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Erasmus MC – Sophia Children’s Hospital, University Medical Centre Rotterdam, Department of Obstetrics and Gynaecology
Corresponding Author: Leonieke J. Breunis, MD, Room EE-2130, Erasmus MC, Wytemaweg 80, 3015 CN Rotterdam, The Netherlands. Telephone: 31-107-030-229; E-mail: l.breunis@erasmusmc.nl
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Erasmus MC – Sophia Children’s Hospital, University Medical Centre Rotterdam, Department of Obstetrics and Gynaecology
Erasmus MC – Sophia Children’s Hospital, University Medical Centre Rotterdam, Department of Paediatrics, Division of Neonatology
Erasmus MC – University Medical Centre Rotterdam, Department of Public Health
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Erasmus MC – Sophia Children’s Hospital, University Medical Centre Rotterdam, Department of Obstetrics and Gynaecology
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Erasmus MC – University Medical Centre Rotterdam, Department of Medical Ethics and Philosophy of Medicine
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Erasmus MC – Sophia Children’s Hospital, University Medical Centre Rotterdam, Department of Obstetrics and Gynaecology
University Medical Centre Groningen, University of Groningen, Department of Health Sciences
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Nicotine & Tobacco Research, Volume 22, Issue 9, September 2020, Pages 1553–1559, https://doi.org/10.1093/ntr/ntz231
Leonieke J Breunis, MD, Jasper V Been, PhD, Lieke de Jong-Potjer, PhD, Eric Ap Steegers, PhD, Inez D de Beaufort, PhD, Marlou La de Kroon, PhD, Hafez Ismaili M’hamdi, PhD, Incentives for Smoking Cessation During Pregnancy: An Ethical Framework, Nicotine & Tobacco Research, Volume 22, Issue 9, September 2020, Pages 1553–1559, https://doi.org/10.1093/ntr/ntz231
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Smoking during pregnancy increases the risk of morbidity and mortality of the mother and child. The inability of the unborn child to protect itself, raises the social and academic responsibility to protect the child from the harmful effects of smoking. Interventions including rewards (incentives) for lifestyle changes are an upcoming trend and can encourage women to quit smoking. However, these incentives can, as we will argue, also have negative consequences, for example the restriction of personal autonomy and encouragement of smoking to become eligible for participation. To prevent these negative consequences, we developed an ethical framework that enables to assess and address unwanted consequences of incentive-based interventions whereby moral permissibility can be evaluated.
The possible adverse consequences of incentives were identified through an extensive literature search. Subsequently, we developed ethical criteria to identify these consequences based on the biomedical ethical principles of Beauchamp and Childress.
Our framework consists of 12 criteria. These criteria concern (1) effectiveness, (2) support of a healthy lifestyle, (3) motivational for the target population, (4) stimulating unhealthy behavior, (5) negative attitudes, (6) personal autonomy, (7) intrinsic motivation, (8) privacy, (9) fairness, (10) allocation of incentives, (11) cost-effectiveness, and (12) health inequity. Based on these criteria, the moral permissibility of potential interventions can be evaluated.
Incentives for smoking cessation are a response to the responsibility to protect the unborn child. But these interventions might have possible adverse effects. This ethical framework aims to identify and address ethical pitfalls in order to avoid these adverse effects.
Although various interventions to promote smoking cessation during pregnancy exist, many women still smoke during pregnancy. Interventions using incentives for smoking cessation during pregnancy are a promising and upcoming trend but can have unwanted consequences. This ethical framework helps to identify and address ethical pitfalls in order to avoid these adverse effects.
It can be a practical tool in the development and evaluation of these interventions and in evaluating the moral permissibility of interventions using incentives for smoking cessation during pregnancy.
Smoking is a major global public health problem that often continues during pregnancy.1 The prevalence of smoking during pregnancy ranges from 0.8% in the African region to 8.1% in the European region, making it a worldwide problem.2 Smoking during pregnancy is not only associated with maternal health risks, but also with mortality and morbidity of the (unborn) child, including preterm delivery and a low birth weight.3–5 In addition, maternal smoking is associated with health problems of the child in later life, including asthma,6 respiratory infections,7 and cancer.8 Although smoking cessation during pregnancy improves perinatal outcomes,9 only half of all regular smokers successfully quit smoking during pregnancy.2 Encouraging the mother to stop smoking therefore has the potential to significantly decrease the risk of adverse health outcomes for the mother and child. Because smoking during pregnancy carries a major public health burden with consequences for the mother and her (unborn) child the social and academic responsibility to protect the (unborn) child is clear and action must be taken.10
Currently, various interventions exist to promote smoking cessation during pregnancy. Although psychosocial interventions and additional nicotine replacement therapy increase the chance of successful cessation,11,12 many women are unable to quit smoking despite these interventions. Therefore, there is a need to develop new smoking cessation interventions tailored to pregnant women.
In recent years, a number of studies investigated whether women can be encouraged to quit smoking during pregnancy by offering them incentives (ie rewards for a specific goal with the purpose to motivate).13,14 Examples of such incentives are cash payments, vouchers exchangeable for (luxury) goods, and salary bonuses.13 Some randomized controlled studies in this area have found promising results in terms of sustained smoking cessation by the end of pregnancy and postpartum.14–16 A recent Cochrane review concluded that the relative risk of smoking abstinence is 2.79 [95% confidence interval 2.10–3.72] at the end of pregnancy and 2.38 [95% confidence interval 1.51–3.69] at longest follow-up (up to 24 weeks postpartum) in favor of incentives.13 Despite these promising results, critics express several issues concerning the use of incentives, such as a potential coercive character,17 the risk of cheating,17 and that they might be considered unfair to people who do not smoke in the first place.18 Because of these potential unintended adverse consequences, we believe an ethical framework may be helpful to identify and address these adverse consequences when designing interventions in this area.
An ethical framework is a systematic categorization of criteria that can be used to determine whether the intervention under scrutiny—in this case incentives for smoking cessation during pregnancy—is morally permissible. We aimed to develop such a framework that can be used as a tool to identify and address ethical pitfalls in order to avoid unintended adverse consequences of incentives aimed at encouraging women to stop smoking during pregnancy.
We performed three semi-structured searches in Pubmed to identify literature broadly relevant to the topic of our framework. Semi-structured searches are more pragmatic than systematic searches used for systematic reviews, less firmly bound by rules and offer the possibility to gain broader knowledge on different subtopics of a main subject.
First, we identified articles concerning the predictors and consequences of smoking and smoking cessation during pregnancy using the following search equation: “(smoke [tiab] OR smoking [tiab]) AND (cessation [tiab] OR quit* [tiab]) AND (pregnan* [tiab] OR fetus [tiab] OR child [tiab] OR perinatal [tiab]) AND (health [tiab] OR risk [tiab] OR birth outcomes [tiab])”.
Secondly, we searched for current research on incentives for smoking cessation during pregnancy using the following search equation: “(smoking [tiab] OR smoke [tiab]) AND pregnan* [tiab] AND (incentive OR reward)”. In addition, we searched systematic reviews on the topic in the Cochrane Library with the terms “smoking” and “pregnancy”. Thirdly, we searched for articles about moral concerns and moral strengths of interventions using incentives for smoking cessation during pregnancy with the following search equation: “(barrier* [tiab] OR pitfall* [tiab] OR problem* [tiab] OR consequence* [tiab] OR concern* [tiab] OR moral [tiab] OR ethic* [tiab] OR facilitator* [tiab]) AND (smoking [tiab] OR smoke [tiab]) AND pregnan* [tiab]”. We did not search for ongoing trials in different databases because these registrations often lack a detailed description of the intervention relevant to allow proper assessment of ethical aspects. The articles that were identified via these searches and used to inform the framework are described in eTable 1, available at Nicotine and Tobacco Research online. Sometimes clarification was needed on certain topics (eg biochemical validation) and additional non-structured searches were performed. We refer to the literature retrieved from these searches in the text.
We explored differences between the interventions, and moral strengths and weaknesses of the interventions. These differences entailed a wide range of details of the study approach and intervention, such as recruitment method, incentive scheme used, and the target population. LB listed these aspects and categorized the moral strengths and weaknesses regarding differences in these aspects between the studies. We used the frameworks of ten Have M et al.19 and Kass20 as guidelines for exploring moral strengths and weaknesses. The framework of ten Have et al. provides a tool for exploring ethical pitfalls in programs for the prevention of overweight and obesity. The ethical principles are similar to some ethical principles within interventions for smoking cessation during pregnancy. The framework of Kass provides a tool for ethics analysis of public health programs in general. We categorized the moral strengths and weaknesses by applying the ethical principles of Beauchamp and Childress,21 which are generally accepted as the overarching ethical principles of biomedical research.20,22 The four principles are beneficence, nonmaleficence, respect for autonomy and justice. A detailed explanation of each principle is stated below. Although there is an abundance of ethical principles available within the domain of bioethics these principles can always be subsumed under one of the four principles of Beauchamp of Childress.
Moral strengths and weaknesses were translated to criteria that can be used to evaluate moral permissibility of an intervention that uses incentives to encourage women to quit smoking during pregnancy. The criteria were developed by LB, JB, and HM. We present our results as an ethical framework, which is presented in supplementary box 1, available at Nicotine and Tobacco Research online. When in supplementary box 1, available at Nicotine and Tobacco Research online a statement is marked “+,” it may be considered a strong aspect of the intervention. This implies that the ethical pitfall does not apply to the (proposed) intervention. When a question is marked “▲”, an ethical pitfall may be present. This does not necessarily imply that the intervention is ethically wrong, but that changes or additions to the (intended) intervention may be advisable. For the purpose of this manuscript when referring to “incentives” we consider solely the rewards women receive for smoking cessation. We consider “the intervention” as the whole infrastructure surrounding the provision of the incentives.
Table 1 provides a summary of the supplementary box 1, available at Nicotine and Tobacco Research online, which we developed based on the various ethical pitfalls that we identified. The criteria are categorized according to the ethical principles of Beauchamp and Childress,21 to evaluate the moral permissibility of a planned or existing intervention for smoking cessation in pregnant women using incentives. Below, we discuss these criteria in more detail.
Ethical Criteria for Interventions Using Incentives to Encourage Pregnant Women to Quit Smokinga
Criterion 1: Is the intervention effective? 
Criterion 2: Does the incentive support a healthy lifestyle? 
Criterion 3: Is the intervention considered a motivator by the target population? 
Criterion 4: Does the intervention avoid stimulating unhealthy behavior? 
Criterion 5: Is the risk for negative attitudes toward participants and the intervention minimized? 
Criterion 6: Is personal autonomy respected? 
Criterion 7: Does the intervention also address intrinsic motivation? 
Criterion 8: Is privacy respected? 
Criterion 9: Is the intervention fair to non-smokers? 
Criterion 10: Does the intervention allocate the incentives to those who deserve them? 
Criterion 11: Is the intervention cost-effective? 
Criterion 12: Does the intervention improve the health of those whose health is most impaired? 
Criterion 1: Is the intervention effective? 
Criterion 2: Does the incentive support a healthy lifestyle? 
Criterion 3: Is the intervention considered a motivator by the target population? 
Criterion 4: Does the intervention avoid stimulating unhealthy behavior? 
Criterion 5: Is the risk for negative attitudes toward participants and the intervention minimized? 
Criterion 6: Is personal autonomy respected? 
Criterion 7: Does the intervention also address intrinsic motivation? 
Criterion 8: Is privacy respected? 
Criterion 9: Is the intervention fair to non-smokers? 
Criterion 10: Does the intervention allocate the incentives to those who deserve them? 
Criterion 11: Is the intervention cost-effective? 
Criterion 12: Does the intervention improve the health of those whose health is most impaired? 
aThis table is a summary of supplementary box 1, available at Nicotine and Tobacco Research online, available at Nicotine and Tobacco Research online. Supplementary box 1, available at Nicotine and Tobacco Research online provides an overview of the ethical criteria and ethical pitfalls within each criterion.
Ethical Criteria for Interventions Using Incentives to Encourage Pregnant Women to Quit Smokinga
Criterion 1: Is the intervention effective? 
Criterion 2: Does the incentive support a healthy lifestyle? 
Criterion 3: Is the intervention considered a motivator by the target population? 
Criterion 4: Does the intervention avoid stimulating unhealthy behavior? 
Criterion 5: Is the risk for negative attitudes toward participants and the intervention minimized? 
Criterion 6: Is personal autonomy respected? 
Criterion 7: Does the intervention also address intrinsic motivation? 
Criterion 8: Is privacy respected? 
Criterion 9: Is the intervention fair to non-smokers? 
Criterion 10: Does the intervention allocate the incentives to those who deserve them? 
Criterion 11: Is the intervention cost-effective? 
Criterion 12: Does the intervention improve the health of those whose health is most impaired? 
Criterion 1: Is the intervention effective? 
Criterion 2: Does the incentive support a healthy lifestyle? 
Criterion 3: Is the intervention considered a motivator by the target population? 
Criterion 4: Does the intervention avoid stimulating unhealthy behavior? 
Criterion 5: Is the risk for negative attitudes toward participants and the intervention minimized? 
Criterion 6: Is personal autonomy respected? 
Criterion 7: Does the intervention also address intrinsic motivation? 
Criterion 8: Is privacy respected? 
Criterion 9: Is the intervention fair to non-smokers? 
Criterion 10: Does the intervention allocate the incentives to those who deserve them? 
Criterion 11: Is the intervention cost-effective? 
Criterion 12: Does the intervention improve the health of those whose health is most impaired? 
aThis table is a summary of supplementary box 1, available at Nicotine and Tobacco Research online, available at Nicotine and Tobacco Research online. Supplementary box 1, available at Nicotine and Tobacco Research online provides an overview of the ethical criteria and ethical pitfalls within each criterion.
When creating any public health intervention, the main goal has to be the improvement of public health and decreasing morbidity and mortality.20 The goals of an incentive-based approach for smoking cessation during pregnancy are a better health for mother and child, obtained by as less as possible exposure to tobacco smoke during pregnancy. This corresponds well with Beauchamp and Childress’s principle of beneficence.21 This principle entails that interventions should be aimed at improving the well-being of those who are being targeted by the intervention.21 Specifying this principle entails that the intervention is (likely to be) effective in decreasing the number of women who smoke during pregnancy, that the incentive supports a healthy lifestyle, and that the intervention is considered a motivator by the target population.
There has to be a scientific base for the effectiveness of the smoking cessation intervention. Although recent literature shows that providing incentives to women to quit smoking during pregnancy results in more women who quit,13 not all intended interventions will succeed. Research has been done on various incentive schemes. For example on contingent (incentives when a participant has quit smoking) and non-contingent incentives (incentives for attendance to a helpful session without the obligation for smoking cessation to receive this incentive),13 the interval between incentives,16 and the added value of a reset when a smoker relapses.23 Also, studies investigating the effect of delayed rewards versus immediate rewards showed that the subjective value of a reward decreases when there is a delay in providing the reward.24,25 In addition, smokers are more likely
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