Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial.

Obtaining informed consent for bloodspot research from newborn screening is particularly challenging due to the hectic environment of the postnatal period and the relatively abstract nature of future, unspecified research on the biospecimens. A randomized controlled trial was conducted in three Michigan hospitals to compare two different consent processes (video and interactive tablet "app") with standard brochure-based consent in the Michigan BioTrust for Health. Results indicated higher knowledge scores for the video and app groups as well as significantly higher scores on satisfaction, amount of information, and clarity with the information provided. More research is needed to find the right amount of information for informed decision-making, and additional feasibility studies are needed to assess implementation strategies.

Improving the Rate of Sufficient Sweat Collected in Infants Referred for Sweat Testing in Michigan.

Objective. Sweat collected for testing should have quantity not sufficient (QNS) rate of ≤10% in babies ≤3 months of age. Michigan (MI) cystic fibrosis (CF) centers' QNS rates were 12% to 25% in 2009. This project was initiated to reduce sweat QNS rates in MI. Methods/Steps. (a) Each center's sweat testing procedures were reviewed by a consultant. (b) Each center received a report with recommendations to improve QNS rates. (c) Technicians visited other participating centers to observe their procedures. Results. A total of 778 infants were identified as positive via CF newborn screening over a 2-year period. The mean age at time of sweat test was 23.2 days (SD ± 13.0 days). The overall QNS percent decreased from 14.4% to 9.5% (P = .04) during the study. Conclusion. This project and teamwork approach led to a decrease of sweat test QNS rates, opportunities to solve a common problem, and improved quality of care.

From newborn screening to population health research: implementation of the Michigan BioTrust for health.

In June 2009, the Michigan Department of Community Health launched the Michigan BioTrust for Health to improve preservation and utility of residual dried blood spots from newborn screening (NBS) for biomedical research while maintaining public support and integrity of NBS. In this article, we chronicle implementation of the BioTrust and document its impact on NBS. Overall, the percentage of new parents who consent to possible future research use of their children's dried blood spots through the BioTrust has remained consistent with previous public opinion surveys. No significant increase in refusal of NBS has been observed despite increased publicity. There was, however, a slight increase in requests to destroy samples following completion of NBS, indicating readily accessible opt-out information. Given adequate training and cooperation of birthing hospital staff, as well as outreach education for parents and health-care providers, we conclude it is possible to implement a biobanking initiative without adversely impacting NBS.

Evaluation of genetic counseling among cystic fibrosis carriers, Michigan Newborn Screening.

OBJECTIVE: A quality improvement (QI) strategy to improve the rate of genetic counseling (GC) services was initiated in cystic fibrosis (CF) care Center E in 2010. This statewide study was conducted to determine: (1) GC rates before and after implementation of the QI strategy at Center E; (2) characteristics associated with not receiving GC; and (3) topic areas addressed during GC. METHODS: The retrospective study included 1,097 CF carriers born from 2008 to 2011 identified through Michigan's Newborn Screening Program. Rate of GC services was determined for Center E and the other four CF centers before and after the QI change. Bivariate and multivariable logistic regression was used to determine associations between select characteristics and not receiving GC. Topic areas discussed during GC sessions were assessed using frequency tables. RESULTS: Rate of GC services in Center E increased from 23% in 2008-2010 to 91% in 2011, while at the other centers approximately 92% received GC services across those years. In 2008-2010, being seen at Center E and black race were significantly associated with increased likelihood of not receiving GC services in adjusted analyses. In 2011, neither characteristic was associated with receipt of GC. Of 16 target topic areas, all were discussed in 85% of GC sessions. CONCLUSIONS: Implementing a QI strategy of providing sweat test results at the GC appointment within Center E resulted in more CF carriers receiving comprehensive GC services. Center-specific procedure differences should be assessed to increase rate of GC services following a positive CF newborn screen.

Variation in immunoreactive trypsinogen concentrations among Michigan newborns and implications for cystic fibrosis newborn screening.

OBJECTIVE: To investigate variation in immunoreactive trypsinogen (IRT) concentrations by race, sex, birth weight, and gestational age and their implications for the use of percentile-based cutoffs for cystic fibrosis (CF) newborn screening (NBS) programs. PATIENTS AND METHODS: This cross-sectional population-based study of resident infants screened in Michigan investigates associations between demographic and perinatal variables and IRT concentrations after controlling for covariates. This study also analyzed how 96th and 99.8th IRT concentration percentiles values calculated by Michigan NBS vary by demographic and perinatal factors. Characteristics of infants having high (≥99.8th percentile) IRT concentrations and negative DNA tests are also explored. RESULTS: IRT mean concentrations and percentiles vary significantly by race, birth weight, gestational age, and to a lesser degree by sex. The greatest variation in mean IRT concentrations was observed among racial categories; black infants had an adjusted mean concentration of 36 ng/ml and Asian/Pacific Islander infants had a mean concentration of 25 ng/ml compared to an average concentration of 28 ng/ml in white infants and infants of other races. CONCLUSIONS: Variation in IRT concentrations resulted in the over-representation of certain groups referred for secondary testing, particularly referrals for sweat testing based on very high (≥99.8th percentile) concentrations alone, which is no longer recommended in Michigan. Further research may be warranted to evaluate initial IRT cutoffs used for CF NBS.