Lesley Sinclair

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.

A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse

BackgroundCurrent Medical Research Council (MRC) guidance on complex interventions advocates pilot trials and feasibility studies as part of a phased approach to the development, testing, and evaluation of healthcare interventions. In this paper we discuss the results of a recent feasibility study and pilot trial for a randomized controlled trial (RCT) of pelvic floor muscle training for prolapse (ClinicalTrials.gov: NCT01136889). The ways in which researchers decide to respond to the results of feasibility work may have significant repercussions for both the nature and degree of tension between internal and external validity in a definitive trial.MethodsWe used methodological issues to classify and analyze the problems that arose in the feasibility study. Four centers participated with the aim of randomizing 50 women. Women were eligible if they had prolapse of any type, of stage I to IV, and had a pessary successfully fitted. Postal questionnaires were administered at baseline, 6 months, and 7 months post-randomization. After identifying problems arising within the pilot study we then sought to locate potential solutions that might minimize the trade-off between a subsequent explanatory versus pragmatic trial.ResultsThe feasibility study pointed to significant potential problems in relation to participant recruitment, features of the intervention, acceptability of the intervention to participants, and outcome measurement. Finding minimal evidence to support our decision-making regarding the transition from feasibility work to a trial, we developed a systematic process (A process for Decision-making after Pilot and feasibility Trials (ADePT)) which we subsequently used as a guide. The process sought to: 1) encourage the systematic identification and appraisal of problems and potential solutions; 2) improve the transparency of decision-making processes; and 3) reveal the tensions that exist between pragmatic and explanatory choices.ConclusionsWe have developed a process that may aid researchers in their attempt to identify the most appropriate solutions to problems identified within future pilot and feasibility RCTs. The process includes three key steps: a decision about the type of problem, the identification of all solutions (whether addressed within the intervention, trial design or clinical context), and a systematic appraisal of these solutions.

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

Health professionals’ perceptions of the barriers and facilitators to providing smoking cessation advice to women in pregnancy and during the post-partum period: a systematic review of qualitative research

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 (

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

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 (

Washout policies in long‐term indwelling urinary catheterization in adults: A short version cochrane review

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.

Barriers and facilitators to smoking cessation in pregnancy and in the post-partum period: The health care professionals’ perspective

BackgroundReducing smoking in pregnancy is a policy priority in many countries and as a result there has been a rise in the development of services to help pregnant women to quit. A wide range of professionals are involved in providing these services, with midwives playing a particularly pivotal role. Understanding professionals’ experiences of providing smoking cessation support in pregnancy can help to inform the design of interventions as well as to improve routine care.MethodsA synthesis of qualitative research of health professionals’ perceptions of the barriers and facilitators to providing smoking cessation advice to women in pregnancy and the post-partum period was conducted using meta-ethnography. Searches were undertaken from 1990 to January 2015 using terms for maternity health professionals and smoking cessation advisors, pregnancy, post-partum, smoking, and qualitative in seven electronic databases. The review was reported in accordance with the ‘Enhancing transparency in reporting the synthesis of qualitative research’ (ENTREQ) statement.ResultsEight studies reported in nine papers were included, reporting on the views of 190 health professionals/key informants, including 85 midwives and health visitors. The synthesis identified that both the professional role of participants and the organisational context in which they worked could act as either barriers or facilitators to an individual’s ability to provide smoking cessation support to pregnant or post-partum women. Underpinning these factors was an acknowledgment that the association between maternal smoking and social disadvantage was a considerable barrier to addressing and supporting smoking cessationConclusionsThe review identifies a role for professional education, both pre-qualification and in continuing professional development that will enable individuals to provide smoking cessation support to pregnant women. Key to the success of this education is recognising the centrality of the professional-client/patient relationship in any interaction. The review also highlights a widespread professional perception of the barriers associated with helping women give up smoking in pregnancy, particularly for those in disadvantaged circumstances. Improving the quality and accessibility of evidence on effective healthcare interventions, including evidence on ‘what works’ to support smoking cessation in disadvantaged groups, should therefore be a priority.PROSPERO 2013CRD42013004170.

Views on and experiences of electronic cigarettes: a qualitative study of women who are pregnant or have recently given birth

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

Financial Incentives for Smoking Cessation in Pregnancy: Randomized Controlled Trial

People requiring long‐term bladder draining with an indwelling catheter can experience catheter blockage. Regimens involving different solutions can be used to wash out catheters with the aim of preventing blockage.

Rewarding smoking cessation in pregnancy‐will women cheat to gain incentives?

Objectives Health care professionals and the health care environment play a central role in protecting pregnant and post‐partum women and their infants from smoking‐related harms. This study aimed to better understand the health professionals perspective on how interactions between women, health care professionals, and the environment influence how smoking is managed. Design Semi‐structured interviews and focus groups. Methods Data were from 48 health care staff involved in antenatal or post‐partum care at two UK sites, including midwives, obstetricians, health visitors, GPs, pharmacists, service commissioners, and Stop Smoking Service (SSS) advisors and managers. Thematic analysis was guided by a social–ecological framework (SEF). Results Themes were divided across three SEF levels and represented factors connected to the management of smoking in the health care context and the beliefs and behaviour of pregnant or post‐partum smokers. Organizational level: Service reconfigurations, ‘last resort’ nicotine replacement therapy prescribing policies, and non‐mandatory training were largely negative factors. There were mixed views on opt‐out referral pathways and positive views on carbon monoxide monitoring. Interpersonal level: Protection of client–professional relationships often inhibited frank discussions about smoking, and weak interservice relationships affected SSS referral motivation and quality. Individual level: Professionals felt community midwives had primary responsibility for managing smoking, although midwives felt underskilled doing this. Midwives’ perceived priority for addressing smoking was influenced by the demands from unrelated organizational initiatives. Conclusions Opportunities to improve clinical support for pregnant smokers exist at organizational, interservice, and health care professional levels. Interactions between levels reflect the importance of simultaneously addressing different level‐specific barriers to smoking cessation in pregnancy. Statement of contribution What is already known on this subject? Few health care professionals discuss smoking cessation support with pregnant or post‐partum women. Identified health care professional‐related barriers to supporting pregnant and post‐partum women to stop smoking include deficits in knowledge and confidence, perceived lack of time, and concerns about damaging client relationships. There is currently a gap in understanding regarding the barriers and facilitators to supporting this group and how interactions between the health care environment and health care professionals influence the way smoking is addressed. What does this study add? This study identifies modifiable factors that can influence cessation support delivery to pregnant and post‐partum women. These factors are mapped across organizational, interpersonal, and individual health care professional levels. Service structure, communication pathways, and policies appear to influence what cessation support is offered. Interpersonal and individual factors influence how this support is delivered.