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  • Journal article
    Elliott P, Eales O, Steyn N, Tang D, Bodinier B, Wang H, Elliott J, Whitaker M, Atchison C, Diggle PJ, Page AJ, Trotter AJ, Ashby D, Barclay W, Taylor G, Ward H, Darzi A, Cooke GS, Donnelly CA, Chadeau-Hyam Met al., 2022,

    Twin peaks: The Omicron SARS-CoV-2 BA.1 and BA.2 epidemics in England.

    , Science, Vol: 376

    Rapid transmission of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant has led to record-breaking incidence rates around the world. The Real-time Assessment of Community Transmission-1 (REACT-1) study has tracked SARS-CoV-2 infection in England using reverse transcription polymerase chain reaction (RT-PCR) results from self-administered throat and nose swabs from randomly selected participants aged 5 years and older approximately monthly from May 2020 to March 2022. Weighted prevalence in March 2022 was the highest recorded in REACT-1 at 6.37% (N = 109,181), with the Omicron BA.2 variant largely replacing the BA.1 variant. Prevalence was increasing overall, with the greatest increase in those aged 65 to 74 years and 75 years and older. This was associated with increased hospitalizations and deaths, but at much lower levels than in previous waves against a backdrop of high levels of vaccination.

  • Journal article
    Danielli S, Donnelly P, Coffey T, Horn S, Ashrafian H, Darzi Aet al., 2022,

    Measuring more than just economic growth to improve well-being

    , Journal of Public Health, Vol: 44, Pages: e76-e78, ISSN: 1741-3842

    It's official: The UK is in a recession. The economy has suffered its biggest slump on record with a drop in gross domestic product (GDP) of 20.4%. 1 This is going to have a significant impact on our health and well-being. It risks creating a spiralling decay as we know good health is not only a consequence, but also a condition for sustained and sustainable economic development. 2 In this way, the health of a nation creates a virtuous circle of improved health and improved economic prosperity. How we measure prosperity is therefore important and needs to be considered.

  • Journal article
    Elliott P, Haw D, Wang H, Eales O, Walters C, Ainslie K, Atchison C, Fronterre C, Diggle P, Page A, Trotter A, Prosolek S, The COVID-19 Genomics UK Consortium COG-UK, Ashby D, Donnelly C, Barclay W, Taylor G, Cooke G, Ward H, Darzi A, Riley Set al., 2021,

    Exponential growth, high prevalence of SARS-CoV-2 and vaccine effectiveness associated with Delta variant

    , Science, Vol: 374, Pages: 1-11, ISSN: 0036-8075

    SARS-CoV-2 infections were rising during early summer 2021 in many countries associated with the Delta variant. We assessed RT-PCR swab-positivity in the REal-time Assessment of Community Transmission-1 (REACT-1) study in England. We observed sustained exponential growth with average doubling time (June-July 2021) of 25 days driven by complete replacement of Alpha variant by Delta, and by high prevalence at younger less-vaccinated ages. Unvaccinated people were three times more likely than double-vaccinated people to test positive. However, after adjusting for age and other variables, vaccine effectiveness for double-vaccinated people was estimated at between ~50% and ~60% during this period in England. Increased social mixing in the presence of Delta had the potential to generate sustained growth in infections, even at high levels of vaccination.

  • Journal article
    Riley S, Ainslie KEC, Eales O, Walters CE, Wang H, Atchison C, Fronterre C, Diggle PJ, Ashby D, Donnelly CA, Cooke G, Barclay W, Ward H, Darzi A, Elliott Pet al., 2021,

    Resurgence of SARS-CoV-2: detection by community viral surveillance

    , Science, Vol: 372, Pages: 990-995, ISSN: 0036-8075

    Surveillance of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has mainly relied on case reporting, which is biased by health service performance, test availability, and test-seeking behaviors. We report a community-wide national representative surveillance program in England based on self-administered swab results from ~594,000 individuals tested for SARS-CoV-2, regardless of symptoms, between May and the beginning of September 2020. The epidemic declined between May and July 2020 but then increased gradually from mid-August, accelerating into early September 2020 at the start of the second wave. When compared with cases detected through routine surveillance, we report here a longer period of decline and a younger age distribution. Representative community sampling for SARS-CoV-2 can substantially improve situational awareness and feed into the public health response even at low prevalence.

  • Journal article
    Bielinska A, Archer S, Obanobi A, Soosaipillai G, Darzi A, Riley J, Urch Cet al., 2021,

    Advance care planning in older hospitalised patients following an emergency admission: a mixed methods study

    , PLoS One, Vol: 16, Pages: 1-14, ISSN: 1932-6203

    Introduction: Although advance care planning may be beneficial for older adults in the last year of life, its relevance following an emergency hospitalisation requires further investigation. This study quantifies the one-year mortality outcomes of all emergency admissions for patients aged 70+ years and explores patient views on the value of advance care planning following acute hospitalisation.Method: This mixed methods study used a two-stage approach: firstly, a quantitative longitudinal cohort study exploring the one-year mortality of patients aged 70+ admitted as an emergency to a large multi-centre hospital cohort; secondly, a qualitative semi-structured interview study gathering information on patient views of advance care planning.Results: There were 14,260 emergency admissions for 70+-year olds over a 12-month period. One-year mortality for admissions across all conditions was 22.6%. The majority of these deaths (59.3%) were within 3 months of admission. Binary logistic regression analysis indicated higher one-year mortality with increasing age and male sex. Interviews with 20 patients resulted in one superordinate theme, “Planning for health and wellbeing in the spectrum of illness”. Sub-themes entitled (1) Advance care planning benefitting healthcare for physical and psycho-social health, (2) Contemplation of physical deterioration death and dying and 3) Collaborating with healthcare professionals to undertake advance care planning, suggest that views of advance care planning are shaped by experiences of acute hospitalisation.Conclusion: Since approximately 1 in 5 patients aged 70+ admitted to hospital as an emergency are in the last year of life, acute hospitalisation can act as a trigger for tailored ACP. Older hospitalised patients believe that advance care planning can benefit physical and psychosocial health and that discussions should consider a spectrum of possibilities, from future health to the potential of chronic illness, disability

  • Journal article
    Moshe M, Daunt A, Flower B, Simmons B, Brown JC, Frise R, Penn R, Kugathasan R, Petersen C, Stockmann H, Ashby D, Riley S, Atchison C, Taylor GP, Satkunarajah S, Naar L, Klaber R, Badhan A, Rosadas C, Marchesin F, Fernandez N, Sureda-Vives M, Cheeseman H, O'Hara J, Shattock R, Fontana G, Pallett SJC, Rayment M, Jones R, Moore LSP, Ashrafian H, Cherapanov P, Tedder R, McClure M, Ward H, Darzi A, Cooke GS, Barclay WS, On behalf of the REACT Study teamet al., 2021,

    SARS-CoV-2 lateral flow assays for possible use in national covid-19 seroprevalence surveys (REACT2): diagnostic accuracy study

    , BMJ: British Medical Journal, Vol: 372, Pages: 1-8, ISSN: 0959-535X

    Objective: To evaluate the performance of new lateral flow immunoassays (LFIAs) suitable for use in a national COVID-19 seroprevalence programme (REACT2).Design: Laboratory sensitivity and specificity analyses were performed for seven LFIAs on a minimum of 200 sera from individuals with confirmed SARS-CoV-2 infection, and 500 pre-pandemic sera respectively. Three LFIAs were found to have a laboratory sensitivity superior to the finger-prick sensitivity of the LFIA currently used in REACT2 seroprevalence studies (84%). These LFIAs were then further evaluated through finger-prick testing on participants with confirmed previous SARS-CoV-2 infection. Two LFIAs (Surescreen, Panbio) were evaluated in clinics in June-July, 2020, and a third LFIA (AbC-19) in September, 2020. A Spike protein enzyme-linked immunoassay (S-ELISA) and hybrid double antigen binding assay (DABA) were used as laboratory reference standards.Setting: Laboratory analyses were performed at Imperial College, London and University facilities in London, UK. Research clinics for finger-prick sampling were run in two affiliated NHS trusts.Participants: Sensitivity analysis on sera were performed on 320 stored samples from previous participants in the REACT2 programme with confirmed previous SARS-CoV-2 infection. Specificity analysis was performed using 1000 pre-pandemic sera. 100 new participants with confirmed previous SARS-CoV-2 infection attended study clinics for finger-prick testing.Main outcome measures: The accuracy of LFIAs in detecting IgG antibodies to SARS-CoV-2 in comparison to two in-house ELISAs.Results: The sensitivity of seven new LFIAs using sera varied between 69% and 100% (vs S-ELISA/hybrid DABA). Specificity using sera varied between 99.6% and 100%. Sensitivity on finger-prick testing for Panbio, Surescreen and AbC-19 was 77% (CI 61.4 to 88.2), 86% (CI 72.7 to 94.8) and 69% (CI 53.8 to 81.3) respectively vs S-ELISA/hybrid DABA. Sensitivity for sera from matched clinical samples performe

  • Journal article
    Danielli S, Patria R, Donnelly P, Ashrafian H, Darzi Aet al., 2021,

    Economic interventions to ameliorate the impact of COVID-19 on the economy and health: an international comparison

    , Journal of Public Health, Vol: 43, Pages: 42-46, ISSN: 1741-3842

    BackgroundThe COVID-19 pandemic continues to challenge governments and policymakers worldwide. They have rightfully prioritised reducing the spread of the virus through social distancing interventions. However, shuttered business and widespread restrictions on travel and mobility have led to an economic collapse with increasing uncertainty of how quickly recovery will be achieved.MethodsThe authors carried out a review of publicly available information on the economic intervention’s countries have put in place to ameliorate the impact of COVID-19.ResultsThe strategies and scale of economic interventions have been broad, ranging from 2.5% to a reported 50% of Gross Domestic Product.ConclusionsNumerous countries are beginning to ease lockdown restrictions and restart economies in different ways. There is therefore evolving, real-world data that should be used dynamically by governments and policymakers. The strategies on restarting the economy must be balanced against the uncertainty of a possible second wave of COVID-19. A nuanced approach to easing restrictions needs to take into account not only immediate risk to life but longer-term risks of widening inequalities and falling life expectancy.

  • Journal article
    Ward H, Atchison C, Whitaker M, Ainslie KEC, Elliott J, Okell L, Redd R, Ashby D, Donnelly C, Barclay W, Darzi A, Cooke G, Riley S, Elliott Pet al., 2021,

    SARS-CoV-2 antibody prevalence in England following the first peak of the pandemic.

    , Nature Communications, Vol: 12, Pages: 1-8, ISSN: 2041-1723

    England has experienced a large outbreak of SARS-CoV-2, disproportionately affecting people from disadvantaged and ethnic minority communities. It is unclear how much of this excess is due to differences in exposure associated with structural inequalities. Here we report from the REal-time Assessment of Community Transmission-2 (REACT-2) national study of over 100,000 people. After adjusting for test characteristics and re-weighting to the population, overall antibody prevalence is 6.0% (95% CI: 5.8-6.1). An estimated 3.4 million people had developed antibodies to SARS-CoV-2 by mid-July 2020. Prevalence is two- to three-fold higher among health and care workers compared with non-essential workers, and in people of Black or South Asian than white ethnicity, while age- and sex-specific infection fatality ratios are similar across ethnicities. Our results indicate that higher hospitalisation and mortality from COVID-19 in minority ethnic groups may reflect higher rates of infection rather than differential experience of disease or care.

  • Journal article
    Espinosa-González AB, Delaney BC, Marti J, Darzi Aet al., 2021,

    The role of the state in financing and regulating primary care in Europe: a taxonomy

    , Health Policy, Vol: 125, Pages: 168-176, ISSN: 0168-8510

    Traditional health systems typologies were based on health system financing type, such as the well-known OECD typology. However, the number of dimensions captured in classifications increased to reflect health systems complexity. This study aims to develop a taxonomy of primary care (PC) systems based on the actors involved (state, societal and private) and mechanisms used in governance, financing and regulation, which conceptually represents the degree of decentralisation of functions. We use nonlinear canonical correlations analysis and agglomerative hierarchical clustering on data obtained from the European Observatory on Health Systems and Policy and informants from 24 WHO European Region countries. We obtain four clusters: 1) Bosnia Herzegovina, Czech Republic, Germany, Slovakia and Switzerland: corporatist and/or fragmented PC system, with state involvement in PC supply regulation, without gatekeeping; 2) Greece, Ireland, Israel, Malta, Sweden, and Ukraine: public and (re)centralised PC financing and regulation with private involvement, without gatekeeping; 3) Finland, Norway, Spain and United Kingdom: public financing and devolved regulation and organisation of PC, with gatekeeping; and 4) Bulgaria, Croatia, France, North Macedonia, Poland, Romania, Serbia, Slovenia and Turkey: public and deconcentrated with professional involvement in supply regulation, and gatekeeping. This taxonomy can serve as a framework for performance comparisons and a means to analyse the effect that different actors and levels of devolution or fragmentation of PC delivery may have in health outcomes.

  • Journal article
    Viner RM, Bonell C, Drake L, Jourdan D, Davies N, Baltag V, Jerrim J, Proimos J, Darzi Aet al., 2021,

    Reopening schools during the COVID-19 pandemic: governments must balance the uncertainty and risks of reopening schools against the clear harms associated with prolonged closure

    , Archives of Disease in Childhood, Vol: 106, Pages: 111-113, ISSN: 0003-9888
  • Journal article
    Sounderajah V, Patel V, Varatharajan L, Harling L, Normahani P, Symons J, Barlow J, Darzi A, Ashrafian Het al., 2020,

    Are disruptive innovations recognised in the healthcare literature? A systematic review

    , BMJ Innovations, Vol: 7, Pages: 208-216, ISSN: 2055-8074

    The study aims to conduct a systematic review to characterise the spread and use of the concept of ‘disruptive innovation’ within the healthcare sector. We aim to categorise references to the concept over time, across geographical regions and across prespecified healthcare domains. From this, we further aim to critique and challenge the sector-specific use of the concept. PubMed, Medline, Embase, Global Health, PsycINFO, Maternity and Infant Care, and Health Management Information Consortium were searched from inception to August 2019 for references pertaining to disruptive innovations within the healthcare industry. The heterogeneity of the articles precluded a meta-analysis, and neither quality scoring of articles nor risk of bias analyses were required. 245 articles that detailed perceived disruptive innovations within the health sector were identified. The disruptive innovations were categorised into seven domains: basic science (19.2%), device (12.2%), diagnostics (4.9%), digital health (21.6%), education (5.3%), processes (17.6%) and technique (19.2%). The term has been used with increasing frequency annually and is predominantly cited in North American (78.4%) and European (15.2%) articles. The five most cited disruptive innovations in healthcare are ‘omics’ technologies, mobile health applications, telemedicine, health informatics and retail clinics. The concept ‘disruptive innovation’ has diffused into the healthcare industry. However, its use remains inconsistent and the recognition of disruption is obscured by other types of innovation. The current definition does not accommodate for prospective scouting of disruptive innovations, a likely hindrance to policy makers. Redefining disruptive innovation within the healthcare sector is therefore crucial for prospectively identifying cost-effective innovations.

  • Report
    Riley S, Walters C, Wang H, Eales O, Ainslie K, Atchison C, Fronterre C, Diggle PJ, Ashby D, Donnelly C, Cooke G, Barclay W, Ward H, Darzi A, Elliott Pet al., 2020,

    REACT-1 round 7 updated report: regional heterogeneity in changes in prevalence of SARS-CoV-2 infection during the second national COVID-19 lockdown in England

    , REACT-1 round 7 updated report: regional heterogeneity in changes in prevalence of SARS-CoV-2 infection during the second national COVID-19 lockdown in England, London, Publisher: Imperial College London

    BackgroundEngland exited a four-week second national lockdown on 2nd December 2020 initiated in response to the COVID-19 pandemic. Prior results showed that prevalence dropped during the first half of lockdown, with greater reductions in higher-prevalence northern regions.MethodsREACT-1 is a series of community surveys of SARS-CoV-2 RT-PCR swab-positivity in England, designed to monitor the spread of the epidemic and thus increase situational awareness. Round 7 of REACT-1 commenced swab-collection on 13th November 2020. A prior interim report included data from 13th to 24th November 2020 for 105,122 participants. Here, we report data for the entire round with swab results obtained up to 3rd December 2020.ResultsBetween 13th November and 3rd December (round 7) there were 1,299 positive swabs out of 168,181 giving a weighted prevalence of 0.94% (95% CI 0.87%, 1.01%) or 94 per 10,000 people infected in the community in England. This compares with a prevalence of 1.30% (1.21%, 1.39%) from 16th October to 2nd November 2020 (round 6), a decline of 28%. Prevalence during the latter half of round 7 was 0.91% (95% CI, 0.81%, 1.03%) compared with 0.96% (0.87%, 1.05%) in the first half. The national R number in round 7 was estimated at 0.96 (0.88, 1.03) with a decline in prevalence observed during the first half of this period no longer apparent during the second half at the end of lockdown. During round 7 there was a marked fall in prevalence in West Midlands, a levelling off in some regions and a rise in London. R numbers at regional level ranged from 0.60 (0.41, 0.80) in West Midlands up to 1.27 (1.04, 1.54) in London, where prevalence was highest in the east and south-east of the city. Nationally, between 13th November and 3rd December, the highest prevalence was in school-aged children especially at ages 13-17 years at 2.04% (1.69%, 2.46%), or approximately 1 in 50.ConclusionBetween the previous round and round 7 (during lockdown), there was a fall in prevalence of SARS-C

  • Journal article
    Orlovic M, Callender T, Riley J, Darzi A, Droney Jet al., 2020,

    Impact of advance care planning on dying in hospital: Evidence from urgent care records

    , PLoS One, Vol: 15, Pages: 1-12, ISSN: 1932-6203

    Place of death is an important outcome of end-of-life care. Many people do not have the opportunity to express their wishes and die in their preferred place of death. Advance care planning (ACP) involves discussion, decisions and documentation about how an individual contemplates their future death. Recording end-of-life preferences gives patients a sense of control over their future. Coordinate My Care (CMC) is London’s largest electronic palliative care register designed to provide effective ACP, with information being shared with urgent care providers. The aim of this study is to explore determinants of dying in hospital. Understanding advance plans and their outcomes can help in understanding the potential effects that implementation of electronic palliative care registers can have on the end-of-life care provided. Retrospective observational cohort analysis included 21,231 individuals aged 18 or older with a Coordinate My Care plan who had died between March 2011 and July 2019 with recorded place of death. Logistic regression was used to explore demographic and end-of-life preference factors associated with hospital deaths. 22% of individuals died in hospital and 73% have achieved preferred place of death. Demographic characteristics and end-of-life preferences have impact on dying in hospital, with the latter having the strongest influence. The likelihood of in-hospital death is substantially higher in patients without documented preferred place of death (OR = 1.43, 95% CI 1.26–1.62, p<0.001), in those who prefer to die in hospital (OR = 2.30, 95% CI 1.60–3.30, p<0.001) and who prefer to be cared in hospital (OR = 2.77, 95% CI 1.94–3.96, p<0.001). “Not for resuscitation” individuals (OR = 0.43, 95% CI 0.37–0.50, p<0.001) and who preferred symptomatic treatment (OR = 0.36, 95% CI 0.33–0.40, p<0.001) had a lower likelihood of in-hospital death. Effective advance care planning is necessary for improve

  • Journal article
    Shaw A, Flott K, Fontana G, Durkin M, Darzi Aet al., 2020,

    No patient safety without health worker safety Comment

    , The Lancet, Vol: 396, Pages: 1541-1543, ISSN: 0140-6736
  • Journal article
    Aufegger L, Bùi KH, Bicknell C, Darzi Aet al., 2020,

    Designing a paediatric hospital information tool with children, parents, and healthcare staff: a UX study

    , BMC Pediatrics, Vol: 20, ISSN: 1471-2431

    BACKGROUND: The hospital patient pathway for having treatment procedures can be daunting for younger patients and their family members, especially when they are about to undergo a complex intervention. Opportunities to mentally prepare young patients for their hospital treatments, e.g. for surgical procedures, include tools such as therapeutic clowns, medical dolls, or books and board games. However, while promising in reducing pre-operative anxiety and negative behaviours, they may be resource intensive, costly, and not always readily available. In this study, we co-designed a digital hospital information system with children, parents and clinicians, in order to prepare children undergoing medical treatment. METHOD: The study took place in the UK and consisted of two parts: In part 1, we purposively sampled 37 participants (n=22 parents, and n=15 clinicians) to understand perceptions and concerns of an hospital information platform specifically design for and addressed to children. In part 2, 14 children and 11 parents attended an audio and video recorded co-design workshop alongside a graphic designer and the research team to have their ideas explored and reflected on for the design of such information technology. Consequently, we used collected data to conduct thematic analysis and narrative synthesis. RESULTS: Findings from the survey were categorised into four themes: (1) the prospect of a hospital information system (parents' inputs); (2) content-specific information needed for the information system (parents' and clinicians' inputs); (3) using the virtual information system to connect young patients and parents (parents' inputs); and (4) how to use the virtual hospital information system from a clinician's perspective (clinicians' inputs). In contrast, the workshop highlighted points in times children were most distressed/relaxed, and derived the ideal hospital visit in both their and their parents' perspectives. CONCLUSIONS: The findings support the use of v

  • Journal article
    Huf S, Kerrison RS, King D, Chadborn T, Richmond A, Cunningham D, Friedman E, Shukla H, Tseng F-M, Judah G, Darzi A, Vlaev Iet al., 2020,

    Behavioral economics informed message content in text message reminders to improve cervical screening participation: Two pragmatic randomized controlled trials

    , Preventive Medicine, Vol: 139, ISSN: 0091-7435

    The objective of the reported research was to assess the impact of text message (SMS) reminders and their content on cervical screening rates. Women invited for cervical screening in Northwest London from February-October 2015 were eligible. 3133 women aged 24-29 (Study 1) were randomized (1, 1) to 'no SMS' (control), or a primary care physician (PCP) endorsed SMS (SMS-PCP). 11,405 women aged 30-64 (Study 2), were randomized (1, 1:1:1:1:1:1) to either: no SMS, an SMS without manipulation (SMS), the SMS-PCP, an SMS with a total or proportionate social norm (SMS-SNT or SMS-SNP), or an SMS with a gain-framed or loss-framed message (SMS-GF and SMS-LF). The primary outcome was participation at 18 weeks. In Study 1 participation was significantly higher in the SMS-PCP arm (31.4%) compared to control (26.4%, aOR, 1.29, 95%CI: 1.09-1·51; p = 0.002). In Study 2 participation was highest in the SMS-PCP (38.4%) and SMS (38.1%) arms compared to control (34.4%), (aOR: 1.19, 95%CI: 1.03-1.38; p = 0.02 and aOR: 1.18, 95%CI: 1.02-1.37; p = 0.03, respectively). The results demonstrate that behavioral SMSs improve cervical screening participation. The message content plays an important role in the impact of SMS. The results from this trial have already been used to designing effective policy for cervical cancer screening. The NHS Cervical Screening Programme started running a London-wide screening SMS campaign which was based on the cervical screening trial described here. According to figures published by Public Health England, after six months attendance increased by 4.8%, which is the equivalent of 13,400 more women being screened at 18 weeks.

  • Journal article
    Ghafur S, Van Dael J, Leis M, Darzi A, Sheikh Aet al., 2020,

    Public perceptions on data sharing: key insights from the UK and the USA

    , The Lancet Digital Health, Vol: 2, Pages: E444-E446, ISSN: 2589-7500
  • Journal article
    Flower B, Brown JC, Simmons B, Moshe M, Frise R, Penn R, Kugathasan R, Petersen C, Daunt A, Ashby D, Riley S, Atchison C, Taylor GP, Satkunarajah S, Naar L, Klaber R, Badhan A, Rosadas C, Kahn M, Fernandez N, Sureda-Vives M, Cheeseman H, O'Hara J, Fontana G, Pallett SJC, Rayment M, Jones R, Moore LSP, Cherapanov P, Tedder R, McClure M, Ashrafian H, Shattock R, Ward H, Darzi A, Elliott P, Barclay W, Cooke Get al., 2020,

    Clinical and laboratory evaluation of SARS-CoV-2 lateral flow assays for use in a national COVID-19 sero-prevalence survey

    , Thorax, Vol: 75, Pages: 1082-1088, ISSN: 0040-6376

    BackgroundAccurate antibody tests are essential to monitor the SARS-CoV-2 pandemic. Lateral flow immunoassays (LFIAs) can deliver testing at scale. However, reported performance varies, and sensitivity analyses have generally been conducted on serum from hospitalised patients. For use in community testing, evaluation of finger-prick self-tests, in non-hospitalised individuals, is required.MethodsSensitivity analysis was conducted on 276 non-hospitalised participants. All had tested positive for SARS-CoV-2 by RT-PCR and were ≥21d from symptom-onset. In phase I we evaluated five LFIAs in clinic (with finger-prick) and laboratory (with blood and sera) in comparison to a) PCR-confirmed infection and b) presence of SARS-CoV-2 antibodies on two “in-house” ELISAs. Specificity analysis was performed on 500 pre-pandemic sera. In phase II, six additional LFIAs were assessed with serum.Findings95% (95%CI [92.2, 97.3]) of the infected cohort had detectable antibodies on at least one ELISA. LFIA sensitivity was variable, but significantly inferior to ELISA in 8/11 assessed. Of LFIAs assessed in both clinic and laboratory, finger-prick self-test sensitivity varied from 21%-92% vs PCR-confirmed cases and 22%-96% vs composite ELISA positives. Concordance between finger-prick and serum testing was at best moderate (kappa 0.56) and, at worst, slight (kappa 0.13). All LFIAs had high specificity (97.2% - 99.8%).InterpretationLFIA sensitivity and sample concordance is variable, highlighting the importance of evaluations in setting of intended use. This rigorous approach to LFIA evaluation identified a test with high specificity (98.6% (95%CI [97.1, 99.4])), moderate sensitivity (84.4% with fingerprick (95%CI [70.5, 93.5])), and moderate concordance, suitable for seroprevalence surveys.

  • Journal article
    Atchison C, Pristerà P, Cooper E, Papageorgiou V, Redd R, Piggin M, Flower B, Fontana G, Satkunarajah S, Ashrafian H, Lawrence-Jones A, Naar L, Chigwende J, Gibbard S, Riley S, Darzi A, Elliott P, Ashby D, Barclay W, Cooke GS, Ward Het al., 2020,

    Usability and acceptability of home-based self-testing for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antibodies for population surveillance

    , Clinical Infectious Diseases, Vol: 2020, Pages: 1-10, ISSN: 1058-4838

    BACKGROUND: This study assesses acceptability and usability of home-based self-testing for SARS-CoV-2 antibodies using lateral flow immunoassays (LFIA). METHODS: We carried out public involvement and pilot testing in 315 volunteers to improve usability. Feedback was obtained through online discussions, questionnaires, observations and interviews of people who tried the test at home. This informed the design of a nationally representative survey of adults in England using two LFIAs (LFIA1 and LFIA2) which were sent to 10,600 and 3,800 participants, respectively, who provided further feedback. RESULTS: Public involvement and pilot testing showed high levels of acceptability, but limitations with the usability of kits. Most people reported completing the test; however, they identified difficulties with practical aspects of the kit, particularly the lancet and pipette, a need for clearer instructions and more guidance on interpretation of results. In the national study, 99.3% (8,693/8,754) of LFIA1 and 98.4% (2,911/2,957) of LFIA2 respondents attempted the test and 97.5% and 97.8% of respondents completed it, respectively. Most found the instructions easy to understand, but some reported difficulties using the pipette (LFIA1: 17.7%) and applying the blood drop to the cassette (LFIA2: 31.3%). Most respondents obtained a valid result (LFIA1: 91.5%; LFIA2: 94.4%). Overall there was substantial concordance between participant and clinician interpreted results (kappa: LFIA1 0.72; LFIA2 0.89). CONCLUSION: Impactful public involvement is feasible in a rapid response setting. Home self-testing with LFIAs can be used with a high degree of acceptability and usability by adults, making them a good option for use in seroprevalence surveys.

  • Journal article
    Fusari G, Gibbs E, Hoskin L, Dickens D, Leis M, Taylor E, Jones F, Darzi Aet al., 2020,

    Protocol for a feasibility study of OnTrack: a digital system for upper limb rehabilitation after stroke.

    , BMJ Open, Vol: 10, Pages: 1-10, ISSN: 2044-6055

    INTRODUCTION: Arm weakness is a common problem after stroke (affecting 450 000 people in the UK) leading to loss of independence. Repetitive activity is critical for recovery but research shows people struggle with knowing what or how much to do, and keeping track of progress. Working with more than 100 therapists (occupational therapists and physiotherapists) and patients with stroke, we codeveloped the OnTrack intervention-consisting of software for smart devices and coaching support-that has the potential to address this problem. This is a protocol to assess the feasibility of OnTrack for evaluation in a randomised control trial. METHODS AND ANALYSIS: A mixed-method, single-arm study design will be used to evaluate the feasibility of OnTrack for hospital and community use. A minimum sample of 12 participants from a stroke unit will be involved in the study for 14 weeks. During week 1, 8 and 14 participants will complete assessments relating to their arm function, arm impairment and activation. During weeks 2-13, participants will use OnTrack to track their arm movement in real time, receive motivational messages and face-to-face sessions to address problems, gain feedback on activity and receive self-management skills coaching. All equipment will be loaned to study participants. A parallel process evaluation will be conducted to assess the intervention's fidelity, dose and reach, using a mixed-method approach. A public and patient involvement group will oversee the study and help with interpretation and dissemination of qualitative and quantitative data findings. ETHICS AND DISSEMINATION: Ethical approval granted by the National Health Service Health Research Authority, Health and Care Research Wales, and the London-Surrey Research Ethics Committee (ref. 19/LO/0881). Trial results will be submitted for publication in peer review journals, presented at international conferences and disseminated among stroke communities. The results of this trial will inform

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