SPECIAL ARTICLE |
Key Words: lead levels evidence-based medicine screening
Abbreviations: USPSTFUS Preventive Services Task Force BLLblood lead level CDCCenters for Disease Control and Prevention
The US Preventive Services Task Force (USPSTF) is redesigning its recommendation statement in response to feedback from primary care clinicians. The USPSTF plans to release, later in 2006, a new, updated recommendation statement that is easier to read and incorporates advances in USPSTF methods. The recommendation statement below is an interim version that combines existing language and elements with a new format. Although the definitions of grades remain the same, other elements have been revised.
| SUMMARY OF RECOMMENDATIONS |
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Pregnant Women
| RATIONALE |
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Detection
There is good evidence that venous sampling accurately detects elevated BLLs and fair evidence that validated questionnaires are modestly useful in identifying children at increased risk for elevated BLLs.
Benefits of Detection and Early Intervention
The USPSTF found good-quality evidence that interventions do not result in sustained decreases in BLLs and found insufficient evidence (no studies) evaluating residential lead hazard-control efforts (ie, dust or paint removal, soil abatement, counseling, or education) or nutritional interventions for improving neurodevelopmental outcomes in children with mildly-to-moderately elevated BLLs. The USPSTF found no studies examining the effectiveness of screening or interventions in improving health outcomes in asymptomatic pregnant women. Given the low prevalence of elevated BLLs in children at average risk and asymptomatic pregnant women, the magnitude of potential benefit cannot be greater than small.
A theoretical benefit of screening is that identification may prevent lead poisoning of other individuals in a shared environment, but the magnitude of this theoretical benefit is uncertain.
Harms of Detection and Early Treatment
There is good-quality evidence that chelation treatment in asymptomatic children does not improve neurodevelopmental outcomes and is associated with a slight diminution in cognitive performance. Chelation therapy may result in transient renal, hepatic, and other toxicity, mild gastrointestinal symptoms, sensitivity reactions, and rare life-threatening reactions. Residential lead-based paint and dust hazard-control treatments may lead to acutely increased BLLs from improper removal techniques. Potential harms of screening are false-positive results, anxiety, inconvenience, work or school absenteeism, and financial costs associated with repeated testing. Although the exact magnitude of these known and potential harms is uncertain, the overall magnitude is at least small.
No studies have directly addressed the harms of screening and interventions for pregnant women. Although there is little specific evidence concerning the potential harms of interventions for pregnant women with elevated BLLs, the magnitude of harms from such interventions is also at least small.
USPSTF Assessment
The USPSTF concludes that the evidence is insufficient to assess the balance between potential benefits and harms of routine screening for elevated BLLs in children at increased risk. Given the significant potential harms of treatment and residential lead hazard abatement, and no evidence of treatment benefit, the USPSTF concluded that the harms of screening for elevated BLLs in children at average risk and in asymptomatic pregnant women outweigh the benefits.
| CLINICAL CONSIDERATIONS |
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2 years of age, decrease during short-term and long-term follow-up without intervention. Most lead is stored in bone. High bone lead levels can be present with normal BLLs, so that BLLs often do not reflect the total amount of lead in the body. This could explain the lack of effect of BLL-lowering measures on reducing neurotoxic effects.
20 µg/dL, whereas chelation therapy is offered to children with BLLs
45 µg/dL. | DISCUSSION |
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10 µg/dL among children 1 to 5 years of age in the United States has declined from 9% between 1988 and 1991 to 1.6% between 1999 and 2002. The decline is attributable primarily to significant reductions of lead in gasoline, air, dietary sources, and residential paint. However, the prevalence varies substantially among different communities and populations: mean BLLs of black children (2.8 µg/dL) remain significantly higher than those of Mexican American (1.9 µg/dL) and non-Hispanic white children (1.8 µg/dL). Approximately 24 million housing units still contain substantial lead hazards, with 1.2 million of these units occupied by low-income families with young children. An estimated 310000 children remain at risk for exposure to harmful levels of lead. Population mean BLLs in women of childbearing age and pregnant women have decreased over the past 2 decades. In 1992, 2 large surveys of low-income pregnant women found that between 0% and 6% of these women had BLLs >15 µg/dL. In a recent sample of respondents to the National Health and Nutrition Examination Survey (NHANES) including 4394 women of childbearing age, the geometric mean BLL was 1.78 µg/dL.1,2
Elevated amounts of lead in the body affect various organ systems, including the cardiovascular, renal, and hepatic, with most symptoms occurring with BLLs
50 µg/dL. Very high levels of inorganic lead exposure may result in death or long-term neurologic sequelae in children. However, neurodevelopmental dysfunction is associated with BLLs as low as 10 µg/dL in young children. The adverse effects of very high maternal BLLs during pregnancy include abortion, stillbirth, preterm delivery, decreased neonatal head circumference, and decreased birth weight. Studies also suggest that mildly elevated maternal BLLs may be associated with increased risk for spontaneous abortion, hypertension in pregnancy, and adverse effects on fetal growth.3 Although very high BLLs during pregnancy are harmful, the adverse effects of antepartum lead levels on the fetus in the range typically found in the United States have not been established.
Scope
The USPSTF examined new evidence published since it addressed the following overarching question in its 1996 recommendation: Does screening children and pregnant women for elevated BLLs result in improved neurodevelopmental outcomes? With this update, the USPSTF also reviewed the evidence on the accuracy of screening tests and the harms of screening and treatment.
Accuracy of Tests
Blood tests or questionnaires may be used to screen for elevated BLLs. Blood lead concentration is more sensitive and specific than free erythrocyte protoporphyrin levels but can be affected by environmental lead contamination and laboratory analytic variation. Erythrocyte (or zinc) protoporphyrin is insensitive to modest elevations in BLL and lacks specificity. Capillary blood lead sampling has false-positive rates of 3% to 9% and false-negative rates of 1% to 8%. The sensitivity and specificity of questionnaires vary considerably with the prevalence of elevated BLLs in the population surveyed and the cutoff BLL that is used. In urban and suburban populations, Centers for Disease Control and Prevention (CDC) screening questionnaires detected 64% to 87% of children with BLLs
10 µg/dL; higher sensitivities (81%100%) were reported for BLLs
15 to 20 µg/dL. Specificity of these questionnaires ranged from 32% to 75%. False-negative results were low (0.2%3.5%) in lower-prevalence populations (2%7%) for BLLs of
10 µg/dL but increased to 19% when the population prevalence of elevated BLLs was higher (17%28%).46
Intervention-Treatment
Treatment options for elevated BLLs include residential lead hazard-control efforts (ie, dust or paint removal, soil abatement, counseling, and education), chelation, and nutritional interventions. Most studies of asymptomatic children evaluate the effects of these interventions on BLLs instead of on clinically relevant neurocognitive outcomes. The USPSTF found no studies evaluating neurocognitive outcomes after residential lead hazard-control efforts or nutritional interventions. These interventions were found to have small, inconsistent, or unsustained effects on BLLs in asymptomatic children with mildly-to-moderately increased BLLs (<45 µg/dL).
There is good evidence that chelating agents benefit children with symptomatic lead poisoning, but there is little evidence available to demonstrate a clinical benefit from chelation therapy for children with BLLs <45 µg/dL. A large, multicenter, randomized, controlled trial assessed the effect of oral chelation therapy with succimer on IQ in children with venous BLLs of 20 to 45 µg/dL.7 At 36 months' follow-up, no statistically significant differences were found between treatment and control groups in mean IQ, parental rating of behavior, or tests of learning ability. In this trial, BLLs decreased in both the treatment and placebo groups, and by 24 months the difference between the treatment and placebo groups was not statistically significant.8,9
The USPSTF found no studies that examined the effectiveness of interventions in pregnant women.
Harms of Screening and Treatment
No new evidence was found regarding the harms of screening in children or pregnant women. The most common harms of screening for elevated lead levels are false-positive capillary results, anxiety, inconvenience, work or school absenteeism, and financial costs associated with return visits and repeated tests. In a randomized, controlled trial, succimer was associated with a slight decrease in cognitive performance.8,9 No studies have directly addressed the harms of interventions for pregnant women.
Research Needs
Community-based interventions for the primary prevention of lead exposure are likely to be more effective, and may be more cost-effective, than office-based screening, treatment, and counseling. Evaluation of the effectiveness of community-based interventions and recommendations regarding their use are important areas of future research.
Recommendations of Others
The CDC recommends universal screening in communities where
12% of children aged 1 to 3 years have elevated blood levels, or, in communities that do not have prevalence data, if
27% of the housing was built before 1950. The CDC recommends targeted screening for all other children based on an individual risk assessment, including whether children receive Medicaid, Supplemental Food Program for Women, Infants and Children (WIC), or other forms of governmental assistance. This approach is also supported by the American College of Preventive Medicine.
The American Academy of Pediatrics recommends that pediatricians learn whether city or state health departments provide guidance for screening children who are not eligible for Medicaid. If no such guidance is available, the American Academy of Pediatrics recommends that pediatricians consider screening all children. Children should, ideally, be tested at 1 and 2 years of age.12
The American Academy of Family Physicians recommends screening 12-month-old infants for lead poisoning if they live in communities in which the prevalence of lead levels requiring intervention is high or undefined; if they live in or frequently visit a home built before 1950 that has dilapidated paint or recent or ongoing renovations or remodeling; if they have close contact with a person who has an elevated BLL or who lives near lead industry or heavy traffic; or if they live with someone whose job or hobby involves lead exposure, uses lead-based pottery, or takes traditional remedies that contain lead.13
Medicaid's Early and Periodic Screening, Diagnostic, and Treatment Program (EPSDT) requires that all children receive a screening blood lead test at 12 and 24 months of age; children between the ages of 36 and 72 months of age must receive a screening blood lead test if they have not previously been screened for lead poisoning.14,15
No national organizations currently recommend screening pregnant women for elevated BLLs.
| APPENDIX 1: USPSTF RECOMMENDATIONS AND RATINGS |
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| APPENDIX 2: USPSTF STRENGTH OF OVERALL EVIDENCE |
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Good: Evidence includes consistent results from well-designed, well-conducted studies in representative populations that directly assess effects on health outcomes.
Fair: Evidence is sufficient to determine effects on health outcomes, but the strength of the evidence is limited by the number, quality, or consistency of the individual studies, generalizability to routine practice, or indirect nature of the evidence on health outcomes.
Poor: Evidence is insufficient to assess the effects on health outcomes because of limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information on important health outcomes.
| USPSTF MEMBERS |
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| FOOTNOTES |
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Address correspondence to Ned Calonge, MD, MPH, Chair, US Preventive Services Task Force, c/o Program Director, USPSTF, Agency for Healthcare Research and Quality, 540 Gaither Rd, Rockville, MD 20850. E-mail: uspstf{at}ahrq.gov
The authors have indicated they have no financial relationships relevant to this article to disclose.
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