Birth weight differences between those offered financial voucher incentives for verified smoking cessation and control participants enrolled in the Cessation in Pregnancy Incentives Trial (CPIT), employing an intuitive approach and a Complier Average Causal Effects (CACE) analysis

McConnachie, Alex; Haig, Caroline; Sinclair, Lesley; Bauld, Linda; Tappin, David

doi:10.1186/s13063-017-2053-x

Cited by 11 publications

(9 citation statements)

References 15 publications

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“…Randomized studies have shown that cooperation and to improve results so far, the only intervention, the financial incentive ["cash incentive"] proved to be the most effective in case of pregnant women in under developed areas [23]. Recently the CPIT trial proved that with offered financial incentives for smoking cessation during pregnancy showed a clinically and statistically significant improvement in cessation among pregnant women [24]. We are aware of the fact that, after cessation of smoking perinatal outcomes have shown slight improvement [25].…”

Section: Discussionmentioning

confidence: 99%

Intrauterine Deaths in North-Eastern Hungary with National and International Comparison

Jashanjeet

Juhász

Tóth

et al. 2018

JPMC

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Objective: Demographic analysis of intrauterine deaths in North-Eastern Hungary with national and international comparison. Materials and methods:The authors collected data from the National Bureau of Statistics' 1996Statistics' -2014 database to assess frequency, gestational age, maternal age and education for six counties of the region. 722 individual cases were analyzed. A regional survey was initiated to collect more detailed data on living environment in the region between 2010 and 2014 through community midwifery services records. Results: Data over 20 years showed most intrauterine deaths [Perinatal mortality, Late fetal death, Stillbirth]occurred between 24th and 36th weeks of which 35% occurred in the North-Eastern region of Hungary. The causes of intrauterine deaths were placental abruption, cord accident, placental insufficiency, malformations and intrauterine infection. Detailed analysis regarding attendance at either the Obstetricians or the community midwifery services, the patient's medical history and the patients' compliance were reported, compliance in 1% completely lacked. Gravidity and multiparity were associated risk factors. A significant proportion was associated with teenage pregnancy, low maternal education, smoking risks, unemployment, dependence on social support, unhygienic environment and smaller accommodations. Lack of cooperation during antenatal care was significant. Conclusion:Frequency and distribution of intrauterine deaths in North-Eastern Hungary show a similar picture as those of socio-economic indices. The unfavorable trend came to an end in 2015, however the national statistics did not show any improvement. The solution to the problem seems to be independent of the service provision, therefore, socio-economic development of affected counties is warranted, and financial incentives and/or government aid provided during pregnancy may improve future perinatal outcomes.

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Section: Discussionmentioning

confidence: 99%

Intrauterine Deaths in North-Eastern Hungary with National and International Comparison

Jashanjeet

Juhász

Tóth

et al. 2018

JPMC

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“…The intention-to-treat estimate will be severely diluted due to low smoking cessation rates and the 'per protocol' analysis will be biased by confounding. Consequently, we will also utilise an instrumental variable approach-complier average causal effect analysiswhich will estimate the true impact of incentive-induced smoking cessation on birth weight [35].…”

Section: Secondary Outcome Analysismentioning

confidence: 99%

The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial

Sinclair

McFadden²,

Tilbrook

et al. 2020

Trials

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Background: Eighty per cent of UK women have at least one baby, making pregnancy an opportunity to help women stop smoking before their health is irreparably compromised. Smoking cessation during pregnancy helps protect infants from miscarriage, still birth, low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. UK national guidelines highlight lack of evidence for effectiveness of financial incentives to help pregnant smokers quit. This includes a research recommendation: within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Methods: The Cessation in Pregnancy Incentives Trial (CPIT) III is a pragmatic, 42-month, multi-centre, parallelgroup, individually randomised controlled superiority trial of the effect on smoking status of adding to usual Stop Smoking Services (SSS) support, the offer of up to £400 of financial voucher incentives, compared with usual support alone, to quit smoking during pregnancy. Participants (n = 940) are pregnant smokers (age > 16 years, < 24 weeks pregnant, English speaking), who consent via telephone to take part and are willing to be followed-up in late pregnancy and 6 months after birth. The primary outcome is cotinine/anabasine-validated abstinence from smoking in late pregnancy. Secondary outcomes include engagement with SSS, quit rates at 4 weeks from agreed quit date and 6 months after birth, and birth weight. Outcomes will be analysed by intention to treat, and regression models will be used to compare treatment effects on outcomes. A meta-analysis will include data from the feasibility study in Glasgow. An economic evaluation will assess cost-effectiveness from a UK NHS perspective. Process evaluation using a casestudy approach will identify opportunities to improve recruitment and learning for future implementation. Research questions include: what is the therapeutic efficacy of incentives; are incentives cost-effective; and what are the potential facilitators and barriers to implementing incentives in different parts of the UK? Discussion: This phase III trial in Scotland, England and Northern Ireland follows a successful phase II trial in Glasgow, UK. The participating sites have diverse SSS that represent most cessation services in the UK and serve demographically varied populations. If found to be acceptable and cost-effective, this trial could demonstrate that financial incentives are effective and transferable to most UK SSS for pregnant women.

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“…The intention to treat estimate will be severely diluted due to low smoking cessation rates and the 'per protocol' analysis will be biased by confounding. Consequently we will also utilise an instrumental variable approach-Complier Average Causal Effect analysis-which will estimate the true impact of incentive inducted smoking cessation on birth weight [35].…”

Section: Secondary Outcome Analysismentioning

confidence: 99%

The Smoking Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a phase III randomised controlled trial

Sinclair

McFadden

Tilbrook

et al. 2019

Preprint

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Background Eighty percent of UK women have at least one baby, making pregnancy an opportunity to help women to stop smoking before their health is irreparably compromised. Smoking cessation during pregnancy helps protect infants from miscarriage, still birth, low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. UK national guidelines highlight lack of evidence for effectiveness of financial incentives to help pregnant smokers quit. This includes a research recommendation: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Methods CPIT III is a pragmatic, 39-month, multi-centre, parallel group, individually randomised controlled superiority trial of the effect on smoking status of adding to usual smoking cessation support the offer of up to £400 of financial voucher incentives, compared with usual support alone, to quit smoking during pregnancy. Participants (n = 940) are pregnant smokers (age > 16, <24 weeks pregnant, English speaking), who consent via telephone to take part and are willing to be followed-up in late pregnancy and 6 months after birth. The primary outcome is cotinine/anabasine validated abstinence from smoking in late pregnancy. Secondary outcomes include engagement with cessation services, quit rates at four weeks from agreed quit date and 6 months after birth, and birth weight. Outcomes will be analysed by intention-to-treat, and regression models will be used to compare treatment effects on outcomes. A meta-analysis will include data from the feasibility study in Glasgow. An economic evaluation will assess cost-effectiveness from a UK NHS perspective. Process evaluation using a case study approach will identify opportunities to improve recruitment and learning for future implementation. Research questions: What is the therapeutic efficacy of incentives? Are incentives cost-effective? What are the potential facilitators and barriers to implementing incentives in different parts of the UK? Discussion This phase III trial in Scotland, England and Northern Ireland, follows a successful phase II trial in Glasgow UK. The participating sites have diverse smoking cessation services, that represent most cessation services in the UK and serve demographically varied populations. If found to be acceptable and cost-effective this trial could demonstrate that financial incentives are effective and transferable to most UK cessation services for pregnant women.Trial registrationCurrent Controlled Trials ISRCTN15236311 date registered 09/10/2017 https://doi.org/10.1186/ISRCTN15236311

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Birth weight differences between those offered financial voucher incentives for verified smoking cessation and control participants enrolled in the Cessation in Pregnancy Incentives Trial (CPIT), employing an intuitive approach and a Complier Average Causal Effects (CACE) analysis

Cited by 11 publications

References 15 publications

Intrauterine Deaths in North-Eastern Hungary with National and International Comparison

Intrauterine Deaths in North-Eastern Hungary with National and International Comparison

The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial

The Smoking Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a phase III randomised controlled trial

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