Andrew Radley

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.

Give It Up For Baby: outcomes and factors influencing uptake of a pilot smoking cessation incentive scheme for pregnant women

BackgroundThe use of incentives to promote smoking cessation is a promising technique for increasing the effectiveness of interventions. This study evaluated the smoking cessation outcomes and factors associated with success for pregnant smokers who registered with a pilot incentivised smoking cessation scheme in a Scottish health board area (NHS Tayside).MethodsAll pregnant smokers who engaged with the scheme between March 2007 and December 2009 were included in the outcome evaluation which used routinely collected data. Data utilised included: the Scottish National Smoking Cessation Dataset; weekly and periodic carbon monoxide (CO) breath tests; status of smoking cessation quit attempts; and amount of incentive paid. Process evaluation incorporated in-depth interviews with a cross-sectional sample of service users, stratified according to level of engagement.ResultsQuit rates for those registering with Give It Up For Baby were 54% at 4 weeks, 32% at 12 weeks and 17% at 3 months post partum (all data validated by CO breath test). Among the population of women identified as smoking at first booking over a one year period, 20.1% engaged with Give It Up For Baby, with 7.8% of pregnant smokers quit at 4 weeks. Pregnant smokers from more affluent areas were more successful with their quit attempt. The process evaluation indicates financial incentives can encourage attendance at routine advisory sessions where they are seen to form part of a wider reward structure, but work less well with those on lowest incomes who demonstrate high reliance on the financial reward.ConclusionsUptake of Give It Up For Baby by the target population was higher than for all other health board areas offering specialist or equivalent cessation services in Scotland. Quit successes also compared favorably with other specialist interventions, adding to evidence of the benefits of incentives in this setting. The process evaluation helped to explain variations in retention and quit rates achieved by the scheme.This study describes a series of positive outcomes achieved through the use of incentives to promote smoking cessation amongst pregnant smokers.

A hard pill to swallow: a qualitative study of women's experiences of adjuvant endocrine therapy for breast cancer

Objective To explore womens experiences of taking adjuvant endocrine therapy as a treatment for breast cancer and how their beliefs about the purpose of the medication, side effects experienced and interactions with health professionals might influence adherence. Design Qualitative study using semistructured, one-to-one interviews. Setting 2 hospitals from a single health board in Scotland. Participants 30 women who had been prescribed tamoxifen or aromatase inhibitors (anastrozole or letrozole) and had been taking this medication for 1–5 years. Results Women clearly wished to take their adjuvant endocrine therapy medication as prescribed, believing that it offered them protection against breast cancer recurrence. However, some women missed tablets and did not recognise that this could reduce the efficacy of the treatment. Women did not perceive that healthcare professionals were routinely or systematically monitoring their adherence. Side effects were common and impacted greatly on the women’s quality of life but did not always cause women to stop taking their medication, or to seek advice about reducing the side effects they experienced. Few were offered the opportunity to discuss the impact of side effects or the potential options available. Conclusions Although most women in this study took adjuvant endocrine therapy as prescribed, many endured a range of side effects, often without seeking help. Advice, support and monitoring for adherence are not routinely offered in conventional follow-up settings. Women deserve more opportunity to discuss the pros, cons and impact of long-term adjuvant endocrine therapy. New service models are needed to support adherence, enhance quality of life and ultimately improve survival. These should ideally be community based, in order to promote self-management in the longer term.

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

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

DOT-C: A cluster randomised feasibility trial evaluating directly observed anti-HCV therapy in a population receiving opioid substitute therapy from community pharmacy

BACKGROUND Direct-acting antiviral therapy (DAAs) for hepatitis C infection (HCV) have a much smaller burden of treatment than interferon-based regimes, require less monitoring and are very effective. New pathways are required to increase access to treatment amongst people prescribed opioid substitution therapy (OST). METHODS An exploratory cluster randomised controlled trial with mixed methods evaluation was undertaken to compare the uptake of dried blood spot testing (DBST) and treatment of people with genotype 1 HCV infection in a conventional service pathway versus a pharmacist-led pathway in a population receiving OST. RESULTS Pharmacies randomised to the conventional pathway obtained 58 DBST from 244 patients (24%):15 new reactive tests and 33 new negative tests were identified. Within the pharmacist-led pathway, 94 DBST were obtained from 262 patients (36%): 26 new reactive tests and 54 new negative tests were identified. Participants in the pharmacist-led pathway were more likely to take a DBST (p<0.003). Of participants referred for treatment through the conventional pathway, 4 patients from 15 with new reactive tests (27%) attended clinic for assessment. In the pharmacist-led treatment pathway, 20 patients from 26 with new reactive tests (77%) attended for assessment blood tests. Participants in the pharmacist-led pathway were more likely to proceed through the assessment for treatment (p<0.002). One participant completed treatment through the conventional pathway and three patients completed treatment through the pharmacist-led pathway. The process evaluation identified key themes important to service user completers and staff participants. CONCLUSION The study provides evidence that testing and treatment for HCV in a pharmacist led-pathway is a feasible treatment pathway for people who receive supervised OST consumption through community pharmacies. This feasibility trial therefore provides sufficient confirmation to justify proceeding to a full trial.

Paying the price for an incentive: An exploratory study of smokers’ reasons for failing to complete an incentive based smoking cessation scheme:

Objectives: In 2009, one Scottish region launched a smoking cessation programme offering a weekly financial incentive of £12.50 over a 12-week period. However, a significant proportion of registered participants dropped out of the programme, some even failing to collect the financial reward they were owed. We explore reasons for disengagement and failure to re-engage within this group. Method: Individuals (n =14) were interviewed in depth. Transcripts from recorded interviews formed the dataset and were analysed using the “Framework” method. Results: Incentives appeared to introduce a potential change/reversal in the felt contractual relationship between service provider and client: the client was now the provider and being paid to quit. This led to an increased sense of obligation towards the service, and enhanced feelings of failure, guilt and shame post-relapse, and reluctance to continue engagement or re-engagement. Other service factors promoting disengagement included issues of practical delivery through location, timing, administrative burden and incentive preference. Conclusion: The future design of incentive-based schemes should be cognisant of the potential impact on the client-professional relationship. Increasing the value of the incentive may overcome clients’ antipathy towards bureaucracy and monitoring, but may simultaneously exacerbate the sense of failure and resultant stigma associated with relapse. It may be more cost-effective to reduce barriers/costs such as inconvenience, lack of privacy, timing and embarrassment of association of attendance at the pharmacy with methadone use. Alternatively, risks may be managed by reframing weekly rewards as three separate month-long stages, increasing a sense of achievement that a particular stage has been achieved before any relapse.

A quasi-experimental evaluation of dried blood spot testing through community pharmacies in the Tayside region of Scotland

Objective Comparison of uptake of dried blood spot testing (DBST) for hepatitis C virus (HCV) infection between community pharmacies and established services. Design Quantitative evaluation of a service development with qualitative process evaluation undertaken in parallel. Setting Six pharmacies from 36 community pharmacies within Dundee City, a large urban settlement with high levels of socioeconomic deprivation. Participants Patients in receipt of opioid substitution therapy (OST) not tested for HCV within 12 months. The 6 pharmacies provided OST for approximately 363 patients from a cohort of 1385 patients within Dundee City. Intervention Provision of DBST by pharmacists. Main outcome measure Receipt of DBST between January and December 2014. Results 43 of 143 service users with no record of testing from the 6 community pharmacies accepted DBST. Of 561 from the remaining 1022 service users with no record of testing, 75 were tested for HCV (30% vs 13%). The OR for increased uptake of testing within the 6 pharmacies was 2.25 (95% CI 1.48 to 3.41, Z statistic=3.81, p=<0.0001) compared with other services. The DBST taken by the pharmacies provided 12 patients with a reactive test. The process evaluation identified key themes important to staff and recipients of the service. A logic model was constructed. Limitations Non-experimental service evaluation performed in community pharmacies records service activity in one location across a single time period. Interpretation Some evidence that DBST from community pharmacies may be feasible. Service users received the service positively. Staff reported that DBST was straightforward and achievable.

Pharmaceutical care of older people: what do older people want from community pharmacy?

To explore older peoples opinions of current community pharmacy provision and identify potential areas for improvement.

A systematic review of grandparents' influence on grandchildren's cancer risk factors

Many lifestyle patterns are established when children are young. Research has focused on the potential role of parents as a risk factor for non communicable disease in children, but there is limited investigation of the role of other caregivers, such as grandparents. The aim of this review was to identify and synthesise evidence for any influence grandparents’ care practices may have on their grandchildren’s long term cancer risk factors. A systematic review was carried out with searches across four databases (MEDLINE, Embase, Web of Science, PsycINFO) as well as searches of reference lists and citing articles, and Google Scholar. Search terms were based on six areas of risk that family care could potentially influence–weight, diet, physical activity, tobacco, alcohol and sun exposure. All study designs were included, as were studies that provided an indication of the interaction of grandparents with their grandchildren. Studies were excluded if grandparents were primary caregivers and if children had serious health conditions. Study quality was assessed using National Institute for Health and Care Excellence checklists. Grandparent impact was categorised as beneficial, adverse, mixed or as having no impact. Due to study heterogeneity a meta-analysis was not possible. Qualitative studies underwent a thematic synthesis of their results. Results from all included studies indicated that there was a sufficient evidence base for weight, diet, physical activity and tobacco studies to draw conclusions about grandparents’ influence. One study examined alcohol and no studies examined sun exposure. Evidence indicated that, overall, grandparents had an adverse impact on their grandchildren’s cancer risk factors. The theoretical work in the included studies was limited. Theoretically underpinned interventions designed to reduce these risk factors must consider grandparents’ role, as well as parents’, and be evaluated robustly to inform the evidence base further.

‘Standing Outside the Junkie Door’—service users’ experiences of using community pharmacies to access treatment for opioid dependency

Aim To explore experiences of service users attending a community pharmacy to receive opiate replacement therapy (ORT). Method Qualitative study involving seven focus groups undertaken within care centres and prison educational centre in Tayside, Scotland using 41 participants. Thematic analysis undertaken of experiences of different groups of service users and carers. Results Participants described the social context surrounding attendance at community pharmacies. Their voices suggested that people prescribed ORT may be treated differently from others accessing care through pharmacies. Participants felt they experienced stigma and discriminatory practices in pharmacies, elsewhere within the healthcare environment, and more generally in society. Participants explained that the way services were organized in pharmacies often denied them the right to confidentiality. However, there were positive experiences of care. The discriminating factor between good and bad experiences was being treated with dignity and respect. Conclusion Participants readily identified examples of poor experiences and of stigma and discrimination, yet valued positive relationships with their pharmacy. Constructive attitudes of pharmacy staff and the ability to form positive relationships improved their experience. The social exclusion delivered through stigmatization mitigates against delivery of a recovery agenda and contributes to health inequalities experienced by this marginalized group.