Prevention of alcohol exposed pregnancies in Europe: the FAR SEAS guidelines.

INTRODUCTION: Drinking during pregnancy is the leading cause of birth defects and child developmental disorders in Europe. The adverse effects of drinking during pregnancy may include physical, behavioural and cognitive problems, known collectively as fetal alcohol spectrum disorders (FASD). Evidence-based comprehensive recommendations at the European level on how to implement preventive and treatment policies to reduce alcohol-exposed pregnancies are needed. FAR SEAS, a tendered service contract (number 20,187,106) awarded by the European Commission, aimed at developing guidelines to respond to this knowledge gap. METHODS: FAR SEAS recommendations were built on (1) a two-phase review of interventions, (2) an international expert consultation, and (3) a pilot study on prevention of FASD conducted in the Mazovia region of Poland. The review of interventions included nineteen electronic open access databases, several repositories of grey literature and a key informant consultation covering most European Union (EU) countries and an additional guidelines search. After triangulating sources, 94 records were collected. Experts contributed in the design of the research questions, addressing the gaps in the literature and reviewing the recommendations formulated. The Polish pilot added nuances from real world practice to the formulated recommendations, resulting in the final set of guidelines for dissemination. RESULTS: The FAR SEAS Guidelines comprise 23 recommendations grouped into different topics areas of policies, communication strategies, screening, brief intervention and referral to treatment, treatment and social services. The recommendations highlight the need to respect women's autonomy and avoid discrimination and stigmatization; using universal screening for women of childbearing age, including detection of other psychosocial risks (such as domestic violence); and individualized, comprehensive and multidisciplinary supportive interventions for those who require it, such as those with alcohol use disorders, including women's partners. Policies to prevent FASD should be multicomponent, and public health communication should combine information about the risks together with self-efficacy messages to promote changes. CONCLUSIONS: The FAR SEAS guidelines are a tool to support policy-makers and service managers in implementing effective programmes to reduce prenatal alcohol exposure among general and at-risk population groups. FASD prevention has to involve comprehensive and multi-level evidence-based policies and practice, with services and activities tailored to the needs of women at differing levels of risk, and with due attention to reducing stigma.

Reducing the risk of prenatal alcohol exposure and FASD through social services: promising results from the FAR SEAS pilot project.

Introduction: Within FAR SEAS, a multi-component evidence-based community intervention was implemented and evaluated in Mazovia (Poland), with the aim of preventing alcohol-exposed pregnancies, and therefore preventing FASD. Methods: Multi-disciplinary professionals from different services (social, addiction, and psychology), recruited women of child-bearing age (pregnant and not pregnant) in local communities, screened them for alcohol risk, and allocated participants (n = 441) to groups for low- (70%), moderate- (23%), or high-risk (7%) of alcohol exposed pregnancy, to provide interventions tailored to their needs. The non-parametric sign test, testing differences between pairs of observations before and after intervention was used to evaluate the outcomes. Results: Follow-up data (collected from 93% of participants) indicated positive changes in the key outcome variables: risky alcohol consumption dropped by 81%, contraception use increased by 15% and visiting a gynecologist increased by 39%; as well as in associated psychosocial risk factors (decrease in cigarette and drug use, domestic violence and depressive symptoms). No changes were noted in frequency of other service use (medical, psychological, or social). The most prominent changes were observed in the moderate-risk group. Discussion: Changing risky behaviors (alcohol consumption and sex without contraception) to prevent alcohol exposed pregnancies is feasible at the local level, even without engagement of medical professionals. Key challenges, related to engaging professionals and local authorities, must be addressed; and procedures should be adapted to local contexts and needs.

Drug policies' sensitivity towards women, pregnancy, and motherhood: a content analysis of national policy and programs from nine countries and their adherence to international guidelines.

BACKGROUND AND OBJECTIVES: Substance use in women is associated with unique psycho-social and physical vulnerabilities and poses complex challenges during pregnancy and motherhood. Gender-sensitive drug policy which considers the needs of women and their children could address these concerns. The objectives of this study were: (1) to systematically explore national-level drug policies' sensitivity and responsiveness to women, pregnant women, and children; and (2) to examine the adherence of drug policies with international guidelines for gender sensitivity in drug policy. METHODS: The research team was diverse professional backgrounds and nine countries. A summative content analysis of national drug policy documents, action plans, and strategies was performed. Specific documents focusing on women, pregnancy, and children were analysed. Specific themes and how frequently they appeared in the documents were identified. This quantification was an attempt to explore usage indicating the relative focus of the policies. A thematic map was developed to understand how national-level drug policies conceive and address specific concerns related to women who use drugs. We adapted the UNODC checklist for gender mainstreaming to assess policies' adherence to international guidelines. RESULTS: Twenty published documents from nine countries were reviewed. The common themes that emerged for women, pregnancy, and children were needs assessment, prevention, treatment, training, supply reduction, and collaboration and coordination. Custody of children was a unique theme for pregnant women. Specific psycho-social concerns and social reintegration were special themes for women, whereas legislation, harm reduction, research, and resource allocation were children-specific additional themes. For women-specific content analysis, special issues/concerns in women with drug misuse, need assessment, and prevention were the three most frequent themes; for the children-specific policies, prevention, training, and treatment comprised the three most occurring themes. For pregnant women/pregnancy, prevention, treatment, and child custody were the highest occurring themes. According to ratings of the countries' policies, there is limited adherence to international guidelines which ensure activities are in sync with the specific needs of women, pregnant women and their children. CONCLUSION: Our analysis should help policymakers revise, update and adapt national policies to ensure they are gender-responsive and address the needs of women, pregnant women and their children.

Effectiveness of a Specialized Brief Intervention for At-risk Drinkers in an Emergency Department: Short-term Results of a Randomized Controlled Trial.

BACKGROUND: Screening, Brief Intervention, and Referral to Treatment (SBIRT) programs have been developed, evaluated, and shown to be effective, particularly in primary care and general practice. Nevertheless, effectiveness of SBIRT in emergency departments (EDs) has not been clearly established. OBJECTIVE: We aimed to evaluate the feasibility and efficacy of an SBIRT program conducted by highly specialized professionals in the ED of a tertiary hospital. METHODS: We conducted a randomized controlled trial to study the feasibility and efficacy of an SBIRT program conducted by alcohol specialists for at-risk drinkers presenting to the ED, measured with the three-item version of the Alcohol Use Disorder Identification Test (AUDIT-C). Patients were randomized to two groups, with the control group receiving two leaflets-one regarding alcohol use and the other giving information about the study protocol. The intervention group received the same leaflets as well as a brief motivational intervention on alcohol use and, where appropriate, a referral to specialized treatment. The primary outcomes were the proportion of at-risk alcohol use measured by AUDIT-C scale and the proportion of patients attending specialized treatment at 1.5 months. RESULTS: Of 3,027 patients presenting to the ED, 2,044 (67%) were potentially eligible to participate, 247 (12%) screened positive for at-risk drinking, and 200 agreed to participate. Seventy-two percent of the participating sample were men, and the mean (±SD) age was 43 (±16.7) years. Follow-up rates were 76.5%. At 1.5 months, the intervention group showed greater reductions in alcohol consumption and fewer patients continuing with at-risk alcohol use (27.8% vs. 48.1%; p = 0.01). The SBIRT program also increased the probability of attending specialized treatment, compared to the control condition (23% vs. 9.8%, p = 0.0119) CONCLUSION: The SBIRT program in the ED was found to be feasible and effective in identifying at-risk drinkers, reducing at-risk alcohol use, and increasing treatment for alcohol problems.

Assessing the Quality of Goal Setting in Behavioural Support for Smoking Cessation and its Association with Outcomes.

BACKGROUND: Smoking cessation behavioural support can be effective but practitioners differ markedly in effectiveness, possibly due to variation in the quality of delivery of key behaviour change techniques, such as goal setting (i.e. setting a quit date). OBJECTIVES: This study aimed to (i) develop a reliable method for assessing the quality of practitioners' support in setting quit dates and (ii) assess whether quality predicts initiation of abstinence as a first step to quitting. METHODS: A scale for scoring the quality of goal setting was developed from national guidance documents and applied to 85 transcribed behavioural support sessions. Inter-rater reliability was assessed. Associations between quality scores and quit attempts were assessed. RESULTS: The 10-item scale produced had good inter-rater reliability (Kappa = 0.68). Higher quality goal setting was associated with increased self-reported quit attempts (p < .001; OR = 2.60, 95 % CI 1.54-4.40). The scale components 'set a clear quit date' (χ (2) (2, N = 85) = 22.3, p < .001) and 'within an appropriate timeframe' (χ (2) (2, N = 85) = 15.5, p < .001) were independently associated with quit attempts. CONCLUSIONS: It is possible to reliably assess the quality of goal setting in smoking cessation behavioural support. Higher quality of goal setting is associated with greater likelihood of initiating quit attempts.

Association of amount and duration of NRT use in smokers with cigarette consumption and motivation to stop smoking: a national survey of smokers in England.

INTRODUCTION: Clinical trials have found that the use of nicotine replacement therapy (NRT) to reduce cigarette consumption results in significant declines in cigarette consumption and increases smokers' propensity to quit. However, observational "real-world" studies have found much smaller effects. This may be because of low levels of NRT use. This study examined the association between amount and duration of NRT use amongst those attempting to reduce their cigarette consumption with motivation to quit and cigarette consumption. METHODS: Data came from 2,158 smokers who took part in the Smoking Toolkit Study. A representative survey of smokers in England aged 16+. RESULTS: Only 54.4% of patch users and 32.2% of non-transdermal NRT users reported using NRT with a frequency that would be expected to substantially influence cigarette consumption (4+ units per day for acute NRT forms and at least daily for transdermal patches). Those using the patch at or above this threshold smoked 1.3 cigarettes per day fewer than those using it below the threshold (p=0.059), whilst those using non-transdermal NRT at or above this threshold smoked 0.9 cigarettes less per day (p=0.022). In both cases, those using NRT more frequently had greater motivation to quit. Less than 1/5th of participants reported using a combination of NRT products. Use of NRT long-term was associated with lower motivation to quit and higher cigarette consumption. CONCLUSION: Smokers attempting to reduce their cigarette intake are underusing NRT and this is associated with cigarette consumption and motivation to quit. These findings may explain why population-based studies have failed to report similar findings to clinical trials.

A method for assessing fidelity of delivery of telephone behavioral support for smoking cessation.

OBJECTIVES: Behavioral support for smoking cessation is delivered through different modalities, often guided by treatment manuals. Recently developed methods for assessing fidelity of delivery have shown that face-to-face behavioral support is often not delivered as specified in the service treatment manual. This study aimed to extend this method to evaluate fidelity of telephone-delivered behavioral support. METHOD: A treatment manual and transcripts of 75 audio-recorded behavioral support sessions were obtained from the United Kingdom's national Quitline service and coded into component behavior change techniques (BCTs) using a taxonomy of 45 smoking cessation BCTs. Interrater reliability was assessed using percentage agreement. Fidelity was assessed by comparing the number of BCTs identified in the manual with those delivered in telephone sessions by 4 counselors. Fidelity was assessed according to session type, duration, counselor, and BCT. Differences between self-reported and actual BCT use were examined. RESULTS: Average coding reliability was high (81%). On average, 41.8% of manual-specified BCTs were delivered per session (SD = 16.2), with fidelity varying by counselor from 32% to 49%. Fidelity was highest in pre-quit sessions (46%) and for BCT "give options for additional support" (95%). Fidelity was lowest for quit-day sessions (35%) and BCT "set graded tasks" (0%). Session duration was positively correlated with fidelity (r = .585; p < .01). Significantly fewer BCTs were used than were reported as being used, t(15) = -5.52, p < .001. CONCLUSIONS: The content of telephone-delivered behavioral support can be reliably coded in terms of BCTs. This can be used to assess fidelity to treatment manuals and to in turn identify training needs. The observed low fidelity underlines the need to establish routine procedures for monitoring delivery of behavioral support.

Was the expansion of the marketing license for nicotine replacement therapy in the United kingdom to include smoking reduction associated with changes in use and incidence of quit attempts?

BACKGROUND: In December 2009 and January 2010, the UK Medicines and Healthcare Products Regulatory Agency expanded the marketing license for a number of nicotine replacement therapies (NRTs) to include smoking reduction without an intention to stop completely. This study examined whether this was associated with a change in incidence of use of NRT for harm reduction (i.e., smoking reduction and/or temporary abstinence) and in smoking cessation activity. METHODS: Data were taken from 10,497 smokers who took part in the Smoking Toolkit Study, which involves monthly representative household surveys of adults aged 16+ in England. Incidence of use of NRT for smoking reduction and/or temporary abstinence and attempts to stop smoking in 2009 was compared with the 2 years following the expansion of the marketing license. RESULTS: Expansion of the license was not associated with an increase in incidence of NRT use for harm reduction, which was already substantial prior to the change. The odds of a quit attempt were lower in the second year following the license change relative to the year before, but there was no change in the success of quit attempts. CONCLUSIONS: Expansion of the UK marketing license for NRT to include smoking reduction without the intention of quitting was not associated with an increase in use of NRT for this purpose. It was followed by a reduction in the incidence of quit attempts (but not their success) although this may have been a continuation of a pre-existing decline.