Maternal Obesity and Patterns in Postnatal Diet, Physical Activity and Weight among a Highly Deprived Population in the UK: The GLOWING Pilot Trial.

Preconception obesity is associated with adverse pregnancy outcomes and deprivation. The postnatal period provides an opportunity for preconception intervention. There is a lack of published postnatal behaviour and weight data to inform intervention needs. Secondary analysis of the GLOWING study explored postnatal diet, physical activity (PA) and weight among women living with obesity in deprivation. Thirty-nine women completed food frequency and PA questionnaires and provided weight measurement(s) between 3-12 months postnatal. Women's diet and PA fell short of national guidelines, especially for fruit/vegetables (median 1.6-2.0 portions/day) and oily fish (0-4 g/day). PA was predominantly light intensity. Patterns in weight change across time points indicated postnatal weight loss compared with 1st (median -0.8 to -2.3 kg) and 3rd-trimester weights (-9.0 to -11.6 kg). Weight loss was higher among women without excessive gestational weight gain (GWG) (-2.7 to -9.7 kg) than those with excessive GWG (2.3 to -1.8 kg), resulting in postnatal weight measurements lower than their 1st trimester. These pilot data suggest preconception interventions should commence in pregnancy with a focus on GWG, and postnatal women need early support to achieve guideline-recommendations for diet and PA. Further research in a larger population could inform preconception intervention strategies to tackle inequalities in maternal obesity and subsequent pregnancy outcomes.

Diet, Physical Activity and Gestational Weight Gain Patterns among Pregnant Women Living with Obesity in the North East of England: The GLOWING Pilot Trial.

Maternal diet, physical activity (PA) behaviours, and gestational weight gain (GWG) are important for optimum health of women and their babies. This secondary analysis of the GLOWING pilot cluster trial explored these among women living with obesity in high deprivation. Pregnant women completed food frequency, PA and psychosocial questionnaires. Weights were retrieved from medical records and measured during routine appointments with midwives. Descriptive and regression analyses were stratified by obesity class. A total of 163 women were recruited; 54.0% had class 1 obesity, 25.8% class 2, 20.2% class 3, and 76.1% lived in the two most deprived quintiles. Women had suboptimal dietary intake, particularly for oily fish, fruit and vegetables. PA was predominantly light intensity, from household, care and occupational activities. Most women gained weight outside of Institute of Medicine (IOM) guideline recommendations (87.8%); women in class 3 obesity were most likely to have inadequate GWG below IOM recommendations (58.3%, p < 0.01) and reduced odds of excessive GWG compared with class 1 (AOR 0.13, 95% 0.04-0.45). Deprived women with obesity have a double inequality as both increase pregnancy risks. This population requires support to meet guideline recommendations for diet, PA and GWG. Further research exploring obesity classes would inform policies and care to achieve the best pregnancy outcomes.

Interventions for tobacco cessation delivered by dental professionals.

BACKGROUND: Dental professionals are well placed to help their patients stop using tobacco products. Large proportions of the population visit the dentist regularly. In addition, the adverse effects of tobacco use on oral health provide a context that dental professionals can use to motivate a quit attempt. OBJECTIVES: To assess the effectiveness, adverse events and oral health effects of tobacco cessation interventions offered by dental professionals. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group's Specialised Register up to February 2020. SELECTION CRITERIA: We included randomised and quasi-randomised clinical trials assessing tobacco cessation interventions conducted by dental professionals in the dental practice or community setting, with at least six months of follow-up. DATA COLLECTION AND ANALYSIS: Two review authors independently reviewed abstracts for potential inclusion and extracted data from included trials. We resolved disagreements by consensus. The primary outcome was abstinence from all tobacco use (e.g. cigarettes, smokeless tobacco) at the longest follow-up, using the strictest definition of abstinence reported. Individual study effects and pooled effects were summarised as risk ratios (RR) and 95% confidence intervals (CI), using Mantel-Haenszel random-effects models to combine studies where appropriate. We assessed statistical heterogeneity with the I2 statistic. We summarised secondary outcomes narratively. MAIN RESULTS: Twenty clinical trials involving 14,897 participants met the criteria for inclusion in this review. Sixteen studies assessed the effectiveness of interventions for tobacco-use cessation in dental clinics and four assessed this in community (school or college) settings. Five studies included only smokeless tobacco users, and the remaining studies included either smoked tobacco users only, or a combination of both smoked and smokeless tobacco users. All studies employed behavioural interventions, with four offering nicotine treatment (nicotine replacement therapy (NRT) or e-cigarettes) as part of the intervention. We judged three studies to be at low risk of bias, one to be at unclear risk of bias, and the remaining 16 studies to be at high risk of bias. Compared with usual care, brief advice, very brief advice, or less active treatment, we found very low-certainty evidence of benefit from behavioural support provided by dental professionals, comprising either one session (RR 1.86, 95% CI 1.01 to 3.41; I2 = 66%; four studies, n = 6328), or more than one session (RR 1.90, 95% CI 1.17 to 3.11; I2 = 61%; seven studies, n = 2639), on abstinence from tobacco use at least six months from baseline. We found moderate-certainty evidence of benefit from behavioural interventions provided by dental professionals combined with the provision of NRT or e-cigarettes, compared with no intervention, usual care, brief, or very brief advice only (RR 2.76, 95% CI 1.58 to 4.82; I2 = 0%; four studies, n = 1221). We did not detect a benefit from multiple-session behavioural support provided by dental professionals delivered in a high school or college, instead of a dental setting (RR 1.51, 95% CI 0.86 to 2.65; I2 = 83%; three studies, n = 1020; very low-certainty evidence). Only one study reported adverse events or oral health outcomes, making it difficult to draw any conclusions. AUTHORS' CONCLUSIONS: There is very low-certainty evidence that quit rates increase when dental professionals offer behavioural support to promote tobacco cessation. There is moderate-certainty evidence that tobacco abstinence rates increase in cigarette smokers if dental professionals offer behavioural support combined with pharmacotherapy. Further evidence is required to be certain of the size of the benefit and whether adding pharmacological interventions is more effective than behavioural support alone. Future studies should use biochemical validation of abstinence so as to preclude the risk of detection bias. There is insufficient evidence on whether these interventions lead to adverse effects, but no reasons to suspect that these effects would be specific to interventions delivered by dental professionals. There was insufficient evidence that interventions affected oral health.

Open urethroplasty versus endoscopic urethrotomy for recurrent urethral stricture in men: the OPEN RCT.

BACKGROUND: Men who suffer recurrence of bulbar urethral stricture have to decide between endoscopic urethrotomy and open urethroplasty to manage their urinary symptoms. Evidence of relative clinical effectiveness and cost-effectiveness is lacking. OBJECTIVES: To assess benefit, harms and cost-effectiveness of open urethroplasty compared with endoscopic urethrotomy as treatment for recurrent urethral stricture in men. DESIGN: Parallel-group, open-label, patient-randomised trial of allocated intervention with 6-monthly follow-ups over 24 months. Target sample size was 210 participants providing outcome data. Participants, clinicians and local research staff could not be blinded to allocation. Central trial staff were blinded when needed. SETTING: UK NHS with recruitment from 38 hospital sites. PARTICIPANTS: A total of 222 men requiring operative treatment for recurrence of bulbar urethral stricture who had received at least one previous intervention for stricture. INTERVENTIONS: A centralised randomisation system using random blocks allocated participants 1 : 1 to open urethroplasty (experimental group) or endoscopic urethrotomy (control group). MAIN OUTCOME MEASURES: The primary clinical outcome was control of urinary symptoms. Cost-effectiveness was assessed by cost per quality-adjusted life-year (QALY) gained over 24 months. The main secondary outcome was the need for reintervention for stricture recurrence. RESULTS: The mean difference in the area under the curve of repeated measurement of voiding symptoms scored from 0 (no symptoms) to 24 (severe symptoms) between the two groups was -0.36 [95% confidence interval (CI) -1.78 to 1.02; p = 0.6]. Mean voiding symptom scores improved between baseline and 24 months after randomisation from 13.4 [standard deviation (SD) 4.5] to 6 (SD 5.5) for urethroplasty group and from 13.2 (SD 4.7) to 6.4 (SD 5.3) for urethrotomy. Reintervention was less frequent and occurred earlier in the urethroplasty group (hazard ratio 0.52, 95% CI 0.31 to 0.89; p = 0.02). There were two postoperative complications requiring reinterventions in the group that received urethroplasty and five, including one death from pulmonary embolism, in the group that received urethrotomy. Over 24 months, urethroplasty cost on average more than urethrotomy (cost difference £2148, 95% CI £689 to £3606) and resulted in a similar number of QALYs (QALY difference -0.01, 95% CI -0.17 to 0.14). Therefore, based on current evidence, urethrotomy is considered to be cost-effective. LIMITATIONS: We were able to include only 69 (63%) of the 109 men allocated to urethroplasty and 90 (80%) of the 113 men allocated to urethrotomy in the primary complete-case intention-to-treat analysis. CONCLUSIONS: The similar magnitude of symptom improvement seen for the two procedures over 24 months of follow-up shows that both provide effective symptom control. The lower likelihood of further intervention favours urethroplasty, but this had a higher cost over the 24 months of follow-up and was unlikely to be considered cost-effective. FUTURE WORK: Formulate methods to incorporate short-term disutility data into cost-effectiveness analysis. Survey pathways of care for men with urethral stricture, including the use of enhanced recovery after urethroplasty. Establish a pragmatic follow-up schedule to allow national audit of outcomes following urethral surgery with linkage to NHS Hospital Episode Statistics. TRIAL REGISTRATION: Current Controlled Trials ISRCTN98009168. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 61. See the NIHR Journals Library website for further project information.

The urethra carries urine from the bladder to the tip of the penis. Men can develop a condition called urethral stricture when part of the urethra narrows due to scarring. This can lead to difficulties in passing urine and can recur. There are two operations for urethral stricture. The standard approach is endoscopic urethrotomy. The alternative is open urethroplasty. This study wanted to find out which operation was preferable in terms of symptom control, time before further surgery and which operation was best value for the NHS. All aspects of the study were informed by patients. Two hundred and twenty-two men who had received at least one previous operation for stricture took part. The choice of operation was decided by chance (randomisation). Of these men, 113 were randomised to urethrotomy and 109 were randomised to urethroplasty. Following their operation, the men filled in questionnaires every 3­6 months for 2 years about their symptoms and if any further surgery was needed. The two groups were then compared. Of the 222 men who took part, 159 provided enough information for inclusion in the comparison (90 were in the urethrotomy group and 69 were in the urethroplasty group). The improvement over time in urinary symptoms was similar for the two groups. Men in the urethrotomy group were twice as likely to need a further operation over the 2-year study period. Very few men experienced serious complications. This study showed that both operations led to symptom improvement for men with recurrent urethral stricture. Urethroplasty, however, appears unlikely to offer good value for money for the NHS. Men needing treatment for recurrent urethral stricture can use this information to weigh up the pros and cons of each operation to decide with their clinical team which one to undergo.

Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial).

BACKGROUND: Urethral stricture affects 0.9% of men. Initial treatment is urethrotomy. Approximately, half of the strictures recur within 4 yr. Options for further treatment are repeat urethrotomy or open urethroplasty. OBJECTIVE: To compare the effectiveness and cost-effectiveness of urethrotomy with open urethroplasty in adult men with recurrent bulbar urethral stricture. DESIGN, SETTING, AND PARTICIPANTS: This was an open label, two-arm, patient-randomised controlled trial. UK National Health Service hospitals were recruited and 222 men were randomised to receive urethroplasty or urethrotomy. INTERVENTION: Urethrotomy is a minimally invasive technique whereby the narrowed area is progressively widened by cutting the scar tissue with a steel blade mounted on a urethroscope. Urethroplasty is a more invasive surgery to reconstruct the narrowed area. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the profile over 24 mo of a patient-reported outcome measure, the voiding symptom score. The main clinical outcome was time until reintervention. RESULTS AND LIMITATIONS: The primary analysis included 69 (63%) and 90 (81%) of those allocated to urethroplasty and urethrotomy, respectively. The mean difference between the urethroplasty and urethrotomy groups was -0.36 (95% confidence interval [CI] -1.74 to 1.02). Fifteen men allocated to urethroplasty needed a reintervention compared with 29 allocated to urethrotomy (hazard ratio [95% CI] 0.52 [0.31-0.89]). CONCLUSIONS: In men with recurrent bulbar urethral stricture, both urethroplasty and urethrotomy improved voiding symptoms. The benefit lasted longer for urethroplasty. PATIENT SUMMARY: There was uncertainty about the best treatment for men with recurrent bulbar urethral stricture. We randomised men to receive one of the following two treatment options: urethrotomy and urethroplasty. At the end of the study, both treatments resulted in similar and better symptom scores. However, the urethroplasty group had fewer reinterventions.

Preoperative behavioural intervention to reduce drinking before elective orthopaedic surgery: the PRE-OP BIRDS feasibility RCT.

BACKGROUND: Heavy alcohol consumption is associated with an increased risk of postoperative complications and extended hospital stay. Alcohol consumption therefore represents a modifiable risk factor for surgical outcomes. Brief behavioural interventions have been shown to be effective in reducing alcohol consumption among increased risk and risky drinkers in other health-care settings and may offer a method of addressing preoperative alcohol consumption. OBJECTIVES: To investigate the feasibility of introducing a screening process to assess adult preoperative drinking levels and to deliver a brief behavioural intervention adapted for the target population group. To conduct a two-arm (brief behavioural intervention plus standard preoperative care vs. standard preoperative care alone), multicentre, pilot randomised controlled trial to assess the feasibility of proceeding to a definitive trial. To conduct focus groups and a national web-based survey to establish current treatment as usual for alcohol screening and intervention in preoperative assessment. DESIGN: A single-centre, qualitative, feasibility study was followed by a multicentre, two-arm (brief behavioural intervention vs. treatment as usual), individually randomised controlled pilot trial with an embedded qualitative process evaluation. Focus groups and a quantitative survey were employed to characterise treatment as usual in preoperative assessment. SETTING: The feasibility study took place at a secondary care hospital in the north-east of England. The pilot trial was conducted at three large secondary care centres in the north-east of England. PARTICIPANTS: Nine health-care professionals and 15 patients (mean age 70.5 years, 86.7% male) participated in the feasibility study. Eleven health-care professionals and 68 patients (mean age 66.2 years, 80.9% male) participated in the pilot randomised trial. An additional 19 health-care professionals were recruited to one of three focus groups, while 62 completed an electronic survey to characterise treatment as usual. INTERVENTIONS: The brief behavioural intervention comprised two sessions. The first session, delivered face to face in the preoperative assessment clinic, involved 5 minutes of structured brief advice followed by 15-20 minutes of behaviour change counselling, including goal-setting, problem-solving and identifying sources of social support. The second session, an optional booster, took place approximately 1 week before surgery and offered the opportunity to assess progress and boost self-efficacy. MAIN OUTCOME MEASURES: Feasibility was assessed using rates of eligibility, recruitment and retention. The progression criteria for a definitive trial were recruitment of ≥ 40% of eligible patients and retention of ≥ 70% at 6-month follow-up. Acceptability was assessed using themes identified in qualitative data. RESULTS: The initial recruitment of eligible patients was low but improved with the optimisation of recruitment processes. The recruitment of eligible participants to the pilot trial (34%) fell short of the progression criteria but was mitigated by very high retention (96%) at the 6-month follow-up. Multimethod analyses identified the methods as acceptable to the patients and professionals involved and offers recommendations of ways to further improve recruitment. CONCLUSIONS: The evidence supports the feasibility of a definitive trial to assess the effectiveness of brief behavioural intervention in reducing preoperative alcohol consumption and for secondary outcomes of surgical complications if recommendations for further improvements are adopted. TRIAL REGISTRATION: Current Controlled Trials ISRCTN36257982. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 12. See the National Institute for Health Research Journals Library website for further project information.

Most patients undergoing knee and hip replacements are over 65 years old. Older patients have an increased risk of complications following surgery. Heavy alcohol consumption in the weeks before surgery increases the risk of complications after surgery, which can extend recovery times. Advice that helps patients reduce their alcohol consumption before surgery may have benefits for recovery. The PRE-OP BIRDS study had two parts: a feasibility study followed by a pilot randomised controlled trial with focus groups and an electronic survey used to characterise usual care in the preoperative assessment clinic. The feasibility study took place at one hospital. It aimed to develop materials that help health-care professionals provide brief advice to patients on how to reduce alcohol consumption before surgery. This brief advice was delivered to eligible patients and the acceptability to staff and patients was assessed in interviews. The pilot trial took place in three hospitals. Patients who agreed to take part were placed, by equal chance, into either a group that received usual care or a group that received usual care plus brief advice about reducing alcohol use. The aim was to count how many people agreed to take part and how many also agreed to complete a follow-up 6 months later. Interviews were carried out with patients and staff to explore their views on the intervention and the trial as a whole. All of this information was collected to help decide if a future larger trial was possible. This work found that the tools used were acceptable to both patients and staff. Although the number of people who agreed to take part was smaller than hoped, almost all of those who took part also completed the 6-month follow-up. Therefore, a future larger trial was found to be possible, but some changes could be made to encourage more people to take part.

Perceived influences on smoking behaviour and perceptions of dentist-delivered smoking cessation advice: A qualitative interview study.

OBJECTIVES: Many factors lead to the commencement and maintenance of smoking, and better understanding of these is relevant in the management of oral health, particularly as smoking cessation advice (SCA) from the dental team is a key component of patient care. Whereas most previous research has focused on dental professionals' perceptions of providing SCA, and identified facilitators and barriers to its provision, there has been more limited research focusing on patients' perceptions of receiving SCA in the dental context. Accordingly, this study aimed to explore the views of smokers with periodontitis receiving dentist-delivered SCA. METHODS: One-to-one, semi-structured interviews were conducted with a purposive sample of 28 adults who smoked tobacco and had recently received SCA during dentist-delivered periodontal therapy. Participants were sampled to reflect a range of ages and smoking behaviours. The interview schedule was based on the Theoretical Domains Framework (TDF) to explore perceived influences on smoking behaviour. Interviews also elicited participants' views on dentist-delivered SCA. Interviews were audio-recorded, transcribed verbatim and analysed thematically, drawing on the TDF. RESULTS: A broad range of perceived influences on smoking behaviour emerged from the data. Influences were allocated into seven prominent TDF domains: (i) social influences (family and friends, social pressures); (ii) social/professional role and identity (secret smoking); (iii) knowledge (experiences/perceptions of smoking cessation medications); (iv) environmental context and resources (social, home and workplace environment, cost of smoking, resentment towards authority); (v) emotions (stress management, pleasure of smoking and fear of quitting); (vi) nature of the behaviour (habitual nature, link to other behaviours, smell); and (vii) beliefs about consequences (health). With regard to views on dentist-delivered SCA, five main themes emerged: (i) opportunistic nature; (ii) personal impact and tangible prompts; (iii) positive context of cessation attempt; (iv) lack of previous support; and (v) differences between dentist-delivered SCA and other setting SCA. CONCLUSIONS: Smokers with periodontitis consider that a wide range of factors influence their smoking behaviour. Dentist-delivered SCA was supported and positively received. Important aspects included the opportunistic nature, personal impact, use of tangible prompts and positive context (of the quit attempt). Future research should focus on optimizing dentist-led smoking cessation intervention based on the themes identified.

Antiplatelet therapy in the primary prevention of cardiovascular disease in patients with chronic obstructive pulmonary disease: a randomised controlled proof-of-concept trial.

The APPLE COPD-ICON2 trial is a prospective 2×2 factorial, double-blinded proof-of-concept randomised controlled trial targeting patients with chronic obstructive pulmonary disease (COPD) without prior history of cardiovascular disease. The primary goal of this trial is to investigate if treatment with antiplatelet therapy will produce the predefined cut-off of platelet inhibition measured using the Multiplate test in COPD patients. Eligible patients were randomised to aspirin plus placebo, ticagrelor plus placebo, aspirin plus ticagrelor or placebo only for 6 months. The primary outcome comprises inhibition (binary response) of arachidonic acid- (ASPI test, cut-off <40) and adenosine diphosphate- (ADP test, cut-off <46) induced platelet aggregation at 6 months. 543 patients were screened and 120 patients were recruited with mean age of 67.5 years; 47.5% patients were male. The per-protocol ASPI test response rate to aspirin was 68.3% (95% CI 52.3-80.9%). The per-protocol ADP test response rate to ticagrelaor was 68.8% (95% CI 50.4-82.6%). Platelet response to antiplatelet therapy with aspirin and ticagrelor was not observed in nearly one-third of COPD patients without prior history of cardiovascular disease. These findings support the high pro-thrombotic milieu and the need for further research to determine the effect of antiplatelet/antithrombotic therapy on cardiovascular morbidity and mortality in COPD patients.

A feasibility study with embedded pilot randomised controlled trial and process evaluation of electronic cigarettes for smoking cessation in patients with periodontitis.

BACKGROUND: Tobacco smoking is a major risk factor for several oral diseases, including periodontitis, and electronic cigarettes (e-cigarettes) are increasingly being used for smoking cessation. This study aimed to assess the viability of delivering and evaluating an e-cigarette intervention for smoking cessation within the dental setting, prior to a definitive study. METHODS: A feasibility study, comprising a pilot randomised controlled trial and qualitative process evaluation, was conducted over 22 months in the Newcastle upon Tyne Hospitals NHS Dental Clinical Research Facility, UK. The pilot trial comprised a two-armed, parallel group, individually randomised, controlled trial, with 1:1 allocation. Participant eligibility criteria included being a tobacco smoker, having periodontitis and not currently using an e-cigarette. All participants received standard non-surgical periodontal therapies and brief smoking cessation advice. The intervention group additionally received an e-cigarette starter kit with brief training. Proposed outcomes for a future definitive trial, in terms of smoking behaviour and periodontal/oral health, were collected over 6 months to assess data yield and quality and estimates of parameters. Analyses were descriptive, with 95% confidence intervals presented, where appropriate. RESULTS: Eighty participants were successfully recruited from a range of dental settings. Participant retention was 73% (n = 58; 95% CI 62-81%) at 6 months. The e-cigarette intervention was well received, with usage rates of 90% (n = 36; 95% CI 77-96%) at quit date. Twenty percent (n = 8; 95% CI 11-35%) of participants in the control group used an e-cigarette at some point during the study (against advice). The majority of the outcome measures were successfully collected, apart from a weekly smoking questionnaire (only 30% of participants achieved ≥ 80% completion). Reductions in expired air carbon monoxide over 6 months of 6 ppm (95% CI 1-10 ppm) and 12 ppm (95% CI 8-16 ppm) were observed in the control and intervention groups, respectively. Rates of abstinence (carbon monoxide-verified continuous abstinence for 6 months) for the two groups were 5% (n = 2; 95% CI 1-17%; control group) and 15% (n = 6; 95% CI 7-29%; intervention group). CONCLUSIONS: Data suggest that a definitive trial is feasible and that the intervention may improve smoking quit rates. Insights were gained into how best to conduct the definitive trial and estimates of parameters to inform design were obtained. TRIAL REGISTRATION: ISRCTN, ISRCTN17731903; registered 19 September 2016 http://www.isrctn.com/ISRCTN17731903.

Preoperative Behavioural Intervention versus standard care to Reduce Drinking before elective orthopaedic Surgery (PRE-OP BIRDS): protocol for a multicentre pilot randomised controlled trial.

BACKGROUND: Evidence suggests that increased preoperative alcohol consumption increases the risk of postoperative complications; therefore, a reduction or cessation in alcohol intake before surgery may reduce perioperative risk. Preoperative assessment presents an opportunity to intervene to optimise patients for surgery. This multicentre, two-arm, parallel group, individually randomised controlled trial will investigate whether a definitive trial of a brief behavioural intervention aimed at reducing preoperative alcohol consumption is feasible and acceptable to healthcare professionals responsible for its delivery and the preoperative elective orthopaedic patient population. METHODS: Screening will be conducted by trained healthcare professionals at three hospitals in the North East of England. Eligible patients (those aged 18 or over, listed for elective hip or knee arthroplasty surgery and scoring 5 or more or reporting consumption of six or more units on a single occasion at least weekly on the alcohol screening tool) who enrol in the trial will be randomised on a one-to-one non-blinded basis to either treatment as usual or brief behavioural intervention delivered in the pre-assessment clinic. Patients will be followed up 1-2 days pre-surgery, 1-5 days post-surgery (as an in-patient), 6 weeks post-surgery, and 6 months post intervention. Feasibility will be assessed through rates of screening, eligibility, recruitment, and retention to 6-month follow-up. An embedded qualitative study will explore the acceptability of study methods to patients and staff. DISCUSSION: This pilot randomised controlled trial will establish the feasibility and acceptability of trial procedures reducing uncertainties ahead of a definitive randomised controlled trial to establish the effectiveness of brief behavioural intervention to reduce alcohol consumption in the preoperative period and the potential impact on perioperative complications. TRIAL REGISTRATION: Reference number ISRCTN36257982.

Alcohol Screening and Brief Intervention in Police Custody Suites: Pilot Cluster Randomised Controlled Trial (AcCePT).

AIMS: There is a clear association between alcohol use and offending behaviour and significant police time is spent on alcohol-related incidents. This study aimed to test the feasibility of a trial of screening and brief intervention in police custody suites to reduce heavy drinking and re-offending behaviour. SHORT SUMMARY: We achieved target recruitment and high brief intervention delivery if this occurred immediately after screening. Low rates of return for counselling and retention at follow-up were challenges for a definitive trial. Conversely, high consent rates for access to police data suggested at least some outcomes could be measured remotely. METHODS: A three-armed pilot Cluster Randomised Controlled Trial with an embedded qualitative interview-based process evaluation to explore acceptability issues in six police custody suites (north east and south west of the UK). Interventions included: 1. Screening only (Controls), 2. 10 min Brief Advice 3. Brief Advice plus 20 min of brief Counselling. RESULTS: Of 3330 arrestees approached: 2228 were eligible for screening (67%) and 720 consented (32%); 386 (54%) scored 8+ on AUDIT; and 205 (53%) were enroled (79 controls, 65 brief advice and 61 brief counselling). Follow-up rates at 6 and 12 months were 29% and 26%, respectively. However, routinely collected re-offending data were obtained for 193 (94%) participants. Indices of deprivation data were calculated for 184 (90%) participants; 37.6% of these resided in the 20% most deprived areas of UK. Qualitative data showed that all arrestees reported awareness that participation was voluntary, that the trial was separate from police work, and the majority said trial procedures were acceptable. CONCLUSION: Despite hitting target recruitment and same-day brief intervention delivery, a future trial of alcohol screening and brief intervention in a police custody setting would only be feasible if routinely collected re-offending and health data were used for outcome measurement. TRIAL REGISTRATION: ISRCTN number: 89291046.

Detailed analysis of patient-reported lower urinary tract symptoms and effect on quality of life after robotic radical prostatectomy.

OBJECTIVE: To prospectively evaluate short- to medium-term patient-reported lower urinary tract symptoms (LUTS) and their effect on health-related quality of life (HRQoL) using validated questionnaires in a large cohort of patients following robotic-assisted radical prostatectomy (RARP) for prostate cancer. MATERIALS AND METHODS: HRQoL and LUTS outcomes were prospectively assessed in 357 consecutive men undergoing RARP at a single center from 2012 to 2015 using the functional assessment of cancer therapy-prostate (FACT-P) and the international consultation on incontinence modular questionnaire-male LUTS (ICIQ-MLUTS). Questionnaires were administered at baseline, 6, 12, and 18 months. Data were analyzed using paired t-tests and ANOVA. RESULTS: Questionnaire completion rates were high (over 60% of eligible men completed 18-month follow-up). Mean Total FACT-P did not significantly change after RARP: 125.95 (standard deviation [SD] = 19.82) at baseline and 125.86 (SD = 21.14) at 18-months (P = 0.55). Mean total ICIQ-MLUTS also remained unchanged: 18.69 (SD = 10.70) at baseline and 18.76 (SD = 11.33) at 18-months (P = 0.11). Mean voiding score significantly reduced from 10.34 (SD = 5.78) at baseline to 6.33 (SD = 3.99) at 6 months after RARP (P<0.001). A reciprocal significant increase in storage score was observed: 5.34 (SD = 4.26) at baseline, 9.65 (SD = 5.71) at 6 months (P<0.001). Subanalyses of ICIQ-MLUTS scores revealed increases in storage symptoms were exclusively within urinary incontinence domains and included significant increases in both urge and stress urinary incontinence scores. CONCLUSION: Overall, patient-reported outcome measures evaluating HRQoL and LUTS do not significantly change after RARP. Detailed analysis reveals significant changes within LUTS domains do occur after surgery which could be overlooked if only total LUTS scores are reported.

Invasive urodynamic testing prior to surgical treatment for stress urinary incontinence in women: cost-effectiveness and value of information analyses in the context of a mixed methods feasibility study.

BACKGROUND: INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?) was a mixed methods study to assess the feasibility of a future randomised controlled trial of invasive urodynamic testing (IUT) prior to surgery for stress urinary incontinence (SUI) in women. Here we report one of the study's five components, with the specific objectives of (i) exploring the cost-effectiveness of IUT compared with clinical assessment plus non-invasive tests (henceforth described as 'IUT' and 'no IUT' respectively) in women with SUI or stress-predominant mixed urinary incontinence (MUI) prior to surgery, and (ii) determining the expected net gain (ENG) from additional research. METHODS: Study participants were women with SUI or stress-predominant MUI who had failed to respond to conservative treatments recruited from seven UK urogynaecology and female urology units. They were randomised to receive either 'IUT' or 'no IUT' before undergoing further treatment. Data from 218 women were used in the economic analysis. Cost utility, net benefit and value of information (VoI) analyses were performed within a randomised controlled pilot trial. Costs and quality-adjusted life years (QALYs) were estimated over 6 months to determine the incremental cost per QALY of 'IUT' compared to 'no IUT'. Net monetary benefit informed the VoI analysis. The VoI estimated the ENG and optimal sample size for a future definitive trial. RESULTS: At 6 months, the mean difference in total average cost was £138 (p = 0.071) in favour of 'IUT'; there was no difference in QALYs estimated from the SF-12 (difference 0.004; p = 0.425) and EQ-5D-3L (difference - 0.004; p = 0.725); therefore, the probability of IUT being cost-effective remains uncertain. The estimated ENG was positive for further research to address this uncertainty with an optimal sample size of 404 women. CONCLUSIONS: This is the largest economic evaluation of IUT. On average, up to 6 months after treatment, 'IUT' may be cost-saving compared to 'no IUT' because of the reduction in surgery following invasive investigation. However, uncertainty remains over the probability of 'IUT' being considered cost-effective, especially in the longer term. The VoI analysis indicated that further research would be of value. TRIAL REGISTRATION: ISRCTN. ISRCTN71327395. Registered 7 June 2010.

Multicentre individual randomised controlled trial of screening and brief alcohol intervention to prevent risky drinking in young people aged 14-15 in a high school setting (SIPS JR-HIGH): study protocol.

INTRODUCTION: Drinking has adverse impacts on health, well-being, education and social outcomes for adolescents. Adolescents in England are among the heaviest drinkers in Europe. Recently, the proportion of adolescents who drink alcohol has fallen, although consumption among those who do drink has actually increased. This trial seeks to investigate how effective and efficient an alcohol brief intervention is with 11-15 years olds to encourage lower alcohol consumption. METHODS AND ANALYSIS: This is an individually randomised two-armed trial incorporating a control arm of usual school-based practice and a leaflet on a healthy lifestyle (excl. alcohol), and an intervention arm that combines usual practice with a 30 min brief intervention delivered by school learning mentors and a leaflet on alcohol. At least 30 schools will be recruited from four regions in England (North East, North West, London, Kent and Medway) to follow-up 235 per arm. The primary outcome is total alcohol consumed in the last 28 days, using the 28 day Timeline Follow Back questionnaire measured at the 12-month follow-up. The analysis of the intervention will consider effectiveness and cost-effectiveness. A qualitative study will explore, via 1:1 in-depth interviews with (n=80) parents, young people and school staff, intervention experience, intervention fidelity and acceptability issues, using thematic narrative synthesis to report qualitative data. ETHICS AND DISSEMINATION: Ethical approval was granted by Teesside University. Dissemination plans include academic publications, conference presentations, disseminating to local and national education departments and the wider public health community, including via Fuse, and engaging with school staff and young people to comment on whether and how the project can be improved. TRIAL REGISTRATION TRIAL: ISRCTN45691494; Pre-results.

Understanding variations in patient screening and recruitment in a multicentre pilot randomised controlled trial: a vignette-based study.

BACKGROUND: The INVESTIGATE-I study was designed to inform a future definitive randomised trial of invasive urodynamic testing, compared to basic clinical assessment with noninvasive tests prior to surgical treatment, in women with stress urinary incontinence or stress-predominant mixed urinary incontinence. In a pilot randomised controlled trial, women from seven participating sites were screened, consented and randomised. Overall, 771 patients were identified from clinic notes and correspondence as being potential recruits and were sent the Patient Information Leaflet. Of those screened, 284 were deemed eligible, giving an overall 'screen positive' rate of 37 %. The numbers screened at individual centres varied between 14 and 399; the 'screen positive' rate varied between 22 and 79 % and the percentage of eligible women recruited varied between 55 and 100 %. The aim of this additional substudy was to explore why 'screen positive' rates may have varied so widely between apparently similar sites. RESULTS: All 11 trial staff involved in screening in the seven recruiting sites were asked to evaluate a series of 20 identical vignettes, mainly based on actual general practitioner referral letters. Of the vignettes, 16 mentioned one or more definite inclusion criteria; the remainder had possible inclusions. Four had definite exclusions; 12 had possible exclusions. Free-text comments were sought to clarify the screeners' decisions. For six vignettes everyone agreed that the patient was eligible; for one all agreed she was not eligible; the breakdown for the remainder was mixed. Free-text comments illuminated uncertainties that may have led to variability in judging potential eligibility. CONCLUSIONS: Variability in judgements about potential trial eligibility highlights the importance of explicit and objective inclusion and exclusion criteria, and of agreed strategies for making judgements when information is missing. During the development and planning of trials, vignettes might be a valuable tool for training those involved in screening and recruiting patients, for identifying potential problems and ensuring greater consistency in the application of eligibility criteria. TRIAL REGISTRATION: ISTCTN registry: ISRCTN71327395 , registered on 7 June 2010.

Dexamethasone and supportive care with or without whole brain radiotherapy in treating patients with non-small cell lung cancer with brain metastases unsuitable for resection or stereotactic radiotherapy (QUARTZ): results from a phase 3, non-inferiority, randomised trial.

BACKGROUND: Whole brain radiotherapy (WBRT) and dexamethasone are widely used to treat brain metastases from non-small cell lung cancer (NSCLC), although there have been no randomised clinical trials showing that WBRT improves either quality of life or overall survival. Even after treatment with WBRT, the prognosis of this patient group is poor. We aimed to establish whether WBRT could be omitted without a significant effect on survival or quality of life. METHODS: The Quality of Life after Treatment for Brain Metastases (QUARTZ) study is a non-inferiority, phase 3 randomised trial done at 69 UK and three Australian centres. NSCLC patients with brain metastases unsuitable for surgical resection or stereotactic radiotherapy were randomly assigned (1:1) to optimal supportive care (OSC) including dexamethasone plus WBRT (20 Gy in five daily fractions) or OSC alone (including dexamethasone). The dose of dexamethasone was determined by the patients' symptoms and titrated downwards if symptoms improved. Allocation to treatment group was done by a phone call from the hospital to the Medical Research Council Clinical Trials Unit at University College London using a minimisation programme with a random element and stratification by centre, Karnofsky Performance Status (KPS), gender, status of brain metastases, and the status of primary lung cancer. The primary outcome measure was quality-adjusted life-years (QALYs). QALYs were generated from overall survival and patients' weekly completion of the EQ-5D questionnaire. Treatment with OSC alone was considered non-inferior if it was no more than 7 QALY days worse than treatment with WBRT plus OSC, which required 534 patients (80% power, 5% [one-sided] significance level). Analysis was done by intention to treat for all randomly assigned patients. The trial is registered with ISRCTN, number ISRCTN3826061. FINDINGS: Between March 2, 2007, and Aug 29, 2014, 538 patients were recruited from 69 UK and three Australian centres, and were randomly assigned to receive either OSC plus WBRT (269) or OSC alone (269). Baseline characteristics were balanced between groups, and the median age of participants was 66 years (range 38-85). Significantly more episodes of drowsiness, hair loss, nausea, and dry or itchy scalp were reported while patients were receiving WBRT, although there was no evidence of a difference in the rate of serious adverse events between the two groups. There was no evidence of a difference in overall survival (hazard ratio 1·06, 95% CI 0·90-1·26), overall quality of life, or dexamethasone use between the two groups. The difference between the mean QALYs was 4·7 days (46·4 QALY days for the OSC plus WBRT group vs 41·7 QALY days for the OSC group), with two-sided 90% CI of -12·7 to 3·3. INTERPRETATION: Although the primary outcome measure result includes the prespecified non-inferiority margin, the combination of the small difference in QALYs and the absence of a difference in survival and quality of life between the two groups suggests that WBRT provides little additional clinically significant benefit for this patient group. FUNDING: Cancer Research UK, Medical Research Council Clinical Trials Unit at University College London, and the National Health and Medical Research Council in Australia.

Acceptability of Financial Incentives for Health Behaviours: A Discrete Choice Experiment.

BACKGROUND: Healthy behaviours are important determinants of health and disease, but many people find it difficult to perform these behaviours. Systematic reviews support the use of personal financial incentives to encourage healthy behaviours. There is concern that financial incentives may be unacceptable to the public, those delivering services and policymakers, but this has been poorly studied. Without widespread acceptability, financial incentives are unlikely to be widely implemented. We sought to answer two questions: what are the relative preferences of UK adults for attributes of financial incentives for healthy behaviours? Do preferences vary according to the respondents' socio-demographic characteristics? METHODS: We conducted an online discrete choice experiment. Participants were adult members of a market research panel living in the UK selected using quota sampling. Preferences were examined for financial incentives for: smoking cessation, regular physical activity, attendance for vaccination, and attendance for screening. Attributes of interest (and their levels) were: type of incentive (none, cash, shopping vouchers or lottery tickets); value of incentive (a continuous variable); schedule of incentive (same value each week, or value increases as behaviour change is sustained); other information provided (none, written information, face-to-face discussion, or both); and recipients (all eligible individuals, people living in low-income households, or pregnant women). RESULTS: Cash or shopping voucher incentives were preferred as much as, or more than, no incentive in all cases. Lower value incentives and those offered to all eligible individuals were preferred. Preferences for additional information provided alongside incentives varied between behaviours. Younger participants and men were more likely to prefer incentives. There were no clear differences in preference according to educational attainment. CONCLUSIONS: Cash or shopping voucher-type financial incentives for healthy behaviours are not necessarily less acceptable than no incentives to UK adults.