Mandatory Prenatal Screening; A Critique of a Ineffective Public Health Initiative – Fay Robinson

The American College of Obstetricians and Gynecologists recently recommended that all pregnant women should be offered prenatal screening for Down syndrome, a genetic disorder caused by the presence of an extra 21^st chromosome with an incidence of 1 in 800 to 1,000 births (1). Prior to this recommendation, which was released on January 2, 2007, the standard of care was to recommend screening on the basis of advanced maternal age (AMA) (1-2). In light of the recent debate of mandating vaccination for the Human Papillomavirus, currently in effect in Texas for school age girls, one has to consider the possibility of a state or nationwide mandate for prenatal screening.

Mandating screening may increase undue anxiety and depression for women who may otherwise might never seek screening, due to their individual risk factors. Additionally, a more effective public health campaign for prenatal screening should include an educational component, and offer screening to all women as opposed to a mandate. Finally, while examining the Theory of Reasoned Action and the Power Coercive model, it is evident that this particular campaign would be ineffective due to the fact that it would eliminate women’s choice to seek prenatal screening and effectively force screening.

Undue Anxiety and Depression

Screening tests are designed to identify diseases or disorders prior to the symptomatic stage which would generally prompt a person to seek medical attention. Results from screening tests can sometimes cause undue anxiety and stress to woman, due to high false positive fractions, or misunderstanding of results. For a screening test to be effective it must produce a high detection rate, or sensitivity, and a low false positive rate. Calculations of sensitivity and false positive fractions require a specific cut-point which classifies each person being screened as positive or negative for the outcome. Due to the nature of the relationship between the false positive rate and the sensitivity of a test, moving the cut-off to reduce the false positive rate would in turn reduce the sensitivity (i.e. testing positive given that the fetus has an abnormality) of the test (3).

Some factors which affect the outcome of prenatal screening test for Down syndrome are a woman’s weight, race/ethnicity and smoking status. Serum markers are generally lower for women who are overweight and increased in women who are underweight. Afro-Caribbean AFP and free ß-hCG levels tend to be increased as compared to Caucasian women, while inhibin levels are increased by approximately 60% in women who smoke as compared to women who do not. Each marker used in the prenatal screening test is used to calculate a risk cut-off. Based on the risk cut-off, a woman is determined to be either a screen positive or a screen negative (4).

These differences in detection rates can have an adverse effect for women who may otherwise not seek prenatal screening. For example, an Afro-Caribbean woman who may not otherwise choose to be screened due to her low calculated risk and her age, will likely test positive due to an increased AFP and free ß-hCG levels when she may be a true negative, therefore increasing her anxiety level associated with this outcome. Furthermore, of all women who screen positive, only a fraction of the women (between 1 in 10 and 1 in 40, depending on the type of test, integrated or quadruple) will actually have a pregnancy with Down syndrome (4). This high false positive rate can cause undue stress and anxiety for the mother, which can in turn negatively affect the fetus.

Although not yet well understood, there is evidence of a relationship between anxiety and depression. Preliminary research indicates that there may be well-defined neural processes that overlap between anxiety and depression as well as developmental factors that could play a role in the relationship (5). A study conducted in Norway in 2004 investigated the association between anxiety and depression in a large population. Results showed that that there was a strong association between anxiety and depression in women (6).

Additional research has confirmed the comorbid relationship between anxiety and depression. In a study of elderly Alzheimer's patients, analyses investigated the differences in the severity and prevalence of anxiety, depression and comorbid anxiety and depressive symptoms. Results indicated that rates of comorbid symptoms of anxiety and depression increased as the patients cognitive abilities declined. This research implies an implicit relationship between increased anxiety and depressive symptoms (7). This research can be applied to the mandate on prenatal screening, in that, a woman who has an increased level of anxiety will most likely experience more depressive symptoms.

Considering the relationship between anxiety and depression, as the results indicated in both the Norway and Alzhiemer’s study mentioned above, a mandate on screening may in fact increase levels and prevalence of depression as well as anxiety. Studies have shown women with higher levels of anxiety related to pregnancy have an increased risk of preterm birth (8). Results from a study in Helsinki, Finland concluded that anxiety and stress during the pregnancy can result in preeclampsia, or pregnancy induced high blood pressure. This study indicated that 30% of the 600 women experience depression with a mean Beck score of 4.5 and 16% of the women experienced anxiety (9). Controlling for confounders (including age, smoking, alcohol consumption, marital status, socioeconomic status, and bacterial vaginosis) the results showed that women with depression had an odds of developing preeclampsia 2.5 higher than those without depression. Similarly, women with anxiety were at a 3 times higher risk for developing preeclampsia (9).

These studies show the obvious link between anxiety and depression. Women, who experience increased levels of anxiety due to a mandated screening procedure, will likely suffer from more depressive symptoms. Both depression and anxiety have a documented affect on the outcome of the pregnancy, including complications such as preeclampsia (9). Additionally, under the mandate, the anxiety related to false positives, coupled with the misunderstanding of what a positive screening test means is likely to increase women’s level of anxiety and depression during pregnancy, consequently increasing the likelihood of developing preeclampsia. A mandate for prenatal screening would increase anxiety and depression among the general pregnant population, while a recommendation for screening would isolate and minimize this for only women who would most likely benefit from screening (i.e. high risk) and those who choose to have screening. It would be in the public health’s best interest to control the amount of undue anxiety and depression among the general population, and provide a less severe approach to promote prenatal screening.

Educational Component

As a public health approach, mandating screening for all pregnant women would encounter some obvious roadblocks. Before considering it as the most effective approach, experts in this field as well as public health officials bear the responsibility of considering less intrusive approaches, for example, an educational approach to inform women of their risks, perceived susceptibility, purpose of screening, perceived reliability of the results, knowledge of false positives and false negatives, among other important information. A more effective approach may be to combine a recommendation for screening along with an educational component, providing women with the knowledge and choice to make the best decision for their individual pregnancy.

An example of a study that was effective in examining women’s lack of education and misunderstanding of invasive prenatal testing (i.e. Amniocentesis, CVS) prenatal screening and their results was conducted in Sweden between 1993 and 1994. This study of 94 pregnant women between the ages of 26 and 46 was conducted to investigate the reasons why women chose to be screened, their knowledge about the procedure and the related anxiety. Cederholm et al found that only about a third of the 94 women (34%) were knowledgeable about the possible risks of the procedure and that the most common reason that women were seeking invasive procedures was maternal age. Additional research in this field has shown that other than advanced maternal age, there are additional risk factors for Down syndrome. Considering women are still mostly undereducated about the risks, AMA remains the most common reason for screening and invasive procedures (10).

The results of the Cenderholm study indicate a general lack of understanding of prenatal screening as well as the risk factors for seeking prenatal screening. Not only were women uneducated about the risks of the procedure, more importantly they were uneducated about their individual risk factors for seeking prenatal screening. An educational public health initiative focusing on broadening women’s understanding of their individual risk factors, such as ultrasound indications and previous history of complications, would be a more effective approach to promote prenatal screening.

The findings presented in the Cenderholm paper were confirmed by a study conducted by Gekas et al in 1997. This study enrolled 200 pregnant women to investigate how informed they were when they gave consent to invasive procedure, after screening positive for Down syndrome. The results showed that over half of the women could not correctly identify their risk of carrying a Down syndrome fetus. Over 60% of the women in the study thought that the results would be 100% accurate, meaning that their was no risk of testing positive if they were a true negative (sensitivity), or testing negative when they were a true positive (specificity) (12).

These results provide more evidence that there is a widespread lack of understanding related to prenatal screening, as related to individual risk factors and screening outcomes. Not only were the women uneducated about their personal risk of carrying a fetus with Down syndrome, but they grossly overestimated how accurate the results would be. An educational approach along with recommendations for screening, as opposed to a mandate for screening, could effectively limit this lack of understanding among the general population (10, 12).

A more in depth understanding of the risks and potential outcomes from prenatal screening may also alleviate some of the anxiety-related problems that arise from prenatal screening. Using this educational campaign, a woman who might otherwise expect her risk of Down syndrome to be, for example 1 in 100, may cause her to experience symptoms of anxiety. Upon being educated about her true, lower risk for Down syndrome, her anxiety and stress related the pregnancy would be reduced, therefore lessening the chance for prenatal complications from an increased anxiety level. The concepts of undue anxiety and depression are tightly intertwined. Once a woman is educated regarding her risks, she is likely to experience less anxiety, which will ultimately lead to a more healthy pregnancy outcome (10, 12, 11, 13).

Additional studies have shown that women generally underestimated their personal risk of carrying a fetus with Down syndrome, or other congenital anomalies. For example, Statham et al found that more than 40% of women were uneducated about how a “1 out of something” risk would apply to their pregnancy (12). More telling in support of an educational approach rather than a mandate screening is a study conducted by Santalahti et al in 1998. This study found that women with higher educational levels had a better understanding of the risks of carrying a fetus with Down syndrome (9). These findings are integral in understanding how an educational approach can have a major impact on the rates of women who seek screening, and for those who do, a better understanding of their individual screening outcomes, without going so far as to mandate screening.

A less intrusive and more acceptable way of ensuring that the women in the highest risk category for a fetal abnormality will get the requisite screening, is educational campaign combined with a recommendation for prenatal screening. Similar types of campaigns have been implemented with populations of pregnant women. A study conducted in South Carolina to promote folic acid use among pregnant women to reduce the risk of spina bifida is an example of a successful educational campaign. The data collected in this study suggest that a well structured, financed and controlled campaign to educate women about their risks for fetal anomalies can be successful. This particular campaign saw an increase of folic acid use among pregnant women increase from 2% to 40%, a dramatic and promising finding for further educational campaigns with this type of sample (14).

Before resorting to a mandate for prenatal screening, an alternative approach is to combine recommended screening to women at high risk with a campaign to educate women on their individual risk factors and understanding of the results. This approach would likely be easier to implement and maintain, as it would less intrusive and allow women to take control over their prenatal testing.

Reasoned Action vs. Power and Coercion

The Theory of Reasoned Action incorporates behavioral intention, perceived social norms and attitudes, where behavioral intention equals a person’s perceived social norms plus their attitudes about the behavior (15). Mandating screening would force women to make critical decisions who might not, under other circumstances, ever choose to have prenatal screening. Advanced maternal age, prior pregnancy complications and ultrasound indications are all risk factors that (according to social norms) that would be weighed when determining whether to have prenatal screening, or not.

Using the Theory of Reasoned Action, one could argue that all women who were concerned about carrying a fetus with a genetic abnormality, such as Down syndrome, or women who were at a predisposed risk (i.e. advanced maternal age, prior pregnancy complications etc.) would seek prenatal screening, without the mandate. A mandate on screening essentially eliminates behavioral intentions. By requiring prenatal screening, social norms would be removed from the equation as well as a woman’s attitudes towards the behavior.

Studies on mandated treatment have investigated the effectiveness of such campaigns on populations such as the mentally ill. Results indicate that the use of power, coercion and mandating increased avoidance behavior and delay of treatment. Over a third of the population in this particular study reported that they experienced at least one barrier to treatment associated with fear and forced treatment (16).

These same types of perceived barriers to treatment can be expected when initiating a mandate for prenatal screening. Women have perceived fears associated with prenatal screening, both in relation to risks of screening and potential positive results. These fears can cause women to avoid the mandated screening or delay treatment, which can be the most detrimental for women who are at the highest risk for carrying a fetus with Down syndrome. Educational campaigns instead of coercive campaigns would be more effective in promoting awareness and would educate women regarding their personal risks, which would in turn increase the number of women who have the highest risk of fetal anomalies to seek screening.

The power-coercive approach is not always an effective means to initiate change. In addition to cognitive influences on behavior, there are also non-cognitive determinants such as ingrained social norms relating to prenatal screening which the power-coercive approach does not take into consideration. Instead of promoting cognitive reasoning to seek prenatal screening, a power-coercive approach effectively eliminates thought and reasoning and a woman’s behavioral intention. For a public health approach to be an acceptable means to initiate change, it should promote choice and education, instead of eliminating them from the equation. These characteristics of a power-coercive approach to change can make it a difficult to be accepted by the community and may be looked upon negatively. Negative attitudes toward a public health approach will only decrease the changes if success (17).

Conclusion

A mandate on prenatal screening for Down syndrome (Trisomy 21) for all pregnant women proves to be an ineffective public health approach to a problem. The health outcome in question is whether or not the public health of the general population would benefit from all women receiving screening.

There are some obvious faults in this approach, as stated above. First of which is the undue anxiety and depression that would be increased among the pregnant population. False positives can be high in screening tests. False positives in the first trimester of pregnancy can produce an unhealthy level of stress for the mother that may in turn produce unsafe high blood pressure during pregnancy known as preeclampsia as well as other fetal complications and anomalies. It would be in the best interest of public health to minimize the number of unnecessary fetal complications and associated maternal complications such as preeclampsia, as well as increased rates of anxiety and depression. This can be achieved by an educational approach combined with recommended prenatal screening.

The approach of mandating prenatal screening has a fundamental flaw; it lacks an educational component. Studies have found that women are generally undereducated or uneducated in relation to screening results and how they relate to their pregnancy. Some women believe that screening tests are conclusive while others are unaware that an invasive procedure is scheduled after a screen positive in the first trimester of pregnancy. With an educational campaign, women will have the opportunity to learn what their risk factors are and how to interpret results. This will limit the number of women who seek screening to those who choose it and those who are at the highest risk.

Finally, a power coercive campaign can be looked upon negatively by the community. These types of campaigns have notoriously caused a backlash of delayed treatment and fear. As referenced previously, with a population of mentally ill patients, the power coercion method was ineffective. This type of mandate would also take away a woman’s behavioral intention, leaving only the government mandate to force a mandate and eliminate the opportunity to make the most effective decision for their individual health. Generally, the ability to make decisions without being mandated promotes a more healthy community, and population interested and dedicated to their own health outcomes.

REFERENCES

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