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Background: Children with inflammatory bowel disease (IBD) experience extraintestinal side effects including altered body composition, impaired muscle strength, and aerobic capacity. Exercise training may remedy these issues. Purpose: To assess the feasibility, safety, participant satisfaction, and efficacy of a training program for youth with IBD. Methods: Children with IBD completed 16 weeks of training (2 supervised + 1 home sessions per week). Feasibility was assessed by tracking recruitment, adherence, and compliance rates. Safety was assessed by tracking symptoms and adverse events. Posttraining interviews gauged satisfaction. Circulating inflammatory markers, body composition, muscle strength, aerobic fitness, and habitual physical activity were measured at baseline, midtraining (8 wk), and posttraining. Results: Eleven youth were recruited and 10 completed the study. Participants adhered to 28 (1) of 32 prescribed supervised sessions and 8 (4) of 16 prescribed home sessions. There were no adverse events, and overall feedback on training was positive. Posttraining, we observed an increase in lean mass (+2.4 [1.1] kg), bone density (+0.0124 [0.015] g·cm−2), aerobic fitness (+2.8 [5.7] mL·kg LM−1· min−1), and vigorous physical activity levels (+13.09 [8.95] min·h−1) but no change in inflammation or muscle strength. Conclusion: Supervised exercise training is feasible, safe, and effective for youth with IBD and should be encouraged. [ABSTRACT FROM AUTHOR]

This qualitative study was informed by critical race feminism and sought to examine Canadian Black women's motivations for participating in the research study that explored their experiences with the police in the context of intimate partner violence (IPV), and the key factors that complicated their decisions. Semistructured interviews were conducted with 25 self-identified women over the age of 18. Findings indicated that Black women's experiences of anti-Black racism and various forms of systemic barriers influenced their decisions to disclose their experiences of IPV. Key themes included the invisibility of Black women's narratives, fostering political change, and the impact of racialized and gendered insider positionality. Given these findings, positioning Black women's narratives at the centre of IPV research creates opportunities for Black women to share their experiences of IPV, recognizes them as experts of their own experiences, identifies their differential experiences accessing services and supports and the barriers that impact their participation in research studies. The study provides strategies on how to increase Black women's participation and engagement in IPV research. [ABSTRACT FROM AUTHOR]

Background: Older adults have historically been excluded from clinical trials, limiting evidence‐based data. An updated picture of the situation with newly marketed medications is needed. We aimed to describe (1) the recommendations specific to older adults in monographs of newly marketed medications; (2) the representation of older adults in clinical trials of those medications. Methods: In November 2020, we listed all medications that received a notice of compliance from Health Canada between January 2006 and September 2020, excluding those with indications irrelevant to community‐dwelling older adults and locally acting medications. We assessed the availability and clarity of recommendations in monographs regarding older adults. Using Clinicaltrials.gov, we identified randomized controlled double‐blind Phase III–IV trials led in Canada/United States of a sample of 30 commonly used medications among those previously listed. We extracted information on study design, participants, and efficacy/safety analysis specific to older patients. We used simple linear regression and Chi‐square/Fisher's exact tests to analyze time trends in the representation of older adults over different periods. Results: A total of 195 monographs were included. Of the 130 monographs reporting a dosing recommendation in older adults, 53 (41%) also reported limited/insufficient data in this population or its subgroups. Of the 373 trials included, 217 (58%) did not integrate a maximum age as an inclusion criterion. However, only 113 (30%) reported including a proportion of older adults representative (or over‐representative) of the Canadian older population. Most trials (n = 289; 78%) did not provide efficacy or safety data specific to older adults. In our sample, the number/proportion of older adults in trials seemed to be increasingly reported over time, either explicitly or implicitly (e.g., inclusion criterion specifies <65 years old). Conclusions: Newly marketed medications still appear to under‐represent older adults. The resulting lack of clear recommendations in monographs compromises evidence‐based practice, thereby perpetuating the risk to older adults' health. [ABSTRACT FROM AUTHOR]

Background: Patient and public involvement (PPI) is a critical priority in research, policy, academia and advocacy organizations. PPI in dementia research is gaining momentum. However, these efforts are missing in international projects aimed at those living with advanced dementia in long‐term care (LTC) homes. Additional complexities can arise in enacting PPI within the context of integration of a palliative approach to care and experiences around end‐of‐life in (EOL) dementia. The mySupport study involved implementing the Family Carer Decision Support (FCDS) intervention for care partners of those living with advanced dementia in LTC in six countries. Research Design and Objective: An interpretive description study was conducted to explore the perspectives of international researchers from six countries on engaging people with lived experiences of dementia and EOL care in research processes. The findings from this study informed the development of a PPI strategy and a subsequent toolkit for the FCDS intervention. Findings: Thirty‐eight interviews were completed with project researchers: 12 from the United Kingdom, 8 from Canada, 7 from Ireland, 4 each from Italy and The Netherlands and 3 from the Czech Republic. Four broad themes describe international researchers' perspectives on advancing methods of engagement for people with lived experiences of dementia and EOL in international PPI activities: (1) Groundwork to engage in research; (2) planning for research activities is key; (3) focus on meaningful engagement and (4) having foresight for practical issues shaping PPI. Discussion and Implications: International projects that involve PPI can present many sources of challenges. The findings in this study highlight important considerations for foundational work for incorporating PPI in international projects. Learning from world leaders and those with lived experiences in various regions can be insightful and help share tools and resources. Patient or Public Contribution: PPI was envisioned as a critical part of conducting the mySupport study. The findings from this study informed the development of a PPI strategy and an international Strategic Guiding Council that included family carers of those living with advanced dementia in LTC homes in six countries. This manuscript focused on the perspectives of researchers on their engagement with people with lived experiences of dementia and EOL. The perspectives of persons with lived experiences on engaging in the mySupport research study will be reported in a forthcoming manuscript. [ABSTRACT FROM AUTHOR]

Youth have a right to participate in research that will inform the care that they receive. Engagement with children and young people has been shown to improve rates of enrollment and retention in clinical trials as well as reduce research waste. The aim of the study is to gain practical insight on the design of trials specifically on (1) recruitment and retention preferences, (2) potential barriers to research, and (3) study design optimization. Based on this youth engagement, we will co‐design two clinical trials in headaches with youth. Two recruitment strategies were used to recruit 16 youth from across Canada (aged 15–18 years) from an existing youth group, the KidsCan Young Persons' Research Advisory Group (YPRAG) and a new youth group in collaboration with Solutions for Kids in Pain (SKIP). Four virtual, semi‐structured discussion groups were held between April and December 2020, which included pre‐circulated materials and utilized two distinct upcoming planned trials as examples for specific methods feedback. Individual engagement evaluations were completed following the final group session using the Public and Patient Engagement Evaluation Tool. Descriptive results were shared with participants prior to publication to ensure appropriate interpretation. The discussion was centred around three themes: recruitment and retention preferences, potential barriers to participation, and study design optimization. Youth indicated that they would prefer to be contacted for a potential study directly by their physician (not over social media), that they would like to develop rapport with study staff, and that one of the barriers to participation is the time commitment. The youth also provided feedback on the design of the clinical trial including outcome measurement tools, data collection, and engagement methods. Feedback on the virtual format of the engagement events indicated that participants appreciated the ease of the online discussion and that the open‐ended discussion allowed for easy exchange of ideas. They felt that despite a gender imbalance (towards females) it was an overall inclusive environment. All participants reported believing that their engagement will make a difference to the work of the research team in designing the clinical trials. Perspectives from a diverse group of youth meaningfully improved the design and conduct of two clinical trials for headaches in children. This study provides a framework for future researchers to engage youth in the co‐design of clinical trials using online engagement sessions. [ABSTRACT FROM AUTHOR]

Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice. In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3–5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with ClinicalTrials.gov , NCT03094715. From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2·58 [95% CI 1·60–4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46–0·98]; p=0·038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone. Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection. EU Horizon 2020. [ABSTRACT FROM AUTHOR]

Purpose: Despite reports of better short-term outcomes, the main criticism for the adoption of the robotic surgery platform for abdominal wall reconstruction (AWR) has been the associated cost, especially in countries with a publicly funded healthcare system such as Canada. We describe our experience in implementation of robotic AWR while ensuring cost-effectiveness. Methods: This is a retrospective cohort analysis of all patients with ventral hernias ranging between 5 to 15 cm who underwent either open or robotic AWR between January 2020 to August 2022. We reviewed patient characteristics, operative time, post-operative length of stay (LOS), and average cost of surgery. Results: 45 patients underwent open repair and 28 underwent robotic repair in the study period. There was no difference in major patient characteristics between the two groups. Operative time was shorter for open repairs (233.2 ± 96.6 min vs. 299.3 ± 71.8 min, p < 0.001). LOS was significantly longer for open repairs (5 days (interquartile range = 4–6) vs. 2 days (IQR = 1.75–3), p < 0.001) and there were significantly more patients who underwent robotic repair who left hospital in less than 3 days (13.3 vs. 64.3%, p < 0.001). The average overall hospital-based cost for each open repair was $26,952.18 when the cost for equipment, operative time, inpatient hospital stay, and epidural use are accounted for, compared to $17,447.40 for robotic repair ($9,504.78 saving per case). Conclusion: With proper selection of patients based on size of hernia, we demonstrate cost conscious adaptation of the robotic technology to AWR. Our future studies will continue to explore the benefits and limits of this approach in complex hernia repair. [ABSTRACT FROM AUTHOR]

Background: Although metastatic germ cell tumor (GCT) is highly curable with initial cisplatin-based chemotherapy (CT), 20–30% of patients relapse. Salvage CT options include conventional (CDCT) and high dose chemotherapy (HDCT), however definitive comparative data remain lacking. We aimed to characterize the contemporary practice patterns of salvage CT across Canada. Methods: We conducted a 30-question online survey for Canadian medical and hematological oncologists with experience in treating GCT, assessing treatment availability, patient selection, and management strategies used for relapsed GCT patients. Results: There were 30 respondents from 18 cancer centers across eight provinces. The most common CDCT regimens used were TIP (64%) and VIP (25%). HDCT was available in 13 centers (70%). The HDCT regimen used included carboplatin and etoposide for two cycles (76% in 7 centers), three cycles (6% in 2 centers), and the TICE protocol (11%, in 2 centers). "Bridging" CDCT was used by 65% of respondents. Post-HDCT treatments considered include surgical resection for residual disease (87.5%), maintenance etoposide (6.3%), and surveillance only (6.3%). Conclusions: HDCT is the most commonly used GCT salvage strategy in Canada. Significant differences exist in the treatment availability, selection, and delivery of HDCT, highlighting the need for standardization of care for patients with relapsed testicular GCT. [ABSTRACT FROM AUTHOR]

To investigate aligner treatment protocols among orthodontists in the United States and Canada and assess the factors influencing clinician choices in aligner systems, treatment protocols, and targeted malocclusions for aligners. A validated online questionnaire was developed specifically for this research and consisted of three sections. Section 1 evaluated demographics and experience with aligners. Section 2 assessed patient selection and demands and clinician confidence in treating various malocclusions with aligners. Section 3 evaluated treatment protocols used by clinicians. The American Association of Orthodontists Partners in Research Program distributed the survey via e-mail to active members in the United States and Canada. A total of 160 providers completed the survey. Aligners were used by 65.00% of respondents, with the Invisalign system the most popular (81.25%). Aligners were mostly used for adults (97.50%). Tipping was ranked as the easiest movement (1.79 ± 1.35). Extrusion (4.34 ± 1.53) and root movement (4.31 ± 1.27) were ranked as the most difficult. Most were confident treating mild (98.8%) and moderate (82.5%) crowded cases, spacing (96.9%), and anterior crossbite (85%). Of the providers, 58.12% recommended aligners to be changed weekly. Respondents who were confident addressing some of the severe malocclusions were more likely to use Invisalign. Invisalign is the most popular aligner system, and clinicians seem to be confident using it. Providers are aware of the pitfalls of aligners; they find it challenging to perform root movement and extrusion, and they seem confident treating mild to moderate malocclusions. They avoid complex cases with impactions and severe skeletal problems. [ABSTRACT FROM AUTHOR]

Background: With nearly one-third of patients with major depressive disorder being resistant to available antidepressants, there is a need to develop new treatments for this population. Stellate ganglion block (SGB) is a procedure used to block sympathetic input to the central autonomic system; it has been administered to treat several conditions, including pain. Recently, indications for SGB have extended and the potential benefits for psychiatric disorders are under investigation. Methods: The Local Injection For Treating Mood Disorders (LIFT-MOOD) study investigated the feasibility of a trial of 2 right-sided injections of bupivacaine 0.5% (7 mL) at the stellate ganglion in participants with treatment-resistant depression (TRD) using a randomized, placebo-controlled, pilot trial. Ten participants were randomized in a 1:1 allocation to receive active treatment or placebo (saline). Primary feasibility outcomes included recruitment rate, withdrawal, adherence, missing data, and adverse events. As a secondary, exploratory objective, we explored the efficacy of SGB in improving symptoms of depression by calculating the change in scores from baseline to follow-up on day 42 for each treatment group. Results: The recruitment rate was reasonable and sufficient, retention and adherence were high, missing data were low, and adverse events were mild and temporary. Both treatment groups demonstrated decreases in Montgomery-Åsberg Depression Rating Scale scores, compared to baseline, by the end of the study. Conclusion: This study supports the feasibility of a confirmatory trial of SGB in participants with TRD. Conclusions regarding efficacy cannot be made based on this preliminary study due to the small number of participants who completed active treatment. Larger-scale randomized controlled trials with long-term follow-ups and alternate sham procedures are needed to assess the efficacy and duration of symptom improvement with the use of SGB in TRD. [ABSTRACT FROM AUTHOR]

Background: The generalizability of treatments examined in rehabilitation randomized controls trials (RCTs) partly depend on the similarity between trial subjects and a stroke rehabilitation inpatient population. The aim of this study was to determine the proportion of stroke rehabilitation inpatients that would have been eligible or ineligible to participate in published stroke RCTs. Methods: This was a secondary analysis of chart review data collected as part of an independent quality improvement initiative. Data pertaining to the characteristics of stroke rehabilitation inpatients (e.g. age, cognitive impairment, previous stroke, comorbidities) were extracted from the medical charts of patients consecutively admitted to an inpatient stroke rehabilitation unit at a large urban rehabilitation hospital in Canada. Using the exclusion criteria categories of stroke RCTs identified from a systematic scoping review of 428 RCTs, we identified how many stroke rehabilitation inpatients would have been eligible or ineligible to participate in stroke RCTs based on their age, cognitive impairment, previous stroke and presence of comorbidities. Results: In total, 110 stroke rehabilitation inpatients were included. Twenty-four percent of patients were 80 years of age or older, 84.5% had queries or concerns regarding patient cognitive abilities, 28.0% had a previous stroke, and 31.8% had a severe stroke. Stroke rehabilitation inpatients had six comorbidities on average. Based on these factors, most stroke rehabilitation inpatients could have been excluded from stroke RCTs, with cognitive impairment the most common RCT exclusion criteria. Conclusions: Changes to the design of RCTs would support the development of clinical practice guidelines that reflect stroke rehabilitation inpatient characteristics, enhancing equity, diversity, and inclusion within samples and the generalizability of results. [ABSTRACT FROM AUTHOR]

Purpose Screening for lung cancer is recommended to reduce lung cancer mortality, but there is no consensus on patient selection for screening in Canada. Risk prediction models are more efficacious than the screening recommendations of the Canadian Task Force on Preventive Health Care (CTFPHC), but it remains to be determined which model and threshold are optimal. Methods We retrospectively applied the PLCOm2012, PLCOall2014 and LLPv2 risk prediction models to 120 lung cancer patients from a Canadian province, at risk thresholds of ≥ 1.51% and ≥ 2.00%, to determine screening eligibility at time of diagnosis. OncoSim modelling was used to compare these risk thresholds. Results Sensitivities of the risk prediction models at a threshold of ≥ 1.51% were similar with 93 (77.5%), 96 (80.0%), and 97 (80.8%) patients selected for screening, respectively. The PLCOm2012 and PLCOall2014 models selected significantly more patients for screening at a ≥ 1.51% threshold. The OncoSim simulation model estimated that the ≥ 1.51% threshold would detect 4 more cancers per 100 000 people than the ≥ 2.00% threshold. All risk prediction models, at both thresholds, achieved greater sensitivity than CTFPHC recommendations, which selected 56 (46.7%) patients for screening. Conclusion Commonly considered lung cancer screening risk thresholds (≥1.51% and ≥2.00%) are more sensitive than the CTFPHC 30-pack–years criterion to detect lung cancer. A lower risk threshold would achieve a larger population impact of lung cancer screening but would require more resources. Patients with limited or no smoking history, young patients, and patients with no history of COPD may be missed regardless of the model chosen. [ABSTRACT FROM AUTHOR]

Objective: It is essential that the embedded process of rural case selection be highlighted and documented to provide reassurance of rigour across rural surgical services supported by generalist surgeons, general practitioners with enhanced surgical skills and general practitioner anaesthetists. This enables feedback and improves the triage and case selection process to ensure the highest quality outcomes. Therefore, this research aims to explore participants' rational criteria for decision making around rural case selection. Design: Participants participated in a series of semi‐structured in‐depth interviews which were coded and underwent thematic analysis. Setting: Six community hospitals in British Columbia, Canada. Participants: General practitioners with enhanced surgical skills, general practitioner anaesthetists, local maternity care providers, and specialists. Results: Based on participant accounts, rural surgical and obstetrical decision‐making processes for local patient selection or regional referral had five major components: (1) Clinical Factors, (2) Physician Factors, (3) Patient Factors, (4) Consensus Between Providers and (5) the Availability of Local Resources. Conclusion: Decision‐making processes around rural surgical and obstetrical patient selection are complex and require comprehensive understanding of local capacity and resources. Current policies and guidelines fail to consider the varying capacities of each rural site and should be hospital specific. [ABSTRACT FROM AUTHOR]

Black youths experience poor mental health especially due to anti‐Black racism. Research related to Black youths have been conducted on Black youths with little or no participation or engagement rather than with Black youths. This paper presents information from a dialogue on decolonizing nursing research. I draw on interviews and conversation cafes with around 120 Black youths in Canada to identify strategies for decolonizing research with Black youths. First, I reflect on my relations with the Indigenous land in which the study was conducted as well as my positionality as a Black woman. In this paper, I discuss how community based participatory action research can integrate capacity building component, amplify youth's voices and capitalize on the agency of youths as fruitful actors. I also reflect on the opportunities and benefits of decolonizing nursing research. [ABSTRACT FROM AUTHOR]

Objectives: To identify the frequency of which a legal guardian is at the bedside of children admitted to the PICU that are eligible for research studies., Design: A prospective, observational study., Setting: Three tertiary Canadian PICUs., Patients: Two hundred one patients were admitted to the PICU between September 2021 and March 2023 (site 1), from March 2019 to March 2020 and March 2022 to March 2023 (site 2), and from March 2019 to March 2020 and July 2020 to November 2021 (site 3)., Interventions: None., Measurements and Main Results: At each center, the duration of consent encounters was recorded for patients eligible for research by documenting the length of each attempt (min). The frequency of parental presence at bedside and the ability for a guardian to make a decision were also recorded. Thirty-five percent of patients eligible for research did not have a legal guardian at the bedside on the first attempted consent encounter. Twenty-three percent of approached patients were not enrolled due to an inability for a consent decision to be made by the child's legal guardian or an inability to contact the guardian before discharge., Conclusions: The absence of legal guardians in the PICU poses a barrier to the enrollment of critically ill children in pertinent research studies and suggests that a model of deferred consent or implied consent would aid in the future of critical care research., Competing Interests: Ms. Assaf disclosed she is a research coordinator with Children’s Hospital of Eastern Ontario. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2024 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)

Background: Facebook is a prominent social medial platform frequently used for business marketing. Researchers are starting to recognize the utility of this platform for developing research awareness, information dissemination, and more recently participant recruitment., Purpose: This paper will provide an overview of methods used in Facebook recruitment through an exemplar study. It will highlight successes and challenges and provide insight into future opportunities for its' use., Methods: Two methods of Facebook recruitment are outlined in this paper: the use of Facebook groups and paid advertising. A step-by-step guide highlights how researchers can implement these specific methods of Facebook recruitment., Results: Facebook was successfully utilized to recruit participants in the exemplar study. Recruitment was completed over a period of 82 days with a total cost of $157.09 Canadian dollars., Conclusion: Facebook is a viable method of recruiting research participants. This method can be cost-effective, timely, and efficient in comparison to traditional research recruitment methods. However, one must balance the benefits and challenges of this type of recruitment., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Introduction: Disparities in clinical trials (CTs) enrollment perpetuate inequities in treatment access and outcomes, but there is a paucity of Canadian data. The objective of this study was to examine disparities in cancer CT enrollment at a large Canadian comprehensive cancer center., Methods: Retrospective study of CT enrollment among new patient consultations from 2006 to 2019, with follow-up to 2021 (N = 154,880), with the primary outcome of enrollment as a binary variable. Factors associated with CT enrollment were evaluated using multivariable Bayesian hierarchical logistic regression with random effects for most responsible physician (MRP) and geography, adjusted for patient characteristics (sex, age, language, geography, and primary care provider [PCP]), area-level marginalization (residential instability, material deprivation, dependency, and ethnic concentration), disease (cancer site and stage), and MRP (department, sex, language, and training). A sensitivity analysis of the cumulative incidence of enrollment was conducted to account for differences in disease type and follow-up length., Results: CT enrollment was 11.2% overall, with a 15-year cumulative incidence of 18%. Lower odds of enrollment were observed in patients who were female (adjusted odds ratio [AOR], 0.82; 95% confidence interval [CI], 0.78-0.86), ≥65 years (AOR vs. <40, 0.61; 95% CI, 0.56-0.66), non-English speakers (0.72; 95% CI, 0.67-0.77), living ≥250 km away (AOR vs. <15 km, 0.71; 95% CI, 0.62-0.80), and without a PCP. Disease characteristics accounted for the largest proportion of observed variation (20.8%), with significantly greater odds of enrollment in patients with genitourinary cancers and late-stage disease., Conclusion: Significant sociodemographic disparities were observed, suggesting the need for targeted strategies to increase diversity in access to cancer CTs in Canada., (© 2024 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.)

Background: The Canadian National Vaccine Safety (CANVAS) network conducted a multi-center, prospective vaccine safety study to collect safety data after dose 1 and 2 of COVID-19 vaccines and follow up safety information 7 months after dose 1., Objective: This study aimed to describe and evaluate the recruitment methods used by CANVAS and the retention of participants by each modality., Methods: CANVAS deployed a multi-pronged recruitment approach to reach a larger sample, without in-person recruitment. Three primary recruitment strategies were used: passive recruitment, technology-assisted electronic invitation through the vaccine booking system (auto-invitation), or auto-registration through the vaccine registries (auto-enrollment)., Results: Between December 2020 and April 2022, approximately 1.3 million vaccinated adults either self-enrolled or were auto-enrolled in CANVAS, representing about 5% of the vaccinated adult Canadian population. Approximately 1 million participants were auto-enrolled, 300,000 were recruited by auto-invitation, and 5,000 via passive recruitment. Overall survey completion rates for dose 1, dose 2 and the 7-month follow-up surveys were 51.7% (681,198 of 1,318,838), 54.3% (369,552 of 681,198), and 66.4% (452,076 of 681,198), respectively. Completion rates were lower among auto-enrolled participants compared to passively recruited or auto-invited participants who self-enrolled. However, auto-enrolled samples were much larger, which offset the lower completion rates., Conclusion: Our data suggest that auto-enrollment provided an opportunity to reach and retain a larger number of individuals in the study compared to other recruitment modalities., Competing Interests: MS has been an investigator on projects funded by GlaxoSmithKline, Merck, Moderna, Pfizer, and Sanofi-Pasteur outside the submitted work. All funds have been paid to his institute, and he has not received any personal payments. LV reports grants from Pfizer outside the submitted work. KT reports grants from the Coalition of Epidemic Preparedness Innovations for COVID-19 vaccine studies. JI has been an investigator on projects funded by GlaxoSmithKline and Sanofi-Pasteur outside the submitted work. All funds have been paid to her institute, and she has not received any personal payment. AM reports grants to her institution from Pfizer and Sanofi-Pasteur, and personal payments for consulting from AstraZeneca, Merck, GlaxoSmithKline, Moderna, Novavax, Pfizer, and Seqirus. JK has been an investigator on projects funded by GlaxoSmithKline, Merck, Moderna, and Pfizer, all outside the submitted work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Soe, Sadarangani, Naus, Muller, Vanderkooi, Kellner, Top, Wong, Isenor, Marty, De Serres, Valiquette, McGeer and Bettinger.)

Objective The COVID-19 pandemic has disrupted healthcare delivery and clinical research worldwide, with data from areas most affected demonstrating an impact on rheumatology care. This study aimed to characterize the impact of the pandemic on the initial presentation of JIA and JIA-related research in Canada. Methods Data collected from the Canadian Alliance of Pediatric Rheumatology Investigators JIA Registry from the year pre-pandemic (11 March 2019 to 10 March 2020) was compared with data collected during the first year of the pandemic (11 March 2020 to 10 March 2021). Outcomes included time from symptom onset to first assessment, disease severity at presentation and registry recruitment. Proportions and medians were used to describe categorical and continuous variables, respectively. Results The median time from symptom onset to first assessment was 138 (IQR 64–365) days pre-pandemic vs 146 (IQR 83–359) days during the pandemic. The JIA category frequencies remained overall stable (44% oligoarticular JIA pre-pandemic, 46.8% pandemic), except for systemic JIA (12 cases pre-pandemic, 1 pandemic). Clinical features, disease activity (cJADAS10), disability (CHAQ) and quality of life (JAQQ) scores were similar between the two cohorts. Pre-pandemic, 225 patients were enrolled, compared with 111 in the pandemic year, with the greatest decrease from March to June 2020. Conclusions We did not observe the anticipated delay in time to presentation or increased severity at presentation, suggesting that, within Canada, care adapted well to provide support to new patient consults without negative impacts. The COVID-19 pandemic was associated with an initial 50% decrease in registry enrolment but has since improved. [ABSTRACT FROM AUTHOR]

Introduction: The identification and treatment of latent tuberculosis infection (LTBI) among immigrants from high-incidence regions who move to low-incidence countries is generally considered an ineffective strategy because only ≈14% of them comply with the multiple steps of the 'cascade of care' and complete treatment. In the Estrie region of Canada, a refugee clinic was opened in 2009. One of its goals is LTBI management. Methods: Key components of this intervention included: close collaboration with community organizations, integration within a comprehensive package of medical care for the whole family, timely delivery following arrival, shorter treatment through preferential use of rifampin, and risk-based selection of patients to be treated. Between 2009–2020, 5131 refugees were evaluated. To determine the efficacy and benefit-cost ratio of this intervention, records of refugees seen in 2010–14 (n = 1906) and 2018–19 (n = 1638) were reviewed. Cases of tuberculosis (TB) among our foreign-born population occurring before (1997–2008) and after (2009–2020) setting up the clinic were identified. All costs associated with TB or LTBI were measured. Results: Out of 441 patients offered LTBI treatment, 374 (85%) were compliant. Adding other losses, overall compliance was 69%. To prevent one case of TB, 95.1 individuals had to be screened and 11.9 treated, at a cost of $16,056. After discounting, each case of TB averted represented $32,631, for a benefit-cost ratio of 2.03. Among nationals of the 20 countries where refugees came from, incidence of TB decreased from 68.2 (1997–2008) to 26.3 per 100,000 person-years (2009–2020). Incidence among foreign-born persons from all other countries not targeted by the intervention did not change. Conclusions: Among refugees settling in our region, 69% completed the LTBI cascade of care, leading to a 61% reduction in TB incidence. This intervention was cost-beneficial. Current defeatism towards LTBI management among immigrants and refugees is misguided. Compliance can be enhanced through simple measures. [ABSTRACT FROM AUTHOR]

Introduction: Various retinal implants are being developed and appear to be a promising option for improving the visual capacities of individuals with retinal dystrophy. A multidisciplinary approach to both assessment of a candidate's factors and rehabilitation could contribute to improved activity and participation. The purpose of this study was (i) to document the approach taken by a multidisciplinary team in the candidate selection process and in training in the use of the Argus II retinal prosthesis system (RPS), and (ii) to examine the effects of the RPS on sensory and mental functions and on activity and participation. Methods: An A1-B1-A2-B2 experimental case report was used, with repeated measures pre- and post-rehabilitation program design. The A phases represent the periods with the system off, whereas the B phases represent the periods with the system on. A 65-year-old man with retinitis pigmentosa and total blindness was followed by a multidisciplinary team for over 18 months. After receiving the retinal implant, he benefited from a 10-week rehabilitation program (twice per week; B1 phase). Results: Globally, the RPS improved vision in the B phases when the system was on and visual acuity was stable at 2.3 logMAR (functional blindness). The participant's mental and neuromusculoskeletal function scores were generally stable throughout the data collection periods. Lower performance on some measures at the end of phase B2 coincided with a negative mood. Discussion: Use of the RPS improved activity, but this did not transfer into greater participation in the living environment. Despite efforts made by the rehabilitation team to manage the user's expectations concerning the RPS, the interventions reactivated his grieving over his vision loss. Implications for Practitioners: New technologies can make users dream of unrealistic possibilities, and managing their expectations requires problem solving supported by a multidisciplinary team. [ABSTRACT FROM AUTHOR]

The increasing dementia prevalence worldwide is driving the testing of novel therapeutic approaches, such as invasive brain technologies, despite limited clinical evidence and the risk of accelerating cognitive decline. Our manuscript (a) reviews the NIH Clinicaltrials.gov database for deep brain stimulation, stem cell implantation, and gene therapy trials on people with dementia; (b) discusses issues on beneficence, nonmaleficence, and autonomy associated with these trials; and (c) proposes nine recommendations that build on elements from the Declaration of Helsinki. We found 49 preregistered high‐risk trials from nine countries planning to or involving 11,801 people with Alzheimer's or Lewy body dementia or dementia secondary to Parkinson's or Huntington's disease. Most of the people with Alzheimer's who are in these trials are from North America and East Asia. There is substantial heterogeneity in the enrolment criteria, even for trials recruiting only those with Alzheimer's disease. Although most trials enrol people in mild to moderate stages of Alzheimer's disease, trials in China enrol people who have severe Alzheimer's. Our findings highlight a pressing need to review and refine the enrolment criteria for invasive neural trials in people with dementia, considering risks, potential benefits, and capacity for informed consent. As a multidisciplinary team from Australia, the USA, Canada, and Germany with expertise in neurology, neuroscience, and ethics, we examine how it is essential to balance the risks of invasive neural research in a vulnerable population with limited capacity to provide informed consent to help advance the body of knowledge regarding a disease with limited therapeutic options. [ABSTRACT FROM AUTHOR]

The Canadian Cancer Clinical Trials Network (3CTN) was established in 2014 to address the decline in academic cancer clinical trials (ACCT) activity. Funding was provided to cancer centres to conduct a Portfolio of ACCTs. Larger centres received core funding and were paired with smaller centres to enable support and sharing of resources. All centres were eligible for incentive-based funding for recruitment above pre-3CTN baseline. Established performance measures were collected and tracked. The overall recruitment target was 50% above pre-3CTN baseline by Year 4. An analysis was completed to identify predictive success factors and descriptive statistics were used to summarize site characteristics and outcomes. From 2014-2018, a total of 11,275 patients were recruited to 559 Portfolio trials, an overall increase of 59.6% above pre-3CTN baseline was observed in Year 4. Twenty-five (51%) adult centres met the Year 4 recruitment target and the overall recruitment target was met within three years. Three factors that correlated with sites' achieving recruitment targets were: time period, region and number of baseline trials. 3CTN was successful in meeting its objectives and will continue to support ACCTs and member cancer centres, monitor performance over time and seek continued funding to ensure success, better trial access and outcomes for patients. [ABSTRACT FROM AUTHOR]

Supplemental digital content is available in the text. Objective: Our objective was to investigate whether women, people 65 yrs and older, or individuals who identify with racial and/or ethnic minority groups, were underrepresented among participants in rehabilitation clinical trials. Design: This is a cross-sectional study of completed rehabilitation clinical trials investigating the number and percentage of women, older adults, and racial and/or ethnic minorities enrolled in rehabilitation clinical trials between January 1, 2011, and January 1, 2020. Secondary outcome measures were inclusion by diagnostic group, as well as International Classification of Functioning, Disability and Health category, and intervention by diagnostic group. Results: Of the 108 studies meeting inclusion criteria, a majority (69%) were based in the United States. Stroke was the most frequent diagnostic group, followed by musculoskeletal conditions. Ninety-six percent of the United States–based trials included at least one female participant in their study, but among specific diagnostic groups, this ranged from 5% to 73%. Age information was reported inconsistently; however, of the trials reporting age, 100% of cardiac trials included older adults, whereas no spinal cord injury (SCI) trials included them. Among trials based in the United States reporting race, 70% of participants were White, followed by 20% Black or African American and 1% Asian. Among trials based in the United States reporting ethnicity, Hispanic or Latino participants were underrepresented overall and among each diagnostic group. Conclusions: In this study, we found that among participants of rehabilitation clinical trials women, older individuals, and racial/ethnic minorities were generally underrepresented. In contrast, Black or African American participants were overrepresented with the exception of cardiac trials. An important finding was that many trials did not report age and/or race/ethnicity. Investigators should aim to include underrepresented populations and improve reporting. [ABSTRACT FROM AUTHOR]

Background: The optimal analgesia method in video-assisted thoracoscopic surgery (VATS) remains controversial. Intercostal nerve blockade (ICNB) is limited by its duration of action. The erector spinae plane (ESP) block has the potential to provide satisfactory analgesia for VATS; however, the effectiveness of continuous ESP versus surgeon-performed ICNB has not been investigated. The objectives of this study were to establish feasibility of patient recruitment and follow-up before undertaking a fully powered randomized controlled trial (RCT); and, secondarily, to compare opioid usage, pain control, and sensory blockade. Methods: This feasibility RCT was undertaken at St Joseph's Hospital, Hamilton, Ontario, Canada, and included 24 patients (>18 years) having elective VATS with at least one overnight stay. Exclusion criteria were patient refusal, body mass index >40 kg/m2, contraindications to neuraxial analgesia techniques as per the American Society of Regional Anesthesia and Pain guidelines, known allergy to local anesthetics, language or comprehension barriers, procedures with a higher chance of open surgery, and regular opioid use for ≥3 months preoperatively. Patients underwent either continuous ESP (n=12) or surgeon-performed ICNB (n=12). All patients received routine intraoperative anesthesia care and multimodal analgesia. Feasibility criteria were recruitment rate of two patients/week and full follow-up in all patients in-hospital. We compared opioid consumption, postoperative pain scores (0–10 numerical rating scale), adverse events, patient satisfaction, and distribution of sensory blockade as clinical outcomes (secondary). Results: Feasibility of primary outcomes was successfully demonstrated. Five patients had an epidural in anticipation of open surgery. Mean opioid consumption as equivalent morphine units was less in the ESP group over the first 24 h (mean difference, 1.63 [95% CI –1.20 to 4.45]) and 48 h (mean difference, 2.34 [95% CI –1.93 to 6.61]). There were no differences in adverse effects. Conclusions: A fully powered RCT is feasible with modifications. Our results also suggest that continuous ESP is safe and can decrease opioid needs. However, it is important to consider procedures to improve compliance to protocol and adherence to assigned interventions. Trial registration: Clinicaltrials.gov identifier: NCT03176667. Registered June 5, 2017. [ABSTRACT FROM AUTHOR]

Background Studies of mild cognitive impairment (MCI) employ rigorous eligibility criteria, resulting in sampling that may not be representative of the broader clinical population. Objective To compare the characteristics of MCI patients in a Calgary memory clinic to those of MCI participants in published Canadian studies. Methods Clinic participants included 555 MCI patients from the PROspective Registry of Persons with Memory SyMPToms (PROMPT) registry in Calgary. Research participants included 4,981 individuals with MCI pooled from a systematic literature review of 112 original, English-language peer- reviewed Canadian studies. Both samples were compared on baseline sociodemographic variables, medical and psychiatric comorbidities, and cognitive performance for MCI due to Alzheimer's disease and Parkinson's disease. Results Overall, clinic patients tended to be younger, more often male, and more educated than research participants. Psychiatric disorders, traumatic brain injury, and sensory impairment were commonplace in PROMPT (up to 83% affected) but > 80% studies in the systematic review excluded these conditions. PROMPT patients also performed worse on global cognition measures than did research participants. Conclusion Stringent eligibility criteria in Canadian research studies excluded a considerable subset of MCI patients with comorbid medical or psychiatric conditions. This exclusion may contribute to differences in cognitive performance and outcomes compared to real-world clinical samples. [ABSTRACT FROM AUTHOR]

Introduction: Transanal total mesorectal excision (taTME) is a novel approach to surgery for rectal cancer. The technique has gained significant popularity in the surgical community due to the promising ability to overcome technical difficulties related to the access of the distal pelvis. Recently, Norwegian surgeons issued a local moratorium related to potential issues with the safety of the procedure. Early adopters of taTME in Canada have recognized the need to create guidelines for its adoption and supervision. The objective of the statement is to provide expert opinion based on the best available evidence and authors' experience. Methods: The procedure has been performed in Canada since 2014 at different institutions. In 2016, the first Canadian taTME congress was held in the city of Toronto, organized by two of the authors. In early 2019, a multicentric collaborative was established [The Canadian taTME expert Collaboration] which aimed at ensuring safe performance and adoption of taTME in Canada. Recently surgeons from 8 major Canadian rectal cancer centers met in the city of Toronto on December 7 of 2019, to discuss and develop a position statement. There in person, meeting was followed by 4 rounds of Delphi methodology. Results: The generated document focused on the need to ensure a unified approach among rectal cancer surgeons across the country considering its technical complexity and potential morbidity. The position statement addressed four domains: surgical setting, surgeons' requirements, patient selection, and quality assurance. Conclusions: Authors agree transanal total mesorectal excision is technically demanding and has a significant risk for morbidity. As of now, there is uncertainty for some of the outcomes. We consider it is possible to safely adopt this operation and obtain adequate results, however for this purpose it is necessary to meet specific requirements in different domains. [ABSTRACT FROM AUTHOR]

Summary: The Canadian FRAX® tool used without bone mineral density (BMD) is highly sensitive for identifying individuals qualifying for pharmacotherapy based upon an intervention threshold of 20% for major osteoporotic fracture risk (MOF) computed with BMD. Introduction: This analysis was performed to inform initial BMD testing as part of Osteoporosis Canada's Guidelines Update for women and men at average risk, assuming a pharmacotherapy intervention threshold of 20% for FRAX® MOF computed with BMD. Methods: Women and men age 50 + without previous low-trauma fracture or high-risk medication use were identified in a BMD registry for the province of Manitoba, Canada. Fracture probability assessments with the Canadian FRAX® tool were computed without and with BMD (denoted MOF-clinical and MOF-BMD, respectively). Results: The study population consisted of 50,700 women (mean age 65.5 ± 9.4 years) and 4152 men (69.2 ± 10.0 years). FRAX MOF-clinical score was > 10% in 33.8% of women and 13.3% of men (P < 0.001). The median (interquartile range [IQR]) age for MOF-clinical to reach 10% in women was 70 (69–72) and 65 years (62–67) years in the absence and presence of additional FRAX clinical risk factors, respectively. In men, comparable ages were 83 years [82–86] and 76 [70–78] years. Using MOF-BMD of 20% as the intervention threshold, 4.3% of women and 0.7% of men qualified for treatment. MOF-clinical > 10% had high sensitivity to identify those qualifying for treatment (99.3% in women and 99.1% in men). An age-based rule ("BMD testing is indicated at age 70 if no additional FRAX clinical risk factors are present, or at age 65 if one or more clinical risk factors exists") gave similarly high sensitivity (women 99.9% and men > 99.9%). Conclusions: FRAX without BMD offers an effective strategy to identify individuals meeting the current Canadian treatment threshold based upon FRAX® with BMD (≥ 20%). Moreover, this can be operationalized using simple age cutoffs of 70 years in the absence of additional clinical risk factors and 65 years in the presence of additional clinical risk factors. [ABSTRACT FROM AUTHOR]

Co‐occurring disorders in mental health and addiction present a high prevalence, but services available to prevent and treat them are often fragmented. Cross‐training activities have been used to help minimise breaks in service continuity. This study assesses to what extent positional clarification (a specific type of cross‐training activity) can help bridge fragmented services for co‐occurring disorders by providing information and promoting interactions to help professionals better orient and treat their clientele. A total of 2,107 participations were recorded for 11 positional clarification events taking place within the Montreal Cross‐Training Program for mental health and substance use disorders between 2010 and 2016. The Kirkpatrick four‐level training evaluation model was used to evaluate these activities. Evaluation questionnaires (n = 1,650) and interviews with a convenience sample of 32 participants were analysed using descriptive statistics and thematic analysis. More than three‐quarters of participants reported that the activity met their expectations and was relevant to their practice. Respondents also reported receiving useful information to better orient their clientele, discovering new resources, learning about the functioning of other resources, identifying members of other networks who could orient them when needed, and learning more about the theme of the activity and the different mechanisms for collaboration among the related services. Among those who participated in more than one positional clarification event, roughly three‐quarters reported that they were able to call upon new resources at least once as a result of their participation, and were able to establish referrals towards resources that were unknown or less familiar to them prior to their participation. Results suggest that the programme meets its service integration objectives and that positional clarification events can lead to changes that can help facilitate the integration of fragmented services by improving participants' knowledge of specific themes and available resources to better orient and treat their clientele. [ABSTRACT FROM AUTHOR]

This paper describes how a study using institutional ethnography (IE) was used as a decolonizing method of inquiry in a rural Indigenous community in Canada. IE honors lived experience, reveals institutional and colonial practices, provides clear empirical evidence, and can offer clear recommendations that can benefit Indigenous communities. At the heart of decolonizing research is the task of shifting whose knowledge is privileged – from those with power (often researchers) to those who are being researched (those subject to the effects of colonization). To highlight how IE can be used as a decolonizing method of inquiry, the authors of this paper (a) point out common pitfalls of academic research and knowledge translation (KT) practices in Indigenous health; (b) highlight decolonizing research principles and how IE can be a decolonizing method of inquiry; and (c) share an example to illustrate how IE was used in a decolonizing health study in a First Nations community context. This paper also outlines critiques of mainstream research and KT practices, highlights principles for conducting research with Indigenous people in Canada, and further discusses how IE is well positioned to facilitate both decolonizing research and strategic KT. [ABSTRACT FROM AUTHOR]

Background: Recruitment to clinical trials is suboptimal, increasing costs, and delaying the potential implementation of clinical advances. Among other barriers, the lack of marketing experience among trialists may limit recruitment. In this observational study, in the context of the Pan-Canadian Early Detection of Lung Cancer Trial, we assessed the value of a motivational survey of study participants in planning a tailored advertising campaign and analysed the value of individual components of advertising in generating telephone calls to the study and recruited subjects. Methods: The Pan-Canadian Early Detection of Lung Cancer Trial was a single arm study assessing risk modelling for lung cancer screening by low-dose computed tomography scan and autofluorescence bronchoscopy. Individuals were recruited to eight sites across Canada without a central marketing plan. On contact with the study, individuals reported how they heard about the study according to a predefined list. One site, the Juravinski Cancer Centre, worked with a marketing expert to develop a survey to assess participant motivations, source of study awareness, and personal habits. The survey was used to develop a media campaign for recruitment. Media events were collected from all sites. The primary analysis assessed the number of telephone contacts and recruited subjects associated with various media factors. Individual print media characteristics were assessed for their effect on recruitment. Results: At all sites, 7059 individuals contacted the study, and 2537 were eligible and recruited. Among 52 individuals completing the Juravinski Cancer Centre survey, motivation included concern for personal risk of lung cancer (71%), followed by desire to contribute to a cure (67%), followed by personal knowledge of a person with lung cancer (50%). Most reported hearing of the study from the newspaper (58%) despite no print ad yet being distributed. With survey input, a newsprint campaign was executed. The number of media events varied by site (median: 13, range: 3–28). Among all recruits, 56.4% reported referral by newspaper followed by family/friend (14%). Telephone contacts and recruited subjects per event varied significantly by site, while unpaid media events appeared superior to paid events. Print media characteristics associated with increased telephone contacts and recruitment included use of a rational appeal (vs a mixed rational–emotional), less use of white space, and larger headline font. Conclusion: A survey of trial candidates provides useful information regarding personal motivation, media use, and lifestyle. Unpaid media events appear superior in generating recruitment, while print media may be superior to radio and television in selecting eligible recruits. The utility of individual print media characteristics appears to differ from the commercial advertising literature. Further research on marketing in clinical trials is encouraged to improve recruitment (ClinicalTrials.gov registration: NCT00751660, https://clinicaltrials.gov/ct2/show/NCT00751660). [ABSTRACT FROM AUTHOR]

Background: In October 2018, Canada became the second country to legalize non-medical cannabis. However, medical cannabis has been legally available in Canada since 2001 and, in 2015, approximately 800,000 Canadians reported using cannabis for medical purposes. Mental health is a common reason reported for using medical cannabis. Objectives: The current study examined perceived mental health among four groups: (1) Non/ex-users; (2) Recent non-medical users; (3) Recent unauthorized medical users; and (4) Recent authorized medical users. Methods: A total of 867 Canadian cannabis users and nonusers aged 16 to 30 were recruited through an online consumer panel in 2017, one year before non-medical cannabis legalization. Logistic and multinomial regression models were fitted to examine differences among cannabis use status and mental health measures. All estimates represent weighted data. Results: Self-reported emotional and mental health problems were higher among unauthorized (83.9%) and authorized medical cannabis users (83.2%) compared to non-medical users and non/ex-users (44.5% and 39.5%, respectively). Medical users were more likely to report using cannabis to manage or improve mental health problems than non-medical users (p <.001). There were few differences between unauthorized and authorized medical users, and between non/ex-users and non-medical users. Conclusions: The findings highlight a discrepancy between the recommendation that individuals with some mental health problems should avoid cannabis and the widespread practice of using cannabis to manage mental health. Education and reduced stigma around using cannabis after legalization in Canada may help address users coming forwards regarding use of cannabis for mental health problems. [ABSTRACT FROM AUTHOR]

Respiratory syncytial virus (RSV) infection is a leading cause of hospitalisation in early childhood and palivizumab is the only licensed intervention for prevention. Palivizumab guidelines should reflect the latest evidence, in addition to cost-effectiveness and healthcare budgetary considerations. RSV experts from Europe, Canada and Israel undertook a systematic review of the evidence over the last 5 years and developed recommendations regarding prophylaxis in industrialised countries. Almost 400 publications were reviewed. This group recommended palivizumab for: preterm infants (<29 and ≤31 weeks gestational age [wGA] and ≤9 and ≤6 months of age, respectively; high-risk 32-35wGA), former preterm children ≤24 months with chronic lung disease/bronchopulmonary dysplasia, children ≤24 months with significant congenital heart disease; and other high-risk populations, such as children ≤24 months with Down syndrome, pulmonary/neuromuscular disorders, immunocompromised, and cystic fibrosis. Up to 5 monthly doses should be administered over the RSV season. It is our impression that the adoption of these guidelines would help reduce the burden of RSV. [ABSTRACT FROM AUTHOR]

Background/aims: Efficient recruitment of eligible participants, optimizing time and sample size, is a crucial component in conducting a successful clinical trial. Inefficient participant recruitment can impede study progress, consume staff time and resources, and limit quality and generalizability or the power to assess outcomes. Recruitment for disease prevention trials poses additional challenges because patients are asymptomatic. We evaluated candidates for a disease prevention trial to determine reasons for nonparticipation and to identify factors that can be addressed to improve recruitment efficiency. Methods: During 2001–2009, the Tuberculosis Trials Consortium conducted Study 26 (PREVENT TB), a randomized clinical trial at 26 sites in four countries, among persons with latent tuberculosis infection at high risk for tuberculosis disease progression, comparing 3 months of directly observed once-weekly rifapentine plus isoniazid with 9 months of self-administered daily isoniazid. During March 2005–February 2008, non-identifying demographic information, risk factors for experiencing active tuberculosis disease, and reasons for not enrolling were collected from screened patients to facilitate interpretation of trial data, to meet Consolidated Standards of Reporting Trials standards, and to evaluate reasons for nonparticipation. Results: Of the 7452 candidates screened in Brazil, Canada, Spain, and the United States, 3584 (48%) were not enrolled, because of ineligibility (41%), site decision (10%), or patient choice (49%). Among those who did not enroll by own choice, and for whom responses were recorded on whether they would accept treatment outside of the study (n = 1430), 68% reported that they planned to accept non-study latent tuberculosis infection treatment. Among 1305 patients with one or more reported reasons for nonparticipation, study staff recorded a total of 1886 individual reasons (reason count: median = 1/patient; range = 1–9) for why patients chose not to enroll, including grouped concerns about research (24% of 1886), work or school conflicts (20%), medication or health beliefs (16%), latent tuberculosis infection beliefs (11%), and patient lifestyle and family concerns (10%). Conclusion: Educational efforts addressing clinical research concerns and beliefs about medication and health, as well as study protocols that accommodate patient-related concerns (e.g. work, school, and lifestyle) might increase willingness to enter clinical trials. Findings from this evaluation can support development of communication and education materials for clinical trial sites at the beginning of a trial to allow study staff to address potential participant concerns during study screening. [ABSTRACT FROM AUTHOR]

Addiction is a crisis affecting many Canadians. Rapid Access Clinics (RAC) are a novel means of providing immediate care, but research on how they improve functional well being in people with substance use issues (PSUI), which is intended to prevent relapse, is limited. In this pilot study, interviews were conducted with clients attending an RAC for PSUI in Toronto, Canada. A deductive thematic analysis was developed from the interviews, focusing on components of the Canadian Model of Occupational Performance and Engagement. Various subthemes related to model components have been identified and discussed, which could guide future research on supporting recovery of PSUI. [ABSTRACT FROM AUTHOR]

Background Selection and sequencing of treatment regimens for individual patients with metastatic colorectal cancer (mcrc) is driven by maintaining reasonable quality of life and extending survival, as well as by access to and cost of therapies. The objectives of the present study were to describe, for patients with mcrc, attrition across lines of systemic therapy, patterns of therapy and their timing, and KRAS status. Methods: A retrospective chart review at 6 Canadian academic centres included sequential patients who were diagnosed with mcrc from 1 January 2009 onward and who initiated first-line systemic treatment for mcrc between 1 January and 31 December 2009. Death was included as a competing risk in the analysis. Results: The analysis included 200 patients who started first-line therapy. The proportions of patients who started second-, third-, and fourth-line systemic therapy were 70%, 30%, and 15% respectively. Chemotherapy plus bevacizumab was the most common first-line combination (66%). The most common first-line regimen was folfiri plus bevacizumab. KRAS testing was performed in 103 patients (52%), and 38 of 68 patients (56%, 19% overall) with confirmed KRAS wild-type tumours received an epidermal growth factor receptor inhibitor (egfri), which was more common in later lines. Most KRAS testing occurred after initiation of second-line therapy. Conclusions: In the modern treatment era, a high proportion of patients receive at least two lines of therapy for mcrc, but only 19% receive egfri therapy. Earlier KRAS testing and therapy with an egfri might allow a greater proportion of patients to access all 5 active treatment agents. [ABSTRACT FROM AUTHOR]

Background: The use of prophylactic mesh in end colostomy procedures has been shown to reduce the rate of parastomal hernia. However, the degree to which the practice has been adopted clinically remains unknown. We conducted a study to evaluate the current opinions and practice patterns of Canadian and US colorectal surgeons with regard to the use of prophylactic mesh in end colostomy.Methods: Between May and July 2017, we conducted an internet-based survey of colorectal surgeons in Canada and the United States (selected at random). Using a questionnaire designed and tested for this study, we assessed the rate of mesh use, types of mesh and placement techniques, and perceived barriers and facilitators associated with the practice.Results: Forty-eight (51.6%) of 93 invited Canadian surgeons and 253 (16.6%) of 1521 invited US surgeons responded (overall response rate 18.6%). Of the 301 respondents, 32 (10.6%) were currently using mesh, 32 (10.6%) had previously used mesh, and 237 (78.7%) had never used mesh. Of 29 respondents currently using mesh, 12 (41.4%) used it only in selected patients; the majority used a sublay technique (20 [69.0%]) and biologic mesh (17 [58.6%]). Most respondents agreed that parastomal hernias are common and negatively affect quality of life; however, there remained concerns about evidence quality and the perceived risk associated with mesh among those who had never or had previously used mesh.Conclusion: Prophylactic mesh placement remains relatively uncommon; when used, biologic mesh was the most common type. Many surgeons were not convinced of the safety or efficacy of prophylactic mesh placement. [ABSTRACT FROM AUTHOR]

Delays in the delivery of bariatric surgery in Canada in the context of the COVID-19 pandemic have not been previously explored. Understanding the potential barriers associated with these delays may help in the implementation and delivery of enhanced bariatric protocols, thereby minimizing health care system burden and improving bariatric delivery. We present the experience of a single high-volume, accredited bariatric program in Edmonton, Alberta, in 2020. Although reductions in bariatric cases occurred during lockdown months, the overall number of cases was comparable to 2019 owing to the adoption of strategies aimed at offsetting the burden of hospital resources. These strategies included optimizing patient selection, implementing bariatric Enhanced Recovery After Surgery protocols, and minimizing unnecessary postoperative investigations to allow most patients to be discharged on postoperative day 1. We advocate to continue optimizing bariatric delivery in the face of the COVID-19 pandemic that so disproportionally affects those with severe obesity and its metabolic complications. [ABSTRACT FROM AUTHOR]

Background: Ambulatory spinal surgery is a care delivery model meant to improve patient outcomes and reduce in-hospital length of stay (LOS). We reviewed the experience of implementing an outpatient spine surgery program in Manitoba, Canada and highlight elements that can be used to reduce LOS and re-presentation to hospital., Methods: This is a retrospective cohort study using data from the Canadian Spine Outcomes and Research Network and independent chart review of adult patients undergoing outpatient spinal surgery between 2015 and 2018. Patient demographics, comorbidities, perioperative course, LOS, and readmissions were analyzed., Results: We included 217 patients in this analysis. The mean LOS was 36.2 hours; 71.98% of patients had a LOS <24 hours. A Kruskal-Wallis test by ranks analysis was conducted and identified 7 elements that correlated with prolonged length of stay (>1 day): age older than 55 (P = 0.027), body mass index >25 (P = 0.045), uncontrolled diabetes (P = 0.015), preoperative use of opioid medication (P = 0.024), American Society of Anesthesiologists classification of 3 (P = 0.023), non-minimally invasive surgical approach, and multilevel procedures. Most (94.1%) of the patients with none of these elements (i.e., age <55, low body mass index, normal/controlled diabetes, minimal preoperative opioid use, American Society of Anesthesiologist classification <3, minimally invasive surgical procedure) had a favorable LOS, <24 hours, compared with 84.8% with 1 risk factor, 80.4% of those with two, 69.8% with three, 53.1% with four, and 31.2% with 5 or more. A small number of patients (14.98%) presented to an emergency department within 90 days of their operation, and there was a 6.28% readmission rate., Conclusions: We identified several patient and surgical criteria that correlate with prolonged length of stays following planned ambulatory spine surgery. Our work provides some empiric evidence to help guide surgeons on which patients and approaches are ideal for ambulatory surgery., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Compassionate use (also referred to as expanded access) is therapeutic use of unauthorized drugs outside of clinical trials. The objective of this review is to discuss practical aspects of the current legal regulations concerning compassionate use that have been introduced in the European Union, the USA (both the Food and Drug Administration regulations and Right-to-try laws), Canada and Australia. We also present main ethical challenges associated with use of unauthorized drugs such as possible difficulties with obtaining informed consent and fair patient selection. Moreover, we discuss guidelines, especially those contained in the Declaration of Helsinki, which may aid doctors in the ethical conduct of compassionate treatments. • Compassionate use is use of unauthorized drugs outside of clinical trials. • Many countries have introduced legal regulations concerning compassionate use. • Compassionate use is associated with a number of ethical challenges. • Ethical review of compassionate use is quite controversial. • Some ethics codes contain guidelines regarding compassionate use. [ABSTRACT FROM AUTHOR]

Objective: For patients suffering from an out-of-hospital cardiac arrest (OHCA), having an initial shockable rhythm is a marker of good prognosis. It has been suggested as one of the main prognosticating factors for the selection of patients for extracorporeal resuscitation (E-CPR). However, the prognostic implication of converting from a non-shockable to a shockable rhythm, as compared to having an initial shockable rhythm, remains uncertain, especially among patients that can otherwise be considered eligible for E-CPR. The objective of this study was to evaluate the association between the initial rhythm and its subsequent conversion and survival following an OHCA, for the general population and for E-CPR candidates.Methods: This study used a registry of OHCA in Montreal, Canada. Adult patients suffering from a non-traumatic OHCA for whom the initial rhythm was known were included. The association between the initial rhythm and its subsequent conversion or not and survival to discharge was assessed using a multivariable logistic regression.Results: Of 6681 included patients, 1788 (27%) had an initial shockable rhythm, 1749 (26%) had pulseless electrical activity (PEA) and no subsequent shockable rhythm, 295 (4%) had PEA and a subsequent shockable rhythm, 2694 (40%) had asystole and no subsequent shockable rhythm, and 155 (2%) asystole and a subsequent shockable rhythm. As compared to patients having an initial shockable rhythm, patients in all other groups had significantly lower odds of survival to hospital discharge (p < 0.001 for all comparisons). Univariate analyses were performed for E-CPR candidates. Among these 556 (8%) patients, more patients with an initial shockable rhythm survived than patients in all other groups (p < 0.001 for all comparisons).Conclusions: The initial rhythm remains a much better prognostic marker than subsequent rhythms for all patients suffering from an OHCA, including in the subset of potential E-CPR candidates. [ABSTRACT FROM AUTHOR]

Prison systems, with the ability to reject or approve applications for conducting research with incarcerated populations, function as shapers of carceral knowledge and thus can potentially close opportunities for new qualitative studies as well as affect the quality and richness of the data obtained. This article describes a collaborative research process wherein access to current prisoners was not granted, and only former prisoners who were not on parole were eligible to participate in the study. We provide a unique reflective analysis of how access barriers altered the scope of our research and may have impacted our findings were it not for a change in our recruitment plan. We also incorporate insights from multiple literatures that speak to the value, challenges, and ethical concerns associated with doing research with former prisoners. Our contribution to the qualitative carceral literature sparks new questions worthy of further in-depth exploration, in particular how to more meaningfully involve former prisoners in the research process. [ABSTRACT FROM AUTHOR]

Purpose: To understand the similarities and differences in the employment participation of people living with arthritis across the life course. Method: Focus groups and interviews were conducted with young (ages 18-34 years, n = 7), middle-aged (ages 35-54 years, n = 13) and older adults (>55 years, n = 25) with arthritis. Participants were asked about the impact of arthritis on employment, experiences with health-related changes, career progression and social role involvement. A modified grounded theory approach was used to inductively analyze the data. Results: Young adults indicated the school-to-work transition as being influential in their employment and described the need to direct their time and energy toward finding work that accommodated health and met career aspirations. Middle-aged adults described how the transition from good health to an arthritis diagnosis disrupted involvement in diverse social roles. However, they often downplayed the impact of arthritis on employment. Older adults described the work-to-retirement transition and their decline in physical functioning as contributing to changing involvement in the labor market. Conclusion: Transitions related to health, career progression and social role involvement shaped employment experiences, and represent opportunities for future research and practice that is tailored to life course issues. Implications for rehabilitation: Little is known about the work experiences of young- and middle-aged adults with arthritis and how they compare to their older counterparts. Life course theory offers an important framework for research and practice by providing a perspective to enhance our understanding of how employment participation differs across phases of life. Salient and diverse changes related to health, career and social role involvement were identified at each life phase and shaped employment. Rehabilitation practitioners should pay special attention to a client’s age, life phase and work history as a strategy to enhance the delivery of interventions that promote work participation. [ABSTRACT FROM AUTHOR]

Summary: We pilot-tested a trial of home exercise on individuals with osteoporosis and spine fracture.Our target enrollment was met, though it took longer than expected. Participants stayed in the study and completed the exercise program with no safety concerns.Future trials should expand the inclusion criteria and consider other changes.Purpose: Osteoporotic fragility fractures create a substantial human and economic burden. There have been calls for a large randomized controlled trial examining the effect of exercise on fracture incidence. The B3E pilot trial was designed to evaluate the feasibility of a large trial examining the effects of home exercise on individuals at high risk of fracture.Methods: Community-dwelling women ≥ 65 years with radiographically confirmed vertebral compression fractures were recruited at seven sites in Canada and Australia. We randomized participants in a 1:1 ratio to a 12-month home exercise program or equal attention control group, both delivered by a physiotherapist (PT). Participants received six PT home visits in addition to monthly phone calls from the PT and a blinded research assistant. The primary feasibility outcomes of the study were recruitment rate (20 per site in 1 year), retention rate (75% completion), and intervention adherence rate (60% of weeks meeting exercise goals). Secondary outcomes included falls, fractures and adverse events.Results: One hundred forty-one participants were recruited; an average of 20 per site, though most sites took longer than anticipated. Retention and adherence met the criteria for success: 92% of participants completed the study; average adherence was 66%. The intervention group did not differ significantly in the number of falls (IRR 0.97, 95% CI 0.58 to 1.63) or fragility fractures (OR 1.11, 95% CI 0.60 to 2.05) compared to the control group. There were 18 serious adverse events in the intervention group and 12 in the control group.Conclusion: An RCT of home exercise in women with vertebral fractures is feasible but recruitment was a challenge. Suggestions are made for the conduct of future trials. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to highlight features of pragmatic real-world integrative oncology research by applying the PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) criteria to an ongoing integrative oncology clinical trial. The ongoing trial is a preference-based randomized comparative effectiveness trial of mindfulness-based cancer recovery (MBCR) versus t'ai chi/qigong (TCQ) for cancer survivors (the Mindfulness and T'ai Chi for Cancer Health [MATCH] study). The primary outcome of the MATCH study is distress, and secondary outcomes are quality of life, sleep disturbance, and physical functioning. The clinical trial is being undertaken at tertiary care cancer centers across two sites in Canada: Calgary (AB) and Toronto (ON), with a sample of 600 cancer survivors who have finished all cancer treatments and are distressed. Methods and Results: The MATCH trial was scored on the explanatory–pragmatic continuum for each of the nine domains of the PRECIS-2 criteria on a scale of 1–5, and was rated as more explanatory than pragmatic, despite initial design efforts being more pragmatic. Areas that were least pragmatic were methods of recruitment, follow-up, and intervention delivery. The more pragmatic areas were setting, outcomes, and data analysis. Conclusions: More efforts toward conducting pragmatic trials are needed in the field of integrative oncology, as cancer-care institutions and policy makers are looking for sustainable interventions within already established treatment models. The PRECIS-2 criteria can help researchers meet these goals in the planning stages of trial development. [ABSTRACT FROM AUTHOR]

BACKGROUND: Ontario’s occupational health and safety prevention system has identified a need for the systematic collection of occupational exposure data for ongoing surveillance and targeted prevention initiatives. OBJECTIVES: To examine the feasibility of collecting occupational exposure information within a primary care clinical setting. METHODS: Five healthcare centres were recruited. Working patients answered basic occupational exposure questions. Clinicians reviewed the answers with patients. Answers were entered into the patient’s electronic medical records (EMRs). A knowledge broker supported the health centres throughout the trial with background information and linking to occupational expertise. Interviews with administrators and clinicians examined the usefulness of the survey to primary care, the barriers and facilitators, and sought suggestions for sustaining the practice. A cross-case analysis, framed by a conceptual model, was conducted from the feedback. RESULTS: Themes highlighted the importance of clinician and administrator buy-in, the perceived relevance of occupational exposures to primary care clinicians and the patient population, and the need for clinicians to feel confident about the health impact and relevance of occupational exposures to presenting clinical problems. CONCLUSION: Clinicians ask work exposure-related questions when patients have a health concern that the clinicians suspect may be related to a work exposure. No clear clinical purpose for routinely asking exposure questions emerged. [ABSTRACT FROM AUTHOR]

Barriers to accessing oral healthcare are public health concerns faced by minorities and immigrants due to socioeconomic marginalization. Therefore, we explored how immigrant parents in Alberta-Edmonton’s Filipino community experience adherence to preventive dental attendance (PDA) for their preschool children and the psychosocial factors influencing parental adherence. Methods: We employed a qualitative focused ethnography design. Data were collected through interviews and focus groups. Audiotapes of sessions were transcribed verbatim and concurrent thematic data analysis was performed. Results: Stressors, resources, paradox and structural barriers comprised emergent psychosocial themes. Upon arriving in Canada, most Filipino parents held low-priority attitudes and perceptions toward PDA. After migration, however, they embraced new knowledge about the importance of PDA for their children. Discussion: Filipino parents were open to the Western model of preventive oral healthcare, with the duration of their time in Canada playing a key role in promoting regular dental visits for their children. [ABSTRACT FROM AUTHOR]

Background: Preparation of a patient's skin by application of an antiseptic solution is performed prior to hand surgery as a standard procedure; this study surveyed current practice and examined conversion to a new technique. Methods: Part 1: an electronic survey was sent to members of the Canadian Society of Plastic Surgeons; Part 2: the current standard technique of nurse-applied antiseptic solution (Povidone 10% w/v (Lernapharm Inc, Saint-Laurent, QC, Canada); Part 3: patients applied their own antiseptic solution (Avagard™ CHG - (Chlorhexidine Gluconate 1% Solution and Ethyl Alcohol 61%, w/w) 3M London, ON, Canada) under nursing supervision; time to complete, cost estimates, and infection rates were compared. Study participants for parts 2 and 3 included a consecutive sample of patients presenting for hand surgery. Results: 32% of Canadian Plastic Surgeons responded to the survey. 81% did not require patients to wash their hands; 82% indicated that the surgeon applied the prep solution; 78% utilized alcohol/chlorhexidine; 82% used a prep kit; no respondents used a technique of patient-applied solution. In the clinical study, 21 patients underwent the standard technique, 24 patients utilized the patient-applied technique. The standard technique averaged 131 seconds, the modified technique 47 seconds, significantly quicker (p<0.0001). No surgical site infections occurred in either group. Conclusions: Changing technique resulted in a significant time savings, allowing for 1 additional procedure to be performed in an average clinic day. Processing and waste from use of the prep kits was eliminated, institutional costs were marginally decreased, and the rate of surgical site infections was not altered. [ABSTRACT FROM AUTHOR]

Purpose:Investigate health care providers’ perceptions of referral and admission criteria to brain injury inpatient rehabilitation in two Canadian provinces. Methods:Health care providers (n = 345) from brain injury programs (13 acute care and 16 rehabilitation facilities) participated in a cross-sectional web-based survey. The participants rated the likelihood of patients (traumatic brain injury and cerebral hypoxia) to be referred/admitted to rehabilitation and the influence of 19 additional factors (e.g., tracheostomy). The participants reported the perceived usefulness of referral/admission policies and assessment tools used. Results:Ninety-one percent acute care and 98% rehabilitation participants reported the person with traumatic brain injury would likely or very likely be referred/admitted to rehabilitation compared to respectively 43% and 53% for the patient with hypoxia. Two additional factors significantly decreased the likelihood of referral/admission: older age and the combined presence of minimal learning ability, memory impairment and physical aggression. Some significant inter-provincial variations in the perceived referral/admission procedure were observed. Most participants reported policies were helpful. Similar assessment tools were used in acute care and rehabilitation. Conclusions:Health care providers appear to consider various factors when making decisions regarding referral and admission to rehabilitation. Variations in the perceived likelihood of referral/admission suggest a need for standardized referral/admission practices.Implications for RehabilitationVarious patient characteristics influence clinicians’ decisions when selecting appropriate candidates for inpatient rehabilitation.In this study, acute care clinicians were less likely to refer patients that their rehabilitation counter parts would likely have admitted and a patient with hypoxic brain injury was less likely to be referred or admitted in rehabilitation than a patient with a traumatic brain injury.Such discrepancies suggest that policy-makers, managers and clinicians should work together to develop and implement more standardized referral practices and more specific admission criteria in order to ensure equitable access to brain injury rehabilitation services. [ABSTRACT FROM PUBLISHER]

Background: The objectives of this study were to describe the impact of trial enrollment at diagnosis on event-free and overall survival in paediatric acute lymphoblastic leukaemic (ALL) using a population-based approach.Methods: We conducted a retrospective cohort study that included children newly diagnosed with ALL between 1 and 14 years of age. The data source was the Cancer in Young People in Canada (CYP-C) national paediatric cancer population-based database. We conducted univariate and multiple Cox proportional hazards models.Results: There were 2569 children with ALL; 1408 (54.8%) were enrolled on a clinical trial at initial diagnosis. Event-free survival at 5 years was 89.8%±0.9 vs 84.1%±1.2. (P<0.0001) for those enrolled and not enrolled on a clinical trial, respectively. Overall survival at 5 years was higher for those enrolled (94.1%±0.7) vs not enrolled (90.5%±1.0; P=0.001). In a model that adjusted for demographic, leukaemic and socioeconomic factors, enrollment on trials was significantly associated with better event-free survival (hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.47-0.95; P=0.023), but not overall survival (HR 0.69, 95% CI 0.44-1.08; P=0.102).Conclusions: Event-free survival was significantly better in children with ALL enrolled on a clinical trial. Future research should identify barriers to clinical trial enrollment for children with ALL. [ABSTRACT FROM AUTHOR]