Imperial College London

Professor the Lord Darzi of Denham PC KBE FRS FMedSci HonFREng

Faculty of MedicineDepartment of Surgery & Cancer

Co-Director of the IGHI, Professor of Surgery
 
 
 
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Contact

 

+44 (0)20 3312 1310a.darzi

 
 
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Location

 

Queen Elizabeth the Queen Mother Wing (QEQM)St Mary's Campus

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Summary

 

Publications

Publication Type
Year
to

2252 results found

Riley S, Ainslie KEC, Eales O, Walters CE, Wang H, Atchinson CJ, Fronterre C, Diggle PJ, Ashby D, Donnelly CA, Cooke G, Barclay W, Ward H, Darzi A, Elliott Pet al., 2020, High prevalence of SARS-CoV-2 swab positivity and increasing R number in England during October 2020: REACT-1 round 6 interim report, Publisher: medRxiv

Background REACT-1 measures prevalence of SARS-CoV-2 infection in representative samples of the population in England using PCR testing from self-administered nose and throat swabs. Here we report interim results for round 6 of observations for swabs collected from the 16th to 25th October 2020 inclusive. Methods REACT-1 round 6 aims to collect data and swab results from 160,000 people aged 5 and above. Here we report results from the first 86,000 individuals. We estimate prevalence of PCR-confirmed SARS-CoV-2 infection, reproduction numbers (R) and temporal trends using exponential growth or decay models. Prevalence estimates are presented both unweighted and weighted to be representative of the population of England, accounting for response rate, region, deprivation and ethnicity. We compare these interim results with data from round 5, based on swabs collected from 18th September to 5th October 2020 inclusive. Results Overall prevalence of infection in the community in England was 1.28% or 128 people per 10,000, up from 60 per 10,000 in the previous round. Infections were doubling every 9.0 (6.1, 18) days with a national reproduction number (R) estimated at 1.56 (1.27, 1.88) compared to 1.16 (1.05, 1.27) in the previous round. Prevalence of infection was highest in Yorkshire and The Humber at 2.72% (2.12%, 3.50%), up from 0.84% (0.60%, 1.17%), and the North West at 2.27% (1.90%, 2.72%), up from 1.21% (1.01%, 1.46%), and lowest in South East at 0.55% (0.45%, 0.68%), up from 0.29% (0.23%, 0.37%). Clustering of cases was more prevalent in Lancashire, Manchester, Liverpool and West Yorkshire, West Midlands and East Midlands. Interim estimates of R were above 2 in the South East, East of England, London and South West, but with wide confidence intervals. Nationally, prevalence increased across all age groups with the greatest increase in those aged 55-64 at 1.20% (0.99%, 1.46%), up 3-fold from 0.37% (0.30%, 0.46%). In those aged over 65, prevalence was 0.81% (0.58%, 0

Working paper

Avery J, Shulakova D, Runciman M, Mylonas GP, Darzi Aet al., 2020, Tactile sensor for minimally invasive surgery using Electrical Impedance Tomography, IEEE Transactions on Medical Robotics and Bionics, Vol: 2, Pages: 561-564, ISSN: 2576-3202

Whilst offering numerous benefits to patients, minimally invasive surgery (MIS) has a disadvantage in the loss of tactile feedback to the surgeon, traditionally offering valuable qualitative tissue assessment, such as tumour identification and localisation. Tactile sensors aim to overcome this loss of sensation by detecting tissue characteristics such as stiffness, composition and temperature. Tactile sensors have previously been incorporated into MIS robotic end effectors, which require lengthy scanning procedures due to localised sensitivity. Distributed tactile sensors, or “artificial skin” offer a map of tissue properties in a single instance but are often not suitable for MIS applications due to limited biocompatibility or large collapsed volumes. We propose a deployable, soft, tactile sensor with a deformable saline chamber and integrated Electrical Impedance Tomography (EIT) electrodes. During contact with tissue, the saline is displaced from the chamber and the lesion size and stiffness can be inferred from the resultant impedance changes. Through optimisation of the EIT measurement protocol and hardware the sensor was capable of localising the centre of mass of palpation targets within 1.5 mm in simulation and 2.3–4.6mm in phantom experiments. Reconstructed image metrics differentiated target objects from 8–30 mm.

Journal article

Ashcroft J, Patel R, Woods A, Darzi A, Singh H, Leff Det al., 2020, Prefrontal transcranial direct-current stimulation improves early technical skills in surgery, Brain Stimulation, Vol: 13, Pages: 1834-1841, ISSN: 1876-4754

BackgroundStudies applying transcranial direct-current stimulation (tDCS) to motor regions to enhance surgical skills have observed modest benefits in performance. Early surgical skills acquisition is known to be dependent on the prefrontal cortex (PFC) which could be a suitable target for performance enhancement in fields with high cognitive demand.ObjectiveTo assess whether prefrontal tDCS could improve early phases of surgical skill development.MethodsIn a randomized sham-controlled double-blind parallel design, 40 surgical novices performed an open knot-tying task repeated in three blocks; pre-, online- and post-tDCS. During online stimulation, participants were randomized to either active tDCS (2 mA for 15 min) to the prefrontal cortex (anode over F3, cathode over F4) or sham tDCS. Performance score (PS) was computed using a validated algorithm and introspective workload domains were assessed using a SURG-TLX questionnaire.ResultsThere was no difference in demographics or PS between groups prior to receiving tDCS. PS significantly improved from pre-to online- (p < 0.001) and from pre-to post-tDCS (p < 0.001) in the active group only. Following active tDCS, PS was closer to the defined proficiency benchmark and significantly greater compared to sham (p = 0.002). Only the active group reported significantly improved temporal demand scores from pre-to online- (p = 0.004) to post-tDCS (p = 0.002).ConclusionsThis study demonstrates significantly improved early phase surgical-skill acquisition following prefrontal tDCS. Further work is required to determine the underlying neurophysiological mechanisms and whether the benefits observed are retained long-term.

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., 2020, High and increasing prevalence of SARS-CoV-2 swab positivity in England during end September beginning October 2020: REACT-1 round 5 updated report

<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>REACT-1 is quantifying prevalence of SARS-CoV-2 infection among random samples of the population in England based on PCR testing of self-administered nose and throat swabs. Here we report results from the fifth round of observations for swabs collected from the 18th September to 5th October 2020. This report updates and should be read alongside our round 5 interim report.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Representative samples of the population aged 5 years and over in England with sample size ranging from 120,000 to 175,000 people at each round. Prevalence of PCR-confirmed SARS-CoV-2 infection, estimation of reproduction number (R) and time trends between and within rounds using exponential growth or decay models.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>175,000 volunteers tested across England between 18th September and 5th October. Findings show a national prevalence of 0.60% (95% confidence interval 0.55%, 0.71%) and doubling of the virus every 29 (17, 84) days in England corresponding to an estimated national R of 1.16 (1.05, 1.27). These results correspond to 1 in 170 people currently swab-positive for the virus and approximately 45,000 new infections each day. At regional level, the highest prevalence is in the North West, Yorkshire and The Humber and the North East with strongest regional growth in North West, Yorkshire and The Humber and West Midlands.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Rapid growth has led to high prevalence of SARS-CoV-2 virus in England, with highest rates in the North of England. Prevalence has increased in all age groups, including those at highest risk. Improved compliance with existing policy and, as necessar

Working paper

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

Aufegger L, Khanh Ha B, Colin B, Ara Det al., 2020, Developing a paediatric virtual hospital information system with children, parents, and healthcare staff: A UX design study, BMC Pediatrics, Vol: 20, ISSN: 1471-2431

BackgroundThe 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.MethodThe 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.ResultsFindings 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.ConclusionsTh

Journal article

Story GW, Kurth-Nelson Z, Crockett M, Vlaev I, Darzi A, Dolan RJet al., 2020, Social discounting of pain, Journal of the Experimental Analysis of Behavior, Vol: 114, Pages: 308-325, ISSN: 0022-5002

Impatience can be formalized as a delay discount rate, describing how the subjective value of reward decreases as it is delayed. By analogy, selfishness can be formalized as a social discount rate, representing how the subjective value of rewarding another person decreases with increasing social distance. Delay and social discount rates for reward are correlated across individuals. However no previous work has examined whether this relationship also holds for aversive outcomes. Neither has previous work described a functional form for social discounting of pain in humans. This is a pertinent question, since preferences over aversive outcomes formally diverge from those for reward. We addressed this issue in an experiment in which healthy adult participants (N = 67) chose the timing and intensity of hypothetical pain for themselves and others. In keeping with previous studies, participants showed a strong preference for immediate over delayed pain. Participants showed greater concern for pain in close others than for their own pain, though this hyperaltruism was steeply discounted with increasing social distance. Impatience for pain and social discounting of pain were weakly correlated across individuals. Our results extend a link between impatience and selfishness to the aversive domain.

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., 2020, High prevalence of SARS-CoV-2 swab positivity in England during September 2020: interim report of round 5 of REACT-1 study, Publisher: Cold Spring Harbor Laboratory Press

Background REACT-1 is a community survey of PCR confirmed swab-positivity for SARS-CoV-2 among random samples of the population in England. This interim report includes data from the fifth round of data collection currently underway for swabs sampled from the 18th to 26th September 2020.Methods Repeated cross-sectional surveys of random samples of the population aged 5 years and over in England with sample size ranging from 120,000 to 160,000 people in each round of data collection. Collection of self-administered nose and throat swab for PCR and questionnaire data. Prevalence of swab-positivity by round and by demographic variables including age, sex, region, ethnicity. Estimation of reproduction number (R) between and within rounds, and time trends using exponential growth or decay model. Assessment of geographical clustering based on boundary-free spatial model.Results Over the 9 days for which data are available, we find 363 positives from 84,610 samples giving a weighted prevalence to date of 0.55% (0.47%, 0.64%) in round 5. This implies that 411,000 (351,000, 478,000) people in England are virus-positive under the assumption that the swab assay is 75% sensitive. Using data from the most recent two rounds, we estimate a doubling time of 10.6 (9.4, 12.0) days covering the period 20th August to 26th September, corresponding to a reproduction number R of 1.47 (1.40, 1.53). Using data only from round 5 we estimate a reproduction number of 1.06 (0.74, 1.46) with probability of 63% that R is greater than 1. Between rounds 4 and 5 there was a marked increase in unweighted prevalence at all ages. In the most recent data, prevalence was highest in the 18 to 24 yrs age group at 0.96% (0.68%, 1.36%). At 65+ yrs prevalence increased 7-fold between rounds 4 and 5 from 0.04% (0.03%, 0.07%) to 0.29% (0.23%, 0.37%). Prevalence increased in all regions between rounds 4 and 5, giving the highest unweighted prevalence in round 5 in the North West at 0.86% (0.69%, 1.06%). In Lond

Working paper

Evans-Harvey K, Erridge S, Karamchandani U, Abdalla S, Beatty JW, Darzi A, Purkayastha S, Sodergren MHet al., 2020, Comparison of surgeon gaze behaviour against objective skill assessment in laparoscopic cholecystectomy-a prospective cohort study, International Journal of Surgery, Vol: 82, Pages: 149-155, ISSN: 1743-9159

BackgroundEye tracking technology may provide the basis of a novel, objective technical skill assessment in surgery. Past research has showed differences in the gaze patterns between expert and novice surgeons. The aim of this study was to investigate the relationship between gaze behaviors and technical skill during laparoscopic cholecystectomy as determined by objective assessment scores.MethodsGaze behaviors of surgeons performing laparoscopic cholecystectomies were mapped using wearable eye tracking apparatus. Two impartial surgeons retrospectively analyzed video footage of the procedure to perform Objective Structured Assessment of Technical Skill (OSATS) assessments. Primary endpoints were correlation between gaze behaviours (dwell time (%) and fixation frequency (count/s)) and OSATS scores. Dwell time was defined as the percentage of time spent fixating on particular visual areas of interest (AOI). Pearson's correlation coefficient was used to estimate the relationship between primary endpoints and AOIs. Statistical significance was set at p < 0.05.Results13 procedures were analyzed. Throughout all operative segments, a negative correlation was present between operating theatre dwell time and OSATS scores (p < 0.05). During dissection of Calot's triangle, there was a strong positive correlation between laparoscopic screen dwell time and OSATS scoring [r = 0.655, p < 0.05]. Scrub nurse dwell time during dissection of Calot's triangle showed a strong negative correlation with OSATS scoring [r = −0.619, p < 0.05]. During dissection of gallbladder fossa, operating theatre fixation frequency negatively correlated against OSATS scores [r = −0.566, p < 0.05].ConclusionThe results suggest a greater focus on significant visual stimuli alongside a lack of attention to non-essential stimuli during critical stages of the operative period is associated with greater technical skill. This aids the validation of eye tracking as an adjunct high-stak

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

Modi H, Singh H, Darzi A, Leff Det al., 2020, Multitasking and time pressure in the operating room: impact on surgeons’ brain function, Annals of Surgery, Vol: 272, Pages: 648-657, ISSN: 0003-4932

Objective:To assess the impact of multitasking and time pressure on surgeons’ brain function during laparoscopic suturing.Summary Background Data:Recent neuroimaging evidencesuggests that deterioration in surgical performance under time pressure is associated with deactivationof the prefrontal cortex (PFC),an area important for executive functions. However, the effect ofmultitasking on operator brain functionremains unknown.Methods:29surgical residentsperformed anintracorporealsuturing task under fourconditions: 1) self-pacedsuturing,2) time-pressured suturing, 3) self-paced suturingplus decision-making, and 4) time-pressured suturing plus decision-making. Subjectiveworkload was quantified using the Surgical Task Load Index. Technical skill was objectively assessed using task progression scores, error scores, leak volumes, and knot tensile strengths. PFC activation was measuredusing optical neuroimaging. Results:Compared with self-paced suturing, subjective workload(au)was significantly greater in time-pressuredsuturing (146.0 vs. 196.0), suturing with decision-making (146.0 vs.182.0), and time-pressuredsuturing with decision-making (146.0 vs.227.0). Technical performance duringcombined suturing and decision-making taskswas inferiortosuturing alone undertime pressure orself-paced conditions(p<0.001).Significant dorsolateral PFC (DLPFC) activations were observed during self-paced suturing, and ventrolateral PFC (VLPFC) deactivations were identified during time-pressuredsuturing. However, suturing in conjunction withdecision-making resulted in 2significantdeactivation across boththe VLPFC and DLPFC (p<0.05). Random effects regression analysis confirmed decision-making predicts VLPFC and DLPFC deactivation (z=-2.62, p<0.05).Conclusions:Performance degradation during high workload conditions is associated with deactivation of prefrontal regions important fo

Journal article

McKinney SM, Sieniek M, Godbole V, Godwin J, Antropova N, Ashrafian H, Back T, Chesus M, Corrado GS, Darzi A, Etemadi M, Garcia-Vicente F, Gilbert FJ, Halling-Brown M, Hassabis D, Jansen S, Karthikesalingam A, Kelly CJ, King D, Ledsam JR, Melnick D, Mostofi H, Peng L, Reicher JJ, Romera-Paredes B, Sidebottom R, Suleyman M, Tse D, Young KC, De Fauw J, Shetty Set al., 2020, Addendum: International evaluation of an AI system for breast cancer screening., Nature, Vol: 586, Pages: E19-E19, ISSN: 0028-0836

Journal article

Cruz Rivera S, Liu X, Chan A-W, Denniston AK, Calvert MJ, Ashrafian H, Beam AL, Collins GS, Darzi A, Deeks JJ, ElZarrad MK, Espinoza C, Esteva A, Faes L, Ferrante di Ruffano L, Fletcher J, Golub R, Harvey H, Haug C, Holmes C, Jonas A, Keane PA, Kelly CJ, Lee AY, Lee CS, Manna E, Matcham J, McCradden M, Moher D, Monteiro J, Mulrow C, Oakden-Rayner L, Paltoo D, Panico MB, Price G, Rowley S, Savage R, Sarkar R, Vollmer SJ, Yau Cet al., 2020, Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension, The Lancet Digital Health, Vol: 2, Pages: e549-e560, ISSN: 2589-7500

The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations for the handling of input and output data, the human–AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understan

Journal article

Maurice J, Lett A, Skinner C, Lim A, Richardson M, Painadath Thomas A, Summers P, Vyas K, Tadbier A, Vilar R, Kuimova M, Miodragovic S, Vergis N, Kelly P, Cordeiro M, Hoare J, Darzi A, Goldin R, Thursz M, Thompson Aet al., 2020, Transcutaneous fluorescence spectroscopy as a tool for non-invasive monitoring of gut function: first clinical experiences, Scientific Reports, Vol: 10, ISSN: 2045-2322

Gastro-intestinal function plays a vital role in conditions ranging from inflammatory bowel disease and HIV through to sepsis and malnutrition. However, the techniques that are currently used to assess gut function are either highly invasive or unreliable. Here we present an alternative, non-invasive sensing modality for assessment of gut function based on fluorescence spectroscopy. In this approach, patients receive an oral dose of a fluorescent contrast agent and a fibre-optic probe is used to make fluorescence measurements through the skin. This provides a readout of the degree to which fluorescent dyes have permeated from the gut into the blood stream. We present preliminary results from our first measurements in human volunteers demonstrating the potential of the technique for non-invasive monitoring of multiple aspects of gastro-intestinal health.

Journal article

Harlow C, Sivananthan A, Ayaru L, Patel K, Darzi A, Patel Net al., 2020, Endoscopic submucosal dissection: an update on tools and accessories, Therapeutic Advances in Gastrointestinal Endoscopy, Vol: 13, Pages: 1-13, ISSN: 2631-7745

Endoscopic submucosal dissection (ESD) is a minimally invasive therapeutic procedure to remove larger polyps or early non-metastatic lesions. It has long been used in Asia, but is now fast growing in popularity in the West.There are multiple challenges faced by ESD practitioners. While the practice of ESD in gastric lesions is relatively well established, the oesophagus with its narrow lumen and challenging workspace, and the colon with its tortuous course and folds are more challenging frontiers. The nature of performing a procedure endoscopically means that conventional methods offer no mechanism for providing counter-traction while performing dissection, impeding visibility and increasing the rate of complications.There are a multitude of tools available to those performing ESD for the different stages of the procedure. This article reviews the accessories currently used in regular ESD practice including the knives used to cut and dissect lesions, the cap and hood devices used to improve visibility and safety, injection fluids to lift the submucosal plane, haemostatic devices, generators, and finally, emerging traction apparatus. There is some evidence behind the use of these tools, however, ESD remains the domain of a small number of practitioners and the practice relies heavily on expert experience. Evolution of the ESD toolbox will make the procedure more accessible to more endoscopists, which in turn will drive the development of a more substantial evidence base to evaluate efficacy and safety of the multitude of tools.

Journal article

Aufegger L, Alabi M, Darzi A, Bicknell Cet al., 2020, Sharing leadership: current attitudes, barriers and needs of clinical and non-clinical managers in UK’s integrated care system, BMJ Leader, Vol: 4, Pages: 128-134, ISSN: 2398-631X

Background As systems become more complex, shared leadership (SL) has been suggested to have a dominant role in improving cross-functional working tailored to organisational needs. Little, however, is known about the benefits of SL in healthcare management, especially for UK’s recently formed integrated care system (ICS). The aim of this study was to understand current attitudes, barriers and needs of clinical and non-clinical managers sharing leadership responsibilities in the ICS.Method Twenty clinical and non-clinical leaders in 15 organisations were interviewed to understand current cross-functional leadership collaborations, and the potential SL may have on the recently established ICS in the National Health Service (NHS). The data were transcribed and analysed thematically.Results Findings showed perceptions and experiences of clinical and non-clinical healthcare management in relation to: (1) motivation to execute a leadership position, including the need to step up and a sense of duty; (2) attitudes towards interdisciplinary working, which is reflected in conflicts due to different values and expertise; (3) SL skills and behaviours, including the need for mutual understanding and cooperative attitudes by means of effective communication and collaboration; and (4) barriers to achieve SL in the ICS, such as bureaucracy, and a lack of time and support.Conclusions SL may help improve current leadership cultures within the NHS; however, for SL to have a tangible impact, it needs to be delivered as part of leadership development for doctors in postgraduate training, and development programmes for aspiring, emerging and established leaders, with clear lines of communication.

Journal article

Davids J, Manivannan S, Darzi A, Giannarou S, Ashrafian H, Marcus HJet al., 2020, Simulation for skills training in neurosurgery: a systematic review, meta-analysis, and analysis of progressive scholarly acceptance., Neurosurgical Review, Vol: 44, Pages: 1853-1867, ISSN: 0344-5607

At a time of significant global unrest and uncertainty surrounding how the delivery of clinical training will unfold over the coming years, we offer a systematic review, meta-analysis, and bibliometric analysis of global studies showing the crucial role simulation will play in training. Our aim was to determine the types of simulators in use, their effectiveness in improving clinical skills, and whether we have reached a point of global acceptance. A PRISMA-guided global systematic review of the neurosurgical simulators available, a meta-analysis of their effectiveness, and an extended analysis of their progressive scholarly acceptance on studies meeting our inclusion criteria of simulation in neurosurgical education were performed. Improvement in procedural knowledge and technical skills was evaluated. Of the identified 7405 studies, 56 studies met the inclusion criteria, collectively reporting 50 simulator types ranging from cadaveric, low-fidelity, and part-task to virtual reality (VR) simulators. In all, 32 studies were included in the meta-analysis, including 7 randomised controlled trials. A random effects, ratio of means effects measure quantified statistically significant improvement in procedural knowledge by 50.2% (ES 0.502; CI 0.355; 0.649, p < 0.001), technical skill including accuracy by 32.5% (ES 0.325; CI - 0.482; - 0.167, p < 0.001), and speed by 25% (ES - 0.25, CI - 0.399; - 0.107, p < 0.001). The initial number of VR studies (n = 91) was approximately double the number of refining studies (n = 45) indicating it is yet to reach progressive scholarly acceptance. There is strong evidence for a beneficial impact of adopting simulation in the improvement of procedural knowledge and technical skill. We show a growing trend towards the adoption of neurosurgical simulators, although we have not fully gained progressive scholarly acceptance for VR-based simulation technologies in neurosurgical education.

Journal article

Dawidziuk A, Patel R, Darzi A, Leff D, Singh Het al., 2020, The Impact of tDCS on fNIRS Haemodynamic Responses During a Surgical Task: A Pilot Study, London Surgical Symposium 2020

Conference paper

Dawidziuk A, Patel R, Darzi A, Leff D, Singh Het al., 2020, Using Optical Neuroimaging to Reveal Mechanisms of Augmentation by Transcranial Electrical Stimulation (TES): A Systematic Review, Brainbox Initiative Virtual Conference 2020

Conference paper

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., 2020, Resurgence of SARS-CoV-2 in England: detection by community antigen surveillance

<jats:title>Summary</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Based on cases and deaths, transmission of SARS-CoV-2 in England peaked in late March and early April 2020 and then declined until the end of June. Since the start of July, cases have increased, while deaths have continued to decrease.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We report results from 594,000 swabs tested for SARS-CoV-2 virus obtained from a representative sample of people in England over four rounds collected regardless of symptoms, starting in May 2020 and finishing at the beginning of September 2020. Swabs for the most recent two rounds were taken between 24th July and 11th August and for round 4 between 22nd August and 7th September. We estimate weighted overall prevalence, doubling times between and within rounds and associated reproduction numbers. We obtained unweighted prevalence estimates by sub-groups: age, sex, region, ethnicity, key worker status, household size, for which we also estimated odds of infection. We identified clusters of swab-positive participants who were closer, on average, to other swab-positive participants than would be expected.</jats:p></jats:sec><jats:sec><jats:title>Findings</jats:title><jats:p>Over all four rounds of the study, we found that 72% (67%, 76%) of swab-positive individuals were asymptomatic at the time of swab and in the week prior. The epidemic declined between rounds 1 and 2, and rounds 2 and 3. However, the epidemic was increasing between rounds 3 and 4, with a doubling time of 17 (13, 23) days corresponding to an R value of 1.3 (1.2, 1.4). When analysing round 3 alone, we found that the epidemic had started to grow again with 93% probability. Using only the most recent round 4 data, we estimated a doubling time of 7.7 (5.5, 12.7) days, corresponding to an R value of 1.7 (1.4, 2.0). Cy

Working paper

Rivera SC, Liu X, Chan A-W, Denniston AK, Calvert MJ, Ashrafian H, Beam AL, Collins GS, Darzi A, Deeks JJ, ElZarrad MK, Espinoza C, Esteva A, Faes L, Di Ruffano LF, Fletcher J, Golub R, Harvey H, Haug C, Holmes C, Jonas A, Keane PA, Kelly CJ, Lee AY, Lee CS, Manna E, Matcham J, McCradden M, Moher D, Monteiro J, Mulrow C, Oakden-Rayner L, Paltoo D, Panico MB, Price G, Rowley S, Savage R, Sarkar R, Vollmer SJ, Yau Cet al., 2020, Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension, BMJ: British Medical Journal, Vol: 370, Pages: 1-14, ISSN: 0959-535X

The SPIRIT 2013 (The Standard Protocol Items: Recommendations for Interventional Trials) statement aims to improve the completeness of clinical trial protocol reporting, by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there is a growing recognition that interventions involving artificial intelligence need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes.The SPIRIT-AI extension is a new reporting guideline for clinical trials protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI. Both guidelines were developed using a staged consensus process, involving a literature review and expert consultation to generate 26 candidate items, which were consulted on by an international multi-stakeholder group in a 2-stage Delphi survey (103 stakeholders), agreed on in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants).The SPIRIT-AI extension includes 15 new items, which were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations around the handling of input and output data, the human-AI interaction and analysis of error cases.SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer-reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.

Journal article

Liu X, Rivera SC, Moher D, Calvert MJ, Denniston AK, Ashrafian H, Beam AL, Chan A-W, Collins GS, Darzi A, Deeks JJ, ElZarrad MK, Espinoza C, Esteva A, Faes L, Di Ruffano LF, Fletcher J, Golub R, Harvey H, Haug C, Holmes C, Jonas A, Keane PA, Kelly CJ, Lee AY, Lee CS, Manna E, Matcham J, McCradden M, Monteiro J, Mulrow C, Oakden-Rayner L, Paltoo D, Panico MB, Price G, Rowley S, Savage R, Sarkar R, Vollmer SJ, Yau Cet al., 2020, Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI Extension, BMJ: British Medical Journal, Vol: 370, ISSN: 0959-535X

The CONSORT 2010 (Consolidated Standards of Reporting Trials) statement provides minimum guidelines for reporting randomised trials. Its widespread use has been instrumental in ensuring transparency when evaluating new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes.The CONSORT-AI extension is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI. Both guidelines were developed through a staged consensus process, involving a literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed on in a two-day consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants).The CONSORT-AI extension includes 14 new items, which were considered sufficiently important for AI interventions, that they should be routinely reported in addition to the core CONSORT 2010 items. CONSORT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention is integrated, the handling of inputs and outputs of the AI intervention, the human-AI interaction and providing analysis of error cases.CONSORT-AI will help promote transparency and completeness in reporting clinical trials for AI interventions. It will assist editors and peer-reviewers, as well as the general readership, to understand, interpret and critically appraise the quality of clinical trial design and risk of bias in the reported outcomes.

Journal article

Cruz Rivera S, Liu X, Chan A-W, Denniston AK, Calvert MJ, SPIRIT-AI and CONSORT-AI Working Group, SPIRIT-AI and CONSORT-AI Steering Group, SPIRIT-AI and CONSORT-AI Consensus Groupet al., 2020, Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension, Nature Medicine, Vol: 26, Pages: 1351-1363, ISSN: 1078-8956

The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations for the handling of input and output data, the human-AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, int

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

Liu X, Cruz Rivera S, Moher D, Calvert MJ, Denniston AK, SPIRIT-AI and CONSORT-AI Working Groupet al., 2020, Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension., Nat Med, Vol: 26, Pages: 1364-1374

The CONSORT 2010 statement provides minimum guidelines for reporting randomized trials. Its widespread use has been instrumental in ensuring transparency in the evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes. The CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a two-day consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The CONSORT-AI extension includes 14 new items that were considered sufficiently important for AI interventions that they should be routinely reported in addition to the core CONSORT 2010 items. CONSORT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention is integrated, the handling of inputs and outputs of the AI intervention, the human-AI interaction and provision of an analysis of error cases. CONSORT-AI will help promote transparency and completeness in reporting clinical trials for AI interventions. It will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the quality of clinical trial design and risk of bias in the reported outcomes.

Journal article

Kontovounisios C, 2020, The impact of the COVID-19 pandemic on colorectal cancer service provision, British Journal of Surgery, Vol: 107, Pages: E521-E522, ISSN: 0007-1323

Journal article

Neves AL, Smalley K, Freise L, Harrison P, Darzi A, Mayer Eet al., 2020, Sharing electronic health records with patients - Who is using the Care Information Exchange portal? A cross-sectional study., Publisher: JMIR Preprints

Background:Sharing electronic health records with patients has been shown to improve patient safety and quality of care, and patient portals represent a powerful and convenient tool to enhance patient access to their own healthcare data. However, adoption rates vary widely across countries and, within countries, across regions and health systems. A better understanding of the characteristics of users and non-users is critical to understand which groups remain underserved or excluded from using such tools.Objective:To identify the determinants of usage of the Care Information Exchange (CIE), a shared patient portal program in the United Kingdom.Methods:A cross-sectional study was conducted, using an online questionnaire. Individual-level data from patients registered in the CIE portal were collected, including age, gender, ethnicity, educational level, health status, postcode, and digital literacy (using the eHEALS tool). Registered individuals were defined as having an account created in the portal, independent of their actual use of the platform, and users were defined as having ever used the portal. Multivariate logistic regression was used to model the probability of being a user. Statistical analysis was performed in R, and Tableau ® was used to create maps of the proportion of CIE users by postcode area.Results:A total of 1,083 subjects replied to the survey (+186% of the estimated minimum target sample). The proportion of users was 61.6% (n=667), and within these, the majority (57.7%, n=385) used the portal at least once a month. To characterise the users and non-users of the system, we performed a sub-analysis of the sample, including only participants that have provided at least information regarding gender and age category. The sub-analysis included 650 individuals (59.8% women, 84.8% over 40 years). The majority of the subjects were white (76.6%, n=498), resident in London (64.7%, n=651), and lived in North West London (55.9%, n=363). Individuals with

Working paper

Ward H, Atchison C, Whitaker M, Ainslie K, Elliot J, Okell L, Redd R, Ashby D, Donnelly C, Barclay W, Darzi A, Cooke G, Riley S, Elliot Pet al., 2020, Antibody prevalence for SARS-CoV-2 in England following first peak of the pandemic: REACT2 study in 100,000 adults, Publisher: bioRxiv

Background England, UK has experienced a large outbreak of SARS-CoV-2 infection. As in USA and elsewhere, disadvantaged communities have been disproportionately affected. Methods National REal-time Assessment of Community Transmission-2 (REACT-2) seroprevalence study using self-administered lateral flow immunoassay (LFIA) test for IgG among a random population sample of 100,000 adults over 18 years in England, 20 June to 13 July 2020. Results Completed questionnaires were available for 109,076 participants, yielding 5,544 IgG positive results and adjusted (for test performance), re-weighted (for sampling) prevalence of 6.0% (95% CI: 5.8, 6.1). Highest prevalence was in London (13.0% [12.3, 13.6]), among people of Black or Asian (mainly South Asian) ethnicity (17.3% [15.8, 19.1] and 11.9% [11.0, 12.8] respectively) and those aged 18-24 years (7.9% [7.3, 8.5]). Care home workers with client-facing roles had adjusted odds ratio of 3.1 (2.5, 3.8) compared with non-essential workers. One third (32.2%, [31.0-33.4]) of antibody positive individuals reported no symptoms. Among symptomatic cases, the majority (78.8%) reported symptoms during the peak of the epidemic in England in March (31.3%) and April (47.5%) 2020. We estimate that 3.36 million (3.21, 3.51) people have been infected with SARS-CoV-2 in England to end June 2020, with an overall infection fatality ratio of 0.90% (0.86, 0.94). Conclusion The pandemic of SARS-CoV-2 infection in England disproportionately affected ethnic minority groups and health and care home workers. The higher risk of infection in these groups may explain, at least in part, their increased risk of hospitalisation and mortality from COVID-19.

Working paper

Soukup T, Lamb BW, Morbi A, Shah NJ, Bali A, Asher V, Gandamihardja T, Giordano P, Darzi A, Green JSA, Sevdalis Net al., 2020, A multicentre cross-sectional observational study of cancer multidisciplinary teams: Analysis of team decision making, Cancer Medicine, Vol: 9, Pages: 7083-7099, ISSN: 2045-7634

BackgroundMultidisciplinary teams (MDT) formulate expert informed treatment recommendations for people with cancer. We set out to examine how the factors proposed by the functional perspective of group decision making (DM), that is, interaction process, internal factors (factors emanating from within the group such as group size), external circumstances (factors coming from the outside of the team), and case‐complexity affect the quality of MDT decision making.MethodsThis was a cross‐sectional observational study. Three cancer MDTs were recruited with 44 members overall and 30 of their weekly meetings filmed. Validated observational instruments were used to measure quality of DM, interactions, and complexity of 822 case discussions.ResultsThe full regression model with the variables proposed by the functional perspective was significant, R2 = 0.52, F(20, 801) = 43.47, P < .001, adjusted R2 = 0.51. Positive predictors of DM quality were asking questions (P = .001), providing answers (P = .001), team size (P = .007), gender balance (P = .003), and clinical complexity (P = .001), while negative socioemotional reactions (P = .007), gender imbalance (P = .003), logistical issues (P = .001), time‐workload pressures (P = .002), and time spent in the meeting (P = .001) were negative predictors. Second half of the meetings also saw significant decrease in the DM quality (P = .001), interactions (P = .001), group size (P = .003), and clinical complexity (P = .001), and an increase in negative socioemotional reactions (P = .001) and time‐workload pressures (P = .001).DiscussionTo the best of our knowledge, this is the first study to attempt to assess the factors proposed by the functional perspective in cancer MDTs. One novel finding is the effect of sociocognitive factors on team DM quality, while another is the cognitive‐catch 22 effect: while the case discussions are significantly simpler in the second half of the meeting, there is significantly less time left to discuss

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

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