Final Research Plan
Iron Deficiency Anemia in Young Children: Screening
July 18, 2013
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.
The final Research Plan is 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 Final Research Plan was available for comment from April 11 until May 8, 2013 at 5:00 p.m., ET.
Routine Iron Supplementation in Children
This analytic framework outlines the evidence areas covered in the review, including the population, routine supplementation, and outcomes, on a visual pathway. On the left side of the framework, the population includes all children ages 6 to 24 months. Initially, the framework assesses routine supplementation via an overarching arrow leading to the right side of the framework for the goal of reducing morbidity (including cognitive, psychomotor, and neurodevelopmental outcomes and developmental delay), mortality, and quality of life. Harms of routine supplementation are examined as an offshoot arrow. In the center of the framework is the intended goal for decreased iron deficiency anemia.
Screening for Iron Deficiency Anemia in Children
This analytic framework outlines the evidence areas covered in the review, including the population, routine supplementation, and outcomes, on a visual pathway. On the left side of the framework, the population includes all children ages 6 to 24 months. Initially, the framework assesses routine supplementation via an overarching arrow leading to the right side of the framework for the goal of reducing morbidity (including cognitive, psychomotor, and neurodevelopmental outcomes and developmental delay), mortality, and quality of life. Harms of routine supplementation are examined as an offshoot arrow. In the center of the framework is the intended goal for decreased iron deficiency anemia.
Routine Iron Supplementation in Children
- What are the benefits of routine iron supplementation on intermediate and clinical health outcomes in children ages 6 to 24 months?
- What are the harms of routine iron supplementation in children ages 6 to 24 months?
Screening for Iron Deficiency Anemia in Children
- What are the benefits of screening for iron deficiency anemia on morbidity, mortality, and quality of life in asymptomatic children ages 6 to 24 months?
- What are the harms of screening for iron deficiency anemia in children ages 6 to 24 months?
- What are the benefits of treatment for iron deficiency anemia on intermediate and clinical health outcomes in children ages 6 to 24 months?
- What are the harms of iron treatment in children ages 6 to 24 months?
- How well does risk assessment identify children who are at increased risk for iron deficiency anemia?
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 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 who are 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 |
| 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 who are not representative of those in the United States; children who are symptomatic for iron deficiency anemia; children ages <6 or >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 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 |
| 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 |
The draft Research Plan was posted for public comment on the U.S. Preventive Services Task Force (USPSTF) Web site from April 11 to May 8, 2013. A few comments requested clarification on the inclusion and exclusion criteria, analytic frameworks, and key questions related to populations, interventions, and outcomes. The Research Plan was revised in response to these comments. Some comments requested that the USPSTF consider assessing iron status and serum transferrin receptor concentration as additional outcomes. Iron status was added as an intermediate outcome in the analytic framework on routine iron supplementation in pregnant women; the other suggested outcome is not routinely used as a screening test in the United States and is therefore not in the scope of this review.