Piloting a complex intervention to promote a tobacco and alcohol-free pregnancy: the Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy study.

BACKGROUND: Tobacco smoking and alcohol consumption before and during pregnancy increase the risk of adverse health outcomes for mother and child. Interventions to address smoking and drinking before and during pregnancy have the potential to reduce early-life health inequalities. In the Smoke and Alcohol Free with EHealth and Rewards (SAFER) pilot study we aimed to evaluate the acceptability, feasibility and effectiveness of a complex intervention supporting women in smoking and alcohol cessation before and during pregnancy. METHODS: From February 2019 till March 2021, we piloted the SAFER pregnancy intervention among pregnant women and women planning pregnancy in South-West Netherlands in an uncontrolled before-after study. Participants were supported in smoking and alcohol cessation via up to six group sessions and an online platform. In addition, biochemically validated cessation was rewarded with incentives (i.e. shopping vouchers) amounting up to 185 euros. We aimed to include 66 women. The primary outcome was smoking and/or alcohol cessation at 34-38 weeks of gestation (if pregnant) or after six group sessions (if not pregnant). Quantitative data were analysed using descriptive statistics. Focus group interviews among those involved in the study were conducted at the end of the study to explore their experiences. Qualitative data was analysed using thematic analysis. RESULTS: Thirty-nine women who smoked were included; no women who consumed alcohol were referred to the study. Unemployment (51%), financial problems (36%) and a smoking partner (72%) were common. Thirteen women (33%) dropped out, often due to other problems impeding smoking cessation or 'being too busy' to participate in the group sessions. Eleven women (28%) had quit smoking at the study's endpoint. The personal and positive approach was highly valued and biochemical validation was felt to be helpful. CONCLUSION: The SAFER pregnancy intervention seems appropriate for women in need of extra support for smoking cessation before and during pregnancy. Its impact on alcohol cessation could not be studied due to recruitment issues. Recruitment and prevention of early dropout need attention in further development of this intervention. TRIAL REGISTRATION: Netherlands Trial Register: NL7493. Date registered: 04/02/2019.

Impact of an Inner-City Smoke-Free Zone on Outdoor Smoking Patterns: A Before-After Study.

INTRODUCTION: On September 2, 2019, Rotterdam's first inner-city outdoor smoke-free zone encompassing the Erasmus MC, a large university hospital in the Netherlands, the Erasmiaans high school, the Rotterdam University of Applied Sciences and the public road in between, was implemented. AIMS AND METHODS: We aimed to assess spatiotemporal patterning of smoking before and after implementation of this outdoor smoke-free zone. We performed a before-after observational field study. We systematically observed the number of smokers, and their locations and characteristics over 37 days before and after implementation of the smoke-free zone. RESULTS: Before implementation of the smoke-free zone, 4098 people smoked in the area every weekday during working hours. After implementation, the daily number of smokers was 2241, a 45% reduction (p = .007). There was an increase of 432 smokers per day near and just outside the borders of the zone. At baseline, 31% of the smokers were categorized as employee, 22% as student and 3% as patient. Following implementation of the smoke-free zone, the largest decreases in smokers were observed among employees (-67%, p value .004) and patients (-70%, p value .049). Before and after implementation, 21 and 20 smokers were visibly addressed and asked to smoke elsewhere. CONCLUSIONS: Implementation of an inner-city smoke-free zone was associated with a substantial decline in the number of smokers in the zone and an overall reduction of smoking in the larger area. Further research should focus on optimizing implementation of and compliance with outdoor smoke-free zones. IMPLICATIONS: A smoke-free outdoor policy has the potential to denormalize and discourage smoking, support smokers who want to quit, and to protect people from secondhand smoke exposure. Implementation of an inner-city smoke-free zone encompassing a large tertiary hospital and two educational institutions was associated with a substantial decline in the number of smokers in the zone, as well as in the larger area. Voluntary outdoor smoke-free zones can help reduce the number of smokers in the area and protect people from secondhand smoke. There is a need to explore effectiveness of additional measures to further improve compliance.

Objective assessment of alcohol consumption in early pregnancy using phosphatidylethanol: a cross-sectional study.

BACKGROUND: Alcohol consumption during pregnancy is associated with major birth defects and developmental disabilities. Questionnaires concerning alcohol consumption during pregnancy underestimate alcohol use while the use of a reliable and objective biomarker for alcohol consumption enables more accurate screening. Phosphatidylethanol can detect low levels of alcohol consumption in the previous two weeks. In this study we aimed to biochemically assess the prevalence of alcohol consumption during early pregnancy using phosphatidylethanol in blood and compare this with self-reported alcohol consumption. METHODS: To evaluate biochemically assessed prevalence of alcohol consumption during early pregnancy using phosphatidylethanol levels, we conducted a prospective, cross-sectional, single center study in the largest tertiary hospital of the Netherlands. All adult pregnant women who were under the care of the obstetric department of the Erasmus MC and who underwent routine blood testing at a gestational age of less than 15 weeks were eligible. No specified informed consent was needed. RESULTS: The study was conducted between September 2016 and October 2017. In total, we received 1,002 residual samples of 992 women. After applying in- and exclusion criteria we analyzed 684 samples. Mean gestational age of all included women was 10.3 weeks (SD 1.9). Of these women, 36 (5.3 %) tested positive for phosphatidylethanol, indicating alcohol consumption in the previous two weeks. Of women with a positive phosphatidylethanol test, 89 % (n = 32) did not express alcohol consumption to their obstetric care provider. CONCLUSIONS: One in nineteen women consumed alcohol during early pregnancy with a high percentage not reporting this use to their obstetric care provider. Questioning alcohol consumption by an obstetric care provider did not successfully identify (hazardous) alcohol consumption. Routine screening with phosphatidylethanol in maternal blood can be of added value to identify women who consume alcohol during pregnancy.

Incentives for Smoking Cessation During Pregnancy: An Ethical Framework.

INTRODUCTION: 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. AIMS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. IMPLICATIONS: 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.

Pediatric patients' views regarding smoke-free hospital grounds compared to those of adults: A survey study.

INTRODUCTION: Children are important stakeholders in discussions about regulation of smoking and protection from secondhand smoke, but are rarely acknowledged as such. We explored the opinion of pediatric patients and other key stakeholders regarding the planned smoke-free zone around the Erasmus MC, a large university hospital in the Netherlands. METHODS: In 2019, we conducted a survey among pediatric patients and their parents, Erasmus MC employees, visitors, and adult patients, before implementation of the outdoor smoke-free zone, to assess their opinions on smoking and the planned smoke-free policy. Qualitative and quantitative data were collected and analyzed mostly using descriptive statistics and thematic analysis. RESULTS: In all, 91 parent-child dyads and 563 employees, visitors, patients and students filled in the questionnaires. Over 90% of children reported that they were regularly exposed to tobacco smoke, most often on the streets. Many underlined the exemplary role of healthcare providers, and 89% felt that nobody should be allowed to smoke near the hospital. Among parents, 89% were (very) positive towards the planned implementation of the smoke-free zone. In addition, 70% of adult patients, 81% of employees, 65% of visitors, 89% of students and 75% of 'others' were (very) positive about the new smoke-free policy. Smokers and former smokers generally were less positive about the policy. CONCLUSIONS: Children generally disapproved smoking around a hospital and felt that healthcare providers should be a good example concerning not smoking. The majority of adult patients, employees and visitors support a smoke-free zone surrounding the hospital, and virtually all pediatric patients and their parents do. Children should be acknowledged as important stakeholders in smoke-free policies and should be involved in planning and implementation.

Smokers' responses to being addressed when smoking in an outdoor voluntary smoke-free zone: An observational study.

INTRODUCTION: Addressing smokers who smoke in a voluntary smoke-free area is vital to its successful implementation. Many people perceive barriers in addressing smokers due to fear of negative responses. Insights in actual responses are currently lacking. METHODS: This is an observational field study at the voluntary smoke-free zone surrounding the Erasmus MC and two schools in Rotterdam, the Netherlands. In the first month after implementing the zone, Erasmus MC representatives performed rounds to address smokers who were smoking inside the zone. Four people observed addressors for two weeks then they also addressed the smokers. Smokers were classified as employees, patients, students, or other. We noted whether smokers were addressed directly or indirectly, and their verbal and behavioral responses to being addressed. Differences between the responses of the groups were assessed using chi-squared tests. RESULTS: In all, 331 smokers were observed of whom 73% were addressed directly. Most verbal reactions were positive (46%) or neutral (18%). Employees were more likely to respond guiltily, whereas patients more often responded angrily than the others. After being addressed, the majority of smokers either extinguished their cigarette (41%) or left to continue smoking outside the smoke-free zone (34%). CONCLUSIONS: Most smokers showed a positive or neutral response when being addressed about smoking inside the smoke-free zone and the majority adapted their behavior to comply with the policy. These findings may help decrease barriers for those in doubt about addressing smokers that fail to comply with a smoke-free policy.

Identifying the Needs for a Web-Based Postpartum Platform Among Parents of Newborns and Health Care Professionals: Qualitative Focus Group Study.

BACKGROUND: During the turbulent postpartum period, there is an urgent need by parents for support and information regarding the care for their infant. In the Netherlands, professional support is provided during the first 8 days postpartum and for a maximum of 8 hours a day. This care is delivered by maternity care assistants (MCAs). Despite the availability of this extensive care, a majority of women prefer to make use of a lesser amount of postpartum care. After this period, access to care is less obvious. Where parents are automatically offered care in the first 8 days after birth, they must request care in the period thereafter. To compensate for a possible gap in information transfer, electronic health (eHealth) can be a valuable, easily accessible addition to regular care. OBJECTIVE: We explored the needs and preferred content by new parents and health care professionals of a web-based platform dedicated to the postpartum period and identified barriers and facilitators for using such a platform. METHODS: We conducted 3 semistructured focus groups among (1) parents of newborns, (2) MCAs, and (3) clinicians and administrators in maternity care. A topic list based on a framework designed for innovation processes was used. Thematic content analysis was applied. RESULTS: In the focus group for parents, 5 mothers and 1 male partner participated. A total of 6 MCAs participated in the second focus group. A total of 5 clinicians and 2 administrators-a member of a stakeholder party and a manager of a maternity care organization-participated in the third focus group. All user groups underlined that a platform focusing on the postpartum period was missing in current care, especially by parents experiencing a gap following the intensive care ending after the first week of childbirth. Parents indicated that they would perceive a postpartum platform as a proper source of reliable information on topics regarding breastfeeding, growth, and developmental milestones, but also as a tool to support them in seeking care with appropriate professionals. They also emphasized the need to receive personalized information and the opportunity to ask questions via the platform. MCAs acknowledged added value of providing additional information on topics that they address during the early postpartum period. MCAs as well as clinicians and administrators would guide parents to such a platform for additional support. All user groups experienced disadvantages of using an authentication procedure and filling out extra questionnaires to receive tailored information. CONCLUSIONS: Our research shows that parents of newborns, MCAs, and clinicians and administrators foresee the additional value of a web-based postpartum platform for at least the whole postpartum period. The platform should be easily accessible and personalized. Content on the platform should contain information regarding breastfeeding, growth, and developmental milestones. A chat function with professionals could be considered as an option.

Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy study: a before-after study protocol.

Despite existing interventions, tobacco smoking and alcohol consumption during pregnancy are common. The Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy intervention combines monthly group sessions, access to a web-based platform and incentives upon biochemically validated cessation for a maximum duration of 6 months to promote cessation of smoking and alcohol use before and during pregnancy. To inform development of the SAFER pregnancy intervention, two focus groups with the target population were held beforehand, with results reported here alongside the final SAFER pregnancy study protocol. In a before-after study we aim to include 66 women who are pregnant or have a wish to become pregnant and who smoke and/or consume alcohol (i.e. target population of the SAFER pregnancy intervention). The primary outcome measure is cessation of smoking and/or alcohol use at 34-38 weeks of gestation, or after six group sessions if women did not become pregnant during the study period. Secondary outcomes focus on the barriers and facilitators for implementation of the SAFER pregnancy intervention.