Lower urinary tract symptoms in men: the TRIUMPH cluster RCT.

Background: Conservative therapies are recommended as initial treatment for male lower urinary tract symptoms. However, there is a lack of evidence on effectiveness and uncertainty regarding approaches to delivery. Objective: The objective was to determine whether or not a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for lower urinary tract symptoms to usual care. Design: This was a two-arm cluster randomised controlled trial. Setting: The trial was set in 30 NHS general practice sites in England. Participants: Participants were adult men (aged ≥ 18 years) with bothersome lower urinary tract symptoms. Interventions: Sites were randomised 1 : 1 to deliver the TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions trial intervention or usual care to all participants. The TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions intervention comprised a standardised advice booklet developed for the trial from the British Association of Urological Surgeons' patient information sheets, with patient and expert input. Patients were directed to relevant sections by general practice or research nurses/healthcare assistants following urinary symptom assessment, providing the manualised element. The healthcare professional provided follow-up contacts over 12 weeks to support adherence to the intervention. Main outcome measures: The primary outcome was the validated patient-reported International Prostate Symptom Score 12 months post consent. Rather than the minimal clinically important difference of 3.0 points for overall International Prostate Symptom Score, the sample size aimed to detect a difference of 2.0 points, owing to the recognised clinical impact of individual symptoms. Results: A total of 1077 men consented to the study: 524 in sites randomised to the intervention arm (n = 17) and 553 in sites randomised to the control arm (n = 13). A difference in mean International Prostate Symptom Score at 12 months was found (adjusted mean difference of -1.81 points, 95% confidence interval -2.66 to -0.95 points), with a lower score in the intervention arm, indicating less severe symptoms. Secondary outcomes of patient-reported urinary symptoms, quality of life specific to lower urinary tract symptoms and perception of lower urinary tract symptoms all showed evidence of a difference between the arms favouring the intervention. No difference was seen between the arms in the proportion of urology referrals or adverse events. In qualitative interviews, participants welcomed the intervention, describing positive effects on their symptoms, as well as on their understanding of conservative care and their attitude towards the experience of lower urinary tract symptoms. The interviews highlighted that structured, in-depth self-management is insufficiently embedded within general practitioner consultations. From an NHS perspective, mean costs and quality-adjusted life-years were similar between trial arms. The intervention arm had slightly lower mean costs (adjusted mean difference of -£29.99, 95% confidence interval -£109.84 to £22.63) than the usual-care arm, and a small gain in quality-adjusted life-years (adjusted mean difference of 0.001, 95% confidence interval -0.011 to 0.014). Conclusions: The intervention showed a small, sustained benefit for men's lower urinary tract symptoms and quality of life across a range of outcome measures in a UK primary care setting. Qualitative data showed that men highly valued the intervention. Intervention costs were marginally lower than usual-care costs. Limitations of the study included that trial participants were unmasked, with limited diversity in ethnicity and deprivation level. Additional research is needed to assess the applicability of the intervention for a more ethnically diverse population.. Trial registration: This trial is registered as ISRCTN11669964. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/90/03) and is published in full in Health Technology Assessment; Vol. 28, No. 13. See the NIHR Funding and Awards website for further award information.

Urinary problems among men become more common with age. Nearly one-third of all men aged > 65 years experience some urinary symptoms, which can have a substantial effect on their daily lives. Symptoms include needing to pass urine more often, urgently or during the night, and difficulties in passing urine. Men are usually diagnosed and treated by their general practitioner, and should be offered advice on controlling their symptoms themselves (e.g. lifestyle changes and exercises) before trying tablets or surgery. However, it is not known how helpful such advice is, and how general practices can effectively provide it. Thirty general practices in the West of England and Wessex took part in the study. Practices were split into two groups, with each practice providing either the TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions care package or the practice's usual care to all of its patients in the trial. The TReatIng Urinary symptoms in Men in Primary Healthcare using nonpharmacological and non-surgical interventions care package included a booklet of advice to help control urinary symptoms, with a nurse or healthcare assistant directing men to relevant sections according to their symptoms, and providing follow-up contacts. We mainly assessed the benefits of the TReatIng Urinary symptoms in Men in Primary Healthcare using nonpharmacological and non-surgical interventions care package, compared with usual care, by using a questionnaire on urinary symptoms completed by participants. A total of 1077 men with urinary symptoms that bothered them joined the study. The main result was that men reported greater improvement in urinary symptoms with the TRIUMPH care package than with usual care, 12 months after joining the study. We also found that men receiving the TRIUMPH care package had a slight improvement in quality of life and outlook on their urinary symptoms. There was no difference between the two groups in the number of patients referred to hospital for treatment, the type, number and severity of side effects or cost to the NHS. Overall, the TRIUMPH care package was more effective in treating men with urinary symptoms than usual care by their general practice.

Cost-effectiveness of a primary healthcare intervention to treat male lower urinary tract symptoms: the TRIUMPH cluster randomised controlled trial.

OBJECTIVES: To estimate the cost-effectiveness of a primary care intervention for male lower urinary tract symptoms (LUTS) compared with usual care. DESIGN: Economic evaluation alongside a cluster randomised controlled trial from a UK National Health Service (NHS) perspective with a 12-month time horizon. SETTING: Thirty NHS general practice sites in England. PARTICIPANTS: 1077 men aged 18 or older identified in primary care with bothersome LUTS. INTERVENTIONS: A standardised and manualised intervention for the treatment of bothersome LUTS was compared with usual care. The intervention group (n=524) received a standardised information booklet with guidance on conservative treatment for LUTS, urinary symptom assessment and follow-up contacts for 12 weeks. The usual care group (n=553) followed local guidelines between general practice sites. MEASURES: Resource use was obtained from electronic health records, trial staff and participants, and valued using UK reference costs. Quality-adjusted life-years (QALYs) were calculated from the EQ-5D-5L questionnaire. Adjusted mean differences in costs and QALYs and incremental net monetary benefit were estimated. RESULTS: 866 of 1077 (80.4%) participants had complete data and were included in the base-case analysis. Over the 12-month follow-up period, intervention and usual care arms had similar mean adjusted costs and QALYs. Mean differences were lower in the intervention arm for adjusted costs -£29.99 (95% CI -£109.84 to £22.63) while higher in the intervention arm for adjusted QALYs 0.001 (95% CI -0.011 to 0.014). The incremental net monetary benefit statistic was £48.01 (95% CI -£225.83 to £321.85) at the National Institute for Health and Care Excellence UK threshold of £20 000 per QALY. The cost-effectiveness acceptability curve showed a 63% probability of the intervention arm being cost-effective at this threshold. CONCLUSIONS: Costs and QALYs were similar between the two arms at 12 months follow-up. This indicates that the intervention can be implemented in general practice at neutral cost. TRIAL REGISTRATION NUMBER: ISRCTN11669964.

Treatment of lower urinary tract symptoms in men in primary care using a conservative intervention: cluster randomised controlled trial.

OBJECTIVE: To determine whether a standardised and manualised care intervention in men in primary care could achieve superior improvement of lower urinary tract symptoms (LUTS) compared with usual care. DESIGN: Cluster randomised controlled trial. SETTING: 30 National Health Service general practice sites in England. PARTICIPANTS: Sites were randomised 1:1 to the intervention and control arms. 1077 men (≥18 years) with bothersome LUTS recruited between June 2018 and August 2019: 524 were assigned to the intervention arm (n=17 sites) and 553 were assigned to the usual care arm (n=13 sites). INTERVENTION: Standardised information booklet developed with patient and expert input, providing guidance on conservative and lifestyle interventions for LUTS in men. After assessment of urinary symptoms (manualised element), general practice nurses and healthcare assistants or research nurses directed participants to relevant sections of the manual and provided contact over 12 weeks to assist with adherence. MAIN OUTCOME MEASURES: The primary outcome was patient reported International Prostate Symptom Score (IPSS) measured 12 months after participants had consented to take part in the study. The target reduction of 2.0 points on which the study was powered reflects the minimal clinically important difference where baseline IPSS is <20. Secondary outcomes were patient reported quality of life, urinary symptoms and perception of LUTS, hospital referrals, and adverse events. The primary intention-to-treat analysis included 887 participants (82% of those recruited) and used a mixed effects multilevel linear regression model adjusted for site level variables used in the randomisation and baseline scores. RESULTS: Participants in the intervention arm had a lower mean IPSS at 12 months (adjusted mean difference -1.81 points, 95% confidence interval -2.66 to -0.95) indicating less severe urinary symptoms than those in the usual care arm. LUTS specific quality of life, incontinence, and perception of LUTS also improved more in the intervention arm than usual care arm at 12 months. The proportion of urology referrals (intervention 7.3%, usual care 7.9%) and adverse events (intervention seven events, usual care eight events) were comparable between the arms. CONCLUSIONS: A standardised and manualised intervention in primary care showed a sustained reduction in LUTS in men at 12 months. The mean difference of -1.81 points (95% confidence interval -0.95 to -2.66) on the IPSS was less than the predefined target reduction of 2.0 points. TRIAL REGISTRATION: ISRCTN Registry ISRCTN11669964.

The Web-Based Pain-at-Work Toolkit With Telephone Support for Employees With Chronic or Persistent Pain: Protocol for a Cluster Randomized Feasibility Trial.

BACKGROUND: Chronic or persistent pain affects one's ability to work or be productive at work, generating high societal and economic burden. However, the provision of work-related advice and support for people with chronic pain is variable or lacking. The Pain-at-Work (PAW) Toolkit was cocreated with people who live with pain, health care professionals, and employers. It aims to increase knowledge about employee rights and how to access support for managing a painful chronic condition in the workplace and provides advice on lifestyle behaviors that facilitate the management of chronic pain. OBJECTIVE: We aimed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing access to the PAW Toolkit and telephone support calls from an occupational therapist (PAW) with treatment as usual (ie, standard support from their employer). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, and safety of this digital workplace health intervention. We will assess the candidate primary and secondary outcomes' feasibility and test research processes for a definitive trial. METHODS: This is an open-label, parallel 2-arm pragmatic feasibility cluster randomized controlled trial with exploratory health economics analysis and a nested qualitative interview study. We aim to recruit 120 participants from at least 8 workplace clusters (any type, >10 employees) in England. The recruitment of workplaces occurs via personal approach, and the recruitment of individual participants is web based. Eligible participants are vocationally active adults aged ≥18 years with internet access and self-reporting chronic pain interfering with their ability to undertake or enjoy productive work. A restricted 1:1 cluster-level randomization is used to allocate employment settings to PAW or treatment as usual; participants are unblinded to group allocation. Following site- and individual-level consent, participants complete a web-based baseline survey (time 0), including measures of work capacity, health and well-being, and health care resource use. Follow-up is performed at 3 months (time 1) and 6 months (time 2). Feasibility outcomes relate to recruitment; intervention fidelity (eg, delivery, reach, uptake, and engagement); retention; and follow-up. Qualitative evaluation (time 2) is mapped to the Capability, Opportunity, Motivation-Behavior model and will explore intervention acceptability to employees and employers, along with individual and contextual factors influencing the delivery and uptake of the intervention. RESULTS: Ethics approval was obtained in March 2023. Trial recruitment began in June 2023. CONCLUSIONS: The PAW Toolkit is the first evidence-based digital health intervention aimed at supporting the self-management of chronic or persistent pain at work. This study will inform the design of a definitive trial, including sample size estimation, approaches to cluster site identification, primary and secondary outcomes' selection, and the final health economic model. Findings will inform approaches for the future delivery of this digital health intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05838677; https://clinicaltrials.gov/study/NCT05838677. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51474.

Cost-effectiveness of a physical activity and behaviour maintenance programme on functional mobility decline in older adults: an economic evaluation of the REACT (Retirement in Action) trial.

BACKGROUND: Mobility limitations in older populations have a substantial impact on health outcomes, quality of life, and social care costs. The Retirement in Action (REACT) randomised controlled trial assessed a 12-month community-based group physical activity and behaviour maintenance intervention to help prevent decline in physical functioning in older adults at increased risk of mobility limitation. We aimed to do an economic evaluation of the REACT trial to investigate whether the intervention is cost-effective. METHODS: In this health economic evaluation, we did cost-effectiveness and cost-utility analyses of the REACT programme versus standard care on the basis of resource use, primary outcome, and health-related quality-of-life data measured in the REACT trial. We also developed a decision analytic Markov model that forecasts the mobility of recipients beyond the 24-month follow-up of the trial and translated this into future costs and potential benefit to health-related quality of life using the National Health Service and Personal Social Services perspective. Participants completed questionnaire booklets at baseline, and at 6, 12, and 24 months after randomisation, which included a resource use questionnaire and the EQ-5D-5L and 36-item short-form survey (SF-36) health-related quality-of-life instruments. The cost of delivering the intervention was estimated by identifying key resources, such as REACT session leader time, time of an individual to coordinate the programme, and venue hire. EQ-5D-5L and SF-36 responses were converted to preference-based utility values, which were used to estimate quality-adjusted life-years (QALYs) over the 24-month trial follow-up using the area-under-the-curve method. We used generalised linear models to examine the effect of the REACT programme on costs and QALYs and adjust for baseline covariates. Costs and QALYs beyond 12 months were discounted at 3·5% per year. This is a pre-planned analysis of the REACT trial; the trial itself is registered with ISRCTN (ISRCTN45627165). FINDINGS: The 12-month REACT programme was estimated to cost £622 per recipient to deliver. The most substantial cost components are the REACT session leader time (£309 per participant), venue hire (£109), and the REACT coordinator time (£80). The base-case analysis of the trial-based economic evaluation showed that reductions in health and social care usage due to the REACT programme could offset the REACT delivery costs (£3943 in the intervention group vs £4043 in the control group; difference: -£103 [95% CI -£695 to £489]) with a health benefit of 0·04 QALYs (0·009-0·071; 1·354 QALYs in the intervention group vs 1·314 QALYs in the control group) within the 24-month timeframe of the trial. INTERPRETATION: The REACT programme could be considered a cost-effective approach for improving the health-related quality of life of older adults at risk of mobility limitations. FUNDING: National Institute for Health Research Public Health Research Programme.

Qualitative Assessment of the Conservative Management of Nocturia with Standardised Written Materials for Lower Urinary Tract Symptoms in Men Treated in Primary Care.

BACKGROUND: Many men prefer conservative treatment of lower urinary tract symptoms (LUTS) but education and self-help guidance are limited in primary care. OBJECTIVE: To report qualitative interview findings for men reporting nocturia in a primary care setting for LUTS. DESIGN, SETTING, AND PARTICIPANTS: TRIUMPH (Treating Urinary Symptoms in Men in Primary Healthcare) is a multicentre cluster randomised trial of standardised manualised care (a booklet delivered by a health care professional) versus usual care for LUTS. The participants (524 in the intervention arm and 553 in the usual care arm) were men presenting for primary care for LUTS at 30 general practice (GP) sites in the UK. INTERVENTION: Delivery of a LUTS self-management booklet by health care staff in comparison to usual care for men with LUTS. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The qualitative component included 58 early-stage (0-3 mo after study enrolment) and 33 late-stage (3-9 mo later) interviews with participants to assess their experience of LUTS and conservative treatment in primary care. Purposive sampling was used to select participants for interview. RESULTS AND LIMITATIONS: Nocturia is a common driver for seeking health care and is perceived by men as relatively acceptable to discuss. Information and self-help guidance were largely absent from descriptions of GP consultations, other than reducing evening caffeine and fluid intake. The TRIUMPH LUTS intervention booklet offers explanations and self-management guidance. Men with long-term disruptive symptoms, a perception that the booklet content was novel or worthwhile, and a belief that self-management might help, were more receptive to the intervention. In follow-up, improvements in nocturia were related to successful implementation of several aspects of the guidance. Most men were willing to complete a bladder diary, but some found it inconvenient, especially men in employment. The characteristics of the trial population mean that the findings may not apply to all men. CONCLUSIONS: Reassuring men that nocturia is part of ageing without offering them information and support risks reinforcing the tendency to discount problematic LUTS. The trial booklet and the training of health care professionals support guidance on nocturia self-management, which is most effective for men receptive to this approach. However, the nature of the trial population means that the findings may not apply to all men. PATIENT SUMMARY: Men are more comfortable in discussing waking at night to urinate than talking about other urinary symptoms with their GP. This problem should lead to a detailed discussion of all urinary symptoms rather than being thought of as a sign of ageing. An information booklet and nurse consultation helped many men to improve this symptom.

Beating Adolescent Self-Harm (BASH): a randomised controlled trial comparing usual care versus usual care plus a smartphone self-harm prevention app (BlueIce) in young adolescents aged 12-17 who self-harm: study protocol.

INTRODUCTION: A mobile app, BlueIce, was codesigned with young people with a history of self-harm to provide them with more accessible and available evidence-based support at times of distress. A preliminary evaluation found that BlueIce was acceptable, safe and used by young people and helped to reduce self-harm. The present study is designed to assess the effectiveness and cost-effectiveness of adding BlueIce to usual Child and Adolescent Mental Health Service (CAMHS). METHODS AND ANALYSIS: This study is a single-blind, randomised controlled trial comparing usual CAMHS care with usual care plus BlueIce. A total of 138 adolescents aged 12-17 with current or a history of self-harm will be recruited through the Oxford Health National Health Service (NHS) Foundation Trust via their CAMHS clinician. The primary outcome is self-harm at 12 weeks assessed using the Risk Taking and Self-Harm Inventory for Adolescents. Secondary outcomes include mood, anxiety, hopelessness, general behaviour, sleep and impact on everyday life at 12 weeks and 6 months. Health-related quality of life and healthcare resource utilisation data will be collected at baseline, 12 weeks and 6 months. Postuse interviews at 12 weeks will determine the acceptability, safety and usability of BlueIce. ETHICS AND DISSEMINATION: The study was approved by the NHS South Central-Oxford B NHS Research Ethics Committee (19/SC/0212) and by the Health Research Authority (HRA) and Health and Care Research Wales. Findings will be disseminated in peer review open-access journals and at academic conferences. TRIAL REGISTRATION NUMBER: ISRCTN10541045.

Cognitive therapy compared with CBT for social anxiety disorder in adolescents: a feasibility study.

BACKGROUND: Social anxiety disorder (SAD) is common, typically starts in adolescence and has a low natural recovery rate. Existing psychological treatments for adolescent SAD are only moderately effective. It is possible that recovery rates for adolescents could be substantially improved by adapting a psychological therapy that is highly effective among adults with SAD. OBJECTIVES: To train child and adolescent mental health services (CAMHS) therapists to deliver cognitive therapy for SAD in adolescents (CT-SAD-A) and assess therapist competence. To estimate the costs to the NHS of training therapists to deliver CT-SAD-A and the mean cost per adolescent treated. To examine the feasibility of a randomised controlled trial (RCT) to compare CT-SAD-A with the general form of cognitive-behavioural therapy that is more commonly used. DESIGN: During the training phase of the study, it became clear that the RCT would not be feasible because of high staff turnover and unfilled posts within CAMHS and changes in the nature of referrals, which meant that few young people with primary SAD were accessing some of the participating services. The study design was altered to comprise the following: a training case series of CT-SAD-A delivered in routine CAMHS, an estimate of the cost to the NHS of training therapists to deliver CT-SAD-A and of the mean cost per adolescent treated, and qualitative interviews with participating young people, parents, therapists and service managers/leads. SETTING: Five CAMHS teams within Berkshire Healthcare and Oxford Health NHS Foundation Trusts. PARTICIPANTS: Eight therapists received training in CT-SAD-A. Twelve young people received CT-SAD-A, delivered by six therapists. Six young people, six parents, seven therapists and three managers participated in qualitative interviews. INTERVENTIONS: Cognitive therapy for social anxiety disorder in adolescents (CT-SAD-A). MAIN OUTCOME MEASURES: Measured outcomes included social anxiety symptoms and diagnostic status, comorbid symptoms of anxiety and depression, social and general functioning, concentration in class and treatment acceptability. Patient level utilisation of the intervention was collected using clinicians' logs. RESULTS: Nine out of 12 participants achieved good outcomes across measures (r ≥ 0.60 across social anxiety measures). The estimated cost of delivering CT-SAD-A was £1861 (standard deviation £358) per person. Qualitative interviews indicated that the treatment was acceptable to young people, parents and therapists, but therapists and managers experienced challenges when implementing the training and treatment within the current CAMHS context. LIMITATIONS: Findings were based on a small, homogeneous sample and there was no comparison arm. CONCLUSIONS: CT-SAD-A is a promising treatment for young people with SAD, but the current CAMHS context presents challenges for its implementation. FUTURE WORK: Further work is needed to ensure that CAMHS can incorporate and test CT-SAD-A. Alternatively, CT-SAD-A should be delivered and tested in other settings that are better configured to treat young people whose lives are held back by SAD. The new schools Mental Health Support Teams envisaged in the 2017 Children's Mental Health Green Paper may provide such an opportunity. FUNDING: The National Institute for Health Research (NIHR) Health Technology Assessment programme. Individual funding was also provided for Cathy Creswell, David M Clark and Eleanor Leigh as follows: NIHR Research Professorship (Cathy Creswell); Wellcome Senior Investigator Award (Anke Ehlers and David M Clark); and the Wellcome Clinical Research Training Fellowship (Eleanor Leigh).

WHY DID WE DO THIS STUDY?: People with social anxiety disorder (SAD) are scared of social situations because they fear embarrassment or humiliation. SAD usually starts at around 13 years of age, typically does not go away without treatment, and leads to personal and social difficulties. Clark and Wells' cognitive therapy for SAD in adults (CT-SAD) is a talking therapy that produces excellent outcomes. CT-SAD has not previously been adapted for or tested with adolescents. WHAT DID WE DO?: We adapted CT-SAD so that it was suitable for adolescents (CT-SAD-A). We intended to compare this with current practice in child and adolescent mental health services (CAMHS). However, we were not able to complete the trial owing to a high staff turnover and a lack of young people with SAD coming into CAMHS. Instead, we examined outcomes for young people who received CT-SAD-A during the therapist training phase and explored the views of young people, their parents, the therapists and CAMHS managers about CT-SAD-A and the study. WHAT DID WE FIND?: Young people's outcomes were very promising; for example, 10 out of 12 participants reported a reliable improvement in social anxiety. The young people and their parents were generally positive about the treatment. Therapists were also positive about the treatment, but they and their managers found it difficult to implement the treatment within their CAMHS teams. The cost to the NHS to treat young people with SAD within this study compared favourably with the cost of treating adults. WHAT DOES THIS MEAN?: We need to be careful about drawing conclusions from a small sample size, but we suggest that further work is needed to ensure that CT-SAD-A can be delivered and tested in CAMHS. Alternatively, CT-SAD-A should be delivered and tested in community or school settings that can treat young people whose lives are held back by SAD.

Urodynamics tests for the diagnosis and management of bladder outlet obstruction in men: the UPSTREAM non-inferiority RCT.

BACKGROUND: Lower urinary tract symptoms (LUTS) in men may indicate bladder outlet obstruction (BOO) or weakness, known as detrusor underactivity (DU). Severe bothersome LUTS are a common indication for surgery. The diagnostic tests may include urodynamics (UDS) to confirm whether BOO or DU is the cause, potentially reducing the number of people receiving (inappropriate) surgery. OBJECTIVES: The primary objective was to determine whether a care pathway including UDS is no worse for symptom outcome than one in which it is omitted, at 18 months after randomisation. Rates of surgery was the key secondary outcome. DESIGN: This was a pragmatic, multicentre, two-arm (unblinded) randomised controlled trial, incorporating a health economic analysis and qualitative research. SETTING: Urology departments of 26 NHS hospitals in England. PARTICIPANTS: Men (aged ≥ 18 years) seeking further treatment, potentially including surgery, for bothersome LUTS. Exclusion criteria were as follows: unable to pass urine without a catheter, having a relevant neurological disease, currently undergoing treatment for prostate or bladder cancer, previously had prostate surgery, not medically fit for surgery and/or unwilling to be randomised. INTERVENTIONS: Men were randomised to a care pathway based on non-invasive routine tests (control) or routine care plus invasive UDS (intervention arm). MAIN OUTCOME MEASURES: The primary outcome was International Prostate Symptom Score (IPSS) at 18 months after randomisation and the key secondary outcome was rates of surgery. Additional secondary outcomes included adverse events (AEs), quality of life, urinary and sexual symptoms, UDS satisfaction, maximum urinary flow rate and cost-effectiveness. RESULTS: A total of 820 men were randomised (UDS, 427; routine care, 393). Sixty-seven men withdrew before 18 months and 11 died (unrelated to trial procedures). UDS was non-inferior to routine care for IPSS 18 months after randomisation, with a confidence interval (CI) within the margin of 1 point (-0.33, 95% CI -1.47 to 0.80). A lower surgery rate in the UDS arm was not found (38% and 36% for UDS and routine care, respectively), with overall rates lower than expected. AEs were similar between the arms at 43-44%. There were more cases of acute urinary retention in the routine care arm. Patient-reported outcomes for LUTS improved in both arms and satisfaction with UDS was high in men who received it. UDS was more expensive than routine care. From a secondary care perspective, UDS cost an additional £216 over an 18-month time horizon. Quality-adjusted life-years (QALYs) were similar, with a QALY difference of 0.006 in favour of UDS over 18 months. It was established that UDS was acceptable to patients, and valued by both patients and clinicians for its perceived additional insight into the cause and probable best treatment of LUTS. LIMITATIONS: The trial met its predefined recruitment target, but surgery rates were lower than anticipated. CONCLUSIONS: Inclusion of UDS in the diagnostic tests results in a symptom outcome that is non-inferior to a routine care pathway, but does not affect surgical rates for treating BOO. Results do not support the routine use of UDS in men undergoing investigation of LUTS. FUTURE WORK: Focus should be placed on indications for selective utilisation of UDS in individual cases and long-term outcomes of diagnosis and therapy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN56164274. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 42. See the NIHR Journals Library website for further project information.

After hospital referral, men with bothersome lower urinary tract symptoms (LUTS) are assessed with standard tests. These include measurement of urine flow rate, bladder diaries and questionnaires, including the International Prostate Symptom Score (IPSS). UPSTREAM (Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods) researched whether or not including an extra test, urodynamics (UDS), helps when considering treatment options. UDS is a more invasive test and measures pressure in the bladder to check whether or not the prostate is causing obstruction. It was presumed that, if there is no obstruction, surgery would not be offered, so that using UDS would reduce the number of prostate operations. Each man participating (820 in total) was assessed with the standard tests. Around half of them had no extra tests (the 'routine care' arm of the trial); the rest had the UDS tests (the 'UDS' arm). Men then went on to have treatment, which they chose having discussed their test results with a urologist. IPSS and other symptom scores were examined for each man 18 months after joining the trial. At 18 months, surgery outcomes were known for 792 men and IPSS was known for 669 men. We investigated if the two trial arms showed similar changes in the IPSS and if there were fewer operations done in the UDS arm. We identified similar reductions in the IPSS in both arms. However, UDS tests did not reduce the number of operations. Analysing all the costs, it was found that a pathway including UDS costs more than routine care. Interviews were conducted that showed that men found UDS acceptable, and that the additional information helped both the men and their doctors consider which treatment would be most appropriate. These results do not support the routine use of UDS in the assessment of every man considering prostate surgery for LUTS. Further exploration of the data may identify circumstances in which UDS could be helpful.

Diagnostic Assessment of Lower Urinary Tract Symptoms in Men Considering Prostate Surgery: A Noninferiority Randomised Controlled Trial of Urodynamics in 26 Hospitals.

BACKGROUND: Prostate surgery can improve lower urinary tract symptoms (LUTS) by relieving bladder outlet obstruction (BOO). However, surgery is less effective without BOO, or if detrusor underactivity is present. Urodynamics (UDS) can identify BOO and measure detrusor activity, but evidence in clinical practice is lacking. OBJECTIVE: Urodynamics for Prostate Surgery Trial: Randomised Evaluation of Assessment Methods (UPSTREAM) aimed to evaluate whether a care pathway including UDS would reduce surgery without increasing urinary symptoms. DESIGN, SETTING, AND PARTICIPANTS: UPSTREAM is a pragmatic, noninferiority, randomised controlled trial in men with bothersome LUTS, in whom surgery was an option, in 26 hospitals in England (ISRCTN56164274). INTERVENTION: Participants were randomised (1:1) to routine care (RC) diagnostic tests, or RC plus UDS. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the International Prostate Symptom Score (IPSS; patient-reported outcome scale from 0 to 35 points) 18 mo after randomisation, with a noninferiority margin of 1 point. Urological surgery rates were a key secondary outcome. The primary outcome was compared between the arms using linear regression, analysed on an intention-to-treat basis. RESULTS AND LIMITATIONS: Between October 2014 and December 2016, 820 men (median age 68 yr) were randomised (393 and 427 in the RC and UDS arms, respectively). The UDS arm showed noninferiority of the mean IPSSs (UDS 12.6; RC 13.1; adjusted difference at 18 mo -0.33 [95% confidence interval {CI} -1.47, +0.80]). In the UDS arm, 153/408 (38%) received surgery compared with 138/384 (36%) in the RC arm (adjusted odds ratio 1.05; 95% CI 0.77, 1.43). A total of 428 adverse events (UDS 234; RC 194) were recorded, with related events similar in both arms and 11 unrelated deaths. CONCLUSIONS: In this population, the UDS randomised group was noninferior to RC for the IPSS but did not reduce surgical rates. This study shows that routine use of UDS in the evaluation of uncomplicated LUTS has a limited role and should be used selectively. PATIENT SUMMARY: For men with uncomplicated lower urinary tract symptoms, symptom improvements after treatment and the number of operations performed are similar, irrespective of whether or not urodynamic tests are conducted in addition to routine tests. Accordingly, routine use of urodynamics has a limited role in this population group.

How European primary care practitioners think the timeliness of cancer diagnosis can be improved: a thematic analysis.

BACKGROUND: National European cancer survival rates vary widely. Prolonged diagnostic intervals are thought to be a key factor in explaining these variations. Primary care practitioners (PCPs) frequently play a crucial role during initial cancer diagnosis; their knowledge could be used to improve the planning of more effective approaches to earlier cancer diagnosis. OBJECTIVES: This study sought the views of PCPs from across Europe on how they thought the timeliness of cancer diagnosis could be improved. DESIGN: In an online survey, a final open-ended question asked PCPs how they thought the speed of diagnosis of cancer in primary care could be improved. Thematic analysis was used to analyse the data. SETTING: A primary care study, with participating centres in 20 European countries. PARTICIPANTS: A total of 1352 PCPs answered the final survey question, with a median of 48 per country. RESULTS: The main themes identified were: patient-related factors, including health education; care provider-related factors, including continuing medical education; improving communication and interprofessional partnership, particularly between primary and secondary care; factors relating to health system organisation and policies, including improving access to healthcare; easier primary care access to diagnostic tests; and use of information technology. Re-allocation of funding to support timely diagnosis was seen as an issue affecting all of these. CONCLUSIONS: To achieve more timely cancer diagnosis, health systems need to facilitate earlier patient presentation through education and better access to care, have well-educated clinicians with good access to investigations and better information technology, and adequate primary care cancer diagnostic pathway funding.

Clinical and Patient-reported Outcome Measures in Men Referred for Consideration of Surgery to Treat Lower Urinary Tract Symptoms: Baseline Results and Diagnostic Findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM).

BACKGROUND: Clinical evaluation of male lower urinary tract symptoms (MLUTS) in secondary care uses a range of assessments. It is unknown how MLUTS evaluation influences outcome of therapy recommendations and choice, notably urodynamics (UDS; filling cystometry and pressure flow studies). OBJECTIVE: To report participants' sociodemographic and clinical characteristics, and initial diagnostic findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM). UPSTREAM is a randomised controlled trial evaluating whether symptoms are noninferior and surgery rates are lower if UDS is included. DESIGN, SETTING, AND PARTICIPANTS: A total of 820 men (≥18 yr of age) seeking treatment for bothersome LUTS were recruited from 26 National Health Service hospital urology departments. INTERVENTION: Care pathway based on routine, noninvasive tests (control) or routine care plus UDS (intervention arm). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome is International Prostate Symptom Score (IPSS) and the key secondary outcome is surgery rates 18 mo after randomisation. International Consultation on Incontinence Questionnaires were captured for MLUTS, sexual function, and UDS satisfaction. Baseline clinical and patient-reported outcome measures (PROMs), and UDS findings were informally compared between arms. Trends across age groups for urinary and sexual PROMs were evaluated with a Cuzick's test, and questionnaire items were compared using Pearson's correlation coefficient. RESULTS AND LIMITATIONS: Storage LUTS, notably nocturia, and impaired sexual function are prominent in men being assessed for surgery. Sociodemographic and clinical evaluations were similar between arms. Overall mean IPSS and quality of life scores were 18.94 and 4.13, respectively. Trends were found across age groups, with older men suffering from higher rates of incontinence, nocturia, and erectile dysfunction, and younger men suffering from increased daytime frequency and voiding symptoms. Men undergoing UDS testing expressed high satisfaction with the procedure. CONCLUSIONS: Men being considered for surgery have additional clinical features that may affect treatment decision making and outcomes, notably storage LUTS and impaired sexual function. PATIENT SUMMARY: We describe initial assessment findings from a large clinical study of the treatment pathway for men suffering with bothersome urinary symptoms who were referred to hospital for further treatment, potentially including surgery. We report the patient characteristics and diagnostic test results, including symptom questionnaires, bladder diaries, flow rate tests, and urodynamics.

Identifying important health system factors that influence primary care practitioners' referrals for cancer suspicion: a European cross-sectional survey.

OBJECTIVES: Cancer survival and stage of disease at diagnosis and treatment vary widely across Europe. These differences may be partly due to variations in access to investigations and specialists. However, evidence to explain how different national health systems influence primary care practitioners' (PCPs') referral decisions is lacking.This study analyses health system factors potentially influencing PCPs' referral decision-making when consulting with patients who may have cancer, and how these vary between European countries. DESIGN: Based on a content-validity consensus, a list of 45 items relating to a PCP's decisions to refer patients with potential cancer symptoms for further investigation was reduced to 20 items. An online questionnaire with the 20 items was answered by PCPs on a five-point Likert scale, indicating how much each item affected their own decision-making in patients that could have cancer. An exploratory factor analysis identified the factors underlying PCPs' referral decision-making. SETTING: A primary care study; 25 participating centres in 20 European countries. PARTICIPANTS: 1830 PCPs completed the survey. The median response rate for participating centres was 20.7%. OUTCOME MEASURES: The factors derived from items related to PCPs' referral decision-making. Mean factor scores were produced for each country, allowing comparisons. RESULTS: Factor analysis identified five underlying factors: PCPs' ability to refer; degree of direct patient access to secondary care; PCPs' perceptions of being under pressure; expectations of PCPs' role; and extent to which PCPs believe that quality comes before cost in their health systems. These accounted for 47.4% of the observed variance between individual responses. CONCLUSIONS: Five healthcare system factors influencing PCPs' referral decision-making in 20 European countries were identified. The factors varied considerably between European countries. Knowledge of these factors could assist development of health service policies to produce better cancer outcomes, and inform future research to compare national cancer diagnostic pathways and outcomes.

A community-based physical activity intervention to prevent mobility-related disability for retired older people (REtirement in ACTion (REACT)): study protocol for a randomised controlled trial.

BACKGROUND: The REtirement in ACTion (REACT) study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial (RCT) with an internal pilot phase. It aims to test the effectiveness and cost-effectiveness of a community, group-based physical activity intervention for reducing, or reversing, the progression of functional limitations in older people who are at high risk of mobility-related disability. METHODS/DESIGN: A sample of 768 sedentary, community-dwelling, older people aged 65 years and over with functional limitations, but who are still ambulatory (scores between 4 and 9 out of 12 in the Short Physical Performance Battery test (SPPB)) will be randomised to receive either the REACT intervention, delivered over a period of 12 months by trained facilitators, or a minimal control intervention. The REACT study incorporates comprehensive process and economic evaluation and a nested sub-study which will test the hypothesis that the REACT intervention will slow the rate of brain atrophy and of decline in cognitive function assessed using magnetic resonance imaging (MRI). Outcome data will be collected at baseline, 6, 12 and 24 months for the main study, with MRI sub-study data collected at baseline, 6 and 12 months. The primary outcome analysis (SPPB score at 24 months) will be undertaken blinded to group allocation. Primary comparative analyses will be on an intention-to-treat (ITT) basis with due emphasis placed on confidence intervals. DISCUSSION: REACT represents the first large-scale, pragmatic, community-based trial in the UK to target the non-disabled but high-risk segment of the older population with an intervention to reduce mobility-related disability. A programme that can successfully engage this population in sufficient activity to improve strength, aerobic capacity, coordination and balance would have a major impact on sustaining health and independence. REACT is also the first study of its kind to conduct a full economic and comprehensive process evaluation alongside the RCT. If effective and cost-effective, the REACT intervention has strong potential to be implemented widely in the UK and elsewhere. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN45627165 . Retrospectively registered on 13 June 2016. Trial sponsor: University of Bath. Protocol Version 1.5.

Written reflection in assessment and appraisal: GP and GP trainee views.

BACKGROUND: In the UK, evidence of written reflection is part of licensing and revalidation for general practitioners (GPs). However, there is little evidence of specific benefits compared to other forms of reflective practice. AIM: To seek GPs' and general practice (GP) trainees' views on the role of written reflection in learning and assessment. DESIGN AND SETTING: An online survey of 1005 GPs and GP trainees (GPTs) in the UK. METHOD: An anonymous questionnaire containing 38 attitudinal items was administered. Descriptive statistics were used to analyse Likert scale responses, thematic analysis for free-text responses. RESULTS: In total 544 GPs and 461 GPTs completed the survey, with 842 (83.8%) agreeing they find verbal reflection with a colleague more useful than written reflection. Three quarters disagreed that written reflection is a way of identifying poorly performing GPs. Over 70% of respondents stated that summative, written reflection is a time-consuming, box-ticking exercise which distracts from other learning. They question its validity as part of assessment and state that its use may contribute to current difficulties with recruitment and retention to GP. CONCLUSIONS: For many GPs, written reflection is an onerous process rather than beneficial to their learning, indicating its continued use in assessment needs to be critically examined.

Processes of behavior change and weight loss in a theory-based weight loss intervention program: a test of the process model for lifestyle behavior change.

BACKGROUND: Process evaluation is important for improving theories of behavior change and behavioral intervention methods. The present study reports on the process outcomes of a pilot test of the theoretical model (the Process Model for Lifestyle Behavior Change; PMLBC) underpinning an evidence-informed, theory-driven, group-based intervention designed to promote healthy eating and physical activity for people with high cardiovascular risk. METHODS: 108 people at high risk of diabetes or heart disease were randomized to a group-based weight management intervention targeting diet and physical activity plus usual care, or to usual care. The intervention comprised nine group based sessions designed to promote motivation, social support, self-regulation and understanding of the behavior change process. Weight loss, diet, physical activity and theoretically defined mediators of change were measured pre-intervention, and after four and 12 months. RESULTS: The intervention resulted in significant improvements in fiber intake (M between-group difference = 5.7 g/day, p < .001) but not fat consumption (-2.3 g/day, p = 0.13), that were predictive of weight loss at both four months (M between-group difference = -1.98 kg, p < .01; R(2) = 0.2, p < 0.005), and 12 months (M difference = -1.85 kg, p = 0.1; R(2) = 0.1, p < 0.01). The intervention was successful in improving the majority of specified mediators of behavior change, and the predicted mechanisms of change specified in the PMBLC were largely supported. Improvements in self-efficacy and understanding of the behavior change process were associated with engagement in coping planning and self-monitoring activities, and successful dietary change at four and 12 months. While participants reported improvements in motivational and social support variables, there was no effect of these, or of the intervention overall, on physical activity. CONCLUSIONS: The data broadly support the theoretical model for supporting some dietary changes, but not for physical activity. Systematic intervention design allowed us to identify where improvements to the intervention may be implemented to promote change in all proposed mediators. More work is needed to explore effective mechanisms within interventions to promote physical activity behavior.

Smoking patterns in Great Britain: the rise of cheap cigarette brands and roll your own (RYO) tobacco.

BACKGROUND: In Britain, the tobacco industry segments cigarettes into four price categories-premium, mid-price, economy and ultra-low-price (ULP). Our previous work shows that tobacco companies have kept ULP prices stable in real terms. Roll your own (RYO) tobacco remains cheaper still. METHODS: Analysis of 2001-08 General Household Survey data to examine trends in use of these cheap products and, using logistic regression, the profile of users of these products. RESULTS: Among smokers, the proportion using cheap products (economy, ULP and RYO combined) increased significantly in almost all age groups and geographic areas. Increases were most marked in under 24 year olds, 76% of whom smoked cheap cigarettes by 2008. All cheap products were more commonly used in lower socio-economic groups. Men and younger smokers were more likely to smoke RYO while women smoked economy brands. Smokers outside London and the South East of England were more likely to smoke some form of cheap tobacco even once socio-economic differences were accounted for. CONCLUSIONS: This paper demonstrates that cheap tobacco use is increasing among young and disadvantaged smokers compromising declines in population smoking prevalence. Thus, tobacco industry pricing appears to play a key role in explaining smoking patterns and inequalities in smoking.

A feasibility study of brief group-based acceptance and commitment therapy for chronic pain in general practice: recruitment, attendance, and patient views.

BACKGROUND: Acceptance and commitment therapy (ACT), a form of cognitive-behavioral therapy, may help meet a need for accessible and cost-effective treatments for chronic pain. ACT has a growing evidence base, but has not yet been tested within general practice settings. AIM: The purpose of the present study was to examine the feasibility of conducting a full-scale randomized controlled trial of ACT in general practice. METHODS: A total of 481 potential participants with chronic pain identified from general practice in southwest England were invited into a treatment trial. Subsequently, 102 (21.2%) of those invited were screened, and 73 (71.6%) of those screened were allocated to ACT plus usual care or usual care alone. The ACT treatment included four, four-hour group-based sessions over two weeks. RESULTS: Twenty-six (70.3%) of the patients allocated to ACT attended three or four sessions. Those who received ACT rated it as credible in a short survey, with Mdn rating 7.0 on a 0-10 scale, across five credibility items. During a post-treatment interview considering 12 aspects of the study from invitation to treatment termination, a median of 79.2% of participants rated the aspects 'acceptable.' Qualitative data from the interviews showed a mixed picture of patient experiences, revealing possible tensions between patients' wishes to avoid discomfort and confusion, and treatment methods that explicitly ask patients to, in essence, 'live with' some discomfort and confusion. CONCLUSIONS: These data suggest that further study of ACT, as a treatment for chronic pain, is feasible in general practice and it may be possible to further optimize the treatment experience.

Solicitations in GP, nurse and pharmacist prescriber consultations: an observational study.

BACKGROUND: The opening solicitation is a key element of the primary care consultation as it enables patients to express their ideas, concerns and expectations that can lead to improved patient outcomes. However, in practice, this may not always occur. With nurses and pharmacists now able to prescribe, this research explored the opening solicitation in a multi-professional context. OBJECTIVE: To compare the nature, frequency and response to opening solicitations used in consultations with nurse prescribers (NPs), pharmacist prescribers (PPs) and GPs. METHODS: An observational study using audio-recordings of NP, PP and GP patient consultations in 36 primary care practices in southern England. Between 7-13 prescriber-patient consultations were recorded per prescriber. A standardized pro forma based upon previous research was used to assess recordings. RESULTS: Five hundred and thirty-three patient consultations (213 GPs, 209 NPs, 111 PPs) were audio-recorded with 51 prescribers. Across the prescribing groups, pharmacists asked fewer opening solicitations, while GPs used more open questions than NPs and PPs. The mean number of patient agenda items was 1.3 with more items in GP consultations. Patients completed their opening agenda in 20% of consultations, which was unaffected by professional seen. Redirection of the patient's agenda occurred at 24 seconds (mean). CONCLUSION: All prescribers should be encouraged to use more open questions and ask multiple solicitations throughout the consultation. This is likely to result in greater expression of patients' concerns and improved patient outcomes.

Understanding tobacco industry pricing strategy and whether it undermines tobacco tax policy: the example of the UK cigarette market.

AIMS: Tobacco tax increases are the most effective means of reducing tobacco use and inequalities in smoking, but effectiveness depends on transnational tobacco company (TTC) pricing strategies, specifically whether TTCs overshift tax increases (increase prices on top of the tax increase) or undershift the taxes (absorb the tax increases so they are not passed onto consumers), about which little is known. DESIGN: Review of literature on brand segmentation. Analysis of 1999-2009 data to explore the extent to which tax increases are shifted to consumers, if this differs by brand segment and whether cigarette price indices accurately reflect cigarette prices. SETTING: UK. PARTICIPANTS: UK smokers. MEASUREMENTS: Real cigarette prices, volumes and net-of-tax- revenue by price segment. FINDINGS: TTCs categorise brands into four price segments: premium, economy, mid and 'ultra-low price' (ULP). TTCs have sold ULP brands since 2006; since then, their real price has remained virtually static and market share doubled. The price gap between premium and ULP brands is increasing because the industry differentially shifts tax increases between brand segments; while, on average, taxes are overshifted, taxes on ULP brands are not always fully passed onto consumers (being absorbed at the point each year when tobacco taxes increase). Price indices reflect the price of premium brands only and fail to detect these problems. CONCLUSIONS: Industry-initiated cigarette price changes in the UK appear timed to accentuate the price gap between premium and ULP brands. Increasing the prices of more expensive cigarettes on top of tobacco tax increases should benefit public health, but the growing price gap enables smokers to downtrade to cheaper tobacco products and may explain smoking-related inequalities. Governments must monitor cigarette prices by price segment and consider industry pricing strategies in setting tobacco tax policies.