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Rationale & Objective: A history of prior abdominal procedures may influence the likelihood of referral for peritoneal dialysis (PD) catheter insertion. To guide clinical decision making in this population, this study examined the association between prior abdominal procedures and outcomes in patients undergoing PD catheter insertion., Study Design: Retrospective cohort study., Setting & Participants: Adults undergoing their first PD catheter insertion between November 1, 2011, and November 1, 2020, at 11 institutions in Canada and the United States participating in the International Society for Peritoneal Dialysis North American Catheter Registry., Exposure: Prior abdominal procedure(s) defined as any procedure that enters the peritoneal cavity., Outcomes: The primary outcome was time to the first of (1) abandonment of the PD catheter or (2) interruption/termination of PD. Secondary outcomes were rates of emergency room visits, hospitalizations, and procedures., Analytical Approach: Cumulative incidence curves were used to describe the risk over time, and an adjusted Cox proportional hazards model was used to estimate the association between the exposure and primary outcome. Models for count data were used to estimate the associations between the exposure and secondary outcomes., Results: Of 855 patients who met the inclusion criteria, 31% had a history of a prior abdominal procedure and 20% experienced at least 1 PD catheter-related complication that led to the primary outcome. Prior abdominal procedures were not associated with an increased risk of the primary outcome (adjusted HR, 1.12; 95% CI, 0.68-1.84). Upper-abdominal procedures were associated with a higher adjusted hazard of the primary outcome, but there was no dose-response relationship concerning the number of procedures. There was no association between prior abdominal procedures and other secondary outcomes., Limitations: Observational study and cohort limited to a sample of patients believed to be potential candidates for PD catheter insertion., Conclusion: A history of prior abdominal procedure(s) does not appear to influence catheter outcomes following PD catheter insertion. Such a history should not be a contraindication to PD., Plain-Language Summary: Peritoneal dialysis (PD) is a life-saving therapy for individuals with kidney failure that can be done at home. PD requires the placement of a tube, or catheter, into the abdomen to allow the exchange of dialysis fluid during treatment. There is concern that individuals who have undergone prior abdominal procedures and are referred for a catheter might have scarring that could affect catheter function. In some institutions, they might not even be offered PD therapy as an option. In this study, we found that a history of prior abdominal procedures did not increase the risk of PD catheter complications and should not dissuade patients from choosing PD or providers from recommending it., (Copyright © 2024 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Cabozantinib, an oral multi-targeted tyrosine kinase inhibitor (TKI), has demonstrated efficacy in metastatic renal cell carcinoma (mRCC). The association between toxicity and therapeutic effectiveness has been established with other TKIs. We investigated whether cabozantinib dose reductions, a surrogate for toxicity and adequate drug exposure, were associated with improved clinical outcomes in mRCC., Methods: Employing the CKCis database, we analyzed patients treated with cabozantinib in the second line or later between 2011 to 2021. The cohort was stratified into those needing dose reductions (DR) during treatment and those not (no-DR). Outcomes, including objective response rate (ORR), time to treatment failure (TTF), and overall survival (OS), were compared based on dose reduction status. The influence of the initial dose on outcomes was also explored., Results: Among 319 cabozantinib-treated patients, 48.3% underwent dose reductions. Response rates exhibited no significant difference between the DR and no-DR groups (15.1% vs. 18.2%, P = .55). Patients with DR had superior median OS (26.15 vs. 15.47 months, P = .019) and TTF (12.74 vs. 6.44 months, P = .022) compared to no-DR patients. These differences retained significance following adjustment for IMDC risk group (OS HR = 0.67, P = .032; TTF HR = 0.65, P = .008). There was no association between the initial dose and ORR, OS, or TTF., Conclusion: This study highlights the link between cabozantinib dose reductions due to toxicity and improved survival and time to treatment failure in mRCC patients. These findings underscore the potential of using on-treatment toxicity as an indicator of adequate drug exposure to individualize dosing and optimize treatment effectiveness. Larger studies are warranted to validate these results and develop individualized strategies for cabozantinib when given alone or in combination with immunotherapy., Competing Interests: Disclosure The authors have stated that they have no conflicts of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: It is important to understand cancer survivors' perceptions about their treatment decisions and quality of life. Methods: We performed a prospective observational cohort study of Canadian patients with small (<2 cm) low-risk papillary thyroid cancer (PTC) who were offered the choice of active surveillance (AS) or surgery (Clinicaltrials.gov NCT03271892). Participants completed a questionnaire one year after their treatment decision. The primary intention-to-treat analysis compared the mean decision regret scale total score between patients who chose AS or surgery. A secondary analysis examined one-year decision regret score according to treatment status. Secondary outcomes included quality of life, mood, fear of disease progression, and body image perception. We adjusted for age, sex, and follow-up duration in linear regression analyses. Results: The overall questionnaire response rate was 95.5% (191/200). The initial treatment choices of respondents were AS 79.1% (151/191) and surgery 20.9% (40/191). The mean age was 53 years (standard deviation [SD] 15 years) and 77% (147/191) were females. In the AS group, 7.3% (11/151) of patients crossed over to definitive treatment (two for disease progression) before the time of questionnaire completion. The mean level of decision regret did not differ significantly between patients who chose AS (mean 22.4, SD 13.9) or surgery (mean 20.9, SD 12.2) in crude ( p  = 0.730) or adjusted ( p  = 0.29) analyses. However, the adjusted level of decision regret was significantly higher in patients who initially chose AS and crossed over to surgery (beta coefficient 10.1 [confidence interval; CI 1.3-18.9], p  = 0.02), compared with those remaining under AS. In secondary adjusted analyses, respondents who chose surgery reported that symptoms related to their cancer or its treatment interfered with life to a greater extent than those who chose AS ( p  = 0.02), but there were no significant group differences in the levels of depression, anxiety, fear of disease progression, or overall body image perception. Conclusions: In this study of patients with small, low-risk PTC, the mean level of decision regret pertaining to the initial disease management choice was relatively low after one year and it did not differ significantly for respondents who chose AS or surgery.

Introduction: Frail older adults make up a substantial portion of the older adult population. However, frail patients are often excluded from randomized controlled trials. This underrepresentation restricts the extent to which trial findings can be generalized to this population. We compared a sample from the Canadian 5C Randomized Controlled Trial investigating comprehensive geriatric assessment (CGA) in the geriatric oncology setting in terms of frailty to patients referred to the Older Adults with Cancer Clinic (OACC) to determine if the trial sample was representative of the normal geriatric oncology practice., Materials and Methods: Baseline CGA data of 5C Trial participants seen at the Princess Margaret Cancer Centre (PM), were compared to data from OACC patients that were seen during the duration of the 5C trial (between April 2018 and April 2020) and that satisfied the 5C inclusion criteria. To assess the frailty of samples, sex, age, disease site, comorbidity level, medical optimization, social supports, functional status, falls risk, nutrition, cognition, and mood were compared between 5C participants and OACC patients using Fisher's exact and independent samples t-test., Results: A sample of 115 5C participants and 205 OACC patients were included. The mean age of 5C participants and OACC patients was 75.4 and 81.6 years, respectively (p < 0.001). The distribution of disease sites was significantly different between the samples (p < 0.001) and OACC patients were also significantly more impaired compared to 5C participants in comorbidity (23.4% versus 10.4% high comorbidity) (p = 0.001), IADL dependence (55.1% versus 42.6%) (p = 0.036), impaired physical function (70.6% versus 31.3%) (p < 0.001), falls risk (67.8% versus 27%) (p < 0.001), impaired nutrition (55.6% versus 40.9%) (p = 0.014), and cognition (47.2% versus 10%) (p < 0.001). There were no differences in sex, medication optimization, poor social supports, and impaired mood between the samples., Discussion: The 5C sample was less frail and younger than patients seen in the geriatric oncology clinic. Finding strategies to address barriers to the inclusion of frailer older adults is important to increase their representation in future trials to allow findings to be generalized to this vulnerable population., Trial Registration: Clinicaltrials.gov # NCT03154671., Competing Interests: Declaration of competing interest There was no conflict of interest. Funding The 5C study is funded by the Canadian Cancer Society (grant #705046). Dr. Puts is supported with a Canada Research Chair in the Care of Frail Older Adults., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Myasthenia Gravis (MG) is an acquired autoimmune condition commonly diagnosed in young people of reproductive age resulting in neuromuscular junction dysfunction. The course of MG during pregnancy and its impact on maternal and neonatal outcomes is vary in the literature. Pregnancy planning is a known strategy and modifiable risk factor in obstetric practice to decrease maternal and neonatal morbidity. We aim to assess if planning a pregnancy impacts maternal and neonatal outcomes, MG exacerbation, and pregnancy-related complications., Methods: This study utilized data from an online, North American survey entitled "A Patient Centered study on Pregnancy in People with Myasthenia Gravis", distributed with the assistance of MG advocacy groups in the United States and Canada. It included individuals with MG who had at least one pregnancy in the last 10-years. Key maternal and neonatal outcomes were compared between planned and unplanned pregnancies., Results: Out of 156 survey participants, 58 had a pregnancy following MG diagnosis, totaling 90 reported pregnancies. Of these, 56 (62.2%) were planned and 34 (37.8%) were unplanned pregnancies. The unplanned pregnancies were associated with more MG exacerbations, hospitalizations, and intensive care unit admission (37.7% vs. 13.7%, 26.5% vs. 11%, and 17.6% vs. 8.9%, respectively, p ≤ .05). The neonatal outcomes did not significantly differ between the groups., Discussion: Planned pregnancies in people with MG may be associated with a reduced gestational and post-partum risk of MG exacerbation, hospitalizations, and ICU admissions. Larger studies are required to confirm this association and account for potential contributing variables., (© 2023 The Authors. Muscle & Nerve published by Wiley Periodicals LLC.)

Introduction: Current guidelines for defining good outcomes in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) are predominately defined by experts. At present, we do not have a patient-anchored definition of what constitutes a "good" outcome. Our study aimed to assess the symptom burden of people living with CIDP, as well as satisfaction with treatments and clinical outcomes., Methods: We conducted an online-survey in CIDP patients registered with the US and Canadian GBS/CIDP foundations. Respondents answered general demographic and clinical questions, as well as satisfaction with current symptom burden and treatments, plus validated outcome measures., Results: A total of 318 individuals with self-reported CIDP completed the online survey, of whom 128 (40%) considered their current disease burden as satisfactory while 190 (60%) did not. Of 305 patients who answered the treatment satisfaction question, 222(74%) were satisfied with their treatments. Patients who were satisfied with their current symptoms had, on average, better scores in quality of life and disease severity scales, although regression modeling showed that only ability to walk, stable symptoms, and health utility scores were associated with symptom satisfaction. Treatment satisfaction was associated with stable symptoms, use of IVIG, and use of one versus no medication., Conclusions: A high proportion of members of the US and Canadian GBS/CIDP Foundations reporting a diagnosis of CIDP were unsatisfied with current symptoms, despite a high level of overall satisfaction with treatments. There is an unmet need for improving long-term outcomes in people with a diagnosis of CIDP, and for studying patient-centered long-term treatment goals., (© 2023. The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature.)

Introduction: Geriatric assessment and management (GAM) is recommended by professional organizations and recently several randomized controlled trials (RCTs) demonstrated benefits in multiple health outcomes. GAM typically leads to one or more recommendations for the older adult on how to optimize their health. However, little is known about how well recommendations are adhered to. Understanding these issues is vital to designing GAM trials and clinical programs. Therefore, the aim of this study was to examine the number of GAM recommendations made and adherence to and satisfaction with the intervention in a multicentre RCT of GAM for older adults with cancer., Materials and Methods: The 5C study was a two-group parallel RCT conducted in eight hospitals across Canada. Each centre kept a detailed recruitment and retention log. The intervention teams documented adherence to their recommendations. Medical records were also reviewed to assess which recommendations were adhered to. Twenty-three semi-structured interviews were conducted with 12 members of the intervention teams and 11 oncology team members to assess implementation of the study and the intervention., Results: Of the 350 participants who were enrolled, 173 were randomized to the intervention arm. Median number of recommendations was seven. Mean adherence to recommendations based on the GAM was 69%, but it varied by type of recommendation, ranging from 98% for laboratory tests to 28% for psychosocial/psychiatry oncology referrals. There was no difference in the number of recommendations or non-adherence to recommendations by sex, level of frailty, or functional status. Oncologists and intervention team members were satisfied with the study implementation and intervention delivery., Discussion: Adherence to recommendations was variable. Adherence to laboratory investigations and further imaging were generally high but much lower for recommendations regarding psychosocial support. Further collaborative work with older adults with cancer is needed to understand how to optimize the intervention to be consistent with patient goals, priorities, and values to ensure maximal impact on health outcomes., Competing Interests: Declaration of Competing Interest Dr. Tina Hsu received financial support from Pfizer, Mylan and Knight Therapeutics for advisory board not related to this study. Dr. Eitan Amir received financial support from Novartis not related to this study. Dr. Emmenegger reports personal fees from Amgen, grants and personal fees from Astellas, grants and personal fees from AstraZeneca, grants and personal fees from Bayer, grants from Clovis, personal fees from Ferring, grants and personal fees from Janssen, personal fees from Knight, grants and personal fees from Merck, grants and personal fees from Novartis, personal fees from Pfizer, grants from Roche Genentech, outside the submitted work., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objective: To identify factors associated with work-related issues in Canadian patients with axial spondyloarthritis., Methods: Data from 542 Canadian patients who participated in the International Map of Axial Spondyloarthritis online survey were analyzed. Participants who were employed, unemployed, or on short-term disability were included in this analysis. Regression analysis was used to study the association between work-related issues, disease activity (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]), and psychological distress (12-item General Health Questionnaire [GHQ-12])., Results: The mean age of surveyed participants was 44.3 (SD 13.9) years, 81% were university educated, and 52.6% employed. A substantial proportion had high disease activity (BASDAI ≥ 4, 72.1%) and psychological distress (GHQ-12 ≥ 3, 53.1%); 81% had work-related issues. This study analyzed responses from a subset of participants who were either employed, unemployed, or on short-term disability (n = 339). Ninety percent of this subset reported at least 1 work-related issue in the year before questionnaire completion, with the most frequent being absenteeism (49.3%) and missing work for healthcare provider visits (42.5%). Factoring in disability benefits eliminated the association between work-related issues and disease activity for all variables except fatigue ( r = 0.217; P = 0.03) and discomfort ( r = 0.196; P = 0.047). Difficulty fulfilling working hours (β 2.342, 95% CI 1.413-3.272) and effect on professional advancement (β 1.426, 95% CI 0.355-2.497) were associated with psychological distress. In the presence of disability benefits, only the effect on professional advancement remained (β 2.304, 95% CI 0.082-4.527)., Conclusion: Work-related issues are associated with worse patient-reported outcomes, both physical and psychological., (Copyright © 2023 by the Journal of Rheumatology.)

Introduction: The field of Continuing Professional Development (CPD) has a role to play in supporting health care professionals as they respond to the COVID-19 pandemic. However, the evolving science of COVID-19, the need for quick action, and the disruption of conventional knowledge networks pose challenges to existing CPD practices. To meet these emergent and rapidly evolving needs, what is required is an approach to CPD that draws insights from the domain of knowledge mobilization (KMb)., Methods: This short report describes a research protocol for exploring rapid KMb responses to COVID-19 at one Canadian academic teaching hospital. The proposed research will proceed as a case study using a mixed methods design collecting quantitative (surveys and Web site use metrics) and qualitative data (interviews) from individuals involved in developing, using, and supporting the KMb resources. Analysis will proceed in two phases: descriptive analysis of data to share insights and integrative analysis of data to build theory., Results: Results from this study will inform the immediate KMb and CPD contribution to the COVID-19 response., Discussion: Findings from this study will also make a broader contribution to the field of CPD, theoretically informing intersections between KMb and CPD and therefore contributing to an integrated science of CPD., Competing Interests: Disclosures: The authors declare no conflict of interest., (Copyright © 2021 The Alliance for Continuing Education in the Health Professions, the Association for Hospital Medical Education, and the Society for Academic Continuing Medical Education.)

Objective: Cancer patients may turn to social media (SM) to cope with distress. We investigated associations between distress and internet/SM use for cancer information/support., Methods: Adult patients at a Canadian cancer centre completed a cross-sectional survey on sociodemographics, health status, use of cancer online resources and distress (EQ5D-5L). Statistical models adjusted for relevant variables., Results: Of 376 participants, median age was 52 years, time since diagnosis was 1.63 years, 272 (74%) had post-secondary education and 192 (51%) were female. For cancer information/support, 276 (73%) used internet and 147 (39%) SM. Dose response relationships were observed between distress and cancer-related internet (p = 0.02), and SM use (p < 0.001). Respondents using internet/SM for cancer information/support reported greater internet confidence (internet OR = 4.0, 95% CI: 1.9-8.3; SM OR = 4.18, 95%, CI: 1.9-11.3), higher education (internet OR = 3.0, 95% CI: 1.7-5.2; SM OR = 2.21, 95% CI: 1.2-4.1) and were more likely female (internet OR = 2.6, 95% CI 1.5-4.6; SM OR = 2.1, 95% CI: 1.3-3.4). For SM for cancer information/support, more used SM > 30 min daily (OR = 3.4; 95% CI: 2.1-5.7), and were distressed (OR = 1.67, 95% CI: 1.0-2.7). SM benefits were to learn about cancer (93; 25%), distract from cancer (85; 23%) and connect with survivors (81; 22%). SM limitations were privacy (161; 43%), quality (90; 24%) and personal applicability (85; 23%). Females used SM more to connect with survivors than males (p = 0.001)., Conclusions: Greater internet confidence, higher education and being female were associated with cancer-related internet/SM use. Distressed cancer patients were also more likely to turn to SM. Privacy concerns may limit SM use for coping. Future research should determine how to optimize SM in caring for and connecting with patients and reduce cancer-related distress., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature.)

Purpose: Health care priorities of individuals may change during a pandemic, which may, in turn, affect health services utilization. We examined Canadians' online relative search interest in five common solid tumors (breast, colon, lung, prostate, and thyroid) during the COVID-19 pandemic to that observed in the same months in the prior 5 years., Methods: We conducted a cross-sectional retrospective study using Google Trends aggregate anonymous online search data from Canada. We compared the respective relative search volumes for breast, colon, lung, prostate, and thyroid cancers for the months March-November 2020 with the mean for the same months in 2015-2019. Welch's two-sample t tests were performed and the raw P values were then adjusted using Benjamini-Hochberg procedure to correct for multiple comparisons. The level of statistical significance was defined by choosing false discovery rate at .05 for the primary analysis., Results: We observed temporary statistically significant reductions in Canadians' relative search volumes for various cancers, largely early in the pandemic, in the spring of 2020. Specifically, significant reductions (after adjustment for multiple comparisons) were observed for breast cancer in April, May, and October 2020; colon cancer in March and April of 2020; lung cancer in April and September 2020; and prostate cancer in April and May 2020. Thyroid cancer relative search volumes were not significantly different from those observed prior to the pandemic., Conclusion: Although Canadians' online interest in various cancers temporarily waned early in the COVID-19 pandemic, recent relative search volumes for various cancers are largely not significantly different from prior to the pandemic., Competing Interests: Patrick BrownStock and Other Ownership Interests: SPDR Dow Jones Industrial Average ETF Trust, iShares US Medical Devices ETFNo other potential conflicts of interest were reported.

Objective: To describe the development of structure, process, and outcome indicators aimed to advance the quality of Reaching, Grasping & Manipulation (RG&M) rehabilitation for Canadians living with spinal cord injury or disease (SCI / D)., Method: Upper extremity rehabilitation experts developed a framework of indicators for evaluation of RG&M rehabilitation quality. A systematic search of the literature identified potential upper extremity indicators that influence RG&M outcomes. A Driver diagram summarized factors influencing upper extremity outcomes to inform the selection of structure and process indicators. Psychometric properties, clinical utility, and feasibility of potential upper extremity measures were considered when selecting outcome indicators., Results: The selected structure indicator is the number of occupational and physical therapists with specialized certification, education, training and/or work experience in upper extremity therapy related to RG&M at a given SCI/D rehabilitation center. The process indicator is the total hours of upper extremity therapies related to RG&M and the proportion of this time allocated to neurorestorative therapy for each individual with tetraplegia receiving therapy. The outcome indicators are the Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) strength and Spinal Cord Independence Measure III (SCIM III) Self-Care subscores implemented at rehabilitation admission and discharge, and SCIM III Self-Care subscore only at 18 months post-admission., Conclusion: The selected indicators align with current practice, will direct the timing of routine assessments, and enhance the volume and quality of RG&M therapy delivered, with the aim to ultimately increase the proportion of individuals with tetraplegia achieving improved upper extremity function by 18 months post-rehabilitation.

Background: Proton pump inhibitors (PPIs) are commonly prescribed medications that have been shown to have contradicting effects on cancer. We aimed to investigate the effect of pantoprazole and other PPIs on prostate cancer (PCa) specific mortality (PCSM), use of androgen deprivation therapy (ADT), and PCa diagnosis using a large Canadian population-based cohort., Methods: We identified 21,512 men aged ≥ 66, with a history of a single negative prostate biopsy and no previous use of any of the analyzed medications between 1994 and 2016. Multivariable Cox regression models with time-dependent covariates were used to assess the associations of PPIs with PCa outcomes. All models included other medications with a putative chemopreventative effect on PCa-outcomes, and were adjusted for age, rurality, comorbidity, and study inclusion year., Results: Over a mean follow-up of 8.06 years (SD 5.44 years), 10,999 patients (51.1%) used a PPI, 5187 patients (24.1%) had PCa, 2043 patients (9.5%) were treated with ADT, and 805 patients (3.7%) died from PCa. For every 6 months of cumulative use, pantoprazole was associated with a 3.0% (95% CI 0.3-6.0%) increased rate of ADT use, while any use of other PPIs was associated with a 39.0% (95% CI 18.0-64.0%) increased risk of PCSM. No association was found with PCa diagnosis., Conclusions: Upon validation of the potentially negative association of PPIs with PCa, PPI use may need to be reassessed in PCa patients.

Objective: A growing interest in functional neurological disorders (FND) has led to the development of specialized clinics. This study aimed to better understand the structure and role of such clinics., Methods: Data were retrospectively collected from clinical records at three national referral centers, two specifically for motor FND and one for FND in general. Data were for 492 consecutive patients referred over a 9- to 15-month period: 100 from the United Kingdom clinic, 302 from the Swiss clinic, and 90 from the Canadian clinic. Data included symptom subtype and duration, comorbid pain and fatigue, disability, and treatment recommendations., Results: The mean age of the 492 patients was 44 years, and most (73%) were female. Most had a prolonged motor FND (mean symptom duration of 6 years); 35% were not working because of ill health, 26% received disability benefits, and up to 38% required a care giver for personal care. In the Swiss cohort, 39% were given a diagnosis of another somatic symptom disorder rather than an FND diagnosis. Pain was common in the United Kingdom (79%) and Canada (56%), as was fatigue (48% and 47%, respectively). Most patients (61%) were offered physiotherapy; referral to neuropsychiatry or psychology differed across centers (32%-100%)., Conclusions: FND specialty clinics have an important role in ensuring correct diagnosis and appropriate treatment. Most patients with motor FND require specialized neurophysiotherapy. Patients readily accepted an integrated neuropsychiatric approach. Close collaboration between FND clinics and acute neurology facilities might improve early detection of FND and could improve outcomes.

Background: SGLT2 inhibition decreases albuminuria and reduces the risk of kidney disease progression in patients with type 2 diabetes. These benefits are unlikely to be mediated by improvements in glycaemic control alone. Therefore, we aimed to examine the kidney effects of the SGLT2 inhibitor dapagliflozin in patients with proteinuric kidney disease without diabetes., Methods: DIAMOND was a randomised, double-blind, placebo-controlled crossover trial done at six hospitals in Canada, Malaysia, and the Netherlands. Eligible participants were adult patients (aged 18-75 years) with chronic kidney disease, without a diagnosis of diabetes, with a 24-h urinary protein excretion greater than 500 mg and less than or equal to 3500 mg and an estimated glomerular filtration rate (eGFR) of at least 25 mL/min per 1·73 m 2 , and who were on stable renin-angiotensin system blockade. Participants were randomly assigned (1:1) to receive placebo and then dapagliflozin 10 mg per day or vice versa. Each treatment period lasted 6 weeks with a 6-week washout period in between. Participants, investigators, and study personnel were masked to assignment throughout the trial and analysis. The primary outcome was percentage change from baseline in 24-h proteinuria during dapagliflozin treatment relative to placebo. Secondary outcomes were changes in measured GFR (mGFR; via iohexol clearance), bodyweight, blood pressure, and concentrations of neurohormonal biomarkers. Analyses were done in accordance with the intention-to-treat principle. This study is registered with ClinicalTrials.gov, NCT03190694., Findings: Between Nov 22, 2017, and April 5, 2019, 58 patients were screened, of whom 53 (mean age 51 years [SD 13]; 32% women) were randomly assigned (27 received dapagliflozin then placebo and 26 received placebo then dapagliflozin). One patient discontinued during the first treatment period. All patients were included in the analysis. Mean baseline mGFR was 58·3 mL/min per 1·73 m 2 (SD 23), median proteinuria was 1110 mg per 24 h (IQR 730-1560), and mean HbA 1c was 5·6% (SD 0·4). The difference in mean proteinuria change from baseline between dapagliflozin and placebo was 0·9% (95% CI -16·6 to 22·1; p=0·93). Compared with placebo, mGFR was changed with dapagliflozin treatment by -6·6 mL/min per 1·73 m 2 (-9·0 to -4·2; p<0·0001) at week 6. This reduction was fully reversible within 6 weeks after dapagliflozin discontinuation. Compared with placebo, bodyweight was reduced by 1·5 kg (0·03-3·0; p=0·046) with dapagliflozin; changes in systolic and diastolic blood pressure and concentrations of neurohormonal biomarkers did not differ significantly between dapagliflozin and placebo treatment. The numbers of patients who had one or more adverse events during dapagliflozin treatment (17 [32%] of 53) and during placebo treatment (13 [25%] of 52) were similar. No hypoglycaemic events were reported and no deaths occurred., Interpretation: 6-week treatment with dapagliflozin did not affect proteinuria in patients with chronic kidney disease without diabetes, but did induce an acute and reversible decline in mGFR and a reduction in bodyweight. Long-term clinical trials are underway to determine whether SGLT2 inhibitors can safely reduce the rate of major clinical kidney outcomes in patients with chronic kidney disease with and without diabetes., Funding: AstraZeneca., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: To date, little research has examined the quality of life and cancer-associated needs of bladder cancer patients. The objective of the current study was to assess the quality of life (QoL), informational needs, and supportive care needs (SCN) in a large sample of muscle invasive (MIBC) and non-muscle invasive (NMIBC) bladder cancer survivors across the treatment trajectory (newly diagnosed and undergoing treatment, post-treatment follow-up, and treatment for advanced/recurrent disease)., Methods: Questionnaires were distributed to a convenience sample of patients registered with Bladder Cancer Canada, the Princess Margaret Cancer Centre, or The Ottawa Hospital. Eligibility criteria included being > 18 years of age, English-speaking, and diagnosed with bladder cancer. The questionnaire included an adapted tool to measure informational needs, and validated measures for QoL (Bladder Utility Symptom Scale, BUSS) and SCN (Cancer Survivors' Unmet Needs Measure, CaSUN). QoL scores and unmet needs were calculated and compared between disease groups and cancer trajectory groups., Results and Limitations: Of the 1126 surveys distributed, 586 were completed (response = 52%). Mean age was 67.3 ± 10.2 years, and 401 participants (68.7%) were male. The mean QoL score (BUSS) for the sample was 78.1 ± 17.9 (median 81.7). Respondents with MIBC had significantly lower QoL scores compared to NMIBC. Further, scores differed across the cancer phase groups with the follow-up surveillance group having significantly higher QoL scores compared to the newly diagnosed and advance/recurrent disease groups. The ten most highly ranked informational needs were from the medical, physical, and practical domains. Eighty-eight percent (95% CI 85-91%) of respondents reported at least one SCN, with a median of 12. Over half of the participants (54%, 95% CI 49-59%) had at least one unmet need and 15% had ≥ 10 unmet needs. Newly diagnosed participants had the highest number of unmet needs., Conclusion: We found that the number of unmet supportive care needs and quality of life differed across cancer trajectory and disease groups. Future efforts should focus on the development and evaluation of tailored resources and programs to address the needs of people diagnosed and treated for BC.

Introduction: Geriatric assessment and management is recommended for older adults with cancer referred for chemotherapy but no randomised controlled trial has been completed of this intervention in the oncology setting., Trial Design: A two-group parallel single blind multi-centre randomised trial with a companion trial-based economic evaluation from both payer and societal perspectives with process evaluation., Participants: A total of 350 participants aged 70+, diagnosed with a solid tumour, lymphoma or myeloma, referred for first/second line chemotherapy, who speak English/French, have an Eastern Collaborative Oncology Group Performance Status 0-2 will be recruited. All participants will be followed for 12 months., Intervention: Geriatric assessment and management for 6 months. The control group will receive usual oncologic care. All participants will receive a monthly healthy ageing booklet for 6 months., Objective: To study the clinical and cost-effectiveness of geriatric assessment and management in optimising outcomes compared with usual oncology care., Randomisation: Participants will be allocated to one of the two arms in a 1:1 ratio. The randomisation will be stratified by centre and treatment intent (palliative vs other)., Outcome: Quality of life., Secondary Outcomes: (1) Cost-effectiveness, (2) functional status, (3) number of geriatric issues successfully addressed, (4) grades3-5 treatment toxicity, (5) healthcare use, (6) satisfaction, (7) cancer treatment plan modification and (8) overall survival., Planned Analysis: For the primary outcome we will use a pattern mixture model using an intent-to-treat approach (at 3, 6 and12 months). We will conduct a cost-utility analysis alongside this clinical trial. For secondary outcomes 2-4, we will use a variety of methods., Ethics and Dissemination: Our study has been approved by all required REBs. We will disseminate our findings to stakeholders locally, nationally and internationally and by publishing the findings., Trial Registration Number: NCT03154671., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Self-efficacy is a known predictor of patient-reported outcomes in individuals with acquired diseases. With an overall objective of better understanding patient-reported outcomes in adults with congenital heart disease, this study aimed to: (i) assess self-efficacy in adults with congenital heart disease, (ii) explore potential demographic and medical correlates of self-efficacy and (iii) determine whether self-efficacy explains additional variance in patient-reported outcomes above and beyond known predictors., Methods: As part of a large cross-sectional international multi-site study (APPROACH-IS), we enrolled 454 adults (median age 32 years, range: 18-81) with congenital heart disease in two tertiary care centres in Canada and Switzerland. Self-efficacy was measured using the General Self-Efficacy (GSE) scale, which produces a total score ranging from 10 to 40. Variance in the following patient-reported outcomes was assessed: perceived health status, psychological functioning, health behaviours and quality of life. Hierarchical multivariable linear regression analysis was performed., Results: Patients' mean GSE score was 30.1 ± 3.3 (range: 10-40). Lower GSE was associated with female sex ( p = 0.025), not having a job ( p = 0.001) and poorer functional class ( p = 0.048). GSE positively predicted health status and quality of life, and negatively predicted symptoms of anxiety and depression, with an additional explained variance up to 13.6%. No associations between self-efficacy and health behaviours were found., Conclusions: GSE adds considerably to our understanding of patient-reported outcomes in adults with congenital heart disease. Given that self-efficacy is a modifiable psychosocial factor, it may be an important focus for interventions targeting congenital heart disease patients' well-being.

Purpose: Renal tumor biopsies have been proposed as a management alternative to avoid treatment of benign or low risk small renal masses. However, many urologists are reluctant to recommend renal tumor biopsy because they feel its result frequently will not impact management. Our primary objective was to evaluate if centers that routinely favor renal tumor biopsy have lower rates of benign histology after surgery than centers where a selective renal tumor biopsy approach is used., Materials and Methods: This was a retrospective multicenter study of patients who underwent partial or radical nephrectomy for a lesion suspicious for localized renal cell carcinoma which measured 4 cm or less (cT1a and pT1a or pT3a) between 2013 and 2015. A logistic regression model was used to examine whether the odds of obtaining a benign tumor following surgery differed between centers that routinely favor renal tumor biopsy and centers where a selective renal tumor biopsy approach is used., Results: A total of 542 small renal masses in 516 patients were included in study. The rate of histologically benign tumors after surgery was 11%. This rate was significantly lower at centers that routinely favor renal tumor biopsy than at centers where a selective renal tumor biopsy approach is used (5% vs 16%, p <0.001). On multivariable analysis older age, smaller tumors and centers where a selective renal tumor biopsy approach is used were significantly associated with greater odds of finding a histologically benign tumor postoperatively. Compared to centers that routinely favor renal tumor biopsy the odds of finding a benign tumor at surgery was 4 times more likely at centers where a selective renal tumor biopsy approach is used (OR 4.1, 95% CI 1.9-8.3)., Conclusions: Routine renal tumor biopsy reduces surgery for benign tumors and the potential for short-term and long-term morbidity associated with these procedures. This study suggests that routine renal tumor biopsy may be a valuable tool to decrease overtreatment of small renal masses., (Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

With the increasing complexity of cancer treatment and the emergence of technologies that offer individualized therapy options for people being treated for the disease, cancer care professionals are facing greater demands for knowledge exchange and information input. The Canadian Partnership for Quality Radiotherapy was established in 2010 in response to such demands and has used both bottom-up and top-down approaches to successfully support improved program planning, treatment delivery, and patient care within the Canadian radiation treatment community. Focusing on shared priorities using this bilateral engagement is a lesson that can be applied broadly across the cancer system.

Background: Thyroid cancer has been rapidly rising in incidence in Canada; however, in contrast, lung cancer appears to be decreasing in incidence in Canadian men and stable in women. Moreover, disease-related mortality risk is generally very low in TC but high in LC. We performed a geographic spatial analysis in metropolitan Toronto, Canada to determine if there is regional variability of respective risks of thyroid cancer (TC) and lung cancer (LC), among women. Women were of particular interest for this study, given their known predilection for thyroid cancer., Methods: The postal codes of all females with TC or LC, residing in metropolitan Toronto from 2004 to 2008, were geocoded to point locations according to 2006 Canadian Census data. The data were analysed using a log-Gaussian Cox Process, where the intensity of age-adjusted cancer cases was modelled as a log-linear combination of the population at risk, explanatory variables (race, immigration, and median household income), and a residual spatially varying random effect. For each respective malignancy, statistical models were fit to make quantify the relationship between cancer incidence and explanatory variables., Results: We included 2230 women with TC and 2412 with LC. The distribution of TC and LC cases contrasted inversely among Toronto neighbourhoods with the highest TC incidence in the Northeast and the highest LC incidence in the Southeast. A higher proportion of Asian ethnicity was associated with higher regional risk of TC and lower risk of LC. A higher proportion of recent immigrants was associated with increased LC and lower TC risk, whereas median household income and proportions of African ethnicity were not significantly associated with risk of either cancer, after adjustment for other socio-demographic variables., Conclusions: We observed contrasting regional distributions of female TC and LC cases in Toronto. The differences were partly attributed to ethnic composition variability and the proportion of recent immigrants, but substantial unexplained residual variation of incidence patterns of these malignancies exists, suggesting that more individual-level research is needed to explain the regional variability of incidence of these malignancies.

Context: Little is known about cancer-related worry in thyroid cancer survivors., Objectives: We quantified cancer-related worry in Canadian thyroid cancer survivors and explored associated factors., Design, Setting, and Participants: We performed a cross-sectional, self-administered, written survey of thyroid cancer survivor members of the Thyroid Cancer Canada support group. Independent factors associated with cancer-related worry were identified using a multivariable linear regression analysis., Main Outcome Measure: We used the Assessment of Survivor Concerns (ASC) questionnaire, which includes questions on worry about diagnostic tests, second primary malignancy, recurrence, dying, health, and children's health., Results: The response rate for eligible members was 60.1% (941 of 1567). Most respondents were women (89.0%; 837 of 940), and the age was < 50 years in 54.0% of participants (508 of 941). Thyroid cancer was diagnosed within ≤ 5 years in 66.1% of participants (622 of 940). The mean overall ASC score was 15.34 (SD, 4.7) (on a scale from 6 [least worry] to 24 [most worry]). Factors associated with increased ASC score included: younger age (P < .001), current suspected or proven recurrent/persistent disease (ie, current proven active disease or abnormal diagnostic tests) (P < .001), partnered marital status (P = .021), having children (P = .029), and ≤5 years since thyroid cancer diagnosis (P = .017)., Conclusions: In a population of Canadian thyroid cancer survivors, cancer-related worry was greatest in younger survivors and those with either confirmed or suspected disease activity. Family status and time since thyroid cancer diagnosis were also associated with increased worry. More research is needed to confirm these findings and to develop effective preventative and supportive strategies for those at risk.

Rationale: Exacerbations of COPD are defined clinically by worsening of chronic respiratory symptoms. Chronic respiratory symptoms are common in the general population. There are no data on the frequency of exacerbation-like events in individuals without spirometric evidence of COPD., Aims: To determine the occurrence of 'exacerbation-like' events in individuals without airflow limitation, their associated risk factors, healthcare utilisation and social impacts., Method: We analysed the cross-sectional data from 5176 people aged 40 years and older who participated in a multisite, population-based study on lung health. The study cohort was stratified into spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and non-COPD (post bronchodilator FEV1/FVC ≥ 0.7 and without self-reported doctor diagnosis of airway diseases) subgroups and then into those with and without respiratory 'exacerbation-like' events in the past year., Results: Individuals without COPD had half the frequency of 'exacerbation-like' events compared with those with COPD. In the non-COPD group, the independent associations with 'exacerbations' included female gender, presence of wheezing, the use of respiratory medications and self-perceived poor health. In the non-COPD group, those with exacerbations were more likely than those without exacerbations to have poorer health-related quality of life (12-item Short-Form Health Survey), miss social activities (58.5% vs 18.8%), miss work for income (41.5% vs 17.3%) and miss housework (55.6% vs 16.5%), p<0.01 to <0.0001., Conclusions: Events similar to exacerbations of COPD can occur in individuals without COPD or asthma and are associated with significant health and socioeconomic outcomes. They increase the respiratory burden in the community and may contribute to the false-positive diagnosis of asthma or COPD., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: Violence associated with pregnancy is a major public health concern, but little is known about it in recent migrant women. This study looked at (1) risk factors for violence associated with pregnancy among newly arrived migrant women in Canada and (2) if those who experienced violence associated with pregnancy had a different health profile or use of healthcare services for themselves or their infants during pregnancy and up to 4 months postpartum compared to other childbearing migrant women., Methods: Pregnant migrant women in Canada <5 years were recruited in 12 hospitals in 3 large cities between 2006 and 2009 and followed to 4 months postpartum. Data were collected on maternal background, migration history, violence associated with pregnancy, maternal and infant physical and mental health, and services used., Results: Of a total of 774 pregnant migrant women, 59 (7.6%) women reported violence associated with pregnancy. Migrant women who experienced violence, compared to those who did not, were at increased risk of violence if they lived without a partner, were asylum seekers, migrated <2 years ago, or had less than high school education. Women who reported violence were less likely to have up-to-date vaccinations, take folic acid before pregnancy, more likely to commence prenatal care after 3 months gestation and to not use contraceptives after birth. They were also more likely to have a history of miscarriage and report more postpartum pain and increased bleeding. They were also more likely to have inadequate social support and report more depression, anxiety, somatization, and posttraumatic stress disorder (PTSD) on standardized tests. No differences were found in the health status of the infants of women who experienced violence compared to those who did not., Conclusions: Clinicians should sensitively ask recent migrant women (asylum seekers, refugees, and nonrefugee immigrants) about violence associated with pregnancy and appropriately assess, treat, and refer them.

A survey of Canadian biotech firms reveals that their biotech collaborations with developing countries are not only significant but also increasingly reciprocal in terms of the exchange of financial resources and technological know-how.

Brain death is defined as the complete and irreversible absence of all brain function. It is diagnosed by means of rigorous testing at the bedside. The advent of neurologic or brain death criteria to establish the death of a person was a significant departure from the traditional way of defining death and remains ethically challenging to some. We review the ethical, cultural, religious and legal issues surrounding brain death and outline an approach to establishing a diagnosis of brain death in clinical practice.