could be considered vulnerable in terms of their characteristics. To the best of our knowledge, no reviews are currently available to identify relevant methods to assess the risk of bias in these algorithms. The primary research question of this review is which strategies can assess the risk of bias in primary health care algorithms toward vulnerable or diverse groups? OBJECTIVE: This review aims to identify relevant methods to assess the risk of bias toward vulnerable or diverse groups in the development or deployment of algorithms in community-based primary health care and mitigation interventions deployed to promote and increase equity, diversity, and inclusion. This review looks at what attempts to mitigate bias have been documented and which vulnerable or diverse groups have been considered. METHODS: A rapid systematic review of the scientific literature will be conducted. In November 2022, an information specialist developed a specific search strategy based on the main concepts of our primary review question in 4 relevant databases in the last 5 years. We completed the search strategy in December 2022, and 1022 sources were identified. Since February 2023, two reviewers independently screened the titles and abstracts on the Covidence systematic review software. Conflicts are solved through consensus and discussion with a senior researcher. We include all studies on methods developed or tested to assess the risk of bias in algorithms that are relevant in community-based primary health care. RESULTS: In early May 2023, almost 47% (479/1022) of the titles and abstracts have been screened. We completed this first stage in May 2023. In June and July 2023, two reviewers will independently apply the same criteria to full texts, and all exclusion motives will be recorded. Data from selected studies will be extracted using a validated grid in August and analyzed in September 2023. Results will be presented using structured qualitative narrative summaries and submitted for publication by the end of 2023. CONCLUSIONS: The approach to identifying methods and target populations of this review is primarily qualitative. However, we will consider a meta-analysis if quantitative data and results are sufficient. This review will develop structured qualitative summaries of strategies to mitigate bias toward vulnerable populations and diverse groups in artificial intelligence models. This could be useful to researchers and other stakeholders to identify potential sources of bias in algorithms and try to reduce or eliminate them. TRIAL REGISTRATION: OSF Registries qbph8; https://osf.io/qbph8. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46684.

Decisional needs assessment for patient-centred pain care in Canada: the DECIDE-PAIN study protocol.

INTRODUCTION: The 2021 Action Plan for Pain from the Canadian Pain Task Force advocates for patient-centred pain care at all levels of healthcare across provinces. Shared decision-making is the crux of patient-centred care. Implementing the action plan will require innovative shared decision-making interventions, specifically following the disruption of chronic pain care during the COVID-19 pandemic. The first step in this endeavour is to assess current decisional needs (ie, decisions most important to them) of Canadians with chronic pain across their care pathways. METHODS AND ANALYSIS: DesignGrounded in patient-oriented research approaches, we will perform an online population-based survey across the ten Canadian provinces. We will report methods and data following the CROSS reporting guidelines.SamplingThe Léger Marketing company will administer the online population-based survey to its representative panel of 500 000 Canadians to recruit 1646 adults (age ≥18 years old) with chronic pain according to the definition by the International Association for the Study of Pain (eg, pain ≥12 weeks). ContentBased on the Ottawa Decision Support Framework, the self-administered survey has been codesigned with patients and contain six core domains: (1) healthcare services, consultation and postpandemic needs, (2) difficult decisions experienced, (3) decisional conflict, (4) decisional regret, (5) decisional needs and (6) sociodemographic characteristics. We will use several strategies such as random sampling to improve survey quality. AnalysisWe will perform descriptive statistical analysis. We will identify factors associated with clinically significant decisional conflict and decision regret using multivariate analyses. ETHICS AND DISSEMINATION: Ethics was approved by the Research Ethics Board at the Research Centre of the Centre Hospitalier Universitaire de Sherbrooke (project #2022-4645). We will codesign knowledge mobilisation products with research patient partners (eg, graphical summaries and videos). Results will be disseminated via peer-reviewed journals and national and international conferences to inform the development of innovative shared decision-making interventions for Canadians with chronic pain.

A Personalized Avatar-Based Web Application to Help People Understand How Social Distancing Can Reduce the Spread of COVID-19: Cross-sectional, Observational, Pre-Post Study.

BACKGROUND: To reduce the transmission of SARS-CoV-2 and the associated spread of COVID-19, many jurisdictions around the world imposed mandatory or recommended social or physical distancing. As a result, at the beginning of the pandemic, various communication materials appeared online to promote distancing. Explanations of the science underlying these mandates or recommendations were either highly technical or highly simplified. OBJECTIVE: This study aimed to understand the effects of a dynamic visualization on distancing. Our overall aim was to help people understand the dynamics of the spread of COVID-19 in their community and the implications of their own behavior for themselves, those around them, the health care system, and society. METHODS: Using Scrum, which is an agile framework; JavaScript (Vue.js framework); and code already developed for risk communication in another context of infectious disease transmission, we rapidly developed a new personalized web application. In our application, people make avatars that represent themselves and the people around them. These avatars are integrated into a 3-minute animation illustrating an epidemiological model for COVID-19 transmission, showing the differences in transmission with and without distancing. During the animation, the narration explains the science of how distancing reduces the transmission of COVID-19 in plain language in English or French. The application offers full captions to complement the narration and a descriptive transcript for people using screen readers. We used Google Analytics to collect standard usage statistics. A brief, anonymous, optional survey also collected self-reported distancing behaviors and intentions in the previous and coming weeks, respectively. We launched and disseminated the application on Twitter and Facebook on April 8, 2020, and April 9, 2020. RESULTS: After 26 days, the application received 3588 unique hits from 82 countries. The optional survey at the end of the application collected 182 responses. Among this small subsample of users, survey respondents were nearly (170/177, 96%) already practicing distancing and indicated that they intended to practice distancing in the coming week (172/177, 97.2%). Among the small minority of people (n=7) who indicated that they had not been previously practicing distancing, 2 (29%) reported that they would practice distancing in the week to come. CONCLUSIONS: We developed a web application to help people understand the relationship between individual-level behavior and population-level effects in the context of an infectious disease spread. This study also demonstrates how agile development can be used to quickly create personalized risk messages for public health issues like a pandemic. The nonrandomized design of this rapid study prevents us from concluding the application's effectiveness; however, results thus far suggest that avatar-based visualizations may help people understand their role in infectious disease transmission.

Physical and cognitive impairments in people suffering from long COVID: protocol for a longitudinal population-based cohort study.

INTRODUCTION: Approximately 33% of people who contracted COVID-19 still experience symptoms 12 weeks after infection onset. This persistence of symptoms is now considered a syndrome itself called 'long COVID'. Evidence regarding long COVID and its cognitive and physical impacts is growing, but the literature is currently lacking objectively measured data to guide towards adapted healthcare trajectories. The objectives are to describe the physical and cognitive impairments experienced by individuals living with long COVID using self-reported and clinical objective measures, and to compare the evolution over time of the physical and cognitive state between adults living with long COVID (at least one physical or cognitive COVID-19 symptom for more than 12 weeks following infection; long COVID group), people who developed COVID-19 but did not experience persistent symptoms (short COVID group) and people who did not develop COVID-19 (control group). METHODS AND ANALYSIS: In this longitudinal cohort study, 120 participants will be recruited in each group. Variables will be collected through three evaluation sessions over 6 months (baseline, 3 months, 6 months). Variables include self-administered questionnaires on health-related quality of life, comorbidity, sleep, pain, anxiety, depressive symptoms, fatigue and cognitive function, as well as objective measures of cognitive (attention, memory, executive functioning) and physical (grip strength, balance, gait speed, gait endurance, VO2, frailty) functions. Activity, heart rate and sleep will be monitored with a fitness tracker watch for 7 days following evaluation sessions. Maximum-likelihood analyses of variance (ANOVAs) will be used to compare data at baseline between groups. Repeated measures ANOVAs will be used to compare the longitudinal performance variations across groups of the self-reported and clinical variables. ETHICS AND DISSEMINATION: Ethics committees of the CIUSSS de la Capitale-Nationale and CIUSSS de l'Est-de-l'Île-de-Montréal approved the project. Results will be disseminated through clinical and community platforms as well as through peer-reviewed manuscripts and international conferences. TRIAL REGISTRATION NUMBER: NCT05216536.

Preclinical models of prostate cancer - modelling androgen dependency and castration resistance in vitro, ex vivo and in vivo.

Prostate cancer is well known to be dependent on the androgen receptor (AR) for growth and survival. Thus, AR is the main pharmacological target to treat this disease. However, after an initially positive response to AR-targeting therapies, prostate cancer will eventually evolve to castration-resistant prostate cancer, which is often lethal. Tumour growth was initially thought to become androgen-independent following treatments; however, results from molecular studies have shown that most resistance mechanisms involve the reactivation of AR. Consequently, tumour cells become resistant to castration - the blockade of testicular androgens - and not independent of AR per se. However, confusion still remains on how to properly define preclinical models of prostate cancer, including cell lines. Most cell lines were isolated from patients for cell culture after evolution of the tumour to castration-resistant prostate cancer, but not all of these cell lines are described as castration resistant. Moreover, castration refers to the blockade of testosterone production by the testes; thus, even the concept of "castration" in vitro is questionable. To ensure maximal transfer of knowledge from scientific research to the clinic, understanding the limitations and advantages of preclinical models, as well as how these models recapitulate cancer cell androgen dependency and can be used to study castration resistance mechanisms, is essential.

Childhood obesity diagnosis and management remains a challenge despite the use of electronic health records: A retrospective study.

Background: The use of electronic health records (EHR) has revolutionized medical practice by improving the quality of care. Childhood obesity (CO) increases the risk of developing other chronic diseases and has a serious psychosocial impact on children. Using EHR may improve this clinical condition since early diagnosis is a crucial means of preventing its negative impacts. Objectives: The aim of the study was to assess the diagnosis and management of CO in a Canadian academic family medicine group unit (FMG-U) that uses EHR with an integrated CO diagnosis tool. Methods: This is a retrospective study conducted in an FMG-U in the province of Quebec. The clinical practice guidelines established by the World Health Organization (WHO) were used to assess diagnosis and management of CO. EHR of every patient from 5 to 12 years old who had a medical appointment at the FMG-U in 2017 (n = 618) were analyzed. EHR use by clinicians was assessed by a closed-ended online survey sent to clinicians who provided pediatric care at that clinic in 2017. Results: We identified 69 patients as obese according to the WHO, of whom 40 had been diagnosed by health professionals at the clinic. Of these, 33 received nutritional counseling; 33 received physical activity counseling; 13 received parent involvement counseling; 19 were referred to another health professional; and 12 were followed up within 6 months. Ten out of 15 clinicians responded to the survey. They all used the EHR integrated CO diagnosis tool but only 20% were truly familiar with it. Conclusions: This study shows that CO is still underdiagnosed in primary care, notwithstanding the use of EHR with integrated tools. This affects the quality of care. Moreover, even if CO were correctly diagnosed, its management remains incomplete. Knowledge translation by medical organizations plays an important role in addressing this problem.

Scaling Up Citizen Workshops in Public Libraries to Disseminate and Discuss Primary Care Research Results: Quasi-Experimental Study.

BACKGROUND: Little is known about engaging patients and stakeholders in the process of scaling up effective knowledge translation interventions targeting the public. OBJECTIVE: Using an integrated knowledge translation approach, we aimed to scale up and evaluate an effective pilot program to disseminate research results in public libraries. METHODS: We conducted a scaling-up study targeting the public. On the basis of our successful pilot project, we codeveloped and implemented a large-scale program of free citizen workshops in public libraries, in a close research partnership with stakeholders and patient representatives. Citizen workshops, each facilitated by 1 participating physician and 1 science communicator, consisted of a 45-minute computer-assisted presentation and a 45-minute open exchange. The intervention outcome was knowledge gained. The scale-up outcomes were satisfaction, appropriateness, coverage, and costs. An evaluation questionnaire was used to collect data of interest. Both quantitative and qualitative analyses were performed. RESULTS: The workshop theme chosen by the patient and stakeholder representatives was the high prevalence of medication overuse among people aged ≥65 years. From April to May 2019, 26 workshops were conducted in 25 public libraries reaching 362 people. The mean age of participants was 64.8 (SD 12.5) years. In total, 18 participating physicians and 6 science communicators facilitated the workshops. Participants reported significant knowledge gain (mean difference 2.1, 95% CI 2.0-2.2; P<.001). The median score for overall public satisfaction was 9 out of 10 (IQR 8-10). The public participants globally rated the workshops as having a high level of appropriateness. Coverage was 92% (25/27) of the total number of public libraries targeted. Costs were CAD $6051.84 (US $4519.69) for workshop design and CAD $22,935.41 (US $17,128.85) for scaling them up. CONCLUSIONS: This project successfully established a large-scale and successful implementation science or knowledge translation bridge among researchers, clinicians, and citizens via public libraries. This study provides a model for a dissemination practice that benefits the public by both engaging them in the dissemination process and targeting them directly.

The Aging, Community and Health Research Unit Community Partnership Program (ACHRU-CPP) for older adults with diabetes and multiple chronic conditions: study protocol for a randomized controlled trial.

BACKGROUND: Older adults (≥65 years) with diabetes and multiple chronic conditions (MCC) (> 2 chronic conditions) experience reduced function and quality of life, increased health service use, and high mortality. Many community-based self-management interventions have been developed for this group, however the evidence for their effectiveness is limited. This paper presents the protocol for a randomized controlled trial (RCT) comparing the effectiveness and implementation of the Aging, Community and Health Research Unit-Community Partnership Program (ACHRU-CPP) to usual care in older adults with diabetes and MCC and their caregivers. METHODS: We will conduct a cross-jurisdictional, multi-site implementation-effectiveness type II hybrid RCT. Eligibility criteria are: ≥65 years, diabetes diagnosis (Type 1 or 2) and at least one other chronic condition, and enrolled in a primary care or diabetes education program. Participants will be randomly assigned to the intervention (ACHRU-CPP) or control arm (1:1 ratio). The intervention arm consists of home/telephone visits, monthly group wellness sessions, multidisciplinary case conferences, and system navigation support. It will be delivered by registered nurses and registered dietitians/nutritionists from participating primary care or diabetes education programs and program coordinators from community-based organizations. The control arm consists of usual care provided by the primary care setting or diabetes education program. The primary outcome is the change from baseline to 6 months in mental functioning. Secondary outcomes will include, for example, the change from baseline to 6 months in physical functioning, diabetes self-management, depressive symptoms, and cost of use of healthcare services. Analysis of covariance (ANCOVA) models will be used to analyze all outcomes, with intention-to-treat analysis using multiple imputation to address missing data. Descriptive and qualitative data from older adults, caregivers and intervention teams will be used to examine intervention implementation, site-specific adaptations, and scalability potential. DISCUSSION: An interprofessional intervention supporting self-management may be effective in improving health outcomes and client/caregiver experience and reducing service use and costs in this complex population. This pragmatic trial includes a scalability assessment which considers a range of effectiveness and implementation criteria to inform the future scale-up of the ACHRU-CPP. TRIAL REGISTRATION: Clinical Trials.gov Identifier NCT03664583 . Registration date: September 10, 2018.

Telehealth in Primary Healthcare: A Portrait of its Rapid Implementation during the COVID-19 Pandemic.

OBJECTIVE: This study documents the adoption of telehealth by various types of primary healthcare (PHC) providers working in teaching PHC clinics in Quebec during the COVID-19 pandemic. It also identifies the perceived advantages and disadvantages of telehealth. METHOD: A cross-sectional study was conducted between May and August 2020. The e-survey was completed by 48/50 teaching primary care clinics representing 603/1,357 (44%) PHC providers. RESULTS: Telephone use increased the most, becoming the principal virtual modality of consultation, during the pandemic. Video consultations increased, with variations by type of PHC provider: between 2% and 16% reported using it "sometimes." The main perceived advantages of telehealth were minimizing the patient's need to travel, improved efficiency and reduction in infection transmission risk. The main disadvantages were the lack of physical exam and difficulties connecting with some patients. CONCLUSION: The variation in telehealth adoption by type of PHC provider may inform strategies to maximize the potential of telehealth and help create guidelines for its use in more normal times.

Risk-Stratified Approach to Breast Cancer Screening in Canada: Women's Knowledge of the Legislative Context and Concerns about Discrimination from Genetic and Other Predictive Health Data.

The success of risk-stratified approaches in improving population-based breast cancer screening programs depends in no small part on women's buy-in. Fear of genetic discrimination (GD) could be a potential barrier to genetic testing uptake as part of risk assessment. Thus, the objective of this study was twofold. First, to evaluate Canadian women's knowledge of the legislative context governing GD. Second, to assess their concerns about the possible use of breast cancer risk levels by insurance companies or employers. We use a cross-sectional survey of 4293 (age: 30-69) women, conducted in four Canadian provinces (Alberta, British Colombia, Ontario and Québec). Canadian women's knowledge of the regulatory framework for GD is relatively limited, with some gaps and misconceptions noted. About a third (34.7%) of the participants had a lot of concerns about the use of their health information by employers or insurers; another third had some concerns (31.9%), while 20% had no concerns. There is a need to further educate and inform the Canadian public about GD and the legal protections that exist to prevent it. Enhanced knowledge could facilitate the implementation and uptake of risk prediction informed by genetic factors, such as the risk-stratified approach to breast cancer screening that includes risk levels.

Personalized Risk Assessment for Prevention and Early Detection of Breast Cancer: Integration and Implementation (PERSPECTIVE I&I).

Early detection of breast cancer through screening reduces breast cancer mortality. The benefits of screening must also be considered within the context of potential harms (e.g., false positives, overdiagnosis). Furthermore, while breast cancer risk is highly variable within the population, most screening programs use age to determine eligibility. A risk-based approach is expected to improve the benefit-harm ratio of breast cancer screening programs. The PERSPECTIVE I&I (Personalized Risk Assessment for Prevention and Early Detection of Breast Cancer: Integration and Implementation) project seeks to improve personalized risk assessment to allow for a cost-effective, population-based approach to risk-based screening and determine best practices for implementation in Canada. This commentary describes the four inter-related activities that comprise the PERSPECTIVE I&I project. 1: Identification and validation of novel moderate to high-risk susceptibility genes. 2: Improvement, validation, and adaptation of a risk prediction web-tool for the Canadian context. 3: Development and piloting of a socio-ethical framework to support implementation of risk-based breast cancer screening. 4: Economic analysis to optimize the implementation of risk-based screening. Risk-based screening and prevention is expected to benefit all women, empowering them to work with their healthcare provider to make informed decisions about screening and prevention.

Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial.

BACKGROUND: Evidence suggests a role for excessive inflammation in COVID-19 complications. Colchicine is an oral anti-inflammatory medication beneficial in gout, pericarditis, and coronary disease. We aimed to investigate the effect of colchicine on the composite of COVID-19-related death or hospital admission. METHODS: The present study is a phase 3, randomised, double-blind, adaptive, placebo-controlled, multicentre trial. The study was done in Brazil, Canada, Greece, South Africa, Spain, and the USA, and was led by the Montreal Heart Institute. Patients with COVID-19 diagnosed by PCR testing or clinical criteria who were not being treated in hospital were eligible if they were at least 40 years old and had at least one high-risk characteristic. The randomisation list was computer-generated by an unmasked biostatistician, and masked randomisation was centralised and done electronically through an automated interactive web-response system. The allocation sequence was unstratified and used a 1:1 ratio with a blocking schema and block sizes of six. Patients were randomly assigned to receive orally administered colchicine (0·5 mg twice per day for 3 days and then once per day for 27 days thereafter) or matching placebo. The primary efficacy endpoint was the composite of death or hospital admission for COVID-19. Vital status at the end of the study was available for 97·9% of patients. The analyses were done according to the intention-to-treat principle. The COLCORONA trial is registered with ClinicalTrials.gov (NCT04322682) and is now closed to new participants. FINDINGS: Trial enrolment began in March 23, 2020, and was completed in Dec 22, 2020. A total of 4488 patients (53·9% women; median age 54·0 years, IQR 47·0-61·0) were enrolled and 2235 patients were randomly assigned to colchicine and 2253 to placebo. The primary endpoint occurred in 104 (4·7%) of 2235 patients in the colchicine group and 131 (5·8%) of 2253 patients in the placebo group (odds ratio [OR] 0·79, 95·1% CI 0·61-1·03; p=0·081). Among the 4159 patients with PCR-confirmed COVID-19, the primary endpoint occurred in 96 (4·6%) of 2075 patients in the colchicine group and 126 (6·0%) of 2084 patients in the placebo group (OR 0·75, 0·57-0·99; p=0·042). Serious adverse events were reported in 108 (4·9%) of 2195 patients in the colchicine group and 139 (6·3%) of 2217 patients in the placebo group (p=0·051); pneumonia occurred in 63 (2·9%) of 2195 patients in the colchicine group and 92 (4·1%) of 2217 patients in the placebo group (p=0·021). Diarrhoea was reported in 300 (13·7%) of 2195 patients in the colchicine group and 161 (7·3%) of 2217 patients in the placebo group (p<0·0001). INTERPRETATION: In community-treated patients including those without a mandatory diagnostic test, the effect of colchicine on COVID-19-related clinical events was not statistically significant. Among patients with PCR-confirmed COVID-19, colchicine led to a lower rate of the composite of death or hospital admission than placebo. Given the absence of orally administered therapies to prevent COVID-19 complications in community-treated patients and the benefit of colchicine in patients with PCR-proven COVID-19, this safe and inexpensive anti-inflammatory agent could be considered for use in those at risk of complications. Notwithstanding these considerations, replication in other studies of PCR-positive community-treated patients is recommended. FUNDING: The Government of Quebec, the Bill & Melinda Gates Foundation, the National Heart, Lung, and Blood Institute of the US National Institutes of Health, the Montreal Heart Institute Foundation, the NYU Grossman School of Medicine, the Rudin Family Foundation, and philanthropist Sophie Desmarais.

Strategies for involving patients and the public in scaling-up initiatives in health and social services: protocol for a scoping review and Delphi survey.

BACKGROUND: The scale-up of evidence-based innovations is required to reduce waste and inequities in health and social services (HSS). However, it often tends to be a top-down process initiated by policy makers, and the values of the intended beneficiaries are forgotten. Involving multiple stakeholders including patients and the public in the scaling-up process is thus essential but highly complex. We propose to identify relevant strategies for meaningfully and equitably involving patients and the public in the science and practice of scaling up in HSS. METHODS: We will adapt our overall method from the RAND/UCLA Appropriateness Method. Following this, we will perform a two-prong study design (knowledge synthesis and Delphi study) grounded in an integrated knowledge translation approach. This approach involves extensive participation of a network of stakeholders interested in patient and public involvement (PPI) in scaling up and a multidisciplinary steering committee. We will conduct a systematic scoping review following the methodology recommended in the Joanna Briggs Institute Reviewers Manual. We will use the following eligibility criteria: (1) participants-any stakeholder involved in creating or testing a strategy for PPI; (2) intervention-any PPI strategy proposed for scaling-up initiatives; (3) comparator-no restriction; (4) outcomes: any process or outcome metrics related to PPI; and (5) setting-HSS. We will search electronic databases (e.g., Medline, Web of Science, Sociological Abstract) from inception onwards, hand search relevant websites, screen the reference lists of included records, and consult experts in the field. Two reviewers will independently select and extract eligible studies. We will summarize data quantitatively and qualitatively and report results using the PRISMA extension for Scoping Reviews (PRISMA-ScR) checklist. We will conduct an online Delphi survey to achieve consensus on the relevant strategies for PPI in scaling-up initiatives in HSS. Participants will include stakeholders from low-, middle-, and high-income countries. We anticipate that three rounds will allow an acceptable degree of agreement on research priorities. DISCUSSION: Our findings will advance understanding of how to meaningfully and equitably involve patients and the public in scaling-up initiatives for sustainable HSS. SYSTEMATIC REVIEW REGISTRATION: We registered this protocol with the Open Science Framework on August 19, 2020 ( https://osf.io/zqpx7/ ).

A Value-Based Comparison of the Management of Ambulatory Respiratory Diseases in Walk-in Clinics, Primary Care Practices, and Emergency Departments: Protocol for a Multicenter Prospective Cohort Study.

BACKGROUND: In Canada, 30%-60% of patients presenting to emergency departments are ambulatory. This category has been labeled as a source of emergency department overuse. Acting on the presumption that primary care practices and walk-in clinics offer equivalent care at a lower cost, governments have invested massively in improving access to these alternative settings in the hope that patients would present there instead when possible, thereby reducing the load on emergency departments. Data in support of this approach remain scarce and equivocal. OBJECTIVE: The aim of this study is to compare the value of care received in emergency departments, walk-in clinics, and primary care practices by ambulatory patients with upper respiratory tract infection, sinusitis, otitis media, tonsillitis, pharyngitis, bronchitis, influenza-like illness, pneumonia, acute asthma, or acute exacerbation of chronic obstructive pulmonary disease. METHODS: A multicenter prospective cohort study will be performed in Ontario and Québec. In phase 1, a time-driven activity-based costing method will be applied at each of the 15 study sites. This method uses time as a cost driver to allocate direct costs (eg, medication), consumable expenditures (eg, needles), overhead costs (eg, building maintenance), and physician charges to patient care. Thus, the cost of a care episode will be proportional to the time spent receiving the care. At the end of this phase, a list of care process costs will be generated and used to calculate the cost of each consultation during phase 2, in which a prospective cohort of patients will be monitored to compare the care received in each setting. Patients aged 18 years and older, ambulatory throughout the care episode, and discharged to home with one of the aforementioned targeted diagnoses will be considered. The estimated sample size is 1485 patients. The 3 types of care settings will be compared on the basis of primary outcomes in terms of the proportion of return visits to any site 3 and 7 days after the initial visit and the mean cost of care. The secondary outcomes measured will include scores on patient-reported outcome and experience measures and mean costs borne wholly by patients. We will use multilevel generalized linear models to compare the care settings and an overlap weights approach to adjust for confounding factors related to age, sex, gender, ethnicity, comorbidities, registration with a family physician, socioeconomic status, and severity of illness. RESULTS: Phase 1 will begin in 2021 and phase 2, in 2023. The results will be available in 2025. CONCLUSIONS: The end point of our program will be for deciders, patients, and care providers to be able to determine the most appropriate care setting for the management of ambulatory emergency respiratory conditions, based on the quality and cost of care associated with each alternative. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/25619.