Kathleen A Boyd

Financial incentives for smoking cessation in pregnancy: Randomised controlled trial

Objective To assess the efficacy of a financial incentive added to routine specialist pregnancy stop smoking services versus routine care to help pregnant smokers quit. Design Phase II therapeutic exploratory single centre, individually randomised controlled parallel group superiority trial. Setting One large health board area with a materially deprived, inner city population in the west of Scotland, United Kingdom. Participants 612 self reported pregnant smokers in NHS Greater Glasgow and Clyde who were English speaking, at least 16 years of age, less than 24 weeks pregnant, and had an exhaled carbon monoxide breath test result of 7 ppm or more. 306 women were randomised to incentives and 306 to control. Interventions The control group received routine care, which was the offer of a face to face appointment to discuss smoking and cessation and, for those who attended and set a quit date, the offer of free nicotine replacement therapy for 10 weeks provided by pharmacy services, and four, weekly support phone calls. The intervention group received routine care plus the offer of up to £400 of shopping vouchers: £50 for attending a face to face appointment and setting a quit date; then another £50 if at four weeks’ post-quit date exhaled carbon monoxide confirmed quitting; a further £100 was provided for continued validated abstinence of exhaled carbon monoxide after 12 weeks; a final £200 voucher was provided for validated abstinence of exhaled carbon monoxide at 34-38 weeks’ gestation. Main outcome measure The primary outcome was cotinine verified cessation at 34-38 weeks’ gestation through saliva (<14.2 ng/mL) or urine (<44.7 ng/mL). Secondary outcomes included birth weight, engagement, and self reported quit at four weeks. Results Recruitment was extended from 12 to 15 months to achieve the target sample size. Follow-up continued until September 2013. Of the 306 women randomised, three controls opted out soon after enrolment; these women did not want their data to be used, leaving 306 intervention and 303 control group participants in the intention to treat analysis. No harms of financial incentives were documented. Significantly more smokers in the incentives group than control group stopped smoking: 69 (22.5%) versus 26 (8.6%). The relative risk of not smoking at the end of pregnancy was 2.63 (95% confidence interval 1.73 to 4.01) P<0.001. The absolute risk difference was 14.0% (95% confidence interval 8.2% to 19.7%). The number needed to treat (where financial incentives need to be offered to achieve one extra quitter in late pregnancy) was 7.2 (95% confidence interval 5.1 to 12.2). The mean birth weight was 3140 g (SD 600 g) in the incentives group and 3120 (SD 590) g in the control group (P=0.67). Conclusion This phase II randomised controlled trial provides substantial evidence for the efficacy of incentives for smoking cessation in pregnancy; as this was only a single centre trial, incentives should now be tested in different types of pregnancy cessation services and in different parts of the United Kingdom. Trial registration Current Controlled Trials ISRCTN87508788.

Oxygen saturation targets in infants with bronchiolitis (BIDS): a double-blind, randomised, equivalence trial

Summary Background The American Academy of Pediatrics recommends a permissive hypoxaemic target for an oxygen saturation of 90% for children with bronchiolitis, which is consistent with the WHO recommendations for targets in children with lower respiratory tract infections. No evidence exists to support this threshold. We aimed to assess whether the 90% or higher target for management of oxygen supplementation was equivalent to a normoxic 94% or higher target for infants admitted to hospital with viral bronchiolitis. Methods We did a parallel-group, randomised, controlled, equivalence trial of infants aged 6 weeks to 12 months of age with physician-diagnosed bronchiolitis newly admitted into eight paediatric hospital units in the UK (the Bronchiolitis of Infancy Discharge Study [BIDS]). A central computer randomly allocated (1:1) infants, in varying length blocks of four and six and without stratification, to be clipped to standard oximeters (patients treated with oxygen if pulse oxygen saturation [SpO2] <94%) or modified oximeters (displayed a measured value of 90% as 94%, therefore oxygen not given until SpO2 <90%). All parents, clinical staff, and outcome assessors were masked to allocation. The primary outcome was time to resolution of cough (prespecified equivalence limits of plus or minus 2 days) in the intention-to-treat population. This trial is registered with ISRCTN, number ISRCTN28405428. Findings Between Oct 3, and March 30, 2012, and Oct 1, and March 29, 2013, we randomly assigned 308 infants to standard oximeters and 307 infants to modified oximeters. Cough resolved by 15·0 days (median) in both groups (95% CI for difference −1 to 2) and so oxygen thresholds were equivalent. We recorded 35 serious adverse events in 32 infants in the standard care group and 25 serious adverse events in 24 infants in the modified care group. In the standard care group, eight infants transferred to a high-dependency unit, 23 were readmitted, and one had a prolonged hospital stay. In the modified care group, 12 infants were transferred to a high-dependency unit and 12 were readmitted to hospital. Recorded adverse events did not differ significantly. Interpretation Management of infants with bronchiolitis to an oxygen saturation target of 90% or higher is as safe and clinically effective as one of 94% or higher. Future research should assess the benefits and risks of different oxygen saturation targets in acute respiratory infection in older children, particularly in developing nations where resources are scarce. Funding National Institute for Health Research, Health Technology Assessment programme.

Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline: Randomised controlled trial

Objective To compare the effects of free nicotine replacement therapy or proactive telephone counselling in addition to standard smoking cessation support offered through a telephone quitline. Design Parallel group, 2×2 factorial, randomised controlled trial. Setting National quitline, England. Participants 2591 non-pregnant smokers aged 16 or more residing in England who called the quitline between February 2009 and February 2010 and agreed to set a quit date: 648 were each randomised to standard support, proactive support, or proactive support with nicotine replacement therapy, and 647 were randomised to standard support with nicotine replacement therapy. Interventions Two interventions were offered in addition to standard support: six weeks’ nicotine replacement therapy, provided free, and proactive counselling sessions (repeat telephone calls from, and interaction with, cessation advisors). Main outcome measures The primary outcome was self reported smoking cessation for six or more months after the quit date. The secondary outcome was cessation validated by exhaled carbon monoxide measured at six or more months. Results At six months, 17.7% (n=229) of those offered nicotine replacement therapy reported smoking cessation compared with 20.1% (n=261) not offered such therapy (odds ratio 0.85, 95% confidence interval 0.70 to 1.04), and 18.2% (n=236) offered proactive counselling reported smoking cessation compared with 19.6% (n=254) offered standard support (0.91, 0.75 to 1.11). Data validated by carbon monoxide readings changed the findings for nicotine replacement therapy only, with smoking cessation validated in 6.6% (85/1295) of those offered nicotine replacement therapy compared with 9.4% (122/1296) not offered such therapy (0.67, 0.50 to 0.90). Conclusions Offering free nicotine replacement therapy or additional (proactive) counselling to standard helpline support had no additional effect on smoking cessation. Trial registration ClinicalTrials.gov NCT00775944.

Cost‐effectiveness of pharmacy and group behavioural support smoking cessation services in Glasgow

AIMS Smokers attending group-based support for smoking cessation in Glasgow are significantly more likely to be successful than those attending pharmacy-based support. This study examined the cost-effectiveness of these two modes of support. DESIGN Combination of observational study data and information from National Health Service (NHS) Greater Glasgow and Clyde smoking cessation services. SETTING Glasgow, Scotland. PARTICIPANTS A total of 1979 smokers who accessed either of the cessation services between March and May 2007. INTERVENTION Two smoking treatment services offering one-to-one support in pharmacies, and providing group counselling in the community. MEASUREMENTS Routine monitoring data on resource use and smoking status (carbon monoxide-validated, self-reported, non-quitters and relapsers) at 4-week follow-up. FINDINGS The incremental cost per 4-week quitter for pharmacy support was found to be approximately 772 pounds sterling, and 1612 pounds sterling for group support, in comparison to self-quit cessation attempts. These findings compare favourably with previously published outcomes from cost-effectiveness smoking cessation studies. Assuming a relapse rate of 75% from 4 weeks to 1 year and a further 35% beyond 1 year, and combining this with an average of 1.98 quality adjusted life years (QALY) gained per permanent cessation, provides an estimated incremental cost per QALY of 4400 pounds sterling for the pharmacy service and 5400 pounds sterling for group support service. CONCLUSIONS Group support and pharmacy-based support for smoking cessation are both extremely cost-effective.

Are financial incentives cost-effective to support smoking cessation during pregnancy?

AIMS To investigate the cost-effectiveness of up to £400 worth of financial incentives for smoking cessation in pregnancy as an adjunct to routine health care. DESIGN Cost-effectiveness analysis based on a Phase II randomized controlled trial (RCT) and a cost-utility analysis using a life-time Markov model. SETTING The RCT was undertaken in Glasgow, Scotland. The economic analysis was undertaken from the UK National Health Service (NHS) perspective. PARTICIPANTS A total of 612 pregnant women randomized to receive usual cessation support plus or minus financial incentives of up to £400 vouchers (US

The cessation in pregnancy incentives trial (CPIT): study protocol for a randomized controlled trial.

609), contingent upon smoking cessation. MEASUREMENTS Comparison of usual support and incentive interventions in terms of cotinine-validated quitters, quality-adjusted life years (QALYs) and direct costs to the NHS. FINDINGS The incremental cost per quitter at 34-38 weeks pregnant was £1127 (

Power and sample size for cost-effectiveness analysis: fFN neonatal screening

1716).This is similar to the standard look-up value derived from Stapleton & Wests published ICER tables, £1390 per quitter, by looking up the Cessation in Pregnancy Incentives Trial (CIPT) incremental cost (£157) and incremental 6-month quit outcome (0.14). The life-time model resulted in an incremental cost of £17 [95% confidence interval (CI) = -£93, £107] and a gain of 0.04 QALYs (95% CI = -0.058, 0.145), giving an ICER of £482/QALY (

Towards Integration of Environmental and Health Impact Assessments for Wild Capture Fishing and Farmed Fish with Particular Reference to Public Health and Occupational Health Dimensions

734/QALY). Probabilistic sensitivity analysis indicates uncertainty in these results, particularly regarding relapse after birth. The expected value of perfect information was £30 million (at a willingness to pay of £30 000/QALY), so given current uncertainty, additional research is potentially worthwhile. CONCLUSION Financial incentives for smoking cessation in pregnancy are highly cost-effective, with an incremental cost per quality-adjusted life years of £482, which is well below recommended decision thresholds.

Analysis of adverse events and quality of life data for an economic evaluation of adjuvant chemotherapy in colorectal cancer: when can we stop collecting?

BackgroundSeventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010) highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit?Design and methodsThis study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy.Participants (n = 600) will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an efficient trial design without introducing outcome bias? Can incentives be introduced in a way that is feasible and acceptable?DiscussionThis phase II trial will establish a workable design to reduce the risks associated with a future definitive phase III multicenter randomized controlled trial and establish a framework to assess the costs and benefits of financial incentives to help pregnant smokers to quit.Trial registrationCurrent Controlled Trials ISRCTN87508788

Bronchiolitis of Infancy Discharge Study (BIDS): a multicentre, parallel-group, double-blind, randomised controlled, equivalence trial with economic evaluation.

Randomised controlled trials (RCTs) which involve cost-effectiveness evaluations rarely use health economic input when undertaking sample size calculations for the trial design; however, in studies undertaken with cost-effectiveness as the primary outcome, sample size calculations should be directly related to the cost-effectiveness result rather than to the effectiveness outcome alone. This paper reports on a case in which a clinical trial design sample size and power calculations were determined with regard to cost-effectiveness using the net monetary benefit (NMB) approach to demonstrate the feasibility of sample size calculation for cost-effectiveness in a real life setting. The proposed RCT of fetal fibronectin screening (fFN) for women with threatened pre-term labour is discussed, followed by the design of a preliminary model to inform the trial design calculation. The predictions from this pre-trial indicate potential cost-savings, but with a marginal detrimental impact on the effectiveness endpoint, neonatal morbidity. The NMB approach for cost-effectiveness is discussed and used to calculate the required sample sizes for different powers. The sample size calculations are then recalculated using a non-inferiority margin, to ensure that the NMB sample size for the trial was also sufficient to demonstrate non-inferiority for the effectiveness endpoint. Finally, a probabilistic analysis explored uncertainty in the model parameters and the impact on sample size. Considerations of economic assessments alongside clinical trials can and should be used to guide conventional trial design. This paper demonstrates the feasibility of such calculations, whilst simultaneously highlighting limitations and demonstrating the role for economic considerations to guide non-inferiority margins.