Factors associated with utilization of maternal serum screening for Down syndrome in mainland China: a cross-sectional study

The purpose of this study was to identify factors affecting the uptake of MSS by Chinese pregnant women so that suitable policies can be developed to ensure MSS is equally accessible to the whole population of mainland China.

From the univariate analysis, all of the factors chosen according to Andersen’s behavioral model were associated with MSS utilization, although some were confounding or indirect factors. Four multilevel regression models were applied stepwise to the data, according to the flow of factors of Andersen’s behavioral model. Major associated factors found through the univariate analysis were included. The results of the multilevel regressions were consistent with Andersen’s behavioral model. All five kinds of factors (contextual, predisposing, enabling, need, and health behavior) from Andersen’s behavioral model were found to be associated with MSS utilization. Aside from the respondents’ demographic characteristics, three intermediate factors, the respondents’ number of prenatal checkups, DS knowledge, and attendance at maternal preparation classes all played an active role in their MSS uptake decision. MSS utilization was also affected by the respondents’ prenatal care service providers. When the three intermediate factors were chosen as outcome variables to fit a further three regression models, the respondents’ education level was a key demographic factor associated with all four outcome variables.

Combining the results of the four models revealed that insufficient education is the single most important demographic factor for MSS underutilization. Also, regular prenatal checkups, health knowledge and attendance at maternal preparation classes were associated with greater MSS uptake, as were the establishment of a positive relationship between the participant and her prenatal care providers, while this relationship was independent of the relationship found above.

Uptake rates for MSS in mainland China are lower compared with the uptake of prenatal screening in other countries (35 % in 1993 and more than 50 % since 2007 for the United Kingdom [22, 23], 44 % in 2004 for Australia [24], 50 % in 1992 and 72 % in 2011–2012 for the United States [25], 84 % in 2006 for Denmark [26]). The experience of the above countries showed that progress in increasing the prenatal screening rate stemmed from using advanced technology and employing effective health policies [27–29]. China introduced MSS technology about 10 years after developed countries. Besides the regulations on technology administration and the national standard operating protocol for MSS and invasive diagnostic test delivery (mainly as clinical practice guidelines) published in 2003 and 2010, there have been no other specific national policies to support better access to MSS and invasive diagnostic tests.

The uptake rate of MSS (23 % of the combined tests between 2009 and 2011 [13]) in The Netherlands was lower than that found in mainland China. The Netherlands maintain a more uniform healthcare system and have better prenatal screening accessibility than China. The screening technology was introduced to the two countries at the same time. China may have a higher uptake rate for MSS than The Netherlands because the combined test was not routinely provided in The Netherlands but was in some healthcare institutions in China. Similar to the experience of other developed countries [14, 16, 30, 31] and earlier research of the Zhejiang data [32], there are regional variations in MSS utilization in China.

Earlier studies from other countries have shown that the factors associated with uptake of MSS and further diagnostic procedures include individual and external factors. Individual factors include age, parity, socioeconomic status, ethnicity, and religion; external factors include local health system and policy arrangement, and providers’ characteristics and attitude [33–39]. In China, more attention is given to the vulnerable population when focusing on essential public health service utilization. Factors including age, gender, education, occupation, insurance status, income, capacity of service providers, and health resource distribution were taken into consideration when suggestions for equitable access were discussed [6]. Similar results regarding the key factors to consider were obtained in this study.

Issues relevant to prenatal test uptake include income and the effect of insurance coverage. In this study, the respondents’ insurance status was not found to be a factor associated with MSS uptake rate, although a review of the Chinese literature found social health insurance was considered a significant enabling factor of service utilization. Prior to the launch of new health system reforms in 2009, MSS was not covered by social health insurance, and most users had to pay for it themselves. The prices then of MSS and further invasive tests were 120 Yuan RMB and over 1000 Yuan RMB, respectively. However, at that time, there was no association between family income and MSS utilization, which indicated that the cost of the test was not the key factor in test underutilization. This suggests that some pregnant women missed MSS not because of financial reasons, but because they were not offered the test—or if the service was provided, the pregnant women may have simply opted out of screening, no matter the price or insurance coverage.

The inverse relationship between age and MSS utilization found in this study was unexpected. In this study, respondents’ age can be treated as either a predisposing factor or a need factor. Older women have a higher risk of having a child affected by a chromosomal disorder, such as DS, than younger childbearing women, so those older than 35 years should be more likely to seek MSS and further diagnostic tests. However, results of this study showed the opposite. One possible reason was that some respondents were recommended to have invasive diagnostic tests directly. Similar studies published in other countries have shown that it was difficult to draw firm conclusions as to the principal factors influencing older women’s uptake of prenatal screening and diagnostic services, and more research is needed [40]. There may be instances such as an older pregnant woman who had already had one healthy baby feeling immune to the increased risk of BD, so not seeking MSS. Miscarriage risk from invasive diagnostic tests could be another potential explanation for lower test uptake rate. Presently, there is not enough related information to draw a definitive conclusion.

Last, the effect of service providers should be noted, as shown by Gitsels-van der Wal et al. who reported a different uptake rate of the combined test among different midwifery practices [13]. Among three models when providers’ levels were included, its effect can only be found in model 1 where MSS utilization was the outcome variable, and women delivered in high-level healthcare institutions were more likely to use MSS. Results of the other two models (models 2 and 3) indicated that there was no relationship between respondents’ health knowledge, frequencies of routine prenatal checkups and service facilities’ level. The process and content of routine prenatal checkups is regulated in China, and all health facilities providing prenatal checkups must meet basic requirements. MSS is treated as a highly technical procedure and only a proportion of health facilities are able to reach the required standard set by the MOH to provide it. Most of the prenatal diagnostic centers who did reach the required standard were tertiary or secondary healthcare institutions. Women who received routine prenatal checkups from other health facilities would probably miss MSS unless there was a network of services that could be accessed.

The limitations of this research should also be mentioned. It is unlikely that the widely differing utilization rates across the country can be explained by variation in individual values alone. Although data on the level, type, and location of healthcare institutions where the respondents delivered (and also received their prenatal care service generally) were collected, detailed information about healthcare resources, and in particular whether the facility could deliver MSS or invasive diagnostic tests, was not collected. Gaps in service capacity and capability among different healthcare institutions could be very important for service utilization. The results of our study show that tertiary healthcare institutions play an active role in MSS and further diagnostic test utilization.

From this research, two policy strategies can be implemented to ensure that all women have equal access to prenatal screening. First, preferential policy strategies should be developed for the vulnerable population. Less-educated women should be provided with enough resource support to help them build their health beliefs, improve their personal health practice, acquire health knowledge and use MSS.

Second, policy strategies on MSS delivery should be developed. International experience indicates that a primary healthcare-centered integrated delivery model was effective and efficient in MSS and further diagnostic test delivery [41]. Till recently, MSS delivery in China is mainly through tertiary healthcare institutions or prenatal diagnostic centers. Service networks are limited, which warrants a change in policy. The transformation of MSS delivery should improve regional variation on MSS uptake rate, as long as the primary healthcare is of sufficient quality, and its responsibility is identified [42].

Chinese health system reforms in 2009 announced a strong Government responsibility for population health and a state-funded public health system. Better health support and policy arrangements, for example social health insurance coverage for the prevention of birth defects and free screening for high-risk pregnant women, will be highlighted.

At the start of 2015, the first 109 healthcare institutions were granted permission to deliver noninvasive prenatal tests (NIPT) from the MOH of China. Although there was not a large sample report in China about its sensitivity and specificity, the risk of miscarriage with NIPT was definitely lower than with MSS plus an invasive diagnostic procedure. The barriers to accessing prenatal screening services found in the present study should also be applied to NIPT uptake.

Further research might expand on this study by combining the providers’ characteristics with the users’ to gather more information.