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Final Research Plan
Final Research Plan for Iron Deficiency Anemia in Pregnant Women: Screening and Supplementation
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.

Preface
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.

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This Final Research Plan was available for comment from April 11 until May 8, 2013 at 5:00 p.m., ET.

Analytic Framework
Routine Iron Supplementation in Pregnant Women
Text Description.Screening for Iron Deficiency Anemia in Pregnant Women
Text Description. 

Key Questions to be Systematically Reviewed
Routine Iron Supplementation in Pregnant Women
What are the benefits of routine iron supplementation on maternal and infant intermediate and clinical health outcomes in pregnant women?
What are the harms of routine iron supplementation in pregnant women?
Screening for Iron Deficiency Anemia in Pregnant Women
What are the benefits of screening for iron deficiency anemia on maternal and infant morbidity, mortality, and quality of life in asymptomatic pregnant women?
What are the harms of screening for iron deficiency anemia in pregnant women?
What are the benefits of treatment for iron deficiency anemia on maternal and infant intermediate and clinical health outcomes in pregnant women?
What are the harms of iron treatment in pregnant women?

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

How well does risk assessment identify pregnant women who are at increased risk for iron deficiency anemia?
What is the yield (number of new diagnoses) of repeat (periodic) screening in asymptomatic pregnant women? At what timing intervals?
Research Approach
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).

Routine Iron Supplementation in Pregnant Women
PopulationsPregnant adolescents and women and their infantsSeverely malnourished populations that are not representative of those in the United States
InterventionsOral iron supplementation, iron-fortified foodsInjectable forms of iron
ComparatorsNo supplementation 
OutcomesKQ 1: Maternal outcomes: Caesarian section 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, hematologic indices and ferritin levels 
KQ 2: More serious harms; discontinuations; accidental overdoseKQ 2: Gastrointestinal outcomes
SettingsPrimary care relevant 
TimingKQ 1: Long-term
KQ 2: Short- or long-term 
Study DesignsKQ 1: Randomized, controlled trials; controlled cohort studies and other controlled observational studies 
KQ 2: Studies from KQ 1 and large uncontrolled observational studiesKQ 1: Uncontrolled studies
Screening for Iron Deficiency Anemia in Pregnant Women
PopulationsPregnant adolescents and women and their infants who are asymptomatic for iron deficiency anemiaSeverely malnourished populations that are not representative of those in the United States; those who are symptomatic for iron deficiency anemia
InterventionsKQs 1, 2: Screening for iron deficiency anemia 
KQs 3, 4: Oral iron supplementation, iron-fortified foodsInjectable forms of iron
ComparatorsKQs 1, 2: No screening for iron deficiency anemia 
KQs 3, 4: No treatment 
OutcomesKQs 1, 3: Maternal outcomes: Caesarian section rates, preterm delivery, postpartum depression
Infant outcomes: Low birth weight, preterm delivery, perinatal mortality, hematologic indices and ferritin levels
KQ 2: Overdiagnosis, anxiety, labeling. 
KQ 3: Maternal outcomes: Incidence of iron deficiency anemia; incidence of iron deficiency; hematologic indices and ferritin levels 
KQ 4: More serious harms; discontinuations and overtreatmentKQ 4: Gastrointestinal outcomes
SettingsPrimary care relevant 
TimingKQs 1, 3: Long-term 
KQs 2, 4: Short- or long-term 
Study DesignsKQs 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 studiesKQ 1, 3: Uncontrolled studies
 
 

Response to Public Comment
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.

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