Ethical approval
The study protocol was developed with the UK Covid-19 Testing Initiatives Evaluation Board (TIEB) and approved by UK Health Security Agency (UKHSA) Urgent Studies Ethics Committee. TIEB was part of the UK Covid-19 testing initiatives evaluation programme, which included academics and public health professionals independent of this study. The motivation for the study came from a request by Merseyside Resilience Forum to UKHSA and NHS England to vary Covid-19 testing policies in response to dangerous levels of NHS staff absence in December 2021. TIEB signed off the study protocol on 4th January 2022 and UKHSA Research Support and Governance Office approved the study on 25th January 2022 as NR0308. The sponsor code for this study is UoL001685 and trial registration code IRAS ID 311842; https://www.isrctn.com/ISRCTN47058442.
Data availability
The study required person identifiable data and the main analyses were conducted on a de-identified extract. The fully anonymised data for reproducing the results are available from https://github.com/iain-buchan/cipha/blob/master/SMART_RR_Anonymised_Data.zip. The study protocol can be downloaded from https://github.com/iain-buchan/cipha/blob/master/SMART_Release_Return.pdf and statistical analysis plan from https://github.com/iain-buchan/cipha/blob/master/SMART_RR_SAP.pdf.
Acknowledgements
We thank all participants and wider staff at Liverpool University Hospitals NHS Trust who supported the study, Cheshire & Merseyside Blood Bikes volunteers who made home-based viral culture swab delivery and collection possible, the UK Testing Initiatives Evaluation Board for their generous support with urgent preparation of the protocol and discussion over interim findings to support policymaking, and UKHSA Research Ethics and Governance Group. Thanks to Kathryn Scott for proofreading this manuscript.
Contributors
IB, XZ and CC drafted the manuscript. IB drafted the protocol, led the study and the preparation of reports and this paper. CC drafted the statistical analysis plan and led data management with GL. CC, DH, GB, SD, MGF and IB ran and corroborated three independent statistical analyses. CS led the study management. TN ran the trial site. TF and ST ran the UKHSA operations for the trial. MH ran the exit questionnaire. MGS and TF led policymaker liaison. LT and CJ ran the viral culture sub-study. RPR and XD performed viral sequencing and bioinformatic analyses. Each author contributed substantial intellectual content during manuscript drafting or revision and accepts accountability for the overall work by ensuring that questions pertaining to the accuracy or integrity of any portion of the work are appropriately investigated and resolved. All authors approved the final version of the manuscript. IB is the study guarantor. The corresponding author (IB) affirms that all the listed authors meet the authorship criteria and that no others meeting the criteria have been omitted.
Funding
This research was commissioned and funded by the UK Health Security Agency and carried out independently by the University of Liverpool. The work was also supported by the Economic and Social Research Council (grant No ES/L011840/1). IB is supported by the National Institute for Health and Care Research (NIHR) as senior investigator award NIHR205131. IB and XZ are also supported by the NIHR Health Protection Research Unit in Gastrointestinal Infections, a partnership between UKHSA, the University of Liverpool, and the University of Warwick (NIHR200910). MGS and LT are supported by the NIHR Health Protection Unit in Emerging and Zoonotic Infections, a partnership between UKHSA, The University of Liverpool and The University of Oxford (NIHR200907). The NIHR had no role in the study design, data collection and analysis, decision to publish, or preparation of the article. LT, RPR and XD are supported by the U.S. Food and Drug Administration Medical Countermeasures Initiative contract 75F40120C00085. The funders had no role in considering the study design or in the collection, analysis, or interpretation of data, writing of the report, or decision to submit the article for publication. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, NIHR, or Department of Health and Social Care.
Competing interests
All authors have completed the ICMJE uniform disclosure form at https://www.icmje.org/disclosure-of-interest and declare: funding from the Department of Health and Social Care, Economic and Social Research Council, and National Institute for Health and Care Research; no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work. IB, TF and MGS were members of the UK Covid-19 Testing Initiatives Evaluation Board but did not take part in sessions where this study was adjudicated. The City of Liverpool received a donation from Innova Medical Group towards the foundation of the Pandemic Institute but neither Innova Medical Group or any other commercial entity gave any support to this study or had any participation in it. Lateral Flow Test supply and company interactions was handled independently by the UK Health Security Agency. LT has received consulting fees from MHRA; and from AstraZeneca and Synairgen, paid to the University of Liverpool; speakers’ fees from Eisai Ltd, and support for conference attendance from AstraZeneca.
Affirmation
IB affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.
Dissemination to participants and related patient and public communities
Findings were presented to the UK Testing Initiatives Evaluation Board and associated patient and public involvement groups throughout the study and in final form in September 2022. TN, as infection prevention and control lead and trial site (Liverpool University Hospitals) lead has disseminated results to participants.
Provenance and peer review
The study was commissioned by the UK’s Department of Health and Social Care. The work has been peer reviewed by external reviewers in the UK Testing Initiatives Evaluation Board at each stage, from protocol formation to presentation of findings.