Evidence and recommendation for mucopolysaccharidosis type II newborn screening in the United States.

Mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, is an X-linked condition caused by pathogenic variants in the iduronate-2-sulfatase gene. The resulting reduced activity of the enzyme iduronate-2-sulfatase leads to accumulation of glycosaminoglycans that can progressively affect multiple organ systems and impair neurologic development. In 2006, the US Food and Drug Administration approved idursulfase for intravenous enzyme replacement therapy for MPS II. After the data suggesting that early treatment is beneficial became available, 2 states, Illinois and Missouri, implemented MPS II newborn screening. Following a recommendation of the Advisory Committee on Heritable Disorders in Newborns and Children in February 2022, in August 2022, the US Secretary of Health and Human Services added MPS II to the Recommended Uniform Screening Panel, a list of conditions recommended for newborn screening. MPS II was added to the Recommended Uniform Screening Panel after a systematic evidence review reported the accuracy of screening, the benefit of presymptomatic treatment compared with usual case detection, and the feasibility of implementing MPS II newborn screening. This manuscript summarizes the findings of the evidence review that informed the Advisory Committee's decision.

Third-Grade Academic Performance and Episodes of Cardiac Care Among Children with Congenital Heart Defects.

Children with congenital heart defects (CHDs) are at risk for poor academic performance. The degree to which receipt of health care services is associated with adverse academic outcomes is not known. We examined the association between episodes of cardiac care and third-grade performance in children with CHD. We identified subjects between 1/1/2008 and 4/30/2012 among 5 centers in North Carolina. We classified children by CHD type and linked subjects to the state educational records. Any inpatient or outpatient cardiac encounter on a date of service was considered an encounter. We calculated the number of encounters by adding the number of inpatient or outpatient cardiac visits prior to the date of the end-of-grade (EOG) tests. We estimated the odds of failing third-grade reading or math EOG tests by episodes of care stratified at the 50th percentile, controlling for CHD type, maternal education, sex, race/ethnicity, birth weight, and gestational age. A total of 184 children had third-grade EOG scores linked to health care records. The median number of episodes of care was 4 (range: 1-60). Those with visits ˃ 50th percentile (> 4 encounters/year over the 4.3 year observation period) had 2.09 (95% CI 1.04, 4.21) greater odds of failing the math EOG compared to those ≤ 50th percentile (1-4 encounters). The third-grade math score declined by 1.5 points (P < 0.008) for every 10 episodes of care. There was no association of episodes of care on third-grade reading performance. Children with CHD with > 4 episodes of cardiac care/year may be at risk for delays in third-grade academic performance. Strategies to minimize school absenteeism may improve academic success in this population.

Caring for Children of Incarcerated Parents.

By age 18, one in fourteen American children has had a parent incarcerated. Although children from all backgrounds experience parental incarceration, racial and ethnic minority groups and those living in poverty are disproportionately affected. Parental incarceration is an adverse childhood experience that can negatively affect health and well-being over the life course. However, resilient children of incarcerated parents can flourish despite profound adversity. Pediatric providers should create safe, inclusive medical homes that foster sensitive disclosures and discussions about parental incarceration. If pediatric providers identify parental incarceration, they should promote foundational relationships and family resilience (including relationships with incarcerated parents when appropriate) and consider referrals to mental health specialists and specialized programs for children of incarcerated parents. Pediatric providers are also uniquely positioned to advocate for partnerships and policies that support children of incarcerated parents.

Health and economic outcomes of newborn screening for infantile-onset Pompe disease.

PURPOSE: To estimate health and economic outcomes associated with newborn screening (NBS) for infantile-onset Pompe disease in the United States. METHODS: A decision analytic microsimulation model simulated health and economic outcomes of a birth cohort of 4 million children in the United States. Universal NBS and treatment was compared with clinical identification and treatment of infantile-onset Pompe disease. Main outcomes were projected cases identified, costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) over the life course. RESULTS: Universal NBS for Pompe disease and confirmatory testing was estimated to cost an additional $26 million annually. Additional medication costs associated with earlier treatment initiation were $181 million; however, $8 million in medical care costs for other services were averted due to delayed disease progression. Infants with screened and treated infantile-onset Pompe disease experienced an average lifetime increase of 11.66 QALYs compared with clinical detection. The ICER was $379,000/QALY from a societal perspective and $408,000/QALY from the health-care perspective. Results were sensitive to the cost of enzyme replacement therapy. CONCLUSION: Newborn screening for Pompe disease results in substantial health gains for individuals with infantile-onset Pompe disease, but with additional costs.

Developing Primary Care-Based Recommendations for Social Determinants of Health: Methods of the U.S. Preventive Services Task Force.

The purpose of the U.S. Preventive Services Task Force (USPSTF) is to provide evidence-based recommendations on primary care screening, behavioral counseling, and preventive medications. A person's health is strongly influenced by social determinants of health, such as economic and social conditions; therefore, preventive recommendations that address these determinants would be ideal. However, differing social determinants have been proposed by a wide range of agencies and organizations, little prevention evidence is available, and responsible parties are in competition, all of which make the creation of evidence-based prevention recommendations for social determinants of health challenging. This article highlights social determinants already included in USPSTF recommendations and proposes a process by which others may be considered for primary care preventive recommendations. In many ways, incorporating social determinants of health into evidence-based recommendations is an evolving area. By reviewing the evidence on the effects of screening and interventions on social determinants relevant to primary care, the USPSTF will continue to provide recommendations on clinical preventive services to improve the health of all Americans.

Causes of Death in Infants and Children with Congenital Heart Disease.

With improved surgical outcomes, infants and children with congenital heart disease (CHD) may die from other causes of death (COD) other than CHD. We sought to describe the COD in youth with CHD in North Carolina (NC). Patients from birth to 20 years of age with a healthcare encounter between 2008 and 2013 in NC were identified by ICD-9 code. Patients who could be linked to a NC death certificate between 2008 and 2016 were included. Patients were divided by CHD subtypes (severe, shunt, valve, other). COD was compared between groups. Records of 35,542 patients < 20 years old were evaluated. There were 15,277 infants with an annual mortality rate of 3.5 deaths per 100 live births. The most frequent COD in infants (age < 1 year) were CHD (31.7%), lung disease (16.1%), and infection (11.4%). In 20,265 children (age 1 to < 20 years), there was annual mortality rate of 9.7 deaths per 1000 at risk. The most frequent COD in children were CHD (34.2%), neurologic disease (10.2%), and infection (9.5%). In the severe subtype, CHD was the most common COD. In infants with shunt-type CHD disease, lung disease (19.5%) was the most common COD. The mortality rate in infants was three times higher when compared to children. CHD is the most common underlying COD, but in those with shunt-type lesions, extra-cardiac COD is more common. A multidisciplinary approach in CHD patients, where development of best practice models regarding comorbid conditions such as lung disease and neurologic disease could improve outcomes in this patient population.

Incorporation of Social Risk in US Preventive Services Task Force Recommendations and Identification of Key Challenges for Primary Care.

IMPORTANCE: In its mission to improve health, the US Preventive Services Task Force (USPSTF) recognizes the strong relationship between a person's health and social and economic circumstances as well as persistent inequities in health care delivery. OBJECTIVE: To assess how social risks have been considered in USPSTF recommendation statements and identify current gaps in evidence needed to expand the systematic inclusion of social risks in future recommendations. EVIDENCE: The USPSTF commissioned a technical brief that reviewed existing literature on screening and interventions for social risk factors and also audited the 85 USPSTF recommendation statements active as of December 2019 to determine how social risks were addressed in clinical preventive services recommendations. FINDINGS: Among the 85 USPSTF recommendation statements reviewed, 14 were focused on preventive services that considered health-related social risks. Social risks were commonly referenced in parts of USPSTF recommendations, with 57 of 85 recommendations including some comment on social risks within the recommendation statement, although many comments were not separate prevention services. Social risks were commented on in USPSTF recommendations as part of risk assessment, as a marker of worse health outcomes from the condition of focus, as a consideration for clinicians when implementing the preventive service, and as a research need or gap on the topic. CONCLUSIONS AND RELEVANCE: This report identified how social risks have been considered in the USPSTF recommendation statements. It serves as a benchmark and foundation for ongoing work to advance the goal of ensuring that health equity and social risks are incorporated in USPSTF methods and recommendations.

Treatment Discontinuation within 3 Years of Levothyroxine Initiation among Children Diagnosed with Congenital Hypothyroidism.

OBJECTIVES: To measure the rates of thyroid gland imaging and levothyroxine (L-T4) discontinuation and to assess whether discontinuation was monitored with thyroid-stimulating hormone testing in subjects with congenital hypothyroidism. STUDY DESIGN: This is a retrospective analysis of claims data from the IBM MarketScan Databases for children born between 2010 and 2016 and continuously enrolled in a noncapitated employer-sponsored private health insurance plan or in Medicaid for ≥36 months from the date of the first filled L-T4 prescription. RESULTS: There were 263 privately insured and 241 Medicaid-enrolled children who met the inclusion criteria. More privately insured than Medicaid-enrolled children had imaging between the first filled prescription and 180 days after the last filled prescription (24.3% vs 12.9%; P = .001). By 36 months, 35.7% discontinued L-T4, with no difference by insurance status (P = .48). Among those who discontinued, 29.1% of privately insured children and 47.7% of Medicaid-enrolled children had no claims for thyroid-stimulating hormone testing within the next 180 days (P = .01). CONCLUSIONS: Nearly one-third of children with suspected congenital hypothyroidism discontinued L-T4 by 3 years and fewer Medicaid-enrolled than privately insured children received timely follow-up thyroid-stimulating hormone testing. Future studies are indicated to understand the quality of care and developmental outcomes for children with congenital hypothyroidism and barriers to guideline adherence in evaluating for transient congenital hypothyroidism.

The North Carolina Experience with Mucopolysaccharidosis Type I Newborn Screening.

OBJECTIVE: To evaluate the performance of a 2-tiered newborn screening method for mucopolysaccharidosis type I (MPS I) in North Carolina. STUDY DESIGN: The screening algorithm included a flow injection analysis-tandem mass spectrometry assay as a first-tier screening method to measure α-L-iduronidase (IDUA) enzyme activity and Sanger sequencing of the IDUA gene on dried blood spots as a second-tier assay. The screening algorithm was revised to incorporate the Collaborative Laboratory Integrated Reports, an analytical interpretive tool, to reduce the false-positive rate. A medical history, physical examination, IDUA activity, and urinary glycosaminoglycan (GAG) analysis were obtained on all screen-positive infants. RESULTS: A total of 62 734 specimens were screened with 54 screen-positive samples using a cut-off of 15% of daily mean IDUA activity. The implementation of Collaborative Laboratory Integrated Reports reduced the number of specimens that screened positive to 19 infants. Of the infants identified as screen-positive, 1 had elevated urinary GAGs and a homozygous pathogenic variant associated with the severe form of MPS I. All other screen-positive infants had normal urinary GAG analysis; 13 newborns had pseudodeficiency alleles, 3 newborns had variants of unknown significance, and 2 had heterozygous pathogenic variants. CONCLUSIONS: An infant with severe MPS I was identified and referred for a hematopoietic stem cell transplant. Newborn IDUA enzyme deficiency is common in North Carolina, but most are due to pseudodeficiency alleles in infants with normal urinary GAG analysis and no evidence of disease. The pilot study confirmed the need for second-tier testing to reduce the follow-up burden.

Early Check: translational science at the intersection of public health and newborn screening.

BACKGROUND: Newborn screening (NBS) occupies a unique space at the intersection of translational science and public health. As the only truly population-based public health program in the United States, NBS offers the promise of making the successes of translational medicine available to every infant with a rare disorder that is difficult to diagnose clinically, but for which strong evidence indicates that presymptomatic treatment will substantially improve outcomes. Realistic NBS policy requires data, but rare disorders face a special challenge: Screening cannot be done without supportive data, but adequate data cannot be collected in the absence of large-scale screening. The magnitude and scale of research to provide this expanse of data require working with public health programs, but most do not have the resources or mandate to conduct research. METHODS: To address this gap, we have established Early Check, a research program in partnership with a state NBS program. Early Check provides the infrastructure needed to identify conditions for which there have been significant advances in treatment potential, but require a large-scale, population-based study to test benefits and risks, demonstrate feasibility, and inform NBS policy. DISCUSSION: Our goal is to prove the benefits of a program that can, when compared with current models, accelerate understanding of diseases and treatments, reduce the time needed to consider inclusion of appropriate conditions in the standard NBS panel, and accelerate future research on new NBS conditions, including clinical trials for investigational interventions. TRIAL REGISTRATION: Clinicaltrials.gov registration # NCT03655223 . Registered on August 31, 2018.

Variation in Gastrostomy Tube Placement in Premature Infants in the United States.

OBJECTIVE: To describe the variation in surgical gastrostomy tube (SGT) placement in premature infants among neonatal intensive care units (NICUs) in the United States. STUDY DESIGN: We identified 8,781 premature infants discharged from 114 NICUs in the Pediatrix Medical Group from 2010 to 2012. The outcome of interest was SGT placement prior to discharge home from an NICU. Unadjusted proportions and adjusted risk estimates were calculated to quantify variation observed among individual NICUs. RESULTS: SGT placement occurred in 360 of 8,781 (4.1%) of infants. Across NICUs, any gastrostomy tube placement ranged from none in 45 NICUs up to 19.6%. Adjusted risk estimates for factors associated with SGT placement included gestational age at birth (odds ratio [OR]: 0.7/week, 95% confidence interval[CI]: [0.65, 0.75]), small for gestational age status (OR: 2.78 [2.09, 3.71]), administration of antenatal steroids (OR: 0.69 [0.52, 0.92]), Hispanic ethnicity (OR: 0.54 [0.37, 0.78]), and higher 5-minute Apgar scores (7-10, OR: 0.54 [0.37, 0.79]). CONCLUSION: Individual NICU center has a strong clinical effect on the probability of SGT placement relative to other medical factors. Future work is needed to understand the cause of this variation and the degree to which it represents over or under use of gastrostomy tubes.

Screening for Hepatitis B Virus Infection in Pregnant Women: US Preventive Services Task Force Reaffirmation Recommendation Statement.

Importance: Screening for hepatitis B virus (HBV) infection during pregnancy identifies women whose infants are at risk of perinatal transmission. Data from a nationally representative sample showed a prevalence of maternal HBV infection of 85.8 cases per 100 000 deliveries from 1998 to 2011 (0.09% of live-born singleton deliveries in the United States). Although there are guidelines for universal infant HBV vaccination, rates of maternal HBV infection have increased annually by 5.5% since 1998. Children infected with HBV during infancy or childhood are more likely to develop chronic infection. Chronic HBV infection increases long-term morbidity and mortality by predisposing infected persons to cirrhosis of the liver and liver cancer. Objective: To update the 2009 US Preventive Services Task Force (USPSTF) recommendation on screening for HBV infection in pregnant women. Evidence Review: The USPSTF commissioned a reaffirmation evidence update to identify substantial new evidence sufficient enough to change the prior recommendation. The USPSTF targeted its evidence review on the effectiveness and potential harms of screening and the effectiveness and harms of case management to prevent perinatal transmission. Findings: The USPSTF previously found adequate evidence that serologic testing for hepatitis B surface antigen accurately identifies HBV infection. Interventions are effective for preventing perinatal transmission, based on foundational evidence and observational studies of US case management programs. In addition, there is evidence that over time, perinatal transmission has decreased among women and infants enrolled in case management, providing an overall substantial health benefit. Therefore, the USPSTF reaffirms its previous conclusion that there is convincing evidence that screening for HBV infection in pregnant women provides substantial benefit. Conclusions and Recommendation: The USPSTF recommends screening for HBV infection in pregnant women at their first prenatal visit. (A recommendation).

Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: US Preventive Services Task Force Reaffirmation Recommendation Statement.

IMPORTANCE: In the United States, the rate of gonococcal ophthalmia neonatorum was an estimated 0.4 cases per 100 000 live births per year from 2013 to 2017. Gonococcal ophthalmia neonatorum can cause corneal scarring, ocular perforation, and blindness as early as 24 hours after birth. In the absence of ocular prophylaxis, transmission rates of gonococcal infection from mother to newborn are 30% to 50%. OBJECTIVE: To reaffirm the US Preventive Services Task Force (USPSTF) 2011 recommendation on ocular prophylaxis for gonococcal ophthalmia neonatorum. EVIDENCE REVIEW: The USPSTF commissioned a reaffirmation evidence update to identify new and substantial evidence sufficient enough to change its prior recommendation. FINDINGS: Using a reaffirmation process, the USPSTF found no new data that would change its previous conclusion that topical ocular prophylaxis is effective in preventing gonococcal ophthalmia neonatorum and related ocular conditions. The USPSTF found no new data that would change its previous conclusion that there is convincing evidence that topical ocular prophylaxis of all newborns is not associated with serious harms. Therefore, the USPSTF reaffirms its previous conclusion that there is convincing evidence that topical ocular prophylaxis for all newborns provides substantial benefit. CONCLUSIONS AND RECOMMENDATION: The USPSTF recommends prophylactic ocular topical medication for all newborns to prevent gonococcal ophthalmia neonatorum. (A recommendation).

Screening for Elevated Blood Lead Levels in Children and Pregnant Women: US Preventive Services Task Force Recommendation Statement.

Importance: Elevated blood lead levels in children are associated with neurologic effects such as behavioral and learning problems, lower IQ, hyperactivity, hearing problems, and impaired growth. In pregnant women, lead exposure can impair organ systems such as the hematopoietic, hepatic, renal, and nervous systems, and increase the risk of preeclampsia and adverse perinatal outcomes. Many of the adverse health effects of lead exposure are irreversible. Objective: To update the 2006 US Preventive Services Task Force (USPSTF) recommendation on screening for elevated blood lead levels in children and pregnant women. Evidence Review: The USPSTF reviewed the evidence on the benefits and harms of screening for and treatment of elevated blood lead levels. In this update, an elevated blood lead level was defined according to the Centers for Disease Control and Prevention reference level of 5 µg/dL. Findings: The USPSTF found adequate evidence that questionnaires and other clinical prediction tools to identify asymptomatic children with elevated blood lead levels are inaccurate. The USPSTF found adequate evidence that capillary blood testing accurately identifies children with elevated blood lead levels. The USPSTF found inadequate evidence on the effectiveness of treatment of elevated blood lead levels in asymptomatic children 5 years and younger and in pregnant women. The USPSTF found inadequate evidence regarding the accuracy of questionnaires and other clinical prediction tools to identify asymptomatic pregnant women with elevated blood lead levels. The USPSTF found inadequate evidence on the harms of screening for or treatment of elevated blood lead levels in asymptomatic children and pregnant women. The USPSTF concluded that the current evidence is insufficient, and that the balance of benefits and harms of screening for elevated blood lead levels in asymptomatic children 5 years and younger and in pregnant women cannot be determined. Conclusions and Recommendation: The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for elevated blood lead levels in asymptomatic children. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for elevated blood lead levels in asymptomatic pregnant persons. (I statement).

Interventions to Prevent Perinatal Depression: US Preventive Services Task Force Recommendation Statement.

Importance: Perinatal depression, which is the occurrence of a depressive disorder during pregnancy or following childbirth, affects as many as 1 in 7 women and is one of the most common complications of pregnancy and the postpartum period. It is well established that perinatal depression can result in adverse short- and long-term effects on both the woman and child. Objective: To issue a new US Preventive Services Task Force (USPSTF) recommendation on interventions to prevent perinatal depression. Evidence Review: The USPSTF reviewed the evidence on the benefits and harms of preventive interventions for perinatal depression in pregnant or postpartum women or their children. The USPSTF reviewed contextual information on the accuracy of tools used to identify women at increased risk of perinatal depression and the most effective timing for preventive interventions. Interventions reviewed included counseling, health system interventions, physical activity, education, supportive interventions, and other behavioral interventions, such as infant sleep training and expressive writing. Pharmacological approaches included the use of nortriptyline, sertraline, and omega-3 fatty acids. Findings: The USPSTF found convincing evidence that counseling interventions, such as cognitive behavioral therapy and interpersonal therapy, are effective in preventing perinatal depression. Women with a history of depression, current depressive symptoms, or certain socioeconomic risk factors (eg, low income or young or single parenthood) would benefit from counseling interventions and could be considered at increased risk. The USPSTF found adequate evidence to bound the potential harms of counseling interventions as no greater than small, based on the nature of the intervention and the low likelihood of serious harms. The USPSTF found inadequate evidence to assess the benefits and harms of other noncounseling interventions. The USPSTF concludes with moderate certainty that providing or referring pregnant or postpartum women at increased risk to counseling interventions has a moderate net benefit in preventing perinatal depression. Conclusions and Recommendation: The USPSTF recommends that clinicians provide or refer pregnant and postpartum persons who are at increased risk of perinatal depression to counseling interventions. (B recommendation).

Behavioral Counseling to Prevent Skin Cancer: US Preventive Services Task Force Recommendation Statement.

Importance: Skin cancer is the most common type of cancer in the United States. Although invasive melanoma accounts for only 2% of all skin cancer cases, it is responsible for 80% of skin cancer deaths. Basal and squamous cell carcinoma, the 2 predominant types of nonmelanoma skin cancer, represent the vast majority of skin cancer cases. Objective: To update the 2012 US Preventive Services Task Force (USPSTF) recommendation on behavioral counseling for the primary prevention of skin cancer and the 2009 recommendation on screening for skin cancer with skin self-examination. Evidence Review: The USPSTF reviewed the evidence on whether counseling patients about sun protection reduces intermediate outcomes (eg, sunburn or precursor skin lesions) or skin cancer; the link between counseling and behavior change, the link between behavior change and skin cancer incidence, and the harms of counseling or changes in sun protection behavior; and the link between counseling patients to perform skin self-examination and skin cancer outcomes, as well as the harms of skin self-examination. Findings: The USPSTF determined that behavioral counseling interventions are of moderate benefit in increasing sun protection behaviors in children, adolescents, and young adults with fair skin types. The USPSTF found adequate evidence that behavioral counseling interventions result in a small increase in sun protection behaviors in adults older than 24 years with fair skin types. The USPSTF found inadequate evidence on the benefits and harms of counseling adults about skin self-examination to prevent skin cancer. Conclusions and Recommendation: The USPSTF recommends counseling young adults, adolescents, children, and parents of young children about minimizing exposure to UV radiation for persons aged 6 months to 24 years with fair skin types to reduce their risk of skin cancer. (B recommendation) The USPSTF recommends that clinicians selectively offer counseling to adults older than 24 years with fair skin types about minimizing their exposure to UV radiation to reduce risk of skin cancer. Existing evidence indicates that the net benefit of counseling all adults older than 24 years is small. In determining whether this service is appropriate in individual cases, patients and clinicians should consider the presence of risk factors for skin cancer. (C recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of counseling adults about skin self-examination to prevent skin cancer. (I statement).

Vitamin D, Calcium, or Combined Supplementation for the Primary Prevention of Fractures in Community-Dwelling Adults: US Preventive Services Task Force Recommendation Statement.

Importance: Because of the aging population, osteoporotic fractures are an increasingly important cause of morbidity and mortality in the United States. Approximately 2 million osteoporotic fractures occurred in the United States in 2005, and annual incidence is projected to increase to more than 3 million fractures by 2025. Within 1 year of experiencing a hip fracture, many patients are unable to walk independently, more than half require assistance with activities of daily living, and 20% to 30% of patients will die. Objective: To update the 2013 US Preventive Services Task Force (USPSTF) recommendation on vitamin D supplementation, with or without calcium, to prevent fractures. Evidence Review: The USPSTF reviewed the evidence on vitamin D, calcium, and combined supplementation for the primary prevention of fractures in community-dwelling adults (defined as not living in a nursing home or other institutional care setting). The review excluded studies conducted in populations with a known disorder related to bone metabolism (eg, osteoporosis or vitamin D deficiency), taking medications known to be associated with osteoporosis (eg, long-term steroids), or with a previous fracture. Findings: The USPSTF found inadequate evidence to estimate the benefits of vitamin D, calcium, or combined supplementation to prevent fractures in community-dwelling men and premenopausal women. The USPSTF found adequate evidence that daily supplementation with 400 IU or less of vitamin D and 1000 mg or less of calcium has no benefit for the primary prevention of fractures in community-dwelling, postmenopausal women. The USPSTF found inadequate evidence to estimate the benefits of doses greater than 400 IU of vitamin D or greater than 1000 mg of calcium to prevent fractures in community-dwelling postmenopausal women. The USPSTF found adequate evidence that supplementation with vitamin D and calcium increases the incidence of kidney stones. Conclusions and Recommendation: The USPSTF concludes that the current evidence is insufficient to assess the balance of the benefits and harms of vitamin D and calcium supplementation, alone or combined, for the primary prevention of fractures in community-dwelling, asymptomatic men and premenopausal women. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of the benefits and harms of daily supplementation with doses greater than 400 IU of vitamin D and greater than 1000 mg of calcium for the primary prevention of fractures in community-dwelling, postmenopausal women. (I statement) The USPSTF recommends against daily supplementation with 400 IU or less of vitamin D and 1000 mg or less of calcium for the primary prevention of fractures in community-dwelling, postmenopausal women. (D recommendation) These recommendations do not apply to persons with a history of osteoporotic fractures, increased risk for falls, or a diagnosis of osteoporosis or vitamin D deficiency.

Screening for Osteoporosis to Prevent Fractures: US Preventive Services Task Force Recommendation Statement.

Importance: By 2020, approximately 12.3 million individuals in the United States older than 50 years are expected to have osteoporosis. Osteoporotic fractures, particularly hip fractures, are associated with limitations in ambulation, chronic pain and disability, loss of independence, and decreased quality of life, and 21% to 30% of patients who experience a hip fracture die within 1 year. The prevalence of primary osteoporosis (ie, osteoporosis without underlying disease) increases with age and differs by race/ethnicity. With the aging of the US population, the potential preventable burden is likely to increase in future years. Objective: To update the 2011 US Preventive Services Task Force (USPSTF) recommendation on screening for osteoporosis. Evidence Review: The USPSTF reviewed the evidence on screening for and treatment of osteoporotic fractures in men and women, as well as risk assessment tools, screening intervals, and efficacy of screening and treatment in subgroups. The screening population was postmenopausal women and older men with no known previous osteoporotic fractures and no known comorbid conditions or medication use associated with secondary osteoporosis. Findings: The USPSTF found convincing evidence that bone measurement tests are accurate for detecting osteoporosis and predicting osteoporotic fractures in women and men. The USPSTF found adequate evidence that clinical risk assessment tools are moderately accurate in identifying risk of osteoporosis and osteoporotic fractures. The USPSTF found convincing evidence that drug therapies reduce subsequent fracture rates in postmenopausal women. The USPSTF found that the evidence is inadequate to assess the effectiveness of drug therapies in reducing subsequent fracture rates in men without previous fractures. Conclusions and Recommendation: The USPSTF recommends screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in women 65 years and older. (B recommendation) The USPSTF recommends screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in postmenopausal women younger than 65 years at increased risk of osteoporosis, as determined by a formal clinical risk assessment tool. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis to prevent osteoporotic fractures in men. (I statement).

Risk Assessment for Cardiovascular Disease With Nontraditional Risk Factors: US Preventive Services Task Force Recommendation Statement.

Importance: Cardiovascular disease (CVD) is the most common cause of death among adults in the United States. Treatment to prevent CVD events by modifying risk factors is currently informed by the Framingham Risk Score, the Pooled Cohort Equations, or similar CVD risk assessment models. If current CVD risk assessment models could be improved by adding more risk factors, treatment might be better targeted, thereby maximizing the benefits and minimizing the harms. Objective: To update the 2009 US Preventive Services Task Force (USPSTF) recommendation on using nontraditional risk factors in coronary heart disease risk assessment. Evidence Review: The USPSTF reviewed the evidence on using nontraditional risk factors in CVD risk assessment, focusing on the ankle-brachial index (ABI), high-sensitivity C-reactive protein (hsCRP) level, and coronary artery calcium (CAC) score; the health benefits and harms of CVD risk assessment and treatment guided by nontraditional risk factors combined with the Framingham Risk Score or Pooled Cohort Equations compared with using either risk assessment model alone; and whether adding nontraditional risk factors to existing CVD risk assessment models improves measures of calibration, discrimination, and risk reclassification. Findings: The USPSTF found adequate evidence that adding the ABI, hsCRP level, and CAC score to existing CVD risk assessment models results in small improvements in discrimination and risk reclassification; however, the clinical meaning of these changes is largely unknown. Evidence on adding the ABI, hsCRP level, and CAC score to the Pooled Cohort Equations is limited. The USPSTF found inadequate evidence to assess whether treatment decisions guided by the ABI, hsCRP level, or CAC score, in addition to risk factors in existing CVD risk assessment models, leads to reduced incidence of CVD events or mortality. The USPSTF found adequate evidence to conceptually bound the harms of early detection and interventions as small. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of using the ABI, hsCRP level, or CAC score in risk assessment for CVD in asymptomatic adults to prevent CVD events. Conclusions and Recommendation: The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of adding the ABI, hsCRP level, or CAC score to traditional risk assessment for CVD in asymptomatic adults to prevent CVD events. (I statement).