Accelerating P300-based neurofeedback training for attention enhancement using iterative learning control: a randomised controlled trial.

Objective. Neurofeedback (NFB) training through brain-computer interfacing has demonstrated efficacy in treating neurological deficits and diseases, and enhancing cognitive abilities in healthy individuals. It was previously shown that event-related potential (ERP)-based NFB training using a P300 speller can improve attention in healthy adults by incrementally increasing the difficulty of the spelling task. This study aims to assess the impact of task difficulty adaptation on ERP-based attention training in healthy adults. To achieve this, we introduce a novel adaptation employing iterative learning control (ILC) and compare it against an existing method and a control group with random task difficulty variation.Approach. The study involved 45 healthy participants in a single-blind, three-arm randomised controlled trial. Each group underwent one NFB training session, using different methods to adapt task difficulty in a P300 spelling task: two groups with personalised difficulty adjustments (our proposed ILC and an existing approach) and one group with random difficulty. Cognitive performance was evaluated before and after the training session using a visual spatial attention task and we gathered participant feedback through questionnaires.Main results. All groups demonstrated a significant performance improvement in the spatial attention task post-training, with an average increase of 12.63%. Notably, the group using the proposed iterative learning controller achieved a 22% increase in P300 amplitude during training and a 17% reduction in post-training alpha power, all while significantly accelerating the training process compared to other groups.Significance. Our results suggest that ERP-based NFB training using a P300 speller effectively enhances attention in healthy adults, with significant improvements observed after a single session. Personalised task difficulty adaptation using ILC not only accelerates the training but also enhances ERPs during the training. Accelerating NFB training, while maintaining its effectiveness, is vital for its acceptability by both end-users and clinicians.

Methods for think-aloud interviews in health-related resource-use research: the PECUNIA RUM instrument.

BACKGROUND: The think-aloud (TA) approach is a qualitative research method that allows for gaining insight into thoughts and cognitive processes. It can be used to incorporate a respondent's perspective when developing resource-use measurement (RUM) instruments. Currently, the application of TA methods in RUM research is limited, and so is the guidance on how to use them. Transparent publication of TA methods for RUM in health economics studies, which is the aim of this paper, can contribute to reducing the aforementioned gap. METHODS: Methods for conducting TA interviews were iteratively developed by a multi-national working group of health economists and additional qualitative research expertise was sought. TA interviews were conducted in four countries to support this process. A ten-step process was outlined in three parts: Part A 'before the interview' (including translation, recruitment, training), Part B 'during the interview' (including setting, opening, completing the instrument, open-ended questions, closing), and part C 'after the interview' (including transcription and data analysis, trustworthiness). CONCLUSIONS: This manuscript describes the step-by-step approach for conducting multi-national TA interviews with potential respondents of the PECUNIA RUM instrument. It increases the methodological transparency in RUM development and reduces the knowledge gap of using qualitative research methods in health economics.

The healthcare system costs of hip fracture care in South Africa.

Despite rapidly ageing populations, data on healthcare costs associated with hip fracture in Sub-Saharan Africa are limited. We estimated high direct medical costs for managing hip fracture within the public healthcare system in SA. These findings should support policy decisions on budgeting and planning of hip fracture services. PURPOSE: We estimated direct healthcare costs of hip fracture (HF) management in the South African (SA) public healthcare system. METHODS: We conducted a micro-costing study to estimate costs per patient treated for HF in five regional public sector hospitals in KwaZulu-Natal (KZN), SA. Two hundred consecutive, consenting patients presenting with a fragility HF were prospectively enrolled. Resources used including staff time, consumables, laboratory investigations, radiographs, operating theatre time, surgical implants, medicines, and inpatient days were collected from presentation to discharge. Counts of resources used were multiplied by unit costs, estimated from the KZN Department of Health hospital fees manual 2019/2020, in local currency (South African Rand, ZAR), and converted to 2020 US$ prices. Generalized linear models estimated total covariate-adjusted costs and cost predictors. RESULTS: The mean unadjusted cost for HF management was US$6935 (95% CI; US$6401-7620) [ZAR114,179 (95% CI; ZAR105,468-125,335)]. The major cost driver was orthopaedics/surgical ward costs US$5904 (95% CI; 5408-6535), contributing to 85% of total cost. The covariate-adjusted cost for HF management was US$6922 (95% CI; US$6743-7118) [ZAR113,976 (95% CI; ZAR111,031-117,197)]. After covariate adjustment, total costs were higher in patients operated under general anaesthesia [US$7251 (95% CI; US$6506-7901)] compared to surgery under spinal anaesthesia US$6880 (95% CI; US$6685-7092) and no surgery US$7032 (95% CI; US$6454-7651). CONCLUSION: Healthcare costs following a HF are high relative to the gross domestic product per capita and per capita spending on health in SA. As the population ages, this significant economic burden to the health system will increase.

Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment.

BACKGROUND: Women with stress urinary incontinence (SUI) experience urine leakage with physical activity. Currently, the interventional treatments for SUI are surgical, or endoscopic bulking injection(s). However, these procedures are not always successful, and symptoms can persist or come back after treatment, categorised as recurrent SUI. There are longstanding symptoms and distress associated with a failed primary treatment, and currently, there is no consensus on how best to treat women with recurrent, or persistent, SUI. METHODS: A two-arm trial, set in at least 20 National Health Service (NHS) urology and urogynaecology referral units in the UK, randomising 250 adult women with recurrent or persistent SUI 1:1 to receive either an endoscopic intervention (endoscopic bulking injections) or a standard NHS surgical intervention, currently colposuspension, autologous fascial sling or artificial urinary sphincter. The aim of the trial is to determine whether surgical treatment is superior to endoscopic bulking injections in terms of symptom severity at 1 year after randomisation. This primary outcome will be measured using the patient-reported International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF). Secondary outcomes include assessment of longer-term clinical impact, improvement of symptoms, safety, operative assessments, sexual function, cost-effectiveness and an evaluation of patients' and clinicians' views and experiences of the interventions. DISCUSSION: There is a lack of high-quality, randomised, scientific evidence for which treatment is best for women presenting with recurrent SUI. The PURSUIT study will benefit healthcare professionals and patients and provide robust evidence to guide further treatment and improve symptoms and quality of life for women with this condition. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number (ISRCTN) registry ISRCTN12201059. Registered on 09 January 2020.

COVID-19 confessions: a qualitative exploration of healthcare workers experiences of working with COVID-19.

OBJECTIVES: To gain insight into the experiences and concerns of front-line National Health Service (NHS) workers while caring for patients with COVID-19. DESIGN: Qualitative analysis of data collected through an anonymous website (www.covidconfidential) provided a repository of uncensored COVID-19 experiences of front-line NHS workers, accessed via a link advertised on the Twitter feed of two high profile medical tweeters and their retweets. SETTING: Community of NHS workers who accessed this social media. PARTICIPANTS: 54 healthcare workers, including doctors, nurses and physiotherapists, accessed the website and left a 'story'. RESULTS: Stories ranged from 1 word to 10 min in length. Thematic analysis identified common themes, with a central aspect being the experience and psychological consequence of trauma. Specific themes were: (1) the shock of the virus, (2) staff sacrifice and dedication, (3) collateral damage ranging from personal health concerns to the long-term impact on, and care of, discharged patients and (4) a hierarchy of power and inequality within the healthcare system. CONCLUSIONS: COVID-19 confidential gave an outlet for unprompted and uncensored stories of healthcare workers in the context of COVID-19. In addition to personal experiences of trauma, there were perceptions that many operational difficulties stemmed from inequalities of power between management and front-line workers. Learning from these experiences will reduce staff distress and improve patient care in the face of further waves of the pandemic.

Modelling the lifetime cost-effectiveness of radical prostatectomy, radiotherapy and active monitoring for men with clinically localised prostate cancer from median 10-year outcomes in the ProtecT randomised trial.

BACKGROUND: Optimal management strategies for clinically localised prostate cancer are debated. Using median 10-year data from the largest randomised controlled trial to date (ProtecT), the lifetime cost-effectiveness of three major treatments (radical radiotherapy, radical prostatectomy and active monitoring) was explored according to age and risk subgroups. METHODS: A decision-analytic (Markov) model was developed and informed by clinical input. The economic evaluation adopted a UK NHS perspective and the outcome was cost per Quality-Adjusted Life Year (QALY) gained (reported in UK£), estimated using EQ-5D-3L. RESULTS: Costs and QALYs extrapolated over the lifetime were mostly similar between the three randomised strategies and their subgroups, but with some important differences. Across all analyses, active monitoring was associated with higher costs, probably associated with higher rates of metastatic disease and changes to radical treatments. When comparing the value of the strategies (QALY gains and costs) in monetary terms, for both low-risk prostate cancer subgroups, radiotherapy generated the greatest net monetary benefit (£293,446 [95% CI £282,811 to £299,451] by D'Amico and £292,736 [95% CI £284,074 to £297,719] by Grade group 1). However, the sensitivity analysis highlighted uncertainty in the finding when stratified by Grade group, as radiotherapy had 53% probability of cost-effectiveness and prostatectomy had 43%. In intermediate/high risk groups, using D'Amico and Grade group > = 2, prostatectomy generated the greatest net monetary benefit (£275,977 [95% CI £258,630 to £285,474] by D'Amico and £271,933 [95% CI £237,864 to £287,784] by Grade group). This finding was supported by the sensitivity analysis. Prostatectomy had the greatest net benefit (£290,487 [95% CI £280,781 to £296,281]) for men younger than 65 and radical radiotherapy (£201,311 [95% CI £195,161 to £205,049]) for men older than 65, but sensitivity analysis showed considerable uncertainty in both findings. CONCLUSION: Over the lifetime, extrapolating from the ProtecT trial, radical radiotherapy and prostatectomy appeared to be cost-effective for low risk prostate cancer, and radical prostatectomy for intermediate/high risk prostate cancer, but there was uncertainty in some estimates. Longer ProtecT trial follow-up is required to reduce uncertainty in the model. TRIAL REGISTRATION: Current Controlled Trials number, ISRCTN20141297: http://isrctn.org (14/10/2002); ClinicalTrials.gov number, NCT02044172: http://www.clinicaltrials.gov (23/01/2014).

Measuring functional limitations after venous thromboembolism: Optimization of the Post-VTE Functional Status (PVFS) Scale.

INTRODUCTION: We recently proposed a scale for assessment of patient-relevant functional limitations following an episode of venous thromboembolism (VTE). Further development of this post-VTE functional status (PVFS) scale is still needed. METHODS: Guided by the input of VTE experts and patients, we refined the PVFS scale and its accompanying manual, and attempted to acquire broad consensus on its use. RESULTS: A Delphi analysis was performed involving 53 international VTE experts with diverse scientific and clinical backgrounds. In this process, the number of scale grades of the originally proposed PVFS scale was reduced and descriptions of the grades were improved. After these changes, a consensus was reached on the number/definitions of the grades, and method/timing of the scale assessment. The relevance and potential impact of the scale was confirmed in three focus groups totaling 18 VTE patients, who suggested additional changes to the manual, but not to the scale itself. Using the improved manual, the κ-statistics between PVFS scale self-reporting and its assessment via the structured interview was 0.75 (95%CI 0.58-1.0), and 1.0 (95%CI 0.83-1.0) between independent raters of the recorded interview of 16 focus groups members. CONCLUSION: We improved the PVFS scale and demonstrated broad consensus on its relevance, optimal grades, and methods of assessing among international VTE experts and patients. The interobserver agreement of scale grade assignment was shown to be good-to-excellent. The PVFS scale may become an important outcome measure of functional impairment for quality of patient care and in future VTE trials.

Cost-Effectiveness of Caries Prevention in Practice: A Randomized Controlled Trial.

A 2-arm parallel-group randomized controlled trial measured the cost-effectiveness of caries prevention in caries-free children aged 2 to 3 y attending general practice. The setting was 22 dental practices in Northern Ireland. Participants were centrally randomized into intervention (22,600 ppm fluoride varnish, toothbrush, a 50-mL tube of 1,450 ppm fluoride toothpaste, and standardized prevention advice) and control (advice only), both provided at 6-monthly intervals during a 3-y follow-up. The primary outcome measure was conversion from caries-free to caries-active states assessed by calibrated and blinded examiners; secondary outcome measures included decayed, missing, or filled teeth surfaces (dmfs); pain; and extraction. Cumulative costs were related to each of the trial's outcomes in a series of incremental cost effectiveness ratios (ICERs). Sensitivity analyses examined the impact of using dentist's time as measured by observation rather than that reported by the dentist. The costs of applying topical fluoride were also estimated assuming the work was undertaken by dental nurses or hygienists rather than dentists. A total of 1,248 children (624 randomized to each group) were recruited, and 1,096 (549 in the intervention group and 547 in the control group) were included in the final analyses. The mean difference in direct health care costs between groups was £107.53 (£155.74 intervention, £48.21 control, P < 0.05) per child. When all health care costs were compared, the intervention group's mean cost was £212.56 more than the control group (£987.53 intervention, £774.97 control, P < 0.05). Statistically significant differences in outcomes were only detected with respect to carious surfaces. The mean cost per carious surface avoided was estimated at £251 (95% confidence interval, £454.39-£79.52). Sensitivity analyses did not materially affect the study's findings. This trial raises concerns about the cost-effectiveness of a fluoride-based intervention delivered at the practice level in the context of a state-funded dental service (EudraCT No: 2009-010725-39; ISRCTN: ISRCTN36180119).

A Randomized Controlled Trial of Caries Prevention in Dental Practice.

We conducted a parallel group randomized controlled trial of children initially aged 2 to 3 y who were caries free, to prevent the children becoming caries active over the subsequent 36 mo. The setting was 22 dental practices in Northern Ireland, and children were randomly assigned by a clinical trials unit (CTU) (using computer-generated random numbers, with allocation concealed from the dental practice until each child was recruited) to the intervention (22,600-ppm fluoride varnish, toothbrush, 50-mL tube of 1,450 ppm fluoride toothpaste, and standardized, evidence-based prevention advice) or advice-only control at 6-monthly intervals. The primary outcome measure was conversion from caries-free to caries-active states. Secondary outcome measures were number of decayed, missing, or filled teeth (dmfs) in caries-active children, number of episodes of pain, and number of extracted teeth. Adverse reactions were recorded. Calibrated external examiners, blinded to the child's study group, assessed the status of the children at baseline and after 3 y. In total, 1,248 children (624 randomized to each group) were recruited, and 1,096 (549 intervention, 547 control) were included in the final analyses. Eighty-seven percent of intervention and 86% of control children attended every 6-mo visit ( P = 0.77). A total of 187 (34%) in the intervention group converted to caries active compared to 213 (39%) in the control group (odds ratio, 0.81; 95% confidence interval, 0.64-1.04; P = 0.11). Mean dmfs of those with caries in the intervention group was 7.2 compared to 9.6 in the control group ( P = 0.007). There was no significant difference in the number of episodes of pain between groups ( P = 0.81) or in the number of teeth extracted in caries-active children ( P = 0.95). Ten children in the intervention group had adverse reactions of a minor nature. This well-conducted trial failed to demonstrate that the intervention kept children caries free, but there was evidence that once children get caries, it slowed down its progression (EudraCT No: 2009-010725-39; ISRCTN: ISRCTN36180119).

Factors influencing adherence to clinical guidelines in the management of cancer-associated thrombosis.

International academic and regulatory guidelines consistently recommend the long-term use of low-molecular-weight heparins (LMWHs) as the standard for the treatment of cancer-associated thrombosis (CAT). However, both physicians and patients are reluctant to follow established guidelines. Insufficient compliance with treatment recommendations among care physicians represents a loss of opportunity for patients at very high risk of recurrence of venous thromboembolism (VTE) and death. Few data are available regarding adherence to CAT clinical practice guidelines. Based on published data, we aimed to review the gap between guidelines and practice to draw a more precise picture of current practice in order to precisely identify the extent to which patient management is currently lacking with respect to treatment guidelines. Published observational studies, registries and surveys on cancer-associated VTE treatment were reviewed. In spite of evidence from randomized controlled trials (RCTs) showing the usefulness of long-term LMWH, only approximately 50% of patients are managed according to established guideline recommendations. Patient profiles and co-morbidities influence compliance with standard guidelines. A better knowledge of physician and patient-related factors that influence therapeutic decisions may improve the implementation of clinical practice guidelines. Efficient awareness programs including a multidisciplinary approach are necessary to implement guidelines aimed at optimizing the therapeutic management of cancer-associated VTE.

PO-25 - FATCAT: an observational cohort study investigating fractal dimension (df) as a biomarker of thrombogenicity in cancer associated thrombosis during chemotherapy for lung cancer.

INTRODUCTION: Venous thromboembolism (VTE), comprising deep vein thrombosis (DVT) and pulmonary embolism (PE) are common complications in patients with cancer, affecting up to 18% of patients. VTE risk is increased by surgery and disease progression, whilst chemotherapy further increases risk up to 7-fold compared to patients without cancer. VTE contributes significantly to morbidity and mortality in patients with cancer, and is the second most common cause of death. Lung cancer is well established to be high risk for VTE, with up to a 22-fold increase in VTE risk associated with this malignancy, and 12% incidence in a recent study of patients with lung cancer undergoing chemotherapy. Furthermore, platinum based chemotherapy agents used in treatment of lung cancer are further associated with increased VTE risk. AIM: Current risk assessment tools have little value in predicting VTE risk, but prophylactic anticoagulation of patients with cancer increases bleeding incidence and no overall survival benefit. There is therefore a need for a pragmatic test with which assesses coagulation in patients with cancer, and potentially predict VTE risk, leading to personalised management and targeted treatment. We have previously demonstrated that fractal dimension (df) is sensitive to changes in clot microstructure in patients with lung cancer, assessing global coagulation in these patients. Furthermore, df is significantly different in patients with extensive disease (stages 3&4), which conventional laboratory markers failed to identify. Given the increased risk of VTE associated with chemotherapy, FATCAT will aim to assess changes in df in a larger cohort of patients with lung cancer undergoing chemotherapy, quantifying changes in df and relating these to clinical outcome. MATERIALS AND METHODS: This is a prospective observational cohort study investigating changes in df in patients with lung cancer undergoing chemotherapy. Patients will have a new diagnosis of cytologically or histologically confirmed lung cancer planned for chemotherapy and no history of previous cancer treatment, any thromboembolic / haemostatic disorders or be on anticoagulation. RESULTS: Following a power calculation, 300 patients will be recruited and followed up for 1 year. df, Doppler ultrasonography and standard coagulation markers will be performed on recruitment, at the mid point, and on completion of chemotherapy in line with standard diagnostic procedures i.e. CT scanning. CONCLUSIONS: The primary endpoint of the study will be VTE diagnosis, whilst secondary outcomes will determine the change in df during and after treatment with chemotherapy.

PO-61 - Patients' Experiences of LIving with CANcer associated thrOmbosis in Spain (PELICANOS).

INTRODUCTION: The Patients' Experiences of LIving with CANcer associated thrombosis (PELICAN) study has identified the experience of cancer-associated thrombosis (CAT) to be a distressing one, for which patients feel ill prepared for and receive insufficient support. However, such data was from a United Kingdom (UK) population and may not be representative of all nationalities, cultures and healthcare systems. AIM: To explore the experience of cancer associated thrombosis amongst patients living in Spain. MATERIALS AND METHODS: Twenty consecutive patients with CAT were recruited from a Spanish University Hospital. Where possible spouses were interviews in conjunction. Semi-structured qualitative interviews were undertaken, assited by a pre-agreed promt list. Interviews were audio recorded and transcribed verbatim. Preliminary data analysis was undertaken using thematic analysis. RESULTS: Several commonalities between UK and Spanish patients were identified including the traumatic nature of the experience, need for information and adaptive behaviors through ritualization. Three new major themes also emerged: Communication needs: over emphasis on heparin injection training, additional need for explanation of cause, response and prognosis The impact of CAT on the concept of self: CAT was considered defining watershed moment, confirmation of seriousness of the cancer, The impact of CAT on the family dynamic: distressing diagnosis for loved ones, exaggerated desire to help which could disempower patient independence. CONCLUSIONS: The experience of CAT is a distressing one which brings with it additional information needs through effective communication. Within the Spanish population, the role of family is of particular importance as well as the impact of CAT on the patient's feelings of worth and personal identity. Effective communication, support and access to information are essential in order to minimize distress and enhance treatment complicance.

Feasibility of pulse oximetry screening for critical congenital heart defects in homebirths.

BACKGROUND: Pulse oximetry has been shown to be a valuable additional screening test for detecting critical congenital heart defects in newborns. The feasibility of homebirth screening by the attending midwife has not been reported previously. AIM: Routine pulse oximetry screening of homebirths at 2 h of age was introduced in a UK tertiary maternity service in January 2014. The process and outcomes were evaluated. METHODS: Retrospective review of the clinical record of all babies undergoing pulse oximetry screening performed following homebirths over a 16-month period was undertaken. The acceptability of screening among the home care team (n=11) was also evaluated. RESULTS: Ninety babies underwent routine pulse oximetry screening within 2 h following homebirth; two had a positive result and were admitted to the neonatal unit with significant respiratory illness. Screening was acceptable and reassuring to midwives enabling prompt postnatal decision making and confirming normal transition without significantly increasing workload. CONCLUSIONS: Early pulse oximetry screening for homebirths is both feasible and acceptable.

Drug information leaflets improve parental knowledge of their child's treatment at paediatric emergency department discharge.

BACKGROUND: Hospital discharge is a complex multidisciplinary process that can lead to non-compliance and drugs-related problems. Crucial issue for children is parental knowledge of discharge treatments, especially in the time-limited and stressful environment of an emergency department (ED). OBJECTIVE: To compare parental correct knowledge of treatment with and without supply of customised drug information leaflets for the 10 most commonly prescribed drugs. METHOD: Inclusion criteria: paediatric patients (0-16 years) with French-speaking parents discharged from ED of the paediatric department of Geneva University Hospitals before (phase A) and after (phase B) intervention. INTERVENTION: Supply and brief comment of drug information leaflets focusing on specific information not available in official drugs information documents. Follow-up Semi-structured phone interview within 72 h after discharge to evaluate the percentage of parents with correct knowledge of dose, frequency, duration and indication of drugs. Multivariate analysis to identify factors associated with correct knowledge (phases A/B, drugs collection at usual pharmacy, drugs categories). RESULTS: 125 patients were included (phase A: 56; phase B: 69). Drug information leaflets were given to 63/69 ED patients (91%), covering 96/138 prescribed drugs (70%). Parental knowledge was significantly improved in phase B (dose: 62.3% to 89.1%; frequency: 57.9% to 85.5%; duration: 34.2% to 66.7%; indication: 70.2% to 94.9%; p<0.0001). Phase B and collection of drugs at usual pharmacy were significant factors associated with correct knowledge. CONCLUSIONS: Drug information leaflets significantly improved treatment knowledge of French-speaking parents after paediatric ED discharge. Leaflets are now available online for general population.

Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) for diagnosis and management of bladder outlet obstruction in men: study protocol for a randomised controlled trial.

BACKGROUND: Lower urinary tract symptoms (LUTS) comprise storage symptoms, voiding symptoms and post-voiding symptoms. Prevalence and severity of LUTS increase with age and the progressive increase in the aged population group has emphasised the importance to our society of appropriate and effective management of male LUTS. Identification of causal mechanisms is needed to optimise treatment and uroflowmetry is the simplest non-invasive test of voiding function. Invasive urodynamics can evaluate storage function and voiding function; however, there is currently insufficient evidence to support urodynamics becoming part of routine practice in the clinical evaluation of male LUTS. DESIGN: A 2-arm trial, set in urology departments of at least 26 National Health Service (NHS) hospitals in the United Kingdom (UK), randomising men with bothersome LUTS for whom surgeons would consider offering surgery, between a care pathway based on urodynamic tests with invasive multichannel cystometry and a care pathway based on non-invasive routine tests. The aim of the trial is to determine whether a care pathway not including invasive urodynamics is no worse for men in terms of symptom outcome than one in which it is included, at 18 months after randomisation. This primary clinical outcome will be measured with the International Prostate Symptom Score (IPSS). We will also establish whether inclusion of invasive urodynamics reduces rates of bladder outlet surgery as a main secondary outcome. DISCUSSION: The general population has an increased life-expectancy and, as men get older, their prostates enlarge and potentially cause benign prostatic obstruction (BPO) which often requires surgery. Furthermore, voiding symptoms become increasingly prevalent, some of which may not be due to BPO. Therefore, as the population ages, more operations will be considered to relieve BPO, some of which may not actually be appropriate. Hence, there is sustained interest in the diagnostic pathway and this trial could improve the chances of an accurate diagnosis and reduce overall numbers of surgical interventions for BPO in the NHS. The morbidity, and therapy costs, of testing must be weighed against the cost saving of surgery reduction. TRIAL REGISTRATION: Controlled-trials.com - ISRCTN56164274 (confirmed registration: 8 April 2014).