Negative Impact of COVID-19 Associated Health System Shutdown on Patients Diagnosed With Colorectal Cancer: A Retrospective Study From a Large Tertiary Center in Ontario, Canada.

Background: In March 2020, a directive to halt all elective and non-urgent procedures was issued in Ontario, Canada because of COVID-19. The directive caused a temporary slowdown of screening programs including surveillance colonoscopies for colorectal cancer (CRC). Our goal was to determine if there was a difference in patient and tumour characteristics between CRC patients treated surgically prior to the COVID-19 directive compared to CRC patients treated after the slowdown. Methods: CRC resections collected within the Champlain catchment area of eastern Ontario in the 6 months prior to COVID-19 (August 1, 2019-January 31, 2020) were compared to CRC resections collected in the 6 months post-COVID-19 slowdown (August 1, 2020-January 31, 2021). Clinical (e.g., gender, patient age, tumour site, and clinical presentation) and pathological (tumour size, tumour stage, nodal stage, and lymphovascular invasion) features were evaluated using chi-square tests, T-tests, and Mann-Whitney tests where appropriate. Results: Three hundred and thirty-eight CRC specimens were identified (173 pre-COVID-19, 165 post-COVID-19 slowdown). CRC patients treated surgically post-COVID-19 slowdown had larger tumours (44 mm vs. 35 mm; P = 0.0048) and were more likely to have presented emergently (24% vs. 10%; P < 0.001). Although there was a trend towards higher tumour stage, nodal stage, and clinical stage, these differences did not reach statistical significance. Other demographic and pathologic variables including patient gender, age, and tumour site were similar between the two cohorts. Interpretation: The COVID-19 slowdown resulted in a shift in the severity of disease experienced by CRC patients in Ontario. Pandemic planning in the future should consider the long-term consequences to cancer diagnosis and management.

Dietary supplements to reduce symptom severity and duration in people with SARS-CoV-2: study protocol for a randomised, double-blind, placebo controlled clinical trial.

INTRODUCTION: COVID-19 has caused morbidity, hospitalisations and deaths worldwide. Despite four approved vaccines for COVID-19 in Canada, there is still a need for effective treatments, especially for people in the community. Vaccine efficacy is not 100% and long-term efficacy is still unknown. Furthermore, there are challenges to herd immunity including vaccine hesitancy and underlying conditions preventing vaccination. We aim to explore if the nutrients vitamin C, vitamin D, vitamin K2 and zinc are an effective treatment option for outpatients diagnosed with COVID-19. The primary outcome is the difference in participant-reported overall health; secondary outcomes include the effect on health status, symptom severity and duration, frequency and length of hospitalisations and mortality. METHODS AND ANALYSIS: This study is a two-arm, parallel-group, double-blind, placebo-controlled, phase III randomised controlled trial. 200 patients will be recruited remotely from COVID-19 test centres in Ottawa, Canada associated with The Ottawa Hospital. Overall health will be measured using the EuroQol Visual Assessment Scale; health status will be measured using the EuroQol 5-dimension 5-level questionnaire; symptom severity and duration will be measured using an independently developed questionnaire; analyses will use an area under the curve approach and compare mean scores using unadjusted t tests. Study data will be recorded on electronic case report forms using the Research Electronic Data Capture platform. An independent data safety and monitoring board will perform ongoing review of the study for feasibility and safety. ETHICS AND DISSEMINATION: This study has received ethical approval from the research ethics boards of the Canadian College of Naturopathic Medicine and the Ottawa Health Sciences Network, as well as regulatory approval from the Therapeutic Products Directorate and Natural and Non-Prescription Health Products Directorate of Health Canada. Results will be published in a peer-reviewed scientific journal with open access. TRIAL REGISTRATION NUMBER: NCT04780061.

Assessing the Implementation and Effectiveness of the Electronic Patient-Reported Outcome Tool for Older Adults With Complex Care Needs: Mixed Methods Study.

BACKGROUND: Goal-oriented care is being adopted to deliver person-centered primary care to older adults with multimorbidity and complex care needs. Although this model holds promise, its implementation remains a challenge. Digital health solutions may enable processes to improve adoption; however, they require evaluation to determine feasibility and impact. OBJECTIVE: This study aims to evaluate the implementation and effectiveness of the electronic Patient-Reported Outcome (ePRO) mobile app and portal system, designed to enable goal-oriented care delivery in interprofessional primary care practices. The research questions driving this study are as follows: Does ePRO improve quality of life and self-management in older adults with complex needs? What mechanisms are likely driving observed outcomes? METHODS: A multimethod, pragmatic randomized controlled trial using a stepped-wedge design and ethnographic case studies was conducted over a 15-month period in 6 comprehensive primary care practices across Ontario with a target enrollment of 176 patients. The 6 practices were randomized into either early (3-month control period; 12-month intervention) or late (6-month control period; 9-month intervention) groups. The primary outcome measure of interest was the Assessment of Quality of Life-4D (AQoL-4D). Data were collected at baseline and at 3 monthly intervals for the duration of the trial. Ethnographic data included observations and interviews with patients and providers at the midpoint and end of the intervention. Outcome data were analyzed using linear models conducted at the individual level, accounting for cluster effects at the practice level, and ethnographic data were analyzed using qualitative description and framework analysis methods. RESULTS: Recruitment challenges resulted in fewer sites and participants than expected; of the 176 target, only 142 (80.6%) patients were identified as eligible to participate because of lower-than-expected provider participation and fewer-than-expected patients willing to participate or perceived as ready to engage in goal-setting. Of the 142 patients approached, 45 (32%) participated. Patients set a variety of goals related to self-management, mental health, social health, and overall well-being. Owing to underpowering, the impact of ePRO on quality of life could not be definitively assessed; however, the intervention group, ePRO plus usual care (mean 15.28, SD 18.60) demonstrated a nonsignificant decrease in quality of life (t24=-1.20; P=.24) when compared with usual care only (mean 21.76, SD 2.17). The ethnographic data reveal a complex implementation process in which the meaningfulness (or coherence) of the technology to individuals' lives and work acted as a key driver of adoption and tool appraisal. CONCLUSIONS: This trial experienced many unexpected and significant implementation challenges related to recruitment and engagement. Future studies could be improved through better alignment of the research methods and intervention to the complex and diverse clinical settings, dynamic goal-oriented care process, and readiness of provider and patient participants. TRIAL REGISTRATION: ClinicalTrials.gov NCT02917954; https://clinicaltrials.gov/ct2/show/NCT02917954.

Many trials of hydroxychloroquine for SARS-CoV-2 were redundant and potentially unethical: an analysis of the NIH clinical trials registry.

OBJECTIVE: We sought to map the landscape of trials investigating hydroxychloroquine (HCQ) for SARS-CoV-2 in order to draw conclusions about how clinical trials have been conducted in the pandemic environment and offer potential regulatory recommendations. STUDY DESIGN AND SETTING: We identified and captured data related to registered studies using HCQ to treat SARS-CoV-2 registered with the publicly available National Institutes of Health (NIH) Clinical Trials Registry between February and November 2020. RESULTS: Between February and November 2020, 206 studies investigating HCQ in SARS-CoV-2 were registered with the NIH Clinical Trials Registry. As of November 2020, 135 studies were listed as ongoing, 22 have been completed, and 46 are either suspended or have been terminated. Reasons for suspension or termination included difficulties with patient recruitment (n = 9), emerging evidence showing a lack of benefit of HCQ (n = 7), and recommendations by regulatory boards to discontinue (n = 10). CONCLUSION: Many clinical trials of HCQ were launched in the first months of the pandemic, and a significant proportion of them remained active as of November 2020. The medical community appears to have responded very quickly to political interest in HCQ, while responding much more slowly to the evolving medical evidence of its lack of efficacy.

Clinical Public Health - Published 44(2) June 2021.

In this issue, Bernard Choi and colleagues have presented their vision of clinical public health as an approach to address complex health issues in our health system. To help stimulate discussion, CIM invited commen-taries from two distinguished scientists to present their views on the concept. We hope this discussion will ultimately guide the direction public health will follow.

Physician preparedness for resource allocation decisions under pandemic conditions: A cross-sectional survey of Canadian physicians, April 2020.

BACKGROUND: Under the pandemic conditions created by the novel coronavirus of 2019 (COVID-19), physicians have faced difficult choices allocating scarce resources, including but not limited to critical care beds and ventilators. Past experiences with severe acute respiratory syndrome (SARS) and current reports suggest that making these decisions carries a heavy emotional toll for physicians around the world. We sought to explore Canadian physicians' preparedness and attitudes regarding resource allocation decisions. METHODS: From April 3 to April 13, 2020, we conducted an 8-question online survey of physicians practicing in the region of Ottawa, Ontario, Canada, organized around 4 themes: physician preparedness for resource rationing, physician preparedness to offer palliative care, attitudes towards resource allocation policy, and approaches to resource allocation decision-making. RESULTS: We collected 219 responses, of which 165 were used for analysis. The majority (78%) of respondents felt "somewhat" or "a little prepared" to make resource allocation decisions, and 13% felt "not at all prepared." A majority of respondents (63%) expected the provision of palliative care to be "very" or "somewhat difficult." Most respondents (83%) either strongly or somewhat agreed that there should be policy to guide resource allocation. Physicians overwhelmingly agreed on certain factors that would be important in resource allocation, including whether patients were likely to survive, and whether they had dementia and other significant comorbidities. Respondents generally did not feel confident that they would have the social support they needed at the time of making resource allocation decisions. INTERPRETATION: This rapidly implemented survey suggests that a sample of Canadian physicians feel underprepared to make resource allocation decisions, and desire both more emotional support and clear, transparent, evidence-based policy.

Transition to virtual appointments for interventional neuroradiology due to the COVID-19 pandemic: a survey of satisfaction.

BACKGROUND: The COVID-19 pandemic has changed the way medicine is practiced, including the implementation of virtual care in many specialties. In the field of interventional neuroradiology (INR), virtual clinics are an uncommon practice with minimal literature to support its use. Our objective was to report prospective, single-centre data regarding patient and physician experience with virtual INR clinics for routine follow-up appointments. METHODS: We surveyed all patients that participated in a virtual INR clinic follow-up appointment at our hospital over a 3 month period. Information gathered included length of appointment delays (ie, wait times), length of appointment times, overall satisfaction, and perceived safety metrics. A survey was also sent out to all physicians who participated in virtual clinics with similar questions. RESULTS: 118/122 patients and 6/6 physicians completed the survey. Wait times before previous in-person appointments were perceived to be much longer than virtual appointments, whereas in-person appointment times were longer. 112/118 (94.9%) patients and 4/6 (67%) physicians reported general satisfaction with their virtual clinic experience. There were 8/118 patients who felt their conditions could not be safely assessed virtually, compared with 1/6 (17%) physicians. Lastly, 72.2% of patients reported that they would prefer virtual or telephone visits in the future for non-urgent follow-up, and 5/6 (83%) of physicians reported the same. CONCLUSION: Virtual INR clinics are more efficient and are preferred among patients and physicians for non-urgent follow-up appointments. Our study demonstrates the feasibility of a virtual platform for INR care, which could be sustainable for future practice.