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PubMed2003

Examination of the communication practices between state newborn screening programs and the medical home.

BACKGROUND: As outlined in the Newborn Screening Task Force report published in August 2000, the newborn screening system is more than just testing, but also involves follow-up, diagnosis, treatment, and evaluation. As such, multiple professional and public partners need to be adequately involved in the system to help ensure success. In addition, newborn screening programs are state-based; therefore, policies and procedures vary from state to state. Historically, there has been little uniformity between state newborn screening programs. OBJECTIVE: To examine the communication practices of state newborn screening programs in the United States, particularly in relation to the medical home. METHODS: A facsimile survey of program staff in all US newborn screening programs. Survey data were collected in August 2000. RESULTS: All 51 programs participated. States were questioned about whether or not they had a procedure to identify the infant's medical home before the child's birth. Twelve states (24%) indicated that there was a procedure in place, whereas 39 states (76%) indicated that either no procedure existed or that they were unsure. In contrast, all state programs (except 1) indicated they notified the primary care physician about abnormal results and the need for follow-up. In addition, state programs reported that primary care physicians have responsibilities within the newborn screening system, particularly related to communicating with parents about screen-positive results and coordinating the collection of a second specimen. Thirty states reported that they directly notified parents of screen-positive infants of results and the need for follow-up as well. In regard to informing parents about newborn screening, 45% of states indicated that primary care physicians had some responsibility in informing parents about newborn screening. Most often, parents were informed about newborn screening just before specimen collection, and the most commonly used techniques to educate parents were informational brochures and conversation. Thirty-five states reported that they engaged in long-term tracking of infants after diagnosis confirmation. Only about half of these states provided long-term tracking of all of the conditions included in their state's newborn screening test panel. Of these 35 states that engaged in long-term tracking, 25 reported that they requested patient information from the primary care physician and/or subspecialist about ongoing treatment and follow-up. CONCLUSIONS: Newborn screening roles and responsibilities vary tremendously between states. Improvements in communication and better-defined protocols are needed, particularly between state newborn screening programs and the medical home. Many states identified the medical home as having significant responsibilities related to the short-term follow-up of screen-positive infants. Identification of the correct medical home before testing would help to reduce unnecessary time and frustration for state newborn screening programs, especially in the follow-up of infants that are difficult to locate. In addition, primary care physicians (ie, the medical home) need to have appropriate and ongoing involvement, including a mechanism to provide feedback to their state newborn screening program. This is particularly important given the adoption of tandem mass spectrometry by an increasing number of states, and the likely expansion of newborn screening in the future. Recommendations include the following: Primary care physicians should have appropriate and ongoing involvement in the newborn screening system and should be appropriately represented on state newborn screening advisory committees. States should develop protocols to identify the medical home before heelstick screening. States should work with families, primary care physicians, and prenatal health care professionals to develop well-defined systems for pretesting education of parents. All newborn screening results (both positive and negative) should be sent to the infant's medical home. If results are not received by the medical home, efforts should be made to obtain results. Medical homes and subspecialists should submit follow-up information on screen-positive infants and infants with confirmed diagnoses to the state newborn screening program, regardless of the existence of state requirements to do so, and efforts to build enhanced direct communication systems, linking state newborn screening programs to community-based medical homes, should continue.

Communication↗
PubMedDate not supplied

Newborn screening: should explicit parental consent be required?

Newborn screening, the first population-based metabolic screening program has been universally conducted for several decades. With the advent of genetic technologies, many genetic/metabolic disorders can be detected pre-symptomatically but might be untreatable. Since the benefits and risks of screening tests on newborns are not fully known, newborn screening programs confront both legal and ethical challenges. This article aims to explore the following questions: (1) Is explicit parental consent required? (2) What level of consent should be sought? and (3) Is screening in the absence of explicit consent legally defensible? This article considers: (1) the introduction of newborn screening, (2) the conditions under which it is conducted (voluntary vs. mandatory), (3) the argument over whether explicit parental consent is required, (4) the conditions under which implied consent may be assumed, and (5) the principles of informing parents. This article concludes that implied consent is not acceptable except for traditional routine screening. Healthcare professionals should provide information about the known benefits and risks of testing and recognize the parental right of refusal. Finally, since the absence of explicit parental consent to newborn screening is not legally defensible, children's advocates should lobby for legislation permitting it in the absence of explicit consent in specific circumstances.

Humans↗
PubMed1997

State-to-state variations in newborn screening policies.

BACKGROUND: Population-based newborn screening for genetic and metabolic disorders is standard practice in all states in the United States. Policies governing newborn screening are determined at the state level; however, and thus, a great degree of variability exists between states regarding many facets of such screening. OBJECTIVE: To gather information relating to the processes, content, and outcomes of policy making affecting newborn screening programs across the United States. METHODS: We surveyed the directors of newborn screening programs for each of the 50 states using a postal questionnaire. The questionnaire solicited information about the specific tests incorporated in each state's panel of screening tests and information pertaining to the policy-making processes by which decisions are reached regarding this testing. RESULTS: Substantial variation exists across states regarding both the processes of policy formulation and the outcomes of decisions made about newborn screening. All states currently screen for phenylketonuria and congenital hypothyroidism. Extensive variation exists across states in testing for other disorders. The processes by which state policy makers arrive at decisions in this area are extremely diverse. Almost three fourths of the states have standing expert advisory bodies who issue recommendations regarding screening program modifications, but the authority granted to these panels varies substantially. Some regional cooperation in this area exists. CONCLUSIONS: Further development of regional cooperation could offer some states greater efficiency in both laboratory testing and screening policy formulation. From the standpoint of an individual state. Wisconsin's approach to policy development in this area is described as a model worthy of consideration.

Health Policy↗
PubMed2003

Newborn screening in Indonesia.

In Indonesia, newborn screening is not yet a policy, and the incidence of preventable causes of mental retardation detected by newborn screening is not known. Congenital hypothyroidism (CH) is not infrequent. Without a screening program, unrecognized CH patients were neglected for years. Since May 1999, the International Atomic Energy Agency (IAEA) has assisted in starting a CH Newborn Screening Project to estimate the local incidence of CH and to evaluate the problems associated with the screening. In June 2000, a pilot study was conducted using primary TSH measurement, supplemented by T4 in infants with elevated TSH. The target was to screen 12,000 newborn infants, using cord blood serum taken at birth, or a heel prick between 2 to 6 days of age. Between June 2000 and February 2001, 3,534 neonates born in 4 hospitals were screened using cord blood serum taken at birth (recall rate 3.3%). From March 2001 onwards, the heel prick method was used and participating hospitals increased from 4 to 7. Using this approach, until August 2001, 3,309 samples were analysed and the recall rate was much lower (0.64%). The number of unsatisfactory samples was relatively high due to an unstable process of blood collection. Parental refusal and low acceptance of screening among policy makers resulted from lack of awareness of the dangers of CH, and the screening program was not considered a health priority. Recall of patients after screening was a major barrier, with problems in tracking patients arising from urbanization and a high rate of relocation. To advance the CH screening program nationwide, infrastructure must be improved along with the recall system, and education as well as information campaigns for parents and medical professionals must be intensified. The Department of Health must be persuaded to give a national mandate.

Attitude to Health↗
PubMedDate not supplied

Counselling in a hospital-based newborn screening service.

The newborn screening and parent counselling service at Howard University Hospital is an integral component of services to newborn infants. The organization of this service presents a model that appears appropriately suited to the general organization of health-care delivery in the United States. Significant features of this service are: hospital-based planning and management of the service; integration of multiscreening components into a unified service; tight integration between screening, education, and counselling; a hospital-based team that provides coherent and in-depth counselling for all screening-related needs; a forum for orienting parents to the benefits of preventive health care; and a context in which to teach students the applied aspects of preventive health care based on early detection of disorders. If we are to have high quality newborn services in this area it may be incumbent on hospital-based health professionals to designate this as a required component of adequate hospital-based services for newborn infants rather than relinquishing the initiative to centralized health planners and legislators.

Counseling↗
PubMed2003

Psychosocial issues in newborn screening for cystic fibrosis.

Newborn screening for cystic fibrosis remains controversial because there is still little agreement that prophylactic interventions provide substantial long-term benefits. In such situations, where there are some medical benefits and the costs are not prohibitive, it is important to consider the psychosocial implications of screening. This paper reviews the evidence on the psychosocial issues raised by newborn screening for cystic fibrosis, in particular the issues of parental attitudes to screening, the evidence from families with an affected infant, the evidence from families with a carrier infant and the lessons for service delivery.

Cystic Fibrosis↗
PubMed2006

Status of newborn screening programs in the United States.

BACKGROUND: Newborn screening programs have expanded over the years; currently, many programs screen for dozens of congenital conditions that, if not detected and treated early, could result in catastrophic health consequences, including death. Some programs, however, still require universal newborn screening for only a few conditions. Although all 51 US programs (all states and the District of Columbia) have statutory screening requirements and similarities exist in many parts of the different screening systems, the enabling statutes, rules, regulations, protocols, and financing strategies vary dramatically. Consequently, there is a significant lack of equity in newborn screening services across the country. METHODS: We investigated program variations existing in and around January 2005 and provide baseline information with which future program comparisons can be made. We used program surveys, electronic searches of legislation, and individual input (validation) from program decision-makers to create a reservoir of program information. RESULTS: Included is a compilation of pertinent newborn screening statutes, information from genetic privacy statutes that potentially affects newborn screening programs, and a review of state laws that affect specimen and information retention. In addition, program policies related to the use of residual newborn screening blood spots are reviewed, along with the developmental processes affecting program informational brochures, including the information contained and the strategies for brochure dissemination. CONCLUSIONS: Building on a progressive and successful history, newborn screening continues as an example of an essential population genetic screening program. As the intricacies of screening systems have increased in complexity, so have the policy issues that shape program successes and failures. The summary information in this article provides a basis for national and individual program evaluation. Indeed, some of the information reported here has already been useful for program refinements reported elsewhere in this supplement.

Confidentiality↗
PubMed1995

The impact of newborn screening on cystic fibrosis testing in Victoria, Australia.

Newborn screening for cystic fibrosis (CF) by examining the levels of immunoreactive trypsinogen was introduced in Victoria in 1989. This was modified by the addition of testing for the common CF gene mutation, delta F508, in 1990. Problems with the first newborn screening protocol were overcome with the addition of the DNA test as there was no need to contact the majority of families, there was a reduced number of sweat tests, and less anxiety was experienced by parents. The mode of diagnosis changed from failure to thrive, steatorrhoea, rectal prolapse, and family history to diagnosis through newborn screening. Newborn screening dramatically reduced the time of diagnosis of CF to approximately six weeks or less in the majority of cases. Since the introduction of newborn screening, the uptake of prenatal diagnosis in CF families has increased two and a quarter fold.

Algorithms↗
PubMed1999

The future of newborn screening belongs to obstetricians.

Newborn screening has been a mainstay of genetic testing for several decades. Molecular biological techniques, pervasive in genetics and in medicine, are shifting the focus of such testing from enzymology to molecular diagnosis. Concomitant developments in the isolation of fetal cells from maternal blood enable molecular analysis to be performed not just postnatally, but in fact as early as the late first trimester. Potential advantages of first trimester prenatal diagnosis of those disorders currently performed postnatally include more reproductive options for couples, and, in selected cases, the fact that certain genetic disorders can be treated much earlier in development, thereby potentially ameliorating the sequelae of these disorders. Thus, the future of newborn screening will belong as much to the obstetrician as to the pediatrician, if not more so.

Female↗
PubMed2004

Recent advances in newborn screening for neurometabolic disorders.

PURPOSE OF REVIEW: Newborn screening for neurometabolic disorders offers a unique and promising opportunity to practice preventive medicine in children with diverse inborn errors of metabolism. The benefits of the early identification and presymptomatic treatment of these disorders are now recognized. RECENT FINDINGS: The rapid pace of developments in the field of expanded newborn screening has been made possible by technological advances in the ability to detect multiple compounds diagnostic of diverse inborn errors of metabolism in neonatal dried blood specimens. Launched by the success of newborn screening for phenylketonuria, experts in this area are optimistic that further public health benefits will follow the same pathway. This review highlights the population model and public health issues inherent in advances in newborn screening for selected neurometabolic disorders. Current and future diagnostic and therapeutic, as well as social and ethical, dilemmas are discussed. SUMMARY: Newborn screening represents one of the major child health advances of this past century. As developments in the field of expanded newborn screening for neurometabolic disease progress forward, the long-term success of this important project will pose future challenges and opportunities.

Blood Chemical Analysis↗
PubMed2025

The acceptability of blood spot screening and genome sequencing in newborn screening: a systematic review examining evidence and frameworks.

BACKGROUND: Population-wide newborn blood spot screening programmes are a successful public health intervention used to detect whether the baby is at risk of certain rare conditions, with the aim of earlier diagnosis and provision of optimal care and treatment. Evaluating candidate conditions to include in newborn blood spot and genetic sequencing raises questions regarding acceptability to parents/carers. METHODS: In the context of the possible expansion of the newborn blood spot screening programme in the United Kingdom, this review aimed to systematically review research on the acceptability to parents of newborn blood spot screening and genetic sequencing. A protocol was developed prior to commencing the review and was registered on the PROSPERO database. A team of researchers carried out the review, with checking at all stages carried out by at least two individuals. We included research published after 2013 with participants who were pregnant or a recent parent of a newborn and were resident in a high-income country. We included quantitative and qualitative studies that investigated the acceptability to parents/carers of newborn blood spot screening or genetic sequencing. Quantitative studies were narratively synthesised, and theories/frameworks identified and evaluated. Qualitative studies were analysed for recurring themes, and a meta-synthesis was carried out to compare and contrast these two types of data. We quality appraised included articles using tools appropriate for their study design. RESULTS: Searches were carried out in September to November 2023 and screening identified 25 relevant research articles. Just over half were from North America, with four existing reviews and nine qualitative studies. Domains of acceptability described in the literature were: support for screening; level of anxiety, information and knowledge; consent; views of the procedure; and support after screening. The research indicated consensus support for blood spot screening, and for expanding to some other conditions, although some parental anxiety was reported. Parents/carers mostly perceived that they had received sufficient information, but the timing of this could be improved. While parents indicated interest in genomic screening, studies highlighted the need for clearer consent procedures and greater support for parents following genomic screening than for blood spot screening. Only three included studies reported using any kind of theoretical framework. DISCUSSION: Most parents/carers found newborn blood spot screening programmes to be acceptable and favoured their large-scale implementation. A minority of parents/carers expressed concerns regarding the acceptability of processes underpinning newborn blood spot screening, such as consent, the timing of receiving information and support available after testing. More research is needed regarding the acceptability of newborn genomic sequencing screening programmes, which are less established compared with newborn blood spot screening programmes. LIMITATIONS: The over-representation of studies conducted in the United States has implications for the applicability of findings to other countries where testing is not typically mandatory and health systems differ considerably. Most studies were of cross-sectional design and there was limited representation of people from lower incomes and non-white ethnicity. While the inclusion of studies only in populations of future or very recent parents provided coherence to the findings, unclear reporting of participants may have resulted in under- or overinclusion of some studies. FUNDING: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR159927.

ACCEPTABILITY↗
PubMed1997

Public participation in medical policy-making and the status of consumer autonomy: the example of newborn-screening programs in the United States.

OBJECTIVES: State newborn-screening programs collectively administer the largest genetic-testing initiative in the United States. We sought to assess public involvement in formulating and implementing medical policy in this important area of genetic medicine. METHODS: We surveyed all state newborn-screening programs to ascertain the screening tests performed, the mechanisms and extent of public participation, parental access to information, and policies addressing parental consent or refusal of newborn screening. We also reviewed the laws and regulations of each state pertaining to newborn screening. RESULTS: Only 26 of the 51 state newborn-screening programs reported having advisory committees that include consumer representation. Fifteen states reported having used institutional review boards, another venue for public input. The rights and roles of parents vary markedly among newborn-screening programs in terms of the type and availability of screening information as well as consent-refusal and follow-up policies. CONCLUSIONS: There is clear potential for greater public participation in newborn-screening policy-making. Greater public participation would result in more representative policy-making and could enhance the quality of services provided by newborn-screening programs.

Advisory Committees↗
PubMed2005

Pediatricians' attitudes toward expanding newborn screening.

OBJECTIVE: Traditional population screening focuses on conditions for which early treatment prevents severe morbidity and mortality. The classic example in pediatrics is newborn screening for phenylketonuria, which began in the 1960s. In 1968, Wilson and Jungner delineated 10 criteria that would justify population screening. These criteria have been reaffirmed by many newborn screening task forces as the standard for adding conditions to newborn screening programs. Today, however, some newborn screening programs are expanding to include conditions that may not meet all of the traditional screening criteria. Little is known about pediatricians' attitudes toward expanding screening. We examine the attitudes of pediatricians and pediatric subspecialists toward screening for cystic fibrosis (CF), Duchenne muscular dystrophy (DMD), fragile X, and type 1 diabetes. METHODS: A cross-sectional survey was conducted of 600 pediatricians, including those who are members of the section of genetics, endocrinology, pulmonology, and neurology of the American Academy of Pediatrics. For each condition, pediatricians were queried about (1) testing high-risk infants, (2) newborn screening, and (3) population screening or testing beyond the newborn period. Demographic data were also collected. RESULTS: A total of 232 (43%) of 537 eligible pediatricians returned surveys. More than 75% support testing high-risk infants for all conditions except type 1 diabetes. CF was the only condition for which >50% supported newborn screening. Newborn screening was preferred over screening older infants for all conditions except fragile X. Subspecialty affiliation did not have a significant impact with respect to attitudes about testing high-risk children, newborn screening, or screening beyond infancy. We analyzed the data by the number of patients with the queried condition under the physician's care and by the number of affected family members. Neither aspect was significant. We also analyzed the data by gender, by year of residency graduation, and by geographic location. None of these factors revealed significant differences in responses. For each condition, 8% to 41% of physicians would personally choose to test their own infant. We found that physicians' opinion about what they would want for their own children correlated with their attitude about population newborn screening. Those who would personally choose testing of their own infants were highly likely to support newborn screening for CF (98%), DMD (94%), and fragile X (98%), but only 78% of those who would personally opt for newborn screening of type 1 diabetes would also endorse population-based screening. This was statistically significant for each condition. Those who would choose not to test their own infants were significantly less likely to support newborn screening of the general population. One third of those who did not want to test their own newborns for CF supported population screening, whereas only one fifth supported DMD and fragile X population screening. For type 1 diabetes, 98% of those who would not personally choose newborn testing did not want it offered as a population screening program. CONCLUSIONS: Most physicians support diagnostic genetic testing of high-risk children but are less supportive of expanding newborn screening, particularly for conditions that do not meet the Wilson and Jungner criteria. Willingness to expand newborn screening does not correlate with professional characteristics but rather with personal interest in testing of their own children.

Attitude of Health Personnel↗
PubMed2004

Newborn screening in India.

Expanded newborn screening (NBS) is aimed for early detection and intervention of treatable inborn errors of metabolism and also to establish incidence of these disorders in this part of the globe. The first expanded NBS programme initiated in the capital city of Andhra Pradesh to screen all the newborns born in four major Government Maternity Hospitals in Hyderabad by heel prick capillary blood collected on S&S 903 filter paper. Chromatographic (TLC and HPLC), electrophoretic (cellulose acetate and agarose) and ELISA based assays have been employed for screening of common inborn errors of metabolism. This study has shown a high prevalence of treatable Inborn errors of metabolism. Congenital hypothyroidsm is the most common disorder (1 in 1700) followed by congenital Adrenal Hyperplasia (1 in 2575) and Hyperhomocystenemia (1 in 100). Interestingly, a very high prevalence of inborn errors of metabolism to the extent of 1 in every thousand newborns was observed. The study reveals the importance of screening in India, necessitating nation wide large-scale screening.

Cystic Fibrosis↗
PubMed2003

Parental attitudes regarding newborn screening of PKU and DMD.

The ability to perform predictive genetic testing of children raises ethical concerns. Current guidelines support the screening of newborns for conditions in which early treatment reduces morbidity and mortality, and oppose most other predictive genetic screening and testing in childhood. Little is known, however, about parental attitudes. We conducted focus groups to gain information on the attitudes, beliefs, and concerns of parents about newborn screening and testing for both treatable and untreatable conditions that present in childhood. Respondents across racial groups support mandatory newborn screening for treatable conditions like phenylketonuria (PKU), citing lack of parental knowledge, and concerns about immature parental decision-makers. Parents do, however, want more information. Citing a variety of psychosocial concerns, respondents believe that parents should have access to predictive genetic testing for childhood onset conditions, even when there are no proven treatments. Respondents want this information to make reproductive and non-reproductive plans and decisions. Although respondents varied in their personal interest in testing, overwhelmingly they believed that the decisions belong to the parents. Professional guidelines that proscribe predictive testing for untreatable childhood onset conditions should be re-examined in light of consumer attitudes.

Age of Onset↗
PubMed2004

Integration of new genetic diseases into statewide newborn screening: New England experience.

Using a data set of newborn screening specimens tested by the New England Newborn Screening Program (NENSP) between January 1999 and February 2003, we analyzed the number of infants with positive newborn screening results and determined how many positive screening results were due to a recent multiplex expansion of services in some of the states. We found that for the subset of the 4-year cohort for which there was a 233% increase in the number of disorders screened (from 9 to 30 disorders), there was a 31% increase in the number of affected infants identified by the screen. We project that if all states in the program expanded their services and if the incidence of disorders is similar across states, there would be an observed 45% increase in the number of infants detected by the screen and a 43% increase in the number of infants for whom the screening algorithm would require some contact with the infants' health care provider. Furthermore, of those requiring contact, we project a 300% increase in the number of screened-positive infants who would be referred to tertiary care centers for a diagnostic evaluation. Increased contact with the medical community from additions to newborn screening as demonstrated in this report emphasizes the need for an approach in which the newborn screening program assures coordinated communications between birth units, laboratory, primary health care providers, and specialists.

Child Health Services↗
PubMed1998

Evaluating newborn screening programmes based on dried blood spots: future challenges.

A UK national programme to screen all newborn infants for phenylketonuria was introduced in 1969, followed in 1981 by a similar programme for congenital hypothyroidism. Decisions to start these national programmes were informed by evidence from observational studies rather than randomised controlled trials. Subsequently, outcome for affected children has been assessed through national disease registers, from which inferences about the effectiveness of screening have been made. Both programmes are based on a single blood specimen, collected from each infant at the end of the first week of life, and stored as dried spots on a filter paper or 'Guthrie' card. This infrastructure has made it relatively easy for routine screening for other conditions to be introduced at a district or regional level, resulting in inconsistent policies and inequitable access to effective screening services. This variation in screening practices reflects uncertainty and the lack of a national framework to guide the introduction and evaluation of new screening initiatives, rather than geographical variations in disease prevalence or severity. More recently, developments in tandem mass spectrometry have made it technically possible to screen for several inborn errors of metabolism in a single analytical step. However, for each of these conditions, evidence is required that the benefits of screening outweigh the harms. How should that evidence be obtained? Ideally policy decisions about new screening initiatives should be informed by evidence from randomised controlled trials but for most of the conditions for which newborn screening is proposed, large trials would be needed. Prioritising which conditions should be formally evaluated, and developing a framework to support their evaluation, poses an important challenge to the public health, clinical and scientific community. In this chapter, issues underlying the evaluation of newborn screening programmes will be discussed in relation to medium chain acyl CoA dehydrogenase deficiency, a recessively inherited disorder of fatty acid oxidation.

Acyl-CoA Dehydrogenase↗
PubMed2003

Analysis of the costs of diagnosing cystic fibrosis with a newborn screening program.

OBJECTIVES: To compare the cost of diagnosing cystic fibrosis (CF) through a newborn screening program with the traditional method and to estimate the cost of CF diagnosis if a national newborn screening program is implemented. STUDY DESIGN: Surveys were conducted to determine the annual number of sweat tests in 1991 and in 2000 after implementation of statewide screening. A national survey of sweat test costs was used to estimate the annual expense for diagnosing CF in the United States through newborn screening. RESULTS: Since the introduction of newborn screening for CF, the numbers of sweat tests ordered annually have decreased from 1670 to 804 (including 134 follow-up tests from screening). The current estimated annual cost of Wisconsin CF newborn screening and diagnosis is $4.58 per newborn infant. The estimated annual cost per newly diagnosed CF infant using the traditional method is $4.97 per newborn infant. If no additional sweat tests were ordered outside of the newborn screening program, the estimated annual cost of a Wisconsin CF newborn screening and diagnosis is $2.66 per newborn and $2.47 per newborn for a national CF newborn screening program. CONCLUSIONS: A CF newborn screening program provides a potentially cost-saving alternative to the traditional method of diagnosis of CF.

Chlorides↗