Breast cancer management pathways during the COVID-19 pandemic: outcomes from the UK ‘Alert Level 4’ phase of the B-MaP-C study

Abstract: Background: The B-MaP-C study aimed to determine alterations to breast cancer (BC) management during the peak transmission period of the UK COVID-19 pandemic and the potential impact of these treatment decisions. Methods: This was a national cohort study of patients with early BC undergoing multidisciplinary team (MDT)-guided treatment recommendations during the pandemic, designated ‘standard’ or ‘COVID-altered’, in the preoperative, operative and post-operative setting. Findings: Of 3776 patients (from 64 UK units) in the study, 2246 (59%) had ‘COVID-altered’ management. ‘Bridging’ endocrine therapy was used (n = 951) where theatre capacity was reduced. There was increasing access to COVID-19 low-risk theatres during the study period (59%). In line with national guidance, immediate breast reconstruction was avoided (n = 299). Where adjuvant chemotherapy was omitted (n = 81), the median benefit was only 3% (IQR 2–9%) using ‘NHS Predict’. There was the rapid adoption of new evidence-based hypofractionated radiotherapy (n = 781, from 46 units). Only 14 patients (1%) tested positive for SARS-CoV-2 during their treatment journey. Conclusions: The majority of ‘COVID-altered’ management decisions were largely in line with pre-COVID evidence-based guidelines, implying that breast cancer survival outcomes are unlikely to be negatively impacted by the pandemic. However, in this study, the potential impact of delays to BC presentation or diagnosis remains unknown

Fidelity Criteria: Development, Measurement, and Validation

Fidelity may be defined as the extent to which delivery of an intervention adheres to the protocol or program model originally developed. Fidelity measurement has increasing significance for evaluation, treatment effectiveness research, and service administration. Yet few published studies using fidelity criteria provide details on the construction of a valid fidelity index. The purpose of this review article is to outline steps in the development, measurement, and validation of fidelity criteria, providing examples from health and education literatures.We further identify important issues in conducting each step. Finally, we raise questions about the dynamic nature of fidelity criteria, appropriate validation and statistical analysis methods, the inclusion of structure and process criteria in fidelity assessment, and the role of program theory in deciding on the balance between adaptation versus exact replication of model programs. Further attention to the use and refinement of fidelity criteria is important to evaluation practice