OBJECTIVE

The objective of this study is to evaluate if racial and other demographic disparities exist between patients who enrolled or declined participation in a congenital cytomegalovirus (cCMV) newborn universal screening research study.

METHODS

We examined characteristics for patients approached over a 2-year period to participate in a cCMV newborn screening study. Maternal characteristics included age, race, ethnicity, preferred language, interpreter need, insurance type, and number of living children. Recruitment period was also examined (pre-pandemic January 1 to December 31, 2019, and during COVID-19 July 1, 2021 to June 30, 2022). Characteristics were compared for patients who enrolled in the study and those who declined participation using descriptive statistics and logistic regression.

RESULTS

Of the study sample (n = 4156), 3148 (75.7%) patients enrolled and 1008 (24.3%) declined. Declined participation rates were 47.2% among non-Hispanic (NH) Black patients and 15.7% among NH White patients. In the final adjusted model, NH Black patients (OR 3.14, 95% CI 2.53-3.90), those with public insurance (OR 1.81, 95% CI 1.48-2.22), and those with four or more children (OR for 4 + children 1.45, 95% CI 1.11-1.90) were the most likely to decline research participation.

CONCLUSIONS

NH Black and NH multiracial patients were among the most likely patient groups to decline study participation. These groups have previously been identified to be at increased risk for cCMV. This differential participation in cCMV research could result in underreported estimates of prevalence. Future cCMV research, including surveillance studies, should include documentation of differential participation to both address efforts to improve research participation and document and address potential bias in results.