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Article History

Received: 14 February 2023

Accepted: 21 August 2023

First Online: 11 September 2023

Declarations

:

: All methods were performed in accordance with relevant guidelines and regulations.

: All data for our study were extracted under the terms of both a legally binding Data Sharing Agreement (DSA) signed by each general practice; also, project-specific approval following submission of a Data Privacy Impact Assessment (DPIA), approved by both NHS Lambeth Clinical Commissioning Group and the Caldicott Guardian on 21st November 2019.

: Caldicott Guardian approval required confirmation that all aspects of the study including ethical approval and patient consent exemptions were compliant with the following UK legislation: Data Protection Act 2018 (Chap. 2, Sects. 8 and 10, in clause 3.3); Health and Social Care Act 2012 (Sect. 261).

: This study was exempt from ethical committee approval and the requirement to obtain individual patient consent. Exemptions for research studies using anonymised primary care data apply to studies fulfilling requirements specified by the national body, the NHS Health Research Authority (HRA) and summarised in the HRA Integrated Research Application System (IRAS) guidance to researchers: . Specifically, written confirmation of exemption has been confirmed by the HRA on the following grounds: patients have been informed through the process termed ‘Fair Processing Notices’ (FPNs) that their health care data would be available for ‘secondary data analysis’ and given the option to opt-out of data sharing through the process termed ‘Informed Dissent’; all data provided to researchers was fully anonymised; all data extracted from general practices was Pseudonymised At Source (PAS); the pseudonymisation process was ‘one-way’ and could not be reverse engineered to obtain any personal identifiers; all Patient Identifiable Data (PID) was removed; ‘low number suppression’ was applied to all research findings, ensuring that data would not be displayed with ≤ 10 patients in any data category (personal communication from HRA, 29th September 2017).

: Not applicable.

: NH, EBT, RD-R, AVu, AVo, KY and VdLM are currently employed by Outcomes Based Healthcare, which receives funding from NHS organisations (including NHS England) for providing analytical services. The remaining authors, HD, SD, SS and MA have no competing interests.