Publications by authors named "Jinshuo Li"

33 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

Effect of quitting smoking on health outcomes during treatment for tuberculosis: secondary analysis of the TB & Tobacco Trial.

Thorax 2021 Jul 16. Epub 2021 Jul 16.

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

Background: Despite treatment, patients with tuberculosis (TB) who smoke have poorer outcomes compared with non-smokers. It is unknown, however, if quitting smoking during the 6 months of TB treatment improves TB outcomes.

Methods: The TB & Tobacco Trial was a double-blind, placebo-controlled randomised trial of cytisine for smoking cessation in 2472 patients with pulmonary TB in Bangladesh and Pakistan. In a secondary analysis, we investigated the hypothesis that smoking cessation improves health outcomes in patients during the TB treatment course. The outcomes included an eight-point TB clinical score, sputum conversion rates, chest X-ray grades, quality of life (EQ-5D-5L), TB cure treatment completion rates and relapse rates. These were compared between those who stopped smoking and those who did not, using regression analysis.

Results: We analysed the data of 2273 (92%) trial participants. Overall, 25% (577/2273) of participants stopped smoking. Compared with non-quitters, those who quit had better TB cure treatment completion rates (91% vs 80%, p<0.001) and lower TB relapse rates (6% vs 14%, p<0.001). Among quitters, a higher sputum conversion rate at week 9 (91% vs 87%, p=0.036), lower mean TB clinical scores (-0.20 points, 95% CI -0.31 to -0.08, p=0.001) and slightly better quality of life (mean EQ-5D-5L 0.86 vs 0.85, p=0.015) at 6 months were also observed. These differences, except quality of life, remained statistically significant after adjusting for baseline values, trial arm and TB treatment adherence rates.

Conclusion: Patients with TB who stop smoking may have better outcomes than those who don't. Health professionals should support patients in stopping smoking.
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http://dx.doi.org/10.1136/thoraxjnl-2020-215926DOI Listing
July 2021

Economics of healthcare access in low-income and middle-income countries: a protocol for a scoping review of the economic impacts of seeking healthcare on slum-dwellers compared with other city residents.

BMJ Open 2021 07 9;11(7):e045441. Epub 2021 Jul 9.

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

Introduction: People living in slums face several challenges to access healthcare. Scarce and low-quality public health facilities are common problems in these communities. Costs and prevalence of catastrophic health expenditures (CHE) have also been reported as high in studies conducted in slums in developing countries and those suffering from chronic conditions and the poorest households seem to be more vulnerable to financial hardship. The COVID-19 pandemic may be aggravating the economic impact on the extremely vulnerable population living in slums due to the long-term consequences of the disease. The objective of this review is to report the economic impact of seeking healthcare on slum-dwellers in terms of costs and CHE. We will compare the economic impact on slum-dwellers with other city residents.

Methods And Analysis: This scoping review adopts the framework suggested by Arksey and O'Malley. The review is part of the accountability and responsiveness of slum-dwellers (ARISE) research consortium, which aims to enhance accountability to improve the health and well-being of marginalised populations living in slums in India, Bangladesh, Sierra Leone and Kenya. Costs of accessing healthcare will be updated to 2020 prices using the inflation rates reported by the International Monetary Fund. Costs will be presented in International Dollars by using purchase power parity. The prevalence of CHE will also be reported.

Ethics And Dissemination: Ethical approval is not required for scoping reviews. We will disseminate our results alongside the events organised by the ARISE consortium and international conferences. The final manuscript will be submitted to an open-access international journal. Registration number at the Research Registry: reviewregistry947.
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http://dx.doi.org/10.1136/bmjopen-2020-045441DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8273471PMC
July 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

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 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

Smoking cessation in severe mental illness: combined long-term quit rates from the UK SCIMITAR trials programme.

Br J Psychiatry 2021 02;218(2):95-97

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

Smoking contributes to health inequalities for people with severe mental illness (SMI). Although smoking cessation interventions are effective in the short term, there are few long-term trial-based estimates of abstinence. The SCIMITAR trials programme includes the largest trial to date of a smoking cessation intervention for people with SMI, but this was underpowered to detect anticipated long-term quit rates. By pooling pilot and full-trial data we found that quit rates were maintained at 12 months (OR = 1.67, 95% CI 1.02-2.73, P = 0.04). Policymakers can now be confident that bespoke smoking cessation interventions produce successful short- and long-term quitting.
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http://dx.doi.org/10.1192/bjp.2019.192DOI Listing
February 2021

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://dx.doi.org/10.3310/hta23430DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6732716PMC
August 2019

Satisfaction with a digitally-enabled telephone health coaching intervention for people with non-diabetic hyperglycaemia.

NPJ Digit Med 2019 4;2. Epub 2019 Feb 4.

5Salford Royal NHS Foundation Trust, Salford, UK.

International evidence shows that lifestyle interventions can effectively reduce the risk of developing diabetes in people with non-diabetic hyperglycaemia (NDH). A candidate intervention that has potential to be rolled out at population level is health coaching. Digital interventions offer the means to potentially enhance user satisfaction with health coaching and improve efficiencies. We used a randomised controlled trial to test whether a digitally-enabled health coaching intervention that included an online dashboard and telephone health coaching improved user satisfaction and cost-efficiencies compared with a telephone only health coaching intervention. The primary outcome was satisfaction measured by Client Satisfaction Questionnaire (CSQ-8). 103 participants with NDH were allocated to the telephone coaching only intervention and 106 participants with NDH were allocated to the digital and telephone coaching intervention. In an intention-to-treat analysis satisfaction was higher in participants allocated to the digital and telephone coaching intervention than those allocated to the telephone only intervention, but the difference was not significant. There were no significant differences between the groups on secondary outcomes (HbA1c, BMI, activation, depression, self-management, health status). From a service commissioning perspective the mean incremental cost of the digitally-enabled intervention was £236 ($332; €270). Call times, including administration, were longer for participants allocated to the digitally-enabled intervention. The results show that user satisfaction with digitally-enabled intervention is broadly equivalent with that of telephone delivered interventions in the context of routinely delivered diabetes prevention programmes. There is scope for future work that assesses how economies of scale can be achieved at larger user bases.
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http://dx.doi.org/10.1038/s41746-019-0080-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6550206PMC
February 2019

The process and delivery of CBT for depression in adults: a systematic review and network meta-analysis.

Psychol Med 2019 09 10;49(12):1937-1947. Epub 2019 Jun 10.

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

Cognitive-behavioural therapy (CBT) is an effective treatment for depressed adults. CBT interventions are complex, as they include multiple content components and can be delivered in different ways. We compared the effectiveness of different types of therapy, different components and combinations of components and aspects of delivery used in CBT interventions for adult depression. We conducted a systematic review of randomised controlled trials in adults with a primary diagnosis of depression, which included a CBT intervention. Outcomes were pooled using a component-level network meta-analysis. Our primary analysis classified interventions according to the type of therapy and delivery mode. We also fitted more advanced models to examine the effectiveness of each content component or combination of components. We included 91 studies and found strong evidence that CBT interventions yielded a larger short-term decrease in depression scores compared to treatment-as-usual, with a standardised difference in mean change of -1.11 (95% credible interval -1.62 to -0.60) for face-to-face CBT, -1.06 (-2.05 to -0.08) for hybrid CBT, and -0.59 (-1.20 to 0.02) for multimedia CBT, whereas wait list control showed a detrimental effect of 0.72 (0.09 to 1.35). We found no evidence of specific effects of any content components or combinations of components. Technology is increasingly used in the context of CBT interventions for depression. Multimedia and hybrid CBT might be as effective as face-to-face CBT, although results need to be interpreted cautiously. The effectiveness of specific combinations of content components and delivery formats remain unclear. Wait list controls should be avoided if possible.
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http://dx.doi.org/10.1017/S003329171900120XDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6712954PMC
September 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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http://dx.doi.org/10.1192/bjb.2019.39DOI Listing
June 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

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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http://dx.doi.org/10.1056/NEJMoa1808779DOI Listing
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

Nicotine preloading for smoking cessation: the Preloading RCT.

Health Technol Assess 2018 08;22(41):1-84

Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.

Background: Nicotine preloading means using nicotine replacement therapy prior to a quit date while smoking normally. The aim is to reduce the drive to smoke, thereby reducing cravings for smoking after quit day, which are the main cause of early relapse. A prior systematic review showed inconclusive and heterogeneous evidence that preloading was effective and little evidence of the mechanism of action, with no cost-effectiveness data.

Objectives: To assess (1) the effectiveness, safety and tolerability of nicotine preloading in a routine NHS setting relative to usual care, (2) the mechanisms of the action of preloading and (3) the cost-effectiveness of preloading.

Design: Open-label randomised controlled trial with examination of mediation and a cost-effectiveness analysis.

Setting: NHS smoking cessation clinics.

Participants: People seeking help to stop smoking.

Interventions: Nicotine preloading comprised wearing a 21 mg/24 hour nicotine patch for 4 weeks prior to quit date. In addition, minimal behavioural support was provided to explain the intervention rationale and to support adherence. In the comparator group, participants received equivalent behavioural support. Randomisation was stratified by centre and concealed from investigators.

Main Outcome Measures: The primary outcome was 6-month prolonged abstinence assessed using the Russell Standard. The secondary outcomes were 4-week and 12-month abstinence. Adverse events (AEs) were assessed from baseline to 1 week after quit day. In a planned analysis, we adjusted for the use of varenicline (Champix; Pfizer Inc., New York, NY, USA) as post-cessation medication. Cost-effectiveness analysis took a health-service perspective. The within-trial analysis assessed health-service costs during the 13 months of trial enrolment relative to the previous 6 months comparing trial arms. The base case was based on multiple imputation for missing cost data. We modelled long-term health outcomes of smoking-related diseases using the European-study on Quantifying Utility of Investment in Protection from Tobacco (EQUIPT) model.

Results: In total, 1792 people were eligible and were enrolled in the study, with 893 randomised to the control group and 899 randomised to the intervention group. In the intervention group, 49 (5.5%) people discontinued preloading prematurely and most others used it daily. The primary outcome, biochemically validated 6-month abstinence, was achieved by 157 (17.5%) people in the intervention group and 129 (14.4%) people in the control group, a difference of 3.02 percentage points [95% confidence interval (CI) -0.37 to 6.41 percentage points; odds ratio (OR) 1.25, 95% CI 0.97 to 1.62;  = 0.081]. Adjusted for use of post-quit day varenicline, the OR was 1.34 (95% CI 1.03 to 1.73;  = 0.028). Secondary abstinence outcomes were similar. The OR for the occurrence of serious AEs was 1.12 (95% CI 0.42 to 3.03). Moderate-severity nausea occurred in an additional 4% of the preloading group compared with the control group. There was evidence that reduced urges to smoke and reduced smoke inhalation mediated the effect of preloading on abstinence. The incremental cost-effectiveness ratio at the 6-month follow-up for preloading relative to control was £710 (95% CI -£13,674 to £23,205), but preloading was dominant at 12 months and in the long term, with an 80% probability that it is cost saving.

Limitations: The open-label design could partially account for the mediation results. Outcome assessment could not be blinded but was biochemically verified.

Conclusions: Use of nicotine-patch preloading for 4 weeks prior to attempting to stop smoking can increase the proportion of people who stop successfully, but its benefit is undermined because it reduces the use of varenicline after preloading. If this latter effect could be overcome, then nicotine preloading appears to improve health and reduce health-service costs in the long term. Future work should determine how to ensure that people using nicotine preloading opt to use varenicline as cessation medication.

Trial Registration: Current Controlled Trials ISRCTN33031001.

Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in ; Vol. 22, No. 41. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta22410DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6099332PMC
August 2018

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

Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care.

BMJ Open 2017 Sep 27;7(9):e016009. Epub 2017 Sep 27.

Whittington Health, London, UK.

Objective: To determine the effectiveness of a web-based self-management programme for people with type 2 diabetes in improving glycaemic control and reducing diabetes-related distress.

Methods And Design: Individually randomised two-arm controlled trial.

Setting: 21 general practices in England.

Participants: Adults aged 18 or over with a diagnosis of type 2 diabetes registered with participating general practices.

Intervention And Comparator: Usual care plus either Healthy Living for People with Diabetes (HeLP-Diabetes), an interactive, theoretically informed, web-based self-management programme or a simple, text-based website containing basic information only.

Outcomes And Data Collection: Joint primary outcomes were glycated haemoglobin (HbA1c) and diabetes-related distress, measured by the Problem Areas in Diabetes (PAID) scale, collected at 3 and 12 months after randomisation, with 12 months the primary outcome point. Research nurses, blind to allocation collected clinical data; participants completed self-report questionnaires online.

Analysis: The analysis compared groups as randomised (intention to treat) using a linear mixed effects model, adjusted for baseline data with multiple imputation of missing values.

Results: Of the 374 participants randomised between September 2013 and December 2014, 185 were allocated to the intervention and 189 to the control. Final (12 month) follow-up data for HbA1c were available for 318 (85%) and for PAID 337 (90%) of participants. Of these, 291 (78%) and 321 (86%) responses were recorded within the predefined window of 10-14 months. Participants in the intervention group had lower HbA1c than those in the control (mean difference -0.24%; 95% CI -0.44 to -0.049; p=0.014). There was no significant overall difference between groups in the mean PAID score (p=0.21), but prespecified subgroup analysis of participants who had been more recently diagnosed with diabetes showed a beneficial impact of the intervention in this group (p = 0.004). There were no reported harms.

Conclusions: Access to HeLP-Diabetes improved glycaemic control over 12 months.

Trial Registration Number: ISRCTN02123133.
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http://dx.doi.org/10.1136/bmjopen-2017-016009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5623569PMC
September 2017

Youth social behaviour and network therapy (Y-SBNT): adaptation of a family and social network intervention for young people who misuse alcohol and drugs - a randomised controlled feasibility trial.

Health Technol Assess 2017 03;21(15):1-260

Birmingham and Solihull Mental Health NHS Foundation Trust, Birmingham, UK.

Background: Family interventions appear to be effective at treating young people's substance misuse. However, implementation of family approaches in UK services is low. This study aimed to demonstrate the feasibility of recruiting young people to an intervention based on an adaptation of adult social behaviour and network therapy. It also sought to involve young people with experience of using substance misuse services in the research process.

Objectives: To demonstrate the feasibility of recruiting young people to family and social network therapy and to explore ways in which young people with experience of using substance misuse services could be involved in a study of this nature.

Design: A pragmatic, two-armed, randomised controlled open feasibility trial.

Setting: Two UK-based treatment services for young people with substance use problems, with recruitment taking place from May to November 2014.

Participants: Young people aged 12-18 years, newly referred and accepted for structured interventions for drug and/or alcohol problems.

Interventions: A remote, web-based computer randomisation system allocated young people to adapted youth social behaviour and network therapy (Y-SBNT) or treatment as usual (TAU). Y-SBNT participants were intended to receive up to six 50-minute sessions over a maximum of 12 weeks. TAU participants continued to receive usual care delivered by their service.

Main Outcome Measures: Feasibility was measured by recruitment rates, retention in treatment and follow-up completion rates. The main clinical outcome was the proportion of days on which the main problem substance was used in the preceding 90-day period as captured by the Timeline Follow-Back interview at 3 and 12 months.

Results: In total, 53 young people were randomised (Y-SBNT,  = 26; TAU,  = 27) against a target of 60 (88.3%). Forty-two young people attended at least one treatment session [Y-SBNT 22/26 (84.6%); TAU 20/27 (74.1%)]; follow-up rates were 77.4% at month 3 and 73.6% at month 12. Data for nine young people were missing at both months 3 and 12, so the main clinical outcome analysis was based on 24 young people (92.3%) in the Y-SBNT group and 20 young people (74.1%) in the TAU group. At month 12, the average proportion of days that the main problem substance was used in the preceding 90 days was higher in the Y-SBNT group than in the TAU group (0.54 vs. 0.41; adjusted mean difference 0.13, 95% confidence interval -0.12 to 0.39;  = 0.30). No adverse events were reported. Seventeen young people with experience of substance misuse services were actively involved throughout the study. They informed key elements of the intervention and research process, ensuring that the intervention was acceptable and relevant to our target groups; contributing to the design of key trial documents, ideas for a new model of public involvement and this report. Two parents were also involved.

Conclusions: The adapted intervention could be delivered in young people's services, and qualitative interviews found that Y-SBNT was acceptable to young people, family members and staff. Engagement of family and network members proved difficult within the intervention and research aspects. The study proved the feasibility of this work in routine services but outcome measurement based on narrow substance use variables may be limited and may fail to capture other important changes in wider areas of functioning for young people. Validation of the EuroQol-5 Dimensions for young people aged 12-18 years should be considered and flexible models for involvement of young people in research are required to achieve inclusive representation throughout all aspects of the research process. Although recommendation of a full trial of the Y-SBNT intervention compared with TAU is not supported, this study can inform future intervention development and UK research within routine addiction services.

Trial Registration: Current Controlled Trials ISRCTN93446265.

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. 21, No. 15. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta21150DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5402218PMC
March 2017

Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR+): study protocol for a randomised controlled trial.

Trials 2017 01 26;18(1):44. Epub 2017 Jan 26.

Mental Health and Addiction Research Group, University of York, Heslington, YO10 5DD, UK.

Background: Smoking is highly prevalent among people who have experience of severe mental ill health, contributing to their poor physical health. Despite the 'culture' of smoking in mental health services, people with severe mental ill health often express a desire to quit smoking; however, the services currently available to aid quitting are those which are widely available to the general population and may not be suitable or effective for people with severe mental ill health. The aim of this study is to explore the effectiveness and cost-effectiveness of a bespoke smoking-cessation intervention specifically targeted at people with severe mental ill health.

Methods/design: SCIMITAR+ is a multicentre, pragmatic, two-arm, parallel-group, individually randomised controlled trial. We aim to recruit 400 participants aged 18 years and above with a documented diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder who smoke. Potentially eligible participants identified in primary or secondary care will be screened, and baseline data collected. Eligible, consenting participants will be randomly allocated to one of two groups. In the intervention arm, the participant will be assigned a mental health professional trained to deliver smoking-cessation interventions who will work with the participant and participant's GP or mental health specialist to provide an individually tailored smoking-cessation service. The comparator arm will be usual care - following current NICE guidelines for smoking cessation, in line with general guidance that is offered to all smokers, with no specific adaptation or enhancement in relation to severe mental ill health. The primary outcome will be self-reported smoking cessation at 12 months verified by expired carbon monoxide (CO) measurement. Secondary outcome measures include Body Mass Index at 12 months, the Fagerström Test for Nicotine Dependence, Motivation to Quit questionnaire, SF-12, PHQ-9, GAD-7, EQ-5D-5 L, and health service utilisation at 6 and 12 months. The economic evaluation at 12 months will be conducted in the form of an incremental cost-effectiveness analysis.

Discussion: SCIMITAR+ trial is the largest trial to our knowledge to investigate the effectiveness of a bespoke smoking-cessation service for people with severe mental ill health.

Trial Registration: International Standard Randomised Controlled Trials Number, ISRCTN72955454 . Registered on 16 January 2015.
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http://dx.doi.org/10.1186/s13063-017-1789-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5270301PMC
January 2017

Comparison of active treatments for impaired glucose regulation: a Salford Royal Foundation Trust and Hitachi collaboration (CATFISH): study protocol for a randomized controlled trial.

Trials 2016 08 26;17(1):424. Epub 2016 Aug 26.

Salford Royal NHS Foundation Trust, Salford, M6 8HD, UK.

Background: Diabetes is highly prevalent and contributes to significant morbidity and mortality worldwide. Behaviour change interventions that target health and lifestyle factors associated with the onset of diabetes can delay progression to diabetes, but many approaches rely on intensive one-to-one contact by specialists. Health coaching is an approach based on motivational interviewing that can potentially deliver behaviour change interventions by non-specialists at a larger scale. This trial protocol describes a randomized controlled trial (CATFISH) that tests whether a web-enhanced telephone health coaching intervention (IGR3) is more acceptable and efficient than a telephone-only health coaching intervention (IGR2) for people with prediabetes (impaired glucose regulation).

Methods: CATFISH is a two-parallel group, single-centre individually randomized controlled trial. Eligible participants are patients aged ≥18 years with impaired glucose regulation (HbA1c concentration between 42 and 47 mmol/mol), have access to a telephone and home internet and have been referred to an existing telephone health coaching service at Salford Royal NHS Foundation Trust, Salford, UK. Participants who give written informed consent will be randomized remotely (via a clinical trials unit) to either the existing pathway (IGR2) or the new web-enhanced pathway (IGR3) for 9 months. The primary outcome measure is patient acceptability at 9 months, determined using the Client Satisfaction Questionnaire. Secondary outcome measures at 9 months are: cost of delivery of IGR2 and IGR3, mental health, quality of life, patient activation, self-management, weight (kg), HbA1c concentration, and body mass index. All outcome measures will be analyzed on an intention-to-treat basis. A qualitative process evaluation will explore the experiences of participants and providers with a focus on understanding usability of interventions, mechanisms of behaviour change, and impact of context on delivery and user acceptability. Qualitative data will be analyzed using Framework.

Discussion: The CATFISH trial will provide a pragmatic assessment of whether a web-based information technology platform can enhance acceptability of a telephone health coaching intervention for people with prediabetes. The data will prove critical in understanding the role of web applications to improve engagement with evidence-based approaches to preventing diabetes.

Trial Registration: ISRCTN16534814 . Registered on 7 February 2016.
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http://dx.doi.org/10.1186/s13063-016-1519-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5000461PMC
August 2016

HeLP-Diabetes: randomised controlled trial protocol.

BMC Health Serv Res 2015 Dec 29;15:578. Epub 2015 Dec 29.

Centre for Application of Health Psychology, University of Southampton, Building 44, Highfield Campus, Southampton, SO17 1BJ, UK.

Background: Type 2 Diabetes Mellitus (T2DM) is common, affecting nearly 400 million people worldwide. Achieving good health for people with T2DM requires active self-management; however, uptake of self-management education is poor, and there is an urgent need to find better, more acceptable, cost-effective methods of providing self-management support. Web-based self-management support has many potential benefits for patients and health services. The aim of this trial is to determine the effectiveness and cost-effectiveness of a web-based self-management support programme for people with T2DM.

Methods: This will be a multi-centre individually randomised controlled trial in primary care, recruiting adults with T2DM who are registered with participating general practices in England. Participants will be randomised to receive either an evidence-based, theoretically informed, web-based self-management programme for people with T2DM which addresses medical, emotional, and role management, called Healthy Living for People with type 2 Diabetes (HeLP-Diabetes) or a simple information website. The joint primary outcomes are glycated haemoglobin (HbA1c) and diabetes-related distress, measured by the Problem Areas In Diabetes (PAID) questionnaire. Secondary outcomes include cardiovascular risk factors, depression and anxiety, and self-efficacy for self-management of diabetes. Health economic data include health service use, costs due to the intervention, and EQ-5D for calculation of Quality Adjusted Life Years (QALYS). Data will be collected at baseline, 3 months and 12 months, with the primary endpoint at 12 months. Practice nurses, blinded to patient allocation, collect clinical data; patients complete online questionnaires for patient reported measures. A sample size of 350 recruited participants allows for attrition of up to 15 % and will provide 90 % power of detecting at a 5 % significance level a true average difference in the PAID score of 4.0 and 0.25 % change in HbA1c (both small effect sizes). The analysis will follow a pre-specified analysis plan, based on comparing the groups as randomised (intention-to-treat).

Discussion: The findings of this trial are likely to be of interest to policy makers, clinicians, and commissioners, all of whom are actively seeking additional forms of self-management support for people with T2DM.

Trial Registration: The Trial Registration number is ISRCTN 02123133 ; date of registration 14.2.13.
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http://dx.doi.org/10.1186/s12913-015-1246-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4696337PMC
December 2015

Bespoke smoking cessation for people with severe mental ill health (SCIMITAR): a pilot randomised controlled trial.

Lancet Psychiatry 2015 May 28;2(5):395-402. Epub 2015 Apr 28.

Faculty of Health & Social Care, University of Hull, Hull, UK.

Background: People with severe mental ill health are three times more likely to smoke but typically do not access conventional smoking cessation services, contributing to widening health inequalities and reduced life expectancy. We aimed to pilot an intervention targeted at smokers with severe mental ill health and to test methods of recruitment, randomisation, and follow up before implementing a full trial.

Methods: The Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR) is a pilot randomised controlled trial of a smoking cessation strategy designed specifically for people with severe mental ill health, to be delivered by mental health nurses and consisting of behavioural support and drugs, compared with a conventional smoking cessation service (ie, usual care). Adults (aged 18 years or older) with bipolar disorder or schizophrenia, who were current smokers, were recruited from NHS primary care and mental health settings in the UK (York, Scarborough, Hull, and Manchester). Eligible participants were randomly allocated to either usual care (control group) or usual care plus the bespoke smoking cessation strategy (intervention group). Randomisation was done via a central telephone system, with computer-generated random numbers. We could not mask participants, family doctors, and researchers to the treatment allocation. Our primary outcome was smoking status at 12 months, verified by carbon monoxide measurements or self-report. Only participants who provided an exhaled CO measurement or self-reported their smoking status at 12 months were included in the primary analysis. The trial is registered at ISRCTN.com, number ISRCTN79497236.

Findings: Of 97 people recruited to the pilot study, 51 were randomly allocated to the control group and 46 were assigned to the intervention group. Participants engaged well with the bespoke smoking cessation strategy, but no individuals assigned to usual care accessed NHS smoking cessation services. At 12 months, 35 (69%) controls and 33 (72%) people assigned to the intervention group provided a CO measurement or self-reported their smoking status. Smoking cessation was highest among individuals who received the bespoke intervention (12/33 [36%] vs 8/35 [23%]; adjusted odds ratio 2·9, 95% CI 0·8-10·5).

Interpretation: We have shown the feasibility of recruiting and randomising people with severe mental ill health in a trial of this nature. The level of engagement with a bespoke smoking cessation strategy was higher than with a conventional approach. The effectiveness and safety of a smoking cessation programme designed particularly for people with severe mental ill health should be tested in a fully powered randomised controlled trial.

Funding: National Institute of Health Research Health Technology Assessment Programme.
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http://dx.doi.org/10.1016/S2215-0366(15)00091-7DOI Listing
May 2015

ADAPTA: A pilot randomised controlled trial of an alcohol-focused intervention versus a healthy living intervention for problem drinkers identified in a general hospital setting.

Drug Alcohol Depend 2015 Sep 29;154:117-24. Epub 2015 Jun 29.

Leeds Addiction Unit, 19 Springfield Mount, Leeds LS2 9NG, United Kingdom. Electronic address:

Aim: To examine the relative feasibility, acceptability, applicability, effectiveness and explore cost-effectiveness of a healthy living focused intervention (HL) compared to an alcohol-focused intervention (AF) for problem drinkers identified in hospital.

Methods: A pragmatic, randomised, controlled, open pilot trial. Feasibility and acceptability were measured by recruitment, attrition, follow-up rates and number of treatment sessions attended. Effectiveness was measured using the Alcohol Use Disorders Identification Test score at six months. Additional economic and secondary outcome measures were collected.

Results: Eighty-six participants were randomised and 72% (n=62) were retained in full participation. Forty-one participants attended at least one treatment session (48%). A greater proportion in the HL group attended all four treatment sessions (33% vs 19%). Follow-up rates were 29% at six months and 22% at twelve months. There was no evidence of a difference in AUDIT score between treatment groups at six months. Mean cost of health care and social services, policing and the criminal justice system use decreased while EQ-5D scores indicated minor improvement in both arms. However, this pilot trial was not powered to detect differences in either measure between groups.

Conclusions: While no treatment effect was observed, this study demonstrated a potential to engage patients drinking at harmful or dependent levels in a healthy living intervention. However, recruitment proved challenging and follow-up rates were poor. Better ways need to be found to help these patients recognise the harms associated with their drinking and overcome the evident barriers to their engagement with specialist treatment.
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http://dx.doi.org/10.1016/j.drugalcdep.2015.06.030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4545229PMC
September 2015
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