This report was supported by grants from - Spiral: Home



Public acceptability of computer-controlled antibiotic management: an exploration of automated dosing and opportunities for implementationTimothy M Rawson1, Damien Ming1, Sally AN Gowers2, David ME Freeman3, Pau Herrero4, Pantelis Georgiou4, Anthony E Cass3, Danny O’Hare2, Alison H Holmes1Affiliations:National Institute for Health Research Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, Imperial College London, Hammersmith Campus, Du Cane Road, London. W12 0NN. United Kingdom.Department of Bioengineering, Imperial College London, South Kensington Campus, London, SW7 2AZ, United KingdomDepartment of Chemistry, Imperial College London, South Kensington Campus, London, SW7 2AZ, United KingdomDepartment of Electrical and Electronic Engineering, Imperial College London, South Kensington Campus, London, SW7 2AZ, United Kingdom*Corresponding author:Dr Timothy M Rawson, Health Protection Research Unit in Healthcare Associated Infections & Antimicrobial Resistance, Hammersmith Hospital, Du Cane Road, London.W12 0NN. United Kingdom. Email: timothy.rawson07@imperial.ac.ukTelephone: 02033132732.Running Title: Citizen perceptions on biosensor technologySearch terms: Patient and Public Engagement, biosensors, machine learningAbstractA paucity of data describing citizen perceptions of novel technologies, including those containing unsupervised computer-controlled systems is currently available. We explored citizen perceptions of using a microneedle biosensor and automated dose control system at a university public festival. Groups of citizens (from 2-6 people per group) attended a short demonstration of a microneedle biosensor and automated dosing system versus a traditional phlebotomy approach over a two-day public festival. Individual groups discussed and reached consensus on a number of short questions regarding their perceptions on the acceptability of such technology. Over the two days, 100 groups participated (56/100 day 1 and 44/100 day 2). The majority of individuals reported high acceptability of microneedle technology (median Likert score 9/10), but the majority believed that doctors should decide what dose of antibiotic is delivered (75/100; 75%). Groups concurred with the acceptability of microneedles to reduce blood tests and pain associated with them. However, concerns were reported over unsupervised computer-controlled programmes making decision about antibiotic dosing. This was driven by concerns over computer error and the inability of systems to contextualise decision making to the human and social context. Future work must consider the greater role of citizen engagement in the development of such technologies, to ensure their acceptability upon implementation in clinical practice.Word count: Abstract: 210Text: 1006Figures: 1Main textDear Editor, We read with interest the article by Pan and colleagues on the role of aptamers in infectious diseases.ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1016/j.jinf.2018.04.007", "ISSN" : "01634453", "author" : [ { "dropping-particle" : "", "family" : "Pan", "given" : "Qin", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Luo", "given" : "Fengling", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Liu", "given" : "Min", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Zhang", "given" : "Xiao-Lian", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Journal of Infection", "id" : "ITEM-1", "issue" : "2", "issued" : { "date-parts" : [ [ "2018", "8" ] ] }, "page" : "83-98", "title" : "Oligonucleotide aptamers: promising and powerful diagnostic and therapeutic tools for infectious diseases", "type" : "article-journal", "volume" : "77" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "¹", "plainTextFormattedCitation" : "1", "previouslyFormattedCitation" : "[1]" }, "properties" : { }, "schema" : "" }1 As well as diagnostic and drug delivery, aptamers have a potential role for facilitating the real-time monitoring of antimicrobial therapy. Within healthcare there is a strong emphasis on the development and introduction of novel technologies, including those that make automated, computer-controlled decisions.ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1097/00000542-200201000-00017", "ISSN" : "0003-3022", "PMID" : "11753004", "abstract" : "Background: The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. A closed-loop anesthesia system was built using BIS as the control variable, a proportional-integral-differential control algorithm, and a propofol target-controlled infusion system as (lie control actuator. Closed-loop performance was assessed in 10 adult patients. Methods: Ten adult patients scheduled to undergo elective hip or knee surgery were enrolled. An epidural cannula was inserted, and 0.5% bupivacaine was used to provide anesthesia to T8 before general anesthesia was Induced using (lie propofol target-controlled infusion system under manual control. After the start of surgery, when anesthesia was clinically adequate, automatic control of anesthesia was commenced using the BIS as the control variable. Adequacy of anesthesia during closed-loop control was assessed clinically and by calculating the median performance error, the median absolute performance error, and the mean offset of the control variable. Results: The median performance error and the median absolute performance error were 2.2 and 8.0%, respectively. Mean offset of the BIS from the set point was 0.9. Cardiovascular parameters were stable during closed-loop control. operating conditions were adequate in all patients but one, who began moving after 45 min of stable anesthesia. No patients reported awareness or recall of Intraoperative events. hi three patients, there was oscillation of the measured BIS around the set point. Conclusions: The system was able to provide clinically adequate anesthesia in 9 of 10 patients. Further studies are required to determine whether control performance can be improved by alterations to the gain factors or by using an effect site-targeted, target-controlled infusion propofol system.", "author" : [ { "dropping-particle" : "", "family" : "Absalom", "given" : "Anthony R", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Sutcliffe", "given" : "Nicholas", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Kenny", "given" : "Gavin N", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Anesthesiology", "id" : "ITEM-1", "issue" : "1", "issued" : { "date-parts" : [ [ "2002" ] ] }, "note" : "NULL", "page" : "67-73", "title" : "Closed-loop Control of Anesthesia Using Bispectral Index", "type" : "article-journal", "volume" : "96" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "²", "plainTextFormattedCitation" : "2", "previouslyFormattedCitation" : "[2]" }, "properties" : { }, "schema" : "" }2 These technologies offer the potential to enhance the precision with which we practice medicine. However, there are also concerns surrounding the safety of such devices, especially when human decision making is removed from their context.ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1001/jama.2017.19198", "ISSN" : "0098-7484", "author" : [ { "dropping-particle" : "", "family" : "Verghese", "given" : "Abraham", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Shah", "given" : "Nigam H.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Harrington", "given" : "Robert A.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "JAMA", "id" : "ITEM-1", "issue" : "1", "issued" : { "date-parts" : [ [ "2018", "1", "2" ] ] }, "page" : "19", "publisher" : "American Medical Association", "title" : "What This Computer Needs Is a Physician", "type" : "article-journal", "volume" : "319" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "³", "plainTextFormattedCitation" : "3", "previouslyFormattedCitation" : "[3]" }, "properties" : { }, "schema" : "" }3 Whilst there is now a healthy debate on the subject of automated, intelligent technologies in the literature and media, there remains a paucity of work exploring citizen views on the acceptability of such intervention.ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1111/acem.12692", "abstract" : "Digital health is an area of growing interest for physicians, patients, and technology companies alike. It promises the ability to engage patients in their care, before, during, and after an emergency department visit. Current efforts to create, study, and disseminate digital health have been limited by lack of user engagement. In this commentary, we outline the imperative for engaging end-users in each phase of digital health design, as well as a few techniques to facilitate better digital health design and implementation. Keywords Digital health; mHealth; patient engagement; design; qualitative Patient engagement is a term used to refer to enhancing patients' ability to fully participate in healthcare, helping them to be \"equipped, enabled, and empowered\" regarding their own health. 1,2 Patient engagement has been repeatedly linked to better health outcomes. 3,4 Digital health, such as wearable technology and mobile phone applications (\"apps\"), is increasingly promoted as a means of facilitating patient engagement. 5,6 Digital health may, for instance, help patients self-monitor; encourage behavior change; improve comprehension of diagnoses and discharge plans; and permit dynamic interchanges between patients, their healthcare data, and clinicians. Digital health tools have been hailed as easily disseminated, low-resource solutions to help patients take ownership of their healthcare journey. 7-9 Despite the rhetoric and hope for digital health, however, patients are not using the tools as much as they could. Typical medical or fitness apps have a 90-day user retention rate of only 27-30%, 10 and 50% of apps are downloaded less than 500 times. 11 The low usage of current digital health tools is not, interestingly, due to a lack of demand. Research in the emergency department (ED) shows that 90% of patients are interested in a technology-based intervention for their health. 12 Recent national surveys show that up to 66% of Americans are interested in specifically using apps and wearable monitors (like FitBit and the AppleWatch) to improve their healthcare. 13", "author" : [ { "dropping-particle" : "", "family" : "Birnbaum", "given" : "Faith", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Lewis", "given" : "Dana M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Rosen", "given" : "Rochelle", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ranney", "given" : "Megan L", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Acad Emerg Med", "id" : "ITEM-1", "issue" : "6", "issued" : { "date-parts" : [ [ "2015" ] ] }, "page" : "754-756", "title" : "Patient engagement and the design of digital health HHS Public Access", "type" : "article-journal", "volume" : "22" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1186/1472-6947-11-15", "abstract" : "Background: Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods: In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results: A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process.", "author" : [ { "dropping-particle" : "", "family" : "Money", "given" : "Arthur G", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Barnett", "given" : "Julie", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Kuljis", "given" : "Jasna", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Craven", "given" : "Michael P", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Martin", "given" : "Jennifer L", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Young", "given" : "Terry", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "BMC Medical Informatics and Decision Making", "id" : "ITEM-2", "issued" : { "date-parts" : [ [ "2011" ] ] }, "page" : "15", "title" : "The role of the user within the medical device design and development process: medical device manufacturers' perspectives", "type" : "article-journal", "volume" : "11" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "^4,5", "plainTextFormattedCitation" : "4,5", "previouslyFormattedCitation" : "[4,5]" }, "properties" : { }, "schema" : "" }4,5Public festivals offer the opportunity to rapidly collect and explore citizen views on focused subjects, having successfully been used by our group to explore a number of infection related topics.ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1111/hex.12604", "ISSN" : "13696513", "author" : [ { "dropping-particle" : "", "family" : "Rawson", "given" : "Timothy M.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Castro-S\u00e1nchez", "given" : "Enrique", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Charani", "given" : "Esmita", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Husson", "given" : "Fran", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Moore", "given" : "Luke S. P.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Holmes", "given" : "Alison H.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ahmad", "given" : "Raheelah", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Health Expectations", "id" : "ITEM-1", "issue" : "June", "issued" : { "date-parts" : [ [ "2017" ] ] }, "page" : "1-8", "title" : "Involving citizens in priority setting for public health research: Implementation in infection research", "type" : "article-journal" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1186/s12879-016-1810-x", "ISSN" : "1471-2334", "PMID" : "27590053", "author" : [ { "dropping-particle" : "", "family" : "Castro-S\u00e1nchez", "given" : "Enrique", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Moore", "given" : "Luke S. P.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Husson", "given" : "Fran", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Holmes", "given" : "Alison H.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "BMC Infectious Diseases", "id" : "ITEM-2", "issue" : "1", "issued" : { "date-parts" : [ [ "2016" ] ] }, "page" : "465", "publisher" : "BMC Infectious Diseases", "title" : "What are the factors driving antimicrobial resistance? Perspectives from a public event in London, England", "type" : "article-journal", "volume" : "16" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "^6,7", "plainTextFormattedCitation" : "6,7", "previouslyFormattedCitation" : "[6,7]" }, "properties" : { }, "schema" : "" }6,7 Within this study, we explored citizen perceptions of using microneedle-based biosensors and computer-controlled dose optimisation software for the delivery of precision antibiotic dosing. Microneedle-based technology is rapidly expanding, with in-vivo clinical studies of these devices underway for monitoring a range of molecules, including antibiotics.ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1039/c8ay00264a", "ISSN" : "17599679", "abstract" : "<p>Although subcutaneously implanted continuous glucose monitoring (CGM) devices have been shown to support diabetes self-management, their uptake remains low due to high costs and poor accuracy and precision arising from their invasiveness.</p>", "author" : [ { "dropping-particle" : "", "family" : "Sharma", "given" : "Sanjiv", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "El-Laboudi", "given" : "Ahmed", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Reddy", "given" : "Monika", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Jugnee", "given" : "Narvada", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Sivasubramaniyam", "given" : "Sujan", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Sharkawy", "given" : "Mohamed", "non-dropping-particle" : "El", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Georgiou", "given" : "Pantelis", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Johnston", "given" : "Desmond", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Oliver", "given" : "Nick", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cass", "given" : "Anthony E.G.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Analytical Methods", "id" : "ITEM-1", "issue" : "18", "issued" : { "date-parts" : [ [ "2018" ] ] }, "page" : "2088-2095", "publisher" : "Royal Society of Chemistry", "title" : "A pilot study in humans of microneedle sensor arrays for continuous glucose monitoring", "type" : "article-journal", "volume" : "10" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "⁸", "plainTextFormattedCitation" : "8", "previouslyFormattedCitation" : "[8]" }, "properties" : { }, "schema" : "" }8This study was performed across two days (28th and 29th April 2018) at a London university public festival. The festival is open to the public and is visited by over 15,000 people annually. A stand was set up in the “infection zone” (which is visited by >3,000) of the festival (Figure 1). Two phlebotomy arms were set up to demonstrate traditional phlebotomy versus the use of microneedle technology for continuous antibiotic monitoring.ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1016/j.elecom.2017.07.011", "ISSN" : "13882481", "abstract" : "A B S T R A C T Antimicrobial resistance is a leading patient safety issue. There is a need to develop novel mechanisms for monitoring and subsequently improving the precision of how we use antibiotics. A surface modified microneedle array was developed for monitoring beta-lactam antibiotic levels in human interstitial fluid. The sensor was fabricated by anodically electrodepositing iridium oxide (AEIROF) onto a platinum surface on the microneedle followed by fixation of beta-lactamase enzyme within a hydrogel. Calibration of the sensor was performed to penicillin-G in buffer solution (PBS) and artificial interstitial fluid (ISF). Further calibration of a platinum disc electrode was undertaken using amoxicillin and ceftriaxone. Open-circuit potentials were performed and data analysed using the Hill equation and log(concentration [M]) plots. The microneedle sensor demonstrated high reproducibility between penicillin-G runs in PBS with mean K m (\u00b1 1SD) = 0.0044 \u00b1 0.0013 M and mean slope function of log(concentration plots) 29 \u00b1 1.80 mV/decade (r 2 = 0.933). Response was reproducible after 28 days storage at 4 \u00b0C. In artificial ISF, the sensors response was K m (\u00b1 1SD) = 0.0077 \u00b1 0.0187 M and a slope function of 34 \u00b1 1.85 mv/decade (r 2 = 0.995). Our results suggest that microneedle array based beta-lactam sensing may be a future application of this AEIROF based enzymatic sensor.", "author" : [ { "dropping-particle" : "", "family" : "Rawson", "given" : "Timothy Miles", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Sharma", "given" : "Sanjiv", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Georgiou", "given" : "Pantelis", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Holmes", "given" : "Alison", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cass", "given" : "Anthony", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "O'Hare", "given" : "Danny", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Electrochemistry Communications", "id" : "ITEM-1", "issued" : { "date-parts" : [ [ "2017", "9" ] ] }, "page" : "1-5", "title" : "Towards a minimally invasive device for beta-lactam monitoring in humans", "type" : "article-journal", "volume" : "82" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1093/jac/dkx458", "ISSN" : "0305-7453", "author" : [ { "dropping-particle" : "", "family" : "Rawson", "given" : "T M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "O\u2019Hare", "given" : "D", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Herrero", "given" : "P", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Sharma", "given" : "S", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Moore", "given" : "L S P", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Barra", "given" : "E", "non-dropping-particle" : "de", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Roberts", "given" : "J A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gordon", "given" : "A C", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Hope", "given" : "W", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Georgiou", "given" : "P", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cass", "given" : "A E G", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Holmes", "given" : "A H", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Journal of Antimicrobial Chemotherapy", "id" : "ITEM-2", "issue" : "4", "issued" : { "date-parts" : [ [ "2018", "4", "1" ] ] }, "page" : "835-843", "title" : "Delivering precision antimicrobial therapy through closed-loop control systems", "type" : "article-journal", "volume" : "73" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "^9,10", "plainTextFormattedCitation" : "9,10", "previouslyFormattedCitation" : "[9,10]" }, "properties" : { }, "schema" : "" }9,10 Over the festival, two researchers (TMR and DM) manned the scenario which was visited by groups of 2-6 people for 10-minute periods. During visits, the group had a 1-minute demonstration of traditional drug monitoring versus the use of microneedle technology on the phlebotomy arms. A simulation of a closed-loop control system for computerised antibiotic dose optimisation using the microneedle technology was then demonstrated. The groups then had the remaining time to attempt phlebotomy and use the microneedles on the demonstration arms and complete a short survey (Appendix 1) providing one set of answers (agreed as a consensus). This methodology was the same on both days except for the questions asked. On day two, individual groups were asked to undertake an additional task to facilitate triangulation of findings from day one. Groups undertook discussion to agree or disagree with the answers obtained from day one and provided comments. For speed and anonymity, group demographics were not collected. All data were collected electronically, using a free data entry interface () and a tablet device. All quantitative responses were analysed in R. Qualitative responses were analysed using line-by-line coding undertaken independently by two researchers (TMR and DM) to group responses into common categories and then themes. This project was reviewed by the regional ethics committee, who deemed that given the anonymous nature of data collection, ethical approval was not required. Participants providing anonymous votes and written justifications at the festival were not required to provide written consent.In total, the stall was visited by 100 groups (56 /100 day one and 44/100 day two). Median (range) group size was 4 (2-6) people. Groups spent a mean (SD) of 7 (3) minutes discussing and responding to the questionnaire after the short demonstration. Overall, the groups demonstrated good knowledge regarding the importance of antibiotic dose optimisation. On day one, 47/57 (82%) of groups identified that individuals need differing doses of antibiotics to treat their infections. The majority believed that antibiotic monitoring was beneficial for improving treatment of infections, stopping the development of drug resistance, and preventing side effects (36/57; 64%). The majority of individuals believed that their doctor should be the individual who decides what dose of antibiotic is delivered (35/57; 63%), followed by a decision from a computer-controlled programme (15/57; 27%). This was corroborated by participating groups on day two (34/44; 77%) with a high level of agreement for the use of microneedles for antibiotic monitoring (40/44; 93%).Figure 1 summarises the groups reported agreement with the use of microneedle-based technology to monitor antibiotic concentrations and automated computer-controlled dosing, respectively. These responses used a Likert scale from 1 to 10, where 10 was strong agreement with the statement. These results demonstrated high agreement with use of microneedle technology scoring a median (IQR) of 9/10 (5-10) with the groups having less confidence in automated dosing systems, scoring a median (IQR) of 6/10 (4-8). Qualitative analysis of the group responses demonstrated common themes driving the agreement with the use of microneedles. These were that the microneedles would be less intrusive and less painful than blood testing. Furthermore, the groups felt that microneedles may also improve the accuracy and therefore effectiveness of antibiotic treatment. However, concerns were also noted about potential errors in the sensor technology and its impact on day-to-day activities, such as showering, if worn for prolonged periods of time. In contrast to sensors, there was a broader range of opinions reported with regards to automated dosing systems. On one hand, citizens believed that computers may be safer and less prone to mistakes compared to humans. However, citizens also reported concerns over the use of unsupervised systems, stating that they would prefer trained humans to be the final decision makers. This was because they believe that humans can contextualise the decisions being made, helping to guide more individualised and humanised decisions on dosing. Although this study was limited by its small sample size, lack of demographic data, and potential for citizens attending to have a favouring view of science; it demonstrates that citizens are willing to accept the use of novel technologies, including those using computer-controlled decisions. However, there are concerns over the unsupervised nature of such systems, with the need for recommendations to be contextualised by a human still favoured. Future work must consider the greater role of citizen engagement in the development of such technologies, to ensure their acceptability upon implementation in clinical practice.Acknowledgements:Contribution statementTMR developed the idea for this study. All authors contributed significantly towards the development of the methodology and demonstration performed during the study. TMR and DM undertook data collection and primary analysis. All authors contributed to the analysis and finalisation of data. TMR drafted the initial draft of the manuscript with all authors significantly contributing to the development and finalisation of the final iteration for submission. AcknowledgementsThe authors would like to acknowledge the National Institute of Health Research Imperial Biomedical Research Centre and the National Institute for Health Research Health Protection Research Unit (NIHR HPRU) in Healthcare Associated Infection and Antimicrobial Resistance at Imperial College London in partnership with Public Health England and the NIHR Imperial Patient Safety Translational Research Centre. They would also like to acknowledge Imperial Biomedical Research Centre (BRC). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the UK Department of Health.FundingThis report was supported by grants from (i) This report is independent research funded by the National Institute for Health Research Invention for Innovation Grant (i4i), Enhanced, Personalized and Integrated Care for Infection Management at Point of Care (EPIC IMPOC), II-LA-0214-20008. (ii) Imperial College Biomedical Research Centre (BRC).Transparency declarations The authors have no conflicts of interest to declare. ReferencesADDIN Mendeley Bibliography CSL_BIBLIOGRAPHY 1Pan Qin, Luo Fengling, Liu Min, Zhang Xiao-Lian. Oligonucleotide aptamers: promising and powerful diagnostic and therapeutic tools for infectious diseases. J Infect 2018;77(2):83–98. Doi: 10.1016/j.jinf.2018.04.007.2Absalom Anthony R, Sutcliffe Nicholas, Kenny Gavin N. Closed-loop Control of Anesthesia Using Bispectral Index. Anesthesiology 2002;96(1):67–73. Doi: 10.1097/00000542-200201000-00017.3Verghese Abraham, Shah Nigam H, Harrington Robert A. What This Computer Needs Is a Physician. JAMA 2018;319(1):19. Doi: 10.1001/jama.2017.19198.4Birnbaum Faith, Lewis Dana M, Rosen Rochelle, Ranney Megan L. Patient engagement and the design of digital health HHS Public Access. Acad Emerg Med 2015;22(6):754–6. Doi: 10.1111/acem.12692.5Money Arthur G, Barnett Julie, Kuljis Jasna, Craven Michael P, Martin Jennifer L, Young Terry. The role of the user within the medical device design and development process: medical device manufacturers’ perspectives. BMC Med Inform Decis Mak 2011;11:15. Doi: 10.1186/1472-6947-11-15.6Rawson Timothy M, Castro-Sánchez Enrique, Charani Esmita, Husson Fran, Moore Luke SP, Holmes Alison H, et al. Involving citizens in priority setting for public health research: Implementation in infection research. Heal Expect 2017;(June):1–8. Doi: 10.1111/hex.12604.7Castro-Sánchez Enrique, Moore Luke SP, Husson Fran, Holmes Alison H. What are the factors driving antimicrobial resistance? Perspectives from a public event in London, England. BMC Infect Dis 2016;16(1):465. Doi: 10.1186/s12879-016-1810-x.8Sharma Sanjiv, El-Laboudi Ahmed, Reddy Monika, Jugnee Narvada, Sivasubramaniyam Sujan, El Sharkawy Mohamed, et al. A pilot study in humans of microneedle sensor arrays for continuous glucose monitoring. Anal Methods 2018;10(18):2088–95. Doi: 10.1039/c8ay00264a.9Rawson Timothy Miles, Sharma Sanjiv, Georgiou Pantelis, Holmes Alison, Cass Anthony, O’Hare Danny. Towards a minimally invasive device for beta-lactam monitoring in humans. Electrochem Commun 2017;82:1–5. Doi: 10.1016/j.elecom.2017.07.011.10Rawson TM, O’Hare D, Herrero P, Sharma S, Moore LSP, de Barra E, et al. Delivering precision antimicrobial therapy through closed-loop control systems. J Antimicrob Chemother 2018;73(4):835–43. Doi: 10.1093/jac/dkx458.-54292560896500Figure 1. Example of demonstration and Likert score summaries of group acceptance of demonstrated technologies at a public festivalSupplementary document 1. Questionnaire questions provided to groups at the public festival.Day 1. True or false: Jim and John need the same amount of antibiotic to treat their infection (picture provided of two people with very different body size)We can monitor antibiotic concentrations to (select one):Improve the treatment of infectionsStop drug-resistant infectionsPrevent side effectsAll of the aboveAntibiotic dosing should be decided by (select one):My doctorA computer programmeMy pharmacistThe drug companyI would wear a microneedle sensor to improve how much antibiotic I receive (Likert score. 1 = strongly disagree, 10 = strongly agree)I would trust a computer to make decisions about my treatment (Likert score. 1 = strongly disagree, 10 = strongly agree)If I had an infection, to improve the dose of antibiotics I receive I would prefer to use (select one):A biosensor on the skin and a doctor to decide the dose of antibioticA biosensor on the skin and a computer to decide the dose of antibioticBlood tests and a doctor to decide the doseI would prefer to take the “normal” dose of antibioticDay 2. Yesterday most people (62.5%) told us that the dose of an antibiotic should be decided by a doctor. Do you agree? (Yes/No)Please explain your groups answer (free text)How happy would you be letting a computer decide the dose of antibiotic for you? (Likert score. 1 = strongly disagree, 10 = strongly agree)Please explain your groups answer (free text)Yesterday, most people said that they would be happy to wear a biosensor patch (microneedle) to help monitor their treatment. Do you agree? (Yes/No)I would wear a microneedle sensor to improve how much antibiotic I receive (Likert score. 1 = strongly disagree, 10 = strongly agree)Please explain your groups answer (free text)Which of the following statements do you agree most with? (select one)We should allow computers to support doctors to make decisions about our treatmentWe should allow computers to make decisions about our treatment as the do not make mistakesWe should stick with our current approach to decision making, as it seems to be working okay ................
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