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

2019 ◽  
Author(s):  
Lesley Sinclair ◽  
Margaret McFadden ◽  
Helen Tilbrook ◽  
Alex Mitchell ◽  
Ada Keding ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Birth Weight ◽  
Pregnant Women ◽  
Financial Incentives ◽  
Late Pregnancy ◽  
Cost Effective ◽  
Phase Iii ◽  
Pregnant Smokers ◽  
Randomised Controlled ◽  
The Uk

Abstract 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.

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

2019 ◽  
Author(s):  
Lesley Sinclair ◽  
Margaret McFadden ◽  
Helen Tilbrook ◽  
Alex Mitchell ◽  
Ada Keding ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Birth Weight ◽  
Attention Deficit Disorder ◽  
Financial Incentives ◽  
Late Pregnancy ◽  
Cost Effective ◽  
Phase Iii ◽  
Pregnant Smokers ◽  
Randomised Controlled ◽  
The Uk

Abstract 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

scholarly journals A protocol for the economic evaluation of the smoking Cessation in Pregnancy Incentives Trial III (CPIT III)

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e038827
Author(s):  
Nicola McMeekin ◽  
Lesley Sinclair ◽  
Linda Bauld ◽  
David Michael Tappin ◽  
Alex Mitchell ◽  
...  
Keyword(s):  
Economic Evaluation ◽  
Usual Care ◽  
Pregnant Women ◽  
Financial Incentives ◽  
Cost Effective ◽  
Good Opportunity ◽  
Link Type ◽  
The Uk ◽  
In Pregnancy

IntroductionSmoking results in an average 10-year loss of life, but smokers who permanently quit before age 40 can expect a near normal lifespan. Pregnancy poses a good opportunity to help women to stop; around 80% of women in the UK have a baby, most of whom are less than 40 years of age. Smoking prevalence during pregnancy is high: 17%–23% in the UK. Smoking during pregnancy causes low birth weight and increases the risk of premature birth. After birth, passive smoking is linked to sudden infant death syndrome, respiratory diseases and increased likelihood of taking up smoking. These risks impact the long-term health of the child with associated increase in health costs. Emerging evidence suggests that offering financial incentives to pregnant women to quit is highly cost effective.This protocol describes the economic evaluation of a multi-centre randomised controlled trial (Cessation in Pregnancy Incentives Trial III, CPIT III) designed to establish whether offering financial incentives, in addition to usual care, is effective and cost effective in helping pregnant women to quit.Methods and analysisThe economic evaluation will identify, measure and value resource use and outcomes from CPIT III, comparing participants randomised to either usual care or usual care plus up to £400 financial incentives. Within-trial and long-term analyses will be conducted from a National Health Service and Personal Social Services perspective; the outcome for both analyses will be quality adjusted life-years measured using EQ-5D-5L. Patient level data collected during the trial will be used for the within-trial analysis, with an additional outcome of cotinine validated quit rates at 34–38 weeks gestation and 6 months postpartum. The long-term model will be informed by data from the trial and published literature.Ethics and disseminationTrial registration numberISRCTN15236311; Pre-results (https://doi.org/10.1186/ISRCTN15236311).

Are financial incentives cost-effective for smoking cessation amongst pregnant women?

2014 ◽  
Vol 24 (suppl_2) ◽  
Author(s):  
KA Boyd ◽  
AH Briggs ◽  
L Bauld ◽  
L Sinclair ◽  
D Tappin
Keyword(s):  
Smoking Cessation ◽  
Pregnant Women ◽  
Financial Incentives ◽  
Cost Effective

scholarly journals Incentives for smoking cessation in pregnancy

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
D Tappin ◽  
L Bauld
Keyword(s):  
Health Care ◽  
Smoking Cessation ◽  
Health Care Workers ◽  
Financial Incentives ◽  
Financial Incentive ◽  
Late Pregnancy ◽  
Incentive Payment ◽  
Smoking During Pregnancy ◽  
Pregnant Smokers ◽  
Care Workers

Abstract Issue/problem Most pregnant smokers reply ‘Yes' when asked ‘Do you want to stop smoking?'. This is usually an honest answer but often without intention. About 10% who intend to quit are likely to attend smoking cessation services. Even with good quality counselling and the offer of nicotine replacement therapy only about 3-5% quit. How can the other 90% be reached? There are two approaches: Redirect counselling away from specialist cessation practitioners and build capacity among all health care workers. This is attractive spreading counselling to health care workers who meet pregnant smokers during routine consultations requiring little resource after training for example General Practitioners, Midwives and Obstetricians. However limited time for training and subsequent counselling endangers the quality and quantity of counselling delivered.Increase the proportion of women who intend to quit smoking during pregnancy by providing a financial incentive payment for engaging with specialist cessation practitioners and quitting. This policy allows counselling to be delivered by specialists and potentially draws in a larger proportion of pregnant smokers, as many as 50%. Results Financial incentives have increased the proportion of smokers who quit by late pregnancy in two large randomised controlled trials. The proportion increased by more than 100%. Local service pilots of financial incentives have seen marked increases in smokers who attend and quit. Lessons There are a number of ways to increase smoking cessation among pregnant women. Research evidence should be translated into effective service models to decide which strategy is most cost-effective. Key messages Counselling is important; however, it has to be sufficient and of good quality. Drawing more pregnant smokers into cessation services will increase the proportion who intend and manage to quit. This may work better than expecting all health care workers to give effective counselling.

Emotion Regulation Difficulties and Social Control Correlates of Smoking among Pregnant Women Trying to Quit

2018 ◽  
Author(s):  
Jennifer Fillo ◽  
Kimberly E. Kamper-DeMarco ◽  
Whitney C. Brown ◽  
Paul R. Stasiewicz ◽  
Clara M. Bradizza
Keyword(s):  
Smoking Cessation ◽  
Emotion Regulation ◽  
Negative Affect ◽  
Social Control ◽  
Pregnant Women ◽  
Nicotine Dependence ◽  
Low Income ◽  
Withdrawal Symptoms ◽  
Smoking During Pregnancy ◽  
Pregnant Smokers

Approximately 15% of US women currently smoke during pregnancy. An important step toward providing effective smoking cessation interventions during pregnancy is to identify individuals who are more likely to encounter difficulty quitting. Pregnant smokers frequently report smoking in response to intrapersonal factors (e.g., negative emotions), but successful cessation attempts can also be influenced by interpersonal factors (i.e., influence from close others). This study examined the association between emotion regulation difficulties, positive and negative social control (e.g., encouragement, criticism), and smoking cessation-related variables (i.e., smoking quantity, withdrawal symptoms) among pregnant smokers. Data were drawn from the pretreatment wave of a smoking cessation trial enrolling low-income pregnant women who self-reported smoking in response to negative affect (N = 73). Greater emotion regulation difficulties were related to greater smoking urges (b = 0.295, p = .042) and withdrawal symptoms (b = 0.085, p = .003). Additionally, more negative social control from close others was related to fewer smoking days (b = -0.614, p = .042) and higher smoking abstinence self-efficacy (b = 0.017, p = .002). More positive social control from close others interacted with negative affect smoking (b = -0.052, p = .043); the association between negative affect smoking and nicotine dependence (b = 0.812, p &lt; .001) only occurred at low levels of positive social control. Findings suggest that emotion regulation difficulties may contribute to smoking during pregnancy by exacerbating women's negative experiences related to smoking cessation attempts. Negative social control was related to lower smoking frequency and greater confidence in quitting smoking, suggesting that it may assist pregnant smokers' cessation efforts. Positive social control buffered women from the effects of negative affect smoking on nicotine dependence.

Financial incentives for smoking cessation during pregnancy: a randomised controlled trial

The Lancet ◽  
2014 ◽  
Vol 384 ◽  
pp. S4 ◽  
Author(s):  
David Tappin ◽  
Linda Bauld ◽  
David Purves ◽  
Kathleen Boyd ◽  
Lesley Sinclair ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Randomised Controlled Trial ◽  
Financial Incentives ◽  
Controlled Trial ◽  
Randomised Controlled

miR-27b-3p is highly expressed in serum of patients with preeclampsia and has clinical significance

2021 ◽  
Vol 21 ◽  
Author(s):  
Yang Yang ◽  
Fang Tang ◽  
Xuezhi Zhao
Keyword(s):  
Blood Pressure ◽  
Birth Weight ◽  
Serum Creatinine ◽  
Pregnant Women ◽  
Clinical Significance ◽  
Roc Curve ◽  
Late Pregnancy ◽  
Healthy Controls ◽  
Urine Protein ◽  
Fetal Birth Weight

Background: Preeclampsia (PE) is defined as a salient complication of late pregnancy. microRNAs (miRNAs) have emerged as critical biological regulators in PE. This study determined miR-27b-3p expression in serum of PE patients and investigated its clinical significance in PE. Methods: Totally 130 pregnant women including 90 PE patients (51 mild PE and 39 severe PE) and 40 healthy controls were enrolled in this study. miR-27b-3p expression in the serum of PE patients and healthy controls was detected using RT-qPCR. The correlation among miR-27b-3p expression and 24-h urine protein, systolic blood pressure (SBP), diastolic blood pressure (DBP), serum creatinine, and fetal birth weight was analyzed using Pearson's correlation coefficient. The targeting relationship between miR-27b-3p and PPARG was verified. PPARG protein level in PE patients was detected using ELISA kits. The predictive efficiency of miR-27b-3p and PPARG in PE was analyzed using the receiver operating characteristic (ROC) curve. Results: Compared to normal pregnant women, PE pregnant women, especially severe PE patients had higher miR-27b-3p expression. miR-27b-3p was positively correlated with 24-h urine protein, SBP, DBP, and serum creatinine, but negatively correlated with fetal birth weight. PPARG was poorly expressed in PE patients and negatively correlated with miR-27b-3p. ROC curve showed that both miR-27b-3p and PPARG had good predictive efficacy on PE. Conclusion: miR-27b-3p expression in serum of pregnant women with PE was positively correlated with the severity of PE symptoms, suggesting the involvement of miR-27b-3p in PE occurrence.

scholarly journals Financial incentives for smoking cessation in pregnancy: randomised controlled trial

BMJ ◽  
2015 ◽  
Vol 350 (jan27 4) ◽  
pp. h134-h134 ◽  
Author(s):  
D. Tappin ◽  
L. Bauld ◽  
D. Purves ◽  
K. Boyd ◽  
L. Sinclair ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Randomised Controlled Trial ◽  
Financial Incentives ◽  
Controlled Trial ◽  
Randomised Controlled ◽  
In Pregnancy

scholarly journals Cost-effectiveness of sacubitril/valsartan in the treatment of heart failure with reduced ejection fraction

Heart ◽  
2017 ◽  
Vol 104 (12) ◽  
pp. 1006-1013 ◽  
Author(s):  
John J V McMurray ◽  
David Trueman ◽  
Elizabeth Hancock ◽  
Martin R Cowie ◽  
Andrew Briggs ◽  
...  
Keyword(s):  
Heart Failure ◽  
Sensitivity Analysis ◽  
Cost Effectiveness ◽  
Ejection Fraction ◽  
Willingness To Pay ◽  
Cost Effective ◽  
Phase Iii ◽  
Reduced Ejection Fraction ◽  
The Uk ◽  
The Cost

ObjectiveChronic heart failure with reduced ejection fraction (HF-REF) represents a major public health issue and is associated with considerable morbidity and mortality. We evaluated the cost-effectiveness of sacubitril/valsartan (formerly LCZ696) compared with an ACE inhibitor (ACEI) (enalapril) in the treatment of HF-REF from the perspective of healthcare providers in the UK, Denmark and Colombia.MethodsA cost-utility analysis was performed based on data from a multinational, Phase III randomised controlled trial. A decision-analytic model was developed based on a series of regression models, which extrapolated health-related quality of life, hospitalisation rates and survival over a lifetime horizon. The primary outcome was the incremental cost-effectiveness ratio (ICER).ResultsIn the UK, the cost per quality-adjusted life-year (QALY) gained for sacubitril/valsartan (using cardiovascular mortality) was £17 100 (€20 400) versus enalapril. In Denmark, the ICER for sacubitril/valsartan was Kr 174 000 (€22 600). In Colombia, the ICER was COP$39.5 million (€11 200) per QALY gained. Deterministic sensitivity analysis showed that results were most sensitive to the extrapolation of mortality, duration of treatment effect and time horizon, but were robust to other structural changes, with most scenarios associated with ICERs below the willingness-to-pay threshold for all three country settings. Probabilistic sensitivity analysis suggested the probability that sacubitril/valsartan was cost-effective at conventional willingness-to-pay thresholds was 68%–94% in the UK, 84% in Denmark and 95% in Colombia.ConclusionsOur analysis suggests that, in all three countries, sacubitril/valsartan is likely to be cost-effective compared with an ACEI (the current standard of care) in patients with HF-REF.

scholarly journals Medicaid Coverage of Smoking Cessation Counseling and Medication Is Underutilized for Pregnant Women

2017 ◽  
Vol 19 (5) ◽  
pp. 656-659 ◽  
Author(s):  
Taneisha S. Scheuermann ◽  
Kimber P. Richter ◽  
Lisette T. Jacobson ◽  
Theresa I. Shireman
Keyword(s):  
Smoking Cessation ◽  
Pregnant Women ◽  
Replacement Therapy ◽  
Nicotine Replacement Therapy ◽  
Claims Data ◽  
Evidence Based ◽  
Smoking Cessation Counseling ◽  
Smoking Cessation Treatment ◽  
Pregnant Smokers ◽  
Cessation Treatment

Abstract Introduction: Policies to promote smoking cessation among Medicaid-insured pregnant women have the potential to assist a significant proportion of pregnant smokers. In 2010, Kansas Medicaid began covering smoking cessation counseling for pregnant smokers. Our aim was to evaluate the use of smoking cessation benefits provided to pregnant women as a result of the Kansas Medicaid policy change that provided reimbursement for physician-provided smoking cessation counseling. Methods: We examined Kansas Medicaid claims data to estimate rates of delivery of smoking cessation treatment to Medicaid-insured pregnant women in Kansas from fiscal year 2010 through 2013. We analyzed the number of pregnant women who received physician-provided smoking cessation counseling indicated by procedure billing codes (ie, G0436 and G0437) and medication (ie, nicotine replacement therapy, bupropion, or varenicline) located in outpatient managed care encounter and fee-for-service claims data. We estimated the number of Medicaid-insured pregnant smokers using the national smoking prevalence (14%) in this population and the number of live births reported in Kansas. Results: Annually from 2010 to 2013, approximately 27.2%–31.6% of pregnant smokers had claims for nicotine replacement therapy, bupropion, or varenicline. Excluding claims for bupropion, a medication commonly prescribed to treat depression, claims ranged from 9.3% to 11.1%. Following implementation of Medicaid coverage for smoking cessation counseling, less than 1% of estimated smokers had claims for counseling. Conclusions: This low claims rate suggests that simply changing policy is not sufficient to ensure use of newly implemented benefits, and that there probably remain critical gaps in smoking cessation treatment. Implications: This study evaluates the use of Medicaid reimbursement for smoking cessation counseling among low-income pregnant women in Kansas. We describe the Medicaid claims rates of physician-provided smoking cessation counseling for pregnant women, an evidence-based and universally recommended treatment approach for smoking cessation in this population. Our findings show that claims rates for smoking cessation benefits in this population are very low, even after policy changes to support provision of cessation assistance were implemented. Additional studies are needed to determine whether reimbursement is functioning as intended and identify potential gaps between policy and implementation of evidence-based smoking cessation treatment.

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