Recruitment, clinical equipoise, patient acceptance and compliance in the UK-ANZ POSNOC trial

Background: POSNOC is a UK-ANZ multicentre, non-inferiority, randomised trial comparing systemic therapy alone with systemic therapy plus Axillary Treatment (Axillary radiotherapy or ALND) for women with <=2 macrometastases at SNB. The primary outcome is axillary recurrence within 5 years. This paper describes screening, recruitment and compliance data. Method(s): Sites were requested on a monthly basis to upload screening data and provide reasons for nonrecruitment of eligible patients into the trial. Sites entered in the online database whether the patients were compliant with their randomisation allocation. Result(s): The study opened in July 2014 and completed target recruitment of 1900 women (24% of those screened) in July 2021, at 95 sites in the UK and 20 sites in Australia and New Zealand. The reason for non-enrolment was unknown in 1300 women. Of the remaining 4774 women with known reasons, who were screened but not randomised, the most common reasons for non-recruitment were due to either patients (n=2219, 46.5%) or their clinicians (n=782, 16.4%) favouring axillary treatment, or patients (n=490, 10.3%) or their clinicians (n=170, 3.6%) not wishing to have axillary treatment. Over the course of the study, there was an increase in the proportion of patients wanting axillary treatment and declining the trial (Mean % patients declined 2015 - 17.9%, 2021 - 39.1%). Mean number of participants recruited per site per month was 0.24 (SD 0.18) overall, 0.25 (SD 0.19) in the UK, and 0.19(SD 0.15) in ANZ. The mean was < 0.3 in 79 sites and >0.9 in only one site. Recruitment rate remained consistent throughout the study (mean 25.3 per month) except for during the first 6 months of recruitment (5.7) and during the COVID pandemic Apr-Sep 2020 (7.5). Of 89 (4.8%) participants non-compliant with allocation, n=45 (50.6%) received systemic therapy alone and n=44 (49.4%) received systemic therapy plus axillary treatment. There was no fluctuation in the direction of non-compliance during the study duration. There was increasing uptake of axillary radiotherapy to treat the axilla instead of ALND over the course of the study in patients receiving axillary treatment (Number who had ART of all who had axilla treatment2014-2017 - 248/454 (54.6 %);2018-2021 - 315/449 (70.2%)). Conclusion(s): Recruitment and compliance with randomised allocation remained consistent over a seven-year period. POSNOC with in-built radiotherapy QA will provide definitive data on axillary management in patients undergoing mastectomy or BCS with <=2 macrometastases on SNB.

A case study of adapting a health insurance decision intervention from trial into routine cancer care.

OBJECTIVE: This study adapted Improving Cancer Patients' Insurance Choices (I Can PIC), an intervention to help cancer patients navigate health insurance decisions and care costs. The original intervention improved knowledge and confidence making insurance decisions, however, users felt limited by choices provided in insurance markets. Using decision trees and frameworks to guide adaptations, we modified I Can PIC to focus on using rather than choosing health insurance. The COVID-19 pandemic introduced unforeseen obstacles, prompting changes to study protocols. As a result, we allowed users outside of the study to use I Can PIC (> 1050 guest users) to optimize public benefit. This paper describes the steps took to conduct the study, evaluating both the effectiveness of I Can PIC and the implementation process to improve its impact. RESULTS: Although I Can PIC users had higher knowledge and health insurance literacy compared to the control group, results were not statistically significant. This outcome may be associated with systems-level challenges as well as the number and demographic characteristics of participants. The publicly available tool can be a resource for those navigating insurance and care costs, and researchers can use this flexible approach to intervention delivery and testing as future health emergencies arise.

A national program for the implementation of lung Stereotactic Ablative Body Radiotherapy (SABR)

Purpose or Objective Following completion of an evaluation program of SABR for primary lung cancer and metachronous extracranial oligometastatic disease, NHS England & NHS Improvement funded a SABR expansion program to increase SABR provision to 50 radiotherapy centres. With reduced access to surgery due to the impact of the COVID-19 pandemic, efforts were focussed on implementing SABR for lung primary and oligometastatic disease in the first instance. Materials and Methods The program consisted of 3 elements, delivered by multi-disciplinary SABR experts from the SABR Consortium and the National Radiotherapy Trials Quality Assurance (RTTQA) Group: Education;Mentorship of RT centres new to SABR by those with extensive experience;QA to ensure the safe and consistent implementation of the technique. A contouring workshop for radiation oncologists was developed by the SABR Consortium Steering Committee. In addition, educational sessions were provided within the SABR Consortium Online Conference, offered free of charge to enable wide access to education and professional development. The Committee produced a Guide for SABR Mentorship, setting out a consistent framework under which mentorship would proceed (Table 1). Mentoring and local protocols followed implementation guidance from the UK SABR Consortium Guidelines. In parallel, RTTQA developed a comprehensive RT QA program (Table 2). Two radiation oncologists and one treatment platform were assessed per hospital. Credentialed clinicians then provided cascade training and education within their departments, formally documenting peer reviews through standard templates provided by RTTQA. (Table Presented) (Table Presented) Results 54 radiation oncologists participated in the contouring workshop. The conference had 1335 registrants, 65% of whom were UK multi-professionals. 15 experienced centres were invited to mentor 24 new SABR sites. Mentors were assigned by equipment for planning and delivery. The mentoring framework was adjusted to accommodate visiting restrictions due to the pandemic and performed remotely through email and video-conferencing instead. The RT QA program commenced in June 2020 with circulation of the facility questionnaire, collecting data on equipment, technique, intention to treat and expected level of mentoring. Responses were used to tailor mentoring and inform what components of the QA program were required for each centre. Contouring submissions were received from 46 radiation oncologists and planning benchmarks were completed by all 24 centres, 22 of which underwent the dosimetry audit. All assessments were reported through standard templates to ensure consistent feedback. Conclusion The implementation of lung SABR was completed in June 2021. Collaboration amongst all stakeholders ensured centres were trained and supported to safely deliver high-quality SABR for lung primary and oligometastatic disease. The education, mentoring and QA program proved effective and has now been rolled out to other oligometastatic sites.

COVID-19 Countermeasures: An Algorithm to Stay Unlocked.

We describe a visual algorithm to help prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) contagion as well as manage COVID-19 disease according to categories of clinical severity. The algorithm is timely, with multiple countries worldwide declaring repeat surges in SARS-CoV-2 infections following the easing of lockdown measures. Its flowchart assimilates key effective interventions in a visual manner that will assist healthcare workers to manage COVID-19 disease algorithmically, and policymakers to suppress further SARS-CoV-2 waves. Importantly, we include the innovative use of topical p-menthane-3,8-diol spray by the British Army for COVID-19 Support Force personnel, which in light of its coronavirucidal properties, deserves wider dissemination. This algorithm has the potential to be updated as numerous studies are concluded globally.

CARDIAC MANIFESTATIONS OF MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN AT A TERTIARY REFERRAL CHILDREN'S HOSPITAL

Background: Since the emergence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), a new multisystem inflammatory syndrome in children (MIS-C) has been described amongst patients with recent past SARS-CoV-2 infection. The primary objective of this study is to describe a single center experience in relation to cardiac manifestations of MIS-C in an ethnically diverse pediatric population. Methods: We conducted a retrospective chart review of pediatric patients less than 21 of age meeting MIS-C criteria who presented to a tertiary care children's hospital from May 2020 to March 2021. Results: Seventy-eight patients diagnosed with MIS-C (average age 9.7 +/- 4.6 years, 57% male) were included in this study (60 Hispanic, 9 non-Hispanic White, 7 Black, and 1 American Indian). The most common presenting symptoms were nausea and vomiting (76%), abdominal pain (71%), appetite changes (69%), fatigue (64%), and conjunctivitis (63%). The average length of intensive care unit stay was 2.5 days while average total hospitalization was 7.3 days. Forty-nine patients (62%) underwent echocardiography. Of those evaluated, there was systolic dysfunction in 45% with an average ejection fraction of 48%, diastolic dysfunction in 14%, valvular disease in 53%, coronary involvement in 16%, and pericardial effusion in 22%. Electrocardiogram was completed on 37 patients (47%) which revealed heart block in 23% and arrhythmia in 3%. Troponin T was elevated in 32% and pro-BNP was elevated in 89%. Ninety-five percent of patients received immunomodulators during their hospitalization, while 94% received methylprednisolone, 59% received intravenous immunoglobulin, and 19% received Anakinra. There was one mortality. Conclusion: The results of this retrospective study contribute to a growing knowledge base in the literature that MIS-C can exhibit a wide spectrum of cardiac manifestations further underscoring the importance of thorough cardiac workup and regular outpatient follow-up in patients diagnosed with MIS-C.

Peloton’s ride to growth

Theoretical basis: The theoretical basis for this case is a focus on vertical integration, first-mover advantage and competitive dynamics. Vertical integration is based on Williamson’s (1979) theory of transaction-cost economics as it relates to vertical integration;the discussion on first-mover advantage is built off of Suarez and Lanzolla’s (2005) dynamics of first-mover advantage;and the analyzes on competitive dynamics derives from the MacMillan et al. (1985) early empirical tests of interfirm rivalry dynamics. Research methodology: The authors conducted extensive research using the following sources: IBISWorld, MergentOnline and academic journals, trade magazines and websites. Additionally, the authors successfully piloted the case on more than 350 undergraduate students enrolled in a business and corporate strategy course. Case overview/synopsis: Peloton used vertical integration to control the creation of its own software, bikes, exercise classes and retail outlets. In doing so, Peloton was one of the first companies in the industry to have near full control of the production process (Gross and Caisman, 2019). Due to this integration, Peloton was one of the fitness equipment industry leaders. However, Peloton’s high level of vertical integration coupled with rapid growth led to lackluster profitability. Given the rise in popularity of in-home exercise equipment, Peloton had room to continue its growth, but the question remained whether it was strategically positioned to do so. Complexity academic level: This case is best taught in undergraduate and graduate strategy courses. For undergraduate courses, it could be incorporated into lessons on competitive dynamics, internal analysis and first-mover advantage and strategic positioning. For graduate courses, it could be incorporated into lessons on vertical integration and delving more in-depth into the long-term sustainability of having a first-mover advantage. © 2021, Emerald Publishing Limited.