Publications by authors named "Steve Parrott"

104 Publications

Long-Term Cost-Effectiveness of Smoking Cessation Interventions in People With Mental Disorders: A Dynamic Decision Analytical Model.

Value Health 2021 Sep 3;24(9):1263-1272. Epub 2021 Jun 3.

Department of Health Sciences, University of York, Heslington, York, UK.

Objectives: People with mental disorders are more likely to smoke than the general population. The objective of this study is to develop a decision analytical model that estimates long-term cost-effectiveness of smoking cessation interventions in this population.

Methods: A series of Markov models were constructed to estimate average lifetime smoking-attributable inpatient cost and expected quality-adjusted life-years. The model parameters were estimated using a variety of data sources. The model incorporated uncertainty through probabilistic sensitivity analysis using Monte Carlo simulations. It also generated tables presenting incremental cost-effectiveness ratios of the proposed interventions with varying incremental costs and incremental quit rates. We used data from 2 published trials to demonstrate the model's ability to make projections beyond the observational time frame.

Results: The average smoker's smoking-attributable inpatient cost was 3 times higher and health utility was 5% lower than ex-smokers. The intervention in the trial with a statistically insignificant difference in quit rate (19% vs 25%; P=.2) showed a 45% to 49% chance of being cost-effective compared with the control at willingness-to-pay thresholds of £20 000 to £30 000/quality-adjusted life-years. The second trial had a significant outcome (quit rate 35.9% vs 15.6%; P<.001), and the corresponding probability of the intervention being cost-effective was 65%.

Conclusions: This model provides a consistent platform for clinical trials to estimate the potential lifetime cost-effectiveness of smoking cessation interventions for people with mental disorders and could help commissioners direct resources to the most cost-effective programs. However, direct comparisons of results between trials must be interpreted with caution owing to their different designs and settings.
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http://dx.doi.org/10.1016/j.jval.2021.04.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8404974PMC
September 2021

ADVANCE integrated group intervention to address both substance use and intimate partner abuse perpetration by men in substance use treatment: a feasibility randomised controlled trial.

BMC Public Health 2021 05 25;21(1):980. Epub 2021 May 25.

Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.

Background: Substance use is a risk factor for intimate partner abuse (IPA) perpetration. Delivering perpetrator interventions concurrently with substance use treatment shows promise.

Methods: The feasibility of conducting an efficacy and cost-effectiveness trial of the ADVANCE 16-week intervention to reduce IPA by men in substance use treatment was explored. A multicentre, parallel group individually randomised controlled feasibility trial and formative evaluation was conducted. Over three temporal cycles, 104 men who had perpetrated IPA towards a female (ex) partner in the past year were randomly allocated to receive the ADVANCE intervention + substance use treatment as usual (TAU) (n = 54) or TAU only (n = 50) and assessed 16-weeks post-randomisation. Participants' (ex) partners were offered support and 27 provided outcome data. Thirty-one staff and 12 men who attended the intervention participated in focus groups or interviews that were analysed using the framework approach. Pre-specified criteria assessed the feasibility of progression to a definitive trial: 1) ≥ 60% of eligible male participants recruited; 2) intervention acceptable to staff and male participants; 3) ≥ 70% of participants followed-up and 4) levels of substance use and 5) IPA perpetrated by men in the intervention arm did not increase from average baseline level at 16-weeks post-randomisation.

Results: 70.7% (104/147) of eligible men were recruited. The formative evaluation confirmed the intervention's acceptability. Therapeutic alliance and session satisfaction were rated highly. The overall median rate of intervention session attendance (of 14 compulsory sessions) was 28.6% (range 14.3-64.3% by the third cycle). 49.0% (51/104) of men and 63.0% (17/27) of their (ex) partners were followed-up 16-weeks post-randomisation. This increased to 100% of men and women by cycle three. At follow-up, neither substance use nor IPA perpetration had worsened for men in the intervention arm.

Conclusions: It was feasible to deliver the ADVANCE intervention in substance use treatment services, although it proved difficult to collect data from female (ex)partners. While some progression criteria were met, others were not, although improvements were demonstrated by the third cycle. Lessons learned will be implemented into the study design for a definitive trial of the ADVANCE intervention.

Trial Registration: ISRCTN79435190 prospectively registered 22nd May 2018.
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http://dx.doi.org/10.1186/s12889-021-11012-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8147906PMC
May 2021

Efficacy and cost-effectiveness of a community-based smoke-free-home intervention with or without indoor-air-quality feedback in Bangladesh (MCLASS II): a three-arm, cluster-randomised, controlled trial.

Lancet Glob Health 2021 05;9(5):e639-e650

Department of Health Sciences, University of York, York, UK; Faculty of Sciences, and Hull York Medical School, University of York, York, UK.

Background: Exposure to second-hand smoke from tobacco is a major contributor to global morbidity and mortality. We aimed to evaluate the efficacy and cost-effectiveness of a community-based smoke-free-home intervention, with or without indoor-air-quality feedback, in reducing second-hand-smoke exposure in homes in Bangladesh.

Methods: We did a three-arm, cluster-randomised, controlled trial in Dhaka, Bangladesh, and randomly assigned (1:1:1) mosques and consenting households from their congregations to a smoke-free-home intervention plus indoor-air-quality feedback, smoke-free-home intervention only, or usual services. Households were eligible if they had at least one resident attending one of the participating mosques, at least one adult resident (age 18 years or older) who smoked cigarettes or other forms of smoked tobacco (eg, bidi, waterpipe) regularly (on at least 25 days per month), and at least one non-smoking resident of any age. The smoke-free-home intervention consisted of weekly health messages delivered within an Islamic discourse by religious leaders at mosques over 12 weeks. Indoor-air-quality feedback comprised providing households with feedback on their indoor air quality measured over 24 h. Households in the usual services group received no intervention. Masking of participants and mosque leaders was not possible. The primary outcome was the 24-h mean household airborne fine particulate matter (<2·5 microns in diameter [PM]) concentration (a marker of second-hand smoke) at 12 months after randomisation. Cost-effectiveness was estimated using incremental cost-effectiveness ratios (ICERs). This trial is registered with ISRCTN, 49975452.

Findings: Between April 11 and Aug 2, 2018, we enrolled 1801 households from 45 mosques. 640 households (35·5%) were assigned to the smoke-free-home intervention plus indoor-air-quality feedback group, 560 (31·1%) to the smoke-free-home intervention only group, and 601 (33·4%) to the usual services group. At 12 months, the adjusted mean difference in household mean 24-h PM concentration was -1·0 μg/m (95% CI -12·8 to 10·9, p=0·88) for the smoke-free-home intervention plus indoor-air-quality feedback group versus the usual services group, 5·0 μg/m (-7·9 to 18·0, p=0·45) for the smoke-free-home intervention only group versus the usual services group, and -6·0 μg/m (-18·3 to 6·3, p=0·34) for the smoke-free-home intervention plus indoor-air-quality feedback group versus the smoke-free-home intervention only group. The ICER for the smoke-free-home intervention plus indoor-air-quality feedback versus usual services was US$653 per quality-adjusted life-year (QALY) gained, which was more than the upper limit of the Bangladesh willingness-to-pay threshold of $427 per QALY.

Interpretation: The smoke-free-home intervention, with or without indoor-air-quality feedback, was neither effective nor cost-effective in reducing household second-hand-smoke exposure compared with usual services. These interventions are therefore not recommended for Bangladesh.

Funding: Medical Research Council UK.

Translation: For the Bengali translation of the abstract see Supplementary Materials section.
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http://dx.doi.org/10.1016/S2214-109X(21)00040-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8064237PMC
May 2021

Cost-effectiveness analysis of public health interventions with impacts on health and criminal justice: An applied cross-sectoral analysis of an alcohol misuse intervention.

Health Econ 2021 May 19;30(5):972-988. Epub 2021 Feb 19.

Centre for Health Economics, Alcuin A Block, University of York, York, UK.

Cost-effectiveness analyses of health care programs often focus on maximizing health and ignore nonhealth impacts. Assessing the cost-effectiveness of public health interventions from a narrow health care perspective would likely underestimate their full impact, and potentially lead to inefficient decisions about funding. The aim of this study is to provide a practical application of a recently proposed framework for the economic evaluation of public health interventions, evaluating an intervention to reduce alcohol misuse in criminal offenders. This cross-sectoral analysis distinguishes benefits and opportunity costs for different sectors, makes explicit the value judgments required to consider alternative perspectives, and can inform heterogeneous decision makers with different objectives in a transparent manner. Three interventions of increasing intensity are compared: client information leaflet, brief advice, and brief lifestyle counseling. Health outcomes are measured in quality-adjusted life-years and criminal justice outcomes in reconvictions. Costs considered include intervention costs, costs to the NHS and costs to the criminal justice system. The results are presented for four different perspectives: "narrow" health care perspective; criminal justice system perspective; "full" health care perspective; and joint "full" health and criminal justice perspective. Conclusions and recommendations differ according to the normative judgment on the appropriate perspective for the evaluation.
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http://dx.doi.org/10.1002/hec.4229DOI Listing
May 2021

Smokeless tobacco products, supply chain and retailers' practices in England: a multimethods study to inform policy.

Tob Control 2021 Jan 7. Epub 2021 Jan 7.

Department of Health Sciences, University of York, York, North Yorkshire, UK.

Background: In England, many people of South Asian origin consume smokeless tobacco (ST). ST use can lead to oral cancer, which is disproportionately high in South Asians. Our aims were to assess the compliance of ST product retailers with statutory regulations and to explore the supply chain of ST.

Methods: We undertook a multimethods study between August 2017 and July 2019 in five English boroughs with a high proportion of ethnic South Asians. We purchased ST products and conducted field surveys with ST retailers at point of sale. Qualitative interviews were conducted with ST retailers and suppliers. ST packs were assessed for regulatory compliance, while quantitative and qualitative data triangulated information on retailers' practices and the ST supply chain.

Results: We collected 41 unique ST products, which included dry snuff, , , chewing tobacco and . ST products were not registered, and demonstrated low compliance with health warning (14.6%) and packaging (56.1%) requirements. ST availability in surveyed boroughs was high (38.2%-69.7%); dry snuff, and were most commonly available. ST retailers demonstrated limited knowledge of regulations, and one-third were found to advertise ST at point of sale. Qualitative insights revealed illicit supply and distribution networks, as well as ST production in discreet locations.

Conclusion: ST products are widely available in England, yet non-compliant with statutory regulations. In order to safeguard consumers, in particular ethnic South Asians, stronger efforts are needed to regulate the supply chain of ST at both national and international levels.
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http://dx.doi.org/10.1136/tobaccocontrol-2020-055830DOI Listing
January 2021

Cost-Effectiveness of Different Formats for Delivery of Cognitive Behavioral Therapy for Depression: A Systematic Review Based Economic Model.

Value Health 2020 12 24;23(12):1662-1670. Epub 2020 Sep 24.

Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England, UK.

Objectives: Cognitive behavioral therapy (CBT) is an effective treatment for depression. Different CBT delivery formats (face-to-face [F2F], multimedia, and hybrid) and intensities have been used to expand access to the treatment. The aim of this study is to estimate the long-term cost-effectiveness of different CBT delivery modes.

Methods: A decision-analytic model was developed to evaluate the cost-effectiveness of different CBT delivery modes and variations in intensity in comparison with treatment as usual (TAU). The model covered an average treatment period of 4 months with a 5-year follow-up period. The model was populated using a systematic review of randomized controlled trials and various sources from the literature.

Results: Incremental cost-effectiveness ratios of treatments compared with the next best option after excluding all the dominated and extended dominated options are: £209/quality-adjusted life year (QALY) for 6 (sessions) × 30 (minutes) F2F-CBT versus TAU; £4 453/QALY for 8 × 30 F2F versus 6 × 30 F2F; £12 216/QALY for 8 × 60 F2F versus 8 × 30 F2F; and £43 072/QALY for 16 × 60 F2F versus 8 × 60 F2F. The treatment with the highest net monetary benefit for thresholds of £20 000 to £30 000/QALY was 8 × 30 F2F-CBT. Probabilistic sensitivity analysis illustrated 6 × 30 F2F-CBT had the highest probability (32.8%) of being cost-effective at £20 000/QALY; 16 × 60 F2F-CBT had the highest probability (31.0%) at £30 000/QALY.

Conclusions: All CBT delivery modes on top of TAU were found to be more cost-effective than TAU alone. Four F2F-CBT options (6 × 30, 8 × 30, 8 × 60, 16 × 60) are on the cost-effectiveness frontier. F2F-CBT with intensities of 6 × 30 and 16 × 60 had the highest probabilities of being cost-effective. The results, however, should be interpreted with caution owing to the high level of uncertainty.
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http://dx.doi.org/10.1016/j.jval.2020.07.008DOI Listing
December 2020

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.

PLoS One 2020 23;15(10):e0240968. Epub 2020 Oct 23.

Centre for Addictive Behaviours Research, London South Bank University, London, England.

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.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0240968PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7584191PMC
December 2020

Cytisine for smoking cessation in patients with tuberculosis: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial.

Lancet Glob Health 2020 11;8(11):e1408-e1417

Department of Health Sciences, Faculty of Sciences, University of York, York, UK; Hull York Medical School, University of York, York, UK.

Background: Smoking cessation is important in patients with tuberculosis because it can reduce the high rates of treatment failure and mortality. We aimed to assess the effectiveness and safety of cystine as a smoking cessation aid in patients with tuberculosis in Bangladesh and Pakistan.

Methods: We did a randomised, double-blind, placebo-controlled, trial at 32 health centres in Bangladesh and Pakistan. Eligible patients were adults (aged >18 years in Bangladesh; aged >15 years in Pakistan) with pulmonary tuberculosis diagnosed in the previous 4 weeks, who smoked tobacco on a daily basis and were willing to stop smoking. Patients were randomly assigned (1:1) to receive behavioural support plus either oral cytisine (9 mg on day 0, which was gradually reduced to 1·5 mg by day 25) or placebo for 25 days. Randomisation was done using pregenerated block randomisation lists, stratified by trial sites. Investigators, clinicians, and patients were masked to treatment allocation. The primary outcome was continuous abstinence at 6 months, defined as self-report (of not having used more than five cigarettes, bidis, a water pipe, or smokeless tobacco products since the quit date), confirmed biochemically by a breath carbon monoxide reading of less than 10 parts per million. Primary and safety analysis were done in the intention-to-treat population. This trial is registered with the International Standard Randomised Clinical Trial Registry, ISRCTN43811467, and enrolment is complete.

Findings: Between June 6, 2017, and April 30, 2018, 2472 patients (1527 patients from Bangladesh; 945 patients from Pakistan) were enrolled and randomly assigned to receive cytisine (n=1239) or placebo (n=1233). At 6 months, 401 (32·4%) participants in the cytisine group and 366 (29·7%) participants in the placebo group had achieved continuous abstinence (risk difference 2·68%, 95% CI -0·96 to 6·33; relative risk 1·09, 95% CI 0·97 to 1·23, p=0·114). 53 (4·3%) of 1239 participants in the cytisine group and 46 (3·7%) of 1233 participants in the placebo group reported serious adverse events (94 events in the cytisine group and 90 events in the placebo group), which included 91 deaths (49 in the cytisine group and 42 in the placebo group). None of the adverse events were attributed to the study medication.

Interpretation: Our findings do not support the addition of cytisine to brief behavioural support for the treatment of tobacco dependence in patients with tuberculosis.

Funding: European Union Horizon 2020 and Health Data Research UK.

Translations: For the Bengali and Urdu translations of the abstract see Supplementary Materials section.
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http://dx.doi.org/10.1016/S2214-109X(20)30312-0DOI Listing
November 2020

A pilot cluster randomised trial of the medicines and alcohol consultation (MAC): an intervention to discuss alcohol use in community pharmacy medicine review services.

BMC Health Serv Res 2020 Oct 12;20(1):943. Epub 2020 Oct 12.

Department of Health Sciences, University of York, York, UK.

Background: Alcohol interventions are important to the developing public health role of community pharmacies. The Medicines and Alcohol Consultation (MAC) is a new intervention, co-produced with community pharmacists (CPs) and patients, which involves a CP practice development programme designed to integrate discussion of alcohol within existing NHS medicine review services. We conducted a pilot trial of the MAC and its delivery to investigate all study procedures to inform progression to a definitive trial.

Methods: This cluster pilot RCT was conducted in 10 community pharmacies in Yorkshire, UK, with a CP from each who regularly conducted Medicine Use Review (MUR) and New Medicine Service (NMS) consultations. Randomisation was conducted using a secure remote randomisation service. Intervention CPs (n = 5) were trained to deliver the MAC in MUR/NMS consultations. Control CPs (n = 5) provided these services as usual. Consecutive MUR/NMS patients were asked by CPs to participate, screened for eligibility (consumption of alcohol at least twice per week), and baseline data collected for those eligible. A two-month follow-up telephone interview was conducted. Blinding of CPs was not possible, but patients were blinded to the alcohol focus of the trial. Primary outcomes were total weekly UK units (8 g of ethanol per unit) of alcohol consumption in the week prior to follow-up, and confidence in medications management. Trial procedures were assessed by recruitment, attrition, and follow-up rates.

Results: 260 patients were approached by CPs to take part in the trial, 68% (n = 178) were assessed for eligibility and 30% (n = 54) of these patients were eligible. Almost all eligible patients (n = 51; 94%) consented to participate, of whom 92% (n = 47) were followed-up at 2 months; alcohol consumption was lower in the intervention arm and confidence in medication management reduced slightly for both groups. Exploration of recall issues at follow-up showed a high level of agreement between a two-item quantity/frequency measure and 7-day guided recall of alcohol consumption.

Conclusions: The pilot trial demonstrates the feasibility of implementing the MAC in community pharmacy and trial recruitment and data collection procedures. However, decommissioning of MURs means that it is not possible to conduct a definitive trial of the intervention in this service.

Trial Registration: ISRCTN57447996.
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http://dx.doi.org/10.1186/s12913-020-05797-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7552554PMC
October 2020

Yorkshire Enhanced Stop Smoking (YESS) study: a protocol for a randomised controlled trial to evaluate the effect of adding a personalised smoking cessation intervention to a lung cancer screening programme.

BMJ Open 2020 09 10;10(9):e037086. Epub 2020 Sep 10.

Department of Respiratory Medicine, Leeds Teaching Hospitals, Leeds, United Kingdom.

Introduction: Integration of smoking cessation (SC) into lung cancer screening is essential to optimise clinical and cost effectiveness. The most effective way to use this 'teachable moment' is unclear. The Yorkshire Enhanced Stop Smoking study will measure the effectiveness of an SC service integrated within the Yorkshire Lung Screening Trial (YLST) and will test the efficacy of a personalised SC intervention, incorporating incidental findings detected on the low-dose CT scan performed as part of YLST.

Methods And Analysis: Unless explicitly declined, all smokers enrolled in YLST will see an SC practitioner at baseline and receive SC support over 4 weeks comprising behavioural support, pharmacotherapy and/or a commercially available e-cigarette. Eligible smokers will be randomised (1:1 in permuted blocks of random size up to size 6) to receive either an enhanced, personalised SC support package, including CT scan images, or continued standard best practice. Anticipated recruitment is 1040 smokers (January 2019-December 2020). The primary objective is to measure 7-day point prevalent carbon monoxide (CO) validated SC after 3 months. Secondary outcomes include CO validated cessation at 4 weeks and 12 months, self-reported continuous cessation at 4 weeks, 3 months and 12 months, attempts to quit smoking and changes in psychological variables, including perceived risk of lung cancer, motivation to quit smoking tobacco, confidence and efficacy beliefs (self and response) at all follow-up points. A process evaluation will explore under which circumstances and on which groups the intervention works best, test intervention fidelity and theory test the mechanisms of intervention impact.

Ethics And Dissemination: This study has been approved by the East Midlands-Derby Research Ethics Committee (18/EM/0199) and the Health Research Authority/Health and Care Research Wales. Results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and via the YLST website.

Trial Registration Numbers: ISRCTN63825779, NCT03750110.
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http://dx.doi.org/10.1136/bmjopen-2020-037086DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7485260PMC
September 2020

A study protocol to assess the feasibility of conducting an evaluation trial of the ADVANCE integrated intervention to address both substance use and intimate partner abuse perpetration to men in substance use treatment.

Pilot Feasibility Stud 2020 11;6:62. Epub 2020 May 11.

9School of Health in Social Science, University of Edinburgh, 8-9 Hope Park Square, Edinburgh, 8HQ 9NW UK.

Background: Strong evidence exists that substance use is a contributory risk factor for intimate partner abuse (IPA) perpetration. Men in substance use treatment are more likely to perpetrate IPA than men from the general population. Despite this, referral pathways are lacking for this group. This trial will assess the feasibility of conducting an evaluation trial of a tailored integrated intervention to address substance use and IPA perpetration to men in substance use treatment.

Methods/design: ADVANCE is a multicentre, parallel-group individually randomised controlled feasibility trial, with a nested formative evaluation, comparing an integrated intervention to reduce IPA + substance use treatment as usual (TAU) to TAU only. One hundred and eight men who have perpetrated IPA in the past 12 months from community substance use treatment in London, the West Midlands, and the South West will be recruited. ADVANCE is a manualised intervention comprising 2-4 individual sessions (2 compulsory) with a keyworker to set goals, develop a personal safety plan and increase motivation and readiness, followed by a 12-session weekly group intervention delivered in substance use services. Men will be randomly allocated (ratio 1:1) to receive the ADVANCE intervention + TAU or TAU only. Men's female (ex) partners will be invited to provide outcome data and offered support from integrated safety services (ISS). Regular case management meetings between substance use and ISS will manage risk. Outcome measures will be obtained at the end of the intervention (approximately 4 months post-randomisation) for all male and female participants. The main objective of this feasibility trial is to estimate parameters required for planning a definitive trial including rates of consent, recruitment, and follow-up by site and group allocation. Nested formative evaluation including focus groups and in-depth interviews will explore the intervention's acceptability to participants, group facilitators, keyworkers and ISS workers. Secondary outcomes include substance use, IPA, mental health, self-management, health and social care service use, criminal justice contacts, and quality of life.

Discussion: Findings from this feasibility trial will inform the design of a multicentre randomised controlled trial evaluating the efficacy and cost-effectiveness of the ADVANCE intervention for reducing IPA and improving the well-being of female (ex)partners.

Trial Registration: ISRCTN79435190.
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http://dx.doi.org/10.1186/s40814-020-00580-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7212681PMC
May 2020

Cost-effectiveness of a specialist smoking cessation package compared with standard smoking cessation services for people with severe mental illness in England: a trial-based economic evaluation from the SCIMITAR+ study.

Addiction 2020 11 3;115(11):2113-2122. Epub 2020 Jun 3.

Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.

Aims: To evaluate the cost-effectiveness of a specialist smoking cessation package for people with severe mental illness DESIGN: Incremental cost-effectiveness analysis was undertaken from the UK National Health Service and Personal Social Services perspective over a 12-month time horizon. Total costs, including smoking cessation, health-care and social services costs and quality-adjusted life years (QALYs), derived from the five-level EuroQol 5-dimension (EQ-5D-5 L), collected from a randomized controlled trial, were used as outcome measures. The bootstrap technique was employed to assess the uncertainty.

Setting: Sixteen primary care and 21 secondary care mental health sites in England.

Participants: Adult smokers with bipolar affective disorder, schizoaffective disorder or schizophrenia and related illnesses (n = 526).

Intervention And Comparator: A bespoke smoking cessation (BSC) package for people with severe mental illness offered up to 12 individual sessions with a mental health smoking cessation practitioner versus usual care (UC). Of the participants who were randomized, 261 were in UC group and 265 were in BSC group.

Measurements: BSC intervention cost was estimated from the treatment log. Costs of UC, health-care and social services and EQ-5D-5 L were collected at baseline, 6- and 12-month follow-ups. Incremental costs and incremental QLAYs were estimated using regression adjusting for respective baseline values and other baseline covariates.

Findings: The mean total cost in the BSC group was £270 [95% confidence interval (CI) = -£1690 to £1424] lower than in the UC group, while the mean QALYs were 0.013 (95% CI = -0.008 to 0.045) higher, leading to BSC dominating UC (76% probability of cost-effective at £20 000/QALY).

Conclusions: A bespoke smoking cessation package for people with severe mental illness is likely to be cost-effective over 12 months compared with usual care provided by the UK's National Health Service and personal social services.
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http://dx.doi.org/10.1111/add.15086DOI Listing
November 2020

Cost-effectiveness of e-cigarettes compared with nicotine replacement therapy in stop smoking services in England (TEC study): a randomized controlled trial.

Addiction 2020 03 4;115(3):507-517. Epub 2019 Dec 4.

Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UK.

Aim: To evaluate the cost-effectiveness of e-cigarettes as a smoking cessation aid used in routine stop smoking services in England.

Design: Cost-effectiveness analysis was performed from the National Health Service (NHS) and Personal Social Services (PSS) perspective for 12-month periods and life-time. Costs, including that of both treatments, other smoking cessation help and health-care services, and health benefits, estimated from EQ-5D-5L and measured in quality-adjusted life-years (QALYs), for the 12-month analysis, came from a randomized controlled trial. Life-time analysis was model-based with input from both trial data and published secondary data sources. Cost-effectiveness was measured by an incremental cost-effectiveness ratio (ICER).

Setting: Three stop-smoking service sites in England.

Participants: Adult smokers (n = 886) who sought help to quit in the participating sites.

Intervention And Comparator: An e-cigarette (EC) starter kit versus provision of nicotine replacement therapy (NRT) for up to 3 months, both with standard behavioural support. A total of 886 participants were randomized (439 in the EC arm, 447 in the NRT arm). Excluding one death in each arm, the 1-year quit rate was 18.0 and 9.9%, respectively.

Measurements: Cost of treatments was estimated from the treatment log. Costs of other smoking cessation help and health-care services and EQ-5D-5 L were collected at baseline, 6- and 12-month follow-ups. Incremental costs and incremental QALYs were estimated using regression adjusting for baseline covariates and their respective baseline values.

Findings: The ICER was £1100 per QALY gained at the 12 months after quit date (87% probability below £20 000/QALY). Markov model estimated the life-time ICER of EC to be £65 per QALY (85% probability below £20 000/QALY).

Conclusion: Using e-cigarettes as a smoking cessation aid with standard behavioural support in stop-smoking services in England is likely to be more cost-effective than using nicotine replacement therapy in the same setting.
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http://dx.doi.org/10.1111/add.14829DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7318206PMC
March 2020

A bespoke smoking cessation service compared with treatment as usual for people with severe mental ill health: the SCIMITAR+ RCT.

Health Technol Assess 2019 09;23(50):1-116

Research and Development, Kent and Medway NHS and Social Care Partnership Trust, Maidstone, UK.

Background: There is a high prevalence of smoking among people with severe mental ill health (SMI). Helping people with SMI to quit smoking could improve their health and longevity, and reduce health inequalities. However, those with SMI are less likely to access and engage with routine smoking cessation services than the general population.

Objectives: To compare the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation (BSC) intervention with usual stop smoking services for people with SMI.

Design: A pragmatic, two-arm, individually randomised controlled trial.

Setting: Primary care and secondary care mental health services in England.

Participants: Smokers aged ≥ 18 years with SMI who would like to cut down on or quit smoking.

Interventions: A BSC intervention delivered by mental health specialists trained to deliver evidence-supported smoking cessation interventions compared with usual care.

Main Outcome Measures: The primary outcome was self-reported, CO-verified smoking cessation at 12 months. Smoking-related secondary outcomes were self-reported smoking cessation, the number of cigarettes smoked per day, the Fagerström Test for Nicotine Dependence and the Motivation to Quit questionnaire. Other secondary outcomes were Patient Health Questionnaire-9 items, Generalised Anxiety Disorder Assessment-7 items and 12-Item Short-Form Health Survey, to assess mental health and body mass index measured at 6 and 12 months post randomisation.

Results: The trial randomised 526 people (265 to the intervention group, 261 to the usual-care group) aged 19 to 72 years (mean 46 years). About 60% of participants were male. Participants smoked between 3 and 100 cigarettes per day (mean 25 cigarettes per day) at baseline. The intervention group had a higher rate of exhaled CO-verified smoking cessation at 6 and 12 months than the usual-care group [adjusted odds ratio (OR) 12 months: 1.6, 95% confidence interval (CI) 0.9 to 2.8; adjusted OR 6 months: 2.4, 95% CI 1.2 to 4.7]. This was not statistically significant at 12 months ( = 0.12) but was statistically significant at 6 months ( = 0.01). In total, 111 serious adverse events were reported (69 in the BSC group and 42 in the usual-care group); the majority were unplanned hospitalisations due to a deterioration in mental health ( = 98). The intervention is likely (57%) to be less costly but more effective than usual care; however, this result was not necessarily associated with participants' smoking status.

Limitations: Follow-up was not blind to treatment allocation. However, the primary outcome included a biochemically verified end point, less susceptible to observer biases. Some participants experienced difficulties in accessing nicotine replacement therapy because of changes in service provision. Efforts were made to help participants access nicotine replacement therapy, but this may have affected participants' quit attempt.

Conclusions: People with SMI who received the intervention were more likely to have stopped smoking at 6 months. Although more people who received the intervention had stopped smoking at 12 months, this was not statistically significant.

Future Work: Further research is needed to establish how quitting can be sustained among people with SMI.

Trial Registration: Current Controlled Trials ISRCTN72955454.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 23, No. 50. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta23500DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6778844PMC
September 2019

E-cigarettes compared with nicotine replacement therapy within the UK Stop Smoking Services: the TEC RCT.

Health Technol Assess 2019 08;23(43):1-82

Health and Lifestyle Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.

Background: Over the past few years, a large number of smokers in the UK have stopped smoking with the help of e-cigarettes. So far, UK Stop Smoking Services (SSSs) have been reluctant to include e-cigarettes among their treatment options because data on their efficacy compared with the licensed medications are lacking.

Objective: The objective was to compare the efficacy of refillable e-cigarettes and nicotine replacement therapy (NRT) products, when accompanied by weekly behavioural support.

Design: A randomised controlled trial comparing e-cigarettes and NRT.

Setting: Three sites that provide local SSSs.

Participants: The participants were 886 smokers seeking help to quit smoking, aged ≥ 18 years, not pregnant or breastfeeding, with no strong preference to use or not to use NRT or e-cigarettes in their quit attempt, and currently not using NRT or e-cigarettes. A total of 886 participants were randomised but two died during the study (one in each study arm) and were not included in the analysis.

Interventions: The NRT arm ( = 446) received NRT of their choice (single or combination), provided for up to 12 weeks. The e-cigarette arm ( = 438) received an e-cigarette starter pack and were encouraged to buy addtional e-liquids and e-cigarette products of their choice. Both arms received the same standard behavioural support. Participants attended weekly sessions at their SSS and provided outcome data at 4 weeks. They were then followed up by telephone at 6 and 12 months. Participants reporting abstinence or at least 50% reduction in cigarette consumption at 12 months were invited to attend for carbon monoxide (CO) validation. Participants/researchers could not be blinded to the intervention.

Main Outcome Measures: The primary outcome was CO-validated sustained abstinence rates at 52 weeks. Participants lost to follow-up or not providing biochemical validation were included as non-abstainers. Secondary outcomes included abstinence at other time points, reduction in smoke intake, treatment adherence and ratings, elicited adverse reactions, and changes in self-reported respiratory health. A cost-efficacy analysis of the intervention was also conducted.

Results: The 1-year quit rate was 9.9% in the NRT arm and 18.0% in the e-cigarette arm (risk ratio 1.83, 95% confidence interval 1.30 to 2.58;  < 0.001). The e-cigarette arm had significantly higher validated quit rates at all time points. Participants in the e-cigarette arm showed significantly better adherence and experienced fewer urges to smoke throughout the initial 4 weeks of their quit attempt than those in the NRT arm, and gave their allocated product more favourable ratings. They were also more likely to be still using their allocated product at 1 year (39.5% vs. 4.3%, χ = 161.4;  < 0.001). Participants assigned to e-cigarettes reported significantly less coughing and phlegm at 1 year than those assigned to NRT (controlling for smoking status). A detailed economic analysis confirmed that, because e-cigarettes incur lower NHS costs than NRT and generate a higher quit rate, e-cigarette use is more cost-effective.

Limitations: The results may not be generalisable to other types of smokers or settings, or to cartridge-based e-cigarettes.

Conclusions: Within the context of multisession treatment for smokers seeking help, e-cigarettes were significantly more effective than NRT. If SSSs provide e-cigarette starter packs, it is likely to boost their success rates and improve their cost-efficacy.

Future Work: The efficacy of e-cigarettes provided with different levels of support will show whether smokers should be encouraged to switch to vaping within support services or whether e-cigarettes can be recommended with less intensive or no support.

Trial Registration: Current Controlled Trials ISRCTN60477608.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 23, No. 43. See the NIHR Journals Library website for further project information. The trial was supported by the Cancer Research UK Prevention Trials Unit (grant A16893).
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6732716PMC
August 2019

ImPROving TB outcomes by modifying LIFE-style behaviours through a brief motivational intervention followed by short text messages (ProLife): study protocol for a randomised controlled trial.

Trials 2019 Jul 26;20(1):457. Epub 2019 Jul 26.

Africa Centre for Tobacco Industry Monitoring and Policy Research, Sefako Makgatho Health Sciences University, Ga-Rankuwa, South Africa.

Background: South Africa is among the seven highest tuberculosis (TB) burden countries. Harmful lifestyle behaviours, such as smoking and alcohol, and poor adherence to medication can affect clinical outcomes. Modification of these behaviours is likely to improve TB treatment outcomes and has proven possible using motivational interviewing (MI) techniques or use of short message service (SMS) text messaging. There have been no studies assessing the effect of combined MI and SMS interventions on multiple lifestyle factors and TB treatment outcomes.

Methods: This is a prospective, multicentre, two-arm individual randomised controlled trial looking at the effectiveness and cost-effectiveness of a complex behavioural intervention (the ProLife programme) on improving TB and lifestyle-related outcomes in three provinces of South Africa. The ProLife programme consists of an MI counselling strategy, delivered by lay health workers, augmented with subsequent SMS. We aim to recruit 696 adult participants (aged 18 years and over) with drug-sensitive pulmonary TB who are current smokers and/or report harmful or hazardous alcohol use. Patients will be consecutively enrolled at 27 clinics in three different health districts in South Africa. Participants randomised individually to the intervention arm will receive three MI counselling sessions one month apart. Each MI session will be followed by twice-weekly SMS messages targeting treatment adherence, alcohol use and tobacco smoking, as appropriate. We will assess the effect on TB treatment success, using standard World Health Organization (WHO) treatment outcome definitions (primary outcome), as well as on a range of secondary outcomes including smoking cessation, reduction in alcohol use, and TB medication and anti-retroviral therapy adherence. Secondary outcomes will be measured at the three-month and six-month follow-ups.

Discussion: This trial aligns with the WHO agenda of integrating TB care with the care for chronic diseases of lifestyle, such as provision of smoking cessation treatments, and with the use of digital technologies. If the ProLife programme is found to be effective and cost-effective, the programme could have significant implications for TB treatment globally and could be successfully implemented in a wide range of TB treatment settings.

Trial Registration: ISRCTN Registry, ISRCTN62728852. Registered on 13 April 2018.
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http://dx.doi.org/10.1186/s13063-019-3551-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6660690PMC
July 2019

Standard smoking cessation services in sites participating in the SCIMITAR+ trial for people with severe mental ill health.

BJPsych Bull 2019 Jun 4:6-11. Epub 2019 Jun 4.

Mental Health and Addiction Research Group, University of York, UK.

Aims and methodThe SCIMITAR+ trial was commissioned to evaluate the effectiveness of a bespoke smoking cessation intervention for people with severe mental ill health compared with usual services. It is difficult to define what constitutes usual care in smoking cessation services. We aimed to define what this was during the trial. Twenty-two National Health Service healthcare providers participated in a bespoke survey asking about usual care in their area. RESULTS: All sites offered smoking cessation support; however, service provider and service type varied substantially. In some cases services were not streamlined, meaning that people received smoking cessation counselling from one organisation and smoking cessation medication from another.Clinical implicationsTo better implement the National Institute for Health and Care Excellence guideline PH48, clearer referral pathways need to be implemented and communicated to patients, staff and carers. People with severe mental ill health need to be able to access services that combine nicotine replacement therapy and behavioural support in a streamlined manner.Declaration of interestNone.
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June 2019

Effectiveness and cost-effectiveness of a tailored text-message programme (MiQuit) for smoking cessation in pregnancy: study protocol for a randomised controlled trial (RCT) and meta-analysis.

Trials 2019 May 22;20(1):280. Epub 2019 May 22.

Division of Primary Care, University of Nottingham, Nottingham, NG7 2RD, UK.

Background: Smoking in pregnancy is a major international public health problem. Self-help support (SHS) increases the likelihood of women stopping smoking in pregnancy and delivering this kind of support by text message could be a cost-effective way to deliver SHS to pregnant women who smoke. SHS delivered by text message helps non-pregnant smokers to stop but the currently available message programmes are not appropriate for use in pregnancy. A randomised controlled trial (RCT) has demonstrated the feasibility and acceptability of using a programme called 'MiQuit' to text SHS support to pregnant women who smoke. Another pilot RCT has shown that it would be feasible to run a larger, multi-centre trial within the UK National Health Service (NHS). The aim of this third RCT is to complete MiQuit's evaluation, demonstrating whether or not this is efficacious for smoking cessation in pregnancy.

Methods/design: This is a multi-centre, parallel-group RCT. Pregnant women aged over 16 years, of less than 25 weeks' gestation who smoke one or more daily cigarettes but smoked at least five daily cigarettes before pregnancy and who understand written English and are being identified in 24 English antenatal care hospitals. Participants are randomised to control or intervention groups in a 1:1 ratio stratified by gestation (< 16 weeks versus ≥ 16 weeks). All participants receive a leaflet on stopping smoking during pregnancy; they are also able to access standard NHS smoking cessation support. Intervention group women also receive the 12-week MiQuit programme of tailored, interactive text message, and self-help cessation support. Women are followed up by telephone at 4 weeks after randomisation and 36 weeks' gestation. The RCT will recruit 692 women (346 per group), enabling a 95% confidence interval for the difference in quit rates to be estimated within ± 3%. To determine whether or not MiQuit helps pregnant smokers to stop, intervention group quit rates from this trial will be combined with those from the two earlier trials in a Trial Sequential Analysis (TSA) meta-analysis to derive a pooled efficacy estimate.

Discussion: If effective, MiQuit will be a cheap, cost-effective method to help pregnant women to stop smoking.

Trial Registration: ClinicalTrials.gov, ID: NCT03231553 . Registered on 20 July 2017.
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http://dx.doi.org/10.1186/s13063-019-3341-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6530023PMC
May 2019

Smoking cessation for people with severe mental illness (SCIMITAR+): a pragmatic randomised controlled trial.

Lancet Psychiatry 2019 May 8;6(5):379-390. Epub 2019 Apr 8.

Bradford District Care NHS Foundation Trust, Bradford, UK.

Background: People with severe mental illnesses such as schizophrenia are three times more likely to smoke than the wider population, contributing to widening health inequalities. Smoking remains the largest modifiable risk factor for this health inequality, but people with severe mental illness have not historically engaged with smoking cessation services. We aimed to test the effectiveness of a combined behavioural and pharmacological smoking cessation intervention targeted specifically at people with severe mental illness.

Methods: In the smoking cessation intervention for severe mental illness (SCIMITAR+) trial, a pragmatic, randomised controlled study, we recruited heavy smokers with bipolar disorder or schizophrenia from 16 primary care and 21 community-based mental health sites in the UK. Participants were eligible if they were aged 18 years or older, and smoked at least five cigarettes per day. Exclusion criteria included substantial comorbid drug or alcohol problems and people who lacked capacity to consent at the time of recruitment. Using computer-generated random numbers, participants were randomly assigned (1:1) to a bespoke smoking cessation intervention or to usual care. Participants, mental health specialists, and primary care physicians were unmasked to assignment. The bespoke smoking cessation intervention consisted of behavioural support from a mental health smoking cessation practitioner and pharmacological aids for smoking cessation, with adaptations for people with severe mental illness-such as, extended pre-quit sessions, cut down to quit, and home visits. Access to pharmacotherapy was via primary care after discussion with the smoking cessation specialist. Under usual care participants were offered access to local smoking cessation services not specifically designed for people with severe mental illnesses. The primary endpoint was smoking cessation at 12 months ascertained via carbon monoxide measurements below 10 parts per million and self-reported cessation for the past 7 days. Secondary endpoints were biologically verified smoking cessation at 6 months; number of cigarettes smoked per day, Fagerström Test for Nicotine Dependence (FTND) and Motivation to Quit (MTQ) questionnaire; general and mental health functioning determined via the Patient Health Questionnaire-9 (PHQ-9), the Generalised Anxiety Disorder-7 (GAD-7) questionnaire, and 12-Item Short Form Health Survey (SF-12); and body-mass index (BMI). This trial was registerd with the ISRCTN registry, number ISRCTN72955454, and is complete.

Findings: Between Oct 7, 2015, and Dec 16, 2016, 526 eligible patients were randomly assigned to the bespoke smoking cessation intervention (n=265) or usual care (n=261). 309 (59%) participants were male, median age was 47·2 years (IQR 36·3-54·5), with high nicotine dependence (mean 24 cigarettes per day [SD 13·2]), and the most common severe mental disorders were schizophrenia or other psychotic illness (n=343 [65%]), bipolar disorder (n=115 [22%]), and schizoaffective disorder (n=66 [13%]). 234 (88%) of intervention participants engaged with the treatment programme and attended 6·4 (SD 3·5) quit smoking sessions, with an average duration of 39 min (SD 17; median 35 min, range 5-120). Verified quit data at 12 months were available for 219 (84%) of 261 usual care and 223 (84%) of 265 intervention participants. The proportion of participants who had quit at 12 months was higher in the intervention group than in the usual care group, but non-significantly (34 [15%] of 223 [13% of those assigned to group] vs 22 [10%] of 219 [8% of those assigned to group], risk difference 5·2%, 95% CI -1·0 to 11·4; odds ratio [OR] 1·6, 95% CI 0·9 to 2·9; p=0·10). The proportion of participants who quit at 6 months was significantly higher in the intervention group than in the usual care group (32 [14%] of 226 vs 14 [6%] of 217; risk difference 7·7%, 95% CI 2·1 to 13·3; OR 2·4, 95% CI 1·2 to 4·6; p=0·010). The incidence rate ratio for number of cigarettes smoked per day at 6 months was 0·90 (95% CI 0·80 to 1·01; p=0·079), and at 12 months was 1·00 (0·89 to 1·13; p=0·95). At both 6 months and 12 months, the intervention group was non-significantly favoured in the FTND (adjusted mean difference 6 months -0·18, 95% CI -0·53 to 0·17, p=0·32; and 12 months -0·01, -0·39 to 0·38, p=0·97) and MTQ questionnaire (adjusted mean difference 0·58, -0·01 to 1·17, p=0·056; and 12 months 0·64, 0·04 to 1·24, p=0·038). The PHQ-9 showed no difference between the groups (adjusted mean difference at 6 months 0·20, 95% CI -0·85 to 1·24 vs 12 months -0·12, -1·18 to 0·94). For the SF-12 survey, we saw evidence of improvement in physical health in the intervention group at 6 months (adjusted mean difference 1·75, 95% CI 0·21 to 3·28), but this difference was not evident at 12 months (0·59, -1·07 to 2·26); and we saw no difference in mental health between the groups at 6 or 12 months (adjusted mean difference at 6 months -0·73, 95% CI -2·82 to 1·36, and 12 months -0·41, -2·35 to 1·53). The GAD-7 questionnaire showed no difference between the groups (adjusted mean difference at 6 months -0·32 95% CI -1·26 to 0·62 vs 12 months -0·10, -1·05 to 0·86). No difference in BMI was seen between the groups (adjusted mean difference 6 months 0·16, 95% CI -0·54 to 0·85; 12 months 0·25, -0·62 to 1·13).

Interpretation: This bespoke intervention is a candidate model of smoking cessation for clinicians and policy makers to address high prevalence of smoking. The incidence of quitting at 6 months shows that smoking cessation can be achieved, but the waning of this effect by 12 months means more effort is needed for sustained quitting.

Funding: National Institute for Health Research Health Technology Assessment Programme.
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http://dx.doi.org/10.1016/S2215-0366(19)30047-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6546931PMC
May 2019

Randomised controlled trial and economic evaluation of a task-based weight management group programme.

BMC Public Health 2019 Apr 2;19(1):365. Epub 2019 Apr 2.

Health and Lifestyle Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, Health and Lifestyle Research Unit, 2 Stayner's Road, London, E1 4AH, UK.

Background: Obesity is a rising global threat to health and a major contributor to health inequalities. Weight management programmes that are effective, economical and reach underprivileged groups are needed. We examined whether a multi-modal group intervention structured to cater for clients from disadvantaged communities (Weight Action Programme; WAP) has better one-year outcomes than a primary care standard weight management intervention delivered by practice nurses (PNI).

Methods: In this randomised controlled trial, 330 obese adults were recruited from general practices in London and allocated (2:1) to WAP (N = 221) delivered over eight weekly group sessions or PNI (N = 109) who received four sessions over eight weeks. Both interventions covered diet, physical activity and self-monitoring. The primary outcome was the change in weight from baseline at 12 months. To indicate value to the NHS, a cost effectiveness analysis estimated group differences in cost and Quality-Adjusted Life-Years (QALYs) related to WAP.

Results: Participants were recruited from September 2012 to January 2014 with follow-up completed in February 2015. Most participants were not in paid employment and 60% were from ethnic minorities. 88% of participants in each study arm provided at least one recorded outcome and were included in the primary analysis. Compared with the PNI, WAP was associated with greater weight loss overall (- 4·2 kg vs. - 2·3 kg; difference = - 1·9 kg, 95% CI: -3·7 to - 0·1; P = 0·04) and was more likely to generate a weight loss of at least 5% at 12 months (41% vs. 27%, OR = 14·61 95% CI: 2·32 to 91·96, P = 0·004). With an incremental cost-effectiveness ratio (ICER) of £7742/QALY, WAP would be considered highly cost effective compared to PNI.

Conclusions: The task-based programme evaluated in this study can provide a template for an effective and economical approach to weight management that can reach clients from disadvantaged communities.

Trial Registration: ISRCTN ISRCTN45820471 . Registered 12/10/2012 (retrospectively registered).
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http://dx.doi.org/10.1186/s12889-019-6679-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6444848PMC
April 2019

A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy.

N Engl J Med 2019 02 30;380(7):629-637. Epub 2019 Jan 30.

From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).

Background: E-cigarettes are commonly used in attempts to stop smoking, but evidence is limited regarding their effectiveness as compared with that of nicotine products approved as smoking-cessation treatments.

Methods: We randomly assigned adults attending U.K. National Health Service stop-smoking services to either nicotine-replacement products of their choice, including product combinations, provided for up to 3 months, or an e-cigarette starter pack (a second-generation refillable e-cigarette with one bottle of nicotine e-liquid [18 mg per milliliter]), with a recommendation to purchase further e-liquids of the flavor and strength of their choice. Treatment included weekly behavioral support for at least 4 weeks. The primary outcome was sustained abstinence for 1 year, which was validated biochemically at the final visit. Participants who were lost to follow-up or did not provide biochemical validation were considered to not be abstinent. Secondary outcomes included participant-reported treatment usage and respiratory symptoms.

Results: A total of 886 participants underwent randomization. The 1-year abstinence rate was 18.0% in the e-cigarette group, as compared with 9.9% in the nicotine-replacement group (relative risk, 1.83; 95% confidence interval [CI], 1.30 to 2.58; P<0.001). Among participants with 1-year abstinence, those in the e-cigarette group were more likely than those in the nicotine-replacement group to use their assigned product at 52 weeks (80% [63 of 79 participants] vs. 9% [4 of 44 participants]). Overall, throat or mouth irritation was reported more frequently in the e-cigarette group (65.3%, vs. 51.2% in the nicotine-replacement group) and nausea more frequently in the nicotine-replacement group (37.9%, vs. 31.3% in the e-cigarette group). The e-cigarette group reported greater declines in the incidence of cough and phlegm production from baseline to 52 weeks than did the nicotine-replacement group (relative risk for cough, 0.8; 95% CI, 0.6 to 0.9; relative risk for phlegm, 0.7; 95% CI, 0.6 to 0.9). There were no significant between-group differences in the incidence of wheezing or shortness of breath.

Conclusions: E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy, when both products were accompanied by behavioral support. (Funded by the National Institute for Health Research and Cancer Research UK; Current Controlled Trials number, ISRCTN60477608 .).
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February 2019

Muslim Communities Learning About Second-hand Smoke in Bangladesh (MCLASS II): study protocol for a cluster randomised controlled trial of a community-based smoke-free homes intervention, with or without Indoor Air Quality feedback.

Trials 2019 Jan 5;20(1):11. Epub 2019 Jan 5.

Department of Health Sciences, Faculty of Sciences, University of York, York, YO10 5DD, UK.

Background: Second-hand smoke (SHS) is a serious health hazard costing 890,000 lives a year globally. Women and children in many economically developing countries are worst affected as smoke-free laws are only partially implemented and homes remain a major source of SHS exposure. There is limited evidence on interventions designed to reduce SHS exposure in homes, especially in community settings. Following a successful pilot, a community-based approach to promote smoke-free homes in Bangladesh, a country with a strong commitment to smoke-free environments but with high levels of SHS exposure, will be evaluated. The study aims to assess the effectiveness and cost-effectiveness of a community-based intervention, Muslims for better Health (M4bH), with or without Indoor Air Quality (IAQ) feedback, in reducing non-smokers' exposure to SHS in the home.

Methods/design: Based on behaviour-change theories, M4bH and IAQ feedback are designed to discourage people from smoking indoors. M4bH consists of a set of messages couched within mainstream Islamic discourse, delivered weekly by faith leaders (imams and khatibs) in mosques over 12 weeks (one message each week). The messages address key determinants of current smoking behaviours including lack of knowledge and misconceptions on specific harms associated with SHS exposure. IAQ feedback consists of personalised information on IAQ measured by a particulate matter (PM) monitor within the home. Following adaptation of M4bH and IAQ feedback for the Bangladeshi context, a three-arm cluster randomised controlled trial will be conducted in Dhaka. Forty-five mosques and 1800 households, with at least one smoker and one non-smoker, will be recruited. Mosques will be randomised to: M4bH and IAQ feedback; M4bH alone; or usual services only. The primary outcome is 24-h mean household concentration of indoor fine particulate matter (PM) at 12 months post randomisation. Secondary outcomes are 24-h mean household PM at 3 months post randomisation, frequency and severity of respiratory symptoms, health care service use and quality of life. A cost-effectiveness analysis and process evaluation will also be conducted.

Discussion: The MCLASS II trial will test the potential of a community-based intervention to reduce second-hand smoke exposure at home and improve lung health among non-smokers in Bangladesh and beyond.

Trial Registration: ISRCTN, ISRCTN49975452 . Registered on 11 January 2018.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6321715PMC
January 2019

Temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations: FAST.

Health Technol Assess 2018 12;22(70):1-82

Respiratory Medicine, Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK.

Background: Asthma exacerbations affect the quality of life of patients with asthma and have a major effect on the overall costs of asthma care. An asthma self-management plan that advises the temporary quadrupling of inhaled corticosteroid dose may prevent asthma exacerbations, but this needs to be confirmed before being adopted widely.

Objectives: To compare the clinical effectiveness and cost-effectiveness of an asthma self-management plan that advises patients to temporarily quadruple the dose of inhaled corticosteroid when asthma control starts to deteriorate with a standard self-management plan.

Design: A multicentre, parallel-group, pragmatic randomised trial, with follow-up for 12 months.

Setting: Primary and secondary care across 207 sites in the UK.

Participants: Asthma patients aged ≥ 16 years treated with an inhaled corticosteroid who had experienced at least one exacerbation in the previous 12 months.

Interventions: Participants were randomised (1 : 1) to a usual-care self-management plan or to a modified self-management plan that advised a temporary quadrupling of the inhaled corticosteroid at the point of asthma deterioration, both of which were actively implemented and supported by local research staff.

Primary Outcome: The primary outcome of 'time to first asthma exacerbation' was defined as the need for systemic corticosteroids (for at least 3 consecutive days) and/or unscheduled health-care consultations for asthma (i.e. reaching zone 3 or 4 of the Asthma UK self-management plan).

Results: A total of 1922 participants were randomised: the primary analysis included 938 participants (97%) in the usual-care group and 933 participants (97%) in the modified self-management group. The number of participants having at least one exacerbation of asthma in the year after randomisation was 484 (51.6%) in the usual-care group and 420 (45.0%) in the modified self-management group [adjusted hazard ratio 0.81, 95% confidence interval (CI) 0.71 to 0.92;  = 0.002]. There were fewer serious adverse events reported in the modified self-management group than in the usual-care group (11 vs. 32, respectively). Eight and six events of pneumonia, lower respiratory tract infections or influenza were reported in the usual-care group and the modified self-management group, respectively. Health-care-related costs were lower in the modified self-management group. The modified self-management group was £24 (bootstrapped 95% CI -£122 to £71) less costly than usual care, with a greater quality-adjusted life-year gain of 0.02 (bootstrapped 95% CI -0.005 to 0.04). Therefore, the modified self-management group was 'dominant', with a 94-95% probability of being cost-effective at the £20,000-30,000 threshold.

Limitations: As the Fourfold Asthma STudy (FAST) was an open-label pragmatic trial, the possibility of treatment bias that may have affected the participants in the modified self-management group cannot be ruled out. Poorer than expected completion of participant diary cards, particularly within the usual-care self-management group, could have led to a null bias, underestimating the true effect of the intervention.

Conclusions: An asthma self-management plan that advises patients to temporarily quadruple their dose of inhaled corticosteroid at the point of asthma symptoms worsening does reduce clinically important asthma exacerbations. In addition, the plan is cost-effective compared with the usual-care self-management plan.

Future Work: To effectively implement asthma self-management plans that advise a temporary quadrupling of inhaled steroid at asthma deterioration into routine practice.

Trial Registration: Current Controlled Trials ISRCTN15441965.

Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in ; Vol. 22, No. 70. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta22700DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6307366PMC
December 2018

Cost-effectiveness of a complex intervention to reduce children's exposure to second-hand smoke in the home.

BMC Public Health 2018 Nov 13;18(1):1252. Epub 2018 Nov 13.

Department of Health Sciences, Seebohm Rowntree, University of York, Heslington, York, YO10 5DD, UK.

Background: Second-hand smoke (SHS) causes numerous health problems in children such as asthma, respiratory tract infections and sudden infant death syndrome. The home is the main source of exposure to SHS for children, particularly for young children. We estimated the cost-effectiveness of a complex intervention designed to reduce SHS exposure of children whose primary caregiver feels unable or unwilling to quit smoking.

Methods: A cost-effectiveness analysis was carried out alongside an open-label, parallel, randomised controlled trial in deprived communities in Nottingham, England. A complex intervention combining behavioural support, nicotine replacement therapy and personalised feedback on home air quality was compared with usual care. A total number of 205 households were recruited, where the main caregivers were aged 18 and over, with a child aged under five years living in their household reporting smoking inside their home. Analyses for this study were undertaken from the National Health Service/Personal Social Services perspective. All costs were estimated in UK pounds (£) at 2013/14 prices. The primary outcome was the incremental cost-effectiveness of change in air quality in the home, measured as average 16-24 h levels of particulate matter of < 2.5 μm diameter (PM), between baseline and 12 weeks. Secondary outcomes included incremental cost per quitter, quit attempts and cigarette consumption in the home. A non-parametric bootstrap re-sampling technique was employed to explore uncertainty around the calculated incremental cost-effectiveness ratios.

Results: The complex intervention achieved reduced PM by 21.6 μg/m (95% CI: 5.4 to 37.9), with an incremental cost of £283 (95% CI: £254-£313), relative to usual care. The incremental cost-effectiveness ratio was £131 (bootstrapped 95% CI: £72-£467) per additional 10μg/m reduction in PM, or £71 (bootstrapped 95% CI: -£57-£309) per additional quitter.

Conclusions: This trial targeted a socio-economically disadvantaged population that has been neglected within the literature. The complex intervention was more costly but more effective in reducing PM2.5 compared with the usual care. It offers huge potential to reduce children's' tobacco-related harm by reducing exposure to SHS in the home. The intervention is considered cost-effective if the decision maker is willing to pay £131 per additional 10μg/m of PM reduction.

Trial Registration: The Smoke Free Homes trial was registered with isrctn.com on 29 January 2013 with the identifier ISRCTN81701383 .
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http://dx.doi.org/10.1186/s12889-018-6140-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6234564PMC
November 2018

A dynamic, modifiable model for estimating cost-effectiveness of smoking cessation interventions in pregnancy: application to an RCT of self-help delivered by text message.

Addiction 2019 02 5;114(2):353-365. Epub 2018 Dec 5.

Division of Primary Care, University of Nottingham, Nottingham, UK.

Background And Aims: Previous evaluations of smoking cessation interventions in pregnancy have several limitations. Our solution to these limitations is the Economics of Smoking in Pregnancy (ESIP) model, which estimates the life-time cost-effectiveness of smoking cessation interventions in pregnancy from a National Health Service (NHS) and personal social services perspective. We aim to (1) describe how ESIP has been constructed and (2) illustrate its use with trial data.

Methods: ESIP links mothers' and offspring pregnancy outcomes to estimate the burdens of smoking-related disease they experience with different rates of smoking in pregnancy, both in pregnancy and throughout their life-times. Smoking rates are inputted by model users. ESIP then estimates the costs of treating disease burdens and also mothers' and offspring life-years and quality-adjusted life years (QALYs). By comparing costs incurred and healthy life following different smoking rates, ESIP estimates incremental cost-effectiveness and benefit-cost ratios for mothers or offspring or both combined. We illustrate ESIP use using data from a pragmatic randomized controlled trial that tested a smoking cessation intervention in pregnancy.

Results: Throughout women's and offspring life-times, the intervention proved cheaper than usual care, having a negative incremental cost of £38.37 (interquartile range = £21.46-56.96) and it improved health, demonstrating a 0.04 increase in incremental QALYs for mothers and offspring, implying that it is 'dominant' over usual care. Benefit-cost ratios suggested that every £1 spent would generate a median of £14 (interquartile range = £8-20) in health-care savings.

Conclusions: Economics of Smoking in Pregnancy is the first economic model to link mothers' and infants' costs and benefits while reporting cost-effectiveness in readily-comparable units. Using ESIP with data from a trial which reported only short-term economic analysis showed that the intervention was very likely to be cost-effective in the longer term and to generate health-care savings.
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http://dx.doi.org/10.1111/add.14476DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6519118PMC
February 2019

Cost-effectiveness of strategies to improve delivery of brief interventions for heavy drinking in primary care: results from the ODHIN trial.

Eur J Public Health 2019 04;29(2):219-225

School of Health and Related Research, University of Sheffield, Sheffield, UK.

Background: Screening and brief interventions (SBIs) for heavy drinking are an effective and cost-effective approach to reducing alcohol-related harm, yet delivery rates remain low. This study uses trial data to estimate the cost-effectiveness of alternative strategies to increase SBI delivery.

Methods: Data from a large cluster-randomized trial were combined with the Sheffield Alcohol Policy Model, a policy appraisal tool, to estimate the cost-effectiveness of eight strategies to increase SBI delivery in primary care in England, Poland and the Netherlands: care as usual (control), training and support (TS), financial reimbursement (FR), referral of patients to an online brief intervention (eBI) and all combinations of TS, FR and eBI. cost-effectiveness was assessed from a healthcare perspective by comparing health benefits (measured in Quality-Adjusted Life Years) with total implementation costs and downstream healthcare savings for each strategy over a 30-year horizon and calculating Incremental cost-effectiveness ratios (ICERs).

Results: All trialled strategies were cost-effective compared to control. TS combined with FR was the most cost-effective approach in England (more effective and less costly than control) and Poland (ICER €4632 vs. next-best strategy). This combination is not cost-effective in the Netherlands, where TS alone is the most cost-effective approach (ICER €3386 vs. next-best strategy).

Conclusions: Structured TS, financial incentives and access to online interventions are all estimated to be cost-effective methods of improving delivery of alcohol brief interventions. TS and FR together may be the most cost-effective approach, however this is sensitive to country characteristics and alternative BI effect assumptions.

Trial Registration: ClinicalTrials.gov trial identifier: NCT01501552.
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http://dx.doi.org/10.1093/eurpub/cky181DOI Listing
April 2019

Cost-Effectiveness of Facilitated Access to a Self-Management Website, Compared to Usual Care, for Patients With Type 2 Diabetes (HeLP-Diabetes): Randomized Controlled Trial.

J Med Internet Res 2018 06 8;20(6):e201. Epub 2018 Jun 8.

Research Department of Primary Care and Population Health, University College London, London, United Kingdom.

Background: Type 2 diabetes mellitus is one of the most common long-term conditions, and costs health services approximately 10% of their total budget. Active self-management by patients improves outcomes and reduces health service costs. While the existing evidence suggested that uptake of self-management education was low, the development of internet-based technology might improve the situation.

Objective: To establish the cost-effectiveness of a Web-based self-management program for people with type 2 diabetes (HeLP-Diabetes) compared to usual care.

Methods: An incremental cost-effectiveness analysis was conducted, from a National Health Service and personal and social services perspective, based on data collected from a multi-center, two-arm individually randomized controlled trial over 12 months. Adults aged 18 or over with a diagnosis of type 2 diabetes and registered with the 21 participating general practices (primary care) in England, UK, were approached. People who were unable to provide informed consent or to use the intervention, terminally ill, or currently participating in a trial of an alternative self-management intervention, were excluded. The participants were then randomized to either usual care plus HeLP-Diabetes, an interactive, theoretically-informed Web-based self-management program, or to usual care plus access to a comparator website containing basic information only. The participants' intervention costs and wider health care resource use were collected as well as two health-related quality of life measures: the Problem Areas in Diabetes (PAID) Scale and EQ-5D-3L. EQ-5D-3L was then used to calculate quality-adjusted life years (QALYs). The primary analysis was based on intention-to-treat, using multiple imputation to handle the missing data.

Results: In total, 374 participants were randomized, with 185 in the intervention group and 189 in the control group. The primary analysis showed incremental cost-effectiveness ratios of £58 (95% CI -411 to 587) per unit improvement on PAID scale and £5550 (95% CI -21,077 to 52,356) per QALY gained by HeLP-Diabetes, compared to the control. The complete case analysis showed less cost-effectiveness and higher uncertainty with incremental cost-effectiveness ratios of £116 (95% CI -1299 to 1690) per unit improvement on PAID scale and £18,500 (95% CI -203,949 to 190,267) per QALY. The cost-effectiveness acceptability curve showed an 87% probability of cost-effectiveness at £20,000 per QALY willingness-to-pay threshold. The one-way sensitivity analyses estimated 363 users would be needed to use the intervention for it to become less costly than usual care.

Conclusions: Facilitated access to HeLP-Diabetes is cost-effective, compared to usual care, under the recommended threshold of £20,000 to £30,000 per QALY by National Institute of Health and Care Excellence.

Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 02123133; http://www.controlled-trials.com/ISRCTN02123133 (Archived by WebCite at http://www.webcitation.org/6zqjhmn00).
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http://dx.doi.org/10.2196/jmir.9256DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6015272PMC
June 2018

Children Learning About Secondhand Smoke (CLASS II): A Pilot Cluster Randomized Controlled Trial.

Nicotine Tob Res 2019 04;21(5):670-677

Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh Teviot Place, Edinburgh, UK.

Introduction: Children exposed to secondhand smoke (SHS) are at increased risk of respiratory illnesses. We piloted a Smoke Free Intervention (SFI) and trial methods before investigating its effectiveness and cost-effectiveness in primary school children.

Methods: In a pilot cluster randomized controlled trial in Bangladesh, primary schools were allocated to usual education (control) or SFI, using minimization. Year-5 children were recruited. Masking treatment allocation was not possible. Delivered by schoolteachers, SFI consisted of two 45-min and four 15-min educational sessions. Our primary outcome was SHS exposure at two months post randomization, verified by children's salivary cotinine. The trial is registered at ISRCTN.com; ISRCTN68690577.

Results: Between April 1, 2015 and June 30, 2015, we recruited 12 schools. Of the 484 children present in Year-5, 481 consented. Six schools were allocated to both SFI (n = 245) and to usual education only (n = 236). Of them, 450 children (SFI = 229; control = 221) who had cotinine levels indicative of SHS exposure were followed-up. All schools were retained, 91% children (208/229) in SFI and 88% (194/221) in the control arm completed primary outcome assessment. Their mean cotinine at the cluster level was 0.53 ng/ml (SD 0.36) in SFI and 1.84 ng/ml (SD 1.49) in the control arm-a mean difference of -1.31 ng/ml (95% CI = -2.86 to 0.24).

Conclusion: It was feasible to recruit, randomize, and retain primary schools and children in our trial. Our study, though not powered to detect differences in mean cotinine between the two arms, provides estimates to inform the likely effect size for future trials.

Implications: In countries with high smoking prevalence, children remain at risk of many conditions due to secondhand smoke exposure. There is little empirical evidence on the effectiveness and cost-effectiveness of interventions that can reduce their exposure to secondhand smoke at homes. CLASS II trial found that a school-based intervention (SFI) has the potential to reduce children's exposure to SHS-an approach that has been rarely used, but has considerable merit in school-based contexts. CLASS II trial provides key information to conduct a future definitive trial in this area of public health, which despite its importance has so far received little attention.
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http://dx.doi.org/10.1093/ntr/nty090DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6468126PMC
April 2019
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