U.S. Preventive Services Task Force

Draft Research Plan

Screening for Iron Deficiency Anemia in Childhood and Pregnancy

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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 Report will form the basis of the USPSTF Recommendation Statement on this topic.

This draft Research Plan is available for comment from April 11 until May 8, 2013 at 5:00 p.m., ET. You may wish to read the entire Research Plan before you comment.

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Note: In the screening analytic frameworks, Key Question 1 focuses on direct evidence on the effectiveness of screening for iron deficiency anemia in improving future health outcomes compared with not screening. Such direct evidence on the effectiveness of screening interventions may be limited. Therefore, the remainder of the analytic framework evaluates the chain of indirect evidence needed to link screening with improvement in important health outcomes. Links in the chain of indirect evidence include the effectiveness of iron treatment for reducing the incidence of future health outcomes and the harms associated with screening and treatments. Implicit in the indirect chain of evidence is that to understand the benefits and harms of screening, it is not sufficient to identify individuals who have iron deficiency anemia; it is also necessary to show that there are effective treatments for those identified. This rationale also applies to the routine supplementation analytic frameworks.

I. Proposed Analytic Framework for Routine Iron Supplementation in Children

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II. Proposed Analytic Framework for Screening for Iron Deficiency Anemia in Children

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III. Proposed Analytic Framework for Routine Iron Supplementation in Pregnant Women

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IV. Proposed Analytic Framework for Screening for Iron Deficiency Anemia in Pregnant Women

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V. Proposed Key Questions to Be Systematically Reviewed

Routine Iron Supplementation in Children

1. What are the benefits of routine iron supplementation in children ages 6 to 24 months on intermediate and clinical health outcomes?
2. What are the harms of routine iron supplementation in children ages 6 to 24 months?

Screening for Iron Deficiency Anemia in Children

1. What are the benefits of screening asymptomatic children ages 6 to 24 months for iron deficiency anemia on morbidity, mortality, and quality of life?
2. What are the harms of screening for iron deficiency anemia in children ages 6 to 24 months?
3. What are the benefits of treatment for iron deficiency anemia in children ages 6 to 24 months on intermediate and clinical health outcomes?
4. What are the harms of iron treatment in children ages 6 to 24 months?

Routine Iron Supplementation in Pregnant Women

1. What are the benefits of routine iron supplementation in pregnant women on maternal and infant intermediate and clinical health outcomes?
2. What are the harms of routine iron supplementation in pregnant women?

Screening for Iron Deficiency Anemia in Pregnant Women

1. What are the benefits of screening asymptomatic pregnant women for iron deficiency anemia on maternal and infant morbidity, mortality, and quality of life?
2. What are the harms of screening for iron deficiency anemia in pregnant women?
3. What are the benefits of treatment for iron deficiency anemia in pregnant women on maternal and infant intermediate and clinical health outcomes?
4. What are the harms of iron treatment in pregnant women?

VI. Proposed Contextual Questions

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

Screening for Iron Deficiency Anemia in Children

1. How well does risk assessment identify children at increased risk for iron deficiency anemia?

Screening for Iron Deficiency Anemia in Pregnant Women

1. How well does risk assessment identify pregnant women at increased risk for iron deficiency anemia?
2. What is the yield (number of new diagnoses) of repeat (periodic) screening in asymptomatic pregnant women, and at what timing intervals?

VII. Proposed Research Approach

The Proposed 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 Report. Criteria are overarching as well as specific to each of the key questions (KQs).

	Include	Exclude
Routine Iron Supplementation in Children
Populations	Children ages 6 to 24 months	Severely malnourished children not representative of those in the United States
Interventions	Oral iron supplementation, iron-fortified formulas and foods	Injectable forms of iron
Comparators	No supplementation
Outcomes	KQ 1: Morbidity (including cognitive, psychomotor, and neurodevelopmental outcomes, developmental delay), mortality, quality of life; incidence of iron deficiency anemia; incidence of iron deficiency; hematologic indices and ferritin levels KQ 2: More serious harms; discontinuations; accidental overdose	KQ 2: Gastrointestinal outcomes, etc.
Settings	Primary care relevant
Timing	KQ 1: Long-term KQ 2: Short- or long-term
Study Designs	KQ 1: Randomized, controlled trials, controlled cohort studies, and other controlled observational studies KQ 2: Studies from KQ 1 and large, uncontrolled observational studies	KQ 1: Uncontrolled studies
Screening for Iron Deficiency Anemia in Children
Populations	Asymptomatic children ages 6 to 24 months	Severely malnourished children not representative of those in the United States Children symptomatic for iron deficiency anemia Children younger than age 4 months or older than age 24 months
Interventions	KQs 1, 2: Screening for iron deficiency anemia KQs 3, 4: Oral iron supplementation, iron-fortified formulas and foods	Injectable forms of iron
Comparators	KQs 1, 2: No screening for iron deficiency anemia KQs 3, 4: No treatment
Outcomes	KQs 1, 3: Morbidity (including cognitive, psychomotor, and neurodevelopmental outcomes, developmental delay), mortality, quality of life KQ 2: Overdiagnosis, anxiety, labeling, etc. KQ 3: Incidence of iron deficiency anemia; incidence of iron deficiency; hematologic indices and ferritin levels KQ 4: More serious harms; discontinuations and overtreatment	KQ 4: Gastrointestinal outcomes, etc.
Settings	Primary care relevant
Timing	KQs 1, 3: Long-term KQs 2, 4: Short- or long-term
Study Designs	KQs 1, 3: Randomized, controlled trials, controlled cohort studies, and other controlled observational studies KQs 2, 4: Studies included from other KQs and large, uncontrolled observational studies	KQ 1, 3: Uncontrolled studies
Routine Iron Supplementation in Pregnant Women
Populations	Pregnant adolescents and women and their infants	Severely malnourished children not representative of those in the United States
Interventions	Oral iron supplementation, iron-fortified foods	Injectable forms of iron
Comparators	No supplementation
Outcomes	KQ 1: Maternal outcomes: Caesarian delivery rates, preterm delivery, postpartum depression; incidence of iron deficiency anemia; incidence of iron deficiency; hematologic indices and ferritin levels Infant outcomes: Low birth weight, preterm delivery, perinatal mortality KQ 2: More serious harms; discontinuations; accidental overdose	KQ 2: Gastrointestinal outcomes, etc.
Settings	Primary care relevant
Timing	KQ 1: Long-term KQ 2: Short- or long-term
Study Designs	KQ 1: Randomized, controlled trials, controlled cohort studies, and other controlled observational studies KQ 2: Studies from KQ 1 and large, uncontrolled observational studies	KQ 1: Uncontrolled studies
Screening for Iron Deficiency Anemia in Pregnant Women
Populations	Pregnant adolescents and women and their infants who are asymptomatic for iron deficiency anemia	Severely malnourished populations not representative of those in the United States Those symptomatic for iron deficiency anemia
Interventions	KQs 1, 2: Screening for iron deficiency anemia KQs 3, 4: Oral iron supplementation, iron-fortified foods	Injectable forms of iron
Comparators	KQs 1, 2: No screening for iron deficiency anemia KQs 3, 4: No treatment
Outcomes	KQs 1, 3: Maternal outcomes: Caesarian delivery rates, preterm delivery, postpartum depression KQ 3: Incidence of iron deficiency anemia; incidence of iron deficiency; hematologic indices and ferritin levels KQs 1, 3: Infant outcomes: Low birth weight, preterm delivery, perinatal mortality KQ 2: Overdiagnosis, anxiety, labeling, etc. KQ 4: More serious harms; discontinuations and overtreatment	KQ 4: Gastrointestinal outcomes, etc.
Settings	Primary care relevant
Timing	KQs 1, 3: Long-term KQs 2, 4: Short- or long-term
Study Designs	KQs 1, 3: Randomized, controlled trials, controlled cohort studies, and other controlled observational studies KQs 2, 4: Studies included from other KQs and large, uncontrolled observational studies	KQ 1, 3: Uncontrolled studies

AHRQ Publication No. 13-05187-EF-5
Current as of April 2013

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Internet Citation:

U.S. Preventive Services Task Force. Screening for Iron Deficiency Anemia in Childhood and Pregnancy: Draft Research Plan. AHRQ Publication No. 13-05187-EF-5. http://www.uspreventiveservicestaskforce.org/draftresplan.htm

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