Gayle, Alicia V.
Minelli, Cosetta
Quint, Jennifer K.
Article History
Received: 4 October 2021
Accepted: 23 December 2021
First Online: 8 January 2022
Declarations
:
: This study was conducted in accordance with the principles of the Declaration of Helsinki. The results of this study were reported adhering to the STROBE (Strengthening The Reporting of OBservational Studies in Epidemiology) guidelines. The protocol for this research was approved by the Independent Scientific Advisory Committee (ISAC) for MHRA Database Research (protocol number 17_086R). Generic ethical approval for observational research using the CPRD with approval from ISAC has been granted by a Health Research Authority (HRA) Research Ethics Committee (East Midlands—Derby, REC reference number 05/MRE04/87). This research was supported by the National Institute for Health Research (NIHR) Imperial Biomedical Research Centre (BRC). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. CPRD operates an opt-in model whereby a GP practice must provide consent for CPRD to collect de-identified primary care data from their practice. This consent must first be in place to enable extractions of data from the primary care EHR. Patients at participating practices have the right to opt-out of sharing and use of their data for research at any time and CPRD respects this choice. Patients are informed that their data are used for public health research and how they can opt-out, via a Fair Processing Notice displayed in the practice waiting room. The CPRD website also provides detailed information for the public informing them of the uses of their data for research purposes and the legal and ethical permissions obtained.
: Not applicable.
: The authors declare that they have no competing interests (both financial and non-financial) related to this manuscript. AVG is an employee and shareholder of AstraZeneca, this affiliation is outside of the submitted work and was conducted independently of AstraZeneca.