Clinical and cost-effectiveness of pessary self-management versus clinic-based care for pelvic organ prolapse in women: the TOPSY RCT with process evaluation.

Background: Pelvic organ prolapse is common, causes unpleasant symptoms and negatively affects women's quality of life. In the UK, most women with pelvic organ prolapse attend clinics for pessary care. Objectives: To determine the clinical effectiveness and cost-effectiveness of vaginal pessary self-management on prolapse-specific quality of life for women with prolapse compared with clinic-based care; and to assess intervention acceptability and contextual influences on effectiveness, adherence and fidelity. Design: A multicentre, parallel-group, superiority randomised controlled trial with a mixed-methods process evaluation. Participants: Women attending UK NHS outpatient pessary services, aged ≥ 18 years, using a pessary of any type/material (except shelf, Gellhorn or Cube) for at least 2 weeks. Exclusions: women with limited manual dexterity, with cognitive deficit (prohibiting consent or self-management), pregnant or non-English-speaking. Intervention: The self-management intervention involved a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a local clinic telephone helpline number. Clinic-based care involved routine appointments determined by centres' usual practice. Allocation: Remote web-based application; minimisation was by age, pessary user type and centre. Blinding: Participants, those delivering the intervention and researchers were not blinded to group allocation. Outcomes: The patient-reported primary outcome (measured using the Pelvic Floor Impact Questionnaire-7) was prolapse-specific quality of life, and the cost-effectiveness outcome was incremental cost per quality-adjusted life-year (a specifically developed health Resource Use Questionnaire was used) at 18 months post randomisation. Secondary outcome measures included self-efficacy and complications. Process evaluation data were collected by interview, audio-recording and checklist. Analysis was by intention to treat. Results: Three hundred and forty women were randomised (self-management, n = 169; clinic-based care, n = 171). At 18 months post randomisation, 291 questionnaires with valid primary outcome data were available (self-management, n = 139; clinic-based care, n = 152). Baseline economic analysis was based on 264 participants (self-management, n = 125; clinic-based care, n = 139) with valid quality of life and resource use data. Self-management was an acceptable intervention. There was no group difference in prolapse-specific quality of life at 18 months (adjusted mean difference -0.03, 95% confidence interval -9.32 to 9.25). There was fidelity to intervention delivery. Self-management was cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained, with an estimated incremental net benefit of £564.32 and an 80.81% probability of cost-effectiveness. At 18 months, more pessary complications were reported in the clinic-based care group (adjusted mean difference 3.83, 95% confidence interval 0.81 to 6.86). There was no group difference in general self-efficacy, but self-managing women were more confident in pessary self-management activities. In both groups, contextual factors impacted on adherence and effectiveness. There were no reported serious unexpected serious adverse reactions. There were 32 serious adverse events (self-management, n = 17; clinic-based care, n = 14), all unrelated to the intervention. Skew in the baseline data for the Pelvic Floor Impact Questionnaire-7, the influence of the global COVID-19 pandemic, the potential effects of crossover and the lack of ethnic diversity in the recruited sample were possible limitations. Conclusions: Self-management was acceptable and cost-effective, led to fewer complications and did not improve or worsen quality of life for women with prolapse compared with clinic-based care. Future research is needed to develop a quality-of-life measure that is sensitive to the changes women desire from treatment. Study registration: This study is registered as ISRCTN62510577. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/82/01) and is published in full in Health Technology Assessment; Vol. 28, No. 23. See the NIHR Funding and Awards website for further award information.

Pelvic organ prolapse is a common and distressing condition experienced by large numbers of women. Prolapse is when the organs that are usually in the pelvis drop down into the vagina. Women experience a feeling of something coming down into the vagina, along with bowel, bladder and sexual problems. One possible treatment is a vaginal pessary. The pessary is a device that is inserted into the vagina and holds the pelvic organs back in their usual place. Women who use a vaginal pessary usually come back to clinic every 6 months to have their pessary removed and replaced; this is called clinic-based care. However, it is possible for a woman to look after the pessary herself; this is called self-management. This study compared self-management with clinic-based care. Three hundred and forty women with prolapse took part; 171 received clinic-based care and 169 undertook self-management. Each woman had an equal chance of being in either group. Women in the self-management group received a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a telephone number for their local centre. Women in the clinic-based care group returned to clinic as advised by the treating healthcare professional. Self-management was found to be acceptable. Women self-managed their pessary in ways that suited their lifestyle. After 18 months, there was no difference between the groups in women's quality of life. Women in the self-management group experienced fewer pessary complications than women who received clinic-based care. Self-management costs less to deliver than clinic-based care. In summary, self-management did not improve women's quality of life more than clinic-based care, but it did lead to women experiencing fewer complications and cost less to deliver in the NHS. The findings support self-management as a treatment pathway for women using a pessary for prolapse.

Effect of 3 months and 12 months of financial incentives on 12-month postpartum smoking cessation maintenance: A randomized controlled trial.

BACKGROUND AND AIMS: Offering financial incentives is effective for smoking cessation during pregnancy. We tested the effectiveness of financial incentives for maintaining postpartum cessation, comparing 12-month and 3-month incentives with each other and with usual care (UC). DESIGN, SETTING AND PARTICIPANTS: This study was a pragmatic, multi-centre, three-arm randomized controlled trial involving four English, National Health Service, stop smoking services. A total of 462 postpartum women (aged ≥ 16 years) took part, who stopped smoking during pregnancy with financial incentives, validated as abstinent from smoking at end of pregnancy or early postpartum. INTERVENTIONS: Interventions comprised (i) UC; (ii) UC plus up to £60 of financial voucher incentives offered to participants and £60 offered to an optional significant-other supporter, over 3 months postpartum, contingent upon validated abstinence ('3-month incentives'); or (iii) UC plus '3-month incentives' plus £180 of vouchers offered to participants over 9 months postpartum, contingent upon abstinence ('12-month incentives'). MEASUREMENTS: Primary outcome: biochemically validated abstinence at 1 year postpartum. To adjust for testing all comparisons between groups with equal precision, P < 0.017 was necessary for significance. SECONDARY OUTCOMES: self-reported and validated abstinence at 3 months postpartum; self-reported abstinence at 1 year postpartum. FINDINGS: Primary outcome ascertainment: abstinence was 39.6% (63/159) 12 months incentives, 21.4% (33/154) 3 months incentives and 28.2% (42/149) UC. Adjusted odds ratios [95% confidence interval (CI)] = 12-month versus 3-month incentives OR = 2.41 (95% CI = 1.46-3.96), P = 0.001; 12 months versus UC 1.67 (1.04-2.70), P = 0.035; 3 months versus UC 0.69 (0.41-1.17), P = 0.174. Bayes factors indicated that for 12-month versus 3-month incentives and 12 months versus UC there was good evidence for the alternative hypothesis, and for 3 months versus UC there was good evidence for the null hypothesis. CONCLUSIONS: This randomized controlled trial provides weak evidence that up to £300 of voucher incentives over 12 months is effective for maintaining smoking abstinence postpartum compared with usual care. There was good evidence that 12-month incentives are superior to those over only 3 months, for which there was no evidence of effectiveness relative to usual care.

Cost-Effectiveness of 2 Models of Pessary Care for Pelvic Organ Prolapse: Findings From the TOPSY Randomized Controlled Trial.

OBJECTIVES: Pelvic organ prolapse is the descent of one or more reproductive organs from their normal position, causing associated negative symptoms. One conservative treatment option is pessary management. This study aimed to to investigate the cost-effectiveness of pessary self-management (SM) when compared with clinic-based care (CBC). A decision analytic model was developed to extend the economic evaluation. METHODS: A randomized controlled trial with health economic evaluation. The SM group received a 30-minute SM teaching session, information leaflet, 2-week follow-up call, and a local helpline number. The CBC group received routine outpatient pessary appointments, determined by usual practice. The primary outcome for the cost-effectiveness analysis was incremental cost per quality-adjusted life year (QALY), 18 months post-randomization. Uncertainty was handled using nonparametric bootstrap analysis. In addition, a simple decision analytic model was developed using the trial data to extend the analysis over a 5-year period. RESULTS: There was no significant difference in the mean number of QALYs gained between SM and CBC (1.241 vs 1.221), but mean cost was lower for SM (£578 vs £728). The incremental net benefit estimated at a willingness to pay of £20 000 per QALY gained was £564, with an 80.8% probability of cost-effectiveness. The modeling results were consistent with the trial analysis: the incremental net benefit was estimated as £4221, and the probability of SM being cost-effective at 5 years was 69.7%. CONCLUSIONS: Results suggest that pessary SM is likely to be cost-effective. The decision analytic model suggests that this result is likely to persist over longer durations.

Assessment of patients with head and neck cancer using the MD Anderson Dysphagia Inventory: Results of a study into its comprehensiveness, comprehensibility and relevance to clinical practice.

BACKGROUND: The MD Anderson Dysphagia Inventory (MDADI) is a widely used patient-reported outcome measure (PROM) which assesses dysphagia-related quality of life (QoL) in head and neck cancer (HNC). Despite its common use in HNC research and clinical practice, few of its psychometric properties have been reappraised since its inception. The aim of this study was to perform a survey-based qualitative analysis of UK HNC clinicians' perceptions of the content validity of the MDADI, evaluating it across the parameters of relevance, comprehensiveness and comprehensibility as per the COSMIN guideline for PROM assessment. RESULTS: Four themes relating to the content validity of the MDADI were identified: (1) MDADI items lack clarity of definition of the terms 'swallowing', 'eating' and 'dysphagia'; (2) the MDADI is perceived to be overly negative in tone including items that service users may find distressing or disempowering; (3) items in the tool are exclusory to specific subgroups of patients, such as those who are nil by mouth or socially isolated; and (4) modifications to the MDADI were suggested and encouraged to make it more clinically useful and patient-centred. CONCLUSIONS: This study indicates that MDADI's content validity is 'insufficient' when rated by COSMIN parameters. This has significant implications for its continued use in HNC research and clinical practice. Further re-evaluation of the content validity of the MDADI is warranted, with potential future amendment of items being indicated if the results of this study are corroborated in subsequent research. WHAT THIS PAPER ADDS: What is already known on the subject The MD Anderson Dysphagia Inventory (MDADI) patient-reported outcome measure of dysphagia-related quality of life is widely used in clinical practice and international clinical trials. Content validity is considered to be the most important property of a tool when assessing its psychometric strengths and weaknesses; however, the MDADI's content validity has not been reappraised since its initial development. What this paper adds to existing knowledge This study presents UK speech and language therapists' opinions and experience of the content validity of the MDADI and this first reappraisal of its content validity since its initial development highlights several issues with this psychometric parameter of the tool. This study highlights that further re-evaluation of the content validity of the MDADI is warranted, with potential future amendment of items being indicated if the results of this study are corroborated in subsequent research. What are the potential or actual clinical implications of this work? Clinicians cannot assume that commonly used outcomes tools have strong psychometric profiles. Consideration of the content validity of outcomes tools during selection for use in clinical and research practice should be key, as this will encourage use of tools that produce relevant, valid data that can contribute meaningfully to patient-centred care.

Assessment of perinatal anxiety: diagnostic accuracy of five measures.

BACKGROUND: Anxiety in pregnancy and after giving birth (the perinatal period) is highly prevalent but under-recognised. Robust methods of assessing perinatal anxiety are essential for services to identify and treat women appropriately. AIMS: To determine which assessment measures are most psychometrically robust and effective at identifying women with perinatal anxiety (primary objective) and depression (secondary objective). METHOD: We conducted a prospective longitudinal cohort study of 2243 women who completed five measures of anxiety and depression (Generalized Anxiety Disorder scale (GAD) two- and seven-item versions; Whooley questions; Clinical Outcomes in Routine Evaluation (CORE-10); and Stirling Antenatal Anxiety Scale (SAAS)) during pregnancy (15 weeks, 22 weeks and 31 weeks) and after birth (6 weeks). To assess diagnostic accuracy a sample of 403 participants completed modules of the Mini-International Neuropsychiatric Interview (MINI). RESULTS: The best diagnostic accuracy for anxiety was shown by the CORE-10 and SAAS. The best diagnostic accuracy for depression was shown by the CORE-10, SAAS and Whooley questions, although the SAAS had lower specificity. The same cut-off scores for each measure were optimal for identifying anxiety or depression (SAAS ≥9; CORE-10 ≥9; Whooley ≥1). All measures were psychometrically robust, with good internal consistency, convergent validity and unidimensional factor structure. CONCLUSIONS: This study identified robust and effective methods of assessing perinatal anxiety and depression. We recommend using the CORE-10 or SAAS to assess perinatal anxiety and the CORE-10 or Whooley questions to assess depression. The GAD-2 and GAD-7 did not perform as well as other measures and optimal cut-offs were lower than currently recommended.

Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial.

Background: Prolapse affects 30-40% of women. Those using a pessary for prolapse usually receive care as an outpatient. This trial determined effectiveness and cost-effectiveness of pessary self-management (SM) vs clinic-based care (CBC) in relation to condition-specific quality of life (QoL). Methods: Parallel-group, superiority randomised controlled trial, recruiting from 16 May 2018 to 7 February 2020, with follow-up to 17 September 2021. Women attending pessary clinics, ≥18 years, using a pessary (except Shelf, Gellhorn or Cube), with pessary retained ≥2 weeks were eligible. Limited manual dexterity; cognitive deficit; pregnancy; or requirement for non-English teaching were exclusions. SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received usual routine appointments. The primary clinical outcome was pelvic floor-specific QoL (PFIQ-7), and incremental net monetary benefit for cost-effectiveness, 18 months post-randomisation. Group allocation was by remote web-based application, minimised on age, user type (new/existing) and centre. Participants, intervention deliverers, researchers and the statistician were not blinded. The primary analysis was intention-to-treat based. Trial registration: https://doi.org/10.1186/ISRCTN62510577. Findings: The requisite 340 women were randomised (169 SM, 171 CBC) across 21 centres. There was not a statistically significant difference between groups in PFIQ-7 at 18 months (mean SM 32.3 vs CBC 32.5, adjusted mean difference SM-CBC -0.03, 95% CI -9.32 to 9.25). SM was less costly than CBC. The incremental net benefit of SM was £564 (SE £581, 95% CI -£576 to £1704). A lower percentage of pessary complications was reported in the SM group (mean SM 16.7% vs CBC 22.0%, adjusted mean difference -3.83%, 95% CI -6.86% to -0.81%). There was no meaningful difference in general self-efficacy. Self-managing women were more confident in self-management activities. There were no reported suspected unexpected serious adverse reactions, and 31 unrelated serious adverse events (17 SM, 14 CBC). Interpretation: Pessary self-management is cost-effective, does not improve or worsen QoL compared to CBC, and has a lower complication rate. Funding: National Institute for Health and Care Research, Health Technology Assessment Programme (16/82/01).

Long-term effects and costs of pelvic floor muscle training for prolapse: trial follow-up record-linkage study.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse affects around 40% of women aged over 50 years. A multicentre parallel group randomised trial (the Pelvic Organ Prolapse PhysiotherapY (POPPY) trial) demonstrated that pelvic floor muscle training (PFMT) was effective in reducing prolapse symptoms compared with no treatment. However, insight into the long-term impact of PFMT on health outcomes and health-service utilisation is scarce. METHODS: This study utilised linkage of Scottish administrative health records to follow-up POPPY trial participants resident in Scotland over 11 years. Mixed effects logistic regression determined the likelihood of receiving further prolapse treatment for those in the PFMT and control groups. Analyses were adjusted for age group, prolapse stage, baseline symptom severity and attitude towards surgery. A cost assessment estimated longitudinal costs to the UK National Health Service (in Scotland) of accessing further prolapse treatment for each trial group. RESULTS: Two hundred and ninety-three women, aged 25 to 79 years, were followed up. One hundred and forty-one women (48.1%) had received further prolapse treatment: 65 (of 149; 43.6%) in the PFMT group compared with 76 (of 144; 52.8%) in the control group. PFMT was associated with a reduction in the odds of any prolapse treatment during follow-up (AOR 0.61; 95% CI 0.37 to 0.99). Total cost of secondary care was £154,544 (GBP) in the PFMT group and £172,549 (GBP) in the control group. CONCLUSIONS: Although PFMT did not lead to significant differences in total costs for further prolapse treatment over a post-intervention period of more than 10 years, it reduced the overall long-term risk of requiring hospital-based treatment for pelvic floor disorders.

Implementation of a national smoke-free prison policy: an economic evaluation within the Tobacco in Prisons (TIPs) study.

OBJECTIVE: To determine the cost-effectiveness of a smoke-free prison policy in Scotland, through assessments of the trade-offs between costs (healthcare and non-healthcare-related expenditure) and outcomes (health and non-health-related non-monetary consequences) of implementing the policy. DESIGN: A health economic evaluation consisting of three analyses (cost-consequence, cost-effectiveness and cost-utility), from the perspectives of the healthcare payer, prison service, people in custody and operational staff, assessed the trade-offs between costs and outcomes. Costs associated with the implementation of the policy, healthcare resource use and personal spend on nicotine products were considered, alongside health and non-health outcomes. The cost-effectiveness of the policy was evaluated over 12-month and lifetime horizons (short term and long term). SETTING: Scotland's national prison estate. PARTICIPANTS: People in custody and operational prison staff. INTERVENTION: Implementation of a comprehensive (indoor and outdoor) smoke-free policy. MAIN OUTCOME MEASURES: Concentration of secondhand smoke, health-related quality of life (health utilities and quality-adjusted life-years (QALY)) and various non-health outcomes (eg, incidents of assaults and fires). RESULTS: The short-term analyses suggest cost savings for people in custody and staff, improvements in concentration of secondhand smoke, with no consistent direction of change across other outcomes. The long-term analysis demonstrated that implementing smoke-free policy was cost-effective over a lifetime for people in custody and staff, with approximate cost savings of £28 000 and £450, respectively, and improvement in health-related quality of life of 0.971 QALYs and 0.262, respectively. CONCLUSION: Implementing a smoke-free prison policy is cost-effective over the short term and long term for people in custody and staff.

Anticipated responses to a hypothetical minimum price for cigarettes and roll-your-own tobacco: an online cross-sectional survey with cigarette smokers and ex-smokers in the UK.

OBJECTIVES: As tobacco companies can circumvent tax increases, a minimum retail price per-cigarette/per-gram of roll-your-own tobacco presents an additional mechanism for governments to reduce smoking. We examined (1) anticipated responses to a hypothetical minimum price-per-cigarette/per-gram among smokers in the UK; (2) what demographic and smoker characteristics are associated with anticipated responses; and (3) whether minimum pricing may help ex-smokers stay quit. DESIGN: Cross-sectional survey (May-July 2019). SETTING: UK. PARTICIPANTS: Adult cigarette smokers (n=2412) and ex-smokers (n=700). MAIN OUTCOME MEASUREMENTS: Anticipated responses to a hypothetical minimum price of £10.00 for 20 cigarettes (£0.50 per-cigarette) and £13.50 for 30 grams of roll-your-own tobacco (£0.45 per-gram); approximately £0.10 per-cigarette/per-gram increases on the cheapest prices in leading UK supermarkets (January 2019). Smokers were presented with ten options (eg, 'Try to quit') and asked which they would do (Yes/No) and then which they would most likely do. Ex-smokers were asked to what extent the minimum prices would help them stay quit (A lot vs Lesser agreement). RESULTS: Among smokers, 55.6% said they would most likely smoke the same amount, 10.7% they would smoke less, 9.5% they would try to quit and 5.8% they would use e-cigarettes more often. Anticipated reactions were associated with demography and smoker characteristics, for example, C2DE (lower social grade) smokers were less likely than ABC1 (higher social grade) smokers to say they would smoke the same as they do now (ORAdj=0.74, 95% CI 0.62 to 0.88). Among ex-smokers, 38.5% said the minimum prices would help them stay quit 'A lot', more so among C2DE than ABC1 participants (ORAdj=1.80, 95% CI 1.30 to 2.49). CONCLUSIONS: In response to a hypothetical minimum price for cigarettes and roll-your-own tobacco, approximately a fifth of smokers in the UK indicated they would smoke less or quit and almost two-fifths of ex-smokers indicated the prices would help them stay quit.

A cluster feasibility trial to explore the uptake and use of e-cigarettes versus usual care offered to smokers attending homeless centres in Great Britain.

Smoking rates in the UK are at an all-time low but this masks considerable inequalities; prevalence amongst adults who are homeless remains four times higher than the national average. The objective of this trial was to assess the feasibility of supplying free e-cigarette starter kits to smokers accessing homeless centres and to estimate parameters to inform a possible future larger trial. In this feasibility cluster trial, four homeless centres in Great Britain were non-randomly allocated to either a Usual Care (UC) or E-Cigarette (EC) arm. Smokers attending the centres were recruited by staff. UC arm participants (N = 32) received advice to quit and signposting to the local Stop Smoking Service. EC arm participants (N = 48) received an EC starter kit and 4-weeks supply of e-liquid. Outcome measures were recruitment and retention rates, use of ECs, smoking cessation/reduction and completion of measures required for economic evaluation. Eighty (mean age 43 years; 65% male) of the 153 eligible participants who were invited to participate, were successfully recruited (52%) within a five-month period, and 47 (59%) of these were retained at 24 weeks. The EC intervention was well received with minimal negative effects and very few unintended consequences (e.g. lost, theft, adding illicit substances). In both study arm, depression and anxiety scores declined over the duration of the study. Substance dependence scores remained constant. Assuming those with missing follow up data were smoking, CO validated sustained abstinence at 24 weeks was 3/48 (6.25%) and 0/32 (0%) respectively for the EC and UC arms. Almost all participants present at follow-up visits completed data collection for healthcare service and health-related quality of life measures. Providing an e-cigarette starter kit to smokers experiencing homelessness was associated with reasonable recruitment and retention rates and promising evidence of effectiveness and cost-effectiveness.

Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial.

BACKGROUND: Pelvic organ prolapse (or prolapse) is a common condition in women where the pelvic organs (bladder, bowel or womb) descend into the vagina and cause distressing symptoms that adversely affect quality of life. Many women will use a vaginal pessary to treat their prolapse symptoms. Clinic-based care usually consists of having a pessary fitted in a primary or secondary care setting, and returning approximately every 6 months for healthcare professional review and pessary change. However, it is possible that women could remove, clean and re-insert their pessary themselves; this is called self-management. This trial aims to assess if self-management of a vaginal pessary is associated with better quality of life for women with prolapse when compared to clinic-based care. METHODS: This is a multicentre randomised controlled trial in at least 17 UK centres. The intervention group will receive pessary self-management teaching, a self-management information leaflet, a follow-up phone call and access to a local telephone number for clinical support. The control group will receive the clinic-based pessary care which is standard at their centre. Demographic and medical history data will be collected from both groups at baseline. The primary outcome is condition-specific quality of life at 18 months' post-randomisation. Several secondary outcomes will also be assessed using participant-completed questionnaires. Questionnaires will be administered at baseline, 6, 12 and 18 months' post-randomisation. An economic evaluation will be carried out alongside the trial to evaluate cost-effectiveness. A process evaluation will run parallel to the trial, the protocol for which is reported in a companion paper. DISCUSSION: The results of the trial will provide robust evidence of the effectiveness of pessary self-management compared to clinic-based care in terms of improving women's quality of life, and of its cost-effectiveness. TRIAL REGISTRATION: ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017.

Adolescents' perceptions of tobacco accessibility and smoking norms and attitudes in response to the tobacco point-of-sale display ban in Scotland: results from the DISPLAY Study.

BACKGROUND: Scotland implemented a ban on open display of tobacco products in supermarkets in April 2013, and small shops in April 2015. This study aimed to quantify changes in perceived tobacco accessibility, smoking norms and smoking attitudes among adolescents in Scotland, following the implementation of partial and comprehensive point-of-sale (POS) tobacco display bans. METHODS: From the Determining the Impact of Smoking Point of Sale Legislation Among Youth (DISPLAY) Study's 2013-2017 annual surveys we retrieved data comprising 6202 observations on 4836 12-17-year-old adolescents from four schools. Applying generalised estimating equations, associations between time (postban: 2016-2017 vs preban:2013) and three outcomes were estimated. Outcomes were perceived commercial access to tobacco, perceived positive smoking norm (friends think it's OK to smoke) and positive smoking attitude (you think it's OK to smoke). Analyses were adjusted for sociodemographics, smoking status, family smoking, friend smoking and e-cigarette use. RESULTS: Crude trends showed an increase over time in perceived accessibility, norms and attitudes. However, after adjustment for confounders, mainly e-cigarette use, we found significant declines in perceived access (OR = 0.72, 95% CI 0.57 to 0.90) and in positive smoking attitude (OR = 0.67, 95% CI = 0.49 to 0.91), but no change in perceived positive smoking norm (OR = 1.00, 95% CI 0.78 to 1.29). Current/past occasional or regular e-cigarette use was associated with higher odds of perceived access (OR = 3.12, 95% CI 2.32 to 4.21), positive norm (OR = 2.94, 95% CI 2.16 to 4.02) and positive attitude (OR = 3.38, 95% CI 2.35 to 4.87). CONCLUSION: Only when taking into account that the use of e-cigarettes increased in 2013-2017 did we find that the POS tobacco display ban in supermarkets and small shops in Scotland was followed by reductions in adolescents' perceived accessibility of tobacco and positive attitudes towards smoking.

How has the introduction of point-of-sale legislation affected the presence and visibility of tobacco retailing in Scotland? A longitudinal study.

BACKGROUND: Reducing the local availability of tobacco is identified as the 'next frontier' in tobacco control. This paper examines the roles of tobacco retail outlet density and tobacco visibility in changing exposure to tobacco retailing before and after the introduction of point-of-sale (POS) legislation in Scotland. METHODS: National tobacco retailer register data were analysed to examine time trends in tobacco retailer density (2012-2017). Results were stratified by local authority, neighbourhood deprivation and urbanity. Next, an annual retail audit using a POS tobacco visibility tool assessed changes in total product visibility in all retail outlets in four study communities between 2013 and 2017. A longitudinal survey (2013-2017) of 5527 adolescents aged 12-17 in the four study communities enabled the calculation of residential and journey-to-school measures of tobacco retailer exposure. Trends were stratified by deprivation, urbanity and socioeconomic status. RESULTS: Retail provision of tobacco declined following the introduction of the POS legislation in 2013. However, there were strong geographic differences; nationally, one-fifth of local authorities have increased provision since 2015. In the four study communities, tobacco retail provision was generally stable over the study period. Although product visibility of tobacco products reduced for adolescents there was growing socioeconomic disparity in the density of tobacco retailers and the visibility of tobacco storage. CONCLUSIONS: The POS ban reduced exposure to tobacco products in communities across Scotland. However, tobacco products remain widely available, and there is growing socioeconomic disparity in the availability and visibility of tobacco.

"It Looks Like an Adult Sweetie Shop": Point-of-Sale Tobacco Display Exposure and Brand Awareness in Scottish Secondary School Students.

INTRODUCTION: As further restrictions have been placed on tobacco advertising and promotions, point-of-sale (PoS) displays of cigarettes in shops have become an increasingly important source of young people's exposure to tobacco products. This study explored the relationship between PoS displays of cigarettes and brand awareness among secondary school students in Scotland. METHODS: Cross-sectional school surveys (n = 1406) and focus groups (n = 86) were conducted with S2 (13-14 years) and S4 (15-16 years) students in four schools of differing socioeconomic status in 2013, prior to the PoS display ban in large shops. Adjusted negative binomial regression analysis examined associations between brand awareness and exposure variables (visiting tobacco retailers, noticing displays of tobacco products). RESULTS: Students visiting small shops more frequently (relative rate ratio [RRR] 1.19, 95% confidence interval [CI] 1.01-1.41) and those who noticed cigarette displays in small shops (RRR 1.24, 95% CI 1.03-1.51) and large supermarkets (RRR 1.15, 95% CI 1.01-1.30) had higher brand awareness. The focus groups supported these findings. Participants described PoS tobacco displays as being eye-catching, colorful and potentially attractive to young people. CONCLUSIONS: This mixed-methods study showed that higher cigarette brand awareness was significantly associated with regularly visiting small shops and noticing PoS displays in small and large shops, even when students' smoking status, smoking in their social networks, leisure activities, and demographics were included as confounding variables. This highlights the importance of PoS displays of tobacco products in increasing brand awareness, which is known to increase youth smoking susceptibility, and thus the importance of implementing PoS display bans in all shops. IMPLICATIONS: As increasing restrictions have been placed on tobacco promotion in many countries, PoS displays of cigarettes in shops have become an important source of young people's exposure to tobacco products and marketing. This mixed-methods study showed that prior to the PoS display ban in Scotland, and controlling for other factors, 13- and 15-year olds who regularly visited small shops and those who noticed PoS displays in small and large shops, had a higher awareness of cigarette brands. This highlights the importance of PoS displays in increasing youth brand awareness, which increases smoking susceptibility, and thus the need for comprehensive bans on PoS displays which cover all shops.

The cost of selective attention in category learning: developmental differences between adults and infants.

Selective attention plays an important role in category learning. However, immaturities of top-down attentional control during infancy coupled with successful category learning suggest that early category learning is achieved without attending selectively. Research presented here examines this possibility by focusing on category learning in infants (6-8months old) and adults. Participants were trained on a novel visual category. Halfway through the experiment, unbeknownst to participants, the to-be-learned category switched to another category, where previously relevant features became irrelevant and previously irrelevant features became relevant. If participants attend selectively to the relevant features of the first category, they should incur a cost of selective attention immediately after the unknown category switch. Results revealed that adults demonstrated a cost, as evidenced by a decrease in accuracy and response time on test trials as well as a decrease in visual attention to newly relevant features. In contrast, infants did not demonstrate a similar cost of selective attention as adults despite evidence of learning both to-be-learned categories. Findings are discussed as supporting multiple systems of category learning and as suggesting that learning mechanisms engaged by adults may be different from those engaged by infants.