Protocol for the ONLOOP trial: pragmatic randomized trial evaluating a province-wide system of personalized reminders for evidence-based surveillance tests in adult survivors of childhood cancer in Ontario.

BACKGROUND: Childhood cancer treatment while often curative, leads to elevated risks of morbidity and mortality. Survivors require lifelong periodic surveillance for late effects of treatment, yet adherence to guideline-recommended tests is suboptimal. We created ONLOOP to provide adult survivors of childhood cancer with detailed health information, including summaries of their childhood cancer treatment and recommended surveillance tests for early detection of cardiomyopathy, breast cancer, and/or colorectal cancer, with personalized reminders over time. METHODS: This is an individually randomized, registry-based pragmatic trial with an embedded process and economic evaluation to understand ONLOOP's impact and whether it can be readily implemented at scale. All adult survivors of childhood cancer in Ontario overdue for guideline-recommended tests will be randomly assigned to one of two arms: (1) intervention or (2) delayed intervention. A letter of information and invitation will detail the ONLOOP program. Those who sign up will receive a personalized toolkit and a screening reminder 6 months later. With the participants' consent, ONLOOP will also send their primary care clinician a letter detailing the recommended tests and a reminder 6 months later. The primary outcome will be the proportion of survivors who complete one or more of the guideline-recommended cardiac, breast, or colon surveillance tests during the 12 months after randomization. Data will be obtained from administrative databases. The intent-to-treat principle will be followed. Based on our analyses of administrative data, we anticipate allocating at least 862 individuals to each trial arm, providing 90% power to detect an absolute increase of 6% in targeted surveillance tests completed. We will interview childhood cancer survivors and family physicians in an embedded process evaluation to examine why and how ONLOOP achieved success or failed. A cost-effectiveness evaluation will be performed. DISCUSSION: The results of this study will determine if ONLOOP is effective at helping adult survivors of childhood cancer complete their recommended surveillance tests. This study will also inform ongoing provincial programs for this high-risk population. TRIAL REGISTRATION: ClinicalTrials.gov NCT05832138.

Adoption, feasibility and safety of a family medicine-led remote monitoring program for patients with COVID-19: a descriptive study.

BACKGROUND: Virtual care for patients with coronavirus disease 2019 (COVID-19) allows providers to monitor COVID-19-positive patients with variable trajectories while reducing the risk of transmission to others and ensuring health care capacity in acute care facilities. The objective of this descriptive analysis was to assess the initial adoption, feasibility and safety of a family medicine-led remote monitoring program, COVIDCare@Home, to manage the care of patients with COVID-19 in the community. METHODS: COVIDCare@Home is a multifaceted, interprofessional team-based remote monitoring program developed at an ambulatory academic centre, the Women's College Hospital in Toronto. A descriptive analysis of the first cohort of patients admitted from Apr. 8 to May 11, 2020, was conducted. Lessons from the implementation of the program are described, focusing on measure of adoption (number of visits per patient total, with a physician or with a nurse; length of follow-up), feasibility (received an oximeter or thermometer; consultation with general internal medicine, social work or mental health, pharmacy or acute ambulatory care unit) and safety (hospitalizations, mortality and emergency department visits). RESULTS: The COVIDCare@Home program cared for a first cohort of 97 patients (median age 41 yr, 67% female) with 415 recorded virtual visits. Patients had a median time from positive testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to first appointment of 3 (interquartile range [IQR] 2-4) days, with a median virtual follow-up time of 8 (IQR 5-10) days. A total of 4 (4%) had an emergency department visit, with no patients requiring hospitalization and no deaths; 16 (16%) of patients required support with mental and social health needs. INTERPRETATION: A family medicine-led, team-based remote monitoring program can safely manage the care of outpatients diagnosed with COVID-19. Virtual care approaches, particularly those that support patients with more complex health and social needs, may be an important part of ongoing health system efforts to manage subsequent waves of COVID-19 and other diseases.

Personalized assessment and management of women at risk for breast cancer in North America.

Many women at increased risk for breast cancer would benefit from referral for genetic testing, enhanced screening, preventive therapy or risk-reducing surgery. We present a visual model and a step-wise approach to assist with a personalized risk stratification and management of these women. We present current recommendations with respect to lifestyle behaviors and mammographic screening, and we review the current evidence regarding enhanced screening and risk-reducing therapies. We discuss the usefulness of three risk-assessment tools in determining whether a woman qualifies for genetic testing, enhanced screening or preventive therapy and present four cases to demonstrate the usefulness of this approach in the clinical setting.