Safety and efficacy of an artificial intelligence-enabled decision tool for treatment decisions in neovascular age-related macular degeneration and an exploration of clinical pathway integration and implementation: protocol for a multi-methods validation study.

INTRODUCTION: Neovascular age-related macular degeneration (nAMD) management is one of the largest single-disease contributors to hospital outpatient appointments. Partial automation of nAMD treatment decisions could reduce demands on clinician time. Established artificial intelligence (AI)-enabled retinal imaging analysis tools, could be applied to this use-case, but are not yet validated for it. A primary qualitative investigation of stakeholder perceptions of such an AI-enabled decision tool is also absent. This multi-methods study aims to establish the safety and efficacy of an AI-enabled decision tool for nAMD treatment decisions and understand where on the clinical pathway it could sit and what factors are likely to influence its implementation. METHODS AND ANALYSIS: Single-centre retrospective imaging and clinical data will be collected from nAMD clinic visits at a National Health Service (NHS) teaching hospital ophthalmology service, including judgements of nAMD disease stability or activity made in real-world consultant-led-care. Dataset size will be set by a power calculation using the first 127 randomly sampled eligible clinic visits. An AI-enabled retinal segmentation tool and a rule-based decision tree will independently analyse imaging data to report nAMD stability or activity for each of these clinic visits. Independently, an external reading centre will receive both clinical and imaging data to generate an enhanced reference standard for each clinic visit. The non-inferiority of the relative negative predictive value of AI-enabled reports on disease activity relative to consultant-led-care judgements will then be tested. In parallel, approximately 40 semi-structured interviews will be conducted with key nAMD service stakeholders, including patients. Transcripts will be coded using a theoretical framework and thematic analysis will follow. ETHICS AND DISSEMINATION: NHS Research Ethics Committee and UK Health Research Authority approvals are in place (21/NW/0138). Informed consent is planned for interview participants only. Written and oral dissemination is planned to public, clinical, academic and commercial stakeholders.

Information sharing challenges in end-of-life care: a qualitative study of patient, family and professional perspectives on the potential of an Electronic Palliative Care Co-ordination System.

OBJECTIVES: To explore current challenges in interdisciplinary management of end-of-life care in the community and the potential of an Electronic Palliative Care Co-ordination System (EPaCCS) to facilitate the delivery of care that meets patient preferences. DESIGN: Qualitative study using interviews and focus groups. SETTING: Health and Social Care Services in the North of England. PARTICIPANTS: 71 participants, 62 health and social care professionals, 9 patients and family members. RESULTS: Four key themes were identified: information sharing challenges; information sharing systems; perceived benefits of an EPaCCS and barriers to use and requirements for an EPaCCS. Challenges in sharing information were a source of frustration for health and social care professionals as well as patients, and were suggested to result in inappropriate hospital admissions. Current systems were perceived by participants to not work well-paper advance care planning (ACP) documentation was often unavailable or inaccessible, meaning it could not be used to inform decision-making at the point of care. Participants acknowledged the benefits of an EPaCCS to facilitate information sharing; however, they also raised concerns about confidentiality, and availability of the increased time and resources required to access and maintain such a system. CONCLUSIONS: EPaCCS offer a potential solution to information sharing challenges in end-of-life care. However, our findings suggest that there are issues in the initiation and documentation of end-of-life discussions that must be addressed through investment in training in order to ensure that there is sufficient information regarding ACP to populate the system. There is a need for further qualitative research evaluating use of an EPaCCS, which explores benefits and challenges, uptake and reasons for disparities in use to better understand the potential utility and implications of such systems.

Challenges for the cataract surgeon treating people with dementia: a qualitative study exploring anesthetic choices.

BACKGROUND: In light of the growing number of people with dementia and age-related cataract, as well as changing anesthetic practices for cataract surgery, this study aimed to explore the experiences of cataract surgeons in managing patients with dementia and making anesthetic decisions. METHODS: This was a qualitative study using semistructured interviews with senior cataract surgeons from two centers in England. Fourteen surgeons were interviewed, and a thematic approach informed by grounded theory was used for the analysis. RESULTS: Choice of anesthesia for people with dementia was a central theme arising from the data. Surgeons varied in their thresholds for using general anesthesia. Decisions about suitability for local anesthesia were limited by time constraints and generally made rapidly and based on instinct; dementia was not always apparent at the point of preassessment. Surgeons used a variety of topical, sub-Tenon's, and sharp needle blocks for people with dementia. Surgeons discussed techniques to help patients tolerate local anesthesia, such as clear communication, a primary nurse, hand-holding, and support from an anesthetist. However, within our sample, some surgeons had had negative experiences of operating on people with dementia, where an incorrect judgment had been made that they could tolerate local anesthetic cataract surgery. CONCLUSION: This study highlights the differing practices of cataract surgeons when making anesthetic choices for people with dementia and the challenges they face. In order to avoid the situation of a patient with dementia becoming distressed during awake surgery, increased time at preassessment and anesthetic support may be beneficial.

Patients' perspectives on timing of urinary catheter removal after surgery.

UNLABELLED: A prolonged catheter duration is a major risk factor for catheter-associated urinary tract infection, with bacteriuria increasing by 5% per day (Gokula et al, 2004). AIM: In this study, the authors explored patients' perceptions of the care process relating to peri-operative catheterisation to identify patient factors that encourage early removal. METHOD: Semi-structured interviews, incorporating a grounded theory approach, were performed on three men and seven women during 2010. Interviews were transcribed and analysed using constant comparative method and thematic framework analysis. RESULTS: Catheter duration ranged 1-10 days. Main themes elicited included: lack of understanding of the purpose and catheterisation process; loss of patient autonomy and dignity; and impact of environmental factors. CONCLUSION: Lack of knowledge of the catheterisation process among participants led to fears and concerns that may have contributed to delayed catheter removal. Changes to patient care that are likely to reduce catheter duration include ensuring the provision of pre-operative information, greater patient involvement in catheter removal decisions, and provision of easily accessible toilet facilities.

Childhood tonsillectomy: who is referred and what treatment choices are made? Baseline findings from the North of England and Scotland Study of Tonsillectomy and Adenotonsillectomy in Children (NESSTAC).

BACKGROUND: Tonsillectomies are frequently performed, yet variations exist in tonsillectomy rates. Clinicians use guidelines, but complex psychosocial influences on childhood tonsillectomy include anecdotal evidence of parental enthusiasm. Studies indicate that undergoing preferred treatment improves outcome. Despite the enthusiasm with which tonsillectomy is offered and sought, there is little evidence of efficacy. This resulted in a randomised controlled trial to evaluate the cost-effectiveness of (adeno)tonsillectomy in children with recurrent sore throats. OBJECTIVE: To compare characteristics of children entering the randomised trial with those recruited to a parallel, non-randomised study, to establish trends in referral and patient preferences for treatment. DESIGN: Baseline data from a randomised controlled trial with parallel non-randomised preference study, comparing surgical intervention with medical treatment in children aged 4-15 years with recurrent sore throat referred to five secondary care otolaryngology departments located in the north of England or west central Scotland. RESULTS: Centres assessed 1546 children; 21% were not eligible for tonsillectomy. Among older children (8-15 years), girls were significantly more likely to be referred to secondary care. Of 1015 eligible children, 268 (28.2%) agreed to be randomised, while 461 (45.4%) agreed to the parallel, non-randomised preference study, with a strong preference for tonsillectomy. Participants reporting that progress at school had been impeded or with more experience of persistent sore throat were more likely to seek tonsillectomy. Referred boys were more likely than girls to opt for medical treatment. Socio-economic data showed no effect. CONCLUSION: Preference for tonsillectomy reflects educational impact and recent experience, rather than age or socio-economic status.

Protocol for north of England and Scotland study of tonsillectomy and adeno-tonsillectomy in children (NESSTAC). A pragmatic randomised controlled trial comparing surgical intervention with conventional medical treatment in children with recurrent sore throats.

BACKGROUND: Uncertainties surrounding the effectiveness and cost-effectiveness of childhood tonsillectomy for recurrent sore throat led the NHS Health Technology Assessment Programme to commission this research to evaluate the effectiveness and cost-effectiveness of tonsillectomy and adeno-tonsillectomy in comparison with standard non-surgical management in children aged under 16 with recurrent throat infections. The aim is to evaluate if tonsillectomy and adeno-tonsillectomy reduces the number of episodes of sore throats among children to a clinically significant extent. METHODS/DESIGN: A simple prospective pragmatic randomised controlled trial with economic analysis and prospective cohort study of non-trial participants comparing surgical intervention with conventional medical treatment. The treatment arm will receive tonsillectomy and adeno-tonsillectomy while in the control arm non-surgical conventional medical treatment only will be used. The primary outcome measure will be reported number of episodes of sore throat over two years with secondary outcomes measures of reported number of episodes of sore throat, otitis media and upper respiratory tract infection which invoke a GP consultation; reported number of symptom-free days; reported severity of sore throats and surgical and anaesthetic morbidity. The study will take place in five hospitals in the UK. The trial population will be 406 children aged 4-15 on their last birthday with recurrent sore throat referred by primary care to the 5 otolaryngology departments. The duration of the study is seven years (July 2001-July 2008). DISCUSSION: As with all pragmatic randomised controlled trials it is impossible to control the external environment in which the research is taking place. Since this trial began a number of factors have arisen which could affect the outcome including; a reduction in the incidence of respiratory tract infections, marked socio-economic differences in consultation rates, the results from the National Prospective Tonsillectomy Audit and the Government's waiting list initiatives.