Effect of COVID-19 pandemic on glycaemic monitoring and other processes of care in Type 2 Diabetes: Protocol for a retrospective cohort study (Preprint)

BACKGROUND Social distancing and other non-pharmaceutical interventions to reduce spread of COVID-19 infection in the UK have led to substantial changes in delivering ongoing care for patients with chronic conditions, including type 2 diabetes mellitus (T2DM). Clinical guidelines for management and prevention of complications for people with T2DM delivered in primary care services advise ‘routine annual reviews’ and were developed when face-to-face consultations were the norm. The shift in consultations from face-to-face to remoted-consultations caused a reduction in direct clinical contact and may impact on the process of care for people with T2DM. OBJECTIVE The aim of this study is to explore the impact of the first year of COVID-19 pandemic on the monitoring of T2DM with ‘routine annual reviews’ from a national primary care perspective in England. METHODS A retrospective cohort study of adults with T2DM will be performed using routinely collected primary care data from the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC). We will describe the change in the rate of monitoring of glycated haemoglobin (HbA1c) between the first year of the COVID pandemic (2020) and the preceding year (2019). We will also report any change in the eight checks that compose the components of these reviews. The change in glycated haemoglobin (HbA1c) monitoring rates will be determined using a multi-level logistic regression model adjusting for patient and practice characteristics and similarly the change in a composite measure of the completeness of all eight checks will be modelled using ordinal regression. The models will be adjusted for the following patient level variables: age, gender, socio economic status, ethnicity, COVID-19 shielding status, duration of diabetes, comorbidities; then at practice-level: urban versus rural, practice size, Quality and Outcomes Framework (QOF) achievement, NHS Region and proportion of face-to-face consultations. Ethical approval was provided by the University of Oxford Medical Sciences Interdivisional Research Ethics Committee (2nd September 2021, Reference: R77306/RE001). RESULTS To create the retrospective diabetic cohort, we will use a representative sample of the adult Orchid-RCGP RSC population of approximately 6.5 million from 721 practices, 128 (17.8%) in the rural setting and 593 (82.2%) urban. The number of adults aged between 18 and 115 years, with a T2DM diagnosis was 393,987 (6.1%). CONCLUSIONS The COVID-19 pandemic has impacted on the delivery of care but little is known on the process of care of people with T2DM. This study will report the impact of the COVID-19 pandemic on these process of care.