The results show that the guidelines for the 11th to 13th week ultrasound scan were not uniformly interpreted and followed when the doctors assessed the constructed case histories. The age criterion was not followed, and women were granted prenatal diagnosis without an indication. Many of the private gynaecologists answered that they would have measured the NT themselves, even though they are not allowed to perform prenatal diagnosis. Distinguishing between ultrasound in routine antenatal care and ultrasound as prenatal diagnosis is difficult.
The results indicate attitudes to constructed case histories, and the question of what kind of examinations the women would have been offered in real life remains unanswered. We nevertheless assume that there is a correlation between how case histories are addressed and clinical practice. The questions pertaining to the age limit and to using anxiety as an indication for prenatal diagnosis were also asked independently of the case histories. These results indicate that many doctors do not enforce the age limit rigidly, and that women are offered prenatal diagnosis on the basis of anxiety as an indication in daily practice as well.
The first case history illustrates the problems associated with the interpretation of the age criterion. Women aged 37 and 38 have approximately an equal risk of having a child with a chromosome aberration (5). There is no good reason why only women aged 38 should be offered prenatal diagnosis. In this case history, the woman was 37 years and two months old at the time of the examination. She would have been 37 years and nine months old at the expected time of delivery. The regulations do not specify whether the age criterion applies to the time of the examination or the expected time of delivery (2). The information leaflet on prenatal diagnosis, which is supplied to pregnant women, and also the guidelines issued by the Norwegian Gynaecological Association, specify the age limit as 38 years at the expected time of delivery (3, 13). All the doctors at the fetal medicine centres were aware of this specification. However, only a minority of the doctors responded that they adhere rigidly to the age criterion, and women who are approaching 38 years at the expected time of delivery are often offered prenatal diagnosis.
More than half of the doctors at the fetal medicine centres would have offered their colleague in case history no. 2 an ultrasound examination including prenatal diagnosis. Four of five respondents in the Directorate of Health were of the opinion that these doctors are violating Norwegian law. Only one of the doctors would have offered this colleague a CUB test, the others would have performed ultrasound with measurement of NT. It may appear that the doctors perceive this violation of the regulations to be less serious if the blood tests are omitted.
Women from countries where screening for trisomy 21 is implemented may find it difficult to accept the strict Norwegian regulations. If their request is rejected in Norway, they travel to their home country to be examined, and many of them come back with test results that Norwegian doctors must consider following up. This may be the reason why one-third of the doctors at the fetal medicine centres would grant prenatal diagnosis to the woman in case history no. 3.
The fourth case history highlights the distinction between ultrasound as part of routine antenatal care and ultrasound as an element of prenatal diagnosis. If suspicion of an abnormality is raised by ultrasound in routine antenatal care, the woman should be referred. Increased NT is the most important marker for chromosome aberration, but measurement of NT is defined as prenatal diagnosis. According to the guidelines, a referral should therefore be based on an impression of increased NT, and not on an accurate measurement. Nevertheless 33 (52 %) of the private gynaecologists reported that they would make a referral only if their own measurement had revealed increased NT. The distinction between examinations based on medical indications on the one hand and prenatal diagnosis on the other is not uniformly practised. One reason might be that Norwegian doctors feel insecure about whether or not they are breaking the law by measuring the NT.
A «Perspectives» article published in the Journal of the Norwegian Medical Association in 2009 argues that good, quality-controlled information is a prerequisite for reflective and responsible pregnant women to make informed and autonomous decisions (14). The distinction between ultrasound as part of routine antenatal care and ultrasound as prenatal diagnosis renders this goal difficult. While strict requirements apply to information and guidance prior to a prenatal diagnostic examination, these obligations do not apply to examinations on the basis of a medical indication.
According to the guidelines, anxiety constitutes a medical indication for ultrasound in regular antenatal care, but not for prenatal diagnosis. The respondents in the Directorate of Health were of the opinion that the woman in case history no. 5 was not entitled to prenatal diagnosis. In practice, many doctors at the fetal medicine centres would nevertheless offer this, with anxiety as an indication. Thus, anxiety functions as a back door to prenatal diagnosis. Our results indicate that Norwegian doctors are uncertain as to whether anxiety is an indication for prenatal diagnosis. We can also see that there is a difference between the number of doctors (n = 16) at the fetal medicine centres who granted prenatal diagnosis, and the number of doctors (n = 9) who claimed that the same woman was entitled to prenatal diagnosis according to the guidelines. This indicates that many doctors would choose to grant prenatal diagnosis in spite of their opinion that according to the guidelines the woman has no such entitlement.
Defining what constitutes «a difficult life situation» is complicated. Should the couple themselves and/or the referring doctor assess this, or should the doctor at the fetal medicine centre make the decision? Subjective assessments form the basis, and the case history illustrates the extent to which the outcomes may vary. The respondents in the Directorate of Health fairly unanimously agreed that this woman was entitled to prenatal diagnosis, but fewer than half of the doctors at the fetal medicine centres concurred. Our results indicate that doctors will be more likely than the respondents in the Directorate of Health to accept prenatal ultrasound on the indication of «anxiety», while with regard to «a difficult life situation» the opposite is the case.
It has been claimed that it is easier to have prenatal diagnosis performed in Central and Eastern Norway than in other regions of the country. A report from the Directorate of Health published in 2011 showed an unbalanced distribution between the counties, and the number of prenatal diagnostic examinations seen in relation to the number of pregnant women older than 38 in the various counties confirms this. In 2009, this ratio was 2.4 in Sør-Trøndelag, 1.8 in Oslo, 1.1 in Rogaland and 0.6 in Aust-Agder (8). Our study did not reveal any differences in the assessments made by the various fetal medicine centres.
We conclude that many doctors failed to comply with the regulations of the Biotechnology Act when assessing the constructed case histories. There was also disagreement regarding the interpretation of the guidelines between the doctors on the one hand and the respondents in the Directorate of Health on the other.