gms | German Medical Science

Out of around 678,000 children born every year 1 to 2% have alcoholic diseased mothers. According to drug-abuse statistics of the German government around 10,000 children are affected by health problems related to alcohol intake of their mothers during pregnancy. The annual incidence of FAS (fetal alcohol syndrome) is estimated to be around 4,000 in Germany.

In Germany the history of alcohol intake is routinely surveyed in pregnant women in the context of prenatal care.

FAS is characterised as prenatal damage of a child, caused by alcohol consumption of its mother during pregnancy. FAS can be graded into different severity levels (grade I to III) and is defined as the prenatal damage of the newborn through the alcohol intake of its mother. Most common symptoms are reduced body length and weight (pre- and postnatal), microcephaly, musculoskeletal, mental and statomotoric developmental retardations and impaired coordinative ability. The best prevention strategy to reduce the incidence of FAS is the identification and the consultation of women at high risk, such as women with alcohol abuse or alcohol dependency before their pregnancy and women, who were substantially drinking during earlier pregnancies. The present HTA (Health Technology Assessment) focuses on selective prevention strategies (i.e. screening strategies), which are directly addressed to the mentioned female risk populations and which are based on early recognition of problematic drinking behaviour during and before pregnancy. In this context, short-term interventions (one time or repeated educational sessions for women with alcohol abuse) have discussed to be of high effectiveness.

The research questions are:

• Which preventive and interventional strategies for women at childbearing age are effective and efficient to prevent FAS? Which strategies to reduce alcohol abuse or to achieve alcohol abstinence during pregnancy in women are effective and efficient? Are there any unintended side effects?
• What is the cost-efficacy of such interventions?
• Are there any ethical, social, juridical and organisational aspects, which have to be considered?

Following outcomes have been selected to answer the research questions:

• Primary outcomes: frequency of established diagnoses of FAS, reduction of alcohol intake or achievement of alcohol abstinence during pregnancy, measured by distinct screening instruments, such as the AUDIT-questionnaire.
• Secondary outcomes: fetal mortality, weight at birth, gestational age at birth, preterm delivery, admissions to neonatal intensive care-units.

A systematic literature research was performed in 30 international databases (for example MEDLINE, EMBASE) with seven predefined keywords. To identify relevant publications, two keyword complexes were connected, one with terms related to FAS, the other with terms related to prevention of alcohol dependency in childbearing women. To describe the effectiveness of preventive strategies the two keyword complexes were linked to terms related to study-quality. The selection of abstracts and of full-text versions was performed according to predefined selection criteria.

Accurate and detailed information on preventive measures in Germany for drug consuming pregnant women and breastfeeding women were not public (for example online) available. Because of that it has contacted the competent authority at the Federal Ministry of Health, and a list of all projects funded with a brief description has been returned.

To determine the quality of the studies internal (risk for biases) and external validity (application of study-results for people beyond the study-populations) were evaluated according to predefined criteria. The contents of the primary and the secondary studies were displayed in table format.

On the basis of the systematic literature research 1,217 abstracts are ordered and delivered. After abstract selection according to predefined selection criteria 188 full-text articles are ordered, of which 175 are actually delivered. 22 publications are added by hand search. After selection of the full-text articles eight primary studies and two secondary studies are included for medical assessment, seven articles for social, ethical, organisational and juridical aspects and 38 articles for background description, respectively. For economic assessment it is not possible to identify any full-text article, but there were five studies identified that deal with economic aspects.

In 2011 and 2012 the German Ministry of Health assisted seven model projects for the enhancement of preventive measures for pregnant and breastfeeding women with substance abuse.

For the medical assessment only eight primary studies of relevance are identified, all of them come from the USA and show reduced methodological quality. In particular there was no blinding in the investigation of outcomes and in some cases outcomes were investigated by the person, who also carried out the intervention. Because of the reduction of the power of these studies it cannot be excluded, that investigations of higher methodological quality would reveal contradictory results.

All primary studies are assessing short-term interventions. When the whole study population is analysed, only one study shows significant better results for the intervention than for the control group. Two studies report positive effects on one of the analysed outcomes. When subgroups are analysed, four further primary studies demonstrate significant positive effects of the intervention.

In all studies positive effects are established not only for the intervention, but also for the control group, suggesting that the application of a screening instrument and the verbalisation of alcohol abuse already reduce the alcohol intake during pregnancy.

An U.S. study estimates that the cost of FAS comes to the equivalent of 2,070.90 Euros in additional costs per year for a child with FAS, compared to a child without the disease. This cost estimate includes costs for medical services and lost productivity.

For the prevention of FAS, studies with ethical, social and juridical aspects could be identified.

A German study on the reduction of alcohol intake during pregnancy demonstrates that FAS-risk is highest in women at older age and that women with high social-economic status are most at risk. Numerous investigations show that children with a family history of any substance abuse are more likely to also develop any kind of substance abuse.

The application of the present results to other countries, such as Germany, is limited. In particular studies from the USA were done in populations of low socio-economic status, whereas in Germany, risk for alcohol abuse is highest in middle-class women at older age.

Nevertheless, studies give meaningful approaches for the prevention of FAS in Germany.

In conclusion short-term interventions, in particular screening interventions and systematic surveillance of alcohol intake reduce alcohol abuse and increase alcohol abstinence in pregnant women (in both, the intervention group, as well as in the control group). From the available data, there is no evidence for the key conditions and for the key factors for the success of interventions.

Primary studies give little details regarding the types of interventions and are varying with regard to the duration and the follow-up of interventions. O’Connor suggests that repeated contacting might improve the effectiveness of short-term interventions. None of the studies is looking for the potential occurrence of side effects of the intervention. There is no information on other types of interventions, such as interventions, taking place outside the clinical setting.

From the ethical point of view a respectful contact with the study populations is highly important, especially in terms of the social context of alcohol abuse (i.e. circumstances, in which alcohol consumption is advocated). From the juridical angle the potential deprivation of the right of custody has to be discussed. From a social point of view women with a high level of alcohol intake (in particular women of high socioeconomic status) and women with previous exposure to violence have to be considered most at risk.

In view of the limited evidence the encouragement of pilot studies is positively evaluated in Germany. The adherence to the academic background of the projects and the transparently reporting of success and failure of the results are essential.

As recommended by the German centre for problems of substance abuse, all assessments of the expectant mother's record of prenatal and natal care should include the T-ACE screening. Further research on FAS should include the following aspects:

• All available studies derive from the US. In particular because of the differing structure of European populations (and the differing risk factors) methodologically highly qualified studies are essential for the successful prevention of FAS in Europe. In addition, the inclusion of patient-relevant outcomes and the blinding of participants are important.
• Evaluation of potential side effects of interventions, such as delirium, depression, anxiety and dropout from prenatal care should be included into further research-projects.
• Further studies, investigating the effect of short-term interventions should concentrate on the question, which factors and settings are related to the success of the interventions.
• Of special interest is the clarification of the required amount of counseling within the interventions, the clarification of the required qualification of the consulter, the optimal length of the intervention and the optimal gestational age for implementing the intervention.
• For successful prevention of FAS, screening for pregnant women with alcohol abuse is presupposed and therefore warrants further research.
• Because alcohol consumption of pregnant women and women at childbearing age and its problems has to be evaluated in the context of society as a whole, further research has to be directed towards behavioural prevention-strategies to reduce the amount of alcohol intake in the general population. Additionally, these strategies should influence social and cultural norms, and should thereby be of indirect preventive effect.
• Further research should focus on women at very high risk (pregnant women with alcohol addiction, pregnant women, who have already given birth to a child with FAS) and women, in who short-term interventions are unlikely to be effective.

The following recommendations can be made:

• As a basis of further prevention strategies more data on prevalence and populations at risk for FAS in Germany are needed.
• Studies on FAS in Germany and expansion of effective pilot studies should be based on a scientific background
• Present screening strategies for pregnant women in Germany should be evaluated and modified when indicated.
• Continuing education on FAS of medical and non-medical staff, who are involved in screening and short-term interventions should communicate skills for negotiations and for a respectful contact with pregnant women. If necessary, women should be transferred to specialised conciliation- and therapy-centres, constitutional cross-linking of all of these centres is a key factor for success.
• Short-term interventions require repeated personal approach during the entire pregnancy, as i.e. alcohol intake is known to rise during the last trimenon of the pregnancy.

The authors declare that they have no competing interests.

Checklist for HTA related documents (Attachment 1 [Attach. 1]).