A multistage mixed-methods evaluation protocol for the UKHSA testing response during the COVID-19 pandemic in England

Introduction In 2020, the UK Health Security Agency (UKHSA) established a large-scale testing programme to rapidly identify individuals in England who were infected with SARS-CoV-2 and had COVID-19. This comprised part of the UK government’s COVID-19 response strategy, to protect those at risk of severe COVID-19 disease and death and to reduce the burden on the health system. To assess the success of this approach, UKHSA commissioned an independent evaluation of the activities delivered by the NHS testing programme in England. The primary purpose of this evaluation is to capture key learnings from the rollout of testing to different target populations via various testing services between October 2020 and March 2022 and to use these insights to formulate recommendations for future pandemic preparedness strategy. Methods The proposed study involves a stepwise mixed-methods approach, aligned with established methods for the evaluation of complex interventions in health. We will retrospectively assess the combined impact of the asymptomatic and symptomatic testing services nationally, including an evaluation of the universal testing service. This will be complemented by ‘deep dive’ evaluations of three testing services: Schools, Adult Social Care (staff and residents in care homes) and Healthcare workers. In the first instance we will develop a Theory of Change, formulated in collaboration with testing service stakeholders to understand the causal pathways and intended and unintended outcomes of each service, also exploring the effect of context on each individual service setting’s intended outcomes. Subsequently, the insights gained will be synthesised to identify indicators to evaluate how the combined aims of the testing programme were achieved. Conclusion This evaluation will be the first of its kind to produce a portfolio of evidence on testing effectiveness and public health impact for the national testing programme in England, encompassing behavioural, economic, equity and public health impact. These findings will strengthen the evidence base on the effectiveness of COVID-19 testing and identify which aspects are necessary to prioritise in mitigating future pandemic threats when deploying a complex public health intervention such as testing. Disclaimer This is a protocol that represents research in progress. This research was commissioned and funded by UKHSA, to be performed between August 2022 and March 2023. The scope and depth of testing services and channels covered by this research were pre-agreed with UKHSA and were limited to the availability and provision of data available at the time this protocol was written. The Corresponding Author has the right to grant on behalf of all authors and does grant on behalf of all authors, an exclusive licence (or non exclusive for government employees) on a worldwide basis to the BMJ Publishing Group Ltd to permit this article (if accepted) to be published in BMJ editions and any other BMJPGL products and sublicences such use and exploit all subsidiary rights, as set out in the licence. No patients or public were involved in this research. Ethics and dissemination The study protocol was granted ethics approval by the UKHSA Research Ethics and Governance Group, reference number NR0347. All relevant ethics guidelines were followed throughout. Findings arising from this evaluation will be used to inform lessons learnt and recommendations for UKHSA on appropriate pandemic preparedness testing programme designs; findings will also be disseminated in peer-reviewed journals and at academic conferences. Transparency declaration The lead author (the manuscript’s guarantor) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; no important aspects of the study have been omitted; and any discrepancies from the study as planned have been explained. Strengths and limitations of the study ### Competing Interest Statement This work was funded by Secretary of State for Health and Social Care acting as part of the Crown through the UK Health Security Agency (UKHSA), reference number C80260/PRO5331. All authors have completed the ICMJE uniform disclosure form at [www.icmje.org/coi_disclosure.pdf][1] and declare: all authors had financial support from the UK Health Security Agency (UKHSA) for the submitted work; EY LLP London has previously received payment for consultancy work and advisory on the NHS Test & Trace response from the UK Department of Health and Social Care, now known as the UK Health Security Agency, Prof. There are no other relationships or activities that could appear to have influenced the submitted work. ### Funding Statement This study was funded by Secretary of State for Health and Social Care acting as part of the Crown through the UK Health Security Agency (UKHSA), reference number C80260/PRO5331. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study protocol has been granted ethical approval by the UKHSA Research Ethics and Governance Group Ref NR0347. All relevant ethics guidelines have been followed. Should the research approach or methods change following this version, the UKHSA Research Ethics and Governance Group will be notified and the appropriate ethical guidelines followed. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present work are contained in the manuscript [1]: http://www.icmje.org/coi_disclosure.pdf