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Draft Research Plan

Draft Research Plan for Elevated Blood Lead Levels in Childhood and Pregnancy: Screening

This opportunity for public comment expired on July 13, 2016 at 8:00 PM EST

Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

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Draft: Proposed Analytic Frameworks

Screening for Elevated Blood Lead Levels in Childhood

Text Description.

The figure depicts the six Key Questions (KQs) to be addressed in the systematic review. The figure illustrates how screening asymptomatic children age 5 years and younger for elevated blood lead levels may improve health outcomes (KQ 1) and the harms of screening (KQ 3).The figure also depicts the accuracy of using questionnaires or clinical prediction tools to identify children who have elevated blood lead levels (KQ 2a) and the accuracy and reliability of capillary blood lead testing (KQ 2b). KQ 4 depicts whether interventions reduce blood lead levels in asymptomatic children with elevated blood lead levels, and KQ 5 depicts whether interventions improve health outcomes. The figure also depicts whether there are harms associated with the interventions (KQ 6).

Screening for Elevated Blood Lead Levels in Pregnancy

Text Description.

The figure depicts the six Key Questions (KQs) to be addressed in the systematic review. The figure illustrates how screening asymptomatic pregnant women for elevated blood lead levels may improve health outcomes (KQ 1) and the harms of screening (KQ 3). The figure also depicts the accuracy of using questionnaires or clinical prediction tools to identify pregnant women who have elevated blood lead levels (KQ 2). The figure illustrates whether interventions reduce blood lead levels (KQ 4a) or gestational hypertension (KQ 4b) in asymptomatic pregnant women with elevated blood lead levels. KQ 5 depicts whether interventions improve health outcomes. The figure also depicts whether there are harms associated with the interventions (KQ 6).

Abbreviation: KQ=key question.

a Interventions include counseling families to reduce lead exposure, nutritional interventions, residential hazard control techniques, and chelation therapy.
b We will include outcomes measured in family members (e.g., siblings, pregnant women in the same household) who are subsequently identified as having elevated blood lead levels after the index family member was found to have an elevated blood lead level during screening.

Draft: Proposed Key Questions to Be Systematically Reviewed

Screening for Elevated Blood Lead Levels in Childhood

1. Is there direct evidence that screening for elevated blood lead levels in asymptomatic children age 5 years and younger improves health outcomes (i.e., reduced cognitive or behavioral problems or learning disorders)?
2. a. What is the accuracy of questionnaires or clinical prediction tools that identify children who have elevated blood lead levels?
    b. What is the accuracy and reliability of capillary blood lead testing in children?
3. What are the harms of screening for elevated blood lead levels (with or without screening questionnaires) in children?
4. Do counseling and nutritional interventions, residential lead hazard control techniques, or chelation therapy reduce blood lead levels in asymptomatic children with elevated blood lead levels?
5. Do counseling and nutritional interventions, residential lead hazard control techniques, or chelation therapy improve health outcomes in asymptomatic children with elevated blood lead levels?
6. What are the harms of interventions in asymptomatic children with elevated blood lead levels?

Screening for Elevated Blood Lead Levels in Pregnancy

1. Is there direct evidence that screening for elevated blood lead levels in asymptomatic pregnant women improves health outcomes (i.e., reduced cognitive problems in offspring and adverse perinatal outcomes)?
2. What is the accuracy of questionnaires or clinical prediction tools that identify pregnant women who have elevated blood lead levels?
3. What are the harms of screening for elevated blood lead levels (with or without screening questionnaires) in asymptomatic pregnant women?
4. a. Do counseling and nutritional interventions, residential lead hazard control techniques, or chelation therapy reduce blood lead levels in asymptomatic pregnant women with elevated blood lead levels?
    b. Do counseling and nutritional interventions, residential lead hazard control techniques, or chelation therapy reduce the rate of gestational hypertension in asymptomatic pregnant women with elevated blood lead levels?
5. Do counseling and nutritional interventions, residential lead hazard control techniques, or chelation therapy improve health outcomes in asymptomatic pregnant women with elevated blood lead levels?
6. What are the harms of interventions in asymptomatic pregnant women with elevated blood lead levels?

Draft: Proposed Contextual Questions

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

Screening for Elevated Blood Lead Levels in Childhood

  1. What is the reliability of venous blood lead testing at various lead levels in children?
  2. What is the association between reduced blood lead levels and improved health outcomes in asymptomatic children with elevated blood lead levels?*
  3. Are there valid risk prediction tools available that identify communities at highest risk for lead exposure that could be used in primary care practices to target screening efforts in children?

Screening for Elevated Blood Lead Levels in Pregnancy

  1. What is the reliability of venous blood lead testing at various lead levels in pregnant women?
  2. What is the association between reduced blood lead levels and improved health outcomes in asymptomatic pregnant women with elevated blood lead levels?*
  3. Are there valid risk prediction tools available that identify communities at highest risk for lead exposure that could be used in primary care practices to target screening efforts in pregnant women?

*We will address these questions only if we find evidence from at least one randomized, controlled trial that eligible interventions are effective in reducing blood lead levels (key question 4) but no or limited evidence about whether screening or interventions improve eligible health outcomes (key questions 1 and 5, respectively).

Draft: Proposed Research Approaches

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions (KQs).

Screening for Elevated Blood Lead Levels in Childhood

  Include Exclude
Populations Asymptomatic children age ≤5 years All other populationsa
Screening tests KQs 1, 3: Measurement of blood lead level (using any method), with or without screening questionnaires or risk prediction tools

KQ 2a: Questionnaires or risk prediction tools that identify children who are more or less likely to have elevated blood lead levels (defined by a minimum threshold of 5 µg/dL)

KQ 2b: Measurement of blood lead levels using capillary blood sampling

All other screening tests
Interventions KQs 4–6: Studies assessing interventions aimed at reducing blood lead levels, including one or more of the following: counseling families to reduce lead exposure, nutritional interventions, residential hazard control techniques, and chelation therapy Policies, laws, or community-based interventions focused on the primary prevention of lead exposure
Comparisons KQs 1, 3: Screened vs. nonscreened groups

KQ 2a: Measurement of blood lead levels using venous blood sampling

KQ 2b: Studies on accuracy of capillary sampling to detect elevated blood lead levels must include a comparison with venous sampling; studies on reliability of capillary sampling must include measures of reproducibility (e.g., test-retest, interlaboratory agreement)

KQs 4–6: Treatment vs. placebo, inactive control, or no treatment

All other comparisons, including head-to-head comparisons of two different interventions
Outcomes KQs 1, 5: Validated measures of cognitive and neurobehavioral outcomes in children, including assessment of IQ or developmentb

KQ 2a: Sensitivity, specificity, discrimination, and calibration

KQ 2b: Sensitivity, specificity, and measures of reproducibility (e.g., test-retest, interlaboratory agreement)

KQ 3: Anxiety, distress, pain, or discomfort related to venous or capillary blood sampling; false-positive results or blood lead levels <5 µg/dL, leading to repeat testing, unnecessary treatment, or both

KQ 4: Blood lead levelsb

KQ 6: Anxiety or distress; inconvenience associated with intervention (e.g., school absenteeism associated with followup testing); morbidity attributed to chelation therapy (e.g., renal toxicity, sensitivity reactions)

All other outcomes, including measures of household lead dust
Study designs KQs 1, 4: RCTs

KQ 2a: Observational studies assessing the accuracy of screening questionnaires for predicting elevated blood lead levels

KQ 2b: Observational studies assessing the accuracy or reliability of capillary sampling to measure blood lead levels

KQ 3: RCTs, CCTs, and cohort studies

KQ 5: RCTs and CCTs

KQ 6: RCTs, CCTs, prospective cohort studies with a concurrent control group, and case-control studies

Systematic reviews,c case series, case reports, or comparison with historical controls
Quality Studies rated good or fair quality Studies rated poor quality
Clinical Setting All KQs: Settings applicable to U.S. primary care settings, including pediatric outpatient clinics, community health clinics, and school-based clinics

KQs 4–6: The above plus settings referable from primary care settings

All other settings, including community health case-finding (e.g., blood lead level monitoring after known environmental exposure)
Country Setting KQs 1–3: Research conducted in the United States or in populations similar to U.S. populations with services and interventions applicable to U.S. practice (i.e., countries with a United Nations Human Development Index of “very high”)

KQs 4–6: Any country

KQs 1–3: Research not relevant to the United States (i.e., countries not categorized as “very high” on the Human Development Index)
Language English language Languages other than English

Abbreviations: CCT = controlled clinical trial; RCT = randomized, controlled trial.

a Studies enrolling older children will be eligible if at least 50% of the sample is age ≤5 years or if studies report outcomes separately for children age ≤5 years.
b We will include outcomes measured in family members (e.g., siblings, pregnant women in the same household) who are subsequently identified as having elevated blood lead levels after the index family member was found to have an elevated blood lead level during screening.
c Systematic reviews are excluded from the evidence review. However, we will conduct a separate search to identify relevant systematic reviews published since the last review to ensure that our database searches have captured all relevant studies. We will describe any relevant systematic reviews in the Discussion section of the report.

Screening for Elevated Blood Lead Levels in Pregnancy

  Include Exclude
Populations All KQs: Asymptomatic pregnant women

KQ 2: Asymptomatic pregnant women and asymptomatic nonpregnant adults

All other populations
Screening tests KQs 1, 3: Measurement of blood lead level (using any method), with or without screening questionnaires or risk prediction tools

KQ 2: Questionnaires or risk prediction tools that identify adults who are more or less likely to have elevated blood lead levels (defined by a minimum threshold of 5 µg/dL)

All other screening tests
Interventions KQs 4–6: Studies assessing interventions aimed at reducing blood lead levels, including one or more of the following: counseling families to reduce lead exposure, nutritional interventions, residential hazard control techniques, and chelation therapy Policies, laws, or community-based interventions focused on the primary prevention of lead exposure
Comparisons KQs 1, 3: Screened vs. nonscreened groups

KQ 2a: Measurement of blood lead levels using venous sampling

KQs 4–6: Treatment vs. placebo, inactive control, or no treatment

All other comparisons, including head-to-head comparisons of two different interventions
Outcomes KQs 1, 5: Validated measures of cognitive and neurobehavioral outcomes in offspring, including assessment of IQ or development;a rates of adverse perinatal outcomes (e.g., premature birth, low birth weight, maternal morbidity and mortality)

KQ 2: Sensitivity, specificity, discrimination, and calibration

KQ 3: Anxiety or distress; false-positive results or blood lead levels <5 µg/dL, leading to repeat testing, unnecessary treatment, or both

KQ 4: Reduction in blood lead level;a reduction in gestational hypertension

KQ 5: Reduction in adverse perinatal outcomes and cognitive problems in offspring

KQ 6: Anxiety or distress; inconvenience associated with intervention (e.g., need for temporary housing due to home lead abatement, work absenteeism associated with followup testing and treatment); morbidity attributed to chelation therapy (e.g., renal toxicity, sensitivity reactions); adverse effects of nutritional supplements (e.g., nausea)

All other outcomes, including measures of household lead dust
Study designs KQs 1, 4: RCTs

KQ 2: Observational studies assessing the accuracy of screening questionnaires for predicting elevated blood lead levels

KQ 3: RCTs, CCTs, or prospective cohort studies

KQ 5: RCTs and CCTs

KQ 6: RCTs, CCTs, prospective cohort studies with a concurrent control group, and case-control studies

Systematic reviews,b case series, case reports, or comparison with historical controls
Quality Studies rated good or fair quality Studies rated poor quality
Clinical Setting All KQs: Settings applicable to U.S. primary care settings where women receive prenatal care, including obstetrics/gynecology outpatient and family medicine clinics

KQs 4–6: The above plus settings referable from primary care settings

All other settings, including community health case-finding (e.g., blood lead level monitoring after known environmental exposure)
Country Setting KQs 1–3: Research conducted in the United States or in populations similar to U.S. populations with services and interventions applicable to U.S. practice (i.e., countries with a United Nations Human Development Index of “very high”)

KQs 4–6: Any country

KQs 1–3: Research not relevant to the United States (i.e., countries not categorized as “very high” on the Human Development Index)
Language English language Languages other than English

Abbreviations: CCT = controlled clinical trial; RCT = randomized, controlled trial.

a We will include outcomes measured in family members (e.g. siblings, pregnant women in the same household) who are subsequently identified as having elevated blood lead levels after the index family member was found to have an elevated blood lead level during screening.
b Systematic reviews are excluded from the evidence review. However, we will conduct a separate search to identify relevant systematic reviews published since the last review to ensure that our database searches have captured all relevant studies. We will describe any relevant systematic reviews in the Discussion section of the report.

Current as of: June 2016

Internet Citation: Draft Research Plan: Elevated Blood Lead Levels in Childhood and Pregnancy: Screening. U.S. Preventive Services Task Force. June 2016.
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/elevated-blood-lead-levels-in-childhood-and-pregnancy-screening

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